(94 days)
The Kimberly-Clark* MicroCool* Surgical Gown, Breathable High Performance, KC 400 (hereinafter referred to as "MicroCool* Surgical Gown") are sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter. The MicroCool* Surgical Gowns meet the Level 4 requirements of the AAMI PB70: 2003 Liquid Barrier classifications.
The MicroCool* Surgical Gowns are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and Ethylene Oxide (EtO) sterilization.
The MicroCool* Surgical Gown is manufactured from a breathable, repellent, non-woven, polypropylene fabric. The fabric is a threelayer lamination that resists tearing and penetration by liquids. The gown is constructed from a spunbond/film/spunbond design and is adhesively laminated. The spunbond layers are comprised of nonwoven polypropylene. The film layer is a multi-layer polypropylene olefin, breathable film. A fluorochemical treatment is added to the film to retard penetration by low surface tension fluids. A polyolefin hot melt adhesive is used to laminate the Spunbond facing lavers to the film layer to complete the composite. A new sleeve design was incorporated to meet Level 4 of the AAMI Liquid Barrier classifications.
The request is for information regarding acceptance criteria and a study proving device performance, relevant to a medical device. However, the provided text describes a Kimberly-Clark MicroCool Surgical Gown, which is a physical product (surgical apparel), not a diagnostic algorithm or AI device that would typically have the requested criteria like "test set," "ground truth," "MRMC study," or "training set."
Therefore, the specific information requested in points 2, 3, 4, 5, 6, 7, 8, and 9 for an AI/algorithm-based device is not applicable to this submission.
Here's the closest interpretation of the provided text in relation to the request:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from ANSI/AAMI PB70: 2003 Level 4 Liquid Barrier) | Reported Device Performance |
|---|---|
| Liquid Barrier Classification: Level 4 (highest level) | Meets Level 4 requirements of AAMI PB70: 2003 Liquid Barrier classifications. |
| Resistance to penetration by blood-borne pathogens (ASTM1671:2003, using Phi-X174 bacteriophage) | Meets requirements of ASTM1671:2003. |
| Flame Resistance | Meets requirements of Flame Resistant CPSC 1610 Class 1. |
| Biocompatibility (ISO 10993 for surface devices with limited contact with breached or compromised surfaces) | Meets biocompatibility requirements of ISO 10993. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This device is a physical product, not an algorithm, so "test set" in the context of data provenance is not relevant. The testing involved physical samples of the gowns. The document does not specify the number of gowns or material samples tested for each criterion, nor their provenance in the sense of data origin.
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)
- Not applicable. "Ground truth" in the context of expert review is for classification or diagnostic tasks. For physical product performance, the "ground truth" is defined by the objective performance standards themselves (e.g., AAMI PB70, ASTM1671, CPSC 1610, ISO 10993) and measured through standardized laboratory tests. The experts involved would be laboratory technicians or engineers performing the tests, but no "ground truth" establishment by medical experts is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically used for reconciling disagreements among human readers or expert reviewers in diagnostic studies. For standardized physical product testing, the results are typically quantitative measurements against defined thresholds, not subjective interpretations requiring adjudication.
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. An MRMC study is for evaluating diagnostic performance, often involving AI assistance to human readers. This device is a surgical gown, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This concept applies to AI algorithms, not physical medical devices like surgical gowns.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Performance standards and laboratory test results. For this device, the "ground truth" is established by the specified industry standards (e.g., AAMI PB70 Level 4 for liquid barrier, ASTM1671 for viral penetration, CPSC 1610 for flame resistance, ISO 10993 for biocompatibility). The device's performance is objectively measured against these established-in-standard criteria in a laboratory setting.
8. The sample size for the training set
- Not applicable. This concept applies to machine learning models, not physical products.
9. How the ground truth for the training set was established
- Not applicable. This concept applies to machine learning models, not physical products.
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510(k) Summary for the Kimberly-Clark* MicroCool* Surgical Gowns. Breathable High Performance. KC400
Intended Use: The Kimberly-Clark* MicroCool* Surgical Gown, Breathable High Performance, KC 400 (hereinafter referred to as "MicroCool* Surgical Gown") are sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter. The MicroCool* Surgical Gowns meet the Level 4 requirements of the AAMI PB70: 2003 Liquid Barrier classifications.
The MicroCool* Surgical Gowns are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and Ethylene Oxide (EtO) sterilization.
Device Description The MicroCool* Surgical Gown is manufactured from a breathable, repellent, non-woven, polypropylene fabric. The fabric is a threelayer lamination that resists tearing and penetration by liquids. The gown is constructed from a spunbond/film/spunbond design and is adhesively laminated. The spunbond layers are comprised of nonwoven polypropylene. The film layer is a multi-layer polypropylene olefin, breathable film. A fluorochemical treatment is added to the film to retard penetration by low surface tension fluids. A polyolefin hot melt adhesive is used to laminate the Spunbond facing lavers to the film layer to complete the composite. A new sleeve design was incorporated to meet Level 4 of the AAMI Liquid Barrier classifications.
Substantial Equivalence: The MicroCool* Surgical Gown that is the subject of this 510(k) is substantially equivalent to the predicate Kimberly-Clark* MicroCool* Surgical Gown (K981393) in intended use, design, materials, and biocompatibility attributes. The performance attributes of the MicroCool* Surgical Gown are substantially equivalent to the predicate gown with the exception that this MicroCool* Surgical Gown meets the AAMI Level 4 liguid barrier requirement.
