AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS

K131893 · Ajw Technology Consultants, Inc. · FSY · Oct 30, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K131893
• Device Name: AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS
• Applicant: Ajw Technology Consultants, Inc.
• Product Code: FSY · General, Plastic Surgery
• Decision Date: Oct 30, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4580
• Device Class: Class 2

Intended Use

The intended use of the Amico iCE LED series surgical lights are to provide high intensity, shadow free illumination to the patient surgical field during surgical procedures. The intended use of the Amico Mira LED series minor surgery lights is to provide high intensity, shadow free illumination to the patient surgical field during minor surgery procedures.

Device Story

Amico iCE and Mira LED series are surgical luminaires providing high-intensity, shadow-free illumination for surgical suites. iCE series (major surgery) and Mira series (minor surgery) utilize ceiling-mounted suspension systems with articulating extension and spring arms for positioning. Lamp heads feature plastic housings, polycarbonate lenses, and steel yokes. Mechanical (iCE) or electronic (Mira) focusing systems, controlled via a center handle, adjust the light field. Optional in-light camera modules with remote control allow recording/display of surgical sites on external monitors. Devices are operated by clinicians in surgical settings. Output is visual illumination of the surgical field; camera output provides visual feedback to assist surgical detail and accuracy. Benefits include improved visibility during procedures. Disposable sterile handles provide a barrier between the device and surgical staff.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included electrical safety (IEC 60601-1), particular requirements for surgical luminaires (IEC 60601-2-41), and electromagnetic compatibility (IEC 60601-1-2).

Technological Characteristics

LED-based surgical luminaires. Materials: plastic housing, polycarbonate lens, steel yoke. Mounting: ceiling, wall, or roll stand. Focusing: mechanical (iCE) or electronic (Mira). Connectivity: optional camera module with remote control and network interface. Service life: 50,000 hours. Power: 75-200W. Standards: IEC 60601-1, IEC 60601-2-41, IEC 60601-1-2.

Indications for Use

Indicated for providing high-intensity, shadow-free illumination to the surgical field during surgical or minor surgical procedures for patients undergoing such interventions.

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

• Mach LED SC (K093009)
• Mach LED MC (K093010)

Reference Devices

• Disposable Light Handle (K020304)

Submission Summary (Full Text)

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# K131893

# 510(k) SUMMARY (as required by 807.92)

**OCT**

**30 2013**

| Regulatory Correspondent: | AJW Technology Consultants, Inc.<br>445 Apollo Beach Blvd.<br>Apollo Beach, FL 33572 USA<br>Janet Douglas<br>Email: [e-mail] |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter of 510(k): | Amico Clinical Solutions Corporation<br>85 Fulton Way<br>Richmond Hill, ON L4B 2N4 Canada<br>Varun Chandan<br>Email: [e-mail]<br>Phone: [phone] ex.5715<br>Fax: [phone] |
| Date of Summary: | September 17, 2013 |
| Trade/Proprietary Name: | Amico Clinical Solutions Corp. - iCE LED Series<br>and Amico Lights Corp. - Mira LED Series Minor<br>Surgical Lights |
| Common/Usual Name: | Surgical Lamp |
| Classification Name: | Class II |
| Product Code: | FSY |

# Intended Use:

#### Device Name: Amico iCE LED Light

The intended use of the Amico iCE LED series surgical lights are to provide high intensity, shadow free illumination to the patient surgical field during surgical procedures.

#### Device Name: Amico Mira LED Series Minor Surgical Light

The intended use of the Amico Mira LED series minor surgery lights is to provide high intensity, shadow free illumination to the patient surgical field during minor surgery procedures.

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## Device Description:

## Amico iCE Series Device Description:

Amico iCE series consists of 3 models - iCE-30-6, iCE-25-6, & iCE-25-3. These are major surgical luminaires that provide illumination in a surgical suite allowing doctors to operate on a patient.. The device comes with several built-in fail safe's preventing any single fault from creating a hazardous situation.

