KIMGUARD ONE-STEP Sterilization Wrap

K142782 · Kimberly-Clark Health Care · FRG · Mar 9, 2015 · General Hospital

Device Facts

• Record ID: K142782
• Device Name: KIMGUARD ONE-STEP Sterilization Wrap
• Applicant: Kimberly-Clark Health Care
• Product Code: FRG · General Hospital
• Decision Date: Mar 9, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended 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: - Lumen Cycle - Non Lumen Cycle - 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.

Device Story

KIMGUARD ONE-STEP® Sterilization Wrap consists of two ultrasonically seamed sheets of nonwoven polypropylene fabric. Used in clinical settings by healthcare providers to wrap medical devices prior to sterilization in V-PRO® 60 Low Temperature Sterilization System. The wrap allows sterilant penetration and aeration during the sterilization cycle while maintaining a microbial barrier to preserve sterility of the enclosed instruments until point of use. The device is single-use and provided non-sterile.

Clinical Evidence

Bench testing only. Validation studies confirmed sterilant penetration, effective aeration, and maintenance of package integrity for 180 days post-sterilization in V-PRO® 60 Low Temperature Sterilization System (Lumen, Non-Lumen, and Flexible cycles). Biocompatibility testing also performed.

Technological Characteristics

Two-sheet ultrasonically seamed nonwoven polypropylene fabric; three-layer SMS (spunbound-meltblown-spunbound) process. Materials: polypropylene, phthalocyanine blue pigment (<2%), titanium dioxide (<1%), anti-static treatment (<0.008%). Thermal bonding with round pin, hexagonal, triangle pattern. Dimensions: square/rectangular sheets. Single-use.

Indications for Use

Indicated for use by healthcare providers to enclose medical devices (metal/non-metal, including rigid/semi-rigid/flexible endoscopes and instruments with diffusion-restricted spaces) for sterilization in V-PRO® 60 Low Temperature Sterilization System (Lumen, Non-Lumen, and Flexible cycles) and to maintain sterility until use.

Regulatory Classification

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.

Predicate Devices

• KIMGUARD ONE-STEP® Sterilization Wrap (K092167)
• KIMGUARD ONE-STEP® Sterilization Wrap (K112805)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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# 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<br>Temperature<br>Sterilizer<br>Cycles | Intended Load |
| Lumen Cycle | Reusable metal and non-metal medical devices including instruments with diffusion-restricted spaces (such as the hinged<br>portion of forceps or scissors) and single, dual or triple channeled rigid/semi-rigid endoscopes, with the following<br>configurations:<br>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<br>Cycle | Reusable metal and non-metal non-lumened medical devices including non-lumened rigid, semi-rigid and flexible<br>endoscopes and medical devices with stainless steel or titanium diffusion-restricted spaces such as the hinged portion of<br>forceps or scissors. |
| Flexible Cycle | Single or dual channeled Flexible Surgical Endoscopes or Bronchoscopes with lumens that have:<br>An inside diameter of 1 mm or larger and a length of 990 mm or shorter. |

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| 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<br>6 surgical forceps<br>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<br>• 6 surgical forceps<br>• 1 SCBI<br>• 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<br>• 6 surgical forceps<br>• 1 SCBI<br>• 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<br>• 6 surgical forceps<br>• 1 SCBI<br>• 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<br>• 6 surgical forceps<br>• 1 SCBI<br>• 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<br>• 6 surgical forceps<br>• 1 SCBI<br>• 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.<br>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)

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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: | [e-mail] |
| 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.

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| TABLE 1: Validated V-PRO® 60 Low Temperature Sterilizer System Cycles | |
|------------------------------------------------------------------------|--|
|------------------------------------------------------------------------|--|

| Cycles | Intended Load |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Lumen<br>Cycle1 | Reusable metal and non-metal medical devices including instruments with diffusion-restricted spaces<br>(such as the hinged portion of forceps or scissors) and single, dual or triple channeled rigid/semi-rigid<br>endoscopes, with the following configurations:<br>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<br>Cycle1 | Single or dual channeled Flexible Surgical Endoscopes or Bronchoscopes with lumens that have:<br>An inside diameter of 1 mm or larger and a length of 990 mm or shorter. |
| Non-Lumen<br>Cycle1 | Reusable metal and non-metal non-lumened medical devices including non-lumened rigid, semi-rigid<br>and flexible endoscopes and medical devices with stainless steel or titanium diffusion-restricted<br>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<br>Package Content Weights<br>MPI Study2 | Description of Loads Used in Sterility<br>Maintenance Validation Study2 |
|-------------|------------------------------------------------------------------------------------------|----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| KC100 | Very Light Weight Package<br>(for example batteries) | 3 lbs. | 3 lb of metal mass<br>6 surgical forceps<br>1 self-contained biological indicator (SCBI)<br>(no tray was included) |
| KC200 | Light Weight Package (for<br>example telescope with light<br>cord) | 6.5 lbs. | • 2.5 lbs metal mass<br>• 6 surgical forceps<br>• 1 SCBI<br>• V-PRO® tray (17" x 10" x 3½") at 4 |
| KC300 | Light to Moderate Weight<br>Package (for example:<br>general use medical<br>instruments) | 9 lbs. | • 5 lbs metal mass<br>• 6 surgical forceps<br>• 1 SCBI<br>• V-PRO® tray (17" x 10" x 3½") at 4 |
| KC400 | Moderate to Heavy Weight<br>Package (for example:<br>general use medical<br>instruments) | 12 lbs. | • 8 lbs metal mass<br>• 6 surgical forceps<br>• 1 SCBI<br>• V-PRO® tray (17" x 10" x 3½") at 4 |
| KC500 | Heavyweight Package (for<br>example: general use<br>medical instruments) | 12 lbs. | • 8 lbs metal mass<br>• 6 surgical forceps<br>• 1 SCBI<br>• V-PRO® tray (17" x 10" x 3½") at 4 |
| KC600 | Very Heavy Weight Package<br>(for example: general use<br>medical instruments) | 12 lbs. | • 8 lbs metal mass<br>• 6 surgical forceps<br>• 1 SCBI<br>• 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.

