(23 days)
No
The description details a mechanical process for oxygen concentration and a basic control board for status indication, with no mention of AI or ML technologies.
Yes
The device is solely intended for medical use in oxygen therapy programs, indicating its classification as a therapeutic device.
No
Explanation: The device is an oxygen concentrator used in oxygen therapy programs. Its function is to provide oxygen to a patient, not to diagnose a condition.
No
The device description clearly outlines a physical, AC-powered oxygen concentrator with mechanical components (compressor, valves) and an electronic control board (OCSI). It 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:
- Intended Use: The intended use clearly states it's for "oxygen therapy programs" and provides "a high level of inspired oxygen." This is a therapeutic use, not a diagnostic one.
- Device Description: The description details how it separates oxygen from ambient air and delivers it to the patient. This is a physical process for delivering a gas, not a test performed on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for 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.
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.
Product codes
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 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.
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
Not Found
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)
Nonclinical Performance: 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, ISO 8359 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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
| 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. |
| Submission
Correspondent | Jennifer McWilliams, Quality Assurance Manager
Nidek Medical Products
3949 Valley East Industrial Drive
Birmingham, AL 35217
Phone (205) 856-7200 ext. 215
Fax (205) 856-0533
jmcwilliams@nidekmedical.com |
| Date Prepared | April 2, 2004 |
| Proposed Device
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
K032509
03/18/04 |
| 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 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. |
:
1
510(K) SUMMARY CONTINUED 6.0
| 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 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. |
| Technological
Characteristics | 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). |
| Nonclinical
Performance | 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, ISO
8359 and FDA Reviewer Guidance document "Excerpts
Related to EMI from November 1993" as appropriate to the
area of usage. |
| Conclusion | The proposed device is substantially equivalent to the legally
marketed 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
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