SCOOP 1

K981080 · Transtracheal Systems · BTO · Jun 17, 1998 · Anesthesiology

Device Facts

• Record ID: K981080
• Device Name: SCOOP 1
• Applicant: Transtracheal Systems
• Product Code: BTO · Anesthesiology
• Decision Date: Jun 17, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Transtracheal catheter for patients requiring high flow supplemental oxygen for the treatment of hypoxemia

Device Story

The SCOOP I is a transtracheal catheter designed for the delivery of supplemental oxygen directly into the trachea. It is intended for patients requiring high-flow oxygen therapy to treat hypoxemia. The device is inserted into the trachea to provide a direct pathway for oxygen, bypassing the upper airway. It is used in a clinical or home setting under the direction of a physician. By delivering oxygen directly to the lungs, the device improves oxygenation efficiency and supports patients with chronic respiratory needs.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Transtracheal catheter for oxygen delivery. Mechanical device; no electronic components, software, or algorithms. Materials and sterilization methods are consistent with standard medical device requirements for respiratory catheters.

Indications for Use

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

Regulatory Classification

Identification

A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.

Submission Summary (Full Text)

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Public Health Service

JUN 17 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K981080 SCOOP I Requlatory Class: II (two) Product Code: 73 BTO March 12, 1998 Dated: Received: March 24, 1998

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 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 additional controls. Existing major regulations affecting your device 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 Failure to comply with the GMP regulation may result in assumptions. 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 requlation 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/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

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

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Enclosure

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Initial 510(k)

1

Device Name: SCOOP I, Transtracheal Catheter

Indications for Use:

Transtracheal catheter for patients requiring high flow supplemental oxygen for the treatment of hypoxemia

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K981080 510(k) Number_

Prescription Use UV X (Per 21 CFR 801.109)

OR Over-the-Counter Use ... . . . . . . . . . . . . . . . . . . . . . . .