(9 days)
The Convertors®Breathable Surgical 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 Breathable Surgical Gown consists of an outer and inner layer of spunmelt polyolefin nonwoven fabric with a middle layer of breathable monolithic film throughout the entire gown. The Breathable Sleeve Surgical Gown consists of sleeves containing a an outer and inner layer of spunmelt polyolefin nonwoven fabric with a middle layer of breathable monolithic film with a gown body comprised of spunmelt nonwoven (SMS) with a polyolefin-based film reinforcement.
The submission for the Convertors® Breathable Surgical Gowns and Breathable Sleeve Surgical Gowns is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a predicate device rather than providing extensive clinical study data to meet specific quantitative performance acceptance criteria. Therefore, much of the requested information regarding detailed study methodology, sample sizes for test/training sets, expert adjudication, MRMC studies, or standalone algorithm performance is not applicable to this type of submission for this particular device.
However, based on the provided text, I can extract the following relevant information regarding the device's assessment:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (What was tested) | Reported Device Performance (Outcome) |
|---|---|
| Biocompatibility Tests: | |
| - Cytotoxicity | Materials were evaluated and found acceptable. |
| - Sensitization | Materials were evaluated and found acceptable. |
| - Irritation/Intracutaneous Reactivity | Materials were evaluated and found acceptable. |
| Functional/Performance Attributes (Implied) | Similar to the predicate device, found acceptable for intended use. |
| Intended Use (Same as predicate) | Protect both surgical patient and operating room personnel from transfer of microorganisms, body fluids, and particulate material. (Device aligns with this intended use). |
| Substantial Equivalence (Overall claim) | Determined to be substantially equivalent to the Convertors® Breathable Surgical Gowns. |
2. Sample size used for the test set and the data provenance:
- The document mentions "All materials used in the fabrication of this Convertors® Breathable Gowns were evaluated". This indicates material-level testing rather than a patient- or case-based "test set" in the context of AI/diagnostic devices. The sample size for material testing (e.g., number of material samples) is not specified.
- Data provenance is not specified (e.g., country of origin). The testing is described as in accordance with "industry recognized test methods."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a surgical gown, and its evaluation focuses on material properties and biocompatibility, not on diagnostic accuracy requiring expert interpretation of medical images or data. Ground truth for biocompatibility is typically established through standardized laboratory tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are relevant for subjective interpretations of data, such as in diagnostic imaging. Biocompatibility tests have objective endpoints.
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:
- Not applicable. This is a surgical gown, not an AI-powered diagnostic tool requiring human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device (surgical gown), not an algorithm or AI system.
7. The type of ground truth used:
- For biocompatibility tests, the ground truth is established by the results of standardized biological qualification safety tests as outlined in ISO 10993 Part-1 "Biological Evaluation of Medical Devices." This includes objective measurements for cytotoxicity, sensitization reactions, and irritation/intracutaneous reactivity.
- For performance attributes, the "ground truth" is adherence to industry-recognized test methods for material properties, which are then compared to the predicate device.
8. The sample size for the training set:
- Not applicable. This submission is for a physical medical device (surgical gown) and does not involve machine learning or a "training set."
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
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OCT 02 2002
Allegiance
Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500 FAX: 847.785.2461
KO23167
SMDA REQUIREMENTS
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Convertors® Breathable Surgical Gowns and Breathable Sleeve Surgical Gowns
| Manufacturer: | Allegiance Healthcare CorporationOne Butterfield TrailEl Paso, Texas 79906 |
|---|---|
| Regulatory Affairs Contact: | Sharon Nichols1500 Waukegan Road MPWMMcGaw Park, IL 60085 |
| Telephone: | (847) 785-3311 |
| Date Summary Prepared: | September, 2002 |
| Common Name: | Convertors®Breathable Surgical Gownsand Breathable Sleeve Surgical Gowns |
| Classification: | Class II per 21CFR § 878.4040 |
| Predicate Device: | Convertors® Breathable Surgical Gowns. |
| Description: | The Breathable Surgical Gown consists of anouter and inner layer of spunmelt polyolefinnonwoven fabric with a middle layer ofbreathable monolithic film throughout the entiregown. The Breathable Sleeve Surgical Gownconsists of sleeves containing a an outer andinner layer of spunmelt polyolefin nonwovenfabric with a middle layer of breathablemonolithic film with a gown body comprised ofspunmelt nonwoven (SMS) with a polyolefin-based film reinforcement. |
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Allegiance
Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847 473 1500 FAX: 847.785.2461
SMDA REQUIREMENTS (continued)
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Convertors® Breathable Surgical Gowns
Surgical apparel are devices intended to be worn Intended Use: by operating room personnel during surgical procedures to protect both the surqical patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material.
- Substantial The Convertors® gowns are substantially Equivalence: equivalent to the Convertors® Breathable gowns in that:
- the intended use is the same
- the performance attributes are similar
- Summary of testing: All materials used in the fabrication of this Convertors®Breathable Gowns 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 irritation/ intracutaneous reactivity. These materials also were tested in accordance with industry recognized test methods 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 logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 02 2002
Ms. Sharon Nichols Regulatory Affairs Manager Allegiance Healthcare Corporation 1500 Waukegan Road, Building WM McGaw Park, Illinois 60085-6787
Re: K023167
Trade/Device Name: Convertors® Breathable Surgical Gowns Regulation Number: 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: 79 FYA Dated: September 20, 2002 Received: September 23, 2002
Dear Ms. Nichols:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Nichols
Please be advised that FDA's issuance of a substantial equivalence determination docs not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618 . 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Allegiance
Allegiance Healthcare 500 Waukenan Roa
Page 1 of 1
510(k) Number (if known):
KO23167 Накнөни
Device Name:
Indications For Use:
Convertors®Breathable Surgical Gowns
The Convertors®Breathable Surgical 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
Olia Sizin
General Hospital, ntrol Dental
510(k) Number: K023167
§ 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.