(104 days)
KIMGUARD ONE-STEP* Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a healthcare provider in the Amsco V-PRO 1 Low Temperature Sterilization System's Cycle or the Amsco V-PRO 1 Plus Low Temperature Sterilization System's Lumen (identical to the V-PRO 1 Cycle) and Non Lumen Cycles. The wrap is intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility of the enclosed device(s) until opened. The wrap was validated to be effectively aerated during the pre-programmed V-PRO 1 and V-PRO 1 Plus Sterilization Cycles.
The KIMGUARD ONE-STEP* Sterilization Wrap is identical to the predicate in intended use, design, materials, and performance. The KIMGUARD ONE-STEP* Sterilization Wrap is comprised of two sheets of KIMGUARD* Sterilization Wrap ultrasonically seamed on two sides. This allows for convenient wrapping with two sheets simultaneously. The sheets of sterilization wrap are square or rectangular fabric produced using a polypropylene three-layer SMS (spunbondmeltblown-spunbond) process.
The provided text describes the acceptance criteria and the summary of testing for the KIMGUARD ONE-STEP* Sterilization Wrap.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Premarket Notification | Compliance with "Premarket Notification [510(k)] Submissions for Medical Sterilization Packaging Systems in Health Care Facilities; Draft Guidance for Industry and FDA (March 7, 2002)" | The KIMGUARD ONE-STEP* Sterilization Wrap performance has been tested in accordance with the applicable requirements recommended in this guidance. |
| Biocompatibility | Compliance with methods of ISO 10993 | Testing included biocompatibility in compliance with the methods of ISO 10993. "All results of testing met acceptance criteria." |
| Sterilant Penetration | Acceptance criteria not explicitly stated but implied to ensure effective sterilization. | Testing included sterilant penetration. "All results of testing met acceptance criteria." The wrap was validated to be effectively aerated during the pre-programmed V-PRO 1 and V-PRO 1 Plus Sterilization Cycles. |
| Physical Integrity | Acceptance criteria not explicitly stated but implied to ensure the wrap maintains its physical characteristics. | Testing included physical integrity. "All results of testing met acceptance criteria." |
| Sterility Maintenance | Ability to maintain sterility of pack contents after sterilization for up to 30 days under standard conditions. | The Wrap has been tested for the ability to maintain sterility of pack contents after sterilization for up to 30 days under standard conditions. "All results of testing met acceptance criteria." Specific maximum wrapped package content weights were validated for each wrap model to maintain sterility: |
| KC100: Max 3 lbs (e.g., 3 lbs metal mass, 6 forceps) | ||
| KC200: Max 6.5 lbs (e.g., 2.5 lbs metal mass, 6 forceps, V-PRO tray 17" x 10" x 3½" at 4 lbs) | ||
| KC300: Max 9 lbs (e.g., 5 lbs metal mass, 6 forceps, V-PRO tray 17" x 10" x 3½" at 4 lbs) | ||
| KC400: Max 10 lbs (e.g., 6 lbs metal mass, 6 forceps, V-PRO tray 17" x 10" x 3½" at 4 lbs) | ||
| KC500: Max 10 lbs (e.g., 5 lbs metal mass, 6 forceps, V-PRO tray 21" x 10" x 3½" at 5 lbs) | ||
| KC600: Max 10 lbs (e.g., 5 lbs metal mass, 6 forceps, V-PRO tray 21" x 10" x 3½" at 5 lbs) |
Study Proving Device Meets Acceptance Criteria:
The document describes a "Summary of Testing" that was conducted to demonstrate the performance of the KIMGUARD ONE-STEP* Sterilization Wrap.
2. Sample size used for the test set and the data provenance:
- Test Set (General): The document states that testing included "biocompatibility in compliance with the methods of ISO 10993, sterilant penetration, and physical integrity." It indicates that "All results of testing met acceptance criteria." However, specific sample sizes for these tests are not provided.
