(27 days)
Not Found
Not Found
No
The summary describes a wound dressing made of traditional materials and focuses on sterilization and material equivalence to a predicate device. There is no mention of AI, ML, image processing, or any computational analysis of data.
No
The device is described as a wound cover, which is a dressing rather than a therapeutic device. It does not actively treat or diagnose a condition.
No
Explanation: The device is described as a wound cover or dressing, and the indicated use is to cover wounds, which is a therapeutic rather than a diagnostic function.
No
The device is a wound dressing, which is a physical product made of materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "The pad is used to cover wounds." This describes a device used directly on the body for wound care, not for testing samples taken from the body (which is the core function of an IVD).
- Device Description: The description focuses on the materials and physical properties of a wound dressing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other elements typically associated with in vitro diagnostics.
- Performance Studies: The performance studies described relate to sterilization and material equivalence, not diagnostic accuracy or performance on biological samples.
Therefore, this device falls under the category of a wound dressing, which is a medical device but not an IVD.
N/A
Intended Use / Indications for Use
The pad is used to cover wounds
Product codes
FRO
Device Description
The pad is composed of the same type of materials as the predicate device. The non-woven outer-wrap has been tested according to the Intensified Shelasnski Repeated Insult Patch Test and is neither a skin irritant nor a skin sensitizer. The pads are available in the same sizes and similar weights.
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
Not Found
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
The finished device has been evaluated using the AAMI Method 1 for microbiological validation of gamma irradiation sterilization. The bioburden has been established and the minimum irradiation dose has been determined and tested for providing a sterility assurance level of 10°. A quarterly dose audit will be performed on the product.
Key Metrics
Not Found
Predicate Device(s)
Kendall's Tendersorb ABD pad
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image shows a black and white logo with the word "HOSPECO" stacked vertically in the center of a cross shape. The cross is white, and the background is black. The entire logo is enclosed in a circle. There is a number "4" in the upper right corner of the image.
Devi
lospital Specialty Company
Personal Care Division of the Tranzonic Companies 7501 Carnegie Avenue • Cleveland, Ohio 44103-4896 P.O. Box 94763 • Cleveland, Ohio 44101-4763 (800) 321-9832 • (216) 361-1230 • (800) B-AT-EASE FAX (216) 361-0829 e-mail HOSPECO@hospeco.com
K 990861
510(k) Summarv
Hospeco
| _Contact: | John Quigley | |
|---|---|---|
| _Company: | Hospital Specialty | |
| Address: | 7501 Carnegie Ave | |
| Cleveland, OH 44103 | ||
| telephone: | 216-361-1230 x 371 | |
| fax: | 216-361-0829 | |
| ice Name: | Classification name: | dressing |
| Trade/Common name: | ABD pad |
Predicate Device: Kendall's Tendersorb ABD pad
Proprietary name:
Device Description: The pad is composed of the same type of materials as the predicate device. The non-woven outer-wrap has been tested according to the Intensified Shelasnski Repeated Insult Patch Test and is neither a skin irritant nor a skin sensitizer. The pads are available in the same sizes and similar weights.
Intended Use: The pad is used to cover wounds.
Technological Characteristics: Non-woven wax-cured polyester is used as a barrier and to wrap the pad instead of non-woven polypropylene.
Supporting Data and Conclusions: The wound dressing is made of similar materials and in a similar manor as the previously cleared device. The finished device has been evaluated using the AAMI Method 1 for microbiological validation of gamma irradiation sterilization. The bioburden has been established and the minimum irradiation dose has been determined and tested for providing a sterility assurance level of 10°. A quarterly dose audit will be performed on the product. Based upon this evidence, the wound dressing is substantially equivalent to the existing legally marketed device.
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure with three lines forming its wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 2 1999
Mr. John Quigley Quality Assurance Manager Hospital Specialty Co. 7501 Carnegie Avenue Cleveland, Ohio 44103
Re: K990861 Trade Name: Hospeco ABD Wound Dressing Regulatory Class: Unclassifed Product Code: FRO Dated: March 15, 1999 Received: March 16, 1999
Dear Mr. Quigley:
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 2. 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. 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.
2
Page 2 - Mr. John Quigley
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 and Radiological Health
Enclosure
3
Page_1_of_1
510(k) Number (if known):
Hospeco ABD wound dressing Device Name:
Indications For Use:
The pad is used to cover wounds
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
INTERED NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ (Per 21 CFR 801.109) OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Signature
(Division Sign-Off)
Division of General Restorative Devices K990861
510(k) Number___