MARK 5 NUVO LITE OCSI AND STD

K082566 · Nidek Medical Products, Inc. · CAW · Dec 3, 2008 · Anesthesiology

Device Facts

• Record ID: K082566
• Device Name: MARK 5 NUVO LITE OCSI AND STD
• Applicant: Nidek Medical Products, Inc.
• Product Code: CAW · Anesthesiology
• Decision Date: Dec 3, 2008
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 868.5440
• Device Class: Class 2
• Attributes: Therapeutic

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 Story

AC-powered oxygen concentrator; utilizes pressure swing adsorption (PSA) to separate oxygen from ambient air. Piston-type compressor draws air through molecular sieve adsorbent; nitrogen retained; oxygen-enriched gas (approx. 90%) output. Used in clinical or home settings; operated by patients or caregivers under physician prescription. Includes status indicators (mains power, oxygen concentration, or system pressure) controlled by model-specific printed circuit board. May be used with humidifiers, tubing, and nasal cannulas. Provides supplemental oxygen to improve patient respiratory status.

Clinical Evidence

Bench testing only. Device performance verified against ISO 8359:1996, EN 60601-1-2:2001, IEC 60601-1:1988 (plus amendments), UL 60601-1:2003, and CAN/CSA-C22.2 No 601.1-M90. No clinical data provided.

Technological Characteristics

AC-powered (115V/230V) oxygen concentrator; PSA technology using molecular sieve adsorbent. Piston-type compressor. Nominal output 90% (+6.5%/-3%) oxygen at 5 l/min. Weight ~14.5 kg. Status indicators (mains power, oxygen concentration/pressure) via PCB. Complies with ISO 8359, IEC 60601-1, and EMI guidance.

Indications for Use

Indicated for patients requiring oxygen therapy programs under physician supervision. Not for life support or life-sustaining use.

Regulatory Classification

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).

Predicate Devices

• Nidek's Mark 5 Nuvo OCSI (M5C5) oxygen concentrator (K040892)
• Nidek's Mark 5 Nuvo (M5C5) oxygen concentrator (K032509)
• Respironics' Everflo L4 oxygen concentrator (K061261)

Submission Summary (Full Text)

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

K082566

# DEC 0 3 2008

#### б 510(k) Summary

.

:

. . . . .

| 510(k) Summary | This summary of 510(k) safety and effectiveness information<br>is being submitted in accordance with the requirements of 21<br>CFR 807.92. |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Nidek Medical Products, Inc.<br>3949 Valley East Industrial Drive<br>Birmingham, AL 35217<br>Phone [phone]<br>Fax [phone] |
| Submission<br>Correspondent | Jennifer McWilliams<br>Quality Assurance Manager<br>Nidek Medical Products<br>[e-mail]<br>Phone [phone] x215<br>Fax [phone] |
| Date Prepared | September 2, 2008 |
| Trade Name<br>Proposed Device #1<br>Proposed Device #2 | Mark 5 Nuvo Lite OCSI<br>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<br>cleared under K040892 on April 29, 2004 |
| Predicate Device #2 | Nidek's Mark 5 Nuvo (M5C5) oxygen concentrator cleared<br>under K032509 on March 18, 2004 |
| Predicate Device #3 | Respironics' Everflo L4 oxygen concentrator cleared under<br>K061261 on June 28, 2006 |
| Performance<br>Standards | No applicable mandatory performance standards or special<br>controls have been established for this device under section<br>514 of the Federal Food, Drug and Cosmetic Act. |
| Indications for Use | The proposed devices are intended solely for medical use in<br>oxygen therapy programs under the supervision of a<br>physician. This device is available by prescription only and<br>is not intended to support or sustain life. |
| Device Description | The proposed device is an AC powered device that provides<br>a high level of inspired oxygen by separating oxygen from<br>ambient air utilizing pressure swing adsorbers (PSA). Air is<br>drawn into the device with a piston-type compressor and<br>exposed to molecular sieve adsorbent that selectively retains<br>nitrogen and other components that are released when the<br>pressure is vented to the atmosphere. This cycle is<br>controlled by an electronic valve and protected from over<br>pressurization by the compressor's pressure relief valve.<br>The device provides a nominal oxygen enriched gas<br>concentration of 90% +6.5%/-3% at a flow rate of 5 l/min<br>±10%. The proposed device is a durable, reusable, semi-<br>portable unit weighing approximately 32 pounds [14.5 kg].<br>The device is available in both 115V and 230V models. |
| | The device status indicators are controlled by a printed<br>circuit board which is device model specific. For the OCSI<br>model, device status indicators are mains power and oxygen<br>concentration. For the STD model, device status indicators<br>are mains power and system pressure. |
| | The proposed device is not life supporting, life sustaining or<br>sterile. |
| | The proposed device may be used with one of the many<br>legally marketed humidifiers, connecting tubing and nasal<br>cannula as prescribed. One of these devices may optionally<br>be included with the device. |
| Technological<br>Characteristics | The proposed devices are substantially equivalent to the<br>predicate devices. The proposed device status indicators and<br>flow control utilize the same technology as currently used in<br>the Nidek Mark 5 Nuvo concentrators. The proposed<br>device's operating principle is the same as Respironic's LA<br>Everflo concentrator. |
| Nonclinical<br>Performance | The device was tested to applicable requirements ISO<br>8359:1996, EN 60601-1-2:2001, IEC 60601-1:1988 +<br>A1:1991 + A2:1995, UL 60601-1:2003, CAN/CSA-C22.2<br>No 601.1-M90, and FDA Reviewer Guidance document<br>"Excerpts Related to EMI from November 1993" as<br>appropriate to the area of usage. |
| Conclusion | The proposed devices are substantially equivalent to the<br>legally marketed predicate devices. |

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

#### б 510(k) SUMMARY CONTINUED

.

.

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

:

:

:

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

### 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 [phone]. 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 [phone] or [phone] 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

Page **_ of _**