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.

AI/ML Overview

Here's an analysis of the provided text regarding the Ocular Force Gauge, addressing the requested information:

Acceptance Criteria and Study Details for the Ocular Force Gauge

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes a "Traditional 510(k) Submission" for the Ocular Force Gauge, seeking substantial equivalence to a predicate device. In this context, specific numerical "acceptance criteria" are not explicitly stated in a tabular format as they would be for a novel device with defined performance thresholds. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to a predicate, the Ophthalmodynamometer, and compliance with relevant standards.

The device performance is primarily reported as meeting pre-determined specifications and demonstrating substantial equivalence.

Acceptance Criteria (Implied by Substantial Equivalence and Standards)	Reported Device Performance
Functional Equivalence: Ability to apply measured force to the surface of the eye.	"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." "The test samples [Ocular Force Gauge and Ophthalmodynamometer] 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..."
Foot Surface Quality: Smooth surface with no defects or debris.	"The foot of each instrument [Ocular Force Gauge and Ophthalmodynamometer] 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."
Biocompatibility: Non-cytotoxic.	"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."
Sterilization Efficacy: Ability to be sterilized to a Sterility Assurance Level (SAL) of 1 x 10^-6.	"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." (Note: "1 x 10to" likely a typo for 1 x 10^-6, a common SAL target).
Compliance with relevant voluntary standards (e.g., ISO for sterilization, biocompatibility).	The device meets ISO 17665-1:2006, ISO 10993-1:2009 & Cor 1:2010, ISO 10993-5:2009, and ISTA 1A 2001.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The document states, "Two bench top tests were used to evaluate and compare the foot surface and the ability to apply force for each device." It then mentions "The test samples were loaded one at a time..." This indicates that multiple units of both the Ocular Force Gauge and the Ophthalmodynamometer were tested, but the exact number of samples (units) of each device tested is not specified.
Data Provenance: The tests were "In vitro preclinical tests" and "bench top tests" performed by Ocular Therapeutix, Inc. This implies the data is retrospective (in the sense that it's prior testing data submitted for regulatory review) and performed in a controlled laboratory setting (likely in the USA, given the submitter's address).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not applicable or not specified. This study did not involve human interpretation or subjective assessment that would require expert consensus for ground truth. It relied on objective measurements and visual inspections against "pre-determined specifications" and standard regulatory tests (e.g., cytotoxicity).
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. As mentioned above, the study involved objective bench testing and compliance with standards, not subjective assessments requiring adjudication. The "visual inspection" of the foot surface would likely have been against a clear specification, rather than requiring expert consensus or adjudication.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

Was an MRMC study done? No. This device is a manual instrument for applying measured force, not an AI or imaging diagnostic device that would typically involve an MRMC study.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Was a standalone study done? This is not an AI algorithm. The device is a physical, manual instrument. Therefore, the concept of a "standalone algorithm" performance study doesn't apply. The performance data presented (bench tests, biocompatibility, sterilization) represents the "standalone" performance of the physical device.

7. Type of Ground Truth Used

The ground truth for the functional and safety aspects of the device was established through:
- Objective physical measurements: Using an Instron machine to measure maximum load and extension for compressive force.
- Visual inspection: For the foot surface quality, against "pre-determined specifications."
- Standardized laboratory tests: ISO 10993-5 for cytotoxicity testing.
- Validated sterilization methods: Gravity steam sterilization demonstrating a specific SAL.
- Compliance with Predicate Device characteristics: Substantial equivalence in "intended use, principle of operation, and technological characteristics" to the Ophthalmodynamometer.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device is a physical instrument, not a machine learning algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this type of device.

Summary

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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 101Bedford, 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:

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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 asterilization process for medical devices
ISO 10993-1:2009 &ISO 10993-1:2009/Cor 1:2010ISO 10993-5:2009	Biological evaluation of medical devices –Part 1: Evaluation and testing within a risk management processPart 5: Tests for in vitro cytotoxicity
ISTA 1A 2001	ISTA Pre-shipment Testing Procedures - Combination Tests forPackaged Products Weighing 150 lbs. (68kg) or less

Standards Applicable to the Ocular Force Gauge

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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.

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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

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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

Regulation Number and Section

§ 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.