(142 days)
Kimberly-Clark Corporation intends to market the sterile KC100 Surgical Drapes as devices made of natural or synthetic material intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. Kimberly-Clark intends to market the sterile KC100 Surgical Equipment Covers which are protective barrier covers that are intended to be used to cover surgical equipment and provide a protective barrier for that equipment.
The surgical drapes and equipment covers described in this 510(k) submission are identical in all specifications to the predicate device models identified in K080629 except for minor variations in the widths and lengths of three models.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | Met acceptance criteria |
| Barrier properties | Met acceptance criteria |
| Tensile strength | Met acceptance criteria |
| Tear strength | Met acceptance criteria |
| Alcohol repellency | Met acceptance criteria |
| Flammability | Met acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for the test set for each individual criterion. It only states that "All results of testing met acceptance criteria."
The data provenance is not explicitly mentioned. However, since this is a 510(k) submission to the FDA, it is highly likely that the testing was conducted by or on behalf of the manufacturer (Kimberly-Clark Corporation) to demonstrate compliance with US regulations. The nature of the tests (biocompatibility, barrier properties, strength, etc.) suggests these would be laboratory-based studies, likely prospective in nature (i.e., conducted specifically for this submission).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This information is not provided in the document. For device performance testing (like material properties), "ground truth" is typically established by standardized testing methods and analytical instruments, not by expert consensus in the same way it would be for diagnostic image interpretation.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. Adjudication methods (like 2+1, 3+1) are relevant for studies where human interpretation or judgment is involved, especially in medical image analysis or clinical trials to resolve discrepancies. For material property testing, the results are typically objectively measured against predefined standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
This information is not applicable and therefore not provided. The device (surgical drapes and equipment covers) is a medical device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance would not be relevant.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
This information is not applicable and therefore not provided. As mentioned above, the device is a physical sterile barrier product, not a software algorithm.
7. The Type of Ground Truth Used
The ground truth used for this testing would be based on objective measurements and predefined material specifications/standards. For example:
- Biocompatibility: Established by reference to ISO 10993 standards and their associated test methods and acceptable limits (e.g., cell viability percentages, irritation scores).
- Barrier properties: Measured against standardized test methods for fluid penetration, microbial penetration, etc., with defined acceptable levels.
- Tensile and tear strength: Measured using force-testing equipment against specified minimum strength requirements.
- Alcohol repellency & Flammability: Measured according to relevant industry standards and acceptable criteria.
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided. As the device is a physical product and not an AI/machine learning model, there is no "training set" in the context of algorithm development. The testing conducted is to verify the physical properties of the manufactured product.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and therefore not provided for the same reason as point 8.
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K083234
510(k) Summary for the Kimberly-Clark* Corporation KC100 Surgical Drapes and Equipment Covers
MAR 2 5 2009
| Date Summarywas Prepared: | October 31, 2008 |
|---|---|
| 510(k) Submitter: | Thomas KozmaDirector, Regulatory AffairsKimberly-Clark Health Care1400 Holcomb Bridge RoadRoswell, GA 30076Ph: 770.587.8393FAX: 920.225.3408Email: thomas.kozma@kcc.com |
| Primary Contactfor this 510(k)Submission: | Lisa Peacock, Consultant to Kimberly-Clark Health CareSciMed, Inc.Ph: 706.216.3413FAX: 800.713.7754Email: lisa.peacock@kcc.com |
| Device CommonName: | Sterile surgical drapes and surgical equipment covers |
| Device ProductCodes andClassificationNames: | KKX Surgical DrapesMMP Protective Barrier Covers |
| Intended Use: | Kimberly-Clark Corporation intends to market the sterileKC100 Surgical Drapes as devices made of natural orsynthetic material intended to be used as a protectivepatient covering, such as to isolate a site of surgical incisionfrom microbial and other contamination. Kimberly-Clarkintends to market the sterile KC100 Surgical EquipmentCovers which are protective barrier covers that areintended to be used to cover surgical equipment andprovide a protective barrier for that equipment. |
| PredicateDevices: | K080629 proMedical Surgical Drapes and proMedicalSurgical Equipment Covers |
| SubstantialEquivalence: | The surgical drapes and equipment covers described in this510(k) submission are identical in all specifications to thepredicate device models identified in K080629 except forminor variations in the widths and lengths of three models. |
Page 1 of 2 - Section 6 510(k) Summary
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Summary of Testing:
The KC100 Surgical Drapes and Equipment Covers are identical to, and meet the same acceptance testing criteria as, their predicate drapes and covers in K080629. 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, and flammability. All results of testing met acceptance criteria.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
NAR 2 5 20080
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Kimberly-Clark Corporation C/o Ms. Lisa Peacock, RAC Consultant to Kimberly-Clark Health Care SciMed, Incorporated 172 Conductor Drive Dawsonville, Georgia 30534
Re: K083234
Trade/Device Name: KC100 Surgical Drapes & KC100 Surgical Equipment Covers Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: February 23, 2009 Received: February 25, 2009
Dear Ms. Peacock:
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. Peacock
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); 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Anthony D. naton bu
Ginette Y. Michaud, M.D. 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): K083234
Device Name: KC100 Surgical Equipment Covers
Indications for Use:
Kimberly-Clark* Corporation intends to market the sterile KC100 Surgical Equipment Covers which are protective barrier covers that are intended to be used to cover surgical equipment and provide a protective barrier for that equipment.