These lamps are a Class 2 device (under FDA) providing max illumination of 160,000 lx, 160.0001x, and 130.000 Ix respectively. These surgical lights are coupled with ceiling mounted suspension systems supporting horizontally articulating extensions arms and horizontally and vertically articulating spring arms. Both arms can rotate either 340 degree (with stop) or infinitely without a stop. The spring arms vertically articulate 50° downwards and 45° upwards. This allows for ease of movement of the lamp head to any given position.

The lamp housing is made of high quality plastic wrapped around an aluminum structure. The front clear glass is made of high quality polycarbonate material. The yoke connecting the lamp head to the spring arms is made of steel.

The lamps also have a built-in mechanical focusing system that is controlled using the center Aluminum and/or plastic handle. Rotating this handle allows the user to expand and contract the lighted field as per the user's requirement. The lamps can also be sold with an optional in-light camera that doubles as a focusing handle. This provides the user with the option to record/display small areas of a surgical site on a large display allowing for greater detail and accuracy during surgeries. A separate remote control is used to control the various functions of the camera.

Available accessories for iCE series surgical lights

- Camera Module
- Remote control for Camera module
- Remote control with network interface for camera module
- Single monitor yoke for flat panel monitors
- Double monitor yoke for flat panel monitors
- Instrument trays
- Trays for CRT Monitors
- Low profile wall control unit

#### Amico Mira LED Series Device Description:

Amico Mira LED series consists of 3 models - Mira LED 90, Mira LED 65 & Mira LED 50. These are minor surgical luminaires that provide illumination in a surgical suite allowing doctors to perform minor surgical procedures on a patient.

These lamps are a Class 2 device (under FDA) providing max illumination of 90.000 1x. 65.000 Ix, and 50.000 Ix respectively. These surgical lights are coupled with ceiling

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mounted suspension systems supporting horizontally articulating extensions arms and horizontally and vertically articulating spring arms. Both arms can rotate either 340 degree (with stop) or infinitely without a stop. The spring arms vertically articulate 50° downwards and 45° upwards. This allows for ease of movement of the lamp head to any given position.

The lamp housing is made of high quality plastic which connects to the front clear glass is made of high quality polycarbonate material. The yoke connecting the lamp head to the spring arms is made of steel.

The lamps also have a built-in electronic focusing system that is controlled using the center Aluminum/plastic handle. Rotating this handle allows the user to expand and contract the lighted field as per the user's requirement.

#### Predicate Device:

### K093009 Mach LED SC K093010 Mach LED MC

#### Substantial Equivalence:

The Amico Clinical Solutions Corp. - iCE LED Series and Amico Lights Corp. - Mira LED Series Minor Surgical Lights are substantially equivalent in intended use and technological characteristics to the Mach LED SC and Mach LED MC surgical lights. Any difference that exists between the Amico Clinical Solutions Corp. - iCE LED Series and Amico Lights Corp. - Mira LED Series Minor Surgical Lights and both predicate devices has no negative effect on safety or effectiveness.

| | Comparison of Technological Char | | | | | |
|----------------|----------------------------------|-----------------|-------------|-------------|--|--|
| Comparison | Applicant Device | | | Predicated | | |
| Elements | | | Device. | Device | | |
| 510(K) | | | K093010 | K093009 | | |
| Number | | | | | | |
| Device Name | Amico iCE LED | Amico Mira LED | Mach LED MC | Mach LED SC | | |
| Technical Data | | | | | | |
| Light | 130,000 - 160,000 | 50,000 - 90,000 | 160,000 | 130,000 | | |
| Intensity | | | | | | |
| (Central | | | | | | |
| Luminance) | | | | | | |
| Color | તેરે રે | તેરે | > 96 | તેરે રે | | |
| Rendering | | | | | | |
| Index (Ra) | | | | | | |
| Color | >90 | તેરે | તેરે રે | તેરે તે રે | | |
| rendering | | | | | | |
| index | | | | | | |
| R9(red) | | | | | | |
| Focusable | 7.6-12.0in | 7.0-12.0in | | | | |
| size of the | | | | | | |
| light field | | | | | | |
| | | | 17-28cm | 17-28cm | | |

