KIMGUARD ONE-STEP STERILIZATION WRAP

• K Number: K082177
• Device Name: KIMGUARD ONE-STEP STERILIZATION WRAP
• Manufacturer: KIMBERLY-CLARK CORP.
• Date Cleared: 2009-03-27 ( 238 days)
• Product Code: FRG
• Regulation Number: 880.6850

Intended Use

KIMGUARD ONE-STEP* Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider by pre-vacuum steam at 270°F/132°C for 4 minutes or by 100% ethylene oxide (EtO) with a concentration of 725-735 mg/L at 131°F/ 55°C and 40% - 80% relative humidity for 60 minutes. 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. The wrap was validated for aeration times for EO sterilization of 8 hours at 55 °C or 12 hours at 43.3 °C. The wrap was validated for dry times for pre-vacuum steam sterilization of 20 minutes for Models 100 and 200, and for 30 minutes for Models 400, 500, and 600. KIMGUARD ONE-STEP* Sterilization Wrap is not indicated for use for gravity steam sterilization. *The KC300 Model KIMGUARD ONE-STEP* Sterilization Wrap is not indicated for use for pre-vacuum steam sterilization. See Wrap Model Recommendations on Page 3.

Device Description

The KIMGUARD ONE-STEP* Sterilization Wrap is comprised of two sheets of KIMGUARD* Sterilization Wrap ultrasonically seamed on two sides. This allows for convenient wrapping with two sheets simultaneously. The sheets of sterilization wrap are square or rectangular fabric produced using a polypropylene three-layer SMS (spunbond-meltblown-spunbond) process.

Predicate Devices

K881471

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a physical sterilization wrap and its performance characteristics, with no mention of software, algorithms, or data processing that would indicate the use of AI or ML.

Therapeutic

No
The device is a sterilization wrap intended to enclose another medical device for sterilization and maintain its sterility, not to provide therapeutic benefit itself.

Diagnostic

No

This device is a sterilization wrap intended to maintain the sterility of other medical devices, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "square or rectangular fabric produced using a polypropylene three-layer SMS (spunbond-meltblown-spunbond) process," indicating it is a physical material, not software.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states that the device is used to enclose other medical devices for sterilization and maintain their sterility. This is a function related to the preparation and storage of medical devices, not the diagnosis of diseases or conditions.
• Device Description: The description details the physical composition and construction of the sterilization wrap. This aligns with a packaging or barrier device, not a diagnostic test.
• Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
  • Analyzing biological samples (blood, urine, tissue, etc.)
  • Detecting specific analytes (proteins, DNA, antibodies, etc.)
  • Providing information for diagnosis, monitoring, or prognosis of a disease or condition.

The device's function is to facilitate the sterilization process and maintain the sterility of other medical devices, which falls under the category of medical device packaging or accessories, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

KIMGUARD ONE-STEP* Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider by pre-vacuum steam at 270°F/132°C for 4 minutes or by 100% ethylene oxide (EtO) with a concentration of 725-735 mg/L at 131°F/ 55°C and 40% - 80% relative humidity for 60 minutes. 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. The wrap was validated for aeration times for EO sterilization of 8 hours at 55 °C or 12 hours at 43.3 °C. The wrap was validated for dry times for pre-vacuum steam sterilization of 20 minutes for Models 100 and 200, and for 30 minutes for Models 400, 500, and 600.

KIMGUARD ONE-STEP* Sterilization Wrap is not indicated for use for gravity steam sterilization.

The KC300 Model KIMGUARD ONE-STEP Sterilization Wrap is not indicated for use for pre-vacuum steam sterilization.

Product codes (comma separated list FDA assigned to the subject device)

FRG

Device Description

The KIMGUARD ONE-STEP* Sterilization Wrap is comprised of two sheets of KIMGUARD* Sterilization Wrap ultrasonically seamed on two sides. This allows for convenient wrapping with two sheets simultaneously. The sheets of sterilization wrap are square or rectangular fabric produced using a polypropylene three-layer SMS (spunbond-meltblown-spunbond) process.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

health care provider

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

KIMGUARD ONE-STEP* Sterilization Wrap performance has been tested in accordance with the applicable requirements recommended in Premarket Notification [510(k)] Submissions for Medical Sterilization Packaging Systems in Health Care Facilities; Draft Guidance for Industry and FDA (March 7, 2002). Testing included biocompatibility (i.e., irritation and sensitization) in compliance with the methods of ISO 10993, sterilant penetration, dry time, and physical integrity. The Wrap has also been tested for the ability to maintain sterility of pack contents after sterilization for up to 30 days under standard conditions. All results of testing met acceptance criteria.

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.

K881471

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

Regulation Number and Section

§ 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).

