(127 days)
Not Found
Not Found
No
The device is a sterilization pouch and the description focuses on its materials, sizes, and performance in sterilization processes, with no mention of AI or ML.
No
The device is a sterilization pouch intended to maintain sterility of another medical device, not to treat or diagnose a medical condition.
No
The device is a sterilization pouch used to enclose other medical devices for sterilization and maintain their sterility. It does not perform any diagnostic function.
No
The device described is a physical sterilization pouch made of Tyvek and film, not a software application.
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 another medical device for sterilization and maintain its sterility. This is a function related to the sterilization and storage of medical devices, not the diagnosis of diseases or conditions using samples from the human body.
- Device Description: The description details the physical components of a pouch designed for sterilization processes. It does not mention any reagents, assays, or components typically associated with in vitro diagnostic tests.
- Performance Studies: The performance studies focus on the ability of the pouch to allow sterilant penetration and maintain a microbial barrier, which are relevant to sterilization packaging, not diagnostic performance.
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Kimberly-Clark™ Self-Seal Pouch for Low Temperature Sterilization is intended to be used to enclose another medical device that is to be sterilized by a health care provider and to maintain sterility of the enclosed device until needed. The sterilization pouch is intended for use with low temperature sterilization processes (hydrogen peroxide gas plasma/STERRAD® sterilization system, peracetic acid gas plasma/Plazlyte™ sterlization process or ethylene oxide).
Product codes
KCT
Device Description
The Kimberly-Clark Self-Seal Pouch is available in sizes to suit the health care provider (3.5 " x 8.5", 5.25" x 10.25", 5" x 15", 7.5" x 13.5", 12" x 15", 12" x 18" & 15.75" x 18"). The pouch has a Tyvek backing with a clear, polyolefin/polyester film laminate material as a front.
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
Test: Sterilant Penetration (STERRAD, Plazlyte and EO); Result: No growth of indicator organism
Test: Microbial Barrier Efficiency (STERRAD, Plazlyte and EO); Result: No growth of indicator organism
Test: Event Related Sterility Maintenance (EO only); Result: Superior to 140 count cloth packages in maintaining sterility
Key Metrics
Not Found
Predicate Device(s)
Medi-Oxide Sterilization Pouch
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
・
:
FEB | | 1998
| 510(k) Summary of Safety and Effectiveness | |
|---|---|
| K973827 |
| Manufacturer: | Kimberly-Clark Corporation
1400 Holcomb Bridge Road
Roswell, GA 30076 |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Affairs
Contact: | Larry R. Kludt
Department of Product Safety
Kimberly-Clark Corporation
1400 Holcomb Bridge Road
Roswell, GA 30076
(770) 587-8303 |
| Summary Date: | September 30, 1997 |
| Product Trade Name: | Kimberly-Clark™ Self-Seal Pouch for Low
Temperature Sterilization |
| Common Name: | Sterilization Pouch |
| Classification: | Pack, Sterilization Wrapper Bag & Accessories |
| Predicate Device: | Medi-Oxide Sterilization Pouch |
| Description: | The Kimberly-Clark Self-Seal Pouch is available in
sizes to suit the health care provider (3.5 " x 8.5",
5.25" x 10.25", 5" x 15", 7.5" x 13.5", 12" x 15",
12" x 18" & 15.75" x 18"). The pouch has a Tyvek
backing with a clear, polyolefin/polyester film
laminate material as a front. |
| Intended Use: | The Kimberly-Clark Self-Seal Pouch for Low
Temperature Sterilization is intended to be used to
enclose another medical device that is to be
sterilized by a health care provider and to maintain
sterility of the enclosed device until needed. The
sterilization pouch is intended for use with low
temperature sterilization processes (hydrogen
peroxide gas plasma/STERRAD® sterilization
system, peracetic acid gas plasma/Plazlyte™
sterlization process or ethylene oxide). |
1
Technological Characteristics
Both the Medi-Oxide pouch and the Kimberly-Clark Seal Pouch for Low Temperature Sterilization are composed of the same materials (a porous, Tyvek backing to allow the sterilant to penetrate into the package and a polyolefin/polyester film as a front to allow viewing of the pouch contents). Both products are intended for use with low temperature sterilization processes and are able to maintain the sterility of their contents once sterilized.
Summary of Testing
Test
Result
Sterilant Penetration (STERRAD, Plazlyte and EO)
Microbial Barrier Efficiency (STERRAD, Plazlyte and EO)
Event Related Sterility Maintenance (EO only) No growth of indicator organism
No growth of indicator organism
Superior to 140 count cloth packages in maintaining sterility
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Larry R. Kludt Manager Requlatory Affairs Kimberly-Clark Corporation 1400 Holcomb Bridge Road Roswell, Georgia 30076
FEB 11 1998
Re : K973827 Kimberly-Clark™ Self-Seal Pouch for Low Trade Name: Temperature Sterilization Requlatory Class: II Product Code: KCT Dated: December 19, 1997 Received: December 22, 1997
Dear Mr. Kludt:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). 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, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A-- ---substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does
3
Page 2 - Mr. Kludt
not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA debtribut in your for equivalence of your device to a legally marketed predicate device results in a classification for your marice 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to one roganized notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fdaygov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
l'age of
510(k) Number (if known): ___ K973827
Device Name Kimberly-Clark™ Self Seal Pouch for Low Temperature Sterilli zation
Indications For Use:
The Kimberly-Clark Th Self-Seal Pouch for Low Temperature Sterilization is intended to be used to enclose another medical device that is to be sterilized by a health care provider and to maintain sterility of the enclosed device until needed. The sterilization pouch is intended for use with low temperature sterilization processes (hydrogen peroxide gas plasma/STERRAD Sterilization System, peracetic acid
(PLEASE DO NOT WILTE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Dental, Infection Control, | |
| and General Hospital Devices | |
| 510(k) Number | K973827 |
| Prescription Use
(Per 21 CFR 801.109) | OR | Over-The-Counter Use X
(Optional Format 1-2-96) |
| ------------------------------------------ | ---- | ----------------------------------------------------------- |
|---|