(90 days)
Not Found
No
The summary describes a transcutaneous nerve stimulator with fixed stimulation parameters set by a clinician, and the user can only adjust intensity. There is no mention of adaptive algorithms, learning from data, or any other characteristics typically associated with AI/ML. The performance study focuses on the clinical efficacy of the stimulation itself, not on the performance of any AI/ML component.
Yes
The device is intended to aid in the reduction of opioid withdrawal symptoms, which is a therapeutic purpose.
No
The device is a transcutaneous nerve field stimulator intended to aid in the reduction of opioid withdrawal symptoms by delivering electrical stimulation. It is not described as diagnosing a condition or disease.
No
The device description explicitly states that the system consists of three main hardware components: a disposable Earpiece, a Cable, and an External Pulse Generator (EPG). This indicates it is a hardware-based medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Sparrow Ascent Function: The Sparrow Ascent is a device that delivers electrical stimulation to the nerves on and around the ear. It is used on the patient's body to alleviate symptoms, not to analyze samples taken from the body.
The description clearly states its function is transcutaneous nerve field stimulation for the reduction of opioid withdrawal symptoms. This is a therapeutic device, not a diagnostic one.
N/A
Intended Use / Indications for Use
The Sparrow Ascent is a transcutaneous nerve field stimulator that is intended to be used in patients experiencing opioid withdrawal in conjunction with standard symptomatic medications and other therapies for opioid withdrawal symptoms under the supervision of trained clinical personnel.
Product codes
PZR
Device Description
The Sparrow Ascent 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 Sparrow Ascent 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. The Sparrow Ascent is to be used in clinical environments (e.g., doctor's office, clinics, rehab centers, and hospitals) and/or at home. Users of the subject device include adults experiencing opioid withdrawal symptoms. Stimulation parameters (i.e., the strength of stimulation) are set by the user's clinician, and users can only adjust stimulation intensity at home. The system consists of three main components 1) a disposable Earpiece, 2) a Cable, and 3) the External Pulse Generator (EPG).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
auricle (ear)
Indicated Patient Age Range
Adult
Intended User / Care Setting
trained clinical personnel.
clinical environments (e.g., doctor's office, clinics, rehab centers, and hospitals) and/or at home.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
A double blind, randomized, controlled, multi-center study was designed to assess the effectiveness of the Sparrow Therapy System. The study evaluated transcutaneous nerve stimulation (tAN) as a method to aid in the reduction of symptoms associated with opioid withdrawal.
The patient population included male and female participants, aged 18-65 with a history of dependence on prescriptive or non-prescriptive opioids. Subjects were enrolled at two US sites based on 90% power at alpha 0.05 for detecting a mean (+SD) reduction in clinical opiate withdrawal scale (COWS) of 17 (+7) points when compared to baseline values. At time of submission, a total of 23 participants were enrolled and 20 received tAN therapy. Study participants were randomized in a 1:1 ratio to one of two groups:
-
- active transcutaneous auricular neurostimulation (tAN) or
-
- delayed-active tAN
Participants in the active tAN group received tAN immediately whereas those in the delayed active tAN had their therapy turned on after a delay (inactive period). All participants were informed of their group assignment at the conclusion of the randomized, double blind period and all continued to receive active tAN throughout the five-day study.
- delayed-active tAN
The primary efficacy endpoint of this study was successful mean percent change in COWS score (defined as a ≥15% reduction) from baseline, 60 minutes after the start of active tAN therapy.
The secondary endpoints of the study included:
- Comparison of mean percent change in COWS score in delayed active tAN versus active tAN groups at 30 minutes
- Comparison of the proportion of participants with a clinically significant reduction in COWS score (defined as a 15% or greater reduction) in delayed-active tAN versus active tAN groups at 30 minutes
- Mean percent change in COWS score from baseline to 30 minutes after start of active tAN therapy
- Mean percent change in COWS score from baseline to 120 minutes after start of active tAN therapy
- Mean percent change in COWS score from baseline to Days 2 through 5 after start of active tAN therapy
Safety Endpoints included the prevalence of all adverse events (AEs), serious adverse events (SAEs), adverse device events (ADEs), serious adverse device effects (SADEs), unanticipated serious adverse device effects (USADEs), and device deficiencies.