Summary

0

K082107

510(k) Summary for the Kimberly-Clark* Corporation KIMGUARD ONE-STEP* Sterilization Wrap (Models KC100, KC200, KC300, KC400, KC500, and KC600)

| Date Summary was Prepared: | March 26, 2009
MAR 2 7 2009 |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Submitter: | Thomas Kozma
Director, Regulatory Affairs
Kimberly-Clark Health Care
1400 Holcomb Bridge Road
Roswell, GA 30076
Ph: 770.587.8393
FAX: [phone]
Email: [e-mail] |
| Primary Contact for this 510(k) Submission: | Lisa Peacock, Consultant to Kimberly-Clark Health Care
SciMed, Inc.
Ph: 706.216.3413
FAX: [phone]
Email: [e-mail] |
| Device Common Name: | Sterilization Wrap |
| Classification Name: | Sterilization Wrap (21 CFR 880.6850) |
| Product Code: | FRG |
| Intended Use: | KIMGUARD ONE-STEP* Sterilization Wrap is intended to be used to
enclose another medical device that is to be sterilized by a health care
provider by pre-vacuum steam at 270°F/132°C for 4 minutes or by
100% ethylene oxide (EtO) with a concentration of 725-735 mg/L at
131°F/ 55°C and 40% - 80% relative humidity for 60 minutes. 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. The
wrap was validated for aeration times for EO sterilization of 8 hours at
55 °C or 12 hours at 43.3 °C. The wrap was validated for dry times for
pre-vacuum steam sterilization of 20 minutes for Models 100 and 200,
and for 30 minutes for Models 400, 500, and 600. |
| | KIMGUARD ONE-STEP* Sterilization Wrap is not indicated for use for gravity steam sterilization. |
| | The KC300 Model KIMGUARD ONE-STEP Sterilization Wrap is not indicated for use for pre-vacuum steam sterilization. |
| | See Wrap Model Recommendations on Page 3. |

Page 1 of 3 - 510(k) Summary

:

1

| Predicate
Devices: | The KIMGUARD ONE-STEP* Sterilization Wrap
(Models KC100, KC200, KC300, KC400, KC500, and KC600) are
substantially equivalent to the predicate KIMGUARD* Regular and
Heavy Duty Sterile Wraps (K881471) |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial
Equivalence: | The KIMGUARD ONE-STEP* Sterilization Wrap is substantially
equivalent to the predicates in intended use, design, and materials.
The predicate devices were constructed of a three-layer laminate
composed of a layer of meltblown polypropylene bonded on both
surfaces with a layer of spunbonded polypropylene. The KIMGUARD
ONE-STEP* Sterilization Wrap is comprised of two sheets of
KIMGUARD* Sterilization Wrap ultrasonically seamed on two sides.
This allows for convenient wrapping with two sheets simultaneously.
The sheets of sterilization wrap are square or rectangular fabric
produced using a polypropylene three-layer SMS (spunbond-
meltblown-spunbond) process. |
| Summary of
Testing: | KIMGUARD ONE-STEP* Sterilization Wrap performance has been
tested in accordance with the applicable requirements recommended in
Premarket Notification [510(k)] Submissions for Medical Sterilization
Packaging Systems in Health Care Facilities; Draft Guidance for
Industry and FDA (March 7, 2002). Testing included biocompatibility
(i.e., irritation and sensitization) in compliance with the methods of ISO
10993, sterilant penetration, dry time, and physical integrity. The Wrap
has also been tested for the ability to maintain sterility of pack contents
after sterilization for up to 30 days under standard conditions. All
results of testing met acceptance criteria. |

and the comments of the country

・

:

.

:

2

| Wrap Model Recommendations
KIMGUARD
ONE-STEP*
Sterilization Wrap
Models | Intended Loads | Maximum
Wrapped
Package
Content
Weights Used
in Sterility
Maintenance
Validation
Study2 | Descriptions of Loads Used in
Sterility Maintenance Validation
Study2 |
|-------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| KC100 | Very Light Weight
Package (for
example: towel
packs) | 3 lbs | 16 huck towels (17"x 29") |
| KC200 | Light Weight
Package (for
example: standard
linen packs) | 6 lbs | 2 huck towels (17"x 29")
2 fluid resistant U-drape (68"x109")
1 fluid resistant universal bar drape
(70" x 108") |
| KC3003 | Light to Moderate
Weight Package (for
example: general use
medical instruments) | 9 lbs | FOR EO:
16 huck towels
2 fluid resistant large drapes (76"x100")
1 fluid resistant small drape (76"x60")
1 fluid resistant table cover (60"x 90") |
| KC4004 | Moderate to Heavy
Weight Package (for
example: general use
medical instruments) | 13 lbs | 4 tray liners 20" x 25" stacked
10" x 10" x 3 ½ " tray containing 11 lbs
of metal mass |
| KC5004 | Heavyweight
Package (for
example: general use
medical instruments) | 17 lbs | 4 tray liners 20" x 25" stacked
10" x 10" x 3 ½ " tray containing
15 lbs of metal mass |
| KC6004 | Very Heavy Weight
Package (for
example: general
use medical
instruments) | 25 lbs | 4 tray liners 20" x 25" stacked
10" x 10" x 3 ½ " tray containing
23 lbs of metal mass |

y individual results may differ the time in handling practices wraping techniques, and folding
individual results and the transferenced costents, which may nut added stress Individual results may differ due to firegularly handle proceded to the may all and and the may and

