(162 days)
Not Found
No
The device description and performance studies focus on the physical properties and sterilization efficacy of the wrap, with no mention of AI or ML.
No.
This device is a sterilization wrap intended to enclose other medical devices for sterilization and maintain their sterility, not to treat or prevent disease directly.
No
This device is a sterilization wrap used to maintain the sterility of other medical devices. It does not diagnose any condition or disease.
No
The device description clearly outlines a physical product made of fabric and adhesive, intended for wrapping medical devices for sterilization. There is no mention of software components.
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 using samples from the human body.
- Device Description: The description details the materials and construction of a sterilization wrap. It does not mention any components or functionalities related to analyzing biological samples.
- 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 diagnostic information
The device is a medical device used in the sterilization process, which is a crucial step in ensuring the safety of other medical devices used in healthcare settings.
N/A
Intended Use / Indications for Use
KimGuard Smart-Fold* Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider by prevacuum steam at 270°F/132°C for 4 minutes or by 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 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 131°F/ 55°C or 12 hours at 110°F/ 43.3°C. The KimGuard Smart-Fold* Sterilization Wrap was validated for dry times for prevacuum steam sterilization of 20 minutes for Model KC250 and for dry times of 30 minutes for Models KC450, KC550 and KC650.
Product codes (comma separated list FDA assigned to the subject device)
FRG
Device Description
KimGuard Smart-Fold* Sterilization Wrap is comprised primarily of two pieces of KimGuard Sterilization Wrap fabric (the blue base layer and the white intermediate layer). The fabric is a nonwoven spunbondmeltblown-spunbond (SMS) fabric composed of a top (inner) layer of spunbond, a center laver of meltblown, and a bottom (outer) layer of spunbond. SMS nonwoven fabrics are composed of polypropylene and white titanium dioxide and phthalocyanine blue pigments. Two strips of blue SMS are adhesively bonded to the white SMS intermediate layer for added strength. The reinforcement strips also contain a "reference line" feature designed to indicate proper sterilization tray placement to the user. Adhesive tape strips with release liners are included to secure the inner layers of the package. Users remove the release liners and use these adhesive strips to secure the wrap prior to sterilization. The Smart-Fold product also incorporates handles and pulls tabs comprised of blue SMS material and adhesive branding labels for aseptic opening.
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 Smart-Fold* Sterilization Wrap has been tested in compliance 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 irritation and sensitization biocompatibility 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 test results 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.
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
§ 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
JAN 1 9 2012
510(k) Summary for the Kimberly-Clark* Corporation KimGuard Smart-Fold* Sterilization Wrap (Models KC250, KC450, KC550 and KC650)
| Device type: | Sterilization Wrap | |
|---|---|---|
| Date of | ||
| Summary: | July 28, 2011 | |
| 510(k) Submitter: | Brenda Shelkey | |
| Associate Director, Quality Assurance & Regulatory | ||
| Affairs | ||
| KIMBERLY-CLARK CORPORATION | ||
| 1400 Holcomb Bridge Road | ||
| Roswell, GA 30076 | ||
| 678-654-8021 | ||
| Brenda.Shelkey@kcc.com | ||
| Establishment Registration Number 1033422 | ||
| Primary Contact | ||
| for this 510(k) | ||
| Submission: | Same as above | |
| Classification | ||
| Regulation: | 21 CFR 880.6850 | |
| Device Class: | Class II | |
| Panel: | General Hospital | |
| Product Code: | FRG |
:
・・ー
1
Intended Use:
KimGuard Smart-Fold* Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider by prevacuum steam at 270°F/132°C for 4 minutes or by 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 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 131°F/ 55°C or 12 hours at 110°F/ 43.3°C. The KimGuard Smart-Fold* Sterilization Wrap was validated for dry times for prevacuum steam sterilization of 20 minutes for Model KC250 and for dry times of 30 minutes for Models KC450, KC550 and KC650.
Wrap Model Recommendations for Pre-Vacuum Steam and for 100% Ethylene Oxide Sterilization'
| KIMGUARD
SMART-
FOLD*
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 |
|----------------------------------------------------------------|---------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| KC250 | Light Weight
Package (for
example: standard
linen packs) | 6 lbs. | 2 huck towels (17 in. x 29 in.)
2 fluid-resistant U-drapes (68 in. x 109 in.)
