(238 days)
KIMGUARD ONE-STEP* Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider by pre-vacuum steam at 270°F/132°C for 4 minutes or by 100% ethylene oxide (EtO) with a concentration of 725-735 mg/L at 131°F/ 55°C and 40% - 80% relative humidity for 60 minutes. 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 for aeration times for EO sterilization of 8 hours at 55 °C or 12 hours at 43.3 °C. The wrap was validated for dry times for pre-vacuum steam sterilization of 20 minutes for Models 100 and 200, and for 30 minutes for Models 400, 500, and 600.
KIMGUARD ONE-STEP* Sterilization Wrap is not indicated for use for gravity steam sterilization.
The KC300 Model KIMGUARD ONE-STEP Sterilization Wrap is not indicated for use for pre-vacuum steam sterilization.
See Wrap Model Recommendations on Page 3.
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 (spunbond-meltblown-spunbond) process.
Here's a breakdown of the acceptance criteria and study information for the KIMGUARD ONE-STEP* Sterilization Wrap, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance (as stated in the document) |
|---|---|---|
| Intended Use Parameters | Sterilization Method: Pre-vacuum steam at 270°F/132°C for 4 minutes OR 100% ethylene oxide (EtO) with a concentration of 725-735 mg/L at 131°F/ 55°C and 40% - 80% relative humidity for 60 minutes.Function: Enclose medical device for sterilization and maintain sterility until opened.Aeration Times (EtO): 8 hours at 55°C OR 12 hours at 43.3°C.Dry Times (Pre-vacuum Steam): 20 minutes for Models 100 and 200; 30 minutes for Models 400, 500, and 600.Exclusion: Not indicated for gravity steam sterilization.KC300 Exclusion: Not indicated for pre-vacuum steam sterilization. | "The wrap was validated for aeration times for EO sterilization of 8 hours at 55 °C or 12 hours at 43.3 °C. The wrap was validated for dry times for pre-vacuum steam sterilization of 20 minutes for Models 100 and 200, and for 30 minutes for Models 400, 500, and 600." (Implies meeting these specific criteria). |
| Biocompatibility | Compliance with ISO 10993 methods (irritation and sensitization). | "Testing included biocompatibility (i.e., irritation and sensitization) in compliance with the methods of ISO 10993." "All results of testing met acceptance criteria." |
| Physical Integrity | "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. Defined content weights for each model (KC100: 3 lbs, KC200: 6 lbs, KC300: 9 lbs for EO, KC400: 13 lbs, KC500: 17 lbs, KC600: 25 lbs). | "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." The table "Wrap Model Recommendations" (Page 2/6) explicitly lists the maximum wrapped package content weights used in the sterility maintenance validation study. |
| Sterilant Penetration | "Testing included...sterilant penetration." "All results of testing met acceptance criteria." | |
| Dry Time | (Duplicated with Intended Use - Included for completeness) | (Duplicated with Intended Use - Included for completeness) |
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not explicitly state the numerical "sample size" for a dedicated "test set" in the context of typical AI/software validation. Instead, it describes various performance tests.
- Sample Size for Sterility Maintenance Validation: The document details the specific items and their weights used for each model in the sterility maintenance validation study (e.g., KC100: 16 huck towels weighing 3 lbs, KC400: 4 tray liners + 11 lbs of metal mass). This implies a certain number of packages and contents were prepared and tested for each model.
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of medical device testing for regulatory submission, these are almost certainly prospective laboratory and/or simulated use studies conducted in a controlled environment, likely within the United States or a country adhering to similar regulatory standards.
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 studies are primarily focused on the physical and functional performance of the sterilization wrap itself, not on interpretation by human experts.
4. Adjudication Method for the Test Set:
This information is not provided as the testing primarily involves objective measurements of material properties, sterilization efficacy, and sterility maintenance, rather than subjective assessments requiring expert 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:
This is not applicable to this device. The KIMGUARD ONE-STEP* Sterilization Wrap is a physical medical device (sterilization wrap), not an AI algorithm. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted or would be relevant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
This is not applicable as the device is a physical sterilization wrap, not an algorithm.
7. The type of ground truth used:
The "ground truth" for the various tests would be based on:
- Physical and Chemical Standards: For biocompatibility (ISO 10993), sterilant penetration, dry time, and physical integrity, the ground truth is established by validated laboratory assays and adherence to specified performance thresholds and industry standards (e.g., absence of irritation/sensitization, successful sterilant penetration, specified dry times, maintaining physical integrity).
