ALM X'TEN (X10) SURGICAL LIGHT SYSTEM

K040735 · Alm S.A. · FSY · May 21, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K040735
• Device Name: ALM X'TEN (X10) SURGICAL LIGHT SYSTEM
• Applicant: Alm S.A.
• Product Code: FSY · General, Plastic Surgery
• Decision Date: May 21, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4580
• Device Class: Class 2

Indications for Use

ALM X'Ten™ (X10) Surgical Light Systems with Energix™ Power Supply are intended to be used to provide visible illumination of the surgical area or the patient. An optional "LEDinside" feature is available and produces lower intensity levels of light intended for minimally invasive surgeries, procedures and examinations. The Energix™ Power Supply is intended for use with surgical light systems.

Device Story

The ALM X'Ten™ Surgical Light System is a ceiling-mounted surgical lighting system used in operating rooms. It provides high-intensity illumination for surgical sites and a lower-intensity "LEDinside" ambient light mode for minimally invasive procedures. The system is powered by the Energix™ Power Supply, which allows for adjustable light intensity via a yoke-mounted keypad or remote RS232 communication. Some configurations include integrated video camera pre-wiring and flat-screen display supports. The device is operated by surgical staff to provide clear visualization of the patient. The system includes bulb failure indicators and an optional LCD for maintenance and operational status. By providing adjustable, reliable illumination, the device assists clinicians in performing surgical tasks, potentially improving procedural accuracy and patient outcomes.

Clinical Evidence

No clinical data is required for this device classification submission; bench testing only.

Technological Characteristics

Ceiling-mounted surgical luminaire; Energix™ Power Supply; adjustable intensity (30, 70, 110, 150 Lux @ 1m); RS232 connectivity; yoke-mounted keypad controls; video camera/flat-screen integration. Conforms to UL 60601-1, UL 60601-2-41, CSA C22.2 No. 601.1, IEC 60601-2-41, EN 60601-1-2, and FCC Part 15.

Indications for Use

Indicated for providing visible illumination of the surgical area or patient during surgical procedures, examinations, and minimally invasive surgeries.

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 Angenieux® (AX) Series Surgical Light (K904965)

Reference Devices

• ALM PrismAlix® (PRX) Series Surgical Lights

Submission Summary (Full Text)

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MAY 21 2004

K040735

## 510(k) SUMMARY

### ALM X'Ten™ Surgical Light System

| Submitted by: | Getinge USA, Inc. (as ALM S.A.'s US Agent)<br>1777 E Henrietta Road<br>Rochester, NY 14623-3133 |
|------------------------|--------------------------------------------------------------------------------------------------|
| Contact Person: | Frederick R. Catt<br>Senior, Regulatory Engineer<br>Phone: [phone]<br>Fax: [phone] |
| Date prepared: | March 19, 2004 |
| Proprietary Name: | ALM X'TenTM Surgical Light System |
| Common Name: | Surgical Light |
| Device Classification: | Surgical Lamp (78 FSY)<br>Class II, as listed per 21 CFR 878.4580 |
| Predicate Device: | ALM Angenieux® (AX) Series Surgical Light [K904965] |

#### Description of Device:

The ALM X'Ten'M Surgical Light System is a new product designation intended to identify a family of surgical lights that will use a similar set of design principals as the Angenieux (AX) Series Surgical Light Systems. The primary predicate device focuses on comparisons to the Angenieux® AX10, which is the medium sized lighthead within the Angenieux® (AX) Series.

The ALM X'Ten™ Surgical Light provides a broadened set of features and options that include video camera and flat screen display capabilities, bulb failure indicator(s), and an ambient light mode ("LEDinside") as results from this redesign effort. The user can toggie from the Surgical Light mode to the Ambient Light mode via use of a keypad switch

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mounted on the yoke of the lighthead. The "LEDinside" mode presents a ring of light mouthed from the bottom surface of the light, centered on the outer periphery of the sterile handle. Intensity can be adjusted to four levels: 30, 70, 110 and 150 Lux (@ 1m) and is sufficient to work on the patient in a dim or darkened operating room.

The ALM X'Ten™ Product Family currently has four configurations available, as shown within Table 1.

#### Table 1

| ALM X'Ten TM Surgical Light and Systems –<br>Designations/Configurations | |
|---------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Model | Description |
| X10 DF | X'TenTM SURGICAL LIGHT, CEILING MOUNTED, ONE X10 LIGHTHEAD |
| X10 duo DF | X'TenTM SURGICAL LIGHT, CEILING MOUNTED, TWO X10 LIGHTHEADS |
| X10 duo DF V | X'TenTM SURGICAL LIGHT, CEILING MOUNTED, TWO X10 LIGHTHEADS<br>WITH ONE OF THOSE INCLUDING VIDEO PREWIRING AND AMBIENT<br>LIGHT ("LEDinside" FUNCTION) |
| X10 duo DF V FS | X'TenTM SURGICAL LIGHT, CEILING MOUNTED, TWO X10 LIGHTHEADS<br>WITH ONE OF THOSE INCLUDING VIDEO PREWIRING AND AMBIENT<br>LIGHT ("LEDinside" FUNCTION), AND ONE FLAT SCREEN SUPPORT |

Note: Additional model configurations are planned for development. These will be incorporating use of the ALM X'Ten™ lighthead subassemblies.

