(90 days)
Not Found
Not Found
No
The description focuses on the physical properties and intended use of a wound dressing, with no mention of AI or ML capabilities.
Yes
The device is a wound dressing intended for the management of partial and full thickness wounds, including various types of ulcers, burns, and abrasions. These applications directly contribute to the treatment and healing of injuries, classifying it as a therapeutic device.
No
This device is described as a wound dressing, used for the management and healing of wounds, not for diagnosing conditions.
No
The device description clearly describes a physical wound dressing made of foam and adhesive materials, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the management of wounds (partial and full thickness). This involves applying a dressing to the external surface of the body to aid in healing.
- Device Description: The description details a sterile, absorptive wound dressing with different layers designed for wound contact, adhesion, and barrier properties.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the body (like blood, urine, tissue) to diagnose a condition, monitor a disease, or screen for health issues. IVDs are specifically designed for these types of in vitro tests.
The device is a wound dressing, which is a medical device used for therapeutic purposes (wound management), not diagnostic purposes.
N/A
Intended Use / Indications for Use
Spyrosorb® Foam Island Wound Dressings provide a degree of absorption and breathability. They are intended for use in the management of partial and full thickness wounds.
The following indications for use are for Prescription Use or under the direction of a health care professional:
Venous stasis ulcers
Diabetic ulcers
Pressure sores
Donor sites
Burns, Minor and Chemical
Abrasions and lacerations
Incisions
The following indications for use are for Over The Counter Use:
Superficial Abrasions, Scrapes, Cuts, and Lacerations
Minor Burns
Product codes
KMF
Device Description
Spyrosorb Foam Island Wound Dressings are sterile, absorptive dressings.
Spyrosorb 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 Spyrosorb is an absorptive foam island dressing. A second layer consisting of a microporous polyurethane self adhesive membrane facilitates the case of application to the wound site. The outermost layer acts as a barrier to exogenous moisture and bacteria while allowing permeability to moisture vapor and oxygen.
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
Under the direction of a health care professional (for prescription use indications).
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)
Spyrosorb Foam Island Wound Dressings have been shown in laboratory tests to be nontoxic, nonirritating, and nonsensitizing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Mitraflex Pigmented Wound Dressings, Ticle Hydropolymer Dressings
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
¥980673
510(k) Spyrosorb@ Foam Island Wound Dressing Innovative Technologies (US) Inc.
MAY 2 I 1998
510(k) Summary K980673
Spyrosorb@ Foam Island Wound Dressing Proprietary Name:
Common Name; Dressing
Classification: Unclassified
- Innovative Technologies (US), Inc. Submitter's Details: 581 Conference Place Golden, CO 80401 (303)271-0340 Tel: (303)271-0397 FAX: Contacts: Andrew M. Reed, Ph.D., Julie Chaffee
Description:
Spyrosorb Foam Island Wound Dressings are sterile, absorplive dressings.
Spyrosorb 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 Spyrosorb is an absorptive foam island dressing. A second layer consisting of a microporous polyurethane self adhesive membrane facilitates the case of application to the wound site. The outcrmost layer acts as a barner to exogenous moisture and bacteria while allowing permeability to moisture vapor and oxygen.
Spyrosorb Foarn Island Wound Dressings are intended for use in the management of partial and full thickness wounds under the direction of a health care professional such as:
Venous stasis ulcers Diabetic ulcers Pressure sores Donor siles
Burns. Minor and Chemical Abrasions and lacerations Incisions
Over the Counter usages include superficial abrasions, scrapes, cuts, and lacerations, as well as minor burns.
Spyrosorb Foam Island Wound Dressings are substantially equivalcat to Mitraflex Pigmented Wound Dressings and Ticle Hydropolymer Dressings. These devices are self-schesive wound dressings which provide a degree of absorption and breathability. They are all intended for use in the management of a wide variety of wounds.
Spyrosorb Foam Island Wound Dressings have been shown in laboratory tests to be nontoxic, nonirritating, and nonsensitizing.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 21 1999
Ms. Julie Chaffee Manager, Quality and Regulatory Affairs Innovative Technologies (US) Incorporated 581 Conference Place Golden, Colorado 80401
Re: K980673 Trade Name: SPYROSORB® Foam Island Wound Dressing Regulatory Class: Unclassified Product Code: KMF Dated: February 19, 1998 Received: February 20, 1998
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. 1.
- This device may not be labeled as having any accelerating effect on the rate of 2. wound healing or epithelization.
- This device may not be labeled as a long-term, permanent, or no-change dressing, or 3. as an 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 inodification in the intended use of the device and would require a premarket notification submission (21 CHR 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.
2
Page 2 - Ms. Chaffee
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 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,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices a ... Radiological Health
Enclosure
3
510(k) Spyrosorb® Foam Island Wound Dressing Innovative Technologies (US) Inc.
Page 1 of 1
PREMARKET NOTIFICATION INDICATIONS FOR USE STATEMENT
510(k) Number:
K980673 Innovative Technologics (US), Inc.
Spyrosorb® Foam Island Wound Dressing Device Name:
Indications for Use:
Spyrosorb Foam Island Wound Dressings provide a degree of absorption and breathability. They are intended for use in the management of partial and full thickness wounds.
The following indications for use are for Prescription Use or under the direction of a health care professional:
Venous stasis ulcers Diabctic ulcers Pressure sores Donor sites
Burus, Minor and Chemical Abrasions and laccrations Incisions
The following indications for use are for Over The Counter Use: Superficial Abrasions, Scrapes, Cuts, and Laccrations Minor Burns
(PLEASE DO NOT WRITE BEI,OW TIUS LINE - CONTINUE ON ANOTHER PAGE IF NIJIN
Concurrence of CDRIL, Office of Device Evaluation (ODE)
Sian-Off
Prescription Use
(Per 21 CFR 801.109)
OR
(Optional Formal 1-2-96)
Over-The-Counter Use