(27 days)
The pad is used to cover wounds
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.
The provided document is a 510(k) summary for the Hospeco ABD pad, a wound dressing device seeking substantial equivalence to a predicate device. This document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way you've described for an AI/ML-based medical device.
The document focuses on demonstrating that the Hospeco ABD pad is substantially equivalent to an existing legally marketed device (Kendall's Tendersorb ABD pad) based on similar materials, manufacturing, and intended use. The "Supporting Data and Conclusions" section primarily addresses sterilization validation and material testing for skin irritation, not clinical performance metrics typically associated with AI/ML device studies.
Therefore, I cannot populate the table or answer most of your questions as the document does not contain the requested information.
Here's an attempt to address your questions based on what is in the provided text, and where it's not present, I will state that:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | "The wound dressing is substantially equivalent to the existing legally marketed device." (Predicate: Kendall's Tendersorb ABD pad) |
| Material Composition | Composed of "the same type of materials as the predicate device." |
| Skin Irritation/Sensitization | Non-woven outer-wrap tested according to Intensified Shelasnski Repeated Insult Patch Test; "neither a skin irritant nor a skin sensitizer." |
| Sterility Assurance Level (SAL) | Evaluated using AAMI Method 1 for microbiological validation of gamma irradiation sterilization. Bioburden established and minimum irradiation dose determined for "providing a sterility assurance level of 10⁻⁶." |
| Quarterly Dose Audit | "A quarterly dose audit will be performed on the product." |
| Sizes and Weights | Available "in the same sizes and similar weights" as the predicate device. |
| Technological Characteristics (Non-woven barrier) | Non-woven wax-cured polyester used as a barrier and to wrap the pad "instead of non-woven polypropylene" (this is a difference but deemed acceptable for equivalence). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not specified. The document primarily refers to material testing and sterilization validation, not a clinical "test set" for performance evaluation in the context of an AI/ML device.
- Data provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/not specified. This type of ground truth establishment is not relevant for this device's type of submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/not specified.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is not an AI/ML-based device, and therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This is not an AI/ML-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the skin irritation test: The "ground truth" would be the observed skin reactions (or lack thereof) in human subjects or in-vitro models according to the Intensified Shelasnski Repeated Insult Patch Test standard.
- For sterilization: The "ground truth" is the verified sterility assurance level of 10⁻⁶ through microbiological testing (bioburden determination and irradiation dose validation) as per AAMI Method 1.
- For material similarity: Comparison to the predicate device's materials.
8. The sample size for the training set
- Not applicable/not specified. This is not an AI/ML-based device and thus does not have a "training set."
9. How the ground truth for the training set was established
- Not applicable/not specified. This is not an AI/ML-based device.
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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 AveCleveland, 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.
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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.
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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
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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___
N/A