(197 days)
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.
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.
The Neurotronics® Nomad device is a digital amplifier designed to measure, amplify, and record physiological signals for Polysomnography (PSG) or Sleep Studies. It aids qualified sleep clinicians in diagnosing Sleep Disorders by allowing analysis of data such as Limb Movement, Respiration Effort, and SpO2. This device is not intended as an apnea monitor or life support device.
Here's an analysis of the provided information regarding acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document describes performance testing in general terms but does not present specific quantitative acceptance criteria values or detailed device performance metrics in a tabular format. Instead, it states that the device was verified and validated according to product specifications, and that test results confirmed the device is in accordance with its specifications.
| Acceptance Criteria Category | Acceptance Criteria (Specific Values) | Reported Device Performance (Specific Values) | Notes |
|---|---|---|---|
| General Performance | Device performs within expected specifications. | "The results of validation and verification confirmed that the device performed within expected specifications." | Broad statement; no specific quantifiable metrics provided. |
| Electromagnetic Compatibility (EMC) | Compliance with relevant EMC standards. | "Tests performed on the device include environmental and mechanical stress testing, electromagnetic immunity and emissions testing..." | Confirmed; no specific immunity levels or emission limits detailed. |
| Environmental & Mechanical Stress | Withstand specified environmental and mechanical conditions. | "...environmental and mechanical stress testing..." | Confirmed; no specific conditions or pass/fail criteria detailed. |
| Medical Device Safety | Compliance with relevant safety standards (e.g., IEC 60601-1). | "...medical device safety testing." | Confirmed; accessories comply with IEC 60601-1 Subclause 56.3(c). |
| Software Verification & Validation | Software functions according to operational requirements. | "Software on the device was verified and validated according to the functionality of the operations of the device." | Confirmed; no specific software test cases or pass rates provided. |
| Risk Evaluation | All identified risks are properly mitigated. | "The risk evaluation also confirmed all the risks have been properly mitigated." | Confirmed; no specific risk details or mitigation strategies provided. |
| Accessories Compliance | Accessories comply with 21 CFR Part 898 for electrode lead wires and patient cables. | "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." | Specific compliance stated for accessories. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a sample size for any clinical test set involving patient data. The performance and safety testing described pertains to device-level engineering and software verification/validation, not a clinical efficacy or performance study involving human subjects and diagnostic outcomes. There is no mention of data provenance (e.g., country of origin, retrospective or prospective) for a clinical test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Since no clinical test set involving human subjects for diagnostic accuracy is described, there is no information provided regarding the number of experts used or their qualifications for establishing ground truth. The device is a physiological signal amplifier, and its performance evaluation focused on its ability to accurately measure, amplify, and record signals, rather than its diagnostic capabilities per se.
4. Adjudication Method for the Test Set:
Given the nature of the described performance and safety testing (device-level engineering), an adjudication method for a clinical test set involving diagnostic outcomes is not applicable and not mentioned in the provided text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described. The document focuses on the device's technical performance and safety, and its substantial equivalence to a predicate device, rather than its impact on human reader performance.
6. If a Standalone (Algorithm Only) Performance Study Was Done:
The Nomad device is described as a "digital amplifier" that measures, amplifies, and records physiological signals. The data is then analyzed by "dedicated Polysomnography software" and "a qualified sleep clinician." The document does not describe a standalone algorithm (i.e., AI or automated interpretation) within the Nomad device that would require an "algorithm only" performance study. The device's role is to acquire data for human interpretation using separate software. So, no standalone algorithm performance study was described or performed as it's not applicable to this type of device.
7. Type of Ground Truth Used:
For the device's performance testing (environmental, mechanical, electromagnetic, safety, and software verification), the "ground truth" was established by engineering specifications, industry standards (e.g., IEC 60601-1, 21 CFR Part 898), and internal product requirements. There is no mention of expert consensus, pathology, or outcomes data as ground truth for such testing.
8. Sample Size for the Training Set:
Since the Nomad device is a physiological signal amplifier and not an AI/machine learning diagnostic algorithm in the context of the provided text, the concept of a "training set" in the context of AI models does not apply. The described testing refers to verification and validation of hardware and software functions. Therefore, no sample size for a training set is provided.
9. How the Ground Truth for the Training Set Was Established:
As there is no training set for an AI/machine learning model described, this question is not applicable. The ground truth for the device's technical specifications and compliance was based on established engineering principles, regulatory standards, and internal product definitions.
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510(K) SUMMARY
Name and Address of Applicant
Nomad is designed and distributed by: Neurotronics®, Inc. 912 NE 2nd Street Gainesville, FL, 32601 Phone.: 352.372.9955
Contact Information:
James Schubert Vice President Tel: 352.372.9955 Ext. 309 Email: James.schubert@neurotronics.com
Fax: 815.550.2871
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.
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Description
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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.
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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.
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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 (800) 638-2041 or (301) 796-7100 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
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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
§ 882.1835 Physiological signal amplifier.
(a)
Identification. A physiological signal amplifier is a general purpose device used to electrically amplify signals derived from various physiological sources (e.g., the electroencephalogram).(b)
Classification. Class II (performance standards).