(164 days)
Not Found
No
The device description and performance studies focus solely on the physical properties and sterilization efficacy of the wrap material, with no mention of AI or ML.
No
This device is a sterilization wrap intended to enclose other medical devices for sterilization and maintain their sterility, not to treat any medical condition.
No
This 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 it is a physical sterilization wrap made of fabric, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the wraps are "intended to enclose another medical device that is to be sterilized by a healthcare provider". This describes a packaging material used in the sterilization process of other medical devices.
- Device Description: The description details the physical composition and construction of the sterilization wrap.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed to perform tests on biological samples (like blood, urine, tissue) to provide diagnostic information. This device's function is to facilitate the sterilization and maintenance of sterility for other medical devices.
N/A
Intended Use / Indications for Use
KIMGUARD ONE-STEP® Sterilization Wraps are intended to enclose another medical device that is to be sterilized by a healthcare provider using:
- V-PRO® 60 Low Temperature Sterilization System that include:
- o Lumen Cycle
- Non Lumen Cycle o
- Flexible Cycle O
KIMGUARD ONE-STEP® Sterilization Wrap (KC100, KC200, KC300 and KC600) 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 ONE-STEP® Sterilization Wraps (KC100, KC300, KC500, and KC600) allowed sterilization of the enclosed devices by the V-PRO® 60 Low Temperature Sterilization System (i.e., Lumen, Non Lumen, and Flexible Cycles). Additionally, the KIMGUARD ONE-STEP® Sterilization Wrap was validated to allow effective aeration under the pre-programmed sterilization cycles.
All models of the KIMGUARD ONE-STEP® Sterilization Wrap (KC100, KC300, KC300, KC500, and KC600) have been validated for use with the V-PRO® 60 Low Temperature Sterilization System cycles in Table 1.
KIMGUARD ONE-STEP® Sterilization Wraps (KC100, KC200, KC300, and KC600) Recommendations for Use with the V-PRO® 60 Low Temperature Sterilization System are provided in Table 2.
Product codes (comma separated list FDA assigned to the subject device)
FRG
Device Description
KIMGUARD* ONE-STEP® Sterilization Wrap is comprised of two sheets of KIMGUARD* Sterilization Wrap that is ultrasonically seamed on two edges. This seamed configuration allows for convenient wrapping of an article using two sheets simultaneously.
The blue or white sheets of sterilization wrap are square or rectangular fabric produced using a three-layer SMS (spunbound-meltblown-spunbound) process. The blue wrap fabric is composed of polypropylene with the addition of 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 anti-static treatment. The white sheet has the same material composition but contains no blue pigment. The wrap allows a sterilized package to be opened aseptically.
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)
Summary of Testing Performed
- V-PRO® 60 Low Temperature Sterilization System Sterilant Penetration: Passed
- Post V-PRO® 60 Low Temperature Sterilization System Sterilization - Maintenance of Package Integrity (30 Days): Passed
- Post V-PRO® 60 Low Temperature Sterilization System Sterilization - Performance Testing: Passed
- Post V-PRO® 60 Low Temperature Sterilization System Sterilization - Material Biocompatibility: Passed
Overall Performance Conclusions:
The nonclinical studies demonstrate that the KIMGUARD* ONE-STEP® Sterilization Wrap performs as intended as a sterilization packaging system of medical devices when terminally sterilized in the V-PRO® 60 Low Temperature Sterilization System (Lumen Cycle, Non Lumen Cycle, and Flexible Cycle). These studies demonstrate that the KIMGUARD* ONE-STEP® Sterilization Wrap met the same criteria as the predicate devices 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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 9, 2015
Halyard Health (formerly known as Kimberly-Clark Health Care) Thomas Kozma, Ph.D. Director of Regulatory Affairs 5450 Windward Parkway Alpharetta, GA 30004
Re: K142782
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: Class II Product Code: FRG Dated: February 12, 2015 Received: February 13, 2015
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Post market Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
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
510(k) Number (if known)
K142782
Device Name
.
