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 (OD or OS) using either hand.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Sight Sciences Viscoelastic Injector, a medical device for delivering viscoelastic fluid during ophthalmic surgery. While the document mentions performance testing, it does not contain the specific details required to fully answer the request regarding acceptance criteria and the comprehensive study that proves the device meets those criteria.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Device integrity	Testing demonstrated that the proposed device performs as intended.
Delivery of viscoelastic solutions	Testing demonstrated that the proposed device performs as intended.
Simulated use testing	Testing demonstrated that the proposed device performs as intended.
Dimensional and visual inspections	Testing demonstrated that the proposed device performs as intended.
Viscoinjector dispensing performances	Testing demonstrated that the proposed device performs as intended and is functionally equivalent to the predicate device.
Intrinsic strength of the materials	Testing demonstrated that the proposed device performs as intended.
Load to which the Sight Science Viscoelastic Injector would be subjected during intended use	Testing demonstrated that the proposed device performs as intended.

Missing Information: The document states that acceptance criteria were "based on viscoinjector dispensing performances, intrinsic strength of the materials, and the load to which the Sight Science Viscoelastic Injector would be subjected during intended use." However, it does not explicitly state the quantitative or qualitative targets for these criteria (e.g., "dispensing accuracy within X%", "material strength > Y MPa"). The reported performance is a general statement that "testing demonstrated that the proposed device performs as intended and is functionally equivalent to the predicate device," without specific data points to correlate to the acceptance criteria.

2. Sample size used for the test set and the data provenance

Sample size for test set: Not specified.
Data provenance: Not specified (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of experts: Not specified.
Qualifications of experts: Not specified.

4. Adjudication method for the test set

Adjudication method: Not specified.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC study: Not applicable. This device is a manually operated instrument for delivering fluid, not an AI-assisted diagnostic or imaging device used by human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Standalone performance: Not applicable. This is a mechanical device, not an algorithm. Its performance is inherent in its physical and mechanical functions, not in an independent algorithm. The "simulated use testing" would be the closest analogue, but it still involves human interaction, albeit in a controlled test environment.

7. The type of ground truth used

Type of ground truth: Not explicitly stated, but based on the nature of the device (a fluid injector), the "ground truth" would likely be derived from:
- Metrological measurements: Precise measurement of dispensed volumes, flow rates, and consistency.
- Physical properties analysis: Testing material strength, durability, and sterility.
- Functional performance: Observational and quantitative data from simulated use, verifying the device's ability to inject viscoelastic fluid smoothly, accurately, and without issues.

8. The sample size for the training set

Sample size for training set: Not applicable. This is a mechanical device, not an AI model that requires a training set.

9. How the ground truth for the training set was established

Ground truth for training set: Not applicable (as above).

Summary

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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS 4.0

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

APPLICANT:	Sight Sciences. Inc.3169 Sacramento StreetSan Francisco, CA 94115Tel: (415) 889-0550	OCT 2 2 201
CONTACT PERSON:	Judy Gordon, D.V.M.ClinReg Consulting Services. Inc.733 Bolsana DriveLaguna Beach, CA 92651iudy@clinregconsulting.comTel: (949) 715-0609Fax: (949) 715-0610
TRADE NAME:	Viscoelastic Injector
COMMON NAME:	Viscoelastic Injector
CLASSIFICATION NAME:	Pump, Infusion, Ophthalmic
DEVICE CLASSIFICATION:	Class II; 21 CFR 880.5725
PRODUCT CODE:	MRH
PREDICATE DEVICE:	iScience Surgical CorporationViscoInjectorK050716

4.1 DEVICE DESCRIPTION

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

Prior to use, the viscoelastic fluid is loaded into the reservoir (polycarbonate) . contained within the handle.
The reservoir communicates with the plunger tube (stainless steel) which is . connected to the injection tube (polyimide). During use, the plunger tube displaces volume in the reservoir thereby dispensing fluid.
. The injection tube is initially located within the cannula (stainless steel), advances and retracts from the device to dispense fluid. The injection tube is analogous to a syringe dispensing-tip.
. The finger wheels move the injection tube in and out of the cannula tip and drive the plunger tube into the reservoir to dispense viscoelastic fluid in a controlled manner.

4.2 INDICATION FOR USE

The Sight Sciences Viscoclastic 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.

4.3 TECHNOLOGICAL CHARACTERISTICS COMPARISON

The intended use and technical features of the Sight Sciences Viscoelastic Injector are substantially equivalent to the Viscolnjector (K050716) marketed by iScience Surgical. Both devices are manually operated for controlled delivery of small amounts of viscoelastic fluid. Fluid is dispensed from each system on the principle of exchanging volumes much like a syringe. Table 1 compares the attributes of the iScience Viscolnjector with the Sight Sciences Viscoelastic Injector.

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TABLE I
TECHNOLOGICAL CHARACTERISTICS COMPARISON
SIGHT SCIENCES VISCOELASTIC INJECTOR AND THE PREDICATE DEVICE

ATTRIBUTE	SIGHT SCIENCESVISCOELASTIC INJECTOR	ISCIENCE VISCOINJECTORPREDICATE DEVICE
Sterile & Single-Use	Yes	Yes
Operation Control	User	User
Ergonomics	Distally-positioned deliverywheel	Proximally-positioned delivery wheel
Passive or EnergizedDevice	Passive	Passive
Reservoir	Internal and Integral Reservoir	Commercial Viscoelastic Cartridge
Dispensing Mechanism	Syringe (Volume Exchange)	Syringe (Volume Exchange)
User Determines Amountof fluid to Dispense	Yes, by rotating the distalfinger wheel	Yes, by rotating the proximal knob

4.4 BRIEF SUMMARY OF PERFORMANCE TEST RESULTS

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

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

ને રે CONCLUSION

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/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 symbol that resembles a caduceus, a traditional symbol of medicine, but with three wavy lines instead of snakes.

Public Health Service

October 22, 2013

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

Sight Sciences, Inc. % Judy F. Gordon, D.V.M ClinReg Consulting Services, Inc. 733 Bolsana Drive Laguna Beach, CA 92651

Re: K132494

Trade/Device Name: Sight Sciences Viscoelastic Injector Regulation Number: 21 CFR 880.5725 Regulation Name: Pump, Infusion, Ophthalmic Regulatory Class: Class II Product Code: MRH Dated: August 19, 2013 Received: August 20, 2013

Dear Dr. Gordon:

We have reviewed vour 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 gencral 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. 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.

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Page 2 – Dr. Judy F. Gordon

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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Indications for Use

510(k) Number: K132494

Device Name: Viscoelastic Injector

Indications For Use:

Prescription Use X (part 21 CFR 801 Subpart D)

AND/OR

· Over-The-Counter Use (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)

Daniel P. Fedorko 2013.10.16 14:12:59 -04'00'

(Division Sign-Off) Division of Ophthalmic and Ear. Nose, and Throat Devices 510(k) Number:_

Page 1 of

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).