(94 days)
Not Found
No
The device is described as a manual, mechanical instrument with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is indicated for applying measured force to the surface of the eye, which is a diagnostic or measurement function, not a therapeutic one. It's used for measurement/assessment, similar to how an ophthalmodynamometer applies and measures force.
No
Explanation: The device is described as "applying measured force to the surface of the eye," which is a therapeutic or interventional action rather than a diagnostic one. While it applies "measured force," the intent is not stated to be for diagnosis or detection of a condition. It is compared to an ophthalmodynamometer, an instrument for applying and measuring force, implying a functional rather than diagnostic purpose.
No
The device description explicitly states it is a "precision spring-scale manual instrument" and a "hand held device" with a physical "foot" that contacts the eye, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "apply measured force to the surface of the eye." This is a physical action performed on the body, not a test performed on a sample taken from the body.
- Device Description: The description details a manual instrument with a "foot" that contacts the eye surface. This aligns with a physical instrument, not a device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting substances, or providing diagnostic information based on in vitro analysis.
- Performance Studies: The performance studies focus on the physical properties of the device (foot surface, compressive force) and biocompatibility (cytotoxicity), which are relevant for a physical medical device, not an IVD.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Ocular Force Gauge does not fit this definition.
N/A
Intended Use / Indications for Use
The Ocular Force Gauge is indicated for applying measured force to the surface of the eye.
Product codes
HKY
Device Description
The Ocular Force Gauge is a non-sterile, reusable, precision spring-scale manual instrument designed and manufactured to apply measured force to the surface of the eye. The hand held device has a smooth "foot" similar to the "foot" of an opthalmodynamometer, an instrument used to apply and measure force on the ocular surface. The Ocular Force Gauge "foot" is the surface of the device that contacts the ocular surface.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
surface of the eye
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)
In vitro preclinical tests were performed to verify and validate the safety and effectiveness of the Ocular Force Gauge and assure substantial equivalence to the predicate device. The Ocular Force Gauge and the Ophthalmodynamometer are both reusable, ophthalmic instruments manufactured from medical grade metal with equivalent operating principles and intended use.
A study evaluating and comparing the Ophthalmodynamometer to the Ocular Force Gauge was performed. Two bench top tests were used to evaluate and compare the foot surface and the ability to apply force for each device. The test samples were loaded one at a time into the lower jaws of an Instron and depressed into the anvil at a rate of 1.0 Inch/Minute. When the load cell reached a force of 1.0 ounce the test ended. The maximum load and extension were recorded, and the jaws returned to the starting position. The foot of each instrument was visually inspected to ensure a smooth surface with no defect or debris in between repetitions of the force testing. All samples met pre-determined specifications for both the foot surface and compressive force.
Ocular Therapeutix completed with passing results a confirmatory cytotoxicty test on the Ocular Force Gauge per ISO 10993-5, Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity.
The Ocular Force Gauge is a reusable, manual ophthalmic instrument that is supplied non-sterile. A cleaning and sterilization was performed on the Ocular Force Gauge demonstrating the device is able to be sterilized by gravity steam sterilization (autoclave) to a sterility assurance level (SAL) of 1 x 10to.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Ophthalmodynamometer
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/2 description: The image shows a handwritten string of characters that appear to be alphanumeric. The string reads 'K132917'. The characters are written in a cursive style, with some connections between the letters and numbers.
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
DEC 2 0 2013
| A. | Submitter Information | |
|---|---|---|
| Submitter's Name: | Ocular Therapeutix, Inc. | |
| Address: | 36 Crosby Drive, Suite 101 | |
| Bedford, MA 02451 | ||
| Telephone: | 781-628-8998 | |
| Fax: | 781-494-6557 | |
| Contact Person: | Eric Ankerud, Executive Vice President Clinical, | |
| Regulatory, Quality | ||
| Date of Preparation: | November 19, 2013 | |
| B. | Subject Device | |
| Trade Name: | Ocular Force Gauge | |
| Common/Usual Name: | Ocular Force Gauge | |
| Classification Name: | 21 CFR 886.1930, Tonometer and accessories | |
| Class: | II | |
| Product Code: | HKY | |
| C. | Predicate Device Name(s): | Ophthalmodynamometer (Pre-amendment device) |
D. Indication for Use:
The Ocular Force Gauge is indicated for applying measured force to the surface of the eye.