KIMGUARD* ONE-STEP® Sterilization Wrap (Models KC100, KC200, KC300, KC500, and KC600)
Indications for Use (Describe)
KIMGUARD ONE-STEP® Sterilization Wraps are intended to enclose another medical device that is to be sterilized by a healthcare provider using:
- V-PRO® 60 Low Temperature Sterilization System that include:
- o Lumen Cycle
- Non Lumen Cycle o
- Flexible Cycle O
KIMGUARD ONE-STEP® Sterilization Wrap (KC100, KC200, KC300 and KC600) 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 ONE-STEP® Sterilization Wraps (KC100, KC300, KC500, and KC600) allowed sterilization of the enclosed devices by the V-PRO® 60 Low Temperature Sterilization System (i.e., Lumen, Non Lumen, and Flexible Cycles). Additionally, the KIMGUARD ONE-STEP® Sterilization Wrap was validated to allow effective aeration under the pre-programmed sterilization cycles.
All models of the KIMGUARD ONE-STEP® Sterilization Wrap (KC100, KC300, KC300, KC500, and KC600) have been validated for use with the V-PRO® 60 Low Temperature Sterilization System cycles in Table 1.
KIMGUARD ONE-STEP® Sterilization Wraps (KC100, KC200, KC300, and KC600) Recommendations for Use with the V-PRO® 60 Low Temperature Sterilization System are provided in Table 2.
| TABLE 1: Validated V-PRO® 60 Low Temperature Sterilizer System Cycles | |
|---|---|
| V-PRO® 60 Low | |
| Temperature | |
| Sterilizer | |
| Cycles | Intended Load |
| Lumen Cycle | Reusable metal and non-metal medical devices including instruments with diffusion-restricted spaces (such as the hinged |
| portion of forceps or scissors) and single, dual or triple channeled rigid/semi-rigid endoscopes, with the following | |
| configurations: | |
| Single or dual channeled devices with stainless steel lumens with An inside diameter of 0.77 mm or larger and a length of 410 mm or shorter Triple channeled devices with stainless steel lumens with An inside diameter of 1.2 mm or larger and a length of 257 mm or shorter. An inside diameter of 1.8 mm or larger and a length of 310 mm or shorter or An inside diameter of 2.8 mm or larger and a length of 317 mm or shorter | |
| Non Lumen | |
| Cycle | Reusable metal and non-metal non-lumened medical devices including non-lumened rigid, semi-rigid and flexible |
| endoscopes and medical devices with stainless steel or titanium diffusion-restricted spaces such as the hinged portion of | |
| forceps or scissors. | |
| Flexible Cycle | Single or dual channeled Flexible Surgical Endoscopes or Bronchoscopes with lumens that have: |
| An inside diameter of 1 mm or larger and a length of 990 mm or shorter. |
3
| TABLE 2: Recommended Loads for KIMGUARD ONE-STEP® Sterilization Wrap (KC100, KC200, KC300, KC400, KC500, & KC600) for use with V-PRO® 60 Low Temperature Sterilizer System | |||
|---|---|---|---|
| KIMGUARD ONE-STEP® Sterilization Wrap Models | Intended Loads1 | Maximum Wrapped Package Content Weights Used in Sterility Maintenance Validation Study2 | Description of Loads Used in Sterility Maintenance Validation Study2 |
| KC100 | Very Light Weight Package (for example batteries) | 3 lbs. | 3 lb of metal mass |
| 6 surgical forceps | |||
| 1 self-contained biological indicator (SCBI) (no tray was included) | |||
| KC200 | Light Weight Package (for example telescope with light cord) | 6.5 lbs. | • 2.5 lbs metal mass |
| • 6 surgical forceps | |||
| • 1 SCBI | |||
| • 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 surgical forceps | |||
| • 1 SCBI | |||
| • V-PRO tray (17" x 10" x 3½") at 4 lbs | |||
| KC400 | Moderate to Heavy Weight Package (for example: general use medical instruments) | 12 lbs. | • 8 lbs metal mass |
| • 6 surgical forceps | |||
| • 1 SCBI | |||
| • V-PRO tray (17" x 10" x 3½") at 4 lbs | |||
| KC500 | Heavyweight Package (for example: general use medical instruments) | 12 lbs. | • 8 lbs metal mass |
| • 6 surgical forceps | |||
| • 1 SCBI | |||
| • V-PRO tray (17" x 10" x 3½") at 4 lbs | |||
| KC600 | Very Heavy Weight Package (for example: general use medical instruments) | 12 lbs. | • 8 lbs metal mass |
| • 6 surgical forceps | |||
| • 1 SCBI | |||
