SURGICAL LIGHT HANDLE COVER

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for Ecolab Inc. The text "Ecolab Inc." is at the top of the image. Below that is the Ecolab logo, with the word "ECOLAB" in bold black letters and a symbol in the middle of the O. There is a registered trademark symbol to the right of the B. : # APR 0 8 2014 K133554 #### Section 5: 510(k) Summary ## Surgical Light Handle Cover As required by 21 CFR 807.92. | Date: | November 11, 2013 | | |---------------------------------------|-----------------------------------------------------------------------------------------------------------------|--| | Administrative Information | | | | Submitter: | Microtek Medical Inc., an Ecolab Company | | | Establishment<br>Registration Number: | 1043582. | | | Contact Person: | Andy Roller<br>370 Wabasha Street North<br>St. Paul, MN 55102-1390<br>Sr. Regulatory Specialist<br>651.293.2080 | | | Device Identification | | | | Device Name: | Surgical Light Handle Cover | | | Common Name: | Surgical Light Accessory | | | Device Classification Name: | Light, Surgical, Accessories | | | Device Classification: | Class II | | | Panel: | General and Plastic Surgery | | | Classification Regulation: | 878.4580 | | | Product Code: | FTA | | Performance Standards: No Recognized Consensus Standards {1}------------------------------------------------ Ecolab Inc. Surgical Light Handle Cover | Predicate Device: | Surgical Lamp Handle and Cover, cleared on 3/20/1999 via K901154 | |-------------------|------------------------------------------------------------------| | Trade Name: | Skytron Disposable Light Handle Cover | Device Description The Surgical Light Handle Cover is a polycarbonate injection molded device shaped to fit a surgical light that has release buttons protruding from the surgical light handle. The Surgical Light Handle Cover has apertures located at the end of the device, proximal to the surgical light, which correspond to the release buttons on the surgical light handle. When the Surgical Light Handle Cover is attached to the light, the release buttons will interface with the apertures to secure the Surgical Light Handle Cover to the light handle. The Surgical Light Handle Cover is hollow in the center, with transparent polycarbonate located near the distal end. The transparent end permits the use of a recording device, which may be mounted onto the surgical light. The transparent end allows light to pass through for the purpose of recording images, it does not provide image enhancement or magnification. #### Statement of Intended Use The Surgical Light Handle Cover is intended to be used as a disposable barrier for a surgical lighting system and which allows the surgical team member to manually adjust the lighting system. This is a single-use device. ### Substantial Equivalence Discussion The predicate device and design basis for the Surgical Light Handle Cover is the Microtek Medical Surgical Lamp Handle and Cover (K901154, cleared 3/20/1990). The fundamental scientific technology of the device remains unchanged in that it is a disposable sterile light cover that allows the user to adjust position of the light during surgical procedures. The following table illustrates the similarities and differences in the product designs. | Property or<br>Characteristic | Proposed Device -<br>Surgical Light Handle Cover | Predicate Device -<br>Surgical Lamp Handle and<br>Cover (K901154) | |----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------| | Intended<br>Use/Indications for<br>Use | A device intended to be used as a<br>disposable barrier for a surgical<br>lighting system and which allows a<br>surgical team member to manually | A device intended to be used as<br>a disposable barrier for a<br>surgical lighting system and<br>which allows a surgical team | | | | Table 1: Substantial Equivalence | | | |--|--|----------------------------------|--|--| |--|--|----------------------------------|--|--| {2}------------------------------------------------ ද | | adjust the lighting system. This is a<br>single-use device | member to manually adjust the<br>lighting system. This is a<br>single-use device | |----------------------------------|------------------------------------------------------------|----------------------------------------------------------------------------------| | Conditions of Use | Single Use, Disposable | Single Use, Disposable | | Materials | Polycarbonate Handle Cover | Polypropylene Handle Cover | | Property or<br>Characteristic | Proposed Device -<br>Surgical Light Handle Cover | Predicate Device -<br>Surgical Lamp Handle and<br>Cover (K901154) | | | Color | Clear - Frosted | | Sterility | Provided sterile | Provided sterile | | Sterility Assurance<br>Level | 10-6 via EO Gas | 10-3 via Gamma Radiation | | Principle of<br>Operation | Sterile cover to allow manipulation<br>of a surgical light | Sterile cover to allow<br>manipulation of a surgical light | | Interface with<br>Surgical Light | Fully detachable | Lamp Handle - Not detachable<br>Handle Cover - Fully<br>detachable | | | Transparent Distal<br>End | Yes | Performance Data Summary Table 2: Performance Data Summary of the Surgical Light Handle Cover | | Requirement | Specification | Method | Result | |-----------------------------------------|---------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|--------|--------| | Packaging | Simulated Distribution-<br>Test | ASTM D4169 | Pass | | | | Dye Migration Test | ASTM F1929 | Pass | | | | Seal Peel Test | ASTM F88 | Pass | | | | Inspection for Shipping<br>Damage | Visual Inspection | Pass | | | Sterility | SAL 10-6 | ISO 11135-1 | Pass | | | | EO/ECH Residuals | ISO 10993-7 | Pass | | | Material<br>Compatibility<br>Evaluation | Cytotoxicity | ISO Elution | Pass | | | | Material Leachables | USP Physical-Chemical<br>Analysis | Pass | | | Functional<br>Requirements | Product must be easily<br>installed and removed | Attached/Detached Surgical<br>Light Handle Cover to surgical<br>light | Pass | | | | Product must not interfere<br>with the functionality of<br>surgical light | With Surgical Light Handle<br>Cover attached: rotate light,<br>move light in transverse<br>direction, compare visual clarity | Pass | | {3}------------------------------------------------ #### Substantial Equivalence Conclusion The differences between the Surgical Light Handle Cover and the predicate device do not constitute a new intended use, and the differences in technological characteristics do not raise different questions of safety and effectiveness. Furthermore, the changes to the device design do not impact the fundamental scientific technology or principle of operation, which is to allow a user to manipulate a surgical light during surgical procedures using a disposable sterile cover. The Surgical Light Handle Cover is substantially equivalent to the predicate device cleared under K901154. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 8, 2014 Microtek Medical, Incorporated An Ecolab Company Mr. Andy Roller Senior Regulatory Specialist 370 Wabasha Street North St. Paul. MN 55102 Re: K133554 Trade/Device Name: Surgical Light Handle Cover Regulation Number: 21 CFR 878.4580 Regulation Name: Light, Surgical, Accessories Regulatory Class: II Product Code: FTA Dated: January 30, 2014 Received: February 12, 2014 Dear Mr. Roller: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into cither 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. {5}------------------------------------------------ ## Page 2 - Mr. Roller 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); 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fdagov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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. Tejashri Clinical D DAGRID Teiashri Purohit-Sheth, M.D. Clinical Deputy Director FOR Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ #### Statement of Indications for Use Section 4: 510(k) Number (if known): _ K133554 Device Name: Surgical Light Handle Cover Model Number: B1-715-65 Indications For Use: A device intended to be used as a disposable barrier for a surgical lighting system and which allows a surgical team member to manually adjust the lighting system. This is a single-use device Image /page/6/Picture/7 description: The image shows the phrase "Prescription Use (Part 21 CFR 801 Subpart D)" in bold font. There is a line underneath the phrase. Above the phrase is a large X mark. AND/OR Over-The-Counter Use (2) CFR 801 Subparl C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (CDDE) Elizabeth F. Claverie -S 2014.04.07 22:55:00 -04'00' 4-1