(94 days)
No
The device is a sterilization wrap and the description focuses on its material composition and physical properties, with no mention of AI or ML.
No
The device is a sterilization wrap intended to maintain the sterility of other medical devices, not to provide therapy itself.
No.
Explanation: The device is a sterilization wrap intended to enclose other medical devices for sterilization and maintain their sterility. It does not perform any diagnostic function.
No
The device description clearly 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 is 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 a sterilization wrap made of fabric, designed to facilitate sterilization and maintain sterility. This aligns with a medical device used in the sterilization process, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the human body (blood, urine, tissue, etc.), detecting specific analytes, or providing information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
KIMGUARD* ONE-STEP* Sterilization Wrap (KC100, KC200, KC300, KC400, KC500 and KC600) are intended to enclose another medical device that is to be sterilized by a healthcare provider using:
- Gravity Steam at 250°F/121°C for 30 minutes. .
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 Wrap (KC100. KC200. KC300, KC400, KC500 and KC600) allowed sterilization of the enclosed devices by the Gravity Steam Sterilization Systems (250°F/121°C for 30 minutes).
KIMGUARD* ONE-STEP* Sterilization Wrap Recommendations for Use within Gravity Steam Systems are provided in Table 1.
Product codes
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 sheets of sterilization wrap are square or rectangular fabric produced using a threelayer SMS (spunbound-meltblown-spunbound) process. The 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 antistatic treatment. 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)
Performance of KIMGUARD* ONE-STEP* Sterilization Wrap (KC100, KC200, KC300, KC400, KC500, KC600) has been tested as summarized below. All results of testing met the same acceptance criteria as the predicate devices demonstrating substantial equivalence to the predicate devices.
Summary of Testing Performed (Gravity Steam Sterilization):
- Sterilant Penetration: Passed
- Package Integrity/Physical Properties: Passed
- Drying and Aeration: Passed
- Maintenance of Package Integrity: Passed
- Biocompatibility (pre- and post-sterilization): Passed
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Summary
K141071 11111 28 2014
Applicant's Name, Address, Telephone, FAX, Contact Person
Applicant Name: Kimberly-Clark Health Care 1400 Holcomb Bridge Road Roswell, GA 30076-2190, USA Address: Establishment Registration #: . 1033422
Contact Name:
Thomas Kozma, Director of Regulatory Affairs e-mail: thomas.kozma@kcc.com phone: (770) 587-8393 (920) 225-3408 fax:
Date: July 11, 2014
1. CLASSIFICATION, COMMON OR USUAL NAME, DEVICE
NAME
.
| Classification: | Class II per 21 CFR 880.6850 |
|---|---|
| Classification Name: | Sterilization Wrap |
| Common/Usual Name: | Sterilization Wrap |
| Product Code: | FRG |
| Proprietary Name | KIMGUARD® ONE-STEP® Sterilization Wrap |
| (Models: KC100, KC200, KC300, KC400, | |
| KC500, and KC600) |
2. PREDICATE DEVICES
KIMGUARD* ONE-STEP* Sterilization Wrap, which is currently manufactured and distributed by Kimberly-Clark Corporation, ( K082177 and K091685).
3. INDICATIONS FOR USE
KIMGUARD* ONE-STEP* Sterilization Wrap (KC100, KC200, KC300, KC400, KC500 and KC600) are intended to enclose another medical device that is to be sterilized by a healthcare provider using:
- Gravity Steam at 250°F/121°C for 30 minutes. .
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 Wrap (KC100. KC200. KC300, KC400, KC500 and KC600) allowed sterilization of the enclosed devices by the Gravity Steam Sterilization Systems (250°F/121°C for 30 minutes).
KIMGUARD* ONE-STEP* Sterilization Wrap Recommendations for Use within Gravity Steam Systems are provided in Table 1.
