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.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Oxy-Serve II Oxygen Conserving Regulator. It focuses on demonstrating substantial equivalence to a predicate device through performance, mechanical, and environmental testing. However, the document does not contain the specific details required to fully address your request in the format of acceptance criteria and the study that proves the device meets them.

Here's a breakdown of what can and cannot be answered based on the provided text:

Information Present in the Document:

Device Name: Oxy-Serve II Oxygen Conserving Regulator
Predicate Device: K010747 - OPC Oxygen Conserving Regulator - Western Medica, Corp.
Performance Testing: The document states that "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." It also mentions "lab testing to have similar performance characteristics" and "passing extensive safety testing."
Conclusion: The device is deemed "substantially equivalent to the legally marketed predicate device and is safe and effective for its intended use."

Information NOT Present in the Document (and therefore cannot be provided in the table or detailed answers):

Specific Acceptance Criteria: The document mentions "performance criteria as intended" but does not define what those criteria are (e.g., flow rate accuracy, oxygen conservation percentage, pressure regulation ranges, environmental durability thresholds).
Reported Device Performance: While it states testing was done, it doesn't provide any quantitative or qualitative results from these tests. It simply says the device meets the criteria and has similar performance to the predicate.
Sample Size for Test Set: Not mentioned.
Data Provenance: Not mentioned (e.g., country of origin, retrospective/prospective).
Number of Experts Used: Not mentioned.
Qualifications of Experts: Not mentioned.
Adjudication Method: Not mentioned.
Multi-Reader Multi-Case (MRMC) Study: This type of study is typically relevant for interpretative devices (like AI in imaging) and is not applicable to a mechanical oxygen conserving regulator. Therefore, it was not done and an effect size cannot be provided.
Standalone Performance: Not explicitly detailed, though the "lab testing" implies an evaluation of the device itself.
Type of Ground Truth: Not explicitly detailed beyond "performance, mechanical, and environmental testing." For a mechanical device, ground truth would usually be established by calibrated measurement instruments against specifications.
Sample Size for Training Set: This is applicable to machine learning models, which this device is not.
How Ground Truth for Training Set was Established: Not applicable for this device.

Based on the available information, here is the closest response I can provide:

The document states that performance, mechanical, and environmental testing were conducted to ensure the Oxy-Serve II Oxygen Conserving Regulator meets its intended performance criteria and is substantially equivalent to the predicate device (K010747 - OPC Oxygen Conserving Regulator - Western Medica, Corp.).

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Meets all intended performance criteria (e.g., oxygen conservation, flow rate accuracy, pressure regulation, durability, safety, environmental tolerances based on predicate device).	The device "meets the performance criteria as intended" and "similar performance characteristics" to the predicate, and passed "extensive safety testing."

Note: Specific quantitative criteria and results are not provided in the submitted text. The acceptance criteria are inferred from the statement "to insure the device meets the performance criteria as intended."

2. Sample sized used for the test set and the data provenance

Sample Size: Not specified in the document.
Data Provenance: Not specified in the document. The testing was described as "lab testing."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable and not mentioned for a mechanical device; ground truth would typically be established by comparing device performance to engineering specifications using calibrated measurement equipment.

4. Adjudication method for the test set

Not applicable/mentioned for this type of mechanical device testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC study was not done. This type of study is relevant for interpretive medical devices (e.g., AI in radiology), not for a mechanical oxygen conserving regulator.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the "performance, mechanical, and environmental testing" would be considered standalone testing of the device itself, without human intervention in its core "performance" assessment (though human operators would conduct the test).

7. The type of ground truth used

The ground truth for this device's performance would be established through a comparison of the device's output (e.g., oxygen flow, conservation rate) against its design specifications and the performance characteristics of its predicate device, using calibrated measurement equipment. The document states it was proven through "lab testing."

8. The sample size for the training set

This is not applicable as the Oxy-Serve II is a mechanical device, not an AI/machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable for this type of device.

Summary

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SEP 2 1 2005

K051988

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:
1. 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:

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Indications for Use: 6.

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.

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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.

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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

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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.__

Page 1 of 1

Regulation Number and Section

§ 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).