(135 days)
NeuroMetrix ASCEND is a peripheral nerve stimulator used for localization and verification of needle placement for perineural application of pharmacological agents.
ASCEND is a battery powered peripheral nerve stimulator. This device is intended for localization and verification of needle placement for perineural application of pharmacological agents. ASCEND consists of the following components: Stimulator, Battery, Bluetooth, Charging Station.
This is a 510(k) premarket notification for the NeuroMetrix ASCEND, a peripheral nerve stimulator. 510(k) submissions typically demonstrate substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies with specific acceptance criteria and performance metrics described in your request for new devices.
Based on the provided text, the following information can be extracted or inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not contain a table of explicit acceptance criteria with quantitative performance metrics (e.g., sensitivity, specificity, accuracy) for the device's function. The submission focuses on demonstrating substantial equivalence to a predicate device based on similar intended use and technological characteristics.
2. Sample Size Used for the Test Set and Data Provenance:
No information regarding a "test set" with a specific sample size or data provenance (country of origin, retrospective/prospective) is provided. This type of data is usually part of clinical studies, which are not typically required for a 510(k) submission seeking substantial equivalence for this class of device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
No information regarding experts establishing ground truth is provided. This is generally associated with performance evaluations that are not part of this 510(k) submission.
4. Adjudication Method:
No adjudication method is mentioned as there is no described test set or performance evaluation requiring such a method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study is mentioned. This type of study would compare human reader performance with and without AI assistance, which is not relevant for a peripheral nerve stimulator that is not an AI-driven image analysis tool.
6. Standalone (Algorithm Only) Performance Study:
No standalone performance study is mentioned. The device is a stimulator, not an algorithm that performs analysis independently. Its function is to provide electrical stimulation for nerve localization.
7. Type of Ground Truth Used:
No specific "ground truth" (e.g., pathology, outcomes data) is mentioned in the context of a performance study. The substantial equivalence relies on the established efficacy and safety of the predicate device and the similar design and intended use of the new device.
8. Sample Size for the Training Set:
No training set or sample size for a training set is mentioned. This is applicable to machine learning or AI-based devices, which this stimulator is not.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as no training set is mentioned.
Summary of Device Acceptance and Study as Per 510(k) Submission:
The NeuroMetrix ASCEND device gained market clearance through a 510(k) Premarket Notification (K091155) by demonstrating substantial equivalence to a legally marketed predicate device, the Stockert GmbH Stimuplex HNS 12 (K052313).
The basis for acceptance was primarily the comparison of intended use, technological characteristics, and verification and validation testing.
- Intended Use: Both devices are used for "localization and verification of needle placement for perineural application of pharmacological agents."
- Technological Characteristics: The submission states that the "technological characteristics of the stimulator in ASCEND and the Stockert GmbH Stimuplex HNS 12 are the same or similar in specification."
- Verification and Validation Testing: The document mentions that "Based on the verification and validation testing presented, the comparison of ASCEND to the predicate supports a finding of substantial equivalence." (However, the details of this testing, specific metrics, or acceptance criteria within that testing are not elaborated in the provided text).
In essence, the "study" proving the device meets acceptance criteria is the comparison to the predicate device and the underlying engineering verification and validation testing to confirm that the new device functions as intended and safely, similar to the predicate. The FDA's decision to clear the device indicates that they found sufficient evidence of substantial equivalence to the predicate.
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SEP = 18 2009
13. 510(K) SUMMARY
510(k) Summary for NeuroMetrix ASCEND
1. SPONSOR
NeuroMetrix, Inc. 62 Fourth Avenue Waltham, MA 02451
| Contact Person: | Rainer Maas |
|---|---|
| Telephone: | (781) 314-2781 |
| Date Prepared: | August 17, 2009 |
DEVICE NAME 2.
| Proprietary Name: | ASCEND |
|---|---|
| Common/Usual Name: | Battery powered peripheral nerve stimulator |
| Classification Name: | 868.2775 BXN Electrical Peripheral Nerve Stimulator |
PREDICATE DEVICES 3.
Stockert GmbH Stimuplex HNS 12 (K052313) .
4. INTENDED USE
ASCEND is a peripheral nerve stimulator used for localization and verification of needle placement for perineural application of pharmacological agents.
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ત્ત્વ DEVICE DESCRIPTION
ASCEND is a battery powered peripheral nerve stimulator. This device is intended for localization and verification of needle placement for perineural application of pharmacological agents.
ASCEND consists of the following components:
5.1 Stimulator
The Stimulator contains the electronic circuitry and software required to electrically stimulate the peripheral nerve. It also contains other functionality such as the user interface.
5.2 Battery
The Stimulator is powered from a high capacity re-chargeable Li-polymer battery. The battery has a nominal voltage of 3.7 V DC and a maximum operating voltage range of 2.75 V to 4.2 V. Its rated capacity is 2140 mAh minimum, 2200 mAh typical. The battery has a built-in safety circuit. The battery is UL recognized.
5.3 Bluetooth
The Stimulator is equipped with a Bluetooth wireless module that provides serial communication between it and other devices.
The Bluetooth module is a Class 1 device that meets the Bluetooth v. 1.2 specifications utilizing the ISM frequency of 2.4 GHz with a variable output power maximum of 12 dBm. The module complies with FCC and CE Marking requirements.
5.4 Charging Station
The Charging Station is used to re-charge the Stimulator's Li-polymer battery.
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BASIS FOR SUBSTANTIAL EQUIVALENCE 6.
ASCEND, which is the subject of this 510(k) Premarket Notification, is substantially equivalent to the predicate Stockert GmbH Stimuplex HNS 12 as previously cleared for marketing. Both ASCEND and the Stockert Stimuplex HNS 12 are used for peripheral nerve localization based on electrical stimulation and have the same Indications for Use.
The technological characteristics of the stimulator in ASCEND and the Stockert GmbH Stimuplex HNS 12 are the same or similar in specification. Based on the verification and validation testing presented, the comparison of ASCEND to the predicate supports a . finding of substantial equivalence.
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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G6 Silver Spring, MD 20993-0002
Mr. Rainer Maas Director of Quality Assurance/Regulatory Affairs NeuroMetrix, Incorporated 62 Fourth Avenue Waltham, Massachusetts 02451
SEP - 3 2009
K091155 Re:
Trade/Device Name: ASCEND Regulation Number: 21 CFR 868.2775 Regulation Name: Electrical Peripheral nerve Stimulator Regulatory Class: II Product Code: BXN Dated: August 17, 2009 Received: August 19, 2009
Dear Mr. Maas:
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. 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.
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.
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Page 2 - Mr. Maas
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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
h for
Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known): Қо 9 // Г
Device Name: ASCEND
Intended Use:
NeuroMetrix ASCEND is a peripheral nerve stimulator used for localization and verification of needle placement for perineural application of pharmacological agents.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
L. Schult
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K091155
NeuroMetrix. Inc. ASC1:ND 510(k)
April 17. 2009
CONFIDENTIAL Page ix
§ 868.2775 Electrical peripheral nerve stimulator.
(a)
Identification. An electrical peripheral nerve stimulator (neuromuscular blockade monitor) is a device used to apply an electrical current to a patient to test the level of pharmacological effect of anesthetic drugs and gases.(b)
Classification. Class II (performance standards).