(346 days)
Not Found
Not Found
No
The summary describes a physical bandage for treating chest wounds and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is intended to treat penetrating chest wounds, manage open pneumothorax, and prevent tension pneumothorax, all of which are therapeutic actions.
No
The device is described as a bandage for treating chest wounds and managing pneumothorax, which are therapeutic actions, not diagnostic ones.
No
The intended use describes a physical bandage for treating chest wounds, which is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used to treat physical wounds and conditions affecting the chest cavity (penetrating chest wounds, open pneumothorax, tension pneumothorax). This is a therapeutic or diagnostic device used directly on the body, not a device used to examine specimens in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on specimens, or providing information about a patient's health status based on in vitro analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely external and mechanical in nature, addressing a physical injury.
N/A
Intended Use / Indications for 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.
Product codes
MGP
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
chest cavity, chest
Indicated Patient Age Range
Not Found
Intended User / Care Setting
temporary and emergency basis
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an image of an abstract caduceus. The caduceus is represented by three stylized lines that resemble a bird in flight. The text is arranged around the top and sides of the circle.
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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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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P.02
Image /page/2/Picture/2 description: The image shows a series of handwritten characters and numbers in black ink against a white background. The sequence reads 'K99 0079'. The style of writing appears to be brushstroke-like, with varying thickness in the lines, giving it a calligraphic feel.
TO
510(k) Number (if known): _ K990079 __
Device Name:_FastSeal_Chest_Wound_Dressing
Indications For 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.
NRE for JZD
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K990079
(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)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
..