| • V-PRO tray (17" x 10" x 3½") at 4 lbs | |||
| 1 Individual results may differ due to factors such as variations in handling practices, wrapping techniques, and folding methods. Results may also differ due to the use of irregularly shaped contents, which may put added stress on the wrap. Each healthcare facility should determine for itself which wrap model is most appropriate for each intended use. | |||
| 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 KIMGUARD ONE-STEP® Sterilization Wraps. |
Type of Use (Select one or both, as applicable)
| | Prescription Use (Part 21 CFR 801 Subpart D)
区 | Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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4
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 (formerly known as Kimberly-Clark Health Care) 5450 Windward Parkwav. Alpharetta. GA 30004. USA
Establishment Registration Number: 1033422
| Contact Name: | Thomas Kozma, Director of Regulatory Affairs |
|---|---|
| E-mail: | thomas.kozma@hyh.com |
| Phone: | 470.448.5681 |
| FAX: | 678.254.0099 |
| DATE PREPARED: | March 6, 2015 |
| TRADE NAME: | KIMGUARD* ONE-STEP® Sterilization Wrap (Models KC100, KC200, KC300, KC400, KC500, and KC600) |
| CLASSIFICATION NAME: | Sterilization Wrap |
| COMMON/USUAL NAME: | Sterilization Wrap |
| PRODUCT CODE: | FRG |
| DEVICE CLASSIFICATION: | Class II per 21 CFR §880.6850 |
| PREDICATE DEVICES: | K092167 and K112805 - KIMGUARD ONE-STEP® Sterilization Wrap (Models KC100, KC200, KC300, KC400, KC500, and KC600). |
INDICATIONS FOR USE
KIMGUARD ONE-STEP® Sterilization Wraps are intended to enclose another medical device that is to be sterilized by a healthcare provider using:
- V-PRO® 60 Low Temperature Sterilization System that include: ●
- o Lumen Cycle
- Non Lumen Cycle o
- Flexible Cvcle O
KIMGUARD* ONE-STEP® Sterilization Wrap (KC100, KC200, KC300, KC400, KC500 and KC600) 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 ONE-STEP® Sterilization Wraps (KC100, KC200, KC300, KC400, KC500, and KC600) allowed sterilization of the enclosed devices by the V-PRO® 60 Low Temperature Sterilization System (i.e., Lumen, Non Lumen, and Flexible Cycles). Additionally, the KIMGUARD ONE-STEP® Sterilization Wrap was validated to allow effective aeration under the pre-programmed sterilization cycles. All models of the KIMGUARD ONE-STEP® Sterilization Wrap (KC100, KC200, KC300, KC400, KC500, and KC600) have been validated for use with the V-PRO® 60 Low Temperature Sterilization System cycles in TABLE 1.
5
| TABLE 1: Validated V-PRO® 60 Low Temperature Sterilizer System Cycles | |
|---|---|
| ------------------------------------------------------------------------ | -- |
| Cycles | Intended Load |
|---|---|
| Lumen | |
| Cycle1 | Reusable metal and non-metal medical devices including instruments with diffusion-restricted spaces |
| (such as the hinged portion of forceps or scissors) and single, dual or triple channeled rigid/semi-rigid | |
| endoscopes, with the following configurations: | |
| Single or dual channeled devices with stainless steel lumens with An inside diameter of 0.77 mm or larger and a length of 410 mm or shorter Triple channeled devices with stainless steel lumens with An inside diameter of 1.2 mm or larger and a length of 257 mm or shorter. An inside diameter of 1.8 mm or larger and a length of 310 mm or shorter or An inside diameter of 2.8 mm or larger and a length of 317 mm or shorter | |
| Flexible | |
| Cycle1 | Single or dual channeled Flexible Surgical Endoscopes or Bronchoscopes with lumens that have: |
| An inside diameter of 1 mm or larger and a length of 990 mm or shorter. | |
| Non-Lumen | |
| Cycle1 | Reusable metal and non-metal non-lumened medical devices including non-lumened rigid, semi-rigid |
| and flexible endoscopes and medical devices with stainless steel or titanium diffusion-restricted | |
| spaces such as the hinged portion of forceps or scissors. |
KIMGUARD ONE-STEP® Sterilization Wraps (KC100, KC200, KC300, KC400, KC500, and KC600) Recommendations for Use with the V-PRO® 60 Low Temperature Sterilization System are provided in TABLE 2.
