The proposed devices are intended solely for medical use in oxygen therapy programs under the supervision of a physician. This device is available by prescription only and is not intended to support or sustain life.

Device Description

The proposed device is an AC powered device that provides a high level of inspired oxygen by separating oxygen from ambient air utilizing pressure swing adsorbers (PSA). Air is drawn into the device with a piston-type compressor and exposed to molecular sieve adsorbent that selectively retains nitrogen and other components that are released when the pressure is vented to the atmosphere. This cycle is controlled by an electronic valve and protected from over pressurization by the compressor's pressure relief valve. The device provides a nominal oxygen enriched gas concentration of 90% +6.5%/-3% at a flow rate of 5 l/min ±10%. The proposed device is a durable, reusable, semi-portable unit weighing approximately 32 pounds [14.5 kg]. The device is available in both 115V and 230V models.

The device status indicators are controlled by a printed circuit board which is device model specific. For the OCSI model, device status indicators are mains power and oxygen concentration. For the STD model, device status indicators are mains power and system pressure.

The proposed device is not life supporting, life sustaining or sterile.

The proposed device may be used with one of the many legally marketed humidifiers, connecting tubing and nasal cannula as prescribed. One of these devices may optionally be included with the device.

AI/ML Overview

The provided text describes a 510(k) summary for the Mark 5 Nuvo Lite OCSI and Mark 5 Nuvo Lite STD oxygen concentrators. The information primarily focuses on regulatory approval, device description, and substantial equivalence to predicate devices, rather than a detailed study reporting acceptance criteria and device performance in the manner typically seen for clinical outcome-based or AI/software device studies.

Therefore, many of the requested categories for a study proving device performance are not explicitly detailed in the provided documents.

Here's an analysis based on the available information:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Stated or Implied)	Reported Device Performance
Nominal oxygen enriched gas concentration: 90% +6.5%/-3%	The device provides a nominal oxygen enriched gas concentration of 90% +6.5%/-3% at a flow rate of 5 l/min ±10%. (This is a design specification and also the stated performance characteristic).
Flow rate: 5 l/min ±10%	The device provides a nominal oxygen enriched gas concentration of 90% +6.5%/-3% at a flow rate of 5 l/min ±10%. (This is a design specification and also the stated performance characteristic).
Weight: Approximately 32 pounds [14.5 kg]	The proposed device is a durable, reusable, semi-portable unit weighing approximately 32 pounds [14.5 kg]. (This is a design specification).
Compliance with ISO 8359:1996	The device was tested to applicable requirements ISO 8359:1996.
Compliance with EN 60601-1-2:2001	The device was tested to applicable requirements EN 60601-1-2:2001.
Compliance with IEC 60601-1:1988 + A1:1991 + A2:1995	The device was tested to applicable requirements IEC 60601-1:1988 + A1:1991 + A2:1995.
Compliance with UL 60601-1:2003	The device was tested to applicable requirements UL 60601-1:2003.
Compliance with CAN/CSA-C22.2 No 601.1-M90	The device was tested to applicable requirements CAN/CSA-C22.2 No 601.1-M90.
Compliance with FDA Reviewer Guidance document "Excerpts Related to EMI from November 1993"	The device was tested to applicable requirements of FDA Reviewer Guidance document "Excerpts Related to EMI from November 1993" as appropriate to the area of usage.
Substantial equivalence to predicate devices	The proposed devices are substantially equivalent to the legally marketed predicate devices (Nidek's Mark 5 Nuvo OCSI (K040892), Nidek's Mark 5 Nuvo (K032509), and Respironics' Everflo L4 (K061261)).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The provided document describes nonclinical performance testing primarily focused on compliance with recognized standards (ISO, EN, IEC, UL, CAN/CSA, FDA guidance for EMI). It does not detail specific "test sets" or "data provenance" in the context of clinical studies with patient data. The testing mentioned would involve laboratory-based assessments of device specifications and safety standards, rather than tests on a "sample size" of patients or patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The document describes testing against engineering specifications and regulatory performance standards, not against expert-established ground truth from clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This type of adjudication is relevant for interpreting clinical data, particularly in medical imaging or diagnostic contexts. The testing here is for engineering performance and regulatory compliance.

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. The device is an oxygen concentrator, not an AI or diagnostic software.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The device is physical hardware (an oxygen concentrator), not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is based on engineering specifications, direct measurements of oxygen concentration and flow rate, and compliance with established national and international safety and performance standards for medical electrical equipment and oxygen concentrators. There is no biological "ground truth" in the clinical sense mentioned.

8. The sample size for the training set

Not applicable. This device does not use a "training set" in the context of machine learning. The design and validation are based on engineering principles and regulatory standards.

