(162 days)
No
The device is a physical sterilization wrap and the description focuses on its material composition and performance in sterilization processes, with no mention of AI or ML.
No
The device is a sterilization wrap intended to enclose other medical devices for sterilization and maintain their sterility, not to provide therapeutic benefit itself.
No
Explanation: The device is a sterilization wrap intended to enclose medical devices for sterilization and maintain their sterility, not to diagnose a condition or disease.
No
The device description clearly states it is a physical wrap made of fabric, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to enclose other medical devices for sterilization and maintain their sterility. It does not mention analyzing samples from the human body (like blood, urine, tissue, etc.) to provide information about a person's health.
- Device Description: The description details the physical composition and structure of the sterilization wrap. It does not describe any components or functionalities related to performing diagnostic tests on biological samples.
- Performance Studies: The performance studies focus on the wrap's ability to maintain sterility and allow sterilant penetration. They do not involve evaluating the accuracy or performance of a diagnostic test.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This sterilization wrap does not fit that definition.
N/A
Intended Use / 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 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)
Product codes
FRG
Device Description
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.
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 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.
Study:
Maintenance of 365-Day Package Integrity
Ethylene Oxide Sterilant Penetration
Pre-Vacuum Steam Sterilant Penetration
Post Sterilization Biocompatibility Testing (Cytotoxicity, ISO 10993-5: 2009; Irritation, ISO 10993-10:2010; Sensitization, ISO 10993-10: 2010.
Results: All 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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around an emblem. The emblem consists of a stylized human figure with three faces, representing the department's focus on health and well-being. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
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.
1
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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (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/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
2
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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*
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: batteries) | 3 lbs. | 16 huck towels (17"x
29") |
| KC200 | Light Weight
Package (for
example: telescope
with light cord) | 6 lbs. | 2 huck towels (17"x
29")
2 fluid resistant U-
drapes (68"x 109")
1 fluid resistant
universal bar drape
(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).
4
This 510(k) Summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Applicant's Name, Address, Telephone, FAX, Contact Person
Halyard Health 5405 Windward Parkway, Alpharetta, GA 30004, USA Establishment Registration Number: 1033422
Contact Name: Monica King, Associate Director of Regulatory Affairs E-mail: Monica.king@hyh.com (678) 477-4165 (Telephone) (678) 254-0347 (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.
5
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*
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: batteries) | 3 lbs. | 16 huck towels (17"x
29") |
| KC200 | Light Weight
Package (for
example: telescope
with light cord) | 6 lbs. | 2 huck towels (17"x
29")
2 fluid resistant U-
drapes (68"x 109")
1 fluid resistant
universal bar drape
(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
6
| Technological
Characteristics | Proposed Device:
KIMGUARD® ONE-STEP® Sterilization
Wrap K143053 | Predicate Device: K3
KIMGUARD® ONE-STEP® Sterilization
Wrap K082554, K082177 |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Halyard Health | Halyard Health (formerly known as
Kimberly-Clark Health Care) |
| Regulation/Product
Code | Sterilization Wrap: 880.6850 / FRG | Sterilization Wrap: 880.6850 / FRG |
| Device Design | Two sheets of medium blue nonwoven
Polypropylene fabric. Each sheet of fabric
is composed of three thermally- bonded
layers consisting of a Meltblown
polypropylene layer surrounded by
Spunbond polypropylene layers (SMS). | Two sheets of medium blue nonwoven
Polypropylene fabric. Each sheet of fabric
is composed of three thermally- bonded
layers consisting of a Meltblown
polypropylene layer surrounded by
Spunbond polypropylene layers (SMS). |
| Method for
bonding
SMS layers | Thermal bonding with round pin,
hexagonal, triangle bond pattern
("daisy" pattern) | Thermal bonding with round pin,
hexagonal, triangle bond pattern
("daisy" pattern) |
| Materials | Polypropylene with blue and white
Pigments | Polypropylene with blue and white
Pigments |
| Over the Counter
Use Device | Yes | Yes |
| Single Use Device | Yes | Yes |
| Biocompatibility | Applicable parts of ISO 10993 - Biological
evaluation of medical devices (see Table 3) | Applicable parts of ISO 10993 - Biological
evaluation of medical devices (see Table 3) |
| Maintenance of
Package Sterility | Real-time testing following sterilization using
pre-vacuum steam or Ethylene Oxide
supports maintenance of package sterility
for 365 days. | Real-time testing following sterilization
using pre-vacuum steam or Ethylene Oxide
supports maintenance of package sterility
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. |
7
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.