- Test Set (Sterility Maintenance): The table detailing "Wrap Model Recommendations" describes specific test loads used in the "Sterility Maintenance Validation Study". These loads represent a sample set for evaluating the ability of each wrap model to maintain sterility. For instance:
- KC100: 3 lbs metal mass, 6 forceps
- KC200: 2.5 lbs metal mass, 6 forceps, V-PRO tray (17" x 10" x 3½") at 4 lbs
- All other models had similar specified loads (e.g., 5 lbs metal mass, 6 forceps, specific V-PRO tray sizes).
- Data Provenance: The document does not specify the country of origin of the data. It is a 510(k) submission to the FDA for a device manufactured by Kimberly-Clark Corporation, which suggests the testing was likely conducted in accordance with US regulatory requirements or international standards recognized by the US. The testing appears to be prospective as it was conducted to support the 510(k) submission for the additional indication for use.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The tests described (biocompatibility, sterilant penetration, physical integrity, sterility maintenance) are laboratory-based performance tests, not clinical studies requiring expert interpretation of results in the same way, for example, a diagnostic imaging AI would. The "ground truth" for these tests would typically be established by validated scientific methods and measurements rather than expert consensus on subjective evaluations.
4. Adjudication method for the test set:
This information is not applicable and therefore not provided in the document. The described tests are objective laboratory measurements, not subjective evaluations requiring adjudication by multiple experts.
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:
This is not applicable. The device is a sterilization wrap, not an AI-assisted diagnostic tool or an imaging device involving human readers or AI. Therefore, no MRMC comparative effectiveness study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This is not applicable. The device is a physical product (sterilization wrap), not an algorithm or AI system.
7. The type of ground truth used:
The ground truth for the tests described is based on:
- Objective Laboratory Measurements: For biocompatibility (ISO 10993), sterilant penetration, and physical integrity, the ground truth is established through standardized laboratory procedures and measurement techniques as defined by relevant industry standards and guidance documents.
- Performance Validation based on Controlled Conditions: For sterility maintenance, the ground truth is established by demonstrating the wrap's ability to maintain sterility of specific, validated test loads for a defined period (up to 30 days) under standard conditions. This involves microbiology testing to confirm the absence of viable microorganisms.
8. The sample size for the training set:
This is not applicable. The device is a physical product, not a machine learning model or AI, and therefore does not have a "training set" in the context of AI development. The document refers to "testing" and "validation studies" for product performance.
9. How the ground truth for the training set was established:
This is not applicable as there is no training set for this type of device.
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NOV - 2 2009
2092167
510(k) Summary for the Kimberly-Clark* Corporation KIMGUARD ONE-STEP* Sterilization Wrap (Models KC100, KC200, KC300, KC400, KC500, and KC600) for the Additional Indication for Use with the Amsco® V-PRO 1 and V-PRO 1 Plus Low Temperature Sterilization Systems
Date Summary was Prepared: 510(k) Submitter and Primary Contact:
October 23, 2009
Sterilization Wrap
FRG
Thomas Kozma, PhD Director, Regulatory Affairs Kimberly-Clark Health Care 1400 Holcomb Bridge Road Roswell, GA 30076 Ph: 770.587.8393 FAX: 920.225.3408 Email: thomas.kozma@kcc.com
Device Common Name: Classification Name:
Sterilization Wrap (21 CFR 880.6850)
Product Code:
Additional Intended Use Subject of this 510(k) Submission: KIMGUARD ONE-STEP* Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a healthcare provider in the Amsco V-PRO 1 Low Temperature Sterilization System's Cycle or the Amsco V-PRO 1 Plus Low Temperature Sterilization System's Lumen (identical to the V-PRO 1 Cycle) and Non Lumen Cycles. The wrap is intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility of the enclosed device(s) until opened. The wrap was validated to be effectively aerated during the pre-programmed V-PRO 1 and V-PRO 1 Plus Sterilization Cycles.
See Wrap Model Recommendations on Page 2 of this Summary.