510(k) Summary - K141071
Page 1 of 4
1
| TABLE 1: Recommended Loads for KIMGUARD* ONE-STEP* Sterilization Wrap for use with Gravity
| Steam Sterilization Systems (250°F/121°C for 30 minutes) | |||
|---|---|---|---|
| KIMGUARD* | |||
| ONE-STEP* | |||
| Sterilization | |||
| Wrap | |||
| Models | Intended Loads¹ | Maximum Wrapped | |
| Package Content | |||
| Weights Used in Sterility | |||
| Maintenance Validation | |||
| Study | Description of Loads | ||
| Used in Sterility | |||
| Maintenance Validation | |||
| Study² | |||
| KC100 | Very Light Weight Package | ||
| (for example batteries) | 3 lbs. | 1 tray liner 20" x 25" | |
| 12.5" x 9" x 1" Tray | |||
| 1 lb of metal mass | |||
| KC200 | Light Weight Package (for | ||
| example telescope with light | |||
| cord) | 6 lbs. | 1 tray liner 20" x 25" | |
| 10" x 20" x 3 ½ Tray | |||
| 3 lbs of metal mass | |||
| KC300 | Light to Moderate Weight | ||
| Package (for example: general | |||
| use medical instruments) | 9 lbs. | 1 tray liner 20" x 25" | |
| 10" x 20" x 3 ½Tray | |||
| 6 lbs of metal mass | |||
| KC400 | Moderate to Heavy Weight | ||
| Package (for example: general | |||
| use medical instruments) | 13 lbs. | 1 tray liner 20" x 25" | |
| 10" x 20" x 3 ½ Tray | |||
| 10 lbs of metal mass | |||
| KC500 | Heavyweight Package (for | ||
| example: general use medical | |||
| instruments) | 17 lbs. | 1 tray liner 20" x 25" | |
| 11" x 22" x 3 ½Tray | |||
| 12 lbs of metal mass | |||
| KC600 | Very Heavy Weight Package | ||
| (for example: general use | |||
| medical instruments) | 25 lbs. | 1 tray liner 20" x 25" | |
| 11" x 22" x 3 ½Tray | |||
| 20 lbs of metal mass |
'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 the most appropriate for each intended use. 11 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.
4. 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 sheets of sterilization wrap are square or rectangular fabric produced using a threelayer SMS (spunbound-meltblown-spunbound) process. The 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 antistatic treatment. The wrap allows a sterilized package to be opened aseptically.
5. 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 (K082177 and K091685) in technology, design, and materials.
2
| Characteristics | Predicate Devices:
KIMGUARD* ONE-STEP* Sterilization
Wrap (K082177 and K091685) | Proposed Device:
KIMGUARD* ONE-STEP* Sterilization Wrap |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Kimberly-Clark Corporation | Kimberly Clark Corporation |
| Regulation/Product
Code | Sterilization Wrap: 880.6850 / FRG | Sterilization Wrap: 880.6850 / FRG
[SAME] |
| Indications for Use | The device is intended to be used to enclose
another medical device that is to be
sterilized by a healthcare provider. It is
intended to allow sterilization of the enclosed
medical device(s) and also maintain sterility
of the enclosed device(s) until opened. Not
indicated for use for gravity steam
sterilization. | KIMGUARD* ONE-STEP* Sterilization Wrap
(KC100, KC200, KC300, KC400, KC500 and
KC600) are intended to enclose another
medical device that is to be sterilized by a
healthcare provider using:
• Gravity Steam at 250°F/121°C for 30
minutes.
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
Parameters | Pre-Vacuum Steam at 270°F/132°C for 4
minutes, EO with a concentration of 725-735
mg/L at 131°F/55°C and 40%-80% relative
humidity for 60 minutes, and Amsco V-ProTM 1 and V-Pro 1 Plus Low Temperature
Sterilization Systems | Gravity Steam at 250°F/121°C for 30 minutes |
| Maintenance of
Package Sterility | For models KC100, KC200, KC300, K400,
KC500, and KC600 for up to 30 days. | Real-time testing following sterilization using
Gravity Steam supports maintenance of
package sterility for 30 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.
[SAME] |
| 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)
[SAME] |
| 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)
[SAME] |
| Materials | Polypropylene with blue and white
pigments | Polypropylene with blue and white
pigments
[SAME] |
| Distribution | Non-Sterile and
Over-the-Counter | Non-Sterile and
Over-the-Counter
[SAME] |
| Single Use Device | Yes | Yes
[SAME] |
Device Comparison Table (Technological, Design, & Materials)
:
510(k) Summary – K141071
.
·
Page 3 of 4
.
3
6. SUMMARY OF NONCLINICAL TESTS:
Performance of KIMGUARD* ONE-STEP* Sterilization Wrap (KC100, KC200, KC300, KC400, KC500, KC600) has been tested as summarized below. All results of testing met the same acceptance criteria as the predicate devices demonstrating substantial equivalence to the predicate devices.
| Summary of Testing Performed
| (Gravity Steam Sterilization) | Results |
|---|---|
| Sterilant Penetration | Passed |
| Package Integrity/Physical Properties | Passed |
| Drying and Aeration | Passed |
| Maintenance of Package Integrity | Passed |
| Biocompatibility (pre- and post-sterilization) | Passed |
7. 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 Gravity Steam Sterilization Systems. These studies demonstrate that the KIMGUARD* ONE-STEP* Sterilization Wrap met the same criteria as the predicate devices and are substantially equivalent.