E. Device Description:
The Ocular Force Gauge is a non-sterile, reusable, precision spring-scale manual instrument designed and manufactured to apply measured force to the surface of the eye. The hand held device has a smooth "foot" similar to the "foot" of an opthalmodynamometer, an instrument used to apply and measure force on the ocular surface. The Ocular Force Gauge "foot" is the surface of the device that contacts the ocular surface.
1
F. Predicate Device(s) Reference:
The Ocular Force Gauge was shown to be substantially equivalent in intended use, principle of operation, and technological characteristics to the legally marketed predicate device, the Ophthalmodynamometer.
G. Performance Data:
In vitro preclinical tests were performed to verify and validate the safety and effectiveness of the Ocular Force Gauge and assure substantial equivalence to the predicate device. The Ocular Force Gauge and the Ophthalmodynamometer are both reusable, ophthalmic instruments manufactured from medical grade metal with equivalent operating principles and intended use.
A study evaluating and comparing the Ophthalmodynamometer to the Ocular Force Gauge was performed. Two bench top tests were used to evaluate and compare the foot surface and the ability to apply force for each device. The test samples were loaded one at a time into the lower jaws of an Instron and depressed into the anvil at a rate of 1.0 Inch/Minute. When the load cell reached a force of 1.0 ounce the test ended. The maximum load and extension were recorded, and the jaws returned to the starting position. The foot of each instrument was visually inspected to ensure a smooth surface with no defect or debris in between repetitions of the force testing. All samples met pre-determined specifications for both the foot surface and compressive force.
Ocular Therapeutix completed with passing results a confirmatory cytotoxicty test on the Ocular Force Gauge per ISO 10993-5, Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity.
The Ocular Force Gauge is a reusable, manual ophthalmic instrument that is supplied non-sterile. A cleaning and sterilization was performed on the Ocular Force Gauge demonstrating the device is able to be sterilized by gravity steam sterilization (autoclave) to a sterility assurance level (SAL) of 1 x 10to.
H. Standards
The Ocular Force Gauge has been designed to comply with the following voluntary standards.
| Standard | Title |
|---|---|
| ISO 17665-1:2006 | Sterilization of health care products -- Moist heat -- Part 1: |
| Requirements for the development, validation and routine control of a | |
| sterilization process for medical devices | |
| ISO 10993-1:2009 & | |
| ISO 10993-1:2009/Cor 1: | |
| 2010 | |
| ISO 10993-5:2009 | Biological evaluation of medical devices – |
| Part 1: Evaluation and testing within a risk management process | |
| Part 5: Tests for in vitro cytotoxicity | |
| ISTA 1A 2001 | ISTA Pre-shipment Testing Procedures - Combination Tests for |
| Packaged Products Weighing 150 lbs. (68kg) or less |
Standards Applicable to the Ocular Force Gauge
2
I. Basis for Determination of Substantial Equivalence:
Upon reviewing the safety and efficacy information provided in this submission and comparing intended use, principle of operation, and overall technological characteristics, the Ocular Force Gauge is determined to be substantially equivalent to the existing legally marketed device, the Ophthalmodynamometer.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/13 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with healthcare, alongside the department's name. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus. The logo is black and white.
December 20, 2013
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Ocular Therapeutix, Inc. % Eric P. Ankerud, J.D. Executive Vice President, Clinical, Regulatory and Quality 36 Crosby Drive. Suite 101 Bedford, MA 01730
Re: K132917
Trade/Device Name: Ocular Force Gauge Regulation Number: 21 CFR 886.1930 Regulation Name: Tonometer and accessories Regulatory Class: Class II Product Code: HKY Dated: November 19, 2013 Received: November 20, 2013
Dear Mr. Ankerud:
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.
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.
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Page 2 – Mr. Eric P. Ankerud –
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.fda.gov/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,
Kesia Y. Alexander -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
5
Ocular Therapeutix, Inc.
Traditional 510(k) Submission
Ocular Force Gauge
Indications for Use Statement
510(k) Number (if known): _K132917
Device Name:
Ocular Force Gauge
Indications for Use:
The Ocular Force Gauge is indicated for applying measured force to the surface of the eye.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jan C. Callaways 2013.12.12 13:14