1 fluid-resistant universal bar drape (70 in.
x 108in.) |
| KC450 | Moderate to Heavy
Weight Package
(for example:
general use medical
instruments) | 13 lbs. | 4 tray liners (20 in. x 25 in.) stacked
10 in. x 10 in. x 3 ½ in. tray containing 11
lbs. of metal mass |
| KC550 | Heavyweight
Package (for
example: general
use medical
instruments) | 17 lbs. | 4 tray liners (20 in. x 25 in.) stacked
10 in. x 10 in. x 3 ½ in. tray containing
15 lbs. of metal mass |
| KC650 | Very Heavy Weight
Package (for
example: general
use medical
instruments) | 25 Ibs. | 4 tray liners (20 in. x 25 in.) stacked
10 in. x 10 in. x 3 ½ in. tray containing 23
lbs. of metal mass |
apping techniques, and tolding methods. Result's may a Individual results may differ due to factors such as var hich may pul action stress on the wap. Each health struit determine for itsell which wrap model is most apropriate for each intended use.
monded to not exceed be maximum wapped package content weble for each maps model. Furthermone, it is recomment its recomments and size of the history
2
Device Description: KimGuard Smart-Fold* Sterilization Wrap is comprised primarily of two pieces of KimGuard Sterilization Wrap fabric (the blue base layer and the white intermediate layer). The fabric is a nonwoven spunbondmeltblown-spunbond (SMS) fabric composed of a top (inner) layer of spunbond, a center laver of meltblown, and a bottom (outer) layer of spunbond. SMS nonwoven fabrics are composed of polypropylene and white titanium dioxide and phthalocyanine blue pigments. Two strips of blue SMS are adhesively bonded to the white SMS intermediate layer for added strength. The reinforcement strips also contain a "reference line" feature designed to indicate proper sterilization tray placement to the user. Adhesive tape strips with release liners are included to secure the inner layers of the package. Users remove the release liners and use these adhesive strips to secure the wrap prior to sterilization. The Smart-Fold product also incorporates handles and pulls tabs comprised of blue SMS material and adhesive branding labels for aseptic opening.
Predicate Device: The KimGuard Smart-Fold* Sterilization Wrap (Models KC250, KC450, KC550, and KC650) is substantially equivalent to the predicate KimGuard One-Step* Sterilization Wrap (Models KC100, KC200, KC300, KC400, KC500, and KC600) (K082177).
Substantial Equivalence: The modified design of KimGuard Smart-Fold* Sterilization Wrap is substantially equivalent to the predicate Kimberly-Clark KimGuard* One-Step* Sterilization Wrap (K082177) in intended use, design, and materials.
Summary of Testing: KimGuard Smart-Fold* Sterilization Wrap has been tested in compliance 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 irritation and sensitization biocompatibility 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 test results met acceptance criteria.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Brenda Shelkey Associate Director, Quality Assurance & Regulatory Affairs Kimbery- Clark Corporation 1400 Holcomb Bridge Road Roswell, Georgia 30076
JAN 1 9 2012
Re: K112300
Trade/Device Name: KimGuard Smart-Fold* Sterilization Wrap (Models KC250, KC450, KC550, AND KC650) Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: January 4, 2012 Received: January 5, 2012
Dear Ms. Shelkey:
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.
4
Page 2 - Ms. Shelkey
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,
Anthony D. Mester
Anthony D. Watson, B.S., M.S., M.B.A. 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 : K112300
Device Name: KimGuard Smart-Fold* Sterilization Wrap (Models KC250, KC450, KC550, and KC650)
Indications for Use:
KimGuard Smart-Fold* Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider by prevacuum steam at 270°F/132°C for 4 minutes or by 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 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 aterilization of 8 hours at 131°F/ 55°C or 12 hours at 110°F/ 43.3°C. The KimGuard Smart-Fold* Sterilization Wrap was validated for dry times for prevacuum steam sterilization of 20 minutes for Model KC250 and for dry times of 30 minutes for Models KC450, KC550 and KC650.
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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth S. Clamie-Williams
(Printed Name)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
6
Indications for Use
Wrap Model Recommendations for Pre-Vacuum Steam and for 100% Ethylene Oxide Sterilization1
| KIMGUARD
SMART-
FOLD*
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 |
|----------------------------------------------------------------|---------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| KC250 | Light Weight
Package (for
example: standard
linen packs) | 6 lbs. | 2 huck towels (17 in. x 29 in.)
2 fluid-resistant U-drapes (68 in. x 109 in.)
1 fluid-resistant universal bar drape (70 in.
x 108in.) |
| KC450 | Moderate to Heavy
Weight Package
(for example:
general use medical
instruments) | 13 lbs. | 4 tray liners (20 in. x 25 in.) stacked
10 in. x 10 in. x 3 ½ in. tray containing 11
lbs. of metal mass |
| KC550 | Heavyweight
Package (for
example: general
use medical
instruments) | 17 lbs. | 4 tray liners (20 in. x 25 in.) stacked
10 in. x 10 in. x 3 ½ in. tray containing
15 lbs. of metal mass |
| KC650 | Very Heavy Weight
Package (for
example: general
use medical
instruments) | 25 lbs. | 4 tray liners (20 in. x 25 in.) stacked
10 in. x 10 in. x 3 ½ in. tray containing 23
lbs. of metal mass |
'n chicular results may offer doe in handing pactios, wayping techriques, and lokling methods. Realls may also differ bell be use of ingularly shood onlarks
hich may put added stress on the wrap. Each healthcare facility should determine for each wrap which wrap model is most appropriate for each intended use.
*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
mich may not asked toes on the was and desemin of asseml of assemble by and transed to ear transed to next transed to next transed to ne creation on excession nor accoad to ght, and size ol
he metal mass).