(61 days)
No
The device description explicitly states it is pneumatic and requires no electrical power source, and the mechanism for sensing inhalation is described as a sensing diaphragm, indicating a mechanical rather than AI/ML approach. There are no mentions of AI, ML, or related terms.
Yes.
The device is intended for ambulatory patients requiring prescribed oxygen administration, delivering oxygen during the inhalation cycle.
No
The device is an oxygen conserving regulator designed to deliver oxygen during the inhalation cycle. It does not perform any diagnostic function such as identifying a disease or condition.
No
The device description clearly states it is constructed of aluminum and brass, is pneumatic, and has physical components like a control knob and outlet ports, indicating it is a hardware device.
Based on the provided text, the Oxy-Serve II Oxygen Conserving Regulator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to deliver oxygen to ambulatory patients during inhalation. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a mechanical regulator that controls the flow of oxygen based on the patient's breathing cycle. It does not analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
Therefore, the Oxy-Serve II Oxygen Conserving Regulator falls under the category of a medical device used for respiratory support, not an IVD.
N/A
Intended Use / Indications for Use
The Oxy-Serve II Oxygen Conserving Regulator is intended as an oxygen conserving pressure regulator for ambulatory patients. The Conserving Regulator delivers a prescribed flow of oxygen only during the inhalation cycle, conserving oxygen during the exhalation cycle.
The Oxy-Serve II Oxygen Conserving Regulator is intended to be used in home, respiratory, pulmonary, and skilled care facilities by ambulatory patients who have been diagnosed as requiring and have been prescribed oxygen administration by a physician. The Conserver is used in conjunction with portable oxygen cylinders to extend the usable cylinder life by delivering oxygen only during the inhalation portion of the patients breathing cycle.
Product codes
NFB
Device Description
The Oxy-Serve II Oxygen Conserving Regulator is a high pressure oxygen regulator integrated with a conserving device to deliver oxygen during the inhalation phase of a patients breathing cycle, thereby extending the useful life of an oxygen cylinder.
The Oxy-Serve II is constructed of aluminum with brass high pressure chamber components. The device is pneumatic and requires no electrical power source. An indexable control knob selects from 11 flow rates ranging from 1 to 6 LPM in .5 LPM increments. Two outlet ports are connectable using a dual lumen cannula. One port senses the inhalation of the patient thus initiating the selected flow to the patient during the full inhalation cycle. Flow ceases at the end of the inhalation cycle. The second port delivers the oxygen.
The device can operate as a conserving regulator, or as a standard continuous flow regulator operable by sliding a switch on the face of the regulator housing. In continuous mode the sensing diaphragm control component is bypassed and a continuous flow of oxygen is delivered at the flow selected by the indexable control knob through the outlet port.
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
home, respiratory, pulmonary, and skilled care facilities
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 Oxy-Serve II Oxygen Conserving Regulator has been subjected to performance, mechanical, and environmental testing to insure the device meets the performance criteria as intended.
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
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).
0
SEP 2 1 2005
Image /page/0/Picture/2 description: The image shows the logo for Superior Products, Inc. The logo includes a diamond shape with the letters "S" and "P" inside. The text below the logo includes the company name, address, and phone and fax numbers. The address is 3786 Ridge Road Cleveland, Ohio 44144, and the phone number is (216) 651-9400.
510(k) SUMMARY
- Submitter Information: 1. Superior Products, Inc. 3786 Ridge Rd. Cleveland, Ohio 44144
| Contact Person: | Ronald Johnston |
|---|---|
| Phone | 216-651-9400 |
| Fax | 216-651-4071 |
- June 1, 2005 2. Date Prepared:
-
- Name of Device:
| Trade Name: | Oxy-Serve II Oxygen Conserving Regulator |
|---|---|
| Common Name: | Oxygen Conserver |
| Classification Name: | Non-continuous ventilator (IPPB), 21 CFR 868.5905 |
| Regulatory Class: | II (two) |
| Product Code: | NFB |
4. Predicate Device Information:
- K010747 - OPC Oxygen Conserving Regulator - Western Medica, Corp.
