The Synergetics VersaVit is an ophthalmic microsurgical system that is indicated for posterior segment (i.e. vitreoretinal) ophthalmic surgery. The integrated light source is intended to illuminate the eye during vitreoretinal procedures.

Device Description

The VersaVit is a compact, stand-alone, portable device with a pneumatic vitrector drive, aspiration, and illumination through an imbedded solid state LED light source.

AI/ML Overview

The provided document is a 510(k) summary for the Synergetics VersaVit, a vitreous aspiration and cutting instrument. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data with acceptance criteria and device performance metrics.

Based on the information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in the format typically seen for clinical trials. Instead, it states that the device "has undergone testing and is in compliance with the applicable requirements of safety standards." and was "found to perform equivalently to the predicate device in a series of bench tests."

Element	Synergetics VersaVit (Subject Device Performance)	Predicate Device (Alcon Accurus, K911808)	Acceptance Criteria (Implied Equivalence)
Intended Use	Posterior Segment Vitrectomies	Anterior and Posterior Segment Ophthalmic Surgery	Substantially Equivalent (for posterior segment)
Microprocessor based	Yes	Yes	Equivalent
Aspiration Pump Type	Diaphragm	Venturi	Sufficient for intended use, functionally equivalent
Operating Pressure	72.5 - 120 PSI	70 - 120 PSI	Within acceptable/equivalent range
Pneumatic Source	Compressed Air, CO2 cartridges	Compressed Air	Functionally equivalent methods
Unit Height x Weight x Depth	10" x 13" x 11"	20" x 19" x 20.5"	Differences allowed if not impacting safety/effectiveness
Unit weight	25 pounds	90 pounds	Differences allowed if not impacting safety/effectiveness
Electrical power specifications	100-120V, 220-240V, 50/60 Hz	100-120V, 220-240V, 50/60 Hz	Equivalent
Consumable Packs provided sterile	Yes	Yes	Equivalent
Consumable Packs method of sterilization	ETO	ETO	Equivalent
Consumable Packs Sterility Assurance Level	10-6	10-6	Equivalent

The "acceptance criteria" here are largely implied to be "substantially equivalent" or "functionally equivalent" to the predicate device for parameters where direct identical values are not present, or "compliant with applicable safety standards" for overall performance.

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

The document mentions "a series of bench tests" and "internal comparative bench testing" but does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective) for these tests. This is typical for a 510(k) application relying on bench testing for equivalence, rather than clinical studies with human subjects.

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

This information is not provided because the submission primarily relies on bench testing and comparison to an existing predicate device rather than human-read image interpretation or diagnostic performance that would require expert-established ground truth.

4. Adjudication method for the test set:

Not applicable, as the document describes bench testing and not a study requiring adjudication of human interpretations or diagnoses.

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:

Not applicable. The document describes a medical device (vitreous aspiration and cutting instrument) and not an AI/CAD system for image interpretation or diagnosis. Therefore, an MRMC study related to human reader improvement with AI assistance would not be relevant.

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

Not applicable. This is not an AI algorithm. The device is a surgical instrument.

7. The type of ground truth used:

For bench testing, the "ground truth" would typically refer to established engineering specifications, performance standards, or known performance characteristics of the predicate device against which the subject device's performance is measured. The document states compliance with "applicable requirements of safety standards" and equivalence to the predicate device's performance.

8. The sample size for the training set:

Not applicable, as this is a medical device and not an AI/machine learning model that requires a training set.

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

Not applicable, as this is a medical device and not an AI/machine learning model.

Summary

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Image /page/0/Picture/1 description: The image shows the word "Synergetics" in bold, black font. To the left of the word is a right-pointing arrow. To the right of the word is the letters "TM" in a smaller font, indicating a trademark.

JUN 2 1 2012

Section 5 510 (k) Summary

Submitted in accordance with the requirements of 21 CFR 807.92

Applicant's Name and Address:	Synergetics3845 Corporate Centre DriveO'Fallon, MO 63368
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Contact Person:

Dan Regan, RA Director (T) 636-794-5013 (F) 636-939-6885

Date Prepared: June 21, 2012

Device Trade Name: VersaVit

Common Name: Vitreous Aspiration and Cutting

Regulation Number: 21 CFR 886.4150

Regulation Name: Vitreous Aspiration and Cutting Instrument

Regulatory Class: Class II

Product Code: HQE

FDA Panel: Ophthalmic

Predicate Device: Alcon Accurus, K911808

Device Description . The VersaVit is a compact, stand-alone, portable device Summary: with a pneumatic vitrector drive, aspiration, and illumination through an imbedded solid´state LED light source.

