(60 days)
Not Found
No
The device description focuses on the physical properties and intended use as a replacement optical prism, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a disposable prism used in applanation tonometers to measure intraocular pressure. While applanation tonometry is a diagnostic procedure, the prism itself does not directly treat or alleviate a disease or condition; it is a component of a diagnostic device.
Yes
The device is described as an "optical image doubling prism for Goldmann applanation style tonometers," and tonometers are used to measure intraocular pressure, which is a diagnostic indicator for conditions like glaucoma. The "Intended Use / Indications for Use" states it's for "Goldmann style applanation tonometers."
No
The device is a physical prism made of PMMA, intended as a replacement for a glass prism in a tonometer. It has specific physical dimensions and weight, indicating it is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is as a disposable applanating and optical doubling prism for Goldmann style applanation tonometers. This device is used to measure intraocular pressure by physically contacting the cornea and optically splitting the image.
- Device Description: The description details a physical prism made of PMMA used in conjunction with a tonometer.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are typically used in laboratory settings or for point-of-care testing involving biological samples.
This device is a medical device used for a diagnostic procedure (measuring intraocular pressure), but it does not fit the definition of an In Vitro Diagnostic device.
N/A
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 tonometers.
Product codes (comma separated list FDA assigned to the subject device)
HKY
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 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.
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
Prescription Use (Part 21 CFR 801 Subpart D)
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)
No performance data is provided since no new questions of safety and effectiveness are raised.
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.
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
§ 886.1930 Tonometer and accessories.
(a)
Identification. A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.
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.
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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
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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) |
|---|
| ------------------------------------------------- |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------- |
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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.