Sparrow Ascent Replacement Kit

Basic Information

• Brand Name: Sparrow Ascent Replacement Kit
• Primary DI: 00850052017033
• Version / Model: 11-110-K
• Company Name: Spark Biomedical Inc.
• Labeler DUNS: 074715155
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-07
• Public Version: 2
• Public Version Date: 2023-10-18
• Public Version Status: Update
• Public Device Record Key: 47726a31-1fab-4646-be26-b1a5b18bc051

Device Description

Separate item for replacement. The Sparrow Ascent Patient Controller is a transcutaneous auricular neurostimulation (tAN) system intended to provide non-invasive, transcutaneous stimulation of the nerves on and/or around the auricle (ear). The device is indicated as an aid in the reduction of opioid withdrawal symptoms in adult patients. The Patient Controller is a battery operated, prescription device that delivers mild electrical stimulation to the nerves on and/or around the auricle (ear), which carry information to the central nervous system.

Device Characteristics

• Single Use: No
• 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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PZR	Percutaneous Nerve Stimulator For Opioid Withdrawal	Neurology	882.5896	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63321	Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator	A body-worn, electronic device intended to provide percutaneous electrical nerve field stimulation (PENFS) applied close to cranial/peripheral nerves around the external ear to achieve remote symptom relief mediated by central nervous system (CNS) pathways and structures [e.g., amygdala, spinal cord neurons]; depending on the treatment protocol and device settings it may be used for opioid withdrawal symptoms (e.g., bone/joint aches, tremor, anxiety), or irritable bowel syndrome [IBS]-associated functional abdominal pain (FAP). It consists of an electrical pulse generator with minimally-invasive electrodes, and accessories (e.g., adhesives, transilluminator). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850052017033	GS1

Premarket Submissions

Submission Number	Supplement Number
K230796	000