(269 days)
KIMGUARD ONE-STEP* Sterilization Wraps are 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 (EO) with a concentration of 725-735 mg/L at 131°F/55°C and 40% - 80% relative humidity for 60 minutes. KIMGUARD ONE-STEP* Sterilization Wrap is also intended to be used in the Amsco® V-PRO™ 1 Low Temperature Sterilization System's cycle, the Amsco® V-PRO™ 1 Plus Low Temperature Sterilization System's Lumen (identical to the V-PROTM 1 Cvcle) and Non Lumen Cycles, and the V-PRO™ Low Temperature Sterilization System's Flexible Cycle. 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 within the period of time for which performance data demonstrating maintenance of sterility has been provided. The wrap was validated for aeration times for EO sterilization of 8 hours at 55 °C or 12 hours at 43.3 °C. The KIMGUARD ONE-STEP* Sterilization 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 300, 400, 500, and 600. The KIMGUARD ONE-STEP* Sterilization Wrap was validated to be effectively aerated during the pre-programmed V-PRO™, the V-PRO™ 1 Plus, and the V-PRO™ Flexible Sterilization Cycles.
KIMGUARD ONE-STEP* Sterilization Wrap is not indicated for use for gravity steam sterilization.
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 rectanqular fabric produced usinq a polypropylene three-layer SMS (spunbond-meltblown-spunbond) process.
The KIMGUARD ONE-STEP* Sterilization Wrap is intended to maintain the sterility of enclosed medical devices until opened, after being sterilized by prevacuum steam, 100% ethylene oxide (EO), or specific Amsco® V-PRO™ Low Temperature Sterilization System cycles.
Here's an analysis of the acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the KIMGUARD ONE-STEP* Sterilization Wrap are related to its ability to maintain sterility after various sterilization methods for specified durations. The reported device performance indicates that the wraps meet these criteria.
| Acceptance Criteria (Sterility Maintenance Duration) | Reported Device Performance |
|---|---|
| Pre-Vacuum Steam Sterilization | |
| KC100 and KC200 Models: At least 30 days | At least 30 days |
| KC300, KC400, KC500, KC600 Models: At least 1 year | At least 1 year |
| EO Sterilization | |
| KC100 and KC200 Models: At least 30 days | At least 30 days |
| KC300, KC400, KC500, KC600 Models: At least 1 year | At least 1 year |
| V-PRO Cycles | |
| All Models (KC100-KC600): At least 30 days | At least 30 days |
Note regarding other criteria: The document also mentions other validated parameters, which, while not presented in a table format with specific acceptance criteria and performance data like sterility maintenance, were assessed for the device. These include:
- Aeration times for EO sterilization: 8 hours at 55 °C or 12 hours at 43.3 °C.
- Dry times for pre-vacuum steam sterilization: 20 minutes for Models 100 and 200; 30 minutes for Models 300, 400, 500, and 600.
- Effective aeration during V-PRO™, V-PROTM 1 Plus, and V-PROTM Flexible Sterilization Cycles.
- Biocompatibility (irritation and sensitization) in compliance with ISO 10993.
- Sterilant penetration characteristics.
- Physical integrity.
2. Sample Size Used for the Test Set and the Data Provenance
The document provides specific details for the maximum wrapped package content weights and descriptions of loads used in the sterility maintenance validation studies for each wrap model and sterilization cycle. These descriptions indicate the specific items (e.g., huck towels, fluid-resistant drapes, metal mass) and their quantities/weights that constituted the 'samples' or 'test sets' used for validating sterility maintenance.
