(18 days)
The Convertors® Fabric-Reinforced 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 Optima® as the base fabric. The gowns are fabric-reinforced with a layer of nonwoven in the body area.
The provided text describes a 510(k) summary for "Convertors® Fabric-Reinforced Gowns" and focuses on their substantial equivalence to a predicate device, as well as biocompatibility testing of the materials. It does not contain information about acceptance criteria or a study demonstrating the device meets those criteria in the context of device performance as would typically be presented for efficacy or diagnostic accuracy.
Therefore, many of the requested sections regarding device performance, sample sizes, expert ground truth, adjudication, MRMC studies, and standalone algorithm performance cannot be extracted from this document as they are not present.
However, I can provide what is available regarding testing and equivalence:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria for device performance (e.g., barrier effectiveness, strength) or report specific device performance metrics against such criteria in a measurable way. Instead, it states that:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility as per ISO 10993 Part-1 | Materials found to be "acceptable for the intended use" based on cytotoxicity, sensitization, and irritation/intracutaneous reactivity tests. |
| Compliance with "industry recognized test methods" | Materials found to be "acceptable for the intended use." |
| Intended Use as surgical apparel | "the intended use is the same" as the predicate device. |
| Performance attributes similar to predicate device | "the performance attributes are similar" to the predicate device. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document only mentions "All materials used...were evaluated through biological qualification safety tests" and "materials also were tested in accordance with industry recognized test methods." No details on sample sizes or data provenance are given for these tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The tests mentioned (biocompatibility, industry-recognized methods) would typically involve laboratory analysis and standardized protocols rather than expert clinical assessment of "ground truth" in the way it's usually defined for AI/diagnostic devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
This is not applicable as the device is a surgical gown, not an AI-assisted diagnostic or decision-making tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a surgical gown, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the biocompatibility tests, the "ground truth" would be the results of standardized biological assays (e.g., cell viability in cytotoxicity, skin reaction in sensitization/irritation). For the "industry recognized test methods," the ground truth would be the results of those specific physical/barrier property tests, compared against established standards. The document does not provide details on these specific standards or assay results.
8. The sample size for the training set
This is not applicable as the device is a surgical gown and does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
This is not applicable as the device is a surgical gown and does not involve a "training set" or ground truth establishment in the context of machine learning or AI.
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APR 16 999
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
| 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: | March 1999 |
| Common Name: | Convertors® Fabric-Reinforced Gowns |
| Classification: | Class II per 21CFR § 878.4040 |
| Predicate Device: | Convertors® Optima® Fabric-ReinforcedGowns. |
| Description: | The gowns are comprised of a single layer ofOptima® as the base fabric. The gowns arefabric-reinforced with a layer of nonwovenin the body area. |
| 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. |
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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
| Substantial Equivalence: | The Convertors® gowns are substantiallyequivalent to the Convertors® Optima®fabric-reinforced gowns in that:- the intended use is the same- the performance attributes aresimilar |
|---|---|
| Summary of testing: | All materials used in the fabrication of thisConvertors® Gowns 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 and Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" surrounding it. The text is written in a simple, sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 16 1999
Ms. Sharon Robbins Allegiance Healthcare Corporation 1500 Waukeqan Road MPWM McGaw Park, Illinois 60085-6787
Re : K991034 Trade Name: Convertors® Surqical Gowns - Fabric -Reinforced Regulatory Class: II Product Code: FYA Dated: March 25, 1999 Received: March 29, 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 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 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 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 regulation 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) 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 ons 20gation" (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
Timothy A 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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:
:
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 K991034 |
|---|---|
| Device Name: | Convertors® Fabric Reinforced Gowns |
| Indications For Use: | The Convertors® Fabric-Reinforced 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)
| Prescription Use(Per 21 CFR 801.109) | or | Over-The Counter Use X |
|---|---|---|
| ------------------------------------------ | ---- | ------------------------------------------------------------------------ |
| (Division Sign-Off) | |
|---|---|
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K991034 |
§ 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.