(223 days)
The device is intended to measure, amplify, and record physiological signals acquired from a patient for archival in a Sleep Study. The physiological signals are recorded and conditioned for analysis and display. The data may be analyzed in real-time or offline on dedicated polysomnography 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.
This device is intended for use on both adults and children only under the direction of a physician or qualified sleep technician.
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 only under the direction of a physician or qualified sleep technician.
This 510(k) summary for the Polysmith Sleep System (K062943) focuses on its substantial equivalence to predicate devices based on technological characteristics, safety, and performance standards, rather than clinical performance acceptance criteria based on a specific study. Therefore, much of the requested information regarding performance metrics, sample sizes, expert involvement, and ground truth types is not present in the provided document.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide specific quantitative acceptance criteria related to a device's diagnostic performance (e.g., sensitivity, specificity for detecting sleep disorders) or a study reporting such performance. Instead, the "acceptance criteria" are implied through compliance with various safety and industrial standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with IEC 601-1 subclause 56.3(c) (Electrode Lead Wires and Patient Cables) | Complies with IEC 601-1 subclause 56.3(c) |
| Compliance with UL 60601-1 | Complies with UL 60601-1 |
| Compliance with EN 60601-1 | Complies with EN 60601-1 |
| Compliance with EN 60601-1-4 | Complies with EN 60601-1-4 |
| Compliance with IEC 60601-2-26:2002 | Complies with IEC 60601-2-26:2002 |
| Compliance with IEC 60601-1-2:2001 | Complies with IEC 60601-1-2:2001 |
| Compliance with IEC 60601-1:1998 | Complies with IEC 60601-1:1998 |
| Compliance with CAN/CSA 22.2 No 601.1 M90 | Complies with CAN/CSA 22.2 No 601.1 M90 |
| Compliance with CAN/CSA-ISO13485:2003 | Complies with CAN/CSA-ISO13485:2003 |
| Compliance with 21 CFR Part 820 (Quality System Regulation) | Complies with 21 CFR Part 820 |
| Compliance with MDD: 93/42/EEC Annex II, IIa | Complies with MDD: 93/42/EEC Annex II, IIa (per manufacturer) |
| Compliance with CISPR 11 Group 1, Class B | Complies with CISPR 11 Group 1, Class B |
| Device designed by a company with a full quality system | Yes, implied by compliance with ISO13485 and 21 CFR 820 |
| Meets safety and performance criteria for Electrical Medical Device in EU | Yes, stated to be guaranteed by compliance with listed standards |
| Verification and validation according to product specifications | Verified and validated |
| Test criteria consist of standardized levels and internal product requirements | Yes, explicitly stated |
| Passing environmental and mechanical stress testing | Tests performed include environmental and mechanical stress |
| Passing electromagnetic immunity and emissions testing | Tests performed include electromagnetic immunity and emissions |
| Passing medical device safety testing | Tests performed include medical device safety |
| Software verified and validated according to device functionality | Software verified and validated |
| Test results confirm device is in accordance with specifications | Yes, stated |
| Class II protection against electric shock | Provides Class II protection |
| Degree of protection against ingress of water: IPX0 | IPX0 |
| Not sterile | Not sterile |
| Not suitable in presence of flammable anesthetic mixture | Not suitable in presence of flammable anesthetic mixture |
| Continuous mode of operation during normal conditions | Continuous mode of operation |
| Externally supplied by direct current source | Externally supplied by direct current source |
| Portable | Portable |
2. Sample size used for the test set and the data provenance
The document does not describe a clinical test set with a specific sample size. The testing described focuses on device safety, electrical performance, and compliance with standards, rather than a clinical validation study involving patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical test set requiring expert-established ground truth is described.
4. Adjudication method for the test set
Not applicable, for the same reason as above.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is described as an amplifier and recorder of physiological signals for use in Polysomnography (PSG) by a qualified sleep clinician to aid in diagnosis. It is not an AI-driven diagnostic tool intended to supercede or augment human reading in the way an MRMC study would evaluate. It is a data acquisition device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The device itself is not an algorithm performing diagnosis. It's a data capture system. Its "performance" is in accurately acquiring and conditioning physiological signals, not in interpreting them. That interpretation is explicitly stated to be done by a "qualified sleep clinician."
7. The type of ground truth used
For the safety and performance testing described, the "ground truth" would be the established requirements and limits set by the various industrial standards (e.g., maximum leakage current, electromagnetic interference limits, stress test resilience, accurate signal amplification).
8. The sample size for the training set
Not applicable. This document describes a medical device for data acquisition, not a machine learning model that requires a training set of data.
9. How the ground truth for the training set was established
Not applicable, for the same reason as above.
Summary of the Study Proving the Device Meets Acceptance Criteria:
The provided 510(k) summary does not detail a single "study" in the sense of a clinical performance trial. Instead, it describes a comprehensive set of engineering, safety, and quality assurance activities that collectively demonstrate the device's adherence to its specifications and relevant regulatory standards.
The "study" comprises:
- Voluntary Compliance with Industrial Standards: The device underwent testing to ensure compliance with a range of international and national standards for medical electrical equipment (e.g., UL 60601-1, EN 60601-1-4, IEC 60601-2-26, CAN/CSA 22.2 No 601.1 M90, CISPR 11). These standards cover aspects like electrical safety, electromagnetic compatibility, and specific requirements for EEG/PSG devices.
