ALM PRISMALIX (PRX) SURGICAL LIGHT

K982063 · Alm Surgical Equipment, Inc. · FSY · Sep 22, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K982063
• Device Name: ALM PRISMALIX (PRX) SURGICAL LIGHT
• Applicant: Alm Surgical Equipment, Inc.
• Product Code: FSY · General, Plastic Surgery
• Decision Date: Sep 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4580
• Device Class: Class 2

Intended Use

ALM Prismalix™ (PRX) Surgical Lights are intended to provide visible illumination for the surgical field or for the examination of the patient. PRX is designed to eliminate shadow, reduce reflected heat, and illuminate surgical incisions of all depths during surgical procedures. The ALM Surgical Lights will be used in indications, which are the same as indications for other surgical lights currently offered for commercial distribution in the United States.

Device Story

Surgical lighting system providing visible illumination for surgical fields and patient examinations; consists of single or multiple lightheads mounted on suspension/spring arms; utilizes halogen lamps (23v/100w) with central optical system and prism reflectors; intensity controlled by remote wall-mounted dimmer; includes manual light pattern adjustment (5.5" to 11"); optional fixed-focus video camera available in 4000 series; operated by surgeons and medical staff in clinical/surgical settings; provides shadow-free, low-heat illumination to assist visualization of surgical incisions; safety features include 360-degree rotation with electrical contacts, friction brakes, and sterilizable/non-sterile handles.

Clinical Evidence

Bench testing only. Device performance verified against IES RP-29-95 recommendations for hospital lighting, achieving 100,000 to 120,000 lux. Safety testing conducted per IEC 601-2-41; UL and C-UL certification obtained.

Technological Characteristics

Halogen lamp (23v, 100w) light source; central optical system with prism reflectors; 400mm/600mm/800mm lighthead diameters; 360-degree suspension rotation; remote transformer; wall-mounted dimmer control; manual light pattern adjustment; ceiling, wall, or mobile mounting; compliant with IEC 601-2-41 and UL standards.

Indications for Use

Indicated for providing visible illumination of the surgical field or patient examination for surgeons and medical caregivers during surgical procedures of all depths.

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

• ALM Surgical Equipment, Inc. (K882613)
• Berchtold Corporation (K922836)
• Steris (Amsco) Corporation (K943288)
• Midmark (Chick Surgical) (K860739)

Submission Summary (Full Text)

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19.5.66

K982063

SEP 2 2 1998

## Summary of Safety and Effectiveness

Prismalix™ Surgical Light June 11, 1998

#### INTENDED USE

ALM Prismalix™ (PRX) Surgical Lights are intended to provide visible illumination for the surgical field or for the examination of the patient. PRX is designed to eliminate shadow, reduce reflected heat, and illuminate surgical incisions of all depths during surgical procedures. The ALM Surgical Lights will be used in indications, which are the same as indications for other surgical lights currently offered for commercial distribution in the United States.

### PRODUCT DESCRIPTION

ALM Surgical Equipment, Inc. has been selling Surgical Lights in the United States since July 1988. The products sold were and are manufactured by the parent company of ALM Surgical Equipment Inc., ALM SA, located in France. The Prismalix™ series continues to be manufactured by the parent organization, ALM SA.

The new product known as "Prismalix™" is of similar technology to surgical lights covered under D.C. Number K882613 issued on June 29, 1988. The differences between the new Prismalix™ models and models previously sold are cosmetic along with the addition of a tilting mechanism (in selected models) which allows variations in pattern size.

The surgical light consists of single or multiple lightheads attached to suspension arms supported from hospital installed mounting plates. Light heads can be positioned for optimal illumination of the surgical site by grasping sterilizable handles or non-sterile handles on the lighthead.

Low voltage power is supplied to the light bulb by way of a remote mounted transformer similar to those used by other surgical lighting manufacturers. Light intensity is controlled by a dimmer system, mounted remotely at a wall location.

