KIMGUARD ONE-STEP Sterilization Wrap

K143053 · Kimberly-Clark Health Care · FRG · Apr 3, 2015 · General Hospital

Device Facts

• Record ID: K143053
• Device Name: KIMGUARD ONE-STEP Sterilization Wrap
• Applicant: Kimberly-Clark Health Care
• Product Code: FRG · General Hospital
• Decision Date: Apr 3, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

KIMGUARD* ONE-STEP* Sterilization Wrap (KC100, KC200) are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider using: · Pre-vacuum steam at 270°F / 132°C for 4 minutes. The wrap was validated for dry times of 20 minutes for models KC100 and KC200. · 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. The wrap was validated for aeration times for EO sterilization of 8 hours at 43.3 °C for models KC100 and KC200. KIMGUARD* ONE-STEP* Sterilization Wrap (KC100, KC200) are intended to allow sterilization of the enclosed medical device(s) and also maintain sterility of the enclosed device(s) until used.

Device Story

Sterilization wrap system consisting of two sheets of nonwoven polypropylene fabric ultrasonically seamed on two edges; enables simultaneous two-sheet wrapping. Used by healthcare providers to enclose medical devices prior to terminal sterilization via pre-vacuum steam or 100% ethylene oxide. Wrap allows sterilant penetration while maintaining package sterility post-sterilization until point of use. Facilitates aseptic opening of sterilized packages. Device is single-use.

Clinical Evidence

Bench testing only. Performance studies validated 365-day package integrity, ethylene oxide sterilant penetration, and pre-vacuum steam sterilant penetration. Biocompatibility testing performed per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation and sensitization) with passing results.

Technological Characteristics

Two-sheet nonwoven polypropylene fabric; three-layer SMS (spunbond-meltblown-spunbond) construction; thermally bonded with round pin/hexagonal/triangle pattern. Materials include polypropylene, <2% phthalocyanine blue pigment, <1% titanium dioxide, <0.009% potassium phosphate anti-static treatment. Biocompatibility per ISO 10993. Single-use.

Indications for Use

Indicated for use by healthcare providers to enclose medical devices for sterilization via pre-vacuum steam or 100% ethylene oxide (EO) and to maintain sterility of the enclosed devices 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 (K082554)
• KIMGUARD* ONE-STEP* Sterilization Wrap (K082177)

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

April 3, 2015

Halyard Health Ms. Monica King Associate Director, Regulatory Affairs 5405 Windward Parkway Alpharetta, GA 30004

Re: K143053

Trade/Device Name: KIMGUARD® ONE-STEP® Sterilization Wrap (KC100, KC200) Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: March 3, 2015 Received: March 4, 2015

Dear Ms. King:

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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Page 2 - Ms. King

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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 [phone] or [phone] 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. Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K143053

Device Name

KIMGUARD* ONE-STEP* Sterilization Wrap (KC100, KC200)

#### Indications for Use (Describe)

KIMGUARD* ONE-STEP* Sterilization Wrap (KC100, KC200) are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider using:

· Pre-vacuum steam at 270°F / 132°C for 4 minutes. The wrap was validated for dry times of 20 minutes for models KC100 and KC200.

· 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. The wrap was validated for aeration times for EO sterilization of 8 hours at 43.3 °C for models KC100 and KC200.

KIMGUARD* ONE-STEP* Sterilization Wrap (KC100, KC200) 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) allowed sterilization of the enclosed devices by the ethylene oxide sterilization and by pre-vacuum cycles.

