NobleStitch EL

Basic Information

• Brand Name: NobleStitch EL
• Primary DI: M705129007
• Version / Model: 12-90-07
• Company Name: Heartstitch, Inc.
• Labeler DUNS: 080248116
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-05-25
• Public Version: 1
• Public Version Date: 2023-06-02
• Public Version Status: New
• Public Device Record Key: d74e082c-0ee4-40a4-8017-68951ffd838b

Device Description

The NobleStitch™ EL system deploys suture to close an open tissue site in the cardiovascular system, including Patent Foramen Ovale (PFO) closure. The NobleStitch™ EL system consists of two suture delivery devices (one identified as ‘S’, and one identified as ‘P’), and one accessory knot delivery device (identified as ‘KwiKnot™’). The devices work in harmony with each other to place sutures and a knot at the closure site. Also included with the system are other accessories that aid the user in the operation of the devices (accessories may vary). The NobleStitch™ EL suture delivery devices each utilize an arm that is preloaded with 4-0 non-absorbable polypropylene monofilament suture. The NobleStitch™ EL knot delivery ‘KwiKnot™’ device is preloaded with a non-absorbable polypropylene radiopaque knot. The devices do not require any suture or knot loading/manipulation prior to use. The NobleStitch™ EL system operates in the following manner: When a suture end is positioned by the NobleStitch™ EL S suture delivery device arm, a needle is deployed from the device; the deployed needle pierces the closure site tissue and engages the suture end located in the device arm. As the needle is then withdrawn from the arm it captures and retains the suture end. The retained suture end is drawn through the tissue and is retained at the tip of the retracted needle until removed by the user at the appropriate time. The opposite end of the same suture is then free to be removed from the device. The same process is then repeated for a second suture using the NobleStitch™ EL P suture delivery device. Both placed sutures (a total of four suture ends) are then threaded through the KwiKnot™ device. The KwiKnot™ device delivers and engages a two-piece knot to secure the suture at the closure site.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57874	Suturing unit, single-use	A non-powered, hand-held device intended to pass sutures or a needle/suture assembly through tissues/prosthetic materials to facilitate suturing during an endoscopic and/or open surgical procedure; it may also knot, cut and/or tighten the sutures/ligature loop during or after placement. It typically consists of a shaft with hooks, catches, clasps, or forceps-like jaws at the distal end, and a proximal handle with controls. It typically has a pointed/cutting component to create a suture tunnel, and is loaded with the sutures or the suture is inserted through the shaft. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M705129007	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	12	French

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 1 – 25 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry
• Type: Special Storage Condition, Specify
• Special Conditions: Keep out of direct sunlight