(123 days)
Not Found
Not Found
No
The device description and performance studies focus on the material properties and biocompatibility of surgical drapes, with no mention of AI or ML.
No
The device is described as a protective patient covering to isolate a surgical site from contamination, which is a barrier function, not a therapeutic one. It does not actively treat, diagnose, mitigate, or prevent disease or injury in a therapeutic sense.
No
This device is a protective patient covering (surgical drape) used to isolate a surgical site from contamination, not to diagnose a condition.
No
The device description clearly states it is comprised of physical materials (polyolefin-based nonwovens and film, polyethylene panels), indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination." This describes a physical barrier used during a medical procedure, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details the materials and construction of a drape, which is consistent with a physical barrier.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
Therefore, the Convertors® Trilaminate Drapes fall under the category of a general medical device used for patient protection during surgery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Convertors®Trilaminate Drapes are devices 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 (comma separated list FDA assigned to the subject device)
KKX
Device Description
These drapes will be comprised of an outer and inner layer of polyolefin-based nonwovens with an inner layer of polyolefin-based film. Several drapes will also have clear polyethylene side panels on either end of the drapes.
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
Summary of testing: All materials used in the fabrication of the Convertors® Trilaminate drapes were evaluated through biological qualification safety tests as outlined in in ISO 10993 Part-1 "Biological Evaluation of Medical Devices". The biocompatibility tests performed were cytotoxicity, sensitization, and intracutaneous reactivity. These materials also were tested in accordance with industry recognized test methods. These materials have met the requirements of the identified tests and were found to be acceptable for the intended use.
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.
Convertors®Trilaminate Drapes
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
§ 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
Image /page/0/Picture/1 description: The image shows the word "Allegiance" in a bold, sans-serif font. To the left of the word is a symbol that resembles a plus sign, but it is made up of many small dots. The symbol is slightly tilted to the left. The word "Allegiance" is written in all capital letters.
FEB 1 1 2003
Allegiance Healthcare
1500 Waukegan Road
McGaw Park, IL 60085
tel 847.785.3311
fax 847.785.2461
SMDA REQUIREMENTS
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Convertors® Trilaminate Drapes
Sponsor:
Allegiance Healthcare Corporation 1500 Waukegan Road MPWM McGaw Park, IL 60085
| Regulatory Affairs Contact: | Sharon Nichols |
|---|---|
| Telephone: | (847) 785-3311 |
| Date Summary Prepared: | September, 2002 |
| Common Name: | Convertors®Trilaminate Drapes |
| Classification: | Class II per 21CFR § 878.4370 |
| Predicate Device: | Convertors®Trilaminate Drapes |
| Description: | These drapes will be comprised of an outer and |
| inner layer of polyolefin-based nonwovens with | |
| an inner layer of polyolefin-based film. Several | |
| drapes will also have clear polyethylene side | |
| panels on either end of the drapes. |
1
Image /page/1/Picture/1 description: The image shows the logo for Allegiance Health. The logo consists of a stylized cross made up of small squares on the left, followed by the word "Allegiance" in a bold, sans-serif font. The word is slightly slanted to the right, giving it a dynamic appearance.
Allegiance Healthcare
1500 Waukegan Road
McGaw Park, IL 60085
tel 847.785.3311
fax 847.785.2461
SMDA REQUIREMENTS (continued)
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Convertors®Trilaminate Drapes
Intended Use: The Convertors®Trilaminate Drapes are devices 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 Convertors® Trilaminate Drapes are substantially equivalent to the Convertors® trilaminate drape materials in that:
- the intended use is the same
- the performance attributes are similar
Summary of testing: All materials used in the fabrication of the Convertors® Trilaminate drapes were evaluated through biological qualification safety tests as outlined in in ISO 10993 Part-1 "Biological Evaluation of Medical Devices". The biocompatibility tests performed were cytotoxicity, sensitization, and intracutaneous reactivity. These materials also were tested in accordance with industry recognized test methods. These materials have met the requirements of the identified tests and were found to be acceptable for the intended use.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a symbol consisting of three stylized human profiles facing to the right, stacked on top of each other. The profiles are simple and abstract, with only the outline of the face and neck visible.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FFB 1 1 2003
Ms. Sharon Nichols Regulatory Affairs Manager Allegiance Healthcare Corporation 1500 Waukegan Road, Building WM McGaw Park, Illinois 60085
Re: K023419
Trade/Device Name: Convertors® Trilaminate Drapes Regulation Number: 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: November 14, 2002 Received: November 15, 2002
Dear Ms. Nichols:
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 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 (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.
3
Page 2 - Ms. Nichols
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 of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply 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 requirements as set forth 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), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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.
Susan Rannes
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Image /page/4/Picture/0 description: The image shows the word "Allegiance" in a bold, sans-serif font. To the left of the word is a symbol resembling a plus sign, but it is made up of many small squares. The word "Allegiance" is written in a slightly slanted, italicized style.
Cardinal Health company
Allegiance Healthcare
1500 Waukegan Road
McGaw Park, IL 60085
tel 847.785.3311
fax 847.785.2461
Page 1 of 1
510(k) Number (if known):
Device Name:
Convertors®Trilaminate Drapes
Indications For Use:
The Convertors®Trilaminate Drapes are devices intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
or
53
Over-The-Counter Use
Oim S. Cim
(Division Sign-Off) Division of Anesthesiology, General Hospital. Infection Control. Denta
510(k) Number: K023419