9. How the ground truth for the training set was established

Not applicable.

Summary

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K082566

DEC 0 3 2008

б 510(k) Summary

. . . . .

510(k) Summary	This summary of 510(k) safety and effectiveness informationis being submitted in accordance with the requirements of 21CFR 807.92.
Submitter	Nidek Medical Products, Inc.3949 Valley East Industrial DriveBirmingham, AL 35217Phone (205) 856-7200Fax (205)856-0533
SubmissionCorrespondent	Jennifer McWilliamsQuality Assurance ManagerNidek Medical Productsjmcwilliams@nidekmedical.comPhone (205) 856-7200 x215Fax (205)856-0533
Date Prepared	September 2, 2008
Trade NameProposed Device #1Proposed Device #2	Mark 5 Nuvo Lite OCSIMark 5 Nuvo Lite STD
Common Name	Oxygen Concentrator or Generator
Classification Name	Generator, Oxygen Portable
Regulation Number	21CFR 868.5440
Class	II
Panel	Anesthesiology
Product Code	CAW
Predicate Device #1	Nidek's Mark 5 Nuvo OCSI (M5C5) oxygen concentratorcleared under K040892 on April 29, 2004
Predicate Device #2	Nidek's Mark 5 Nuvo (M5C5) oxygen concentrator clearedunder K032509 on March 18, 2004
Predicate Device #3	Respironics' Everflo L4 oxygen concentrator cleared underK061261 on June 28, 2006
PerformanceStandards	No applicable mandatory performance standards or specialcontrols have been established for this device under section514 of the Federal Food, Drug and Cosmetic Act.
Indications for Use	The proposed devices are intended solely for medical use inoxygen therapy programs under the supervision of aphysician. This device is available by prescription only andis not intended to support or sustain life.
Device Description	The proposed device is an AC powered device that providesa high level of inspired oxygen by separating oxygen fromambient air utilizing pressure swing adsorbers (PSA). Air isdrawn into the device with a piston-type compressor andexposed to molecular sieve adsorbent that selectively retainsnitrogen and other components that are released when thepressure is vented to the atmosphere. This cycle iscontrolled by an electronic valve and protected from overpressurization by the compressor's pressure relief valve.The device provides a nominal oxygen enriched gasconcentration of 90% +6.5%/-3% at a flow rate of 5 l/min±10%. The proposed device is a durable, reusable, semi-portable unit weighing approximately 32 pounds [14.5 kg].The device is available in both 115V and 230V models.
	The device status indicators are controlled by a printedcircuit board which is device model specific. For the OCSImodel, device status indicators are mains power and oxygenconcentration. For the STD model, device status indicatorsare mains power and system pressure.
	The proposed device is not life supporting, life sustaining orsterile.
	The proposed device may be used with one of the manylegally marketed humidifiers, connecting tubing and nasalcannula as prescribed. One of these devices may optionallybe included with the device.
TechnologicalCharacteristics	The proposed devices are substantially equivalent to thepredicate devices. The proposed device status indicators andflow control utilize the same technology as currently used inthe Nidek Mark 5 Nuvo concentrators. The proposeddevice's operating principle is the same as Respironic's LAEverflo concentrator.
NonclinicalPerformance	The device was tested to applicable requirements ISO8359:1996, EN 60601-1-2:2001, IEC 60601-1:1988 +A1:1991 + A2:1995, UL 60601-1:2003, CAN/CSA-C22.2No 601.1-M90, and FDA Reviewer Guidance document"Excerpts Related to EMI from November 1993" asappropriate to the area of usage.
Conclusion	The proposed devices are substantially equivalent to thelegally marketed predicate devices.

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б 510(k) SUMMARY CONTINUED

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services. The seal is circular with text around the perimeter. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA". In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 0 8 2008

Ms. Jennifer McWiliams Quality Assurance Manager Nidek Medical Products, Incorporated 3949 Valley East Industrial Drive Birmingham, Alabama 35217

Re: K082566

Trade/Device Name: Mark 5 Nuvo Lite OCSI Mark 5 Nuvo Lite STD Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: September 2, 2008 Received: September 4, 2008

Dear Ms. McWiliams:

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 such 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 - Ms. McWiliams

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Clu G

Chiu Lin. Ph.D. Director Division of Anesthesiology. General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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5 INDICATIONS FOR USE

510(k) Number (if known):

Device Names:

Mark 5 Nuvo Lite OCSI Mark 5 Nuvo Lite STD

Indications for Use:

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K082566

Page _ of _

Regulation Number and Section

§ 868.5440 Portable oxygen generator.

(a)
Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).(b)
Classification. Class II (performance standards).