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Pre-Vacuum Steam and Ethylene Oxide Sterilization Cycles (Table 1):
- KC100 (3 lbs): 16 huck towels (17"x 29")
- KC200 (6 lbs): 2 huck towels (17"x 29"), 2 fluid resistant U-drape (68"x109"), 1 fluid resistant universal bar drape (70" x 108")
- KC300 (9 lbs):
- Pre-Vacuum Steam: 15 huck towels (17"x 29"), 1 small fluid resistant drape (60"x 76"), 5 lbs of metal mass
- EO: 16 huck towels, 2 fluid resistant large drapes (76"x100"), 1 fluid resistant small drape (76"x60"), 1 fluid resistant table cover (60"x 90")
- KC400 (13 lbs): 4 tray liners 20" x 25" stacked, 10" x 10" x 3 ½ " tray containing 11 lbs of metal mass
- KC500 (17 lbs): 4 tray liners 20" x 25" stacked, 10" x 10" x 3 ½ " tray containing 15 lbs of metal mass
- KC600 (25 lbs): 4 tray liners 20" x 25" stacked, 10" x 10" x 3 ½ " tray containing 23 lbs of metal mass
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Amsco V-PRO™ Low Temperature Sterilization System (Table 2):
- KC100 (3 lbs): 3 lbs metal mass, 6 forceps
- KC200 (6.5 lbs): 2.5 lbs metal mass, 6 forceps, V-PRO tray (17" x 10" x 3½") at 4 lbs
- KC300 (9 lbs): 5 lbs metal mass, 6 forceps, V-PRO tray (17" x 10" x 3½") at 4 lbs
- KC400 (10 lbs): 6 lbs metal mass, 6 forceps, V-PRO tray (17" x 10" x 3½") at 4 lbs
- KC500 (10 lbs): 5 lbs metal mass, 6 forceps, V-PRO tray (21" x 10" x 3½") at 5 lbs
- KC600 (10 lbs): 5 lbs metal mass, 6 forceps, V-PRO tray (21" x 10" x 3½") at 5 lbs
The document does not specify the exact number of replicates (i.e., how many times each load/wrap combination was tested) within these studies. The data provenance is not explicitly stated as retrospective or prospective, nor does it mention a country of origin, but it is part of a 510(k) submission to the US FDA, implying the studies were conducted to meet US regulatory requirements.
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. For sterility maintenance studies of this nature, the "ground truth" is typically established through microbiological culture methods to detect microbial ingress, rather than expert interpretation of images or other subjective assessments.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method, as the sterility maintenance testing would involve objective laboratory assessments (e.g., growth or no-growth in culture media) rather than subjective expert review needing 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. The device is a sterilization wrap, not an AI-powered diagnostic tool, so MRMC studies involving human readers and AI assistance are irrelevant to its evaluation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable for the same reasons as #5. The device is a physical product, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for sterility maintenance testing would be based on microbiological assay results (i.e., sterility testing). If a wrapped package is challenged and subsequently tested for the presence of viable microorganisms, the absence of growth would indicate sterility was maintained. This is a direct, objective measure of the device's primary function in this context. Other aspects like biocompatibility (ISO 10993) would use endpoints specified by that standard.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical product and does not involve AI or machine learning models that require a "training set."
9. How the Ground Truth for the Training Set was Established
This is not applicable for the same reasons as #8.