Key Results:
Mean reduction in COWS score was 7.2 at 30 minutes and further reduced to 8.6 at 120 minutes. This reduction was further increased across days 2 through 5 with a 9.3-point reduction at Day 3 and a 13.1-point reduction at Day 5. The overall repeated measures ANOVA (RMANOVA) yielded significance and Bonferroni pairwise comparisons yielded significant differences at each time point when compared to baseline. At the conclusion of Day 1 (120 minutes), 93.8% of participants had a clinically significant reduction in COWS score. This increased to 100% on Day 2 and was sustained across Day 5. Therefore, the primary endpoint of this study (defined as a ≥15% reduction in COWS score) from baseline to 60 minutes after start of active tAN therapy was successfully met.
Key Metrics
Mean reduction in COWS score was 7.2 at 30 minutes and further reduced to 8.6 at 120 minutes. This reduction was further increased across days 2 through 5 with a 9.3-point reduction at Day 3 and a 13.1-point reduction at Day 5. At the conclusion of Day 1 (120 minutes), 93.8% of participants had a clinically significant reduction in COWS score. This increased to 100% on Day 2 and was sustained across Day 5.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5896 Percutaneous nerve stimulator for substance use disorders.
(a)
Identification. A percutaneous nerve stimulator for substance use disorders is a device that stimulates nerves percutaneously to aid in the reduction of withdrawal symptoms associated with substance use disorders.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The patient-contacting components of the device must be demonstrated to be biocompatible.
(2) Electromagnetic compatibility and electrical, mechanical, and thermal safety testing must be performed.
(3) Electrical performance testing of the device and electrodes must be conducted to validate the specified electrical output and duration of stimulation of the device.
(4) Software verification, validation, and hazard analysis must be performed.
(5) Sterility testing of the percutaneous components of the device must be performed.
(6) Shelf life testing must be performed to demonstrate continued sterility, package integrity, and device functionality over the specified shelf life.
(7) Labeling must include the following:
(i) A detailed summary of the device technical parameters;
(ii) A warning stating that the device is only for use on clean, intact skin;
(iii) Instructions for use, including placement of the device on the patient; and
(iv) A shelf life.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 20, 2023
Spark Biomedical, Inc. % Allison Komiyama, PhD VP of MedTech Innovation Ram+ 2251 San Diego Avenue, Suite B-257 San Diego, California 92110
Re: K230796
Trade/Device Name: Sparrow Ascent Regulation Number: 21 CFR 882.5896 Regulation Name: Percutaneous nerve stimulator for substance use disorders Regulatory Class: Class II Product Code: PZR Dated: March 22, 2023 Received: March 22, 2023
Dear Dr Komiyama:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Doe W. Kumsa -S (Affiliate)
for Pamela Scott
Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K230796
Device Name Sparrow Ascent
Indications for Use (Describe)
The Sparrow Ascent is a transcutaneous nerve field stimulator that is intended to be used in patients experiencing opioid withdrawal in conjunction with standard symptomatic medications and other therapies for opioid withdrawal symptoms under the supervision of trained clinical personnel.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image contains the logo for Spark Biomedical. The logo consists of a hexagon made up of six triangles in alternating colors of orange, teal, and dark blue. To the right of the hexagon is the word "SPARK" in orange, block letters, with the word "BIOMEDICAL" in smaller, gray letters underneath.
