K Number
K082566
Device Name
MARK 5 NUVO LITE OCSI AND STD
Date Cleared
2008-12-03

(90 days)

Product Code
Regulation Number
868.5440
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
More Information

Not Found

No
The device description focuses on the physical and electronic components controlling the pressure swing adsorption process, with no mention of AI or ML algorithms for control, analysis, or prediction. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".

Yes
The device is used in oxygen therapy programs under the supervision of a physician, providing oxygen-enriched air for medical treatment.

No

The device is described as an AC powered device that provides a high level of inspired oxygen, intended for oxygen therapy programs. There is no mention of it being used to diagnose conditions or process diagnostic information.

No

The device description clearly outlines a physical, AC-powered device utilizing a compressor, molecular sieve adsorbent, electronic valve, and pressure relief valve to produce oxygen. It also mentions a printed circuit board controlling status indicators. This is a hardware device with embedded software, not a software-only medical device.

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
  • Device Function: The description clearly states the 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)." This is a device that delivers a gas to the body for therapeutic purposes.
  • Intended Use: The intended use is "solely for medical use in oxygen therapy programs under the supervision of a physician." This is a therapeutic application, not a diagnostic one involving testing bodily specimens.
  • Lack of Specimen Analysis: There is no mention of the device analyzing any bodily fluids, tissues, or other specimens.

Therefore, this device falls under the category of a therapeutic medical device, specifically an oxygen concentrator, and not an In Vitro Diagnostic.

N/A

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

CAW

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Under the supervision of a physician.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The device was tested to applicable requirements ISO 8359:1996, EN 60601-1-2:2001, IEC 60601-1:1988 + A1:1991 + A2:1995, UL 60601-1:2003, CAN/CSA-C22.2 No 601.1-M90, and FDA Reviewer Guidance document "Excerpts Related to EMI from November 1993" as appropriate to the area of usage.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K040892, K032509, K061261

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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).

0

K082566

DEC 0 3 2008

б 510(k) Summary

.

:

. . . . .

| 510(k) Summary | This summary of 510(k) safety and effectiveness information
is being submitted in accordance with the requirements of 21
CFR 807.92. |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Nidek Medical Products, Inc.
3949 Valley East Industrial Drive
Birmingham, AL 35217
Phone (205) 856-7200
Fax (205)856-0533 |
| Submission
Correspondent | Jennifer McWilliams
Quality Assurance Manager
Nidek Medical Products
jmcwilliams@nidekmedical.com
Phone (205) 856-7200 x215
Fax (205)856-0533 |
| Date Prepared | September 2, 2008 |
| Trade Name
Proposed Device #1
Proposed Device #2 | Mark 5 Nuvo Lite OCSI
Mark 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 concentrator
cleared under K040892 on April 29, 2004 |
| Predicate Device #2 | Nidek's Mark 5 Nuvo (M5C5) oxygen concentrator cleared
under K032509 on March 18, 2004 |
| Predicate Device #3 | Respironics' Everflo L4 oxygen concentrator cleared under
K061261 on June 28, 2006 |
| Performance
Standards | No applicable mandatory performance standards or special
controls have been established for this device under section
514 of the Federal Food, Drug and Cosmetic Act. |
| Indications for Use | 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. |
| Technological
Characteristics | The proposed devices are substantially equivalent to the
predicate devices. The proposed device status indicators and
flow control utilize the same technology as currently used in
the Nidek Mark 5 Nuvo concentrators. The proposed
device's operating principle is the same as Respironic's LA
Everflo concentrator. |
| Nonclinical
Performance | The device was tested to applicable requirements ISO
8359:1996, EN 60601-1-2:2001, IEC 60601-1:1988 +
A1:1991 + A2:1995, UL 60601-1:2003, CAN/CSA-C22.2
No 601.1-M90, and FDA Reviewer Guidance document
"Excerpts Related to EMI from November 1993" as
appropriate to the area of usage. |
| Conclusion | The proposed devices are substantially equivalent to the
legally marketed predicate devices. |

1

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.

3

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

4

5 INDICATIONS FOR USE

510(k) Number (if known):

Device Names:

Mark 5 Nuvo Lite OCSI Mark 5 Nuvo Lite STD

Indications for Use:

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.

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

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