(209 days)
Not Found
No
The device description and performance studies focus on the material properties and sterilization efficacy of the wrap, with no mention of AI or ML.
No.
This device is a sterilization wrap intended to maintain the sterility of other medical devices, not to provide a therapeutic effect itself.
No
The device is a sterilization wrap intended to enclose other medical devices for sterilization and maintain their sterility. It does not perform any diagnostic function.
No
The device description clearly outlines the physical components of the sterilization wrap, including nonwoven fabric, reinforcement strips, and pull tabs, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to enclose another medical device for sterilization and maintain its 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 a sterilization wrap. It does not mention any components or functionalities related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information.
Therefore, the KIMGUARD* Smart Fold* Sterilization Wrap is a medical device used in the sterilization process, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
KIMGUARD* Smart Fold* Sterilization Wrap (KC450 and KC650) is intended to enclose another medical device that is to be sterilized by a healthcare provider using:
- Advanced Sterilization Products' STERRAD® Sterilization Systems that include:
- STERRAD® 100S o
- STERRAD® NX® [Standard Cycle, Advanced Cycle] O
- STERRAD® 100NX®). [Standard Cycle, Flex Cycle, EXPRESS cycle, DUO Cycle] C
KIMGUARD* Smart Fold* Sterilization Wraps (KC450 are intended to allow sterlization of the enclosed medical device(s) and also maintain sterility of the enclosed device(s) until used.
Test results validated that KIMGUARD* Smart Fold* Sterlization Wrap (KC450 and KC650) allowed sterilization of the enclosed devices by the Advanced Sterilization Products STERRAD® 100S, NX® [Standard Cycle and Advanced Cycle and Advanced Cycle], and 100NX . (Standard Cycle, Flex Cycle, DUO Cycle)), (Refer to the STERRAD Sterilization System User's Guide for complete instructions on load(s) and cycle(s), including chamber loading instructions.)
The KC450 and KC650 models of the KIMGUARD* Smart Fold* Sterilization Wrap have been validated for use with the STERRAD® 100S, STERRAD® NX®, and STERRAD® 100 NX® cycles in Table 1.
KIMGUARD* Smart Fold* Sterilization Wrap Recommendations for Use with the Advanced Sterilization Systems are provided in Table 2.
Product codes (comma separated list FDA assigned to the subject device)
FRG
Device Description
KIMGUARD* Smart Fold* Sterilization Wrap is comprised of two pre-shaped sheets of KIMGUARD Sterilization Wrap (blue base sheet and white intermediate sheet), which include reinforcement strips, and adhesively seamed on three edges to allow convenient wrapping with two sheets (i.e., white and blue) simultaneously. The fabric is a nonwoven spunbondmeltblown-spunbond (SMS) composite sheet manufactured with polypropylene with less than 2% by weight of phthalocyanine blue pigment, less than 1% by weight titanium dioxide pigment, and less than 0.008% by weight of a potassium phosphate anti-static treatment. Two strips of blue SMS are adhesively bonded to the white SMS intermediate layer for added strength. These reinforcement strips also function as a "reference line" to indicate proper sterilization tray placement by the user. The Smart-Fold wrap also incorporates pull tabs comprised of blue SMS material for convenient aseptic opening of wrapped packages.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was conducted to show that the KIMGUARD* Smart Fold* Sterilization Wrap maintains sterility until used, after completion of the sterilization processes provided by the STERRAD® Sterilization Systems. The following Table summarizes performance evaluations performed.
Performance Requirement
STERRAD Sterilant Penetration
Material Compatibility/Biocompatibility post-sterilization using maximum hydrogen peroxide concentration
- Cytotoxicity per ISO 10993-5:2009 Elution Method using MEM extraction
- Dermal Irritation per ISO 10993-10:2010, Intracutaneous reactivity using two extracts (i.e., 0.9% Sodium Chloride, USP and Sesame Oil, NF)
Material Usability post-sterilization
Maintenance of Package Integrity (180 Days)
Results
Passed
Passed
Passed
Passed
Overall Performance Conclusions
The nonclinical studies demonstrate that the KIMGUARD* Smart Fold* Sterilization Wrap performs as intended as a sterilization packaging system of medical devices when sterilized in the STERRAD® Sterilization Systems. These studies show that the KIMGUARD* Smart Fold* Sterilization Wrap (KC450 and KC650) met the same criteria as the predicate device and are substantially equivalent.
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.
