D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEM

K983797 · Dutch Ophthalmic USA, Inc. · HQE · Mar 3, 1999 · Ophthalmic

Device Facts

• Record ID: K983797
• Device Name: D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEM
• Applicant: Dutch Ophthalmic USA, Inc.
• Product Code: HQE · Ophthalmic
• Decision Date: Mar 3, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The D.O.R.C. Harmony Total vitrectomy system is a surgical system for ophthalmic surgery intended for use in surgery of the posterior segment (vitrectomy).

Device Story

D.O.R.C. Harmony Total Vitrectomy System is an integrated surgical platform for posterior segment eye surgery. System components include main unit, multifunction footswitch, trolley, and automatic infusion pole. Device provides vitreous cutting (guillotine cutter), aspiration (venturi), phacofragmentation (40 kHz), illumination (dual halogen light source), diathermy (13.56 MHz), air infusion, and viscous fluid injection/extraction. Operated by ophthalmic surgeon via multifunction footswitch. System is AC powered and requires medical grade compressed air. Provides surgeon control over surgical functions to perform vitrectomy; benefits include consolidated surgical capabilities in one system.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological and operational characteristics compared to legally marketed predicate devices.

Technological Characteristics

Integrated vitrectomy system; pneumatic or electric guillotine cutter; venturi aspiration; 40 kHz phacofragmentation; 13.56 MHz diathermy; dual halogen fiber optic light source; air infusion; viscous fluid injection/extraction. Multifunction footswitch control. AC powered with compressed air requirement. Non-computer based system.

Indications for Use

Indicated for patients undergoing posterior segment ophthalmic surgery (vitrectomy).

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 Surgical Accurus (unknown)
• Storz Millenium (K961310)
• MID Labs SupraVit/VitMate (K932669/K924222)
• Scieran Vit Commander (K961738)

Submission Summary (Full Text)

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3/3/99

K983797

510(k) Summary Dutch Ophthalmic, USA D.O.R.C. Harmony Total (per 21 CFR 807.92)

#### SUBMITTER NAME AND ADDRESS 1.

Dutch Ophthalmic, USA One Little River Road P.O. Box 968 Kingston, NH 03848

| Contact Person: | Mark W. Furlong, President |
|-----------------|----------------------------|
| | Telephone: [phone] |

Date Prepared: October 26, 1998

# 2. DEVICE NAME

| Proprietary Name: | D.O.R.C. Harmony Total Vitrectomy System |
|----------------------|------------------------------------------|
| Common/Usual Name: | Vitrectomy System |
| Classification Name: | Vitreous Aspiration & Cutting Instrument |
| | (86HOE & 21CFR 886.4150) |

#### 3. PREDICATE DEVICE/S

| Manufacturer | Product Name | 510(k) Number |
|----------------|------------------|-----------------|
| Alcon Surgical | Accurus | unknown |
| Storz | Millenium | K961310 |
| MID Labs | SupraVit/VitMate | K932669/K924222 |
| Scieran | Vit Commander | K961738 |

# 4. DEVICE DESCRIPTION

The D.O.R.C. Harmony Total Vitrectomy System is an integrated system for posterior segment eye surgery. It provides the majority of functions required by the ophthalmic

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surgeon for performing a vitrectomy including vitreous cutting and aspiration, phacofragmentation, illumination, diathermy, air system and viscous fluid injection/extraction. The system is operated from one multifunction footswitch which gives the surgeon control over all of the surgical functions.

The D.O.R.C. Harmony Total Vitrectomy System which includes the system, multifunction footswitch, trolley, automatic infusion pole and various sterile and non-sterile accessories provides the majority of functions needed to complete a posterior segment vitrectomy. The system is ac powered and also requires a source of medical grade compressed air to provide for some of the system functions.

#### న. INTENDED USE

The D.O.R.C. Harmony Total Vitrectomy System is a surgical system for ophthalmic surgery intended for use in surgery of the posterior segment (vitrectomy).