DATE PREPARED
June 20, 2023
MANUFACTURER AND 510(k) OWNER
Spark Biomedical, Inc. 18208 Preston Road, Suite D9 531, Dallas, TX 75252 Telephone: +1 (844) 654-7775 Official Contact: Brent Croft, VP of Quality & Regulatory
REPRESENTATIVE/CONSULTANT
Allison C. Komiyama, Ph.D., RAC Erin A. Gontang, Ph.D. RQM+ Telephone: +1 (412) 816-8253 Email: akomiyama@rqmplus.com, egontang@rqmplus.com
DEVICE INFORMATION
| Proprietary Name/Trade Name: | Sparrow Ascent |
|---|---|
| Common Name: | Percutaneous Nerve Stimulator For Opioid Withdrawal |
| Classification Name | Percutaneous nerve stimulator for substance use disorders |
| Regulation Number: | 21 CFR 882.5896 |
| Class: | Class II |
| Product Code: | PZR |
| Premarket Review: | Neurological and Physical Medicine Devices (OHT5) |
| Neuromodulation and Rehabilitation Devices (DHT5B) | |
| Review Panel: | Neurology |
EXISTING DEVICE IDENTIFICATION
The Sparrow Ascent is substantially equivalent to the following predicate:
| 510(k) Number | Predicate Device Name / Manufacturer | Primary Predicate |
|---|---|---|
| K201873 | Sparrow Therapy System / Spark Biomedical, Inc. | ✓ |
The predicate device has not been subject to a design related recall.
DEVICE DESCRIPTION
The Sparrow Ascent 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.
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Image /page/4/Picture/0 description: The image shows the logo for Spark Biomedical. The logo consists of a hexagon made up of six triangles, colored in orange, teal, and blue. To the right of the hexagon is the word "SPARK" in orange, with the word "BIOMEDICAL" in a smaller font below it in gray.
The Sparrow Ascent 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. The Sparrow Ascent is to be used in clinical environments (e.g., doctor's office, clinics, rehab centers, and hospitals) and/or at home. Users of the subject device include adults experiencing opioid withdrawal symptoms. Stimulation parameters (i.e., the strength of stimulation) are set by the user's clinician, and users can only adjust stimulation intensity at home. The system consists of three main components 1) a disposable Earpiece, 2) a Cable, and 3) the External Pulse Generator (EPG).
INDICATIONS FOR USE
The Sparrow Ascent is a transcutaneous nerve field stimulator that is intended to be used in patients experiencing opioid withdrawal in conjunction with standard symptomatic medications and other therapies for opioid withdrawal symptoms under the supervision of trained clinical personnel.
COMPARISON OF INDICATIONS FOR USE STATEMENT
The Indications for Use statements of the subject device and the predicate device are identical. The intended use of both devices, to reduce the signs and symptoms associated with opioid withdrawal, is the same.
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Image /page/5/Picture/0 description: The image contains the logo for Spark Biomedical. The logo consists of a hexagon made up of six triangles in alternating colors of orange and teal. To the right of the hexagon is the word "SPARK" in orange, block letters. Below "SPARK" is the word "BIOMEDICAL" in smaller, black, block letters.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
Spark Biomedical, Inc. believes that the Sparrow Ascent is substantially equivalent to the predicate device based on the information summarized here:
The subject device has the same intended use and similar technological characteristics as the device cleared in K201873. Identical to the device cleared in K201873, the subject device is designed to deliver stimulation transcutaneously. The Sparrow Ascent has undergone nonclinical testing to ensure that any differences in technological characteristics (i.e., design) do not affect safety and effectiveness when compared to the predicate device. The Sparrow Ascent leverages prior clinical testing of the predicate device to help demonstrate effectiveness of the subject device.
