MARK 5 NUVO OCSI (M5C5), MODELS 505 AND 905

K040892 · Nidek Medical Products, Inc. · CAW · Apr 29, 2004 · Anesthesiology

Device Facts

• Record ID: K040892
• Device Name: MARK 5 NUVO OCSI (M5C5), MODELS 505 AND 905
• Applicant: Nidek Medical Products, Inc.
• Product Code: CAW · Anesthesiology
• Decision Date: Apr 29, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The proposed device is 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; uses pressure swing adsorption (PSA) to separate oxygen from ambient air. Piston-type compressor draws air through molecular sieve adsorbent; nitrogen retained; oxygen enriched gas released. Motorized rotary 4-way valve controls cycle; pressure relief valve prevents over-pressurization. Produces 90% ±3% oxygen concentration at 5 l/min ±10%. Includes oxygen concentration status indicator (OCSI) board to alert operator if concentration drops below set point. Used in clinical or home settings; operated by patients or caregivers under physician prescription. May be used with humidifiers, tubing, and nasal cannulas. Benefits patients by providing supplemental oxygen therapy.

Clinical Evidence

Bench testing only. Device validated against EN 60601-1-2:2001, IEC 60601-1-2:2001, UL 60601-1:2003, CAN/CSA-C22.2 No 601.1-M90, and ISO 8359 standards to ensure electrical safety, electromagnetic compatibility, and performance specifications.

Technological Characteristics

AC-powered oxygen concentrator; pressure swing adsorption (PSA) technology; molecular sieve adsorbent. Nominal output 90% ±3% O2 at 5 l/min. Weight ~50 lbs. Models: 115V/230V. Standards: EN 60601-1-2:2001, IEC 60601-1-2:2001, UL 60601-1:2003, CAN/CSA-C22.2 No 601.1-M90, ISO 8359. Includes OCSI board for concentration monitoring.

Indications for Use

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

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

• Mark 5 Nuvo (M5C5) Concentrator (K032509)

Submission Summary (Full Text)

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| 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. |
| Submission<br>Correspondent | Jennifer McWilliams, Quality Assurance Manager<br>Nidek Medical Products<br>3949 Valley East Industrial Drive<br>Birmingham, AL 35217<br>Phone [phone] ext. 215<br>Fax [phone]<br>[e-mail] |
| Date Prepared | April 2, 2004 |
| Proposed Device<br>Trade Name | Mark 5 Nuvo OCSI (M5C5) |
| 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(s) | Mark 5 Nuvo (M5C5) Concentrator<br>K032509<br>03/18/04 |
| 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 device is 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. |

:

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## 510(K) SUMMARY CONTINUED 6.0

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| 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 until they are released when<br>the pressure is vented to the atmosphere. This cycle is<br>controlled by a motorized rotary 4-way valve and protected<br>from over pressurization by the compressor's pressure relief<br>valve. The device provides a nominal oxygen enriched gas<br>concentration of 90% ±3% at a flow rate of 5 l/min ±10%.<br>The oxygen concentration status indicator (OCSI) board<br>controls the device status indicators including an operator<br>alert when the oxygen concentration in the product gas is<br>below the set point. It is not a life-supporting, life-sustaining<br>or sterile device. |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The proposed device is a durable, reusable, semi-portable<br>unit weighing approximately 50 pounds [23 kg]. The device<br>is available in both 115V and 230V models that have been<br>designed and validated according to applicable requirements<br>of EN 60601-1-2:2001, IEC 60601-1-2:2001, UL 60601-<br>1:2003, CAN/CSA-C22.2 No 601.1-M90 with A1 &<br>A2:1999, ISO 8359 and FDA Reviewer Guidance document<br>"Excerpts Related to EMI from November 1993" as<br>appropriate to the area of usage. |
| | 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 device is exactly the same as the predicate<br>device except the board configuration was modified to<br>incorporate an oxygen concentration status indicator (OCSI). |
| Nonclinical<br>Performance | The device was tested to applicable requirements EN 60601-<br>1-2:2001, IEC 60601-1-2:2001, UL 60601-1:2003,<br>CAN/CSA-C22.2 No 601.1-M90 with A1 & A2:1999, ISO<br>8359 and FDA Reviewer Guidance document "Excerpts<br>Related to EMI from November 1993" as appropriate to the<br>area of usage. |
| Conclusion | The proposed device is substantially equivalent to the legally<br>marketed predicate device. |

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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## APR 2 9 2004

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

Re: K040892

Trade Name: Mark 5 Nuvo OSCI (M5C5) Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: April 2, 2004 Received: April 6, 2004

Dear Ms. McWilliams:

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 interstatc 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.

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

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Page 2 - Ms. Jennifer McWilliams

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Declons of 2 vice as described in your Section 5 IV(k) I his letter will anow you to ocgin marketing your antial equivalence of your device to a legally premarket notification. The PDA miding of casion 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 If you desire specific advice for your act [phone]. Also, please note the regulation entitled, Comact the Office of Compinance an (est notification" (21CFR Part 807.97). You may obtain Misolahuilig by reference to promainsvisibilities under the Act from the Division of Small other general information on your responser Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Carl

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

Enclosure

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## INDICATIONS FOR USE 5.0

510(k) Number (if known):

Device Name:

Indications for Use:

The Mark 5 Nuvo OCSI (M5C5) Oxygen Concentrator is 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 Usc X (Part 21 CFR 801 Subpart D)

AND/OR

K040892

Mark 5 Nuvo OCSI (M5C5)

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)

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of Anesthesiology, General Hospital, Infection Control Dental

510(k) Number: K040892

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