These models of the KIMGUARD* ONE-STED* Sterilization Wrap have been validated for use with the ethylene oxide and pre-vacuum cycles in Table 1 (see page 2 of 2)

Page 1 of 2

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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Continuation Page Indications for Use Statement K143053 KIMGUARD* ONE-STEP* Sterilization Wrap (KC100/KC200) Page 2 of 2

# TABLE 1: KIMGUARD* ONE-STEP* Sterilization Wrap Recommendations for Use with the Pre-Vacuum Steam or Ethylene Oxide1

| KIMGUARD*<br>Sterilization Wrap<br>Models | Intended Loads | Maximum Wrapped<br>Package Content<br>Weights Used<br>in Sterility<br>Maintenance<br>Validation Study2 | Descriptions of<br>Loads Used in<br>Sterility<br>Maintenance<br>Validation Study2 |
|-------------------------------------------|------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| KC100 | Very Light Weight<br>Package (for<br>example: batteries) | 3 lbs. | 16 huck towels (17"x<br>29") |
| KC200 | Light Weight<br>Package (for<br>example: telescope<br>with light cord) | 6 lbs. | 2 huck towels (17"x<br>29")<br>2 fluid resistant U-<br>drapes (68"x 109")<br>1 fluid resistant<br>universal bar drape<br>(70" x 108") |

1Individual 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 the KIMGUARD* Sterilization Wraps (i.e.: the number and size of the fluid resistant linens or the weight of the metal mass).

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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 5405 Windward Parkway, Alpharetta, GA 30004, USA Establishment Registration Number: 1033422

Contact Name: Monica King, Associate Director of Regulatory Affairs E-mail: [e-mail] [phone] (Telephone) [phone] (Fax)

| DATE PREPARED: | April 2, 2015 |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| TRADE NAME: | KIMGUARD* ONE-STEP* Sterilization Wrap (Models KC100 & KC200) |
| CLASSIFICATION NAME: | Sterilization Wrap |
| COMMON/USUAL NAME: | Sterilization Wrap |
| PRODUCT CODE: | FRG |
| DEVICE CLASSIFICATION: | Class II per 21 CFR §880.6850 |
| PREDICATE DEVICES: | KIMGUARD* ONE-STEP* Sterilization Wrap, [510(k) Notification K082554 for ethylene oxide and K082177 for pre-vacuum steam, clearances on May 1, 2009 and March 27, 2009, respectively] |

#### INDICATIONS FOR USE

KIMGUARD* ONE-STEP* Sterilization Wrap (KC100, KC200) are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider using:

- Pre-vacuum steam at 270°F / 132°C for 4 minutes. The wrap was validated for dry times ● of 20 minutes.
- . 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. The wrap was validated for aeration times for EO sterilization of 8 hours at 55°C or 12 hours at 43.3°C.

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KIMGUARD* ONE-STEP* Sterilization Wrap (KC100, KC200) 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) allowed sterilization of the enclosed devices by the ethylene oxide sterilization and by prevacuum cycles.

These models of the KIMGUARD* ONE-STEP* Sterilization Wrap have been validated for use with the ethylene oxide and pre-vacuum cycles in Table 1 below.

| KIMGUARD*<br>Sterilization Wrap<br>Models | Intended Loads | Maximum Wrapped<br>Package Content<br>Weights Used<br>in Sterility<br>Maintenance<br>Validation Study2 | Descriptions of<br>Loads Used in<br>Sterility<br>Maintenance<br>Validation Study2 |
|-------------------------------------------|------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| KC100 | Very Light Weight<br>Package (for<br>example: batteries) | 3 lbs. | 16 huck towels (17"x<br>29") |
| KC200 | Light Weight<br>Package (for<br>example: telescope<br>with light cord) | 6 lbs. | 2 huck towels (17"x<br>29")<br>2 fluid resistant U-<br>drapes (68"x 109")<br>1 fluid resistant<br>universal bar drape<br>(70" x 108") |

## TABLE 1: KIMGUARD* ONE-STEP* Sterilization Wrap Recommendations for Use with the Pre-Vacuum Steam or Ethylene Oxide"

'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 the KIMGUARD* Sterilization Wraps (i.e.: the number and size of the fluid resistant linens or the weight of the metal mass).

#### DESCRIPTION OF DEVICE

KIMGUARD* ONE-STEP* Sterilization Wrap is comprised of two sheets of KIMGUARD* Sterilization Wrap ultrasonically seamed on two edges. This allows for convenient wrapping with two sheets simultaneously.