The Synergetics VersaVit is an ophthalmic microsurgical Indications for Use: system that is indicated for posterior segment (i.e. vitreoretinal) ophthalmic surgery. The integrated light

Page 1 of 4

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Image /page/1/Picture/0 description: The image contains the logo for "Synergetics". The logo consists of a geometric shape resembling a diamond made up of smaller squares on the left, followed by the word "Synergetics" in a bold, sans-serif font. There is a superscript "TM" symbol to the right of the word.

Section 5 510 (k) Summary

Submitted in accordance with the requirements of 21 CFR 807.92

source is intended to illuminate the eve during vitreoretinal procedures.

Technological characteristics:

Summary of The Synergetics VersaVit is equivalent to the predicate device, the Alcon Accurus in terms of its intended use, technological characteristics, energy used, materials, and FDA-recognized standards used for performance testing.

The subject device includes 1) a console for controlling the functions and for powering the device; 2) consumable convenience packs, which include fluid aspiration drainage bags; and 3) a control accessory (foot pedal).

A comparison matrix is included below.

Summary of Non-

The VersaVit has undergone testing and is clinical tests: in compliance with the applicable requirements of safety standards. The subject device was found to perform equivalently to the predicate device in a series of bench tests. Therefore, the subject device and the predicate device have similar safety, effectiveness, and performance profiles.

Substantial Equivalence Basis:

The conclusions performed by independent laboratories and internal comparative bench testing provide objective evidence to substantiate the Synergetics VersaVit is as safe and effective as the predicate device, the Alcon Accurus.

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Image /page/2/Picture/0 description: The image shows the word "Synergetics" in a bold, sans-serif font. To the left of the word is a geometric shape that looks like a diamond made up of smaller squares and triangles. The letters are black, and the geometric shape is white with black outlines. The trademark symbol is located at the top right of the word.

Section 5 510 (k) Summary.

Submitted in accordance with the requirements of 21 CFR 807.92

Element	Synergetics VersaVit(Subject Device)	Alcon Accurus(Predicate DeviceK911808)
Intended Use	Posterior SegmentVitrectomies	Anterior and PosteriorSegment OphthalmicSurgery
Microprocessor based	Yes	Yes
Aspiration Pump Type	Diaphragm	Venturi
Operating Pressure	72.5 - 120 PSI	70 - 120 PSI
Pneumatic Source	Compressed AirCO2 cartridges	Compressed Air
Unit Height x Weight xDepth	10" x 13" x 11"	20" x 19" x 20.5"
Unit weight	25 pounds	90 pounds
Electrical powerspecifications	100-120V220-240V50/60 Hz	100-120V220-240V50/60 Hz
Consumable Packsprovided sterile	Yes	Yes
Consumable Packsmethod of sterilization	ETO	ETO

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Image /page/3/Picture/0 description: The image shows the logo for "Synergetics™". The logo consists of a geometric shape resembling a diamond made up of smaller squares on the left, followed by the word "Synergetics" in a bold, sans-serif font. The letters are closely spaced, and the "TM" symbol is placed as a superscript to the right of the word.

Section 5

510 (k) Summary

Submitted in accordance with the requirements of 21 CFR 807.92

Comparison of Technical Characteristics
Element	Synergetics VersaVit(Subject Device)	Alcon Accurus(Predicate DeviceK911808)
Consumable PacksSterility AssuranceLevel	10-6	10-6

Quality Management System:

Synergetics is an ISO 13485 compliant company and is required to ensure our quality management system and design control practices fully comply with internal quality system standards and domestic regulations. Pursuant to our design control process, Synergetics has established a risk management process that ensures during the design validation phase, the safety and effectiveness of the device meets applicable input requirements and complies with applicable harmonized standards.

Risk Management:

Risk Management has been implemented and complies with ISO 14971, Medical Devices - Application of Risk Management to Medical Devices and GHTF/SGS/N15R8, Implementation of Risk Management Principles and Activities within a Quality Management System.

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

JUN 2 1 2012

Synergetics c/o Mr. Ned Devine Underwriters Laboratories, Inc. 333 Pfingsten Road Northbrook, IL 60062

Re: K121675

Trade Name: Versa Vit Regulation Number: 21 CFR 886.4150 Regulation Name: Vitreous aspiration and cutting instrument Regulatory Class: Class II Product Code: HOE Dated: June 5, 2012 Received: June 6, 2012

Dear Mr. Devine:

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. 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

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Page 2 -- Mr. Ned Devine

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,
Kesia Alexander

Malvina B. Eydelman, M.D. Director Division of Ophthalmic. Neurological 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): K121675

Device Name: Synergetics VersaVit

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)

(Division Sign-Off)

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K121675

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Regulation Number and Section

§ 886.4150 Vitreous aspiration and cutting instrument.

(a)
Identification. A vitreous aspiration and cutting instrument is an electrically powered device, which may use ultrasound, intended to remove vitreous matter from the vitreous cavity or remove a crystalline lens.(b)
Classification. Class II (special controls). The device, when it is phacofragmentation unit replacement tubing, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.