Results may also differ due to the on irregulary shaped content, which intended use.
facility should determine for itself which wrap model is most appropriated for on
first recommended to not exceed the most a most appoprate for each micriced do.
I it is recommended to not except persize content weights included for the KMGUARD lices for mended to not exceed the number individual content includes hat were video hour model house house house house house house house hour mass. is recommended to not exceed the number and size of the weight of the weigh mass).
Sterilization Wraps (i.e.: the number and size of the weight of the weigh mass).
Sterilized

Sterilization Wraps (i.e.: the number and size of the
pletion Wran is not indicated for use for pre-vacuum steam sterilization.

Sterlization Wraps (i.e. the number and indicated for use for use for use for use for use includination
Sterlization West Medication Wes is not indicated for use for use for "The KC300 Model KiMGUARD Waps were validated to the Piction Mult S bsorne find heatmal inen, and i
"The KC400, KC500, and KC600 model was were validation will 3 lbs models. The KC50, and KC600 modelwaps were validated to stelling syles with helt below in the recommended that is is ecommended to not exeed 3 the find resistant intenting of the min these much in the common
the user not include fluit not been evaluated with these models.

3

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized representation of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 7 2009

Kimberly-Clark Corporation C/o Ms. Lisa Peacock, RAC SciMed, Incorporated 172 Conductor Drive Dawsonville, Georgia 30534

Re: K082177

Trade/Device Name: KIMGUARD ONE-STEP* Sterilization Wrap (Models KC100, KC200, KC300, KC400, KC500, and KC600)

Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: March 9, 2009 Received: March 10, 2009

Dear Ms. Peacock:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

4

Page 2 - Ms. Peacock

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours,

Antony D. morton bon

Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

5

Indications for Use

510(k) Number (if known): _K082177

KIMGUARD ONE-STEP* Sterilization Wrap (Models KC100, KC200, Device Name: KC300, KC400, KC500, and KC600)

Indications for Use:

KIMGUARD ONE-STEP* Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider by pre-vacuum steam at 2709F/132°C for 4 minutes or by 100% ethylene oxide (EtO) with a concentration of 725-735 mg/L at 131°F/ 55°C and 40% - 80% relative humidity for 60 minutes. The wrap is intended to allow sterilization of the enclosed medical device(s) and also to maintain interility of the enclosed device(s) until opened. The wrap was validated for aeration sterilized the oncliebed as not (9) or 12 hours at 43.3 ℃. The wrap was times for 20 cry times for pre-vacuum steam sterilization of 20 minutes for Models 100 and 200, and for 30 minutes for Models 400, 500, and 600.

KIMGUARD ONE-STEP* Sterilization Wrap is not indicated for use for gravity steam sterilization.

The KC300 Model KIMGUARD ONE-STEP Sterilization Wrap is not indicated for use for pre-vacuum steam sterilization.

See Wrap Model Recommendations on Page 2.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

× Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shiela H. Murphy, D

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K0821

6

Indications for Use

| KIMGUARD
ONE-STEP*
Sterilization Wrap
Models | Intended Loads1 | Maximum
Wrapped
Package
Content
Weights Used
in Sterility
Maintenance
Validation
Study2 | Descriptions of Loads Used in
Sterility Maintenance Validation
Study2 |
|-------------------------------------------------------|------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| KC100 | Very Light Weight
Package (for
example: towel
packs) | 3 lbs | 16 huck towels (17"x 29") |
| KC200 | Light Weight
Package (for
example: standard
linen packs) | 6 lbs | 2 huck towels (17"x 29")
2 fluid resistant U-drape (68"x109")
1 fluid resistant universal bar drape
(70" x 108") |
| KC3003 | Light to Moderate
Weight Package (for
example: general use
medical instruments) | 9 lbs | FOR EO:
16 huck towels
2 fluid resistant large drapes (76"x100")
1 fluid resistant small drape (76"x60")
1 fluid resistant table cover (60"x 90") |
| KC4004 | Moderate to Heavy
Weight Package (for
example: general use
medical instruments) | 13 lbs | 4 tray liners 20" x 25" stacked
10" x 10" x 3 ½ " tray containing 11 lbs
of metal mass |
| KC5004 | Heavyweight
Package (for
example: general use
medical instruments) | 17 lbs | 4 tray liners 20" x 25" stacked
10" x 10" x 3 ½ " tray containing
15 lbs of metal mass |
| KC6004 | Very Heavy Weight
Package (for
example: general use medical
instruments) | 25 lbs | 4 tray liners 20" x 25" stacked
10" x 10" x 3 ½ " tray containing
23 lbs of metal mass |

Individual results may differ due to factors such as variations in handling practices, wrapping techniques, and folling methods individual results may differ due its valiation minding phavos, magend syres on the wrap. Each healthcare facility should determine for itself which wrap model is most appropriate for each intended use.

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