# BASIS FOR SUBSTANTIAL EQUIVALENCE 6.

Operational and technological characteristics form the basis for the determination of substantial equivalence of the D.O.R.C. Harmony Total with legally marketed predicate devices. Information supplied in this premarket notification includes descriptive information about the intended use, operation and technological characteristics. The following table summarizes the technological characteristics of the D.O.R.C. Harmony Total in comparison to the predicate devices.

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| | D.O.R.C. Harmony<br>Total | Alcon Surgical<br>Accurus | Storz Millenium | MID Labs<br>SupraVit/VitMate<br>Vitreoretinal<br>System | Scieran<br>Technologies<br>Vit Commander |
|--------------------------|-----------------------------------------|----------------------------------------------|-----------------------------------------|---------------------------------------------------------|------------------------------------------|
| 510(k) number | current submission | unknown | K961310 | K932669/K24222 | K961738 |
| Intended Use | Posterior segment<br>ophthalmic surgery | Posterior segment<br>ophthalmic surgery | Posterior segment<br>ophthalmic surgery | Posterior segment<br>ophthalmic surgery | Posterior segment<br>ophthalmic surgery |
| Features/Specifications | | | | | |
| Computer Based System | NO | YES | YES | unknown | unknown |
| Vitrectomy | YES | YES | YES | YES | YES |
| type: | guillotine cutter | guillotine or radial<br>reciprocating cutter | guillotine cutter | guillotine cutter | guillotine cutter |
| drive mechanism: | pneumatic or electric | pneumatic<br>800 or 1200<br>cuts/minute | pneumatic | pneumatic | electric |
| maximum cut rate | 800 cuts/minute | | 750 cuts/minute | 800 cuts/minute | 2500 cuts/minute |
| Irrigation/Aspiration | YES | YES | YES | YES | YES |
| aspiration type: | venturi | venturi | venturi | unknown | unknown |
| linear control: | YES | YES | YES | YES | YES |
| maximum vacuum: | 500 mm Hg | 600 mm Hg | 550 mm Hg | 500 mm Hg | 600 mm Hg |
| Phacofragmentation | YES | YES | YES | YES | NO |
| frequency: | 40 kHz | 40 kHz | 28.5 khz | 40 khz | |
| Diathermy | YES | YES | YES | YES | YES |
| frequency: | 13.56 MHz | unknown | unknown | 600 khz | unknown |
| maximum power: | 12 watts | unknown | 7.5 watts | 10 watts | unknown |
| Fiber Optic Light Source | YES | YES | YES | YES | NO |
| dual/single output: | dual | dual | dual | dual | |
| lamp type: | halogen | unknown | unknown | unknown | |
| lamp wattage: | 150 watts | unknown | unknown | unknown | |
| Air Infusion | YES | YES | YES | YES | NO |
| maximum pressure: | 95 mm Hg | 120 mm Hg | 100 mm Hg | 99 mm Hg | |
| Viscous Fluid Injection | YES | YES | NO | NO | NO |
| viscosities: | 1000 or 5000 cs | 1000 or 5000 cs | | | |
| Viscous Fluid Extraction | YES | YES | NO | NO | NO |
| Multifunction Footswitch | YES | YES | YES | YES | YES |

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged around the caduceus in a circular fashion. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 3 1999

Mr. Mark W. Furlong President Dutch Ophthalmic, USA One Little River Road P.O. Box 968 Kingston, NH 03848

Re: K983797

Trade Name: D.O.R.C. Harmony Total Vitrectomy System Regulatory Class: II Product Code: HQE Dated: February 17, 1999 Received: February 24, 1999

Dear Mr. Furlong:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .

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# Page 2 -Mr. Mark W. Furlong, President

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a Iegally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

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. .. .

The D.O.R.C. Harmony Total vitrectomy system is a surgical system for ophthalmic surgery intended for use in surgery of the posterior segment (vitrectomy).

:

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off)

(Division Sign-Off) Division of Ophthalmic Device 510(k) Number.

Prescription Use
(Per 21 CFR 801.109) ✓

Over-The-Counter Use_