(104 days)
Not Found
No
The document describes a sterilization wrap and its physical properties and performance in sterilization cycles. There is no mention of AI or ML technology.
No.
The device is a sterilization wrap used to maintain sterility of other medical devices; it does not have a direct therapeutic effect on a patient.
No
This device is a sterilization wrap used to maintain the sterility of other medical devices, not to diagnose medical conditions.
No
The device description clearly states it is a physical sterilization wrap made of polypropylene fabric, which is a hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the wrap is used to enclose another medical device for sterilization and to maintain sterility. This is a function related to the preparation and storage of medical devices, not the diagnosis of diseases or conditions using samples from the human body.
- Device Description: The description details the materials and construction of the wrap, which is a physical barrier. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information
The device is a sterilization packaging system, which falls under a different category of medical devices.
N/A
Intended Use / 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.
Product codes
FRG
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare provider
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
All results of testing met acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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
| KIMGUARD
ONE-STEP*
Sterilization
Wrap Models | Intended Loads | Maximum
Wrapped
Package
Content
Weights Used in
Sterility
Maintenance
Validation
Study2 | Descriptions of Loads Used in Sterility
Maintenance Validation Study2 |
|-------------------------------------------------------|------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| KC100 | Very Light Weight
Package (for example
batteries) | 3 lbs | • 3 lbs metal mass
• 6 forceps |
| KC200 | Light Weight Package
(for example telescope
with 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 Moderate
Weight Package (for
example: general use
medical instruments) | 9 lbs | • 5 lbs metal mass
• 6 forceps
• V-PRO tray (17" x 10" x 3½") at 4 lbs |
| KC400 | Moderate to Heavy
Weight Package (for
example: general use
medical 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: general
use medical
instruments) | 10 lbs | • 5 lbs metal mass
• 6 forceps
• V-PRO tray (21" x 10" x 3½") at 5 lbs |
| KC600 | Very Heavy Weight
Package (for example:
general use medical
instruments) | 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).
2
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.
3
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
4
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)