The KIMGUARD ONE-STEP* Sterilization Wrap (Models KC100, KC200, KC300, KC400, KC500, and KC600) for the additional indication for use with the Amsco V-PRO 1 and V-PRO 1 Plus Low Temperature Sterilization Systems is substantially equivalent to the predicate KIMGUARD ONE-STEP* Sterilization Wrap (Models KC100,
KC200, KC300, KC400, KC500, and KC600) (K082177).
Predicate Devices:
Substantial Equivalence: The KIMGUARD ONE-STEP* Sterilization Wrap is identical to the predicate in intended use, design, materials, and performance. The KIMGUARD ONE-STEP* Sterilization Wrap is comprised of two sheets of KIMGUARD* Sterilization Wrap ultrasonically seamed on two sides. This allows for convenient wrapping with two sheets simultaneously. The sheets of sterilization wrap are square or rectangular fabric produced using a polypropylene three-layer SMS (spunbondmeltblown-spunbond) process.
Page 1 of 2 - 510(k) Summary
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K092167
page 2 of 2
Summary of Testina:
KIMGUARD ONE-STEP* Sterilization Wrap performance has been tested in accordance with the applicable requirements recommended in Premarket Notification [510(k)] Submissions for Medical Sterilization Packaging Systems in Health Care Facilities; Draft Guidance for Industry and FDA (March 7, 2002). Testing included biocompatibility in compliance with the methods of ISO 10993, sterilant penetration, and physical integrity. The Wrap has also been tested for the ability to maintain sterility of pack contents after sterilization for up to 30 days under standard conditions. All results of testing met acceptance criteria.
Wrap Model Recommendations for Amsco V-PRO 1 and V-PRO 1 Plus Low Temperature Sterilization1
| KIMGUARDONE-STEP*SterilizationWrap Models | Intended Loads | MaximumWrappedPackageContentWeights Used inSterilityMaintenanceValidationStudy2 | Descriptions of Loads Used in SterilityMaintenance Validation Study2 |
|---|---|---|---|
| KC100 | Very Light WeightPackage (for examplebatteries) | 3 lbs | • 3 lbs metal mass• 6 forceps |
| KC200 | Light Weight Package(for example telescopewith light cord) | 6.5 lbs | • 2.5 lbs metal mass• 6 forceps• V-PRO tray (17" x 10" x 3½") at 4 lbs |
| KC300 | Light to ModerateWeight Package (forexample: general usemedical instruments) | 9 lbs | • 5 lbs metal mass• 6 forceps• V-PRO tray (17" x 10" x 3½") at 4 lbs |
| KC400 | Moderate to HeavyWeight Package (forexample: general usemedical instruments) | 10 lbs | • 6 lbs metal mass• 6 forceps• V-PRO tray (17" x 10" x 3½") at 4 lbs |
| KC500 | Heavyweight Package(for example: generaluse medicalinstruments) | 10 lbs | • 5 lbs metal mass• 6 forceps• V-PRO tray (21" x 10" x 3½") at 5 lbs |
| KC600 | Very Heavy WeightPackage (for example:general use medicalinstruments) | 10 lbs | • 5 lbs metal mass• 6 forceps• V-PRO tray (21" x 10" x 3½") at 5 lbs |
Individual results may differ due to factors such as variations in handling practices, wrapping techniques, and folding methods. Results may also differ due to the use of irregularly shaped contents, which may put added stress on the wrap. Each healthcare facility should determine for itself which wrap model is most appropriate for each intended use. 1 t is recommended to not exceed the maximum wrapped package content weights indicated for each wrap model.
Furthermore, it is recommended to not exceed the number, weight, and size of individual content types that were validated for the KIMGUARD Sterilization Wraps (i.e.; the weight of the metal mass).