- Microbiological Standards: For sterility maintenance, the ground truth is the absence of microbial growth in the packaged contents after the specified sterilization process and storage period, assessed using standard microbiological testing methods.
- Pre-defined Parameters: For sterilization cycle parameters (temperature, time, concentration, humidity) and aeration/dry times, the ground truth is whether the device performed effectively within those pre-defined parameters.
8. The sample size for the training set:
This is not applicable. As a physical medical device, there is no "training set" in the context of an AI algorithm. The device's performance is established through direct physical, chemical, and microbiological testing.
9. How the ground truth for the training set was established:
This is not applicable for the reasons stated in point 8.
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510(k) Summary for the Kimberly-Clark* Corporation KIMGUARD ONE-STEP* Sterilization Wrap (Models KC100, KC200, KC300, KC400, KC500, and KC600)
| Date Summary was Prepared: | March 26, 2009MAR 2 7 2009 |
|---|---|
| 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 Contact for 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 Common Name: | Sterilization Wrap |
| Classification Name: | Sterilization Wrap (21 CFR 880.6850) |
| Product Code: | FRG |
| Intended Use: | KIMGUARD ONE-STEP* Sterilization Wrap is intended to be used toenclose another medical device that is to be sterilized by a health careprovider by pre-vacuum steam at 270°F/132°C for 4 minutes or by100% ethylene oxide (EtO) with a concentration of 725-735 mg/L at131°F/ 55°C and 40% - 80% relative humidity for 60 minutes. The wrapis intended to allow sterilization of the enclosed medical device(s) andalso to maintain sterility of the enclosed device(s) until opened. Thewrap was validated for aeration times for EO sterilization of 8 hours at55 °C or 12 hours at 43.3 °C. The wrap was validated for dry times forpre-vacuum steam sterilization of 20 minutes for Models 100 and 200,and for 30 minutes for Models 400, 500, and 600. |
| KIMGUARD ONE-STEP* Sterilization Wrap is not indicated for use for gravity steam sterilization. | |
| The KC300 Model KIMGUARD ONE-STEP Sterilization Wrap is not indicated for use for pre-vacuum steam sterilization. | |
| See Wrap Model Recommendations on Page 3. |
Page 1 of 3 - 510(k) Summary
:
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| PredicateDevices: | The KIMGUARD ONE-STEP* Sterilization Wrap(Models KC100, KC200, KC300, KC400, KC500, and KC600) aresubstantially equivalent to the predicate KIMGUARD* Regular andHeavy Duty Sterile Wraps (K881471) |
|---|---|
| SubstantialEquivalence: | The KIMGUARD ONE-STEP* Sterilization Wrap is substantiallyequivalent to the predicates in intended use, design, and materials.The predicate devices were constructed of a three-layer laminatecomposed of a layer of meltblown polypropylene bonded on bothsurfaces with a layer of spunbonded polypropylene. The KIMGUARDONE-STEP* Sterilization Wrap is comprised of two sheets ofKIMGUARD* 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 fabricproduced using a polypropylene three-layer SMS (spunbond-meltblown-spunbond) process. |
| Summary ofTesting: | KIMGUARD ONE-STEP* Sterilization Wrap performance has beentested in accordance with the applicable requirements recommended inPremarket Notification [510(k)] Submissions for Medical SterilizationPackaging Systems in Health Care Facilities; Draft Guidance forIndustry and FDA (March 7, 2002). Testing included biocompatibility(i.e., irritation and sensitization) in compliance with the methods of ISO10993, sterilant penetration, dry time, and physical integrity. The Wraphas also been tested for the ability to maintain sterility of pack contentsafter sterilization for up to 30 days under standard conditions. Allresults of testing met acceptance criteria. |
and the comments of the country
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| Wrap Model RecommendationsKIMGUARDONE-STEP*Sterilization WrapModels | Intended Loads | MaximumWrappedPackageContentWeights Usedin SterilityMaintenanceValidationStudy2 | Descriptions of Loads Used inSterility Maintenance ValidationStudy2 |
|---|---|---|---|
| KC100 | Very Light WeightPackage (forexample: towelpacks) | 3 lbs | 16 huck towels (17"x 29") |
| KC200 | Light WeightPackage (forexample: standardlinen packs) | 6 lbs | 2 huck towels (17"x 29")2 fluid resistant U-drape (68"x109")1 fluid resistant universal bar drape(70" x 108") |
| KC3003 | Light to ModerateWeight Package (forexample: general usemedical instruments) | 9 lbs | FOR EO:16 huck towels2 fluid resistant large drapes (76"x100")1 fluid resistant small drape (76"x60")1 fluid resistant table cover (60"x 90") |
| KC4004 | Moderate to HeavyWeight Package (forexample: general usemedical instruments) | 13 lbs | 4 tray liners 20" x 25" stacked10" x 10" x 3 ½ " tray containing 11 lbsof metal mass |
| KC5004 | HeavyweightPackage (forexample: general usemedical instruments) | 17 lbs | 4 tray liners 20" x 25" stacked10" x 10" x 3 ½ " tray containing15 lbs of metal mass |
| KC6004 | Very Heavy WeightPackage (forexample: generaluse medicalinstruments) | 25 lbs | 4 tray liners 20" x 25" stacked10" x 10" x 3 ½ " tray containing23 lbs of metal mass |
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{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized representation of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 7 2009
Kimberly-Clark Corporation C/o Ms. Lisa Peacock, RAC SciMed, Incorporated 172 Conductor Drive Dawsonville, Georgia 30534
Re: K082177
Trade/Device Name: KIMGUARD ONE-STEP* Sterilization Wrap (Models KC100, KC200, KC300, KC400, KC500, and KC600)
Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: March 9, 2009 Received: March 10, 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.
