O2N DEMAND-II, VICTOR MODEL OCPR-II

K992659 · Thermadyne Holings Corp. · NFB · Sep 3, 1999 · Anesthesiology

Device Facts

• Record ID: K992659
• Device Name: O2N DEMAND-II, VICTOR MODEL OCPR-II
• Applicant: Thermadyne Holings Corp.
• Product Code: NFB · Anesthesiology
• Decision Date: Sep 3, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The O2n Demand-II is intended as an oxygen conserving pressure regulator for ambulatory patients. This is the same intended use as the predicated unit (K963247).

Device Story

The O2n Demand-II is an oxygen conserving pressure regulator designed for ambulatory patients. It functions by regulating oxygen flow from a supply source to the patient, conserving oxygen usage compared to continuous flow systems. The device is intended for use in ambulatory settings to support patients requiring supplemental oxygen. It operates as a mechanical pressure regulator; it does not utilize electronic sensors, software, or algorithms. The device is used by patients to manage oxygen delivery, potentially increasing the duration of oxygen supply and improving patient mobility.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical oxygen conserving pressure regulator. No electronic components, software, or external energy sources. Designed for ambulatory oxygen delivery.

Indications for Use

Indicated for ambulatory patients requiring oxygen therapy via an oxygen conserving pressure regulator.

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.

Predicate Devices

• K963247

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/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 an abstract symbol that resembles an eagle or bird in flight, composed of flowing lines. The image is in black and white.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 6 2002

Mr. Dick Langford Victor Equipment Company P.O. Drawer 1007 Denton, TX 76202

K992659 Re:

K992659
O2n Demand-II, Victor Model OCPR-II, and Oxygen Conserving Pressure Regulator-II (OCPR-II)

Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator Regulatory Class: II (two) Product Code: 73 NFB

Dear Mr. Langford:

This letter corrects our substantially equivalent letter of September 3 1999, regarding the This letter corrects our substantially equivalent news of onserving Pressure Regulator-II (OCPRO2n Demand-II, Victor Model OCPR-II, and Oxygen Conserving correct product co O2n Demand-II, Victor Model OCF X-II, and Oxygon Geller Ally
II). 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 We have reviewed your Section > IQ(x) prematice is substantially equivalent (for the indications
referenced above and have determined the device is substanted in interstate referenced above and have determined the devices marketed in interstate for use stated in the enclosure) it regally nianced tecalcal Device Amendments, or to
commerce prior to May 28, 1976, the enactment of the Federal Food. Drug. commerce prior to May 28, 1976, the enactinent and of the Federal Food, Drug, devices that have been reclassified in accordance was as archives and over of the Act. The and Cosmetic Act (Act) that do not require approvate or a provisions of the Act. The Act. The
You may, therefore, market the device, subject to the general construction f You may, therefore, market the device, subject to the gentlation, listing of
general controls provisions of the Act include requirements misbranding and general controls provisions of the Act mender requirement.
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 If your device is classified (see above) nito crain to as if ependations affecting your device can
may be subject to such additional controls. Existing major regulation FDA may be subject to such additional controls. Existing mays of 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 500 to 898. In addition be found in the Code of Federal Regalations, in the Federal Register.

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## Page 2 -- Mr. Dick Langford

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA \$ issualice of a succession with other requirements of the Act
that FDA has made a determination that your device complies with opension . You must that FDA has made a decemmanon that your arres by other Federal agencies. You must or any Federal statutes and regulations administer of registration and listing (21
comply with all the Act's requirements, including, but not mastice requirements as set comply with all the Act S requirements, monamas comments or crice requirements as set
CFR Part 807); labeling (21 CFR Part 801); and if explicable, the electronic CFR Part 807); iabeling (21 CFR Pat 801); good analities (21); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000-1050 forth in the quality systems (QD) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-

This letter will allow you to begin marketing your device as described in your Section 510(k)
10 legally This letter will allow you to begin makemig your artial equivalence of your device to a legally premarket notification. The FDA inding of substantial of are 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 If you desire specific advice for your devices), please contact the Office of additionally 21 CFK Part 809.10 for miro attends on the promotion and advertising of
Compliance at [phone]. Additionally, for questions on the promotion and advertisi Compliance at [phone]. Additionally, 18. queen [phone]. Also, please note the your device, prease contact the Offee of eet career to premarket notification's and 807.97).
regulation entitled, "Misbranding by reference to premarket many be obtained from regulation entitled, "Misoraliung of reference to printer the Act may be obtained from the Other general miorination on your responsionated and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address [phone] fda gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Der Tulli

-Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page

510(K) Number (if known): x992659 (Special 510 (k): Device Modification)

02N-Demand-II Device Name:

Indications For Use: The O2n Demand-II is intended as an oxygen conserving pressure regulator for ambulatory patients. This is the same intended use as the predicated unit (K963247).

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

USD

Concultrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

W. Roff

141. on Sign-Off) of Cardiovascular, Respiratory, ಿದ ಅಂದಾlegical Devices

510(k) Number _