The sheets of sterilization wrap are square or rectanqular fabric produced using a three-layer SMS (spunbond-meltblown-spunbond) process. The wrap fabric (white or blue color) is composed of polypropylene with the addition of less than 2% by weight of phthalocvanine blue pigment (blue fabric only), less than 1% by weight titanium dioxide pigment, and less than 0.009% by weight of a potassium phosphate anti-static treatment. The wrap allows a sterilized package to be opened aseptically.

K143053 KIMGUARD* ONE-STEP* Sterilization Wrap (KC100/KC200) Halvard Health

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| Technological<br>Characteristics | Proposed Device:<br>KIMGUARD® ONE-STEP® Sterilization<br>Wrap K143053 | Predicate Device: K3<br>KIMGUARD® ONE-STEP® Sterilization<br>Wrap K082554, K082177 |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Halyard Health | Halyard Health (formerly known as<br>Kimberly-Clark Health Care) |
| Regulation/Product<br>Code | Sterilization Wrap: 880.6850 / FRG | Sterilization Wrap: 880.6850 / FRG |
| Device Design | Two sheets of medium blue nonwoven<br>Polypropylene fabric. Each sheet of fabric<br>is composed of three thermally- bonded<br>layers consisting of a Meltblown<br>polypropylene layer surrounded by<br>Spunbond polypropylene layers (SMS). | Two sheets of medium blue nonwoven<br>Polypropylene fabric. Each sheet of fabric<br>is composed of three thermally- bonded<br>layers consisting of a Meltblown<br>polypropylene layer surrounded by<br>Spunbond polypropylene layers (SMS). |
| Method for<br>bonding<br>SMS layers | Thermal bonding with round pin,<br>hexagonal, triangle bond pattern<br>("daisy" pattern) | Thermal bonding with round pin,<br>hexagonal, triangle bond pattern<br>("daisy" pattern) |
| Materials | Polypropylene with blue and white<br>Pigments | Polypropylene with blue and white<br>Pigments |
| Over the Counter<br>Use Device | Yes | Yes |
| Single Use Device | Yes | Yes |
| Biocompatibility | Applicable parts of ISO 10993 - Biological<br>evaluation of medical devices (see Table 3) | Applicable parts of ISO 10993 - Biological<br>evaluation of medical devices (see Table 3) |
| Maintenance of<br>Package Sterility | Real-time testing following sterilization using<br>pre-vacuum steam or Ethylene Oxide<br>supports maintenance of package sterility<br>for 365 days. | Real-time testing following sterilization<br>using pre-vacuum steam or Ethylene Oxide<br>supports maintenance of package sterility<br>for 30 days. |

# Table 2: Device Comparison Table - Technological Characteristics

# SUMMARY OF NONCLINICAL TESTS

Performance testing was conducted to show that the KIMGUARD* ONE-STEP* Sterilization Wrap (KC100, KC200) maintains sterility until used, after completion of the sterilization process in the pre-vacuum and ethylene oxide sterilization systems.

# Table 3: Sterilization Wrap Performance Tests

| Study | Results |
|------------------------------------------------------------------|---------|
| Maintenance of 365-Day Package Integrity | Passed |
| Ethylene Oxide Sterilant Penetration | Passed |
| Pre-Vacuum Steam Sterilant Penetration | Passed |
| Post Sterilization Biocompatibility Testing (Cytotoxicity, ISO | Passed |
| 10993-5: 2009; Irritation, ISO 10993-10:2010; Sensitization, ISO | |
| 10993-10: 2010. | |

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# OVERALL PERFORMANCE CONCLUSIONS

The nonclinical studies demonstrate that the KIMGUARD* ONE-STEP* Sterilization Wrap (KC100, KC200) performs as intended as a sterilization packaging system of medical devices when terminally sterilized in the pre-vacuum steam and ethylene oxide sterilization systems. These studies show that the KIMGUARD* ONE-STEP* Sterilization Wrap (KC100, KC200) met the same criteria as the predicate device and are substantially equivalent.