SPYROFLEX FOAM ISLAND WOUND DRESSING, SPYROFLEX FOAM ISLAND WOUND DRESSING, TINTED, SPYROFOAM

{0}------------------------------------------------ 974520 FEB - 6 1998 # 510(k) SPYROFLEX® Foam Island Wound Dressing Innovative Technologies (US) Inc. ## 510(k) Summary #### Prescription Use | Proprietary Name: | SPYROFLEX® Foam Island Wound Dressing | |----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common Name: | Dressing | | Classification: | Unclassified | | Submitter's Details: | Innovative Technologies (US), Inc.<br>581 Conference Place<br>Golden, CO 80401<br>Tel: (303)271-0340<br>FAX: (303)271-0397<br>Contacts: Andrew M. Reed, Ph.D., Julie Chaffee | #### Description: રોગ્ર SPYROFLEX Foam Island Wound Dressings are sterile, absorptive dressings. SPYROFLEX combines the moist wound environment properties of film dressings with the absorptive qualities of traditional therapies in a structure which is both adhesive and conformable. The wound contact surface of SPYROFLEX is an absorptive foam island dressing. A second layer consisting of a microporous polyarethane self adhesive membrane facilitates the ease of application to the wound site. This layer is moisture vapor permeable and impermeable to microorganisms and liquids. SPYROFLEX Foam Island Wound Dressings are intended for use in the management of: | Venous stasis ulcers | Partial-thickness wounds | |----------------------|---------------------------| | Diabetic ulcers | Superficial burns | | Pressure sores | Abrasions and lacerations | | Donor sites | Full-thickness wounds | | Blisters | Skin tears | | Incisions | Dermal lesions | | Severe sunburn | Minor chemical burns | | Poison Ivy | Thermal burns | SPYROFLEX Foam Island Wound Dressings are substantially equivalent to SPYROFLEX Pigmented Wound Dressings, and Tielle Hydropolymer Dressings. These devices are self-adhesive wound dressings which provide a degree of absorption and breathability. They are all intended for use in the management of a wide variety of dermal lesions and injuries. SPYROFLEX Foam Island Wound Dressings have been shown in laboratory tests to be nontoxic, nonirritating, and nonsensitizing. {1}------------------------------------------------ ## 510(k) SPYROFLEX® Foam Island Wound Dressing Innovative Technologies (US) Inc. ## 510(k) Summary ### Over-The-Counter Use | Proprietary Name: | SPYROFLEX® Foam Island Wound Dressing | |----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common Name: | Dressing | | Classification: | Unclassified | | Submitter's Details: | Innovative Technologies (US), Inc.<br>581 Conference Place<br>Golden, CO 80401<br>Tel: (303)271-0340<br>FAX: (303)271-0397<br>Contacts: Andrew M. Reed, Ph.D., Julie Chaffee | #### Description: : SPYROFLEX Foam Island Wound Dressings are sterile, absorptive dressings. SPYROFLEX combines the moist wound environment properties of film dressings with the absorptive qualities of traditional therapies in a structure which is both adhesive and conformable. The wound contact surface of SPYROFLEX is an absorptive foam island dressing. A second layer consisting of a microporous polyurethane self adhesive membrane facilitates the ease of application to the wound site. This layer is moisture vapor permeable and impermeable to microorganisms and liquids. SPYROFLEX Foam Island Wound Dressings are intended for use in the management of: - Abrasions Superficial Blisters Minor Burns Superficial Cuts Superficial Lacerations Superficial Scrapes Minor Rash SPYROFLEX Foam Island Wound Dressings are substantially equivalent to SPYROFLEX Pigmented Wound Dressings, and Tielle Hydropolymer Dressings. These devices are self-adhesive wound dressings which provide a degree of absorption and breathability. They are all intended for use in the management of a wide variety of dermal lesions and injuries. SPYROFLEX Foam Island Wound Dressings have been shown in laboratory tests to be nontoxic, nonirritating, and nonsensitizing. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure. The logo is black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB -6 1998 Ms. Julie Chaffee · Manager, Quality and Regulatory Affairs Innovative Technologies (US), Inc. 581 Conference Place 80401 Golden, Colorado Re: K974520 SPYROFLEX® Foam Island Wound Dressing Regulatory Class: Unclassified Product Code: MGP Dated: December 1, 1997 December 2, 1997 Received: 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 (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 In addition, FDA may publish further announcements action. 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. {3}------------------------------------------------ ## Page 2 - Ms. Julie Chaffee 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, Coley ia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ 510(k) SPYROFLEX® Foam Island Wound Dressing Innovative Technologies (US) Inc. Page 1 of 1 ### PREMARKET NOTIFICATION ## INDICATIONS FOR USE STATEMENT 510(k) Number: K974520 Innovative Technologies (US), Inc. Device Name: ば SPYROFLEX® Foam Island Wound Dressing Indications for Use: - Prescription Use - SPYROFLEX Foam Island Wound Dressings provide a degree of absorption and breathability. They are intended for use in the management of the following: - Venous stasis ulcers Diabetic ulcers Pressure sores Donor sites Blisters Incisions Severe sunburn Poison Ivy - Partial-thickness wounds Superficial burns Abrasions and lacerations Full-thickness wounds Skin tears Dermal lesions Minor chemical burns Thermal burns (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) hoceee Division of General Restorative Devices 510(k) Number K974520 **Prescription Use** (Per 21 CFR 801.109) OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96) {5}------------------------------------------------ 510(k) SPYROFLEX® Foam Island Wound Dressing Innovative Technologies (US) Inc. Page 1 of 1 # PREMARKET NOTIFICATION # INDICATIONS FOR USE STATEMENT 510(k) Number: K974520 Innovative Technologies (US), Inc. Device Name: SPYROFLEX® Foam Island Wound Dressing Indications for Use: - Over-The-Counter Use - SPYROFLEX Foam Island Wound Dressings provide a degree of absorption and breathability. They are intended for use in the management of the following: - Abrasions Superficial Blisters Minor Burns Superficial Cuts Superficial Lacerations Superficial Scrapes Minor Rash (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 | K974520 | | Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use<br>(Optional Format 1-2-96) | |------------------------------------------|----|--------------------------------------------------| |------------------------------------------|----|--------------------------------------------------| ર્ણ વડ