(23 days)
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.
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 until they are released when the pressure is vented to the atmosphere. This cycle is controlled by a motorized rotary 4-way valve and protected from over pressurization by the compressor's pressure relief valve. The device provides a nominal oxygen enriched gas concentration of 90% ±3% at a flow rate of 5 l/min ±10%. The oxygen concentration status indicator (OCSI) board controls the device status indicators including an operator alert when the oxygen concentration in the product gas is below the set point. It is not a life-supporting, life-sustaining or sterile device.
The proposed device is a durable, reusable, semi-portable unit weighing approximately 50 pounds [23 kg]. The device is available in both 115V and 230V models that have been designed and validated according to applicable requirements of EN 60601-1-2:2001, IEC 60601-1-2:2001, UL 60601-1:2003, CAN/CSA-C22.2 No 601.1-M90 with A1 & A2:1999, ISO 8359 and FDA Reviewer Guidance document "Excerpts Related to EMI from November 1993" as appropriate to the area of usage.
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.
The provided text is a 510(k) summary for the Nidek Medical Products, Inc. Mark 5 Nuvo OCSI (M5C5) Oxygen Concentrator. This document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.
This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Mark 5 Nuvo Concentrator K032509) by detailing the device description, technological characteristics, and nonclinical performance (compliance with various electrical and safety standards).
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Information on sample size, data provenance, number or qualifications of experts, or adjudication methods for a test set.
- Details about a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance study.
- The type of ground truth used, sample size for the training set, or how ground truth was established for the training set.
The core of this 510(k) is that the proposed device is "exactly the same as the predicate device except the board configuration was modified to incorporate an oxygen concentration status indicator (OCSI)." The performance claims revolve around the device providing a "nominal oxygen enriched gas concentration of 90% ±3% at a flow rate of 5 l/min ±10%" and the OCSI board controlling a "operator alert when the oxygen concentration in the product gas is below the set point." However, it does not present a specific study with defined acceptance criteria to quantitatively prove these performance metrics in the way your request describes. It primarily relies on compliance with existing safety and electrical standards and the substantial equivalence to the predicate device.
{0}------------------------------------------------
| 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. |
| SubmissionCorrespondent | Jennifer McWilliams, Quality Assurance ManagerNidek Medical Products3949 Valley East Industrial DriveBirmingham, AL 35217Phone (205) 856-7200 ext. 215Fax (205) 856-0533jmcwilliams@nidekmedical.com |
| Date Prepared | April 2, 2004 |
| Proposed DeviceTrade 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) ConcentratorK03250903/18/04 |
| 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 device is 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. |
:
{1}------------------------------------------------
510(K) SUMMARY CONTINUED 6.0
| 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 until they are released whenthe pressure is vented to the atmosphere. This cycle iscontrolled by a motorized rotary 4-way valve and protectedfrom over pressurization by the compressor's pressure reliefvalve. The device provides a nominal oxygen enriched gasconcentration of 90% ±3% at a flow rate of 5 l/min ±10%.The oxygen concentration status indicator (OCSI) boardcontrols the device status indicators including an operatoralert when the oxygen concentration in the product gas isbelow the set point. It is not a life-supporting, life-sustainingor sterile device. |
|---|---|
| The proposed device is a durable, reusable, semi-portableunit weighing approximately 50 pounds [23 kg]. The deviceis available in both 115V and 230V models that have beendesigned and validated according to applicable requirementsof EN 60601-1-2:2001, IEC 60601-1-2:2001, UL 60601-1:2003, CAN/CSA-C22.2 No 601.1-M90 with A1 &A2:1999, ISO 8359 and FDA Reviewer Guidance document"Excerpts Related to EMI from November 1993" asappropriate to the area of usage. | |
| 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 device is exactly the same as the predicatedevice except the board configuration was modified toincorporate an oxygen concentration status indicator (OCSI). |
| NonclinicalPerformance | The device was tested to applicable requirements EN 60601-1-2:2001, IEC 60601-1-2:2001, UL 60601-1:2003,CAN/CSA-C22.2 No 601.1-M90 with A1 & A2:1999, ISO8359 and FDA Reviewer Guidance document "ExcerptsRelated to EMI from November 1993" as appropriate to thearea of usage. |
| Conclusion | The proposed device is substantially equivalent to the legallymarketed predicate device. |
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with outstretched wings, rendered in a simple, abstract design.
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
{3}------------------------------------------------
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 (301) 594-4646. 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 (800) 638-2041 or (301) 443-6597 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
{4}------------------------------------------------
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
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)
fexlllm
of Anesthesiology, General Hospital, Infection Control Dental
510(k) Number: K040892
Page __ of
§ 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).