Illumination is measured in footcandles or lux (1 footcandle equals 10.764 lux). Reference publication RP-29-95 Lighting for Hospitals and Health Care Facilities chapter 4, section 11, page 18. Illuminating Engineering

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Society of North America. New York, NY 1995. IES recommends a minimum illumination level at the surgical site of 2,500 footcandles when the light is positioned one meter above the site. The Prismalix™ series meets and exceeds this recommendation.

The previous range of lighting covered under K882613 is referenced by the three sizes of light heads; 500 mm or 5000 series, 700mm or 7000 series, and 900mm or 9000 series. The Prismalix™ series will be referenced by three sizes of light heads; 400mm or 4000 series, 600mm or 6000 series, and 800mm or 8000 series.

It is possible to provide a fixed focus video camera in selected 4000 series light heads. This Prismavision camera is similar in overall design and construction to the current ALM fixed focus camera, and other surgical/endoscopic video cameras offered for commercial distribution in the United States.

Contained in Section II of this submission are brochures that provide photos and specifications of some of the various models offered as part of the PRX series. The design of the PRX series is similar in overall design and construction to the current ALM products; and other surgical lights with variable pattern sizes, offered for commercial distribution in the United States.

### RATIONALE FOR SUBSTANTIAL EQUIVALENCE

The ALM Prismalix™ Surgical Light is substantially equivalent in materials, design, and function to surgical lights currently in commercial distribution in the United States. Specifically, the ALM Prismalix™ Surgical Light is substantially equivalent to the following systems:

- 1. ALM Surgical Equipment, Inc. 1820 North Lemon Street, Anaheim, CA 92801 Reviewed by the FDA (K882613), 06/29/88
- 2. Berchtold Corporation, 1950 Hanahan Road, Charleston, SC 29419 Reviewed by the FDA (K922836), 10/09/92
- 3. Steris (Amsco)Corporation, 5960 Heisley Road, Mentor, OH 44060. Reviewed by the FDA (K943288), 10/17/94

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- 4. Midmark (Chick Surgical), Versailles, OH 45380 Reviewed by the FDA (K860739), 03/28/86
All of these systems are ceiling, wall or mobile mounted surgical lights intended to provide acceptable levels of illumination to the surgical site.

All of these systems are modular in design to allow for maximum flexibility in meeting the needs of individual users during a variety of procedures.

The following charts provide a comparison of features of the ALM Prismalix™ Surgical Light to other similar commercially marketed systems.

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## ALM PRX compared to ALM ECL/PRC

