(269 days)
No
The document describes a physical sterilization wrap and its intended use and validation, with no mention of AI or ML technology.
No
The device is a sterilization wrap intended to maintain sterility of medical devices, not to directly treat or diagnose a disease.
No
The device is a sterilization wrap intended to enclose other medical devices for sterilization and maintain their sterility, not to diagnose a condition or disease.
No
The device description clearly states the device is a physical wrap made of polypropylene fabric, not software.
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 device is a sterilization wrap used to enclose other medical devices for sterilization and maintain their sterility. It does not mention any use in the examination of specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details the physical composition and construction of the wrap, not a device designed to analyze biological samples.
- Lack of IVD Characteristics: The text does not mention any components or functions typically associated with IVDs, such as reagents, assays, sample handling, or analytical measurements of biological markers.
Therefore, the KIMGUARD ONE-STEP* Sterilization Wrap falls under the category of a medical device used in the sterilization process, not an in vitro diagnostic device.
N/A
Intended Use / 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 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.
Product codes
FRG
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.
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
health care 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 sterility of pack contents after sterilization 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
JUN 2 2 2 2012
KII2805
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ಸ್ಕ
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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 Shelkey |
| Associate Director, Quality Assurance & Regulatory | |
| Affairs | |
| KIMBERLY-CLARK CORPORATION | |
| 1400 Holcomb Bridge Road | |
| Roswell, GA 30076 | |
| 678-654-8021 | |
| Brenda.Shelkey@kcc.com | |
| Establishment Registration Number 1033422 | |
| Primary Contact | |
| for this 510(k) | |
| Submission: | Brenda Shelkey |
| Associate Director, Quality Assurance & Regulatory | |
| Affairs | |
| KIMBERLY-CLARK CORPORATION | |
| 1400 Holcomb Bridge Road | |
| Roswell, GA 30076 | |
| 678-654-8021 | |
| Brenda.Shelkey@kcc.com | |
| Confidentiality | |
| Request: | Pursuant to 21 CFR 807.95, please treat with |
| confidentiality the additional information presented in | |
| this notification and Kimberly-Clark's intent to market the | |
| medical devices described herein with changes. | |
| Classification | |
| Regulation: | 21 CFR 880.6850 |
| Device Class: | Class II |
| Panel: | General Hospital |
| Product Code: | FRG |
· - .. . .
: ! 【 :
:
Page 1 of 5 - Section 9 510(k) Summary
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1
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
2
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 |
| 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: towel
packs) | 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 Moderate
Weight Package (for
example: general use
medical 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 mass
For 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") |
| KC4003 | Moderate to Heavy
Weight Package (for
example: general use
medical instruments) | 13 lbs | 4 tray liners 20" x 25" stacked
10" x 10" x 3 ½ " tray containing 11 lbs of
metal mass |
| KC5003 | Heavyweight
Package (for
example: general use
medical instruments) | 17 lbs | 4 tray liners 20" x 25" stacked
10" x 10" x 3 ½ " tray containing
15 lbs of metal mass |
| KC6003 | Very Heavy Weight
Package (for
example: general
use medical
instruments) | 25 lbs | 4 tray liners 20" x 25" stacked
10" x 10" x 3 ½ " tray containing
23 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
3
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
| 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 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
4
| Models | Pre-Vacuum Steam
Sterilization | EO Sterilization | V-PRO Cycles |
|----------------------------------------------------------------------------------------|-----------------------------------|------------------|------------------|
| KIMGUARD One-Step*
Sterilization Wrap
Models KC100 and
KC200 | At least 30 days | At least 30 days | At least 30 days |
| KIMGUARD One-Step*
Sterilization Wrap
Models KC300,
KC400, KC500 and
KC600 | At least 1 year | At least 1 year | At least 30 days |
.
:
:
:
.
and the same of the same of the same of the seat of the seat of
.
- Province Comment
Table 3: Maintenance of Package Sterility Recommendations
:
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Page 5 of 5 - Section 9 510(k) Summary
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:
5
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
7
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
8
Table 1. Wrap Model Recommendations for Pre-Vacuum Steam and Ethylene Oxide Sterilization Cvcles1
| 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: towel
packs) | 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 Moderate
Weight Package (for
example: general use
medical 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 mass
For 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") |
| KC4003 | Moderate to Heavy
Weight Package (for
example: general use
medical.instruments) | 13 lbs | 4 tray liners 20" x 25" stacked
10" x 10" x 3 ½ " tray containing 11 lbs of
metal mass |
| KC5003 | Heavyweight
Package (for
example: general use
medical instruments) | 17 lbs | 4 tray liners 20" x 25" stacked
10" x 10" x 3 ½ " tray containing
15 lbs of metal mass |
| KC6003 | Very Heavy Weight
Package (for
example: general
use medical
instruments) | 25 lbs | 4 tray liners 20" x 25" stacked
10" x 10" x 3 ½ " tray containing
23 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
Page 2 of 4
9
| Table 2. Wrap Model Recommendations for Amsco V-PRO'™ 1, V-PRO 1 | |
|---|---|
| Plus and Flexible Cvcle' Low Temperature Sterilization System |
| 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 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
10
| Models | Pre-Vacuum Steam
Sterilization | EO Sterilization | V-PRO Cycles |
|----------------------------------------------------------------------------------------|-----------------------------------|------------------|------------------|
| KIMGUARD One-Step*
Sterilization Wrap
Models KC100 and
KC200 | At least 30 days | At least 30 days | At least 30 days |
| KIMGUARD One-Step*
Sterilization Wrap
Models KC300,
KC400, KC500 and
KC600 | 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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:
:
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K112895 KIMGUARD ONE-STEP* Sterilization Wrap
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