(103 days)
,
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of the drape material, 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 rather than a therapeutic one.
No
Explanation: The device is described as a protective patient covering for surgical sites, intended to isolate against contamination. Its description and performance studies focus on material properties, biocompatibility, and physical integrity, not on detecting, monitoring, or predicting health conditions or diseases.
No
The device description clearly states it is composed of fabric and includes physical performance testing, indicating it is a physical medical device, 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, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on the physical composition of the drape (fabric, reinforcement, adhesive). This aligns with a physical barrier device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information. The testing described focuses on physical properties and biocompatibility, which are relevant for a surgical drape.
Therefore, the Convertors® SMS Drapes and Accessories are medical devices, but they do not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Convertors® SMS Drapes and Accessories Intended Use: 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 a trilaminate Spunbond/Meltblown/Spunbond Polyolefin nonwoven fabric with an adhesively laminated reinforcement fabric around the fenestration.
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)
The Convertors® Drape material is substantially equivalent to the Kimberly-Clark SMS (Evolution III) drapes:
- the intended use is the same
- the performance attributes are similar
All materials used in the fabrication of this Convertors drape materials were evaluated through biological qualification safety tests as outlined in the ISO 10993 Part-1 "Biological Evaluation of of of Medical Devices". The biocompatibility tests were cytotoxicity, sensitization, and and irritation/ intracutaneous reactivity. Flammability testing was performed. The physical tests performed on the SMS material were hydrostatic head, impact penetration, alcohol repellency, elmendorf tear and tensile. These materials have met the arab 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)
Kimberly-Clark Evolution III Drapes
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
MAY 27 1997
Allegiance
Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500 FAX: 847.785.2460
XII. SMDA REQUIREMENTS
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Convertors® SMS Drapes and Accessories
| Manufacturer: | Allegiance Healthcare Corporation
Convertors® Operations
One Butterfield Trail
El Paso, Texas 79906 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Affairs Contact: | Sharon Robbins
Allegiance Healthcare Corporation
1500 Waukegan Road MPK
McGaw Park, IL 60085 |
| Telephone: | (847) 785-3311 |
| Date Summary Prepared: | January, 1997 |
| Common Name: | Convertors® SMS Drapes and Accessories |
| Classification: | Class II per 21CFR § 878.4370 |
| Predicate Device: | Kimberly-Clark Evolution III Drapes |
| Description: | These drapes will be composed of a trilaminate
Spunbond/Meltblown/Spunbond Polyolefin
nonwoven fabric with an adhesively laminated
reinforcement fabric around the fenestration. |
1
Allegiance
Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847 473 1500 FAX: 847.785.2460
SMDA REQUIREMENTS (continued) XII.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Convertors® SMS Drapes and Accessories
The Convertors® SMS Drapes and Accessories Intended Use: 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:
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Summary of testing:
The Convertors® Drape material is substantially equivalent to the Kimberly-Clark SMS (Evolution III) drapes:
-
the intended use is the same
-
the performance attributes are similar
All materials used in the fabrication of this Convertors drape materials were evaluated through biological qualification safety tests as outlined in the ISO 10993 Part-1 "Biological Evaluation of of of Medical Devices". The biocompatibility tests were cytotoxicity, sensitization, and and irritation/ intracutaneous reactivity. Flammability testing was performed. The physical tests performed on the SMS material were hydrostatic head, impact penetration, alcohol repellency, elmendorf tear and tensile. These materials have met the arab requirements of the identified tests and were found to be acceptable for the intended use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus-like symbol with three parallel lines forming a wing-like shape. Encircling the symbol are the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 27 1997
Ms. Sharon Robbins Regulatory Affairs Manager Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787
K970554 Re : Convertors SMS Drapes Trade Name: Requlatory Class: II Product Code: KKX April 1, 1997 Dated: Received: April 29, 1997
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 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 controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of t 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 Good Manufacturing Practice 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 requlation 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
3
Page 2 - Ms. Robbins
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) Additionally, for questions on the promotion and 594-4692. 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,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/17 description: The image shows the word "Allegiance" in a bold, sans-serif font. To the left of the word is a square made up of smaller squares. The word is in black and the background is white.
Allegiance Healthcare Corpora 1500 Waukegan Road AcGaw Park, Illinois 60085-6787 47.473.1500 FAX: 847.785.2460
Page 1 of 1
1 11:44
510(k) Number (if known):
Unknown K470554
Device Name:
Convertors® SMS Drapes and
Indications For Use:
The Convertors® SMS Drapes and Accossonies are 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
Olin S. Lim
(Division Sign-Off) Division of Dental, Infection Control. and General Hospital Devic
510(k) Number K970554