FASTSEAL CHEST WOUND DRESSING

K990079 · Greenfield Medical Technologies, Inc. · MGP · Dec 23, 1999 · SU

Device Facts

• Record ID: K990079
• Device Name: FASTSEAL CHEST WOUND DRESSING
• Applicant: Greenfield Medical Technologies, Inc.
• Product Code: MGP · SU
• Decision Date: Dec 23, 1999
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

To be used as a temporary bandage to treat penetrating chest wounds that could compromise the pleural space of the chest cavity, such as: gunshot wounds, stab wounds and fragment wounds. To be used on a temporary and emergency basis in the management of an open pneumothorax condition. To prevent a tension pneumothorax, and for reinflate a collapsed lung without using invasive procedures.

Device Story

FastSeal Chest Wound Dressing is a temporary, emergency bandage for penetrating chest wounds. It manages open pneumothorax by sealing the wound to prevent tension pneumothorax and allow lung reinflation. Used in emergency settings by medical personnel; applied directly to the wound site. Acts as a physical barrier to the pleural space; prevents air entry while managing existing pneumothorax. Benefits patient by stabilizing chest cavity and restoring lung function without immediate invasive surgical intervention.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Temporary adhesive bandage/dressing for chest wounds. Designed to seal penetrating injuries to the pleural space. Non-invasive application.

Indications for Use

Indicated for patients with penetrating chest wounds (gunshot, stab, fragment) and open pneumothorax. Used for temporary, emergency management to prevent tension pneumothorax and facilitate lung reinflation without invasive procedures.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 3 1999

Mr. Donald R. Gorsuch President Greenfield Medical Technologies, Inc. P.O. Box 283 Northborough, Massachusetts 01532

Re: K990079 Trade Name: FastSeal Chest Wound Dressing Regulatory Class: Unclassified Product Code: MGP Dated: October 21, 1999 Received: October 22, 1999

Dear Mr. Gorsuch:

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 requirement, 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. Donald R. Gorsuch

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 vour 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/dsmamain.html".

Sincerely yours.

Neil R.P. Ogden

James E. Dillard, III

James E. Dillard II Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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TO

510(k) Number (if known): _ K990079 __

Device Name:_FastSeal_Chest_Wound_Dressing

Indications For Use:

- 1. To be used as a temporary bandage to treat penetrating chest wounds that could compromise the pleural space of the chest cavity, such as: gunshot wounds, stab wounds and fragment wounds.
- 2. To be used on a temporary and emergency basis in the management of an open pneumothorax condition.
- 3. To prevent a tension pneumothorax, and for reinflate a collapsed lung without using invasive procedures.

NRE for JZD

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K990079

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

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