(354 days)
Not Found
Not Found
No
The 510(k) summary describes a standard wound dressing with no mention of AI, ML, image processing, or any data-driven analytical capabilities.
No
The device, SPYROFLEX Wound Dressings, is intended for wound care management (e.g., abrasions, burns, cuts), which is a supportive rather than therapeutic function. It helps create a healing environment but doesn't actively treat or cure the underlying condition.
No
The device, SPYROFLEX Wound Dressings, is intended for wound management (e.g., abrasions, burns, cuts), which is a treatment or protective function, not a diagnostic one.
No
The device description clearly describes a physical wound dressing made of multiple layers, including adhesive and a polyurethane membrane. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a wound dressing for managing various types of skin injuries (abrasions, blisters, burns, cuts, etc.). This is a topical application for wound care.
- Device Description: The description details the physical structure and function of a wound dressing, focusing on absorption, breathability, and creating a protective environment.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue) to provide information about a person's health status, disease, or condition. IVDs are used for diagnostic purposes in vitro (outside the body).
This device is a medical device, specifically a wound dressing, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
SPYROFLEX Pigmented Wound Dressings For OTC Use are intended for use in the management of. Abrasions Blisters Burns (sun burns, carpet burns, friction burns, minor chemical and heat burns) Cuts Lacerations Poison Ivy Rash Scrapes
Product codes
MGP
Device Description
SPYROFLEX® is a sterile, conformable, absorptive dressing. SPYROFLEX dressings consists of two layers, each specifically engineered to give SPYROFLEX its unique blend of "ease of use" features while maintaining a protective moist healing environment. The wound contact surface of SPYROFLEX is a porous, non-toxic adhesive which facilitates ease of application to the wound site. A second layer consisting of a microporous polyurethane membrane acts as a reservoir for wound exudate. The outer layer performs as a barrier to bacteria, dirt, and liquids.
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
OTC Use
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
N/A
0
OCL 2 4 1997
510(k) Summary
SPYROFLEX® Pigmented Wound Dressing For OTC Use Proprietary Name:
| Common Name: | Dressing |
|---|---|
| -------------- | ---------- |
- Unclassified Classification:
- PolyMedica Industries, Inc. Submitter's Details: 581 Conference Place Golden, CO 80401 Tel: (303)271-0300 FAX: (303)271-0397 Contacts: Andrew M. Reed, Ph.D., Julie Chaffee
Description:
SPYROFLEX® is a sterile, conformable, absorptive dressing.
SPYROFLEX dressings consists of two layers, each specifically engineered to give SPYROFLEX its unique blend of "ease of use" features while maintaining a protective moist healing environment.
The wound contact surface of SPYROFLEX is a porous, non-toxic adhesive which facilitates ease of application to the wound site. A second layer consisting of a microporous polyurethane membrane acts as a reservoir for wound exudate. The outer layer performs as a barrier to bacteria, dirt, and liquids.
SPYROFLEX Pigmented Wound Dressings are intended for use in the management of.
Abrasions Blisters Burns (sun burns, carpet burns, friction burns, minor chemical and heat burns) Cuts Lacerations Poison Ivy Rash Scrapes
SPYROFLEX Pigmented Wound Dressings For OTC Use are substantially equivalent to SPYROFLEX Pigmented Wound Dressings. These devices are self-adhesive wound dressings which provide a degree of absorption and breathability. They are intended for use in the management of a wide variety of wounds and injuries. These dressings have been shown in laboratory tests to be nontoxic, nonirritating, and nonsensitizing.
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 4 1997
Ms. Julie Chaffee Manager, Regulatory and Quality Assurance Innovative Technologies (US) Inc. 581 Conference Place Golden, Colorado 80401
Re: K964398
SPYROFLEX® Pigmented Wound Dressings for OTC Use Regulatory Class: Unclassified Product Code: MGP Dated: October 3, 1997 Received: October 6, 1997
Dear Ms. Chaffee:
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 (the 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.
-
- This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
-
- This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
-
- This device may not be labeled as a treatment or a cure for any type of wound.
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
2
Page 2 - Ms. Julie Chaffee
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 your 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.
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 Division of Small Manufacturers Assistance at the number 800 638-2041 or 301-443-6597 or 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
Enclosure
3
PREMARKET NOTIFICATION
INDICATIONS FOR USE STATEMENT
| 510(k) Number: | K964398 |
|---|---|
| Unassigned | |
| PolyMedica Industries, Inc. |
Device Name: SPYROFLEX® Pigmented Wound Dressings For OTC Use
Indications for Use:
SPYROFLEX Wound Dressings provide a degree of absorption and breathability. They are intended for use in the management of the following:
Abrasions Blisters Burns (sun burns, carpet burns, friction burns, minor chemical and heat burns) Cuts Lacerations Poison Ivy Rash Scrapes
(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 | K964398 |
| Prescription Use
(Per 21 CFR 801.109) | OR | Over-The-Counter Use
(Optional Format 1-2-96) |
| ------------------------------------------ | ---- | -------------------------------------------------- |
|---|