| Subject Device | Primary Predicate | Comparison | |
|---|---|---|---|
| Indications for Use | The Sparrow Ascent is a | ||
| transcutaneous nerve | |||
| field stimulator that is | |||
| intended to be used in | |||
| patients experiencing | |||
| opioid withdrawal in | |||
| conjunction with | |||
| standard symptomatic | |||
| medications and other | |||
| therapies for opioid | |||
| withdrawal symptoms | |||
| under the supervision of | |||
| trained clinical personnel. | The Sparrow Therapy | ||
| System is a | |||
| transcutaneous nerve field | |||
| stimulator that is intended | |||
| to be used in patients | |||
| experiencing opioid | |||
| withdrawal in conjunction | |||
| with standard | |||
| symptomatic medications | |||
| and other therapies for | |||
| opioid withdrawal | |||
| symptoms under the | |||
| supervision of trained | |||
| clinical personnel. | Identical | ||
| Product Code / | |||
| Regulation | PZR / 21 CF 882.5846 | PZR / 21 CF 882.5846 | Identical |
| Patient Population | Adult | Adult | Identical |
| Maximum Voltage | |||
| (V) | 2.5 @ 500 Ω | ||
| 10 @ 2K Ω | |||
| 50 @ 10K Ω | 2.5 @ 500 Ω | ||
| 10 @ 2K Ω | |||
| 50 @ 10K Ω | Identical | ||
| Maximum Current | |||
| (mA) | 5.0 @ 500 Ω | ||
| 5.0 @ 2K Ω | |||
| 5.0 @ 10K Ω | 5.0 @ 500 Ω | ||
| 5.0 @ 2K Ω | |||
| 5.0 @ 10K Ω | Identical | ||
| Maximum Pulse | |||
| Width (µs) | 750 | 750 | Identical |
| Maximum Frequency | |||
| (Hz) | 150 | 150 | Identical |
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Image /page/6/Picture/1 description: The image contains the logo for Spark Biomedical. The logo consists of a hexagon made up of six triangles in the colors orange, teal, and blue. To the right of the hexagon is the word "SPARK" in orange, block letters. Below the word "SPARK" is the word "BIOMEDICAL" in smaller, gray block letters.
SUMMARY OF NON-CLINICAL TESTING
The submission demonstrated compliance to the Special Controls per 21 CFR 882.5896. In addition to verification and validation testing of the Sparrow Ascent, the following tests were performed to support the clearance of K201873 and are applicable to the subject device.
Biocompatibility
- ISO 10993-1 Biological Evaluation Of Medical Devices Part 1: Evaluation And . Testing Within A Risk Management Process
- ISO 10993-5 Biological Evaluation Of Medical Devices Part 5: Tests For In Vitro . Cytotoxicity
- . ISO 10993-10 Biological Evaluation Of Medical Devices — Part 10: Tests For Skin Sensitization
- . ISO 10993-23 Biological Evaluation Of Medical Devices — Part 23: Tests For Irritation
- Supportive information from the RESTORE clinical study (please refer to the ● Summary of Clinical Testing section below for information that supports biocompatibility of the Earpiece)
Software Verification
- . IEC 62304 Medical Device Software — Software Lifecycle Processes
- ISO 14971 Medical Devices Application Of Risk Management To Medical Devices ●
Electromagnetic Compatibility and Electrical Safety
- . ANSI/AAMI 60601-1 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD) (Consolidated Text) (Includes ANSI/AAMI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012)
- . ANSI/AAMI 60601-1-11 Medical Electrical Equipment - Part 1-11: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment
- ANSI/AAMI/IEC 60601-1-2 Medical electrical equipment Part 1-2: General . requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
SUMMARY OF CLINICAL TESTING
Based on its technical performance and stimulation output data, no new clinical testing was required for the Sparrow Ascent. Clinical testing of the predicate device is summarized below.
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Image /page/7/Picture/0 description: The image contains the logo for Spark Biomedical. The logo consists of a hexagon made up of six triangles in alternating colors of orange and teal. To the right of the hexagon is the word "SPARK" in orange, block letters. Below "SPARK" is the word "BIOMEDICAL" in smaller, black, block letters.
A double blind, randomized, controlled, multi-center study was designed to assess the effectiveness of the Sparrow Therapy System. The study evaluated transcutaneous nerve stimulation (tAN) as a method to aid in the reduction of symptoms associated with opioid withdrawal.
