(49 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of the drape materials, with no mention of AI or ML.
No.
The Convertors® Trilaminate Drapes are described as protective patient coverings intended to isolate a surgical site from contamination, which falls under the category of maintaining sterility during procedures rather than directly treating or diagnosing a disease or condition.
No
The device is described as a protective patient covering (drape) used to isolate a surgical site, and its description and performance studies focus on material properties and biocompatibility, not on diagnosing medical conditions.
No
The device description clearly states it is composed of nonwoven fabrics and a synthetic polymer film, indicating it 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: 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 on a patient's body.
- Device Description: The description details the materials used to create a physical drape.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used for diagnostic purposes by analyzing samples taken from the body. This device is a physical barrier used on the body during a procedure.
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
KKX
Device Description
These drapes will be composed of nonwoven fabrics adhesively laminated to a synthetic polymer film. The film is a finely embossed blended polyethylene construction. The drapes 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
All materials used in the fabrication of the Convertors® Trilaminate drapes were evaluated through biological qualification safety tests as outlined 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 for hydrostatic head. impact penetration, synthetic blood penetration (ASTM 1670-1995), Phi X174 (ASTM 1671-1995), Grab Tensile, Basis Weight, and flammability, Class 1. These materials have met the requirements of the identified tests and were found to be acceptable for the intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Convertors® Drape Materials
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
JUL 10 1998
Allegiance
Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500 FAX: 847.785.2461
SMDA REQUIREMENTS XII.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Convertors® Trilaminate Drapes
| Manufacturer: | Allegiance Healthcare Corporation
Convertors® Operations
One Butterfield Trail
El Paso, Texas 79906 |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Affairs Contact: | Sharon Robbins
Allegiance Healthcare Corporation
1500 Waukegan Road MPWM
McGaw Park, IL 60085 |
| Telephone: | (847) 785-3311 |
| Date Summary Prepared: | May 1998 |
| Common Name: | Convertors® Trilaminate Drapes |
| Classification: | Class II per 21CFR § 878.4370 |
| Predicate Device: | Convertors® Drape Materials |
| Description: | These drapes will be composed of nonwoven
fabrics adhesively laminated to a synthetic
polymer film. The film is a finely embossed
blended polyethylene construction. The drapes
also have clear polyethylene side panels on
either end of the drapes. |
1
Allegiance
Allegiance Healthcare Corporation 1500 Waukegan Road AcGaw Park. Illinois 60085-6787 847.473.1500 AX: 847.785.2461
SMDA REQUIREMENTS (continued) XII.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Convertors® Trilaminate Drapes
The Convertors® Trilaminate Drapes are devices Intended Use: intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The Convertors® Trilaminate Drapes are Substantial Equivalence:
substantially equivalent to the Convertors® 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 in in ISO 10993 Part-1 "Biological outlined 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 for hydrostatic head. impact penetration, synthetic blood penetration (ASTM 1670-1995), Phi X174 (ASTM 1671-1995), Grab Tensile, Basis Weight, and flammability, Class 1. These materials have met the requirements of the identified tests and were found to be acceptable for the intended use.
2
XIII. SAMPLE
A prototype drawing of a drape has been provided (enclosed) to visually assist with the review. (See Appendix K).
KIT CERTIFICATION XIV.
This submission is for drapes only. This submission is not for a kit or tray. As with the predicate device, these drapes will be placed in kits and trays that are already cleared through the premarket notification process or are exempt per the Convenience Kit Guidance dated 5/97 which allow drapes to be placed in kits and trays.
21 CFR 807.95 -CONFIDENTIALITY XIV.
Allegiance Healthcare Corporation regards its intent to market the Convertors® drape material as confidential commercial information. We have not divulged this intent to market information to anyone other than Allegiance employees and even then on a need-to-know basis. Therefore, we request that FDA treat this information in a confidential manner.
3
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 0 1998
Ms. Sharon Robbins ·Regulatory Affairs Manager Alleqiance Healthcare Corporation 1500 Waukegan Road MPWM McGaw Park, Illinois 60085-6787
K981818 Re : Convertors® Trilaminate Drapes Trade Name: Requlatory Class: II Product Code: KKX Dated: May 21, 1998 Received: May 22, 1998
Dear Ms. Robbins:
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 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). You may, therefore, market the device, subject to the general The general controls controls provisions of the Act. 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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 In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531
4
Page 2 - Ms. Robbins
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA asboing 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) 594-4692. 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 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/dsma/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
5
Image /page/5/Picture/0 description: The image shows the word "Allegiance" in a bold, sans-serif font. To the left of the word is a graphic of a cluster of dots arranged in a diamond shape. The word is slightly slanted to the right, giving it a dynamic appearance. The overall impression is one of strength and stability.
Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 17.473.1500 FAX: 847.785.2461
Page 1 of 1
510(k) Number (if known):
Unknown
Convertors® Trilaminate Drapes
Indications For Use:
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Device Name:
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)
1
Prescription Use (Per 21 CFR 801.109) or
Over-The-Counter Use X
Olin S. Lim
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devi 510(k) Number