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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, with three overlapping faces suggesting a sense of community or interconnectedness. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure, emphasizing the organization's name and national affiliation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 10, 2014
Kimberly-Clark Health Care Dr. Thomas Kozma Director of Regulatory Affairs 1400 Holcomb Bridge Road Roswell, GA 30076
Re: K140963
Trade/Device Name: KIMGUARD* Smart-Fold* Sterilization Wrap (Models KC450 and KC650) Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: September 25, 2014 Received: September 26, 2014
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. 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.
1
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 of medical devicerelated 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 yours.
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
K140963 510(k) Number (if known)
Device Name
●
KIMGUARD* Smart Fold* Sterilization Wrap (Models KC450 and KC650)
Indications for Use (Describe)
KIMGUARD* Smart Fold* Sterilization Wrap (KC450 and KC650) is intended to enclose another medical device that is to be sterilized by a healthcare provider using:
- Advanced Sterilization Products' STERRAD® Sterilization Systems that include:
- STERRAD® 100S o
- STERRAD® NX® [Standard Cycle, Advanced Cycle] O
- STERRAD® 100NX®). [Standard Cycle, Flex Cycle, EXPRESS cycle, DUO Cycle] C
KIMGUARD* Smart Fold* Sterilization Wraps (KC450 are intended to allow sterlization of the enclosed medical device(s) and also maintain sterility of the enclosed device(s) until used.
Test results validated that KIMGUARD* Smart Fold* Sterlization Wrap (KC450 and KC650) allowed sterilization of the enclosed devices by the Advanced Sterilization Products STERRAD® 100S, NX® [Standard Cycle and Advanced Cycle and Advanced Cycle], and 100NX . (Standard Cycle, Flex Cycle, DUO Cycle)), (Refer to the STERRAD Sterilization System User's Guide for complete instructions on load(s) and cycle(s), including chamber loading instructions.)
The KC450 and KC650 models of the KIMGUARD* Smart Fold* Sterilization Wrap have been validated for use with the STERRAD® 100S, STERRAD® NX®, and STERRAD® 100 NX® cycles in Table 1.
KIMGUARD* Smart Fold* Sterilization Wrap Recommendations for Use with the Advanced Sterilization Systems are provided in Table 2.
(continued on next 3 pages)
3
| TABLE 1: Validated Advanced Sterilization Products (ASP) STERRAD® 100S, STERRAD® NX®, and STERRAD® 100NX® Cycles | |
|---|---|
| ASP | |
| STERRAD® | |
| System and | |
| Cycle | Intended Load |
| STERRAD® | |
| 100S | Reusable metal and non-metal medical devices, including up to 10 lumens of the following dimensions per chamber load: |
| • An inside diameter of 1 mm or larger and a length of 125 mm or shorter of single-channel stainless steel lumens. | |
| • An inside diameter of 2 mm or larger and a length of 250 mm or shorter of single-channel stainless steel lumens. | |
| • An inside diameter of 3 mm or larger and a length of 400 mm or shorter of single-channel stainless steel lumens. | |
| • An inside diameter of 6 mm or larger and a length of 310 mm or shorter of single-channel Teflon/Polyethylene lumens. | |
| STERRAD® | |
| NX® | |
| Standard | |
| Cycle | Reusable metal and non-metal medical devices, including up to 10 lumens of the following dimensions per chamber load: |
| • An inside diameter of 1 mm or larger and a length of 150 mm or shorter of single-channel stainless steel lumens. | |
| • An inside diameter of 2 mm or larger and a length of 400 mm or shorter of single-channel stainless steel lumens. | |
| STERRAD® | |
| NX® | |
| Advanced | |
| Cycle | Reusable metal and non-metal medical devices, including up to 10 lumens of the following dimensions per chamber load: |
| • An inside diameter of 1 mm or larger and a length of 500 mm or shorter of single-channel stainless steel lumens. | |
| OR | |
| One single-channel Flexible Endoscope with or without a silicone mat and no additional load. The flexible endoscope may contain: | |
| • A single-channel Teflon®/Polyethylene lumen with an inside diameter of 1 mm or larger and a length of 850 mm or shorter. | |
| STERRAD® | |
| 100NX® | |
| Standard | |
| Cycle | Reusable metal and non-metal medical devices, including up to 10 lumens of the following dimensions per chamber load: |
| • An inside diameter of 0.7 mm or larger and a length of 500 mm or shorter of single-channel stainless steel lumens. (A maximum of two flexible endoscopes, one per tray per sterilization cycle.) | |
