LAFACI

K032400 · Vision Pro, LLC · FYD · May 7, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K032400
• Device Name: LAFACI
• Applicant: Vision Pro, LLC
• Product Code: FYD · General, Plastic Surgery
• Decision Date: May 7, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5070
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The LaFaci Surgical System is intended for use during LASIK procedures. The LaFaci Surgical System consists of a reusable Handpiece, Surgical Cart, and disposable Tubing Accessories. The LaFaci System provides ocular fixation and containment of surgical field, corneal flap placement and flap re-positioning, and is used for ophthalmic plume aspiration, fluid aspiration, and the delivery of micro filtered air to the surgical field.

Device Story

LaFaci Surgical System integrates multiple LASIK surgical functions into single handpiece; system includes reusable handpiece, surgical cart, and disposable four-lumen tubing. Functions include: sterile saline irrigation; fluid aspiration; micro-filtered air delivery; plume evacuation; manual ocular fixation; corneal flap placement/repositioning via integrated spatula platform. Used in surgical setting by ophthalmologists. Cart features adjustable instrument tray and tubing swing arm for operational efficiency. System consolidates tools previously requiring separate devices, simplifying surgical workflow and maintaining sterile field.

Clinical Evidence

No clinical performance data was required or performed. Evidence is based on bench testing of the handpiece and the plume evacuation, irrigation, aspiration, and air delivery functions, which were determined to be acceptable.

Technological Characteristics

System comprises reusable handpiece, surgical cart, and disposable four-lumen tubing. Materials are biocompatible. Functions include fluid/plume management and mechanical ocular fixation/flap manipulation. Electrical safety compliant with UL 60601-1 and EN 60601-1-1-2. No software-based algorithms or automated processing described.

Indications for Use

Indicated for use during LASIK procedures to provide ocular fixation, surgical field containment, corneal flap placement/repositioning, ophthalmic plume aspiration, fluid aspiration, and delivery of micro-filtered air.

Regulatory Classification

Identification

Air-handling apparatus for a surgical operating room is a device intended to produce a directed, nonturbulent flow of air that has been filtered to remove particulate matter and microorganisms to provide an area free of contaminants to reduce the possibility of infection in the patient.

Special Controls

*Classification.* Class II (special controls). The device, when it is an air handling bench apparatus, an air handling room apparatus, or an air handling enclosure apparatus, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.

Predicate Devices

• Dell PlumeSafe and Plume Aspiration fixation Ring Handpiece (K924732 or K924731)
• Visx Star 3 Plume Evacuation (Unknown)
• Accurus Surgical System (K911808)
• Schuco-Vac Model 178 Aspirator (K935218)
• Slade LASIK Aspiration Lid Speculum (Exempt)
• Kritzinger-Udegraf LASIK Irrigation Cannula-16 guage (Exempt)
• Continuous Fluid Air Exchange (K963434)
• Regulator, pressure, gas cylinder (K852649)
• Gimble-Chayet LASIK Drain (Exempt)
• Melki Lasik Flap Stabilizer (Exempt)
• Maldonado LASIK Posterior Ablation Platform (Exempt)
• Kraff Nasal Solid Blade Speculum (Exempt)
• Whitten LASIK Fixation Ring (Exempt)

Submission Summary (Full Text)

{0}------------------------------------------------

MAY = 7 2004

# 510(k) Summary of Safety and Effectiveness

| 510(k) Summary | This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 C.F.R. § 807.92. | | |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Submitter | Vision Pro LLC<br>4309 I-49 South Service Road<br>Opelousas, LA 70570 | | |
| Contact Person | Julie Powell<br>Emergo Group, Inc.<br>2519 McMullen Booth Road<br>Suite 510-295<br>Clearwater, FL 33761<br>Phone: [phone]<br>Fax: [phone]<br>E Mail: [e-mail] | | |
| Date Prepared | April 7, 2004 | | |
| Name of device | LaFaci™ Surgical System | | |
| Classification Names | Apparatus, air handling, room | | |
| Device Classification | Regulatory Class: II<br>Product Code: FYD<br>Classification Panels: General & Plastic Surgery<br>Regulation Number: 21 C.F.R. 878.5070 | | |