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# 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.

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# Device Comparison Table (Technological, Design, & Materials)

| Characteristics | Predicate Devices:<br>KIMGUARD* ONE-STEP® Sterilization<br>Wrap (KC100, KC200, KC300, KC400,<br>KC500, & KC600) (K092167 & 112805) | Proposed Device:<br>KIMGUARD* ONE-STEP® Sterilization<br>Wrap (KC100, KC200, KC300, KC400,<br>KC500, & KC600) |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Kimberly-Clark Corporation | Kimberly Clark Corporation |
| Regulation/Product<br>Code | Sterilization Wrap: 880.6850 / FRG | Sterilization Wrap: 880.6850 / FRG |
| Indications for Use | The device is intended to be used to enclose<br>another medical device that is to be sterilized by a<br>healthcare provider by the Amsco® V-PRO™ 1<br>Plus Low Temperature Sterilization System's<br>Lumen (identical to the V-PRO™ 1 Cycle) and<br>Non-Lumen Cycles, and the V-PRO™ Low<br>Temperature Sterilization System's Flexible Cycle.<br>The wrap is intended to allow sterilization of the<br>enclosed medical device(s) and also to maintain<br>sterility of the enclosed device(s) until opened<br>within the period of time for which performance<br>data demonstrating maintenance of sterility has<br>been provided. The KIMIGUARD ONE-STEP*<br>Sterilization Wrap was validated to be effectively<br>aerated during the pre-programmed V-PRO™, V-<br>PRO™ 1 Plus, and V-PRO™ Flexible Cycles. | KIMGUARD ONE-STEP® Sterilization Wraps are<br>intended to enclose another medical device that<br>is to be sterilized by a healthcare provider using:<br>· V-PRO® 60 Low Temperature Sterilization<br>System that include:<br>o Lumen Cycle<br>o Non Lumen Cycle<br>o Flexible Cycle<br>KIMGUARD* ONE-STEP® Sterilization Wrap<br>(KC100, KC200, KC300, KC400, KC500 and<br>KC600) are intended to allow sterilization of the<br>enclosed medical device(s) and also maintain<br>sterility of the enclosed device(s) until used. |
| Sterilization Cycles | Amsco® V-PRO™ 1 Plus Low Temperature<br>Sterilization System's Lumen (identical to the<br>V-PRO™ 1 Cycle) and Non-Lumen Cycles,<br>and the V-PRO max Low Temperature<br>Sterilization System's Flexible Cycle | V-PRO® 60 Low Temperature<br>Sterilization System:<br>o Lumen Cycle<br>o Non Lumen Cycle<br>o Flexible Cycle |
| Maintenance of<br>Package Sterility | For models KC100, KC200, KC300, K400,<br>KC500, and KC600 for at least 30 days. | Real-time testing following sterilization using<br>the V-PRO® 60 Low Temperature<br>Sterilization System supports maintenance<br>of package sterility for 180 days for all<br>models of KIMGUARD* ONE-STEP® Sterilization<br>Wrap. |
| Technology | Tortuous sheet material used to enclose<br>medical devices that are to be sterilized by a<br>healthcare provider to allow sterilization of<br>the enclosed medical device(s) and maintain<br>sterility of the enclosed device(s) until used. | Tortuous sheet material used to enclose<br>medical devices that are to be sterilized by a<br>healthcare provider to allow sterilization of<br>the enclosed medical device(s) and maintain<br>sterility of the enclosed device(s) until used. |
| Device Design | Two sheets of nonwoven polypropylene<br>fabric. Each sheet is composed of three<br>thermally- bonded layers consisting of a<br>Meltblown polypropylene layer surrounded by<br>Spunbound polypropylene layers (SMS) | Two sheets of nonwoven polypropylene<br>fabric. Each sheet is composed of three<br>thermally- bonded layers consisting of a<br>Meltblown polypropylene layer surrounded<br>by Spunbound polypropylene layers (SMS) |
| Method for bonding<br>SMS layers | Thermal bonding with round pin, hexagonal,<br>triangle bond pattern ("daisy" pattern) | Thermal bonding with round pin, hexagonal,<br>triangle bond pattern ("daisy" pattern) |
| Materials | Polypropylene with blue and white<br>pigments | Polypropylene with blue and white<br>pigments |
| Distribution | Non-Sterile and<br>Over-the-Counter | Non-Sterile and<br>Over-the-Counter |
| Single Use Device | Yes | Yes |

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# 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<br>Sterilant Penetration | Passed |
| Post V-PRO® 60 Low Temperature Sterilization System<br>Sterilization - Maintenance of Package Integrity (30 Days) | Passed |
| Post V-PRO® 60 Low Temperature Sterilization System<br>Sterilization - Performance Testing | Passed |
| Post V-PRO® 60 Low Temperature Sterilization System<br>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.