| STERRAD® | |
| 100NX® | |
| Flex Cycle | One or two single-channel Flexible Endoscope with or without a silicone mat and no additional load. The flexible endoscope may |
| contain: | |
| • A single-channel Teflon®/Polyethylene lumen with an inside diameter of 1 mm or larger and a length of 850 mm or shorter. (A maximum of two flexible endoscopes, one per tray per sterilization cycle). | |
| STERRAD® | |
| 100NX® | |
| EXPRESS | |
| Cycle | Non-lumened reusable metal and non-metal devices requiring surface sterilization, and sterilization of diffusion-restricted spaces such as |
| the hinged portions of forceps and scissors, and rigid or semi-rigid endoscopes without lumens. | |
| STERRAD® | |
| 100NX® | |
| DUO Cycle | One or two single-channel Flexible Endoscope with accessory devices that are normally connected to it, with or without a silicone mat. |
| The flexible endoscope may contain: | |
| • A single-channel Teflon®/Polyethylene lumen with an inside diameter of 2 mm or larger and a length of 250 mm or shorter. | |
| • Accessory devices that are normally connected to a flexible endoscope during use. | |
| • Flexible endoscopes without lumens |
4
TABLE 2: Recommended Loads for KIMGUARD* Smart-Fold* Sterilization Wrap for use with Advanced Sterilization Products
[Standard Cycle, Flex Cycle, EXPRESS Cycle, DUO Cycle])
| KIMGUARD* Smart
Fold* Sterilization
Wrap Models | Intended Loads1 | Maximum Wrapped Package
Content Weights Used in Sterility
Maintenance Validation Study | Description of Leads Used in
Sterility Maintenance Validation
Study |
|-------------------------------------------------------|-------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| KC450 | Moderate to heavy weight
package (e.g., general use
medical instruments | 10.7 lbs. | •APTIMAX® Instrument Tray (23 in.
x 11 in. x 4in.) with Tray Mat
•Metal and non-metal instruments |
| KC650 | Very heavy weight package (e.g.,
general use medical instruments | 10.7 lbs. | •APTIMAX® Instrument Tray (23 in.
x 11 in. x 4in.) with Tray Mat
•Metal and non-metal instruments |
l htended loads include: Medical Instruments without lumens that include telescopes, cameras, light cords, and general use medical instruments
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
X | Over-The-Counter Use (21 CFR 801 Subpart C)
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5
This 510(k) Summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| Applicant's Name, Address, Telephone, FAX, Contact Person
Halyard Health (f/k/a Kimberly-Clark Health Care)
1400 Holcomb Bridge Road Roswell, GA 30076-2190, USA
Establishment Registration Number: 1033422
Contact Name: Thomas Kozma, PhD, Director of Regulatory Affairs
E-mail: thomas.kozma@hyh.com
(770) 587-8393 (Telephone)
| (920) 225-3408 (Fax) | |
|---|---|
| DATE PREPARED: | November 07, 2014 |
| TRADE NAME: | KIMGUARD* Smart-Fold* Sterilization Wrap (Models KC450 and |
| KC650) | |
| CLASSIFICATION NAME: | Sterilization Wrap |
| COMMON/USUAL NAME: | Sterilization Wrap |
| PRODUCT CODE: | FRG |
| DEVICE CLASSIFICATION: | Class II per 21 CFR §880.6850 |
| PREDICATE DEVICES: | KimGuard* Smart-Fold* Sterilization Wrap (Models KC250, |
| KC450, KC550, and KC650) cleared January 19, 2013 | |
| (K112300). | |
| KimGuard* ONE-STEP Sterilization Wrap (Models KC100, | |
| KC200, KC300, KC400, KC500, and KC600 cleared August 20, | |
| 2013 (K113806) |
Indications for Use
KIMGUARD* Smart Fold* Sterilization Wrap (KC450 and KC650) is intended to be used to enclose another medical device that is to be sterilized by a healthcare provider using:
- Advanced Sterilization Products' STERRAD® Sterilization Systems that include: .
- o STERRAD® 100S
- STERRAD® NX® |Standard Cycle, Advanced Cycle]
- o STERRAD® 100NX®). [Standard Cycle, Flex Cycle, EXPRESS cycle, DUO Cycle]
KIMGUARD* Smart Fold* Sterilization Wraps (KC450 and KC650) are intended to allow sterilization of the enclosed medical device(s) and also maintain sterility of the enclosed device(s) until used.
Test results validated that KIMGUARD* Smart Fold* Sterilization Wrap (KC450 and KC650) allowed sterilization of the enclosed devices by the Advanced Sterilization Products STERRAD® Sterilization Systems (STERRAD® 100S, NX® [Standard Cycle and Advanced Cycle], and 100NX®. [Standard Cycle, Flex Cycle, EXPRESS cycle, DUO Cycle]). (Refer to the STERRAD®
6
Sterilization System User's Guide for complete instructions on load(s) and cycle(s), including chamber loading instructions.)
