(21 days)
The Convertors® 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 gowns are comprised of a single layer of spunlaced nonwoven fabric with a polyethylene reinforcement in the chest area and a breathable monolithic film in the sleeves.
The information provided describes the acceptance criteria and the study conducted for the Convertors® Surgical Gowns.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: No cytotoxicity | Acceptable (evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1) |
| Biocompatibility: No sensitization | Acceptable (evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1) |
| Biocompatibility: No irritation/intracutaneous reactivity | Acceptable (evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1) |
| Performance attributes (implied: protection from transfer of microorganisms, body fluids, and particulate material) | Acceptable (tested in accordance with industry recognized test methods and found to be acceptable for the intended use) |
| Substantially equivalent to predicate device (Convertors® Optima Gowns) | Determined to be substantially equivalent (intended use is the same, performance attributes are similar) |
2. Sample size used for the test set and data provenance
- Sample Size: The document does not specify a distinct "test set" sample size in terms of number of gowns. Instead, it states that "All materials used in the fabrication of this Convertors® Gowns were evaluated." This implies that material samples, rather than a fixed number of complete gowns, were subjected to the tests.
- Data Provenance: Not explicitly stated (e.g., country of origin). The testing was conducted by or on behalf of Allegiance Healthcare Corporation. The study appears to be prospective in the sense that the new gown design was tested for safety and performance.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts
- This information is not provided in the document. The tests performed are laboratory-based biological and performance assessments, not subjective evaluations requiring expert consensus on a "ground truth" for individual cases.
4. Adjudication method for the test set
- This information is not applicable as the tests performed are objective laboratory assessments (e.g., cytotoxicity, sensitization, irritation, physical performance attributes). There is no mention of human adjudication for these types of tests.
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, an MRMC comparative effectiveness study was not done. This device (surgical gowns) is not an AI-powered diagnostic or assistive technology that would involve human readers or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm performance study was not done. This device is a physical product (surgical gown) and does not involve an algorithm.
7. The type of ground truth used
- The "ground truth" for the performance and safety of the surgical gowns was established based on adherence to recognized industry standards (e.g., ISO 10993 Part-1 for biological evaluation) and approved test methods for material properties. The results of these objective laboratory tests served as the basis for determining acceptability.
8. The sample size for the training set
- This information is not applicable. The context is the testing of a physical medical device (surgical gown), not a machine learning model. Therefore, there is no "training set" in the sense of data used to train an algorithm.
9. How the ground truth for the training set was established
- This information is not applicable for the reasons stated in point 8.
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SEP 2 2 1999
4 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: | July, 1999 |
| Common Name: | Convertors® Surgical Gowns |
| Classification: | Class II per 21CFR § 878.4040 |
| Predicate Device: | Convertors® Optima Gowns. |
| Description: | The gowns are comprised of a single layer ofspunlaced nonwoven fabric with a polyethylenereinforcement in the chest area and abreathable monolithic film in the sleeves. |
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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) XII.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Convertors® Gowns
.
| Intended Use: | Surgical apparel are devices intended to be wornby operating room personnel during surgicalprocedures to protect both the surgical patientand the operating room personnel from thetransfer of microorganisms, body fluids andparticulate material. |
|---|---|
| Substantial Equivalence: | The Convertors® gowns are substantiallyequivalent to the Convertors® gowns in that:- the intended use is the same- the performance attributes are thesimilar |
| Summary of testing: | All materials used in the fabrication of thisConvertors® Gowns were evaluated throughbiological qualification safety tests as outlined in ISO10993 Part-1 "Biological Evaluation of MedicalDevices". The biocompatibility tests performed werecytotoxicity, sensitization, and irritation/intracutaneous reactivity. These materials also weretested in accordance with industry recognized testmethods and were found to be acceptable for theintended use. |
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. In the center of the seal is a stylized image of a bird or eagle with three curved lines representing its wings or feathers. The bottom of the seal has a wavy line design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 2 1999
Ms. Sharon Robbins Regulatory Affairs Manager Alleqiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787
Re : K992951 Covertors® Surgical Gowns Trade Name: Regulatory Class: II Product Code: FYA August 31, 1999 Dated: Received: September 1, 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, Druq, 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 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. ਬੋ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 requlatory 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) 594-4690. 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" (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,
Susan Runner
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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Allegiance
Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 473.1500 X: 847.785.2461
Page 1 of 1
510(k) Number (if known):
K942951 Unknown
Device Name:
Convertors® Surgical Gowns
Indications For Use:
The Convertors® 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.
Olin S. Lim
ivision of Dental, Infection Control, Anaral Hosni
(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
§ 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.