(55 days)
Not Found
No
The device description and performance studies focus on material properties and physical performance, with no mention of AI/ML or related concepts like image processing, training sets, or performance metrics associated with AI/ML algorithms.
No
The device, equipment covers, are protective barriers used during surgery to maintain a sterile field, not to treat a disease or condition in a patient.
No
Explanation: The device is described as equipment covers/drapes intended to be used as a protective patient covering to isolate a surgical site, which is a barrier function, not a diagnostic one. No diagnostic capabilities or claims are mentioned.
No
The device description clearly states the equipment covers are made of polyethylene and are physical equipment drapes, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that these are "equipment covers" or "equipment drapes" used as a "protective patient covering" to isolate a surgical site. This describes a physical barrier used during a medical procedure.
- Device Description: The description confirms they are made of polyethylene and are covers.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. IVDs are typically used in laboratories or point-of-care settings for analysis of biological samples.
The description aligns with a Class I or Class II medical device used for infection control during surgery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
MMP, KXX
Device Description
The International Medsurg Connections equipment covers are made of polyethylene. The covers are offered sterile and non-sterile.
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 following tests were performed on the finished Medsurg equipment covers:
Test Method: Flammability Testing, Class 1; Standard Used: 16 CFR 1610
Test Method: Hyrostatic Pressure Test - Fluid Penetration Test; Standard Used: AATCC Test Method 127-1989
Test Method: Grab Tensile; Standard Used: ASTM D882-91
Test Method: Tear Resistance - Strip Tensile; Standard Used: ASTM D1424-96
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 102
Schaumburg, Illinois 60173-5921 |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------|
| Regulatory Affairs Contact: | Michele Vovolka
P.O. Box 848
Grayslake, 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
:
2
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
3
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
4
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
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