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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 eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the bird-like figure. The text is in all capital letters and is evenly spaced around the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Dr. Thomas Kozma Director of Regulatory Affairs Kimberly-Clark Corporation 1400 Holcomb Bridge Road Roswell, Georgia 30076
NOV - 2 2009
Re: K092167
Trade/Device Name: KIMGUARD ONE-STEP* Sterilization Wrap (Models KC100, KC200, KC300, KC400, KC500 and KC600) for the Use With the Lumen Cycle of the Amsco V-PRO 1 Low Temperature Sterilization System and With the Lumen and Non Lumen Cycles of the Amsco V-PRO 1 Plus Low Temperature Sterilization System
Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II · Product Code: FRG Dated: October 5, 2009 Received: October 7, 2009
Dear Dr. Kozma:
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- Dr. Kozma
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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Anthony D. Roberts Jr.
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): K092167
Device Name: _ KIMGUARD ONE-STEP* Sterilization Wrap (Models KC100, KC200, KC300, KC400, KC500, and KC600) for the Additional Indication for Use with the Amsco® V-PRO™ 1 and V-PRO 1 Plus Low Temperature Sterilization Systems
Indications for Use:
KIMGUARD ONE-STEP* Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a healthcare provider in the Amsco V-PRO 1 Low Temperature Sterilization System's Cycle or the Amsco V-PRO 1 Plus Low Temperature Sterilization System's Lumen (identical to the V-PRO 1 Cycle) and Non Lumen Cycles. The wrap is intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility of the enclosed device(s) until opened. The wrap was validated to be effectively aerated during the pre-programmed V-PRO 1 and V-PRO 1 Plus Sterilization Cycles.
KIMGUARD ONE-STEP* Sterilization Wrap Recommendations for use with the Amsco V-PRO 1 and V-PRO 1 Plus Low Temperature Sterilization Systems are provided on Page 2.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
<PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
| Eli sheth P. Clavene-Wilde | |
|---|---|
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K092167 |
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Indications for Use
Wrap Model Recommendations for Amsco V-PRO 1 and V-PRO 1 Plus Low Temperature Sterilization'
| KIMGUARDONE-STEP*SterilizationWrap Models | Intended Loads | MaximumWrappedPackageContentWeights Usedin SterilityMaintenanceValidationStudy2 | Descriptions of Loads Used inSterility Maintenance ValidationStudy2 |
|---|---|---|---|
| KC100 | Very Light WeightPackage (forexample batteries) | 3 lbs | 3 lbs metal mass 6 forceps |
| KC200 | Light WeightPackage (forexample telescopewith light cord) | 6.5 lbs | 2.5 lbs metal mass 6 forceps V-PRO tray (17" x 10" x 3½") at 4 lbs |
| KC300 | Light to ModerateWeight Package(for example:general usemedicalinstruments) | 9 lbs | 5 lbs metal mass 6 forceps V-PRO tray (17" x 10" x 3½") at 4 lbs |
| KC400 | Moderate to HeavyWeight Package(for example:general usemedicalinstruments) | 10 lbs | 6 lbs metal mass 6 forceps V-PRO tray (17" x 10" x 3½") at 4 lbs |
| KC500 | HeavyweightPackage (forexample: generaluse medicalinstruments) | 10 lbs | 5 lbs metal mass 6 forceps V-PRO tray (21" x 10" x 3½") at 5 lbs |
| KC600 | Very Heavy WeightPackage (forexample: generaluse medicalinstruments) | 10 lbs | 5 lbs metal mass 6 forceps V-PRO tray (21" x 10" x 3½") at 5 lbs |
Individual results may differ due to factors such as variations in handling practices, wrapping techniques, and folding methods. Results may also differ due to the use of iregularly shaped contents, which may put added stress on the wrap. Each healthcare facility should determine for itself which wrap model is most appropriate for each intended use. 2 It is recommended to not exceed the maximum wrapped package content weights indicated for each wrap model. Furthernore, it is recommended to not exceed the number, weight, and size of individual content types that were validated for the KIMGUARD Sterilization Wraps (i.e .: the weight of the metal mass).
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).