(15 days)
The Convertors® Breathable Gowns are devices intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material.
The gowns are comprised of a single layer of spunlaced nonwoven fabric laminated to a breathable impervious film.
This document does not contain the requested information regarding acceptance criteria and a study proving device performance against those criteria.
The provided text is a 510(k) summary for a medical device (Convertors® Breathable Gowns). It focuses on:
- Device identification and classification.
- Statement of substantial equivalence to a predicate device based on similar intended use and performance attributes.
- Summary of biological qualification safety tests (cytotoxicity, sensitization, irritation/intracutaneous reactivity) conducted according to ISO 10993 Part-1. It states these materials were "found to be acceptable for the intended use" but does not define specific acceptance criteria or provide detailed performance data.
- FDA's response letter, confirming substantial equivalence and allowing the device to be marketed.
Missing Information:
The document lacks the following details typically expected for describing acceptance criteria and a study showing performance:
- A table of acceptance criteria and reported device performance: While it mentions biological qualification tests, it doesn't specify numerical or qualitative acceptance criteria (e.g., "cytotoxicity level must be below X" or "no irritation observed in Y% of subjects") nor does it provide the results of these tests in a comparative format.
- Sample size used for the test set and data provenance: No details on the number of samples or subjects used in the biological qualification tests, or the origin of this data (e.g., country, retrospective/prospective).
- Number of experts and their qualifications for ground truth: Not applicable for biological safety tests.
- Adjudication method: Not applicable for biological safety tests.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable for this type of device (surgical gown) and the described tests.
- Standalone (algorithm only) performance: Not applicable as this is not an AI-powered device.
- Type of ground truth used: Not explicitly defined beyond the "biological qualification safety tests" and "industry recognized test methods."
- Sample size for the training set: Not applicable as this is not an AI-powered device.
- How ground truth for the training set was established: Not applicable.
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AUG 12 1999
Allegiance
Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500 FAX: 847.785.2461
XII. SMDA REQUIREMENTS
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| Manufacturer: | Allegiance Healthcare CorporationOne Butterfield TrailEl Paso, Texas 79906 |
|---|---|
| Regulatory Affairs Contact: | Sharon Robbins1500 Waukegan Road MPWMMcGaw Park, IL 60085 |
| Telephone: | (847) 785-3311 |
| Date Summary Prepared: | June, 1999 |
| Common Name: | Convertors® Breathable Gowns |
| Classification: | Class II per 21CFR § 878.4040 |
| Predicate Device: | Convertors® Breathable Gowns. |
| Description: | The gowns are comprised of a single layer ofspunlaced nonwoven fabric laminated to abreathable impervious film. |
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Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500 FAX: 847.785.2461
SMDA REQUIREMENTS (continued) XII.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Convertors® Gowns
| Intended Use: | Surgical apparel are devices intended to beworn by operating room personnel duringsurgical procedures to protect both the surgicalpatient and the operating room personnel fromthe transfer of microorganisms, body fluids andparticulate material. |
|---|---|
| Substantial Equivalence: | The Convertors® gowns are substantiallyequivalent to the Convertors® Breathablegowns in that: |
| - the intended use is the same- the performance attributes are thesimilar | |
| Summary of testing: | All materials used in the fabrication of thisConvertors® Breathable Gowns were evaluatedthrough biological qualification safety tests asoutlined in ISO 10993 Part-1 "Biological Evaluationof Medical Devices". The biocompatibility testsperformed were cytotoxicity, sensitization, andirritation/ intracutaneous reactivity. Thesematerials also were tested in accordance withindustry recognized test methods and were foundto be acceptable for the intended use. |
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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 stylized eagle with three stripes forming its body and wings. The eagle is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the border of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 12 1999
Ms. Sharon Robbins Regulatory Affairs Manager Alleqiance Healthcare Corporation 1500 Waukegan Road, Building MP-WM McGaw Park, Illinois 60085
K992514 Re :
Trade Name: Convertors® Breathable Surgical Gowns Requlatory Class: II Product Code: FYA Dated: July 27, 1999 Received: July 28, 1999
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 controls provisions of the Act. The general controls provisions of the Act include requirements for annual reqistration, listing of devices, qood 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 Regulations, 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 Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action. 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
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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 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) 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 genera Other qeneral 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 Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the word "Allegiance" in a stylized font. The word is written in black and appears to be the logo of a company or organization. To the left of the word is a graphic of a plus sign made up of small dots.
Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500 FAX: 847.785.2461
Page 1 of 1
| 510(k) Number (if known): | Unknown K992514 |
|---|---|
| Device Name: | Convertors® Breathable Gowns |
| Indications For Use: | The Convertors® Breathable Gowns are devices intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE)
Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The Counter Use Prescription Use or (Per 21 CFR 801.109) 19 (Division Sign-Off)
Stronon Sign-Off)
Vision of Dental, Infection Control,
d General Hospital, Devices and General Hospital Device 510(k) Number
19
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.