LITEPORT LP100 SURGICAL ILLUMINATOR

K041621 · Medical Vision Industries, Inc. · FTF · Sep 13, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K041621
• Device Name: LITEPORT LP100 SURGICAL ILLUMINATOR
• Applicant: Medical Vision Industries, Inc.
• Product Code: FTF · General, Plastic Surgery
• Decision Date: Sep 13, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4580
• Device Class: Class 2

Intended Use

The LitePort@LP100 Surgical Illuminator provides supplemental illumination in surgical procedures in the thoracic and abdominal cavities.

Device Story

LitePort LP100 is a tubular, self-contained, sterile, disposable surgical illuminator; battery-powered. Used for supplemental illumination in thoracic and abdominal surgical cavities via trochar or tube. Operated by surgeons during procedures to improve visualization of the surgical field. Device provides localized light source; eliminates need for external light cables. Benefits include enhanced visibility in deep surgical sites; disposable nature ensures sterility and convenience.

Clinical Evidence

Bench testing only. Performance testing evaluated illumination levels and duration of useful light levels. Sterility and packaging validation studies conducted to ensure design specifications are met.

Technological Characteristics

Tubular, self-contained, battery-powered surgical illuminator. Disposable. Designed for use with trochar or tube for deep cavity illumination. Complies with voluntary performance standards for surgical lamps.

Indications for Use

Indicated for supplemental surgical illumination within the thoracic and abdominal cavity during surgical procedures.

Regulatory Classification

Identification

A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.

Special Controls

*Classification.* Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, 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

• Suncoast Medical Manufacturers, Inc. Flexible Illuminator (K840371, K840373)

Submission Summary (Full Text)

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

## SEP 1 3 2004

1.

:

# 12

Hidh 519/13

Safe Medical Devices Act of 1990, 21 CFR 807.92 Regulatory Authority:

Device Name: LitePort® LP100 Surgical Illuminator

Common Name(s): Surgical light Illumination device

Classification Name(s): Surgical Lamp

Establishment Information/Owner Operator ID: 2. Name: Medical Vision Industries, Inc.

> Owner/Op. ID Number: Pending

2209 Warmsprings Rd. Address: Modesto, CA 95356 [phone] [phone]

#### 3. Classification(s):

Sec. 878.4580 Surgical lamp.

(a) Identification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.

(b) Classification. Class II.

Classification Panel: General and Plastic Surgery Devices Panel

Product Code(s): FTF

### 4. Performance Standards

Food and Drug Administration mandated Performance standards are not in effect. The LitePort® LP100 Surgical Illuminator complies with voluntary Performance Standards applicable to all existing surgical lamps.

### ડાં Special Controls:

As a Class II medical device, the LitePort® LP100 Surgical Illuminator is subject to the Special Controls requirement. At the present time we are not aware of Special Controls designed and intended to specifically cover surgical illumination equipment. Identifiable controls of a general nature are as follows:

- (i) Compliance with design specifications,
- Compliance with specified labeling requirements. (ii)

### (. Summary Basis for Equivalence:

The device is demonstrated substantially equivalent based on illumination technology, functional parameters, materials, indications for use, electrical safety, performance testing and sterility validation. All testing is conducted in accordance with appropriate ISO/EN test protocols.

### 7-Legally Marketed Comparison Device:

Medical Vision Industries, Inc. believes that the LitePort® LP100 Surgical Rluminator is substantially equivalent to the following device system identified earlier and marketed by Suncoast Medical Manufacturers:

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

041621 2/2

### Suncoast Medical Manufacturers, Inc. Flexible Illuminator; K840371, K840373

The Suncoast device is cleared for marketing, having met the requirements for a finding of substantial equivalence on March 24th, 1984. The comparison device contains and accessories system that performs substantially the same function as the proposed LitePort® LP100 Surgical Illuminator. Equivalence can be seen in the basic design, materials, intended use and performance characteristics. Particular reference should be made to the fact that the Suncoast device and the LitePort® LP100 Surgical Illuminator are designed to provide illumination to deep abdominal or thoracic surgical procedures via the use of trochar or tube.

#### હે. Description of the Device:

The LitePort® LP100 illumination device is a tubular fully self contained, sterile, disposable surgical illuminator powered by batteries.

Intended Use. Supplemental surgical illumination within the thoracic and abdominal cavity.

### Summary of Non-Clinical testing:

The Liteport surgical illumination units were tested for performance ilhumination levels and duration of useful light levels. Additionally, sterility and packaging validation studies are designed to assure the device meets its design specifications. The devices perform according to predetermined performance requirements, providing evidence of their ability to operate within their specified environment. Product performance specifications were validated using an appropriate methodology.

- 9. Company Contact: Mr. Chris A. Wolff [phone] [phone]
### 10. Submission Correspondent:

Mr. David W. Schlerf Buckman Company, Inc. 200 Gregory Lane, Suite C -100 Pleasant Hill, CA 94523-3389 925.356.2640 - 925.356.2654 - fax

### 11. Manufacturing Facility:

The devices are manufactured under contract at the following address; 2209 Warmsprings Rd. Modesto, CA 95356 [phone] [phone]

The devices are manufactured by Medical Vision Industries, Inc. and are shipped for sale or distribution in the U.S.A and elsewhere.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized lines forming the body and wings.

SEP 1 3 2004

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medical Vision Industries, Inc. c/o Mr. David W. Schlerf Buckman Company, Inc. 200 Gregory Lane, Suite C-100 Pleasant Hill, California 94523

Re: K041621

K041021
Trade/Device Name: LitePort® LP100 Surgical Illuminator Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical Lamp Regulatory Class: II Product Code: FTF Dated: March 31, 2004 Received: June 16, 2004

Dear Mr. Schlerf:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreours) is stgmy and ment date of the Medical Device Amendments, or to commerce phor to May 20, 1978, in accordance with the provisions of the Federal Food, Drug, de vices mat nave been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, mererore, mantes of the Act include requirements for annual registration, listing of gencral controls provisions of assice, 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 ri your device is classified (600 a00 70) als. Existing major regulations affecting your device can may be subject to back as a suble to be subjections, 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 r that FDA has made a determination that your device complies with other requirements of the Act that I Dr Has Intacted and regulations administered by other Federal agencies. You must or any I cueral statuted and regisments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K I at 607); idoomig (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

Page 2 - Mr. David W. Schlerf

This letter will allow you to begin marketing your device as described in your Section 510(k) This lotter will and h your he FDA finding of substantial equivalence of your device to a legally prematicated predicated on " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you dome specific and 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 other Echoral 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,

Muriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

**510(k) Number**: K041621

### LITEPORT@LP100 SURGICAL ILLUMINATOR Device Name(s):

### Intended Use Statement(s):

The LitePort@LP100 Surgical Illuminator provides supplemental illumination in surgical procedures in the thoracic and abdominal cavities.

Over-The-Counter Use AND/OR x Prescription Use (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

**510(k) Number** K041621

Page _ 1 _____________________________________________________________________________________________________________________________________________________________________

LITEPORT.DOC