(55 days)
These equipment covers are equipment drapes or drape accessories made of natural or synthetic materials intended to be used as a protective patient covering such as to isolate a site of surgical incision from microbial and other contamination.
The International Medsurg Connections equipment covers are made of polyethylene. The covers are offered sterile and non-sterile.
The provided text describes a 510(k) premarket notification for "International Medsurg Connections Equipment Covers." This document is for a medical device that falls under the category of protective covers, and not an AI/ML-driven diagnostic or analytical device. Therefore, many of the requested elements of the prompt related to AI/ML device testing (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set size, ground truth for training set) are not applicable to the submitted document.
However, I can still extract the acceptance criteria related information about the device and the study as much as possible from the provided context.
1. A table of acceptance criteria and the reported device performance
The document lists performance tests conducted, implying these methods establish the acceptance criteria for the device based on established standards. The document states that the tests were performed, indicating compliance, but it does not explicitly provide numerical "reported device performance" values or specific "acceptance criteria" values for comparison in most cases.
| Test Method | Standard Used | Implicit Acceptance Criteria / Reported Performance |
|---|---|---|
| Flammability Testing, Class 1 | 16 CFR 1610 | Met "Class 1" (implies compliance with the standard) |
| Hydrostatic Pressure Test - Fluid Penetration Test | AATCC Test Method 127-1989 | Testing performed (implies compliance with the standard) |
| Grab Tensile | ASTM D882-91 | Testing performed (implies compliance with the standard) |
| Tear Resistance - Strip Tensile | ASTM D1424-96 | Testing performed (implies compliance with the standard) |
| Other characteristics listed under "Substantial Equivalence" | N/A | - Intended use is the same - Size, configuration, color are similar - Made of polyethylene - Physical properties are similar |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for the stated tests (Flammability, Hydrostatic Pressure, Grab Tensile, Tear Resistance). It also does not provide information on data provenance (country of origin, retrospective/prospective). This is typical for submissions for physical barrier devices where the testing refers to material properties rather than clinical data.
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. This device is an equipment cover, a physical product, not one requiring expert interpretation or ground truth establishment in a clinical or diagnostic context. The "ground truth" for these tests would be the material's physical properties meeting the specified standard.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for subjective assessments or discrepancy resolution in diagnostic studies, not for objective material property testing.
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
Not applicable. This is not an AI-assisted diagnostic or analytical device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm or software device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is compliance with established engineering and material standards (e.g., 16 CFR 1610 for flammability, AATCC Test Method 127-1989 for fluid penetration, ASTM D882-91 for grab tensile, ASTM D1424-96 for tear resistance). These are objective measurements against defined criteria.
8. The sample size for the training set
Not applicable. This is not a machine learning/AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning/AI device.
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K01423)
Attachment D
510(k) Summary
FEB 1 9 2002
INTERNATIONAL MEDSURG CONNECTIONS EQUIPMENT COVERS
| Manufacturer: | International Medsurg Connections, Inc.1000 E. Woodfield Road, Suite 102Schaumburg, Illinois 60173-5921 |
|---|---|
| Regulatory Affairs Contact: | Michele VovolkaP.O. Box 848Grayslake, Illinois 60030 |
| Telephone: | (847) 856-0355 |
| Date Summary Prepared: | December 17, 2001 |
| Product Trade Name: | International Medsurg Connections Equipment Covers |
| Common Name: | Equipment Covers |
| Classification: | Non-classified |
Predicate Devices:
Cover-All, Drape-It-All - Pinnacle Products, Inc. - K962288 Equipment Covers - United States Surgical - K961699 Sterile Equipment Covers - Custom Medical Products, Ltd. - K931417
- The International Medsurg Connections equipment covers are made of Description: polyethylene. The covers are offered sterile and non-sterile.
- Intended Use: These equipment covers are equipment drapes or drape accessories made of natural or synthetic materials intended to be used as a protective patient covering such as to isolate a site of surgical incision from microbial and other contamination.
Substantial Equivalence:
The International Medsurg Connections Equipment Covers are substantially equivalent to the Pinnacle Products, United States Surgical, and Custom Medical Product equipment covers in that they provide the following characteristics:
- Intended use is the same
- Size, configuration, color are similar
- Made of polyethylene
- Physical properties are similar
CONFIDENTIAL
{1}------------------------------------------------
Attachment D
510(k) Summary
Summary of Testing:
100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
.
. The following tests were performed on the finished Medsurg equipment covers:
| Test Method | Standard Used |
|---|---|
| Flammability Testing, Class 1 | 16 CFR 1610 |
| Hyrostatic Pressure Test - Fluid Penetration Test | AATCC Test Method 127-1989 |
| Grab Tensile | ASTM D882-91 |
| Tear Resistance - Strip Tensile | ASTM D1424-96 |
CONFIDENTIAL
:
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its body and wings. The bird is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circular border.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
International MedSurg Connection Regulatory Consultant C/O Ms. Michele H. Vovolka Vantage Consulting International Limited P.O. Box 848 Grayslake, Illinois 60030
Re: K014239
Trade/Device Name: International Medsurg Connections Equipment Covers Regulation Number: 878.4370 Regulation Name: Equipment Covers Regulatory Class: Unclassified and II Product Code: MMP and KXX Dated: December 17, 2001 Received: December 26, 2001
FEB 1 9 2002
Dear Ms. Vovolka:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements
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Page 2 - Ms. Vovolka
of the Act or any Federal statutes and regulations administered by other Federal agencies. or the 100 cm.) - with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and ifbang (21 er read in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A. Ulatowski Timothy Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
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Attachment E
510(k) Number (if known):
International Medsurg Connections Equipment Covers Device Name:
Indications For Use:
These equipment covers are equipment drapes or drapes and of natural or synthetic These equipment covers are equipment of are accessons final of the color control of the colors
materials intended to be used as protective patient covering such as to isolate materials intended to oc and other contamination.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
CONTINUE OF CONTINUE OF NEEDED) NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use
(Division Sign-Off)
Division of Dental, Infection Control, And General Hospital Devices
KO14239
510(k) Number
CONFIDENTIAL
Page 13 of 13
§ 878.4370 Surgical drape and drape accessories.
(a)
Identification. A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.(b)
Classification. Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.