(354 days)
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
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.
This document is a 510(k) summary for a wound dressing, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed standalone performance studies with acceptance criteria, expert adjudication, or MRMC studies.
Therefore, many of the requested elements for describing acceptance criteria and a study proving a device meets them are not applicable or cannot be extracted from the provided text.
Here is an attempt to address the requested information based only on the provided text, indicating where information is not present:
Acceptance Criteria and Device Performance Study for SPYROFLEX® Pigmented Wound Dressing
As this is a 510(k) submission, the primary "acceptance criterion" for market clearance is demonstrating substantial equivalence to a legally marketed predicate device. The performance data presented are primarily laboratory tests to support safety and basic functionality.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: | |
| Non-toxic | Shown in laboratory tests |
| Non-irritating | Shown in laboratory tests |
| Non-sensitizing | Shown in laboratory tests |
| Functionality: | |
| Sterile | Description indicates device is sterile |
| Conformable | Description indicates device is conformable |
| Absorptive | Description indicates device is absorptive; "provides a degree of absorption" |
| Breathable | "provides a degree of breathability" |
| Barrier to bacteria, dirt, and liquids | Outer layer performs as a barrier to bacteria, dirt, and liquids |
| Ease of application (non-toxic adhesive) | Porous, non-toxic adhesive facilitates ease of application |
| Acts as a reservoir for wound exudate | Microporous polyurethane membrane acts as a reservoir for wound exudate |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided text. The term "laboratory tests" is used generally.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The tests are described as "laboratory tests."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not applicable. The provided document does not describe studies involving human readers or expert-established ground truth for performance. The "ground truth" for the safety endpoints (non-toxic, non-irritating, non-sensitizing) would be derived directly from the results of the laboratory tests themselves rather than expert consensus on diagnostic images or similar.
4. Adjudication Method for the Test Set
- Not applicable. No human adjudication process is described for the laboratory tests mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC comparative effectiveness study was not conducted or reported in this 510(k) summary. This type of study is typically relevant for diagnostic imaging AI devices, not wound dressings.
6. Standalone (Algorithm Only) Performance Study
- Not applicable. This device is a physical wound dressing, not an algorithm. Therefore, a standalone (algorithm only) performance study is not relevant or applicable. The "performance" described relates to its physical and biological properties.
7. Type of Ground Truth Used
- The "ground truth" for the safety claims (non-toxic, non-irritating, non-sensitizing) was established through laboratory test results. For example, irritation would be assessed via standard dermatological patch tests, and toxicity via cytotoxicity assays or similar.
- The "ground truth" for functional claims (absorptive, breathable, barrier properties) would also be established through physical and material science laboratory testing methodologies.
8. Sample Size for the Training Set
- Not applicable. This device does not involve machine learning or AI, and therefore, there is no "training set."
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.
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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.
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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
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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
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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) |
|---|---|---|
| ------------------------------------------ | ---- | -------------------------------------------------- |
N/A