(146 days)
The KARL STORZ-ENDOSKOPE Sterilization Trays are intended only for use to encase and protect specific KARL STORZ reusable medical devices for sterilization in STERRAD 100S and NX Sterilization Systems, as indicated. STERRAD Sterilization Systems are pre-set and the cycle parameters can not be adjusted.
The KARL STORZ-ENDOSKOPE Sterilization Trays are intended only for use to encase and protect specific KARL STORZ reusable medical devices for sterilization in STERRAD 100S and NX Sterilization Systems, as indicated.
The provided text describes a 510(k) premarket notification for Karl Storz-Endoscope Sterilization Trays. It primarily focuses on the regulatory approval and the intended use of the sterilization trays with specific sterilization systems.
Unfortunately, the document does not contain the detailed information requested regarding the acceptance criteria, specific study results, sample sizes for test and training sets, expert qualifications, or adjudication methods that would typically be found in a clinical study report or a detailed validation study.
The document is a letter from the FDA confirming substantial equivalence and an "Indications for Use" statement, with a table showing compatibility with specific sterilization systems and maximum product loads. These are statements of intended function and compatibility, not a report of performance metrics or specific study results against acceptance criteria.
Therefore, most of the requested information cannot be extracted from this document.
Here's what can be provided based on the text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative "acceptance criteria" for device performance in terms of efficacy or safety from a study. Instead, it provides a "Sterilization Compatibility and Max Load" table, which acts as a statement of intended performance under specific conditions.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compatibility with STERRAD 100S System | |
| Flexible Endoscope Tray, P/N 39402AS | Not compatible (✓ is not present) |
| Camera Tray, P/N 39301HCTS | Compatible (✓ present) |
| Telescope Tray, P/N 39301BS | Compatible (✓ present) |
| Compatibility with STERRAD NX "Advanced" Cycle | |
| Flexible Endoscope Tray, P/N 39402AS | Compatible (✓ present) |
| Camera Tray, P/N 39301HCTS | Not compatible (✓ is not present) |
| Telescope Tray, P/N 39301BS | Not compatible (✓ is not present) |
| Max. Product Load Per Tray | |
| Flexible Endoscope Tray, P/N 39402AS | 1 flexible fiberscope, 1 fiber optic cable |
| Camera Tray, P/N 39301HCTS | 1 camera head |
| Telescope Tray, P/N 39301BS | 2 rigid telescopes |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The document describes a medical device, not an AI or diagnostic tool that relies on expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable/provided. The device is a sterilization tray, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. The device is a sterilization tray, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided within this document. For a sterilization tray, "ground truth" would likely relate to efficacy studies (e.g., microbial kill rates, material compatibility, maintenance of sterility) conducted as part of the validation process, but these details are not in the FDA letter.
8. The sample size for the training set
This information is not provided in the document.
9. How the ground truth for the training set was established
This information is not provided in the document.
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Image /page/0/Picture/0 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an eagle-like symbol with three curved lines representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Ms. Monika Campbell Senior Regulatory Submission Specialist Karl Storz Endoscopy-America. Incorporated 2151 East Grand Avenue El Segundo, California 90245
AUG 1 8 2009
Re: K090818
Trade/Device Name: Karl Storz-Endoscope Sterilization Trays Regulation Number: 880,6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: June 11, 2009 Received: June 16, 2009
Dear Ms. Campbell:
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.
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.
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Page -2 Ms. Campbell
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); 2 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/CDRHOffice s/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Susan Runner
Susan Runner, D.D.S. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K090818
Device Name: KARL STORZ-ENDOSKOPE Sterilization Trays
Indications for Use: The KARL STORZ-ENDOSKOPE Sterilization Trays are intended only for use to encase and protect specific KARL STORZ reusable medical devices for sterilization in STERRAD 100S and NX Sterilization Systems, as indicated. STERRAD Sterilization Systems are pre-set and the cycle parameters can not be adjusted.
Table 1 provides the sterilization compatibility for STERRAD Sterilization Cycles and Max Load with KARL STORZ-ENDOSKOPE Sterilization Trays and instruments.
| Tray Name | IntendedContent | STERRAD100S | STERRAD NX"Advanced"Cycle | Max. Product Load Per Tray |
|---|---|---|---|---|
| Flexible Endoscope Tray,P/N 39402AS | FlexibleEndoscope | ✓ | 1 flexible fiberscope1 fiber optic cable | |
| Camera Tray,P/N 39301HCTS | Camera Head | ✓ | 1 camera head | |
| Telescope Tray,P/N 39301BS | Rigid Telescopes | ✓ | 2 rigid telescopes |
Table 1-Sterilization Compatibility and Max Load
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shela Murphy, MS
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control. Dental Devic
510(k) Number. K090818
§ 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).