| Wrap Models | Intended Loads1 | Maximum Wrapped
Package Content Weights
MPI Study2 | Description of Loads Used in Sterility
Maintenance Validation Study2 |
|-------------|------------------------------------------------------------------------------------------|----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| KC100 | Very Light Weight Package
(for example batteries) | 3 lbs. | 3 lb of metal mass
6 surgical forceps
1 self-contained biological indicator (SCBI)
(no tray was included) |
| KC200 | Light Weight Package (for
example telescope with light
cord) | 6.5 lbs. | • 2.5 lbs metal mass
• 6 surgical forceps
• 1 SCBI
• V-PRO® tray (17" x 10" x 3½") at 4 |
| KC300 | Light to Moderate Weight
Package (for example:
general use medical
instruments) | 9 lbs. | • 5 lbs metal mass
• 6 surgical forceps
• 1 SCBI
• V-PRO® tray (17" x 10" x 3½") at 4 |
| KC400 | Moderate to Heavy Weight
Package (for example:
general use medical
instruments) | 12 lbs. | • 8 lbs metal mass
• 6 surgical forceps
• 1 SCBI
• V-PRO® tray (17" x 10" x 3½") at 4 |
| KC500 | Heavyweight Package (for
example: general use
medical instruments) | 12 lbs. | • 8 lbs metal mass
• 6 surgical forceps
• 1 SCBI
• V-PRO® tray (17" x 10" x 3½") at 4 |
| KC600 | Very Heavy Weight Package
(for example: general use
medical instruments) | 12 lbs. | • 8 lbs metal mass
• 6 surgical forceps
• 1 SCBI
• V-PRO® tray (17" x 10" x 3½") at 4 |
number, weight, and size of individual content types that were validated for KIMGUARD ONE-STEP® Sterilization Wraps.
6
Description of Device
KIMGUARD* ONE-STEP® Sterilization Wrap is comprised of two sheets of KIMGUARD* Sterilization Wrap that is ultrasonically seamed on two edges. This seamed configuration allows for convenient wrapping of an article using two sheets simultaneously.
The blue or white sheets of sterilization wrap are square or rectangular fabric produced using a three-layer SMS (spunbound-meltblown-spunbound) process. The blue wrap fabric is composed of polypropylene with the addition of 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 anti-static treatment. The white sheet has the same material composition but contains no blue pigment. The wrap allows a sterilized package to be opened aseptically.
Substantial Equivalence to Predicate Device
KIMGUARD ONE-STEP® Sterilization Wrap (i.e., subject of this Premarket Notification) is substantially equivalent to the predicate Kimberly-Clark KIMGUARD* ONE-STEP® Sterilization Wraps (K092167 & K112805) in technology, design, and materials.
The following table compares the subject KIMGUARD* ONE-STEP® Sterilization Wrap to the predicate KIMGUARD* ONE-STEP® Sterilization Wrap.