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| | ALM PRISMALIX™ | ALM PRISMATIC® | | ALM PRISMALIX™ | Berchtold |
|------------------------------------------|----------------------------------------------------------------------|-------------------------------------------|------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Intended Use | Illumination of surgical field. | Illumination of surgical field. | Intended Use | Illumination of surgical field. | Illumination of surgical field. |
| Components | Suspension Arms (1 to 3) | Suspension Arms (1 to 3) | Components | Suspension Arms (1 to 3) | Suspension Arms (1 to 3) |
| | Spring Arms (1 to 3) | Spring Arms (1 to 3) | | Spring Arms (1 to 3) | Spring Arms (1 to 3) |
| | Light Head (1 to 3) | Light Head (1 to 3) | | Light Head (1 to 3) | Light Head (1 to 3) |
| | Dimmer Control (1 to 3) | Dimmer Control (1 to 3) | | Dimmer Control (1 to 3) | Dimmer Control (1 to 3) |
| | Transformer (1 to 3) | Transformer (1 to 3) | | Transformer (1 to 3) | Transformer (1 to 3) |
| | Lamps (1 to 3), per light head | Lamps (1 to 3), per light head | | Lamps (1 to 3), per light head | Lamps (2), per light head |
| | Portable | Portable | | Portable | Portable |
| | Wall Mount | Wall Mount | | Wall Mount | Wall Mount |
| | Ceiling Fixture | Ceiling Fixture | | Video Camera | Video Camera |
| Features and Technical<br>Specifications | Halogen Lamp (23v, 100w) | Halogen Lamp (24v, 120w) | | Ceiling Fixture | Ceiling Fixture |
| | 360° Suspension Rotation | 360° Suspension Rotation | Features and Technical<br>Specifications | Halogen Lamp (23v, 100w) | Halogen Lamp (22.8v, 100-<br>150w) |
| | Sealed Light Head | Sealed Light Head | | 360° Suspension Rotation | 360° Suspension Rotation |
| | Central Optical System | Central Optical System | | Sealed Light Head | Sealed Light Head |
| | 100,000 to 120,000 lux | 55,000 to 120,000 lux | | Central Optical System | Central Optical System |
| | Input Voltage 120v | Input Voltage 120v | | 100,000 to 120,000 lux | 90,000 to 150,000 lux |
| | Low Voltage Consumption:<br>4 to 12 amps | Low Voltage Consumption:<br>5 to 15 amps | | Input Voltage 120v | Input Voltage 120v |
| | Graduated Dimmer Controls | Graduated Dimmer Controls | | Low Voltage Consumption:<br>4 to 12 amps | Low Voltage Consumption:<br>5 to 11 amps |
| | 19" to 35" Light Head Diameter | 20 to 36" Light Head Diameter | | Graduated Dimmer Controls | Graduated Dimmer Controls |
| | Light Pattern Adjustment (5.5" to<br>11"), adjustment method, Manual | 28" fixed column of light, 8"<br>pattern. | | 19" to 35" Light Head Diameter | 17.5" to 37" Light Head Diameter |
| | Reflector Type: Prisms | Reflector Type: Prisms | | Light Pattern Adjustment (5.5" to<br>11"),<br>adjustment method, Manual | Light Pattern Adjustment (5.8" to<br>13.65"),<br>adjustment method, Manual |
| | Reflector Type: Prisms | Reflector Type: Parabolic<br>Reflector | | | |

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## Table II ALM compared to Berchtold

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#

| | ALM PRISMALIX™ | STERIS (AMSCO) |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Illumination of surgical field. | Illumination of surgical field. |
| Components | Suspension Arms (1 to 3)<br>Spring Arms (1 to 3)<br>Light Head (1 to 3)<br>Dimmer Control (1 to 3)<br>Transformer (1 to 3)<br>Lamps (1 to 3), per light head<br>Portable<br>Wall Mount<br>Ceiling Fixture | Suspension Arms (1 to 3)<br>Spring Arms (1 to 3)<br>Light Head (1 to 3)<br>Dimmer Control (1 to 3)<br>Transformer (1 to 3)<br>Lamps (2), per light head<br>Portable<br>Wall Mount<br>Ceiling Fixture |
| Features and Technical<br>Specifications | Halogen Lamp (24v, 100w)<br>360° Suspension Rotation<br>Sealed Light Head<br>Central Optical System<br>100,000 to 120,000 lux<br>Input Voltage 120v<br>Low Voltage Consumption:<br>4 to 12 amps<br>Graduated Dimmer Controls<br>19" to 35" Light Head Diameter<br>Light Pattern Adjustment (5.5" to<br>11"),<br>adjustment method, Manual<br>Reflector Type: Prisms | Halogen Lamp (22v, 220w)<br>360° Suspension Rotation<br>Sealed Light Head<br>Central Optical System<br>161,400 lux<br>Input Voltage 120v<br>Low Voltage Consumption:<br>10 Amps<br>Graduated Dimmer Controls<br>24" Light Head Diameter<br>Light Pattern Adjustment (5.8" to<br>7.8"),<br>adjustment method, Manual<br>Reflector Type: Parabolic<br>Reflector |