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JUN 2 2 2 2012
KII2805
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510(k) Summary for the Kimberly-Clark* Corporation KIMGUARD ONE-STEP* Sterilization Wrap (Models KC100 – KC600)
| Date of Submission: | September 9, 2011 |
|---|---|
| Device type: | Sterilization Wrap |
| 510(k) Submitter: | Brenda ShelkeyAssociate Director, Quality Assurance & RegulatoryAffairsKIMBERLY-CLARK CORPORATION1400 Holcomb Bridge RoadRoswell, GA 30076678-654-8021Brenda.Shelkey@kcc.comEstablishment Registration Number 1033422 |
| Primary Contactfor this 510(k)Submission: | Brenda ShelkeyAssociate Director, Quality Assurance & RegulatoryAffairsKIMBERLY-CLARK CORPORATION1400 Holcomb Bridge RoadRoswell, GA 30076678-654-8021Brenda.Shelkey@kcc.com |
| ConfidentialityRequest: | Pursuant to 21 CFR 807.95, please treat withconfidentiality the additional information presented inthis notification and Kimberly-Clark's intent to market themedical devices described herein with changes. |
| ClassificationRegulation: | 21 CFR 880.6850 |
| Device Class: | Class II |
| Panel: | General Hospital |
| Product Code: | FRG |
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Page 1 of 5 - Section 9 510(k) Summary
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Intended Use:
KIMGUARD ONE-STEP* Sterilization Wraps are intended to be used to enclose another medical device that is to be sterilized by a health care provider by prevacuum steam at 270°F/132°C for 4 minutes or by 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131°F/55°C and 40% - 80% relative humidity for 60 minutes. KIMGUARD ONE-STEP* Sterilization Wrap is also intended to be used in the Amsco® V-PRO™ 1 Low Temperature Sterilization System's cycle, the Amsco® V-PRO™ 1 Plus Low Temperature Sterilization System's Lumen (identical to the V-PROTM 1 Cvcle) and Non Lumen Cycles, and the V-PRO™ Low Temperature Sterilization System's Flexible Cycle. 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 within the period of time for which performance data demonstrating maintenance of sterility has been provided. The wrap was validated for aeration times for EO sterilization of 8 hours at 55 °C or 12 hours at 43.3 °C. The KIMGUARD ONE-STEP* Sterilization 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 300, 400, 500, and 600. The KIMGUARD ONE-STEP* Sterilization Wrap was validated to be effectively aerated during the pre-programmed V-PRO™, the V-PRO™ 1 Plus, and the V-PRO™ Flexible Sterilization Cycles.
KIMGUARD ONE-STEP* Sterilization Wrap is not indicated for use for gravity steam sterilization.
Device Description: 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 rectanqular fabric produced usinq a polypropylene three-layer SMS (spunbond-meltblown-spunbond) process.
Substantial Equivalence: KIMGUARD ONE-STEP* Sterilization Wrap is substantially equivalent to the predicate Kimberly-Clark KIMGUARD* ONE-STEP* Sterilization Wrap (K082177,K091685, and K092167) in intended use, design, and materials.
Summary of Testing: KIMGUARD ONE-STEP* Sterilization Wrap was previously tested in compliance with the irritation and sensitization biocompatibility methods of ISO 10993 and cleared under K082177 and K091685. Sterilant penetration, dry time, and physical integrity were validated and cleared under K082177, K091685 and K092167. The wrap, Models KC300, KC400, KC500, and KC600, has been tested and shown to maintain sterility of pack contents after sterilization for at least one (1) year under standard conditions following pre-vacuum steam and ethylene oxide sterilization cycles. The wrap, Models KC100 and KC200, has been tested and shown to maintain
Page 2 of 5 - Section 9 510(k) Summary
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sterility of pack contents after sterllization for at least 30 days under standard conditions following pre-vacuum steam and ethylene oxide sterilization. The wrap, Models KC100, KC200, KC300, KC400, KC500, and KC600, has been tested and shown to maintain sterility of pack contents after sterllization for at least 30 days under standard conditions following sterilization with the Amsco V-PRO 1 and V-PRO 1 Plus and Flexible Cycle Low Temperature Sterilization Systems. Additionally, the wrap, Models KC100 through KC600, has been tested for use in the V-PRO 16 Low Temperature Sterilization System's Flexible Cycle being considered under K102330 filed by STERIS Corporation.
