PROCARE PLUS VITRECTOMY SYSTEM

K120170 · Visioncare Devices, Inc. · HQE · May 30, 2012 · Ophthalmic

Device Facts

• Record ID: K120170
• Device Name: PROCARE PLUS VITRECTOMY SYSTEM
• Applicant: Visioncare Devices, Inc.
• Product Code: HQE · Ophthalmic
• Decision Date: May 30, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ProCare Plus™ Vitrectomy System is a portable surgical system intended for use in both anterior and posterior segment (vitrectomy) ophthalmic surgeries.

Device Story

ProCare Plus Vitrectomy System is a portable, AC/battery-powered surgical system for anterior and posterior segment ophthalmic surgeries. Operated by a surgeon via a multifunction footswitch, the system provides vitreous cutting, aspiration, illumination, and fluid-air exchange. It utilizes a pneumatic guillotine-style cutter and an electrical aspiration pump. The system includes an HB LED light source for internal illumination and provides air pressure for intraocular pressure maintenance. The device is used in clinical settings to assist surgeons in removing vitreous, lens fragments, or foreign bodies, and managing retinal detachments or vitreous loss. By providing precise control over cutting and aspiration, the system facilitates complex ophthalmic procedures, potentially improving surgical outcomes and patient recovery.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), photobiological safety (IEC 62471, EN ISO 15004-2), sterilization validation (ISO 11137-1/2, ISO 11737-1/2), and packaging (ISO 11607-1). In-house performance testing verified pneumatic cutting, aspiration, light source output, and battery performance.

Technological Characteristics

Portable AC/Li-Ion battery-powered system. Pneumatic guillotine cutter (max 3000 cuts/min). Electrical aspiration (max 400 mmHg). HB LED light source. Air infusion (max 95 mmHg). Multifunction footswitch control. Sterilization via radiation (ISO 11137). Non-computer-based system.

Indications for Use

Indicated for ophthalmic surgical procedures including removal of vitreous (clouding, hemorrhage, trauma, foreign bodies, inflammation, endophthalmitis, uveitis), removal of lens fragments post-cataract surgery, removal of vitreous traction for retinal detachment, diagnostic vitreous sampling, treatment of vitreous loss, cleaning vitreous strands from cataract wounds, internal illumination, and air pressure maintenance for intraocular pressure.

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

• Syntec Vitman (K980480)
• YPR 2001 (K904909)
• Intrector (K896622)

Submission Summary (Full Text)

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MAY 3 0 2012

Image /page/0/Picture/1 description: The image shows a logo with the text "VISIONCARE DEVICES" at the bottom. Above the text, there are three mountain-like shapes with the letters "VCD" in between. At the top of the image, there is a handwritten number "K120170".