The KC450 and KC650 models of the KIMGUARD* Smart Fold* Sterilization Wrap have been validated for use with the STERRAD® 100S, STERRAD® NX®, and STERRAD® 100 NX® cycles in Table 1.
| TABLE 1: Validated Advanced Sterilization Products (ASP) STERRAD® 100S, STERRAD® NX®, and STERRAD®
| 100NX® Cycles | |
|---|---|
| ASP | |
| STERRAD® | |
| System | |
| and Cycle | Intended Load |
| STERRAD® | |
| 100S | Reusable metal and non-metal medical devices, including up to 10 lumens of the following dimensions per chamber |
| load: | |
| An inside diameter of 1 mm or larger and a length of 125 mm or shorter of single-channel stainless steel lumens. An inside diameter of 2 mm or larger and a length of 250 mm or shorter of single-channel stainless steel lumens. An inside diameter of 3 mm or larger and a length of 400 mm or shorter of single-channel stainless steel lumens. An inside diameter of 6 mm or larger and a length of 310 mm or shorter of single-channel Teflon/Polyethylene lumens. | |
| STERRAD® | |
| NX® | |
| Standard | |
| Cycle | Reusable metal and non-metal medical devices, including up to 10 lumens of the following dimensions per chamber |
| load: | |
| An inside diameter of 1 mm or larger and a length of 150 mm or shorter of single-channel stainless steel lumens. An inside diameter of 2 mm or larger and a length of 400 mm or shorter of single-channel stainless steel lumens. | |
| STERRAD® | |
| NX® | |
| Advanced | |
| Cycle | Reusable metal and non-metal medical devices, including up to 10 lumens of the following dimensions per chamber load: |
| An inside diameter of 1 mm or larger and a length of 500 mm or shorter of single-channel stainless steel lumens. OR | |
| One single-channel Flexible Endoscope with or without a silicone mat and no additional load. The flexible endoscope may contain: | |
| A single-channel Teflon®/Polyethylene lumen with an inside diameter of 1 mm or larger and a length of 850 mm or shorter. | |
| STERRAD® | |
| 100NX® | |
| Standard | |
| Cycle | Reusable metal and non-metal medical devices, including up to 10 lumens of the following dimensions per chamber load: An inside diameter of 0.7 mm or larger and a length of 500 mm or shorter of single-channel stainless steel lumens. (A maximum of two flexible endoscopes, one per tray per sterilization cycle.) |
| STERRAD® | |
| 100NX® | |
| Flex Cycle | One or two single-channel Flexible Endoscope with or without a silicone mat and no additional load. The flexible endoscope may contain: A single-channel Teflon®/Polyethylene lumen with an inside diameter of 1 mm or larger and a length of 850 mm or shorter. (A maximum of two flexible endoscopes, one per tray per sterilization cycle). |
| STERRAD® | |
| 100NX® | |
| EXPRESS | |
| Cycle | Non-lumened reusable metal and non-metal devices requiring surface sterilization, and sterilization of diffusion- restricted spaces such as the hinged portions of forceps and scissors, and rigid or semi-rigid endoscopes without lumens. |
| STERRAD® | |
| 100NX® | |
| DUO Cycle | One or two single-channel Flexible Endoscope with accessory devices that are normally connected to it, with or without a silicone mat. The flexible endoscope may contain: A single-channel Teflon®/Polyethylene lumen with an inside diameter of 2 mm or larger and a length of 250 mm or shorter. Accessory devices that are normally connected to a flexible endoscope during use. Flexible endoscopes without lumens |
7
KIMGUARD* Smart Fold* Sterilization Wrap Recommendations for Use with the Advanced Sterilization Products STERRAD® Sterilization Systems are provided in Table 2.
