TRANSTRACHEAL AUGMENTED VENTILATION OXYGEN CONCENTRATOR MODEL NUMBER TTAV 1000

K981078 · Transtracheal Systems · CAW · Jul 23, 1998 · Anesthesiology

Device Facts

• Record ID: K981078
• Device Name: TRANSTRACHEAL AUGMENTED VENTILATION OXYGEN CONCENTRATOR MODEL NUMBER TTAV 1000
• Applicant: Transtracheal Systems
• Product Code: CAW · Anesthesiology
• Decision Date: Jul 23, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

High flow oxygenation for patients requiring supplemental oxygen for the treatment of hypoxemia

Device Story

The Transtracheal High Flow 1000 (TTHF 1000) is a respiratory device designed to deliver high flow oxygen to patients suffering from hypoxemia. It functions by providing supplemental oxygen directly to the patient's airway. The device is intended for prescription use in a clinical or home setting under the guidance of a healthcare provider. By facilitating high flow oxygenation, the device assists in correcting hypoxemia, thereby improving patient oxygen saturation levels and respiratory function.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on 510(k) regulatory review.

Technological Characteristics

Respiratory oxygen delivery system; high flow configuration. Technical specifications and materials not detailed in the provided documentation.

Indications for Use

Indicated for patients requiring supplemental oxygen for the treatment of hypoxemia.

Regulatory Classification

Identification

A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL 23 1998

Mr. Lewis Ward Transtracheal Systems, Inc. c/o L. W. Ward and Associates, Inc. 4655 Kirkwood Court Boulder, CO 80301

K981078 Re: TTHF 1000 Regulatory Class: II (two) Product Code: 73 CAW Dated: June 26, 1998 July 1, 1998 Received:

Dear Mr. Ward:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such Existing major regulations affecting your device additional controls. can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Lewis Ward

This letter will allow you to begin marketing your device as described in your 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 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## K981078 Initial 510(k)

Device Name: Transtracheal High Flow 1000

Indications for Use:

High flow oxygenation for patients requiring supplemental oxygen for the treatment of hypoxemia

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) X

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

OR Over-the-Counter Use_

510(k) Number _