| Product Name | ModelCode | Cover Materials |
|---|---|---|
| Mayo Stand Cover | 88656 | Blue polyethylene with air-laid reinforcement |
| Table Cover | 886738866689564 | Blue polyethylene with air-laid reinforcement |
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shale H. Murphy, ID
(Division Sign-Oft) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K083234
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Indications for Use
510(k) Number (if known): K083234
Device Name: KC100 Surgical Drapes
Indications for Use:
Kimberly-Clark* Corporation intends to market the sterile KC100 Surgical Drapes as devices made of natural or synthetic material intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. See Page 2 for product list.
Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use × (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)
Shule A. Murphy 18
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K083234
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Page 2 of 2
Indications for Use Product List
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| Product Name | Model Code | Drape Materials |
|---|---|---|
| Angiography Surgical Drape | 89583 | SMS base panel with air-laid pad and polyethylene |
| Clear Legging Surgical Drape | 89195 | Polyethylene |
| Universal Extremity SurgicalDrape | 89191 | SMS base panel with air-laid pad |
| Legging Surgical Drape | 70093855 | SMS panel |
| Head Surgical Drape | 70093879 | SMS panel |
| Side Surgical Drape | 89556 | SMS base panel with air-laid pad |
| Top Surgical Drape | 89554 | SMS base panel with air-laid pad |
| Bottom Surgical Drape | 89555 | SMS base panel with air-laid pad |
| Bar Surgical Drape | 89533 | SMS base panel with air-laid pad |
| Arthroscopy Surgical Drape | 88661 | SMS base panel with polyethylene |
| Under Buttocks Surgical Drape | 89584 | SMS base panel with air-laid pad and polyethylene |
| Split EENT Surgical Drape | 89197 | SMS base panel with air-laid pad |
| Lithotomy Surgical Drape | 89198 | SMS base panel with air-laid pad |
| Laparoscopy T Surgical Drape | 89199 | SMS base panel with air-laid pad |
| Thyroid Surgical Drape | 89539 | SMS base panel with air-laid pad |
| Minor Procedure SurgicalDrape | 89531 | SMS base panel with air-laid pad |
| Lap Chole Surgical Drape | 89538 | SMS base panel with air-laid pad |
| Cystoscopy T Surgical Drape | 89196 | SMS base panel with air-laid pad |
| Chest Surgical Drape | 89561 | SMS base panel with air-laid pad |
| Utility Surgical Drape | 89536 | Air-laid absorbent panel |
| Split Surgical Drape | 89190 | Polyethylene |
| U Surgical Drape | 89532 | SMS base panel with air-laid pad |
| Laparotomy Surgical Drape | 89537 | SMS base panel with air-laid pad |
| Shoulder Arthroscopy SurgicalDrape | 89558 | SMS base panel with polyethylene |
| Body Split Surgical Drape | 89560 | SMS base panel with air-laid pad and polyethylene |
| Body Split Surgical Drape | 89557 | SMS base panel with air-laid pad |
| Half Surgical Drape | 89534 | SMS panel |
| Large Surgical Drape | 79535 | SMS panel |
| Universal Spine Surgical Drape | 89193 | SMS base panel with air-laid pad and polyethylene |
| Dental Surgical Drape | 89543 | SMS base panel with air-laid pad |
| Stockinette Surgical Drape | 044001-700 | Polyethylene stockinette |
and the comments of the country
§ 878.4370 Surgical drape and drape accessories.
(a)
Identification. A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.(b)
Classification. Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.