1246 Redwood Blvd.
Redding, California 96001 [phone]

| 5 | 510(K) Summary | |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 5.1 | Date Prepared: | 1/13/2012 |
| 5.2 | 510(K) Submission<br>Type: | This is a traditional 510(K) |
| 5.3 | Submitter/Owner: | VisionCare Devices, Inc.<br>FDA #2939964<br>1246 Redwood Boulevard<br>Redding, California 96003<br>[phone] Phone<br>[phone] Fax |
| 5.4 | Key Contacts: | Kurtis Montegna<br>Regulatory Affairs Manager<br>[e-mail]<br>Susan Cook<br>General Manger<br>[e-mail] |
| 5.5 | Trade Name | ProCare PlusTM Vitrectomy System |
| 5.6 | Common Name | Vitrectomy System |
| 5.7 | Classification Name: | 886.4150 Vitreous Aspiration and cutting instrument.<br>Product Codes (HQE) |
| 5.8 | Predicate Devices | K980480 - Syntec Vitman - HQC (Primary Predicate Device)<br>K904909 - YPR 2001 - HQE (Secondary Predicate Device)<br>K896622 - Intrector - HKP (Secondary Predicate Device) |
| 5.9 | Device Description | The ProCare PlusTM Vitrectomy System is a portable surgical system intended for use in both |
| 5.10 System Power | The ProCare Plus™ Vitrectomy System is an AC powered<br>device with an internal Li-Ion battery that provides backup<br>power in the event that AC power is interrupted. | |
| 5.11 System Control | The system is primarily run from one multifunction<br>footswitch which gives the surgeon control over all of the<br>surgical functions. | |
| 5.12 System Functions | The ProCare Plus Vitrectomy system provides many of<br>the functions required by the ophthalmic surgeon for<br>performing a vitrectomy including vitreous cutting and<br>aspiration, illumination, and fluid-air exchange. | |
| 5.13 Intended Use: | The ProCare Plus™ Vitrectomy System is a portable<br>surgical system intended for use in both anterior and<br>posterior segment (vitrectomy) ophthalmic surgeries. | |
| 5.14 Indications for Use: | The PROCARE PLUS™ Vitrectomy System is indicated<br>for use in support of the following ophthalmic surgical<br>procedures: | |
| | Removal of vitreous in cases of vitreous clouding, diabetic vitreal<br>hemorrhaging, trauma, including contusions, penetrations, and<br>intraocular foreign bodies; opacity, inflammation, endophthalmitis<br>(bacterial or fungal), uvitis | |
| | Removal of lens fragments after cataract surgery; | |
| | Remove vitreous traction under the retina producing<br>localized or complete retinal detachment; | |
| | Removal of samples of vitreous for diagnostic purposes, i.e.<br>endophthalmitis; | |
| | Treatment of vitreous loss during cataract surgery; | |
| | Clean vitreous strands from the cataract wound; | |
| | Provide internal illumination for vitreous surgery; | |
| | Provide air pressure for maintaining intraocular pressure for<br>retinal surgery. | |
| | Identical to predicate devices | |

anterior and posterior segment (vitrectomy) ophthalmic surgeries.

VisionCare Devices, Inc. FDA Device Registration Number 2939964 [phone], [e-mail], [e-mail]

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Image /page/1/Picture/0 description: The image shows a logo for VisionCare Devices. The logo includes three mountain peaks above the letters V, C, and D. Above the logo is the number K120170.

1246 Redwood Blvd.
Redding, California 96001
[phone]

.

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Image /page/2/Picture/0 description: The image shows a logo for VisionCare Devices. The logo features the letters "VCD" in a stylized font, with a mountain range above the letters. Below the letters is the text "VisionCare Devices" in a smaller font.

[phone]

| | Current<br>Submission | Primary Predicate | Secondary Predicates | |
|-------------------------------------|---------------------------------------------|---------------------------------------------|---------------------------------------------|---------------------------------------------|
| | ProCare Plus | Vitman | YPR 2001 | Intrector |
| <b>510(K) Number</b> | | K980480 | K904909 | K896622 |
| <b>Intended Use</b> | Anterior/Posterior<br>Ophthalmic<br>Surgery | Anterior/Posterior<br>Ophthalmic<br>Surgery | Anterior/Posterior<br>Ophthalmic<br>Surgery | Anterior/Posterior<br>Ophthalmic<br>Surgery |
| <b>Computer Based System</b> | No | No | No | No |
| <b>Vitrectomy</b> | | | | |
| Type: | Guillotine | Guillotine | Guillotine | Guillotine |
| Drive Mechanism: | Pneumatic. | Pneumatic | Pneumatic | Pneumatic |
| Maximum Cut Rate: | 3000 cuts/minute | 2000 cuts/minute | 1200 cuts/minute | 1200 cuts/minute |
| <b>Irrigation/Aspiration</b> | Yes | Yes | Yes | Yes |
| Aspiration Type | Electrical | Venturi | Venturi | Syringe |
| Linear Control: | Yes | Yes | Yes | Yes |
| Maximum Vacuum: | 400 mmHg | 400 mmHg | 400 mmHg | Unknown |
| <b>Phacofragmentation</b> | No | Yes | No | No |
| <b>Diathermy</b> | No | No | No | No |
| <b>Fiber Optic Light<br/>Source</b> | Yes | Yes | Yes | No |
| Dual/single output: | Single | Dual | Single | NA |
| Lamp Type: | HB LED | Halogen | Halogen | NA |
| <b>Air Infusion</b> | Yes | Yes | Yes | No |
| Maximum Pressure: | 95 mmHg | 95 mmHg | 95 mmHg | NA |
| <b>Multifunction<br/>Footswitch</b> | Yes | Yes | Yes | No |
| <b>Power</b> | | | | |
| AC Power: | Yes | Yes | Yes | Yes |
| Battery: | Yes | Yes | No | Yes |