| TABLE 2: Recommended Loads for KIMGUARD* Smart-Fold* Sterilization Wrap for use with Advanced
Sterilization Products (ASP) STERRAD® Sterilization Systems (STERRAD® 100S, NX® [Standard
| Cycle, Advanced Cycle], and 100NX® [Standard Cycle, Flex Cycle, EXPRESS Cycle, DUO Cycle]) | |||
|---|---|---|---|
| KIMGUARD* | |||
| Smart Fold* | |||
| Sterilization Wrap | |||
| Models | Intended Loads¹ | Maximum Wrapped | |
| Package Content Weights | |||
| Used in Sterility | |||
| Maintenance Validation | |||
| Study² | Description of Leads Used | ||
| in Sterility Maintenance | |||
| Validation Study | |||
| KC450 | Moderate to heavy weight | ||
| package (e.g., general use | |||
| medical instruments | 10.7 lbs. | •APTIMAX® Instrument Tray | |
| (23 in. x 11 in. x 4in.) with | |||
| Tray Mat | |||
| •Metal and non-metal | |||
| instruments | |||
| KC650 | Very heavy weight package | ||
| (e.g., general use medical | |||
| instruments | 10.7 lbs. | •APTIMAX® Instrument Tray | |
| (23 in. x 11 in. x 4in.) with | |||
| Tray Mat | |||
| •Metal and non-metal | |||
| instruments |
Intended loads include: Medical Instruments with and without lumens that include telescopes, cameras, light cords, and general use medical instruments
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 (i.e. the number and size of the fluid resistant linens or the weights of the metal mass)
DESCRIPTION OF DEVICE
KIMGUARD* Smart Fold* Sterilization Wrap is comprised of two pre-shaped sheets of KIMGUARD Sterilization Wrap (blue base sheet and white intermediate sheet), which include reinforcement strips, and adhesively seamed on three edges to allow convenient wrapping with two sheets (i.e., white and blue) simultaneously. The fabric is a nonwoven spunbondmeltblown-spunbond (SMS) composite sheet manufactured with polypropylene with less than 2% by weight of phthalocyanine blue pigment, less than 1% by weight titanium dioxide pigment, and less than 0.008% by weight of a potassium phosphate anti-static treatment. Two strips of blue SMS are adhesively bonded to the white SMS intermediate layer for added strength. These reinforcement strips also function as a "reference line" to indicate proper sterilization tray placement by the user. The Smart-Fold wrap also incorporates pull tabs comprised of blue SMS material for convenient aseptic opening of wrapped packages.
The following table compares the subject KIMGUARD* Smart Fold* Sterilization to the predicate KIMGUARD Sterilization Wrap devices.
8
| General Comparison Matrix Overview: Subject and Predicate Device | |||
|---|---|---|---|
| Subject Device | Predicate | Predicate | |
| Characteristic | KIMGUARD* Smart-Fold* | ||
| Sterilization Wrap (models | |||
| KC450 and KC650) | KIMGUARD* Smart-Fold* | ||
| Sterilization Wrap (models | |||
| KC250, KC450, KC550, and | |||
| KC650) | KIMGUARD* ONE-STEP* | ||
| Sterilization Wrap (models | |||
| KC100, KC200, KC300, | |||
| KC400, KC500, KC600) | |||
| 510(k) Number | TBD | K112300 | K113806 |
| Regulation/ | |||
| Product Code | Sterilization Wrap: | ||
| 21CFR880.6850 | |||
| FRG | [SAME] | [SAME] | |
| Intended Use | Intended to allow sterilization of | ||
| the enclosed medical device(s) | |||
| and also maintain sterility of the | |||
| enclosed device(s) until used. | [SAME] | [SAME] | |
| Sterilization | |||
| Modality | STERRAD® (hydrogen peroxide) | ||
| Sterilization Systems | Pre-Vacuum Steam and | ||
| Ethylene Oxide | [SAME] | ||
| Base Materials | |||
| of | |||
| Construction | Three-layer SMS (spunbond- | ||
| meltblown-spunbond) fabric | [SAME] | [SAME] | |
| Packaging | Bulk and Non-sterile | [SAME] | [SAME] |
| Use | Over the Counter/Single Use | [SAME] | [SAME] |
SUMMARY OF NONCLINICAL TESTS
Performance testing was conducted to show that the KIMGUARD* Smart Fold* Sterilization Wrap maintains sterility until used, after completion of the sterilization processes provided by the STERRAD® Sterilization Systems. The following Table summarizes performance evaluations performed.
| Performance Requirement | Results |
|---|---|
| STERRAD Sterilant Penetration | Passed |
| Material Compatibility/Biocompatibility post-sterilization | |
| using maximum hydrogen peroxide concentration | |
| · Cytotoxicity per ISO 10993-5:2009 Elution Method using | |
| MEM extraction | |
| · Dermal Irritation per ISO 10993-10:2010, Intracutaneous | |
| reactivity using two extracts (i.e., 0.9% Sodium Chloride, | |
| USP and Sesame Oil, NF) | Passed |
| Material Usability post-sterilization | Passed |
| Maintenance of Package Integrity (180 Days) | Passed |
Overall Performance Conclusions
The nonclinical studies demonstrate that the KIMGUARD* Smart Fold* Sterilization Wrap performs as intended as a sterilization packaging system of medical devices when sterilized in the STERRAD® Sterilization Systems. These studies show that the KIMGUARD* Smart Fold* Sterilization Wrap (KC450 and KC650) met the same criteria as the predicate device and are substantially equivalent.