Sensor Medical Single Use Tonometer Prism

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 13, 2015 Sensor Medical Technology, LLC % Ms. Maureen O'Connell President O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, MA 01864 Re: K152308 Trade/Device Name: Sensor Medical Single Use Tonometer Prism Regulation Number: 21 CFR 886.1930 Regulation Name: Tonometer and Accessories Regulatory Class: Class II Product Code: HKY Dated: August 13, 2015 Received: August 17, 2015 Dear Ms. O'Connell: 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 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}------------------------------------------------ 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 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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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. Deborah L. Falls -S for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) Device Name Sensor Medical Single Use Tonometer Prism Indications for Use (Describe) The Sensor Medical Single Use Tonometer Prism is intended for use as a disposable applanating and optical doubling prism for Goldmann style applanation tonometers. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| | <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | |----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------| |----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------| CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ### 510(k) SUMMARY ## Sensor Medical Technology LLC Sensor Medical Single Use Tonometer Prism # Name of Device and Name/Address of Sponsor Sensor Medical Single Use Tonometer Prism Sensor Medical Technology LLC 23175 224th Place SE, Suite C Maple Valley, WA 98038 ## Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared Maureen O'Connell O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, MA 01864 (978) 207-1245 Phone: Date Prepared: July 24, 2015 Common or Usual Name Tonometer Prism # Classification Name and Regulation Manual Tonometer 21 CFR 886.1930. HKY Ophthalmic Panel #### Predicate Devices Luneau Tonometer Separation Prisms (K023838) #### Intended Use / Indications for Use The Sensor Medical Single Use Tonometer Prism is intended for use as a disposable applanating and optical doubling prism for Goldmann style applanation tonometer. #### Device Description The Sensor Medical Single Use Tonometer Prism is used as the optical image doubling prism for Goldmann applanation style tonometers. The prism is a precise optical replacement for the current glass Goldmann {4}------------------------------------------------ tonometer. The Sensor Medical Single Use Tonometer Prism is made from PMMA. The corneal contact diameter is 6.6 +/-0.1mm. The total length of the prism is 30.0 +/- 0.1mm. The prism weighs 1.8 +/- 0.1 g. ## Performance Data No performance data is provided since no new questions of safety and effectiveness are raised. ## Substantial Equivalence Sensor Medical Technology, LLC believes that the Sensor Medical Single Use Tonometer Prism described in this notification and for use under the conditions of proposed labeling is a Class II device which is substantially equivalent to a legally marketed predicate device. The Sensor Medical Single Use Tonometer Prism is substantially equivalent to the Luneau Tonometer Separation Prisms (K023838) (the "predicate device") that the FDA has already cleared. The Sensor Medical Single Use Tonometer Prism has the same intended use, technological characteristics. and principles of operation as the previously cleared predicate. The intended use of the Sensor Medical Single Use Tonometer Prism and the intended use of the Luneau Tonometer Separation Prisms cleared in K023838 are identical. Both devices are disposable, sterile applanating tonometer prisms used in Goldmann style tonometers for measurement of intraocular pressure. Both devices are prescription devices used by trained professionals. The Sensor Medical Single Use Tonometer Prism has the same technological characteristics as the Luneau Tonometer Separation Prisms cleared in K023838. Both devices are disposable applanating and optical doubling prisms for use in Goldmann style applanation tonometers for measurement of intraocular pressure. Both devices are provided sterile for single use. Both devices are made from PMMA and both devices have the same size and weight. In summary, Sensor Medical Single Use Tonometer Prism has the same intended use as the previously cleared predicate device. In addition, the Sensor Medical Single Use Tonometer Prism has the same technological characteristics as its predicate. Therefore, the Sensor Medical Single Use Tonometer Prism is substantially equivalent to the predicate device.