NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800

K092699 · Neurotronics, Inc. · GWL · Mar 18, 2010 · Neurology

Device Facts

• Record ID: K092699
• Device Name: NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800
• Applicant: Neurotronics, Inc.
• Product Code: GWL · Neurology
• Decision Date: Mar 18, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1835
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The device is intended to measure, amplify, and record physiological signals acquired from a patient for archival in a Sleep Study, such as Limb Movement, Body Position, Respiration fffort, and SpO2. The data may be analyzed in real-time or offline on dedicated polystemporably software running on a personal computer by a qualified sleep clinician to aid in the diagnosis of Sleep Disorders. This device, or any accessory, is not to be used alone as an apnea monitor or as a component in an apnea monitoring system. This device, or any accessory, is not to be used alone as a life support device or as a critical component of a life support system. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

Device Story

Nomad is a digital amplifier for polysomnography (PSG) or sleep studies; captures bio-potential signals including limb movement, body position, respiration effort, and SpO2. Device transfers raw physiological data to Polysmith software on a personal computer. Operated by qualified sleep clinicians or technicians in clinical settings; used under physician direction. Clinicians review recorded data to score polysomnograms and diagnose sleep disorders. Device does not directly contact patients; uses standard accessories (e.g., oximeter finger probes). Benefits include standardized signal acquisition for sleep disorder assessment.

Clinical Evidence

Bench testing only. Device underwent electromagnetic, environmental, mechanical stress, and medical device safety testing. Software functionality was verified and validated against product specifications. No clinical data required.

Technological Characteristics

Digital physiological signal amplifier. Connectivity: transfers data to PC via Polysmith software. Complies with IEC 60601-1 and 21 CFR 898 for electrode lead wires and patient cables. Non-sterile. Class II device.

Indications for Use

Indicated for adults and children requiring measurement, amplification, and recording of physiological signals (Limb Movement, Body Position, Respiration Effort, SpO2) for polysomnography/sleep studies to aid in sleep disorder diagnosis. Not for use as a standalone apnea monitor or life support system.

Regulatory Classification

Identification

A physiological signal amplifier is a general purpose device used to electrically amplify signals derived from various physiological sources (e.g., the electroencephalogram).

Predicate Devices

• Neurotronics Sphinx

Submission Summary (Full Text)

{0}------------------------------------------------

K092699

#### 510(K) SUMMARY

## Name and Address of Applicant

Nomad is designed and distributed by: Neurotronics®, Inc. 912 NE 2nd Street Gainesville, FL, 32601 Phone.: [phone]

Contact Information:

James Schubert Vice President Tel: [phone] Ext. 309 Email: [e-mail]

Fax: [phone]

#### Indications for Use:

The Nomad device is a digital amplifier capable of measuring bio-potential signals that may be incorporated into a Polysomnogram.

The device is intended to measure, amplify, and record physiological signals acquired from a patient for archival in a Sleep Study, such as Limb Movement, Respiration Effort, and SpO2. The data may be analyzed on dedicated Polysomnography software running on a personal computer by a qualified sleep clinician to aid in the diagnosis of Sleep Ding on s

This device, or any associated accessories, is not to be used alone as an apnea monitor or as a component in an apnea monitoring system.

This device, or any associated accessories, is not to be used as a life support device or as a critical component of a life support system.

The device is not sterile.

The device does not directly contact patients. Accessories that contact patients, such as oximeter finger probe, are the same accessories used with other legally marketed products. Jan a oxime, good laboratory practice studies were not required per 21 CFR Part 58.

The device was subjected to electromagnetic, environmental, safety and performance testing. The results of validation and verification confirmed that the device performed within expected specifications. The risk evaluation also confirmed all the risks have been properly mitingted.

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

***** The device is substantially equivalent to the predicate as stated.

{1}------------------------------------------------

#### Description

្រី

ﺮﺓ ﺍﻟ

The device is intended to amplify and record physiologic potentials used for Polysomnography (PSG) or Sleep Studies. The bio-potentials are transferred to Polysmith polysomnography software running on a personal computer. Qualified practitioners use the information to score Polysomnograms and diagnose Sleep Disorders. The device is intended for use on both adults and children under the direction of a physician or qualified sleep technician.

#### Intended Use

The device is intended to measure, amplify, and record physiological signals acquired from a patient for archival in a Sleep Study, such as Limb Movement, Body Position, Respiration fffort, and SpO2. The data may be analyzed in real-time or offline on dedicated polystemporably software running on a personal computer by a qualified sleep clinician to aid in the diagnosis of Sleep Disorders.

This device, or any accessory, is not to be used alone as an apnea monitor or as a component in an apnea monitoring system.

This device, or any accessory, is not to be used alone as a life support device or as a critical component of a life support system.

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

#### Performance and Safety Testing

The accessories of the device comply with IEC 60601-1 Subclause 56.3(c) as determined by 21 CFR Part 898: Performance Standard for Electrode Lead Wires and Patient Cables.

The device was verified and validated according to the product specifications. The test criteria consists of standardized levels and internal product requirements. Tests performed on the device include environmental and mechanical stress testing, electromagnetic immunity and emissions. testing, and medical device safety testing. Software on the device was verified and validated according to the functionality of the operations of the device. The test results confirm that the device is in accordance with its specifications.

### STATEMENT OF SUBSTANTIAL EQUIVALENCE

Based on the statements made above, the device and the predicates have the same intended use, the same principles of operation, similar physical/functional descriptions, and equivalent voluntary standards.

Therefore, Neurotronics, Inc. believes that the Nomad is substantially equivalent to the predicate device, the Neurotronics Sphinx.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight. The symbol is composed of three curved lines that converge at the bottom.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

# MAR 1 8 2010

Neurotronics®, Inc. c/o Mr. James Schubert Vice President 912 NE 2nd Street Gainesville, FL 32601

Re: K092699

Trade/Device Name: NOMAD, Polysmith Sleep System Regulation Number: 21 CFR 882.1835 Regulation Name: Physiological Signal Amplifier Regulatory Class: Class II Product Code: GWL, MNR, and DQA Dated: February 12, 2010 Received: February 12, 2010

Dear Mr. Schubert:

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. 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.

{3}------------------------------------------------

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/MedicalDevices/Safety/ReportalProblem/default.htm 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Neurotronics Special 510(k)

#### G. Indications for Use Statement

K092699 510(k) Number (if known): _

Device Name: NOMAD, Polysmith Sleep System

Indications for Use:

The Nomad device is a digital amplifier capable of measuring bio-potential signals that may be incorporated into a Polysomnogram.

The device is intended to measure, amplify, and record physiological signals acquired from a patient for archival in a Sleep Study, such as Limb Movement, Respiration Effort, and SpO2. The data may be analyzed on dedicated polysomnography software running on a personal computer by a qualified sleep clinician to aid in the diagnosis of Sleep Disorders.

This device is not to be used alone as an apnea monitor or as a critical component in an apnea monitoring system.

This device is intended for use on both adults and children on the order of physician.

This device, or any accessory, is not to be used alone as a life support device or as a critical component of a life support system.

The device is not sterile.

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE

IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

JOE HUTTER

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

NOMAD

Page 8 of 28

510(k) Number K092699