5. Device Description:
The Oxy-Serve II Oxygen Conserving Regulator is a high pressure oxygen regulator integrated with a conserving device to deliver oxygen during the inhalation phase of a patients breathing cycle, thereby extending the useful life of an oxygen cylinder.
The Oxy-Serve II is constructed of aluminum with brass high pressure chamber components. The device is pneumatic and requires no electrical power source. An indexable control knob selects from 11 flow rates ranging from 1 to 6 LPM in .5 LPM increments. Two outlet ports are connectable using a dual lumen cannula. One port senses the inhalation of the patient thus initiating the selected flow to the patient during the full inhalation cycle. Flow ceases at the end of the inhalation cycle. The second port delivers the oxygen.
The device can operate as a conserving regulator, or as a standard continuous flow regulator operable by sliding a switch on the face of the regulator housing. In continuous mode the sensing diaphragm control component is bypassed and a continuous flow of oxygen is delivered at the flow selected by the indexable control knob through the outlet port.
1
Indications for Use: 6.
The Oxy-Serve II Oxygen Conserving Regulator is intended as an oxygen conserving pressure regulator for ambulatory patients. The Conserving Regulator delivers a prescribed flow of oxygen only during the inhalation cycle, conserving oxygen during the exhalation cycle.
7. Intended Use:
The Oxy-Serve II Oxygen Conserving Regulator is intended to be used in home, respiratory, pulmonary, and skilled care facilities by ambulatory patients who have been diagnosed as requiring and have been prescribed oxygen administration by a physician. The Conserver is used in conjunction with portable oxygen cylinders to extend the usable cylinder life by delivering oxygen only during the inhalation portion of the patients breathing cycle.
8. Substantial Equivalence:
The Oxy-Serve II Oxygen Conserving Regulator is substantially equivalent to K010747 -OPC Oxygen Conserving Regulator - Western Medica. The device has the same technological characteristics (i.e., materials, energy source, mode of operation) as the predicate device and functions similarly through the use of a pressure regulator and flow sensing diaphragms to control the delivery of the oxygen.
ರಿ. Performance Testing:
The Oxy-Serve II Oxygen Conserving Regulator has been subjected to performance, mechanical, and environmental testing to insure the device meets the performance criteria as intended.
10. Conclusions:
The Oxy-Serve II Oxygen Conserving Regulator, having the same intended use as the predicate device, and having been proven through lab testing to have similar performance characteristics, as well as passing extensive safety testing, is substantially equivalent to the legally marketed predicate device and is safe and effective for its intended use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a stylized caduceus symbol. The caduceus is a staff with two snakes coiled around it, often associated with medicine and healthcare. The seal is simple and monochromatic.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 1 2005
Mr. Ronald Johnson Director of Engineering Superior Products, Incorporated 3786 Ridge Road Cleveland, Ohio 44144
Re: K051988
Trade/Device Name: Oxy-Serve II Oxygen Conserving Regulator Regulation Number: 21 CFR 868.5905 Regulation Name: Non-Continuous Ventilator (IPPB) Regulatory Class: II Product Code: NFB Dated: September 12, 2005 Received: September 13, 2005
Dear Mr. Johnston:
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 the Fouchar F USA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include controls 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 (1 wr 1) it is a may 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 – Mr. Johnston
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that I DA s issualited or a bour device complies with other requirements mean that IDA has made a decemand regulations administered by other Federal agencies. of the Act of ally rederal bate and rightenents, including, but not limited to: registration You must comply with an the Her Pier 801); good manufacturing practice allo listing (21 CFR Part 807), abolity systems (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality ajones of the moved 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) This letter will anow you to objail made of substantial equivalence of your device to a premits in the confication. The PDF 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), If you desire specific aurres for your at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division Inay other general meetiment on one Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chris
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
510(k) Number (if known): OS 1988
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Oxy-Serve II Oxygen Conserving Regulator is intended as an oxygen conserving The Oxy-Selve if Oxygon Ochserving Regulation Regulator delivers a pressure "regulator" for "announcery" parents" since "conserving oxygen during the exhalation cycle.
Prescription Use × (Per 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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Clur
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number.__
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