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# Table IV

| | ALM PRISMALIX™ | MIDMARK/CHICK |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| Intended Use | Illumination of surgical field. | Illumination of surgical field. |
| Components | Suspension Arms (1 to 3) | Suspension Arms (1 to 3) |
| Features and Technical<br>Specifications | Spring Arms (1 to 3) | Spring Arms (1 to 3) |
| | Light Head (1 to 3) | Light Head (1 to 3) |
| | Dimmer Control (1 to 3) | Dimmer Control (1 to 3) |
| | Transformer (1 to 3) | Transformer (1 to 3) |
| | Lamps (1 to 3), per light head | Lamps (2), per light head |
| | Portable | Portable |
| | Wall Mount | Wall Mount |
| | Ceiling Fixture | Ceiling Fixture |
| | Halogen Lamp (23v, 100w) | Halogen Lamp (22.8v, 100-<br>150w) |
| | 360° Suspension Rotation | 360° Suspension Rotation |
| | Sealed Light Head | Sealed Light Head |
| | Central Optical System | Central Optical System |
| | 100,000 to 120,000 lux | 55,000 to 107,000 lux |
| | Input Voltage 120v | Input Voltage 120v |
| | Low Voltage Consumption:<br>4 to 12 amps | Low Voltage Consumption:<br>5 to 11 amps |
| | Graduated Dimmer Controls | Graduated Dimmer Controls |
| | 19" to 35" Light Head Diameter<br>Light Pattern Adjustment (5.5" to<br>11"),<br>adjustment method, Manual | 17.5" to 37" Light Head Diameter<br>Light Pattern Adjustment (5.8" to<br>7.8"),<br>adjustment method, Manual |
| | Reflector Type: Prisms | Reflector Type: Parabolic<br>Reflector |

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### Safety Features

The ALM Prismalix™ Surgical Light described in this premarket notification was designed to meet criteria for Surgical Lighting as outlined in IEC 601-2-41 and manufactured using component materials accepted by Underwriters Laboratories.

360° rotation of the system's suspension arm and lighthead is made possible through the use of fully rotating electrical contacts, eliminating the possibility of twisting, binding and breaking of any internal wiring.

Each bulb in the lighthead is energized by 4 amps of low voltage power (23 volts).

Both sterile and non-sterile positioning devices are provided to maintain integrity of the sterile environment during surgical procedures.

All rotating joints in the suspension system are equipped with fully adjustable friction brakes to avoid unintentional movement after positioning of the lighthead for a procedure.

ALM has completed appropriate safety testing and has received Notice of Authorization to Apply the UL and C-UL Marks from Underwriters Laboratories, Inc., International Compliance Services on May 29, 1998. A copy of the notification is included in Section IV.

The PRX 4000, 6000, and 8000 series products referenced in this premarket notification are identical to those referenced in the above letter by Underwriters Laboratories, Inc.

### ADVERSE SAFETY AND EFFECTIVENESS INFORMATION

For correct and effective use of the ALM PRX Surgical Light and to avoid potential safety hazards, it is essential to follow the recommendations contained in the manuals provided with the device. Any use of the apparatus requires full understanding of user instructions. The apparatus is only to be used for purposes specified here.

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Professional installation is required to ensure that all local standards and codes are met. Failure to meet these standards could result in injury or harm to patients and healthcare personnel.

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SEP 2 2 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Susan Nielsen Director of Operations ALM Surgical Equipment, Inc. 1820 North Lemon Street Anaheim, California 92801

Re: K982063

Trade Name: ALM Prismalix (PRX) Surgical Light Regulatory Class: II Product Code: FSY Dated: August 7, 1998 Received: August 11, 1998

Dear Ms. Nielsen:

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 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). 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 (QS) 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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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 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 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/dsma/dsmamain.html".

Sincerely yours,

focella

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

Enclosure

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510K Number (if known): K982463

Device Name: ALM Prismalix (PRX) Surgical Light

Indications For Use: ALM Prismalix (PRX) Surgical Lights are intended to provide visible illumination for the surgical field or for the examination of the patient. PRX is designed to eliminate shadows, reduce reflected heat, and illuminate surgical incisions of all depths during surgical procedures. Use.is by surgeons and other medical care givers.

The ALM PRX Surgical Lights will be used in indications which are the same as indications for other surgical lights currently offered for commercial distribution in the United States.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109

OR

Over-The-Counter Use

picello

(Optional Format 1-2-96)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K982063