VICTOR MODEL OCPR OXYGEN CONSERVING PRESSURE REGULATOR

K963247 · Thermadyne Holings Corp. · NFB · Nov 7, 1996 · Anesthesiology

Device Facts

• Record ID: K963247
• Device Name: VICTOR MODEL OCPR OXYGEN CONSERVING PRESSURE REGULATOR
• Applicant: Thermadyne Holings Corp.
• Product Code: NFB · Anesthesiology
• Decision Date: Nov 7, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Oxygen Conserving Pressure Regulator (OCPR) is a demand oxygen delivery system that delivers oxygen only during inspiration while providing oxygen saturations equivalent to steady flow. The OCPR extends the useful life of portable oxygen cylinders, increasing oxygen savings and cost savings.

Device Story

Oxygen Conserving Pressure Regulator (OCPR) functions as demand oxygen delivery system; connects to portable oxygen cylinders. Device senses patient inspiratory effort; triggers oxygen flow only during inspiration phase of breathing cycle. Operation results in reduced oxygen consumption compared to continuous flow; extends duration of portable oxygen supply. Used in clinical or home settings; operated by patients or caregivers. Healthcare providers use device to manage oxygen therapy efficiency; benefits include increased patient mobility due to longer cylinder life and reduced refill frequency.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Demand oxygen delivery system; mechanical pressure regulator; connects to portable oxygen cylinders. Operates via inspiratory flow sensing mechanism to gate oxygen delivery. No software or electronic components described.

Indications for Use

Indicated for patients requiring supplemental oxygen therapy who use portable oxygen cylinders. Device delivers oxygen on-demand during inspiration to maintain oxygen saturation levels equivalent to steady flow while extending cylinder duration.

Regulatory Classification

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

FEB 26 2002

Mr. R. Clark Sherwin, P.E.
Victor Equipment Company
P.O. Drawer 1007
Denton, TX 76202

Re: K963247
Oxygen Conserving Pressure Regulator
Regulation Number: 868.5905
Regulation Name: Noncontinuous Ventilator
Regulatory Class: II (two)
Product Code: 73 NFB

Dear Mr. Sherwin:

This letter corrects our substantially equivalent letter of November 7, 1996, regarding Oxygen Conserving Pressure Regulator. Our letter identified the product code as 73 BZD. This is in error; the correct product code is 73 NFB as indicated above.

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 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.

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Page 2 – Mr. R. Clark Sherwin, P.E.

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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control 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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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 and additionally 21 CFR Part 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,


Enclosure

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Page 1 of 1

510(k) Number (if known): K96 32 47

Device Name: Oxygen Conserving Pressure Regulator

Indications For Use:

INDICATIONS FOR USE: The Oxygen Conserving Pressure Regulator (OCPR) is a demand oxygen delivery system that delivers oxygen only during inspiration while providing oxygen saturations equivalent to steady flow. The OCPR extends the useful life of portable oxygen cylinders, increasing oxygen savings and cost savings.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Richard D. Phillips
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K963247

Prescription Use ☑ (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)