(103 days)
The Convertors® SMS Drapes and Accessories 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.
These drapes will be composed of a trilaminate Spunbond/Meltblown/Spunbond Polyolefin nonwoven fabric with an adhesively laminated reinforcement fabric around the fenestration.
The provided text describes the 510(k) summary for the Allegiance Convertors® SMS Drapes and Accessories. It outlines the device's intended use and claims of substantial equivalence to a predicate device, the Kimberly-Clark Evolution III Drapes. The testing described focuses on material properties and biocompatibility rather than a clinical performance study with human subjects or AI-assisted diagnostic tasks.
Therefore, many of the requested categories (such as MRMC study, effect size, human readers, training set details, and specific expert qualifications for ground truth in a clinical context) are not applicable to this submission.
Here is the information that can be extracted or deduced from the provided text:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Test Performed) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| Cytotoxicity | Met the requirements of the identified tests and found acceptable. |
| Sensitization | Met the requirements of the identified tests and found acceptable. |
| Irritation/Intracutaneous Reactivity | Met the requirements of the identified tests and found acceptable. |
| Physical Properties: | |
| Flammability | Performed; met the requirements of the identified tests and found acceptable. |
| Hydrostatic Head | Performed; met the requirements of the identified tests and found acceptable. |
| Impact Penetration | Performed; met the requirements of the identified tests and found acceptable. |
| Alcohol Repellency | Performed; met the requirements of the identified tests and found acceptable. |
| Elmendorf Tear | Performed; met the requirements of the identified tests and found acceptable. |
| Tensile Strength | Performed; met the requirements of the identified tests and found acceptable. |
| Overall Equivalence: | |
| Intended Use | Same as predicate device (Kimberly-Clark SMS (Evolution III) drapes). |
| Performance attributes | Similar to predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample size: Not specified. The testing was conducted on material samples, not on a human patient population.
- Data provenance: Not specified. This was material testing, not human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The ground truth for this device involved laboratory testing against material standards, not expert medical opinion on clinical cases. The tests were likely conducted by qualified laboratory personnel.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical diagnostic studies involving human readers and interpretation. This submission describes physical and biological material 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:
- No MRMC comparative effectiveness study was done. This device is a surgical drape, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical product (surgical drape), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth was established by recognized industry standards and test methodologies for biocompatibility and physical material properties, as outlined in ISO 10993 Part-1 "Biological Evaluation of Medical Devices" and other unspecified physical test standards.
8. The sample size for the training set:
- Not applicable. This device is a physical product, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. No training set was used.
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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 CorporationConvertors® OperationsOne Butterfield TrailEl Paso, Texas 79906 |
|---|---|
| Regulatory Affairs Contact: | Sharon RobbinsAllegiance Healthcare Corporation1500 Waukegan Road MPKMcGaw 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 trilaminateSpunbond/Meltblown/Spunbond Polyolefinnonwoven fabric with an adhesively laminatedreinforcement fabric around the fenestration. |
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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.
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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
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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
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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
§ 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.