{1}------------------------------------------------

## Predicate Device(s)

| 510(k)<br>Number | Device | Manufacturer |
|-----------------------|----------------------------------------------------------------------------------------|------------------------|
| | | |
| | | |
| K924732 or<br>K924731 | Dell PlumeSafe and Plume Aspiration fixation<br>Ring Handpiece (PlumeSafe 601 or 1201) | Buffalo Filter / Asico |
| Unknown | Visx Star 3 Plume Evacuation | Visx, Inc. |
| K911808 | Accurus Surgical System | Alcon Laboratories |
| K935218 | Schuco-Vac Model 178 Aspirator | Schuco, Inc. |
| Exempt | Slade LASIK Aspiration Lid Speculum | ASICO |
| Exempt | Kritzinger-Udegraf LASIK Irrigation Cannula-<br>16 guage | ASICO |
| K963434 | Continuous Fluid Air Exchange | Escalon Trek Medical |
| K852649 | Regulator, pressure, gas cylinder | C.R.Bard |
| Exempt | Gimble-Chayet LASIK Drain | Katina |
| Exempt | Melki Lasik Flap Stabilizer | Rhein Medical Inc. |
| Exempt | Maldonado LASIK Posterior Ablation<br>Platform | Rhein Medical, Inc. |
| Exempt | Kraff Nasal Solid Blade Speculum | ASICO |
| Exempt | Whitten LASIK Fixation Ring | ASICO |

### Device Description

LaFaci™ Surgical System combines multiple functions commonly utilized during LASIK into a single hand piece allowing for the delivery of sterile balanced saline irrigation solution to the surgical field, fluid aspiration from the surgical field, delivery of micro-filtered air to the surgical field, and plume evacuation from the surgical field. All of these functions are generated and delivered from the LaFaci™ Surgical Cart to the LaFaci™ Handpiece through fourlumen surgical tubing.

LaFaci™ Handpiece also provides manual ocular fixation, and provides a platform for the temporary placement of the corneal flap during ablation. In addition the platform can be manually pivoted over the corneal bed thereby providing a spatula means to reposition the flap onto the stromal bed.

The LaFaci™ Surgical Cart accessories include an adjustable instrument tray, and handpiece tubing swing arm that provides sterile setup and operational efficiency during surgery. The LaFaci™ Surgical Cart disposable accessories include the LaFaci

{2}------------------------------------------------

Handpiece Tubing Set (sterile) and the LaFaci Smoke/Fluid Evacuation Accessories (non-sterile).

#### Indications

- The LaFaci Surgical System is intended for use during LASIK for Use procedures. The LaFaci Surgical System consists of a reusable Handpiece, Surgical Cart, and disposable Tubing Accessories. The LaFaci System provides ocular fixation and containment of surgical field, corneal flap placement and flap re-positioning, and is used for ophthalmic plume aspiration, irrigation, fluid aspiration, and the delivery of micro filtered air to the surgical field.
# Nonclinical

### Performance

The materials with patient contact are biocompatible. Bench testing of the Handpiece and the plume evacuation, irrigation, aspiration, and air delivery functions have been tested and determined to be acceptable. The LaFaci Surgical System will comply with UL 60601-1 and EN

60601-1-1-2 electrical testing.

### Clinical

Performance No clinical performance data was required or performed.

Conclusion The LaFaci Surgical System is substantially equivalent to the predicate devices that are currently being marketed.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of a stylized caduceus, which is a symbol often associated with healthcare and medicine. The caduceus consists of a staff with two snakes coiled around it and a pair of wings at the top.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY = 7 2004

Emergo Group, Inc. C/O Julie Powell Senior Consultant 2519 McMullen Booth Road Suite 510-295 Clearwater, FL 33761

Re: K032400

Trade/Device Name: LaFaci Surgical System Regulation Number: 21 CFR 878.5070 Regulation Name: Air-handling apparatus for a surgical operating room Regulatory Class: Class II Product Code: FYD Dated: August 4, 2003 Received: August 8, 2003

Dear Ms. Powell:

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

{4}------------------------------------------------

Page 2 - Ms. Julie Powell

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.

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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely yours,

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

Enclosure

{5}------------------------------------------------

### INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K032400

Device Name: LaFaci Surgical System

### Indications for Use:

The LaFaci Surgical System is intended for use during LASIK procedures. The LaFaci Surgical System consists of a reusable Handpiece, Surgical Cart, and disposable Tubing Accessories. The LaFaci System provides ocular fixation and containment of surgical field, corneal flap placement and flap re-positioning, and is used for ophthalmic plume aspiration, fluid aspiration, and the delivery of micro filtered air to the surgical field.

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

OR

510(k) Number _K032400

Prescription Use _ V (Per 21 CFR 801.109) (Division Sign-Off) Division of Ophthalmic Ear. Nose and Throat Devises

510(k) Number
C.R. Butterman

the

Over Use

Counter