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized human figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 28, 2014
Kimberly-Clark Health Care Dr. Thomas Kozma Director of Regulatory Affairs 1400 Holcomb Bridge Road Roswell, GA 30076-2190
Re: K141071
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: June 17, 2014 Received: June 18, 2014
Dear Dr. Kozma:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
5
Page 2 – Dr. Kozma
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mary S. Runner -S
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
6
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below
510(k) Number (if known)
K141071
Device Name
KIMGUARD* ONE-STEP* Sterlization Wrap (Models KC100, KC300, KC300, KC500, and KC600)
Indications for Use (Describe)
KIMGUARD* ONE-STEP* Sterilization Wrap (KC100, KC300, KC500 and KC600) are intended to enclose another medical device that is to be sterilized by a healthcare provider using:
- Gravity Steam at 250°F/121°C for 30 minutes. ◆
KIMGUARD* ONE-STEP* Sterilization Wrap (KC100, KC200, KC500 and KC600) are intended to allow sterilization of the enclosed medical device(s) and also maintain sterlity of the enclosed device(s) until used.
Test results validated that KIMGUARD* ONE-STEP* Sterliization Wrap (KC100, KC300, KC300 and KC600) allowed sterlization of the enclosed devices by the Gravity Steam Sterlization Systems (250°F/121°C for 30 minutes).
KIMGUARD* ONE-STEP* Sterilization Wrap Recommendations for Use within Gravity Steam Systems are provided in Table 1.
7
| TABLE 1: Recommended Loads for KIMGUARD* ONE-STEP* Sterilization Wrap for use with Gravity Steam Sterilization
| Systems (250°F/121°C for 30 minutes) | |||
|---|---|---|---|
| KIMGUARD* ONE- | |||
| STEP* Sterilization | |||
| Wrap Models | Intended Loads1 | Maximum Wrapped Package | |
| Content Weights Used in Sterility | |||
| Maintenance Validation Study | Description of Loads Used in | ||
| Sterility Maintenance | |||
| Validation Study2 | |||
| KC100 | Very Light Weight Package (for | ||
| example batteries) | 3 lbs. | 1 tray liner 20" x 25" | |
| 12.5" x 9" x 1" Tray | |||
| 1 lb of metal mass | |||
| KC200 | Light Weight Package (for | ||
| example telescope with light cord) | 6 lbs. | 1 tray liner 20" x 25" | |
| 10" x 20" x 3 ½ Tray | |||
| 3 lbs of metal mass | |||
| KC300 | Light to Moderate Weight | ||
| Package (for example: general | |||
| use medical instruments) | 9 lbs. | 1 tray liner 20" x 25" | |
| 10" x 20" x 3 ½ Tray | |||
| 6 lbs of metal mass | |||
| KC400 | Moderate to Heavy Weight | ||
| Package (for example: general | |||
| use medical instruments) | 13 lbs. | 1 tray liner 20" x 25" | |
| 10" x 20" x 3 ½ Tray | |||
| 10 lbs of metal mass | |||
| KC500 | Heavyweight Package (for | ||
| example: general use medical | |||
| instruments) | 17 lbs. | 1 tray liner 20" x 25" | |
| 11" x 22" x 3 ½ Tray | |||
| 12 lbs of metal mass | |||
| KC600 | Very Heavy Weight Package (for | ||
| example: general use medical | |||
| instruments) | 25 lbs. | 1 tray liner 20" x 25" | |
| 11" x 22" x 3 ½ Tray | |||
| 20 lbs of metal mass |
incividual results may differ due to factors such as variations in handing pracices, wraping techniques, and folding methods. Results may also differ due to the use of impact contents, which may put added stress on the wap. Each healthcare facilly should delemine for itself which wrap model is the most appropriate for each intended use.
It is recommended to not exceed the maximum 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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
K | 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)
Elizabeth F. Claverie -S
DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=1300055864, cn=Ellzabeth F. Claverie -S Date: 2014.07.28 16:06:17 -04'00'
Digitally signed by Elizabeth F. Claverie -S
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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
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