(127 days)
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
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.
Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study proving the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implied) | Reported Device Performance | Meets Criteria? |
|---|---|---|---|
| Sterilant Penetration (STERRAD, Plazlyte, EO) | Sterilant effectively penetrates the pouch to sterilize the enclosed device. | No growth of indicator organism | Yes |
| Microbial Barrier Efficiency (STERRAD, Plazlyte, EO) | Pouch prevents microbial ingress after sterilization. | No growth of indicator organism | Yes |
| Event Related Sterility Maintenance (EO only) | Pouch maintains sterility for a specified period and conditions. | Superior to 140 count cloth packages in maintaining sterility | Yes |
Note on Acceptance Criteria: The document directly states the "Result" for each test but doesn't explicitly state the numerical or qualitative "Acceptance Criteria" that were pre-defined. However, the reported results ("No growth of indicator organism" and "Superior to 140 count cloth packages") implicitly serve as the acceptance criteria being met. "No growth" signifies successful performance for the first two and "Superior to" indicates acceptable performance for the third.
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not explicitly state the sample sizes used for the sterilant penetration, microbial barrier efficiency, or event-related sterility maintenance tests.
The data provenance (e.g., country of origin, retrospective or prospective) is not mentioned in the provided document. As this is a 510(k) submission to the US FDA, it can be inferred that the studies were conducted to meet US regulatory requirements, but the specific location of the study (e.g., laboratory, institution) or its design (retrospective/prospective) is not detailed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the 510(k) summary. These tests are laboratory-based and generally rely on standard microbiological and physical testing protocols, not expert interpretation of results in the way, for example, a medical imaging study would. The "ground truth" would be established by the objective outcome of the microbiological cultures (growth/no growth) and the physical integrity tests.
4. Adjudication Method for the Test Set
This section is not applicable as the tests described are objective laboratory tests with clear endpoints (e.g., "no growth") rather than subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned and is not applicable to this type of device (sterilization pouch). MRMC studies are typically used for diagnostic devices, particularly in medical imaging, to assess human reader performance with and without AI assistance. This device is a passive sterilization packaging material.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device is a physical product (a sterilization pouch), not an algorithm or AI system. The tests performed are standalone in the sense that they assess the intrinsic performance of the pouch itself.
7. The Type of Ground Truth Used
The ground truth for the tests appears to be:
- Sterilant Penetration: Objective microbiological culture results (absence of indicator organism growth after sterilization).
- Microbial Barrier Efficiency: Objective microbiological culture results (absence of indicator organism growth after exposure to microbes).
- Event Related Sterility Maintenance: Objective microbiological culture results comparing the pouch's ability to maintain sterility against a reference standard (140 count cloth packages).
8. The Sample Size for the Training Set
This question is not applicable as the device is a physical product, not a machine learning algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as the device is a physical product, not a machine learning algorithm requiring a training set.
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FEB | | 1998
| 510(k) Summary of Safety and Effectiveness | |
|---|---|
| K973827 |
| Manufacturer: | Kimberly-Clark Corporation1400 Holcomb Bridge RoadRoswell, GA 30076 |
|---|---|
| Regulatory AffairsContact: | Larry R. KludtDepartment of Product SafetyKimberly-Clark Corporation1400 Holcomb Bridge RoadRoswell, GA 30076(770) 587-8303 |
| Summary Date: | September 30, 1997 |
| Product Trade Name: | Kimberly-Clark™ Self-Seal Pouch for LowTemperature 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 insizes 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 Tyvekbacking with a clear, polyolefin/polyester filmlaminate material as a front. |
| Intended Use: | The Kimberly-Clark Self-Seal Pouch for LowTemperature Sterilization is intended to be used toenclose another medical device that is to besterilized by a health care provider and to maintainsterility of the enclosed device until needed. Thesterilization pouch is intended for use with lowtemperature sterilization processes (hydrogenperoxide gas plasma/STERRAD® sterilizationsystem, peracetic acid gas plasma/Plazlyte™sterlization process or ethylene oxide). |
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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
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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
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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
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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
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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) |
|---|---|---|
| ------------------------------------------ | ---- | ----------------------------------------------------------- |
§ 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).