| Table 1. Wrap Model Recommendations for Pre-Vacuum Steam and Ethylene |
|---|
| Oxide Sterilization Cycles1 |
| KIMGUARDONE-STEP*SterilizationWrap Models | Intended Loads | MaximumWrappedPackageContentWeights Used inSterilityMaintenanceValidationStudy2 | Descriptions of Loads Used in SterilityMaintenance Validation Study2 |
|---|---|---|---|
| KC100 | Very Light WeightPackage (forexample: towelpacks) | 3 lbs | 16 huck towels (17"x 29") |
| KC200 | Light Weight Package(for example:standard linen 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") |
| KC300 | Light to ModerateWeight Package (forexample: general usemedical instruments) | 9 lbs | For Pre-Vacuum Steam:15 huck towels (17"x 29")1 small fluid resistant drape (60"x 76")5 lbs of metal massFor 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") |
| KC4003 | 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 lbs ofmetal mass |
| KC5003 | 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 |
| KC6003 | 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 |
Individual results may differ due to factors such as variations in handling practices, wrapping techniques, and folding mornodal router 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. it 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
Page 3 of 5 - Section 9 510(k) Summary
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validated for the KIMGUARD ONE-STEP* Sterilization Wraps (i.e.: the number and size of the fluid resistant linens or the weight of the metal mass).
"The KC400, KC500 model wraps were validated for sterilant penetration with 3 lbs of non-fluid resistant linen, and it is recommended to not exceed 3 lbs of non-fluid resistant linen in sterilization cycles with these models. It is recommended that the user not include fluid-resistant linens in KC600 model wraps, as use of such fluid resistant materials has not been evaluated with these models.
Table 2. Wrap Model Recommendations for Amsco V-PRO™ 1. V-PRO 1 Plus and Flexible Cycle1 Low Temperature Sterilization System
| 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 irregularly shaped contents, which may put added stress on the wrap. Each healthcare facility should determine for itself which wrap grade 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. Furthermore, it is recommended to not exceed the number, weight, and size of individual content types that were validated for the KIMGUARD ONE-STEP Sterilization Wraps (i.e.: the weight of the metal mass).
Page 4 of 5 - Section 9 510(k) Summary
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| Models | Pre-Vacuum SteamSterilization | EO Sterilization | V-PRO Cycles |
|---|---|---|---|
| KIMGUARD One-Step*Sterilization WrapModels KC100 andKC200 | At least 30 days | At least 30 days | At least 30 days |
| KIMGUARD One-Step*Sterilization WrapModels KC300,KC400, KC500 andKC600 | At least 1 year | At least 1 year | At least 30 days |
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and the same of the same of the same of the seat of the seat of
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Table 3: Maintenance of Package Sterility Recommendations
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Page 5 of 5 - Section 9 510(k) Summary
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Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
Ms. Brenda Shelkey Associate Director, Quality Assurance & Regulatory Kimberly-Clark Corporation 1400 Holcomb Bridge Road Building 300 Roswell, Georgia 30076
JUN 2 2 2012
Re: K112805
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: June 14, 2012 Received: June 14, 2012
Dear Ms. Shelkey:
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.
{6}------------------------------------------------
Page 2- Ms. Shelkey
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/CDRHOffices/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Th for
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: K112805
KIMGUARD ONE-STEP* Sterilization Wrap (Models KC100, KC200, Device Name: KC300, KC400, KC500, and KC600)
Indications for Use:
KIMGUARD ONE-STEP* Sterilization Wraps are 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 (EO) with a concentration of 725-735 mg/L at 131°F/55°C and 40% - 80% relative humidity for 60 minutes. KIMGUARD ONE-STEP* Sterilization Wrap is also intended to be used in the Amsco® V-PRO™ 1 Low Temperature Sterilization System's cycle, the Amsco® V-PRO™ 1 Plus Low Temperature Sterilization System's Lumen (identical to the V-PRO™ 1 Cycle) and Non Lumen Cycles, and the V-PRO™ Low Temperature Sterilization System's Flexible Cycle. 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 within the period of time for which performance data demonstrating maintenance of sterility has been provided. The wrap was validated for aeration times for EO sterilization of 8 hours at 55 ℃ or 12 hours at 43.3 °C. The KIMGUARD ONE-STEP* Sterilization Wrap were validated for dry times for pre-vacuum steam sterilization of 20 minutes for Models 100 and 200, and for 30 minutes for Models 300, 400, 500, and 600. The KIMGUARD ONE-STEP* Sterilization Wrap was validated to be effectively aerated during the pre-programmed V-PRO™, V-PROTM 1 Plus, and the V-PROTM Flexible Sterilization Cycles.
