(28 days)
Not Found
Not Found
No
The provided 510(k) summary describes a hemostatic patch and does not mention any AI or ML components, image processing, or data-driven performance metrics typically associated with AI/ML devices.
Yes
The devices are indicated for the management and rapid control of bleeding wounds, which is a therapeutic function.
No
Explanation: The device is indicated for the local management and promotion of rapid control of bleeding wounds, which describes a therapeutic function rather than a diagnostic one.
No
The provided 510(k) summary describes a "patch" which is a physical device intended for the local management of bleeding wounds. There is no mention of software as the primary or sole component.
Based on the provided information, neither ProDein™Patch nor SyvekPatch™ are IVDs (In Vitro Diagnostics).
Here's why:
- IVDs are used to examine specimens taken from the human body. This includes things like blood, urine, tissue, etc., to provide information about a person's health.
- The intended use of both ProDein™Patch and SyvekPatch™ is for the local management of bleeding wounds. This is a direct application to the body's surface to control bleeding, not an examination of a specimen.
The descriptions clearly indicate these are topical devices for wound care and bleeding control, which falls outside the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
ProDein™Patch: ProDein™Patch is indicated for use in the local management of bleeding wounds such as lacerations, abrasions and nose bleeds.
SyvekPatch™: SyvekPatch™ is intended for use under the direction of a healthcare professional for the following indications: SyvekPatch™ is indicated for the promotion of rapid control of bleeding in patients following hemodialysis and in patients on anticoagulation therapy. SyvekPatch™ is indicated for use in the local management of bleeding wounds such as vascular access site, percutaneous catheters or tubes and surgical debridement.
Product codes (comma separated list FDA assigned to the subject device)
KMF
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
ProDein™Patch: Over-The-Counter Use
SyvekPatch™: Prescription Use, under the direction of a healthcare professional
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5090 Liquid bandage.
(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird-like figure.
DEC 18 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sergio Finkielsztein, President Marine Polymer Technologies, Inc. 107 Water Street Danvers, Massachusetts 01923
Re: K984177 Trade Name: Syvekpatch (prescription) Prodein (over-the-counter) Regulatory Class: Unclassifed Product Code: KMF Dated: November 19,1998 Received: November 20,1998
Dear Mr. Finkielsztein:
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 enclosures) 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). You may, therefore, market your device subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:
- This device may not be labeled for use on third degree burns. 1.
- This device may not be labeled as having any accelerating effect on the rate of wound healing or 2. epithelization.
- This device may not be labeled as a long-term, permanent, or no-change dressing, or as an 3. artificial (synthetic) skin.
- This device may not be labeled as a treatment or a cure for any type of wound. 4.
The labeling claims listed above would be considered a major modification in the intended use of the device and would require a premarket notification submission (21 CFR 807.81).
The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, 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 vour device can be found in the Code of Federal Regulations (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP 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,
1
Page 2 - Sergio Finkielsztein
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 (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.
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
2
Indications for Use Statement
Page 1 of 1
510(k) Number : K984177
ProDein™Patch Device Name:
Indications for use:
ProDein™Patch is indicated for use in the local management of bleeding wounds such as lacerations, abrasions and nose bleeds.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K984177 |
| Prescription Use
(Per 21 C.F.R. 801.109) | OR | Over-The-Counter Use X
(Optional Format 1-2-96) |
| --------------------------------------------- | ---- | ---------------------------------------------------- |
|---|
3
Indications for Use Statement
Page 1 of 1
510(k) Number : K984177
SyvekPatch™ Device Name:
Indications for use:
SyvekPatch™ is intended for use under the direction of a healthcare professional for the following indications:
SyvekPatch™ is indicated for the promotion of rapid control of bleeding in patients following hemodialysis and in patients on anticoagulation therapy.
SyvekPatch™ is indicated for use in the local management of bleeding wounds such as vascular access site, percutaneous catheters or tubes and surgical debridement.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative Devices, | |
| 510(k) Number | K984177 |
| Prescription Use | OR | Over-The-Counter Use |
|---|---|---|
| (Per 21 C.F.R. 801.109) | (Optional Format 1-2-96) | |