### Table 1- Predicate Device Comparison Table

. :

・

VisionCare Devices, Inc. FDA Device Registration Number 2939964 [phone], [e-mail], [e-mail]

:

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Image /page/3/Picture/0 description: The image shows a logo for VisionCare Devices. The logo includes the text "VISIONCARE DEVICES" in a stylized font. Above the text, there is an image of mountains with the letters "VCD" in the foreground and the number "K120170" above the mountains.

1246 Redwood Blvd. Redding, California 96001 [phone]

| 5.15 Substantial Equivalence Summary - Differences | | |
|----------------------------------------------------|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate Device(s) | ProCare Plus Vitrectomy<br>System difference | Summary |
| Venturi Vacuum<br>Syringe Vacuum | On-board vacuum pump | The on-board vacuum pump produces the<br>same vacuum characteristics and<br>pressures as both the venturi and manual<br>syringe vacuum systems. The vacuum<br>pump is substantially equivalent to the<br>predicate device. |
| Halogen Lamps | LED | Halogen lamps have been replaced with a<br>LED lamp that significantly reduces heat<br>and significantly reduces "Blue Light<br>Toxicity". LED tested to harmonized<br>standards and is substantially equivalent to<br>the predicate device. |
| Ni-Cd Battery | Li-Ion Battery | The Syntec Vitman contained a Ni-Cd<br>battery that allows 10 minutes of<br>operational backup power. The ProCare<br>Plus™ Vitrectomy System contains a Li-Ion<br>battery that provides operational power for<br>up to 8 hours. Batteries are rechargeable<br>and substantially equivalent to the<br>predicate device. |

Operational and technological characteristics form the basis for the determination of substantial equivalence of the ProCare Plus Vitrectomy System with legally marketed predicate devices.

VisionCare Devices, Inc. FDA Device Registration Number 2939964 [phone], [e-mail], [e-mail]

5-4

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Image /page/4/Picture/0 description: The image shows the text "K120/70" at the top. Below that is a logo with three mountain peaks and the letters "VCD" in a stylized font. Underneath the logo, the words "VISIONCARE DEVICES" are printed in capital letters. The last line of text is illegible.

[phone]

.

#### 5.16 Non-Clinical Tests

The ProCare Plus Vitrectorny System has passed all safety tests for demonstrated compliance with the applicable non-clinical tests below:

| Standard/Guideline | Title |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1 | Medical equipment/medical electrical equipment - Part 1: General<br>requirements for basic safety and essential performance |
| IEC 60601-1-2 | Medical Electrical Equipment - Part 1: General requirements for safety<br>to collateral Standard: Electromagnetic Compatibility requirements and<br>tests. |
| EN ISO 15004-2 | Ophthalmic instruments - Fundamental requirements and test<br>methods -- Part 2: Light hazard protection |
| ISO 11137-1 | Sterilization of Health Care Product Requirements for Validation and<br>Routine Control-Radiation Sterilization |
| ISO 11137-2 | Sterilization of health care products-Radiation-Part 2: Establishing<br>the sterilization dose. |
| ISO 11737-1 | Sterilization of medical devices-Microbiological methods-Part 1:<br>Determination of a population of microorganisms on products. |
| ISO 11737-2 | Sterilization of medical devices-Microbiological methods-Part 2:<br>Tests of sterility performed in the definition, validation and<br>maintenance of a sterilization process. |
| ISO 11607-1 | Packaging for Terminally Sterilized Medical Devices |
| IEC 62471 | Photobiological Safety of lamps and lamp systems |

VisionCare Devices, Inc. FDA Device Registration Number 2939964 [phone], [e-mail], [e-mail]

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Image /page/5/Picture/0 description: The image shows the logo for VisionCare Devices. The logo includes the text "VisionCare Devices" in a stylized font. Above the text is an image of three mountain peaks with the letters V, C, and D in front of each peak. Above the logo is the text "R120170" in a cursive font.