KIMGUARD ONE-STEP* Sterilization Wraps are not indicated for use for gravity steam sterilization.
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)
Elizth F. Chamire-Willer
ion of Anesthesionaly, Goneral Hos
K112895 KIMGUARD ONE-STEP* Sterilization Wrap
510(k) Numbe
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Table 1. Wrap Model Recommendations for Pre-Vacuum Steam and Ethylene Oxide Sterilization Cvcles1
| KIMGUARDONE-STEP*SterilizationWrap Models | Intended Loads | MaximumWrappedPackageContentWeights Used inSterilityMaintenanceValidationStudy2 | Descriptions of Loads Used in SterilityMaintenance Validation Study2 |
|---|---|---|---|
| KC100 | Very Light WeightPackage (forexample: towelpacks) | 3 lbs | 16 huck towels (17"x 29") |
| KC200 | Light Weight Package(for example:standard linen 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") |
| KC300 | Light to ModerateWeight Package (forexample: general usemedical instruments) | 9 lbs | For Pre-Vacuum Steam:15 huck towels (17"x 29")1 small fluid resistant drape (60"x 76")5 lbs of metal massFor 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") |
| KC4003 | 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 lbs ofmetal mass |
| KC5003 | 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 |
| KC6003 | 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 |
' Individual results may differ due to factors such as variations in handling practices, wroping techniques, and folding methods. Results may also differ due to the use of irregularly shaped contents, which may put added stress on the menous. They also they also olifer doo to the asso of itself which wrap model is most appropriate for each intended use.
with is recommended to not exceed the maximum wrapped package content weights indicated for each ware model. it is roommondou to not exceed the number, weight, and size of individual content types that were Futuremore, it is recommended to not bloods the hands, we and size of the fluid resistant linens or the weight of the metal mass).
welglif of the metal mass;
3 The KC400, KC500, and KC600 model wraps were validated for sterilant penetration with has models The KC400, RC300, and RO00 model Maps were validation of sterilization ordels will these models. It is
linen, and it is recommended to not exceed 3 lbs of non-fluid research iment, and its recommended to the exceed i bother hand in KC400, KC500, and KC600 model wraps, as use of such fluid resistant materials has not been evaluated with these models.
K112895 KIMGUARD ONE-STEP* Sterilization Wrap
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| Table 2. Wrap Model Recommendations for Amsco V-PRO'™ 1, V-PRO 1 | |
|---|---|
| Plus and Flexible Cvcle' Low Temperature Sterilization System |
| KIMGUARDONE-STEP*SterilizationWrap Models | Intended Loads | MaximumWrappedPackage.ContentWeights 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 folling methods. Results may also differ due to the use of irregularly shaped contents, which may put added stress on the wrap. methous: Tresults may also differ doo or mogulary of the spropriate for each intended use.
Each healthcare facility should determine for itself which wrappropriate for each w ² It is recommended to not exceed the maximum wapped 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 r dithornere, it is 1000mmbhidou to not Sterliization Wraps (i.e.: the weight of the metal mass).
K112895 KIMGUARD ONE-STEP* Sterilization Wrap
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| Models | Pre-Vacuum SteamSterilization | EO Sterilization | V-PRO Cycles |
|---|---|---|---|
| KIMGUARD One-Step*Sterilization WrapModels KC100 andKC200 | At least 30 days | At least 30 days | At least 30 days |
| KIMGUARD One-Step*Sterilization WrapModels KC300,KC400, KC500 andKC600 | At least 1 year | At least 1 year | At least 30 days |
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Table 3: Maintenance of Package Sterility Recommendations
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K112895 KIMGUARD ONE-STEP* Sterilization Wrap
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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).