BENJAMIN ENVOY PHACO HANDPIECE

K022833 · Benjamin Biomedical, Inc. · HQC · Sep 9, 2002 · Ophthalmic

Device Facts

• Record ID: K022833
• Device Name: BENJAMIN ENVOY PHACO HANDPIECE
• Applicant: Benjamin Biomedical, Inc.
• Product Code: HQC · Ophthalmic
• Decision Date: Sep 9, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4670
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

As an accessory for the Storz Premiere phacoemulsification system, the Benjamin ENVOY Hand Piece intended for use in cataract surgery to breakup, emulsify and extract the cataract.

Device Story

Benjamin ENVOY Phaco Handpiece is a replacement accessory for Bausch and Lomb Premiere and Protégé phacoemulsification systems. Device uses piezoelectric transduction to longitudinally oscillate a cutting tip at 28 kHz resonant frequency. Features integral colinear irrigation and coaxial aspiration fluidic pathways. Used by surgeons in clinical cataract surgery settings. Handpiece connects to host console via multi-contact electrical connector and fluidic tubing. Output is mechanical oscillation of the tip to emulsify cataractous lens material, which is then aspirated through the handpiece. Benefits include compatibility with existing surgical consoles for cataract removal.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is based on design, material, and functional comparison to the predicate device.

Technological Characteristics

Piezoelectric transduction; 28 kHz resonant frequency; 2 piezocrystals; titanium, silicone, and stainless steel construction; integral colinear irrigation and coaxial aspiration pathways; steam sterilization; compatible with Premiere and Protégé consoles via multi-contact electrical connector and luer fittings.

Indications for Use

Indicated for use in cataract surgery to breakup, emulsify, and extract cataracts in patients requiring phacoemulsification.

Regulatory Classification

Identification

A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.

Predicate Devices

• Storz Premiere ® Microsurgical System (K946227)

Submission Summary (Full Text)

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9 2002 SEP

K022833

# 510(K) SUMMARY (as required by 807.92(c))

| Submitter of 510(k): | Benjamin Biomedical, Inc.<br>3125 Tyrone Blvd.<br>St. Petersburg, FL 33710<br>Phone: [phone]<br>Fax: [phone] |
|----------------------|------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Joe Morrison |
| Date of Summary: | July 2, 2002 |
| Trade Name: | Benjamin ENVOY Phaco Handpiece |
| Classification Name: | Unit, Phacofragmentation |
| Predicate Device: | Storz Premiere ® Microsurgical System K946227 |

# Intended Use:

As an accessory for the Storz Premiere phacoemulsification system, the Benjamin ENVOY Hand Piece intended for use in cataract surgery to breakup, emulsify and extract the cataract.

#### Device Description:

- The Envoy is a Class II phacofragmentation handpiece device per 886.4670 of 21 1. General: The handpiece uses a piezoelectric transduction method to longitudinally oscillate a CFR. cutting tip (not included with the device) at a resonant frequency of 28 kHz. The device has integral colinear irrigation and coaxial aspiration fluidic pathways.
- 2. Host Phacofragmentation System: The device is intended as a replacement for the phacofragmentation handpiece used on the Bausch and Lomb Premiere™ and Protégé™ phacofragmentation system consoles. These systems has been commercially available in the U.S. for approximately 10 years. To insure compatibility with the host system, the Envoy handpiece is designed to be equivalent to the original handpiece used on the previously mentioned systems.

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| PARAMETER | BENJAMIN<br>ENVOY | STORZ<br>PREMIERE™ |
|----------------------|----------------------------------------|--------------------|
| Intended use | Phacofragmentation | Same |
| Design | Piezoelectric<br>Transduction | Same |
| Materials | Titanium, Silicone,<br>Stainless steel | Same |
| Operating frequency | 28 kHz | Same |
| Qty. piezocrystals | 2 | Same |
| Sterilization method | Steam only | Same |
| Host system | Premiere™ and<br>Protégé™ | Same |
| Biocompatibility | Meets ISO 10993-1 | Same |
| Patient contact | Indirect (fluids) | Same |
| Device setup | Connect tubing1 | Same |
| | Tip installation2 | Same |
| | System connection3 | Same |

:

# PHACO HANDPIECE COMPARISON SUMMARY

1 Male and Female non-locking luer fittings.

2 #4-40 UNC-2B threaded connection.

3 Multi-contact electrical connector.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 9 2002

Benjamin Biomedical, Inc. c/o Mr. Mark Job TUV America, Inc. 1775 Old Highway 8 New Brighton, MN 55112-1891

Re: K022833

Trade/Device Name: Benjamin Envoy Phoco Handpiece Regulation Number: 886.4670 Regulation Name: Phacofragmentation System Regulatory Class: II Product Code: HQC Dated: July 2, 2002 Received: August 26, 2002

Dear Mr. Job:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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); 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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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html

Sincerely vours.

A. Ralph Rosenthal

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

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510(k) Number (if known): KO22833

Benjamin ENVOY Phaco Handpeice Device Name:

### Indications For Use:

As an accessory for the Storz Premiere phacoemulsification system, the Benjamin ENVOY Hand Piece intended for use in cataract surgery to breakup, emulsify and extract the cataract.

# (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

# Concurrence of CDRH, Office of Device Evaluation (ODE)

Euretta Reese

Onhthalmic

510(k) Number K022833

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)