REMCORE REMOTE CONTROLLED OXYGEN REGULATOR

K060265 · Remcore, Inc. · CAN · Oct 25, 2006 · Anesthesiology

Device Facts

• Record ID: K060265
• Device Name: REMCORE REMOTE CONTROLLED OXYGEN REGULATOR
• Applicant: Remcore, Inc.
• Product Code: CAN · Anesthesiology
• Decision Date: Oct 25, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2700
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Remcore Remote Control Oxygen Delivery system is an adjunct to the use of supplemental oxygen prescribed by a physician for a patient whose lung disease limits his or her ability to adequately supply the body with oxygen. The amount of supplemental oxygen needed to continuously provide the oxygen saturation prescribed will vary with different degrees of exertion. Current oxygen delivery systems do not allow a patient to alter the flow rate of oxygen when the patient is not next to the oxygen source. The Remore Remote Control Oxygen Delivery System allows a patient to change the flow rate, as prescribed by the physician, in accordance with the activity of the patient. For example, a patient might require 2 liters/minute of supplemental oxygen at rest, but 5 liters/minute to climb the stairs. The Remcore system will allow the patient sitting downstairs to remotely increase the oxygen flow rate to 5 liters/minute, regardless of where in the house the oxygen tank or concentrator is located, and after arriving upstairs to remotely return the oxygen flow rate to 2 liters/minute.

Device Story

Device acts as remote interface for supplemental oxygen delivery systems; allows patients to adjust oxygen flow rates remotely. Input: user-initiated commands via remote control. Transformation: remote signal transmitted to oxygen source to modulate flow rate. Output: adjusted oxygen flow. Used in home environment by patients. Benefit: enables patient to maintain prescribed oxygen saturation during varying levels of physical exertion without needing to be physically adjacent to the oxygen source (tank or concentrator).

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Pressure regulator system; remote control interface for flow rate adjustment. Class I device, product code CAN.

Indications for Use

Indicated for patients with lung disease requiring physician-prescribed supplemental oxygen who need to adjust flow rates based on exertion levels.

Regulatory Classification

Identification

A pressure regulator is a device, often called a pressure-reducing valve, that is intended for medical purposes and that is used to convert a medical gas pressure from a high variable pressure to a lower, more constant working pressure. This device includes mechanical oxygen regulators.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a staff entwined by two snakes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Kevin Jorczak Vice President Remcore, Incorporated 14 Bond Street Boston, Massachusetts 02118

OC1 2 5 2006

Re: K060265

Trade/Device Name: Remcore Remote Control Oxygen Delivery System Regulation Number: 21 CFR 868.2700 Regulation Name: Pressure Regulator Regulatory Class: I Product Code: CAN Dated: October 3, 2006 Received: October 6, 2006

Dear Mr. Jorczak:

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. Jorczak

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device 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), please contact the Office of Compliance at [phone]. 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 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/industry/support/index.html.

Sincerely yours,

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): K060265

## Device Name: Remcore Remote Control Oxygen Delivery System

Indications for Use:

The Remcore Remote Control Oxygen Delivery system is an adjunct to the use of supplemental oxygen prescribed by a physician for a patient whose lung disease limits his or her ability to adequately supply the body with oxygen. The amount of supplemental oxygen needed to continuously provide the oxygen saturation prescribed will vary with different degrees of exertion. Current oxygen delivery systems do not allow a patient to alter the flow rate of oxygen when the patient is not next to the oxygen source. The Remore Remote Control Oxygen Delivery System allows a patient to change the flow rate, as prescribed by the physician, in accordance with the activity of the patient. For example, a patient might require 2 liters/minute of supplemental oxygen at rest, but 5 liters/minute to climb the stairs. The Remcore system will allow the patient sitting downstairs to remotely increase the oxygen flow rate to 5 liters/minute, regardless of where in the house the oxygen tank or concentrator is located, and after arriving upstairs to remotely return the oxygen flow rate to 2 liters/minute.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

of Anesthesiology, General Hospital, ontrol, Dental Devices

K060265

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