#### Intended Use:

The ALM X'Ten™ Surgical Lights are intended to be used to provide visible illumination of the surgical area or the patient. The "LEDinside" ambient light mode is intended for minimally invasive surgeries, procedures and examinations.

#### Nonclinical Comparisons to Predicate Device

The ALM X'Ten'™ Surgical Light (subject device) is similar to the predicate device with the following modifications:

- The ALM X'Ten™ Surgical Light uses the Energix™ Power Supply (WPS) to . provide the electrical power to the light source. Surgical Light intensity levels are adjustable from the Energix keypad or remotely with RS232 communication port option. Bulb failure indicators provided. Optional LCD provides operation and maintenance information about the surgical light system, lightheads and bulbs.
- The ALM X'Ten™ introduces the "LED inside" option feature. This is an ambient . light used to illuminate a larger patient area and is intended for minimally invasive surgery applications. Controls are located on the yoke keypad for switchover from Surgical Light to Ambient Light. "LED inside" light level adjustments are at 30, 70, 110 and 150 Lux.

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- Added Capabilities of Video Camera (fixed focus or zoom), Multi-Media and Flat . Screen Displays (Note: ALM X'Ten™ with "LED inside" feature is included) similar to the ALM PrismAlix® (PRX) Series Surgical Lights.
- Added an optional adapter for single use sterile sleeves/gloves on a standard . handle system.
- Modified lighthead design, updating its appearance and suspension means. .

#### Test Data:

The test data supports conformance to:

- UL 60601-1 Standard for Medical Electrical Equipment, Part 1: General Requirements . for Safety
- UL60601-2-41 Medical electrical equipment Part 2-41: Particular requirements for . the safety of surgical luminaires and luminaires for diagnostics
- CSA C22.2 No. 601.1 Medical Electrical Equipment, Part 1: General Requirements for . Safety
- CSA C.22.2 No. 60601-2-41 Medical electrical equipment Part 2-41: Particular . requirements for the safety of surgical luminaires and luminaires for diagnostics
- IEC 60601-2-41 Medical electrical equipment Part 2-41: Particular requirements for . the safety of surgical luminaires and luminaires for diagnostics
- EN 60601-1-2 Medical electrical equipment Part 1-2: General requirements for safety . - Collateral standard: Electromagnetic compatibility - Requirements and tests
- . FCC Part 15
- Software used in the ALM X'Ten™ Surgical Light was tested according to the . appropriate FDA Software Guidance Documents, per its determination as a Minor Level of Concern.

#### Clinical Data:

No clinical data is required for this device classification submission.

#### Conclusion:

The modifications incorporated into the ALM X'Ten™ Surgical Light System designs use those desired design features from both the ALM PrismAlix® (PRX) Series and Angenieux® (AX10) Surgical Light Systems. Based upon the information provided herein this 510(k) Premarket Notification, we conclude that ALM X'Ten' Surgical Light Systems are substantially equivalent to the predicate device(s) and is safe and effective when used as intended.

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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 consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 1 2004

ALM S.A. c/o Mr. Frederick R. Catt Senior Regulatory Engineer Getinge USA, Inc 1777 East Henrietta Road Rochester, New York 14623

Re: K040735

K040733
Trade/Device Name: ALM X Ten™ Surgical Light System with Energix™ Power Supply Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: II Product Code: TSY Dated: April 30, 2004 Received: May 3, 2004

Dear Mr. Catt:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave leviewed your becamed 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 encrease) to regarry the Medical Device Amendments, or to commerce prior to May 20, 1978, the ensordance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). alle Cosment Act (71ct) that do not requent to the general controls provisions of the Act. The You may, therefore, manxet the act include requirements for annual registration, listing of general controls provisions of use tice, 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 If your device is classified (600 a00 vyrols. Existing major regulations affecting your device can may be subject to such additional controlio visitions, Title 21, Parts 800 to 898. In addition, FDA may be found in the overning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r least of advised that I DTT Pressan that your device complies with other requirements of the Act that IDA has Inade a dotermissions administered by other Federal agencies. You must or any recetal statutes and regulanents annouding, but not limited to: registration and listing (21 Comply with an the Hec oreense than and the start \$01); good manufacturing practice requirements as set CFN in the quality systems (QS) regulation (21 CFR Part 820), and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Frederick R. Catt

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin marketing of substantial equivalence of your device to a legally premaired notification. The PDF mailing of cation 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 If you desire specific advice for your as [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 gelleral information on Jour response Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam 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

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### Indications for Use

510(k) Number (if known): K 040735

# Device Name: ALM X'Ten™ Surgical Light System with Energix™ Power Supply

Indications for Use:

ALM X'Ten™ (X10) Surgical Light Systems with Energix™ Power Supply are intended ALM X Tell "" (X10) Surgical Elght Systems hands in the surgical area or the patient.

An optional "LEDinside" feature is available and produces lower intensity levels of An optional LEDIffside Teature is a railable and procedures and examinations.

The Energix™ Power Supply is intended for use with surgical light systems.

V Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

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

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**510(k) Number** K040735