(168 days)
The Kimberly-Clark* KC100 Surgical Gowns are sterile, single use devices 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.
The Kimberly-Clark* KC100 Surgical Gowns are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and Ethylene Oxide (EtO) sterilization.
Disposable gowns are used in the OR as a protective covering, for operating room staff, from the transfer of microorganisms, body fluids and particulates. Kimberly-Clark's KC100 Surgical Gowns are comprised of a single layer of SMS (spunbond/meltblown/spunbond polypropylene) fabric. The gowns consist of 100% polyester cuffs sewn to the end of the sleeves using polyester thread. The gowns also have a manual closure system.
The provided text describes a 510(k) summary for Kimberly-Clark KC100 Surgical Gowns. This document is a premarket notification for a medical device and focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than detailing studies about AI algorithms or software performance.
As such, the requested information regarding AI device acceptance criteria and study details (sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, ground truth types, training set sample size, and ground truth establishment for training set) cannot be extracted from the provided text because it pertains to the approval of physical surgical gowns, not an AI/ML device.
However, I can provide the acceptance criteria and study information related to the surgical gowns themselves based on the text:
1. Table of Acceptance Criteria and Reported Device Performance (for KC100 Surgical Gowns):
| Acceptance Criteria Category | Specific Tests Conducted | Reported Device Performance |
|---|---|---|
| Material Properties | Barrier properties (e.g., fluid resistance, microbial barrier) | Met acceptance criteria |
| Tensile and tear strength | Met acceptance criteria | |
| Alcohol repellency | Met acceptance criteria | |
| Flammability | Met acceptance criteria | |
| Linting | Met acceptance criteria | |
| Biocompatibility | Cytotoxicity | Met acceptance criteria (in compliance with ISO 10993 methods) |
| Irritation | Met acceptance criteria (in compliance with ISO 10993 methods) | |
| Sensitization | Met acceptance criteria (in compliance with ISO 10993 methods) |
2. Study that Proves the Device Meets Acceptance Criteria:
The study conducted was a bench testing to demonstrate that the KC100 Surgical Gowns are identical to and meet the same acceptance testing criteria as their predicate device (K091097 proMedical Surgical Gowns).
- Sample size used for the test set and the data provenance: The document does not specify exact sample sizes for each test. It states "Testing included..." implying a standard set of tests for medical devices of this type. The provenance of the data is not explicitly stated beyond being conducted for the Kimberly-Clark Corporation. This would be considered internal company testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These are physical product performance tests, not AI-driven diagnostic tests requiring expert ground truth for interpretation.
- Adjudication method for the test set: Not applicable for physical product testing described.
- 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 for a physical medical product, not an AI device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is for a physical medical product, not an AI device.
- The type of ground truth used: The "ground truth" here is objective measurements against established international standards (like ISO 10993 for biocompatibility) and performance specifications for surgical gowns.
- The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided text concerns the regulatory approval of physical surgical gowns based on equivalence to a predicate device through standard product performance and biocompatibility testing, not an AI device.
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Image /page/0/Picture/0 description: The image shows the Kimberly-Clark logo. The logo consists of a stylized "K" symbol on the left, followed by the text "Kimberly-Clark" in bold, sans-serif font. The "K" symbol is a geometric shape with intersecting lines, enclosed in a circle.
K093//5
510(k) Summary for the Kimberly-Clark* Corporation KC100 Surgical Gowns
| Date Summary was Prepared: | March 4, 2010 | MAR 1 9 2010 |
|---|---|---|
| 510(k) Submitter: | Marcia Johnson, RACTechnical Leader, Regulatory AffairsKimberly-Clark Health Care1400 Holcomb Bridge RoadRoswell, GA 30076Ph: 770.587.8566FAX: 920.380.6351Email: Marcia.johnson@kcc.com | |
| Primary Contact for this 510(k) Submission: | Marcia Johnson, RACTechnical Leader, Regulatory AffairsKimberly-Clark Health Care1400 Holcomb Bridge RoadRoswell, GA 30076Ph: 770.587.8566FAX: 920.380.6351Email: Marcia.johnson@kcc.com | |
| Device Common Name: | Sterile surgical gowns | |
| Trade Name: | KC100 Surgical Gowns | |
| Device Product Codes and Classification Names: | FYA Surgical Gowns | |
| Predicate Device: | K091097 proMedical Surgical Gowns | |
| Device Description: | Disposable gowns are used in the OR as a protective covering, for operating room staff, from the transfer of microorganisms, body fluids and particulates. Kimberly-Clark's KC100 Surgical Gowns are comprised of a single layer of SMS (spunbond/meltblown/spunbond polypropylene) fabric. The gowns consist of 100% polyester cuffs sewn to the end of the sleeves using polyester thread. The gowns also have a manual closure system. |
Page 1 of 2 - Section 6 510(k) Summary
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Intended Use:
The Kimberly-Clark* KC100 Surgical Gowns are sterile, single use devices 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.
The Kimberly-Clark* KC100 Surgical Gowns are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and Ethylene Oxide (EtO) sterilization.
Technological Characteristics The Kimberly-Clark* KC100 Surgical Gowns have the same design, material and chemical characteristics of the predicate device.
Summary of Testing:
The KC100 Surgical Gowns are identical to, and meet the same acceptance testing criteria as, their predicate gowns in K091097. Testing included biocompatibility (i.e., cytotoxicity, irritation, and sensitization) in compliance with the methods of ISO 10993, barrier properties, tensile and tear strength, alcohol repellency, flammability, and linting. All results of testing met acceptance criteria
Substantial Equivalence:
The surgical gowns described in this 510(k) submission are identical in all specifications to the predicate device models identified in K091097.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or feathers.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR 1 9 2010
Ms. Marcia Johnson Regulatory Affairs Kimberly-Clark Corporation 1400 Holcomb Bridge Road Roswell, Georgia 30076
Re: K093115
Trade/Device Name: KC100 Surgical Gowns Regulation Number: 21CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: March 9, 2010 Received: March 12, 2010
Dear Ms. Johnson:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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- Ms. Johnson
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 (OS) 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/CDRHOffices/ ucm 1 15809.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.
Susan Quiñones
Anthony D. Watson, B.S., M.S., M.B.A:
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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Indications for Use
510(k) Number (if known): __ _ _ K093115
Device Name: KC100 Surgical Gowns
Indications for Use:
The Kimberly-Clark* KC100 Surgical Gowns are sterile, single use devices intended to be worn by operating room personnel during surgical procedures to protect hoth the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
The Kimberly-Clark* KC100 Surgical Gowns are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and Ethylene Oxide (EtO) sterilization.
See Page 2 for product list.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Geetha Jayou.
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:__K093115
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Page 2 of 2
KO93115
:
Addendum
The KC100 Surgical Gowns are available under the following Reference Numbers and descriptions.
:
.
| Sterile Gowns | |
|---|---|
| 99284 | KC100 Surgical Gown, Large |
| 99285 | KC100 Surgical Gown, X-Large |
| 99294 | KC100 Surgical Gown, Large, X-Long |
| 99295 | KC100 Surgical Gown, X-Large, X-Long |
| Non-Sterile Gowns | |
| 79284 | KC100 Surgical Gown, Large |
| 79285 | KC100 Surgical Gown, X-Large |
| 79294 | KC100 Surgical Gown, Large, X-Long |
| 79295 | KC100 Surgical Gown, X-Large, X-Long |
§ 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.