- Quality System Compliance: The manufacturer's adherence to 21 CFR Part 820 (Quality System Regulation) and CAN/CSA-ISO13485:2003 (Medical Devices Quality Management Systems) ensures that the device was designed, manufactured, and tested under a robust quality management framework.
- Verification and Validation Activities: The device was "verified and validated according to the product specifications." This included:
- Environmental and mechanical stress testing.
- Electromagnetic immunity and emissions testing.
- Medical device safety testing.
- Software verification and validation according to its functionality.
The overall conclusion is that "The test results confirm that the device is in accordance with its specifications," thereby meeting the implicit acceptance criteria set by these standards and internal product requirements for a device intended to measure, amplify, and record physiological signals for Polysomnography. The device's substantial equivalence to predicates was based on similar indications for use, intended use, and technological characteristics, as well as adherence to these safety and performance standards.
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Traditional 510(K) Notification Polysmith Sleep System
510(k) Summary
September 26, 2006
Name and Address of Applicant
Neurotronics, Inc. 102 NE 10 Avenue Ste. 5 Gainesville, FL, 32601
Phone: 352.372.9955 Fax 815.550.2871
Primary Contact
Jennifer Laine Hardware Design Manager 352.372.9955 ext. 302
Proprietary Name of Device
Polysmith Sleep System
Common Names of the Device
Polysomnography Monitoring System
Device Classification
The device is classified as a Class II device by the Neurology Panel under 21 CFR Part 882.1400 "Electroencephalograph" : ી. ટે, OLV, DAA
Establishment Registration Number of Manufacturer
1063925
Legally Marketed Predicate
Nihon Kohden PSG Input Box, Model JE-912AK, cleared under 510(k), K022121 Polysmith cleared under 510(k), K971803
MAY - 9 2007
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Traditional 510(K) Notification Polysmith Sleep System
Summary of Technological Characteristics of Device Compared to Predicates
The device has similar indications for use and intended use as the predicate devices. Both systems sample, filter, amplify, and transfer biologic potentials critical in Sleep Studies to a personal computer running dedicated PSG software. They are both non-ambulatory devices and applicable to patients of all ages.
The energy source for both the device and predicates is equivalent. They receive power and ground via the USB port of a PC. Neither device makes physical contact with the patient; the patient-side electronics of both are electrically isolated from the computer mains.
Description
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 only 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 EEG, EOG, EMG, Respiration Effort, and SpO2. The data may be analyzed in real-time or offline on dedicated polysomnography 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 appea 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 601-1 subclause 56.3(c) as determined by 21 CFR Part 898: Performance Standard for Electrode Lead Wires and Patient Cables.
The device complies voluntarily with the following industrial standards:
UL 60601-1 EN 60601-1 EN 60601-1-4 IEC 60601-2-26:2002 IEC 60601-1-2:2001 IEC 60601-1:1998
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Traditional 510(K) Notification Polysmith Sleep System
CAN/CSA 22.2 No 601.1 M90 CAN/CSA-ISO13485:2003 21 CFR Part 820 MDD: 93/42/EEC Annex II, IIa (per manufacturer) CISPR 1 1 Group 1, Class B
These standards guarantee that the device was designed by a company possessing a full quality system and meets the safety and performance criteria required for an Electrical Medical Device in markets within the European Union. The device was verified and validated according to the product specifications. The test criteria consist 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 device. The test results confirm that the device is in accordance with its specifications.
Classification Criteria
- The device provides Class II protection against electric shock. .
- The device does not contact the patient directly but plugs into medical grade electrodes and ● probes which are electrically floating and at times have conductive contact with the skin of the patient. These accessories are legally marketed and sold in the United States.
- The degree of protection against the ingress of water is IPX0. .
- . The device is not sterile.
- . The use of the device is not suitable in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide.
- During normal operating conditions, the device is in a continuous mode of operation. .
- The device is externally supplied by a direct current source, and at times may supply non . harmful energy to the patient to monitor physiological processes.
- The device is portable. It may be moved while worn by the patient or between uses. .
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Neurotronics, Inc. c/o Ms. Dawn M. Lauryn Quality Manager 102 NE 10th Avenue, Suite 5 Gainesville, FL, 32601
Re: K062943 Trade/Device Name: Polysmith Sleep System Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLZ, OLV, DQA Dated (Date on orig SE ltr): February 8, 2007 Received (Date on orig SE ltr): February 8, 2007 APR - 9 2012
Dear Ms. Lauryn:
This letter corrects our substantially equivalent letter of May 9, 2007.
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 (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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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 vours.
Kesia Alexander
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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Indications for Use Statement
510(k) Number (if known):_
Device Name: Polysmith Sleep System
Indications for Use:
The device is intended to measure, amplify, and record physiological signals acquired from a patient for archival in a Sleep Study. The physiological signals are recorded and conditioned for analysis and display. The data may be analyzed in real-time or offline on dedicated polysomnography 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.
This device is intended for use on both adults and children only under the direction of a physician or qualified sleep technician.
| 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)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K062943
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).