(99 days)
Not Found
Not Found
No
The summary describes a sterile wound dressing and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is described as a wound dressing, which is used for protection and healing, not for active therapeutic treatment of a disease or condition.
No
The device is described as a "POLYSTOMY STERILE WOUND DRESSING" used for various tube sites. This indicates it is for protection, coverage, or management of existing wounds/sites, not for identifying or diagnosing a condition.
No
The device description explicitly states "FERRIS POLYOSTOMY STERILE WOUND DRESSING," which is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended uses listed (Ostomy Tube Sites, Drainage Tube Sites, Gastrointestinal Tube Sites, Feeding Tube Sites) describe applications for wound dressings applied to the body surface around tubes. This is a topical application for wound management.
- Device Description: The device is described as a "STERILE WOUND DRESSING". Wound dressings are typically considered medical devices for external use, not for testing samples taken from the body.
- Lack of IVD Characteristics: The information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition
- Using reagents or assays
Therefore, based on the provided text, the FERRIS POLYOSTOMY STERILE WOUND DRESSING is a medical device intended for wound care, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Ostomy Tube Sites
Drainage Tube Sites
Gastrointestinal Tube Sites
Feeding Tube Sites
Product codes (comma separated list FDA assigned to the subject device)
KMF
Device Description
PolyOstomy Sterile Wound Dressing
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 (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
§ 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three swooping lines representing its wings. The eagle is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 27 1999
Mr. Theodore R. Thorsen Directory, Ouality Assurance Ferris Manufacturing Corporation 16W300 83rd Street Burr Ridge, Illinois 60521
Re: K991729
Trade Name: PolyOstomy Sterile Wound Dressing Regulatory Class: Unclassified Product Code: KMF Dated: July 14, 1999 Received: July 15, 1999
Dear Mr. Thorsen:
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 of the Act. The general controls provisions 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 (OS) 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 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.
1
Page 2 - Mr. Theodore R. Thorsen
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,
Neil R.P. Ogden
Colin M. Winter Ph.D., P.Eng.
Celia M. Witten, Ph.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
COULL PART SURVE
1779
Page I of
510(K) NUMBER (IF KNOWN) : _ K991729
DEVICE NAME: FERRIS POLYOSTOMY STERILE WOUND DRESSING
INDICATIONS FOR USE:
Ostomy Tube Sites
Drainage Tube Sites
Gastrointestinal Tube Sites
Feeding Tube Sites
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The-Counter-Use (Per 21 CFR 801.109) (Optional Format 1-2-96)