{4}------------------------------------------------
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,
Antony D. morton bon
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
{5}------------------------------------------------
Indications for Use
510(k) Number (if known): _K082177
KIMGUARD ONE-STEP* Sterilization Wrap (Models KC100, KC200, Device Name: KC300, KC400, KC500, and KC600)
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 health care provider by pre-vacuum steam at 2709F/132°C for 4 minutes or by 100% ethylene oxide (EtO) with a concentration of 725-735 mg/L at 131°F/ 55°C and 40% - 80% relative humidity for 60 minutes. The wrap is intended to allow sterilization of the enclosed medical device(s) and also to maintain interility of the enclosed device(s) until opened. The wrap was validated for aeration sterilized the oncliebed as not (9) or 12 hours at 43.3 ℃. The wrap was times for 20 cry times for pre-vacuum steam sterilization of 20 minutes for Models 100 and 200, and for 30 minutes for Models 400, 500, and 600.
KIMGUARD ONE-STEP* Sterilization Wrap is not indicated for use for gravity steam sterilization.
The KC300 Model KIMGUARD ONE-STEP Sterilization Wrap is not indicated for use for pre-vacuum steam sterilization.
See Wrap Model Recommendations 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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shiela H. Murphy, D
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K0821
{6}------------------------------------------------
Indications for Use
| KIMGUARDONE-STEP*Sterilization WrapModels | Intended Loads1 | MaximumWrappedPackageContentWeights Usedin SterilityMaintenanceValidationStudy2 | Descriptions of Loads Used inSterility Maintenance ValidationStudy2 |
|---|---|---|---|
| KC100 | Very Light WeightPackage (forexample: towelpacks) | 3 lbs | 16 huck towels (17"x 29") |
| KC200 | Light WeightPackage (forexample: standardlinen packs) | 6 lbs | 2 huck towels (17"x 29")2 fluid resistant U-drape (68"x109")1 fluid resistant universal bar drape(70" x 108") |
| KC3003 | Light to ModerateWeight Package (forexample: general usemedical instruments) | 9 lbs | FOR EO:16 huck towels2 fluid resistant large drapes (76"x100")1 fluid resistant small drape (76"x60")1 fluid resistant table cover (60"x 90") |
| KC4004 | Moderate to HeavyWeight Package (forexample: general usemedical instruments) | 13 lbs | 4 tray liners 20" x 25" stacked10" x 10" x 3 ½ " tray containing 11 lbsof metal mass |
| KC5004 | HeavyweightPackage (forexample: general usemedical instruments) | 17 lbs | 4 tray liners 20" x 25" stacked10" x 10" x 3 ½ " tray containing15 lbs of metal mass |
| KC6004 | Very Heavy WeightPackage (forexample: general use medicalinstruments) | 25 lbs | 4 tray liners 20" x 25" stacked10" x 10" x 3 ½ " tray containing23 lbs of metal mass |
Individual results may differ due to factors such as variations in handling practices, wrapping techniques, and folling methods individual results may differ due its valiation minding phavos, magend syres on the wrap. Each healthcare facility should determine for itself which wrap model is most appropriate for each intended use.
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§ 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).