1246 Redwood Blvd. Redding, California 96001 [phone]

| In-House Testing | Title |
|------------------|----------------------------------------|
| P1-112411 | Main AC Electrical System |
| P1-112511 | Internal DC Electrical System |
| P1-112611 | Pneumatic Cutting System |
| P1-112711 | Pneumatic Air Exchange System |
| P1-112811 | Vacuum System |
| P1-112911 | Lightsource |
| P1-113011 | Battery Performance Testing |
| P1-113111 | Pneumatic Handpiece Testing |
| P1-113211 | Ergonomics/Portable System Testing |
| P1-113311 | Medical Air Gas Cylinders & Regulators |
| FP1-113411 | Foot Control |
| P1-051112 | Pneumatic Handpiece HSP Burst Testing |

#### 5.17 Summary of Non-Clinical Tests

Updated technology has been extensively tested to recognized standards. The technological characteristics affecting the performance of the system are substantially equivalent to those of the predicate devices previously listed.

The ProCare Plus Vitrectorny System will be manufactured in compliance with FDA and ISO quality system requirements. System validation and verification will demonstrate that the functional requirements and system specifications have been met prior to commercial release.

Based upon the design, intended use, indications for use, classification, and safety testing the ProCare Plus Vitrectomy System is substantially equivalent, in whole or part, to the listed predicate devices (K980480, K904909, and K896622).

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The logo is black and white.

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

VisionCare Devices, Inc. c/o Mr. Kurtis Montegna Regulatory Affairs Manager 1246 Redwood Blvd. Redding, CA 96003

MAY 3 0 2012

Re: K120170

Trade/Device Name: ProCare Plus Vitrectomy System Regulation Number: 21 CFR 886.4150 Regulation Name: Vitreous aspiration and cutting instrument Regulatory Class: II Product Code: HQE Dated: Not Dated Received: May 18, 2012

Dear Mr. Montegna:

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 todevices 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

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### Page 2 - Mr. Kurtis Montegna

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/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

Enclosures

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# Indications for Use

510(K) Number (if known): K120170

Device Name: ProCare Plus Vitrectomy System

Indications For Use:

The VCD HSP VitCutter and Accessories is a single use (disposable) product intended for use in both anterior and posterior segment (vitrectomy) ophthalmic surgeries when used with a pneumatically-driven vitrectomy system or phacoemulsification system that has a pneumaticallydriven vitrectomy module.

Prescription use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (Part 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

15120170
510(k) Number

Page 1 of 2

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## Indications for Use

510(K) Number (if known): K120170

Device Name: ProCare Plus Vitrectomy System

Indications For Use:

The PROCARE PLUS™ Vitrectorny System is indicated for use in support of the following ophthalmic surgical procedures:

Removal of vitreous in cases of vitreous clouding, diabetic vitreal hemorrhaging, trauma, including contusions, penetrations, and intraocular foreign bodies; opacity, inflammation, endophthalmitis (bacterial or fungal), uvitis

- Removal of lens fragments after cataract surgery; .
- Remove vitreous traction under the retina producing localized or complete retinal detachment; .
- Removal of samples of vitreous for diagnostic purposes, i.e. endophthalmitis; t
- � Treatment of vitreous loss during cataract surgery;
- . Clean vitreous strands from the cataract wound;
- Provide internal illumination for vitreous surgery; ●
- Provide air pressure for maintaining intraocular pressure for retinal surgery. �

AND/OR Prescription use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (Part 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 K120170

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