The Sight Sciences Viscoelastic Injector is a manually operated device for delivery of small amounts of viscoelastic fluid, for example Healon™ or HealonGV™ from Abbott Medical Optics (AMO), Amvisc™ from Bausch & Lomb, or PROVISC™ from Alcon, during ophthalmic surgery.

Device Description

The Sight Sciences Viscoelastic Injector is a sterile, single use, manually operated instrument used by ophthalmologists to deliver small amounts of viscoelastic into the eye during ophthalmic surgery. The Viscoelastic Injector is designed to function with commonly used viscoelastic fluids made commercially available by companies such as Abbott Medical Optics (AMO), Bausch & Lomb, and Alcon. The Sight Sciences Viscoelastic Injector dispenses fluid on the principle of exchanging volumes much like a syringe. The handheld instrument includes a cannula, injection tube, internal reservoir, plunger tube and finger wheels. The finger wheels on the handle of the device are used to advance the plunger tube into the viscoelastic fluid reservoir thereby dispensing viscoelastic fluid. The finger wheels are placed on both sides of the handle facilitating viscoelastic delivery in either the left or right eye (00 or OS) using either hand.

AI/ML Overview

The provided text does not contain detailed acceptance criteria or a study proving the device meets those criteria in the typical format for medical device performance studies (e.g., sensitivity, specificity, accuracy for diagnostic devices, or specific numerical targets for functional performance).

The document is a 510(k) summary for a "Viscoelastic Injector," indicating it's a submission for regulatory clearance in the US, asserting substantial equivalence to a predicate device. The information provided is primarily for regulatory purposes and highlights manufacturing, design, and general performance testing rather than a clinical efficacy study with detailed metrics and statistical analysis.

Based on the available text, here's what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Viscoelastic injector dispensing performance	"performs as intended"
Intrinsic strength of the materials	"performs as intended"
Load to which the Sight Science Viscoelastic Injector would be subjected during intended use	"performs as intended"
Equivalence to the predicate device	"functionally equivalent to the predicate device"
Meeting all product design requirements and applicable standards	"meets all product design requirements and applicable standards"
Safety and effectiveness	"is safe and effective"

Missing Information: Specific, quantifiable acceptance criteria (e.g., "dispenses fluid within +/- X% of target volume," "material strength exceeds Y MPa," "withstands Z N of force") are not provided. The reported performance is general and qualitative ("performs as intended," "functionally equivalent").

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

Sample Size: Not specified. The document states "performance testing was conducted," but no number of devices tested or the amount of data collected (e.g., number of injections, duration of tests) is given.
Data Provenance: Not specified, but given the nature of a 510(k) submission for a manufacturing and design modification, it's highly likely this was retrospective testing performed on manufactured devices in an engineering lab setting, rather than human-centric prospective studies. The country of origin for the data is not mentioned but can be inferred to be within the US or by the manufacturer, Sight Sciences, Inc., based in California.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable for this type of device and study. The "ground truth" for a mechanical device like a viscoelastic injector typically refers to engineering specifications, material properties, and functional output (e.g., volume dispensed, pressure exerted). It doesn't involve clinical "experts" establishing a ground truth in the same way as a diagnostic imaging device. The testing would be against established engineering standards and validated measurement techniques.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods (2+1, 3+1, etc.) are used in clinical studies where human interpretation of data (e.g., medical images) requires consensus. This device's performance testing would involve objective measurements against engineering specifications.

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

No comparison study mentioned. The document states the device is "manually operated" by ophthalmologists, but there's no mention of a comparative effectiveness study involving human readers (ophthalmologists) with and without the device, or against a different device, to measure improvement in human performance "with AI vs without AI assistance." This device is a tool, not an AI diagnostic assistant.

6. Standalone (Algorithm Only) Performance:

Not applicable. This device is a manually operated mechanical injector, not an AI algorithm. Its performance is tied directly to its physical function.

7. Type of Ground Truth Used:

The "ground truth" for this device's performance testing would be based on engineering specifications and validated metrology/measurement standards. For example, the accuracy of dispensed volume would be measured against a known reference standard using calibrated equipment. The material strength would be tested against established mechanical engineering limits. The text broadly refers to "viscoelastic injector dispensing performance, intrinsic strength of the materials, and the load to which the Sight Science Viscoelastic Injector would be subjected during intended use" as the basis for acceptance criteria, implying these engineering and functional benchmarks.

8. Sample Size for the Training Set:

Not applicable. This is a mechanical device, not an AI system that requires a training set.