7
Device Comparison Table (Technological, Design, & Materials)
| Characteristics | Predicate Devices:
KIMGUARD* ONE-STEP® Sterilization
Wrap (KC100, KC200, KC300, KC400,
KC500, & KC600) (K092167 & 112805) | Proposed Device:
KIMGUARD* ONE-STEP® Sterilization
Wrap (KC100, KC200, KC300, KC400,
KC500, & KC600) |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Kimberly-Clark Corporation | Kimberly Clark Corporation |
| Regulation/Product
Code | Sterilization Wrap: 880.6850 / FRG | Sterilization Wrap: 880.6850 / FRG |
| Indications for Use | The device is intended to be used to enclose
another medical device that is to be sterilized by a
healthcare provider by 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 KIMIGUARD ONE-STEP*
Sterilization Wrap was validated to be effectively
aerated during the pre-programmed V-PRO™, V-
PRO™ 1 Plus, and V-PRO™ Flexible Cycles. | KIMGUARD ONE-STEP® Sterilization Wraps are
intended to enclose another medical device that
is to be sterilized by a healthcare provider using:
· V-PRO® 60 Low Temperature Sterilization
System that include:
o Lumen Cycle
o Non Lumen Cycle
o Flexible Cycle
KIMGUARD* ONE-STEP® Sterilization Wrap
(KC100, KC200, KC300, KC400, KC500 and
KC600) are intended to allow sterilization of the
enclosed medical device(s) and also maintain
sterility of the enclosed device(s) until used. |
| Sterilization Cycles | 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 max Low Temperature
Sterilization System's Flexible Cycle | V-PRO® 60 Low Temperature
Sterilization System:
o Lumen Cycle
o Non Lumen Cycle
o Flexible Cycle |
| Maintenance of
Package Sterility | For models KC100, KC200, KC300, K400,
KC500, and KC600 for at least 30 days. | Real-time testing following sterilization using
the V-PRO® 60 Low Temperature
Sterilization System supports maintenance
of package sterility for 180 days for all
models of KIMGUARD* ONE-STEP® Sterilization
Wrap. |
| Technology | Tortuous sheet material used to enclose
medical devices that are to be sterilized by a
healthcare provider to allow sterilization of
the enclosed medical device(s) and maintain
sterility of the enclosed device(s) until used. | Tortuous sheet material used to enclose
medical devices that are to be sterilized by a
healthcare provider to allow sterilization of
the enclosed medical device(s) and maintain
sterility of the enclosed device(s) until used. |
| Device Design | Two sheets of nonwoven polypropylene
fabric. Each sheet is composed of three
thermally- bonded layers consisting of a
Meltblown polypropylene layer surrounded by
Spunbound polypropylene layers (SMS) | Two sheets of nonwoven polypropylene
fabric. Each sheet is composed of three
thermally- bonded layers consisting of a
Meltblown polypropylene layer surrounded
by Spunbound polypropylene layers (SMS) |
| Method for bonding
SMS layers | Thermal bonding with round pin, hexagonal,
triangle bond pattern ("daisy" pattern) | Thermal bonding with round pin, hexagonal,
triangle bond pattern ("daisy" pattern) |
| Materials | Polypropylene with blue and white
pigments | Polypropylene with blue and white
pigments |
| Distribution | Non-Sterile and
Over-the-Counter | Non-Sterile and
Over-the-Counter |
| Single Use Device | Yes | Yes |
8
SUMMARY OF NONCLINICAL TESTS
Performance of KIMGUARD* ONE-STEP® Sterilization Wrap (KC100, KC200, KC300, KC400, KC500, KC600) has been tested in accordance with the applicable requirements. All results of testing met acceptance criteria demonstrating that the KIMGUARD* ONE-STEP® Sterilization Wrap allows sterilization of contents by the V-PRO® 60 Low Temperature Sterilization System (Lumen Cycle, Non Lumen Cycle, and Flexible Cycle) and maintains sterility of contents until used.
| Summary of Testing Performed | Results |
|---|---|
| V-PRO® 60 Low Temperature Sterilization System | |
| Sterilant Penetration | Passed |
| Post V-PRO® 60 Low Temperature Sterilization System | |
| Sterilization - Maintenance of Package Integrity (30 Days) | Passed |
| Post V-PRO® 60 Low Temperature Sterilization System | |
| Sterilization - Performance Testing | Passed |
| Post V-PRO® 60 Low Temperature Sterilization System | |
| Sterilization - Material Biocompatibility | Passed |
Overall Performance Conclusions
The nonclinical studies demonstrate that the KIMGUARD* ONE-STEP® Sterilization Wrap performs as intended as a sterilization packaging system of medical devices when terminally sterilized in the V-PRO® 60 Low Temperature Sterilization System (Lumen Cycle, Non Lumen Cycle, and Flexible Cycle). These studies demonstrate that the KIMGUARD* ONE-STEP® Sterilization Wrap met the same criteria as the predicate devices and are substantially equivalent.
BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE:
Based on the intended use, technological characteristics, performance data and nonclinical tests performed, the subject KIMGUARD* ONE-STEP® Sterilization Wrap is substantially equivalent and is as safe and as effective as the legally marketed predicate devices, K092167 and K112805.