KARL STORZ -ENDOSCOPE STERILIZATION TRAYS, MODELS 39402AS, 39301HCTS, 39301BS

K090818 · KARL STORZ Endoscopy-America, Inc. · KCT · Aug 18, 2009 · General Hospital

Device Facts

• Record ID: K090818
• Device Name: KARL STORZ -ENDOSCOPE STERILIZATION TRAYS, MODELS 39402AS, 39301HCTS, 39301BS
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: KCT · General Hospital
• Decision Date: Aug 18, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended 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.

Device Story

Device consists of sterilization trays designed to encase and protect specific Karl Storz reusable medical devices (flexible endoscopes, camera heads, rigid telescopes) during the sterilization process. Trays are used in clinical settings to facilitate sterilization via STERRAD 100S and NX Sterilization Systems. Trays provide physical protection for instruments during handling and sterilization cycles. Operation is manual; healthcare personnel place instruments into designated trays before loading into the sterilization system. System parameters are pre-set and non-adjustable. Benefit is the maintenance of sterility and protection of delicate endoscopic equipment.

Clinical Evidence

Bench testing only.

Technological Characteristics

Sterilization trays designed for compatibility with STERRAD 100S and NX hydrogen peroxide gas plasma sterilization systems. Trays are specific to instrument types (flexible endoscope, camera, telescope) with defined maximum product loads. Non-powered, passive containment device.

Indications for Use

Indicated for use as a protective container for specific Karl Storz reusable medical devices (flexible endoscopes, camera heads, rigid telescopes) during sterilization in STERRAD 100S and NX systems.

Regulatory Classification

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.

Submission Summary (Full Text)

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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 [phone] or [phone] 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 | Intended<br>Content | STERRAD<br>100S | STERRAD NX<br>"Advanced"<br>Cycle | Max. Product Load Per Tray |
|-----------------------------------------|-----------------------|-----------------|-----------------------------------|----------------------------------------------|
| Flexible Endoscope Tray,<br>P/N 39402AS | Flexible<br>Endoscope | | ✓ | 1 flexible fiberscope<br>1 fiber optic cable |
| Camera Tray,<br>P/N 39301HCTS | Camera Head | ✓ | | 1 camera head |
| Telescope Tray,<br>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