VERSAVIT

K121675 · Synergetics, Inc. · HQE · Jun 21, 2012 · Ophthalmic

Device Facts

• Record ID: K121675
• Device Name: VERSAVIT
• Applicant: Synergetics, Inc.
• Product Code: HQE · Ophthalmic
• Decision Date: Jun 21, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4150
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

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 Story

VersaVit is a compact, portable, microprocessor-based ophthalmic microsurgical system; used in clinical settings for posterior segment (vitreoretinal) surgery. Device features pneumatic vitrector drive, fluid aspiration, and integrated solid-state LED illumination. Inputs include compressed air or CO2 cartridges for pneumatic power; operator controls via foot pedal. System transforms pneumatic energy into mechanical cutting and aspiration actions; provides illumination for surgical visualization. Output consists of controlled vitreous cutting and aspiration, and eye illumination. Physician operates device to perform vitrectomy; output allows surgeon to remove vitreous humor and visualize surgical field. Benefits include portability and compact form factor compared to traditional larger surgical consoles.

Clinical Evidence

Bench testing only. No clinical data presented. Subject device performed equivalently to the predicate device in a series of bench tests confirming safety and effectiveness profiles.

Technological Characteristics

Microprocessor-based console; pneumatic vitrector drive; diaphragm aspiration pump; solid-state LED light source. Dimensions: 10" x 13" x 11"; weight: 25 lbs. Power: 100-120V/220-240V, 50/60 Hz. Pneumatic source: compressed air or CO2 cartridges. Consumables: sterile, ETO-sterilized. Compliance: ISO 13485, ISO 14971.

Indications for Use

Indicated for patients undergoing posterior segment (vitreoretinal) ophthalmic surgery requiring vitreous aspiration, cutting, and illumination.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Alcon Accurus (K911808)

Submission Summary (Full Text)

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21675

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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: | Synergetics<br>3845 Corporate Centre Drive<br>O'Fallon, MO 63368 |
|-------------------------------|------------------------------------------------------------------|
|-------------------------------|------------------------------------------------------------------|

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

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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<br>(Subject Device) | Alcon Accurus<br>(Predicate Device<br>K911808) |
|---------------------------------------------|------------------------------------------|---------------------------------------------------------|
| Intended Use | Posterior Segment<br>Vitrectomies | Anterior and Posterior<br>Segment Ophthalmic<br>Surgery |
| Microprocessor based | Yes | Yes |
| Aspiration Pump Type | Diaphragm | Venturi |
| Operating Pressure | 72.5 - 120 PSI | 70 - 120 PSI |
| Pneumatic Source | Compressed Air<br>CO2 cartridges | Compressed Air |
| Unit Height x Weight x<br>Depth | 10" x 13" x 11" | 20" x 19" x 20.5" |
| Unit weight | 25 pounds | 90 pounds |
| Electrical power<br>specifications | 100-120V<br>220-240V<br>50/60 Hz | 100-120V<br>220-240V<br>50/60 Hz |
| Consumable Packs<br>provided sterile | Yes | Yes |
| Consumable Packs<br>method 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<br>(Subject Device) | Alcon Accurus<br>(Predicate Device<br>K911808) |
| Consumable Packs<br>Sterility Assurance<br>Level | 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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Image /page/4/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in bold, uppercase letters. The text is black and appears to be printed on a white background. The words are evenly spaced and aligned horizontally.

Image /page/4/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" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.

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 [phone] or [phone] 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:

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.

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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