Summary of Testing: The Kimberly-Clark* MicroCool* Surgical Gown has been tested in compliance with the requirements of Level 4 liquid barrier performance of ANSI/AAMI PB70: 2003 "Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities." The MicroCool* Surgical Gown also meets the requirements of ASTM1671:2003 Standard test method for resistance of materials used in protective clothing to penetration by blood-borne pathogens using Phi-X174 bacteriophage penetration as a test system. The MicroCool* Surgical Gown meets the requirements of Flame Resistant CPSC 1610 Class 1. The MicroCool* Surgical Gown has been tested in compliance with the biocompatibility requirements of ISO 10993 for surface devices with limited contact with breached or compromised surfaces. " Registered Trademark of Kimberly-Clark Worldwide. Inc. or its affiliates.
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The text is in all caps and is relatively small compared to the eagle symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. David M. Lee Associate Director of Regulatory Affairs Kimberly-Clark Corporation 1400 Holcomb Bridge Road Building 300, #1092 Roswell, Georgia 30076
Re: K091357
Trade/Device Name: MicroCOOL* Surgical Gowns, Breathable High Performance, KC400
Regulation Number: 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: July 14, 2009 Received: July 16, 2009
Dear Mr. Lee:
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 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- Mr. Lee
Please be advised that FDA's issuance of a substantial equivalence determination does 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRH Offices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Centron v. Wilson for
S. D. S. M.
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): __
Device Name: MicroCOOL* Surgical Gowns, Breathable High Performance, KC400
Indications for Use:
The Kimberly-Clark* MicroCOOL* Surgical Gowns, are sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter. The MicroCool* Surgical Gown meets the Level 4 requirements of the AAMI Liquid Barrier classifications.
The Kimberly-Clark* MicroCool* Surgical Gowns are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and Ethylene Oxide (EtO) sterilization.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shula H. Murphy, MD
Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
0(k)Number: K091357
Page 1 of 2 - Section 5. Indications for Use
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Addendum
The MicroCOOL* Surgical Gowns are available under the following Reference Numbers and descriptions.
| NewProductOASISCode | Product Description |
|---|---|
| Sterile Codes | |
| 92038 | MicroCool* Surgical Gown, Breathable High Performance, KC400, Large, X-Long |
| 92042 | MicroCool* Surgical Gown, Breathable High Performance, KC400, X-Large, X-Long |
| 92320 | MicroCool* Surgical Gown, Breathable High Performance, KC400, Large, with Secure-Fit |
| 92321 | MicroCool* Surgical Gown, Breathable High Performance, KC400, X-Large, with Secure-Fit |
| 92323 | MicroCool* Surgical Gown, Breathable High Performance, KC400, XX-Large, with Secure-Fit |
| 92330 | MicroCool* Surgical Gown, Breathable High Performance, KC400, Large, Specialty, with Secure-Fit |
| 92331 | MicroCool* Surgical Gown, Breathable High Performance, KC400, X-Large, Specialty, with Secure-Fit |
| 92333 | MicroCool* Surgical Gown, Breathable High Performance, KC400, XX-Large, Specialty, with Secure-Fit |
| 92336 | MicroCool* Surgical Gown, Breathable High Performance, KC400, Small |
| 92338 | MicroCool* Surgical Gown, Breathable High Performance, KC400, Small, with Secure-Fit |
| 92340 | MicroCool* Surgical Gown, Breathable High Performance, KC400, Large |
| 92342 | MicroCool* Surgical Gown, Breathable High Performance, KC400, X-Large |
| 92344 | MicroCool* Surgical Gown, Breathable High Performance, KC400, XX-Large |
| 92351 | MicroCool* Surgical Gown, Breathable High Performance, KC400, Large, Specialty |
| 92353 | MicroCool* Surgical Gown, Breathable High Performance, KC400, X-Large, Specialty |
| 92354 | MicroCool* Surgical Gown, Breathable High Performance, KC400, Large, with Secure-Fit |
| 92355 | MicroCool* Surgical Gown, Breathable High Performance, KC400, X-Large, with Secure-Fit, |
| 92357 | MicroCool* Surgical Gown, Breathable High Performance, KC400, XX-Large, Specialty |
| 92358 | MicroCool* Surgical Gown, Breathable High Performance, KC400, XX-Large, with Secure-Fit |
| Non-sterile Codes | |
| 72438 | MicroCool* Surgical Gown, Breathable High Performance, KC400, Large |
| 72445 | MicroCool* Surgical Gown, Breathable High Performance, KC400, X-Large |
| 72447 | MicroCool* Surgical Gown, Breathable High Performance, KC400, XX-Large |
| 72448 | MicroCool* Surgical Gown, Breathable High Performance, KC400, XX-Large, with Secure-Fit, |
| 72451 | MicroCool* Surgical Gown, Breathable High Performance, KC400, Large, Specialty |
| 72453 | MicroCool* Surgical Gown, Breathable High Performance, KC400, X-Large, Specialty |
| 72454 | MicroCool* Surgical Gown, Breathable High Performance, KC400, Large, with Secure-Fit |
| 72455 | MicroCool* Surgical Gown, Breathable High Performance, KC400, X-Large, with Secure-Fit |
| 72457 | MicroCool* Surgical Gown, Breathable High Performance, KC400, XX-Large, Specialty |
| 73038 | MicroCool* Surgical Gown, Breathable High Performance, KC400, Large, X-Long |
| 73041 | MicroCool* Surgical Gown, Breathable High Performance, KC400, X-Large, X-Long |
| 79729 | MicroCool* Surgical Gown, Breathable High Performance, KC400, Large |
| 79739 | MicroCool* Surgical Gown, Breathable High Performance, KC400, X-Large |
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§ 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.