The patient population included male and female participants, aged 18-65 with a history of dependence on prescriptive or non-prescriptive opioids. Subjects were enrolled at two US sites based on 90% power at alpha 0.05 for detecting a mean (+SD) reduction in clinical opiate withdrawal scale (COWS) of 17 (+7) points when compared to baseline values. At time of submission, a total of 23 participants were enrolled and 20 received tAN therapy. In brief, study participants were randomized in a 1:1 ratio to one of two groups:
-
- active transcutaneous auricular neurostimulation (tAN) or
-
- delayed-active tAN
Participants in the active tAN group received tAN immediately whereas those in the delayed active tAN had their therapy turned on after a delay (inactive period). All participants were informed of their group assignment at the conclusion of the randomized, double blind period and all continued to receive active tAN throughout the five-day study.
The primary efficacy endpoint of this study was successful mean percent change in COWS score (defined as a ≥15% reduction) from baseline, 60 minutes after the start of active tAN therapy.
The secondary endpoints of the study included:
- Comparison of mean percent change in COWS score in delayed active tAN versus active tAN groups at 30 minutes
- Comparison of the proportion of participants with a clinically significant reduction in COWS score (defined as a 15% or greater reduction) in delayed-active tAN versus active tAN groups at 30 minutes
- Mean percent change in COWS score from baseline to 30 minutes after start of active tAN therapy
- Mean percent change in COWS score from baseline to 120 minutes after start of active tAN therapy
- Mean percent change in COWS score from baseline to Days 2 through 5 after start of active tAN therapy
Safety Endpoints included the prevalence of all adverse events (AEs), serious adverse events (SAEs), adverse device events (ADEs), serious adverse device effects (SADEs), unanticipated serious adverse device effects (USADEs), and device deficiencies.
The clinical study demonstrated that the subject device met the primary endpoint. Subject demographics and baseline characteristics were similar to those reported in the publication
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Image /page/8/Picture/0 description: The image contains the logo for Spark Biomedical. The logo consists of a geometric shape on the left, resembling a stylized snowflake or star, with alternating teal and orange segments. To the right of the geometric shape, the word "SPARK" is written in large, bold, orange letters. Below "SPARK", the word "BIOMEDICAL" is written in smaller, gray letters.
reporting results from which the predicate device, the NSS-2 Bridge, was granted FDA clearance (DEN170018). In the publication, the average age at enrollment was 32.9 years, the proportion of male participants was 65% and the most commonly used opioid was heroin (68%). In the subject device study, the average age at enrollment was 35.5, the proportion of male participants was 65%, and the most commonly used opioid was heroin (89.5%) across all participants. In the NSS-2 Bridge study, the average baseline COWS score across all enrolled participants was 20.1. Similarly, the average baseline COWS score in the subject device study was 15.6. These values both correspond to moderate withdrawal symptoms. Also similar to the NSS-2 Bridge study, most patients fell into the moderate withdrawal category (72.6% in the predicate device study compared to 95% in the subject device study).
Mean reduction in COWS score was 7.2 at 30 minutes and further reduced to 8.6 at 120 minutes. This reduction was further increased across days 2 through 5 with a 9.3-point reduction at Day 3 and a 13.1-point reduction at Day 5. The overall repeated measures ANOVA (RMANOVA) yielded significance and Bonferroni pairwise comparisons yielded significant differences at each time point when compared to baseline. At the conclusion of Day 1 (120 minutes), 93.8% of participants had a clinically significant reduction in COWS score. This increased to 100% on Day 2 and was sustained across Day 5. Therefore, the primary endpoint of this study (defined as a ≥15% reduction in COWS score) from baseline to 60 minutes after start of active tAN therapy was successfully met.
Spark Biomedical has sponsored several additional clinical studies. One study in particular, the RESTORE Trial, is investigating whether Sparrow Ascent can improve relapse prevention in adults suffering from opioid use disorder. In 14 patients, who experienced a total of 943.6 hours of skin contact with an active Earpiece, there were no instances of adverse tissue reactions reported.
CONCLUSION
Based on non-clinical testing, it can be concluded that the subject device does not raise concerns of safety or effectiveness compared to the predicate device. The identical indications for use, and similar technological characteristics and performance characteristics for the proposed Sparrow Ascent demonstrate the subject device is substantially equivalent to the predicate device.