9. How Ground Truth for the Training Set was Established:

Not applicable. As above, no training set for an AI-like system is involved.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 5, 2014

ClinReg Consulting Services, Inc. c/o Judy Gordon, D.V.M. 733 Bolsana Drive Laguna Beach, CA 92651

Re: K143205

Trade/Device Name: Viscoelastic Injector Regulation Number: 21 CFR 880.5725 Regulation Name: Pump, Infusion, Ophthalmic Regulatory Class: Class II Product Code: MRH Dated: November 5, 2014 Received: November 7, 2014

Dear Dr. Gordon:

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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Page 2 - Judy Gordon, D.V.M.

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 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/Resourcesfor You/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 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 vours.

Kesia Y. Alexander -A

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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Page 1 of 1

510(k) Number (if known):K143205

Device Name: VISCOELASTIC INJECTOR

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ X

Over-The-Counter Use ____________

(Per 21 CFR 801.109)

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This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

APPLICANT	Sight Sciences, Inc.3000 Sand Hill RoadBuilding 3, Suite 105Menlo Park, CA 94025Tel: (415) 889-0550
OFFICIALCORRESPONDENT	Judy Gordon, D.V.M.ClinReg Consulting Services, Inc.733 Bolsana DriveLaguna Beach, CA 92651judy@clinregconsulting.comTel: (949) 715-0609Fax: (949) 715-0610
TRADE NAME:	Viscoelastic Injector
CLASSIFICATIONNAME:	Pump, Infusion, Ophthalmic
DEVICECLASSIFICATIONAND PRODUCTCODE	Class II per 21 CFR 880.5725, MRH

SUBSTANTIAL EQUIVALENCE:

The modified Sight Sciences Viscoelastic Injector is substantially equivalent to the original Sight Sciences Viscoelastic Injector cleared under K132494. Minor design modifications that improve device manufacturability were made to the reservoir system, priming nozzle, and injection tube. The modified Viscoelastic Injector has the same intended use and basic scientific technology as the original model.

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DESCRIPTION OF THE DEVICE:

Image /page/4/Figure/3 description: The image shows a diagram of The Sight Sciences Viscoelastic Injector. The diagram labels the different parts of the injector, including the cannula, finger wheels, reservoir and plunger tube, locking mechanism, injection tube, and viscoelastic fluid. The viscoelastic fluid is located inside the injection tube. The reservoir and plunger tube are located inside the handle shell.

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INDICATIONS FOR USE:

The Sight Sciences Viscoelastic Injector is a manually operated device for delivery of small amounts of viscoelastic fluid, for example HealonGV or HealonGVTM from Abbott Medical Optics (AMO), Amvisc™ from Bausch & Lomb, or PROVISCTM from Alcon, during ophthalmic surgery.

TECHNICAL CHARACTERISTICS:

The Sight Sciences Viscoelastic Injector consists of the following components and accessories:

Cannula
Injection tube
Internal reservoir
Plunger tube
Finger wheels

The Viscoelastic Injector dispenses fluid on the principle of exchanging volumes much like a syringe. The components responsible for the fluid dispensing are the following:

· The reservoir within the handle is analogous to a syringe plunger. Prior to use, the viscoelastic fluid is loaded into the reservoir.
· The plunger tube is connected to the injection tube and it communicates with the reservoir. During use the plunger tube acts like a graduated cylinder.
· The injection tube, initially located within the cannula, advances and retracts from the device to dispense fluid. The injection tube is analogous to a syringe dispensing-tip.
· The user interfaces with the device by using the finger wheels. This action is analogous to moving the dispensing tip to the desired location and depressing the plunger handle.

PERFORMANCE DATA:

The Viscoelastic Injector's descriptive characteristics are well-defined and adequate to ensure equivalence to the predicate device. Additionally, performance testing was conducted to evaluate device integrity and the delivery of viscoelastic solutions. Acceptance criteria was based on viscoelastic injector dispensing performance, intrinsic strength of the materials, and the load to which the Sight Science Viscoelastic Injector would be subjected during intended use.

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Testing demonstrated that the proposed device performs as intended and is functionally equivalent to the predicate device.

CONCLUSION:

The Sight Sciences Viscoelastic Injector meets all product design requirements and applicable standards and embodies technological characteristics similar to the predicate device, the device has been shown to be substantially equivalent to the predicate device, and is safe and effective.

Regulation Number and Section

§ 880.5725 Infusion pump.

(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).