(146 days)
Not Found
Not Found
No
The device is a sterilization tray, a passive container, and the description focuses on its protective function during sterilization. There is no mention of any computational or analytical capabilities.
No.
The device is a sterilization tray used to encase and protect medical devices, not to treat a disease or condition.
No
Explanation: The device is described as sterilization trays used to encase and protect medical devices for sterilization, not for diagnostic purposes.
No
The device description clearly states it is a physical sterilization tray, which is a hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as encasing and protecting reusable medical devices for sterilization. This is a process related to the preparation of medical devices for use, not for diagnosing a condition or analyzing a sample from the human body.
- Device Description: The description reiterates the purpose of protecting devices during sterilization.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Measuring analytes
- Using reagents
Therefore, the KARL STORZ-ENDOSKOPE Sterilization Trays are a medical device used in the sterilization process, not an in vitro diagnostic device.
N/A
Intended Use / 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 | Intended
Content | STERRAD
100S | STERRAD NX
"Advanced"
Cycle | Max. Product Load Per Tray |
|---|---|---|---|---|
| Flexible Endoscope Tray,
P/N 39402AS | Flexible
Endoscope | | ✓ | 1 flexible fiberscope
1 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
Product codes (comma separated list FDA assigned to the subject device)
KCT
Device Description
Not Found
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
Not Found
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)
Not Found
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.
Not Found
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
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.
1
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
2
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 | Intended
Content | STERRAD
100S | STERRAD NX
"Advanced"
Cycle | Max. Product Load Per Tray |
|-----------------------------------------|-----------------------|-----------------|-----------------------------------|----------------------------------------------|
| Flexible Endoscope Tray,
P/N 39402AS | Flexible
Endoscope | | ✓ | 1 flexible fiberscope
1 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