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| Comparison of Technological Characteristics | | | | |
|---------------------------------------------|------------------|------------------------------|------------------------------------|---------------------------------|
| Comparison<br>Elements | Applicant Device | Applicant Device | Predicated<br>Device<br>K093010 | Predicated<br>Device<br>K093009 |
| 510(k)<br>Number | | | | |
| Device Name | Amico iCE LED | Amico Mira LED | Mach LED MC | Mach LED SC |
| Color<br>temperature<br>(Kelvin) | 4500K | 4500K | 3750, 4000,<br>4250,<br>4500, 4750 | 4500K |
| Diameter of<br>the lamp<br>head | 25-30in | 18in | 57cm | 57cm |
| Total power<br>consumption | 150-200 | 75 | 120 W | 45 W |
| Brightness<br>Control | 5-100% | 5-100% | 5-100% | 5-100% |
| # of other<br>LED's | 208-320 | 144 | 112 | 28 |
| LED service<br>life | 50,000 | 50,000 | > 40.000 h | > 40.000 h |
| Mounting<br>Options | Ceiling, Wall, | Ceiling, Wall,<br>Roll Stand | Ceiling, Wall,<br>Roll Stand | Ceiling, Wall,<br>Roll Stand |

#### Sterilization and Shelf-Life

The Disposable Light Handle (K020304) is used as an accessory to the Amico Clinical Solutions Corp. - iCE LED Series and Amico Lights Corp. - Mira LED Series Minor Surgical Lights. The Disposable Light Handle provides a sterile interface between the Amico Clinical Solutions Corp. - iCE LED Series and Amico Lights Corp. - Mira LED Series Minor Surgical Lights, and the Surgeon or Scrub Nurse.

#### Non-Clinical Testing:

Electrical Safety testing was carried out on the Amico Clinical Solutions Corp. - iCE LED Series and Amico Lights Corp. - Mira LED Series Minor Surgical Lights. Below is a summary of the performed testing:

Attachment A: IEC 60601-1 Medical electrical equipment

Part 1: General requirements for basic safety and essential performance

Report Reference No .: 100874632MTL-002

· Result: Pass

Attachment B: IEC 60601-2-41 Medical electrical equipment

Part 2-41: Particular requirements for the safety of surgical luminaires and luminaires for diagnosis

Report Reference No .: 100874632MTL-003

Result: Pass

Attachment C: Constructional Data Report

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Report Reference No .: 100874632MTL-001 Result: Pass

Attachment D: IEC 60601-1-2 (Ed. 3): 2007 - Medical electrical equipment Part 1-2:General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests

Report Reference No.: 100874632ATL-003

Result: Pass

Attachment E: IEC 60601-1-2 (Ed. 3): 2007 - Medical electrical equipment Part 1-2:General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests

Report Reference No .: 100874632ATL-004 Result: Pass

#### Electrical Safety Testing Conclusions:

Based on the performed testing it has been shown that Amico Clinical Solutions Corp. iCE LED Series and Amico Lights Corp. - Mira LED Series Minor Surgical Lights has been proven to be safe and effective and poses no foreseen hazards. No Open Items remain from the planned Amico Clinical Solutions Corp. - iCE LED Series and Amico Lights Corp. - Mira LED Series Minor Surgical Lights Electrical Safety Testing.

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction 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 bird-like figure.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Conter - W 066-G609 Silver Spring, MD 20993-0002

October 30, 2013

Amico Clinical Solutions Corporation % Ms. Janet Douglas AJW Technology Consultants, Incorporated 445 Apollo Beach Boulevard Apollo Beach, Florida 33572

Re: K131893

Trade/Device Name: Amico iCE LED Light Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: Class II Product Code: FSY Dated: September 17, 2013 Received: September 27, 2013

Dear Ms. Douglas:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Janet Douglas

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Mark N. Melkerson -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K131893

Device Name: Amico iCE LED Light

The intended use of the Amico iCE LED series surgical lights are to provide high intensity, shadow free illumination to the patient surgical field during surgical procedures.

Prescription Use X (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Long H. Chen -A for MXM Page I of I (Division Sign-Off) Division of Surgical Devices 510 (k) Number: K131893

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Indications for Use

510(k) Number (if known): K131893

Device Name: Amico Mira LED Series Minor Surgical Light

The intended use of the Amico Mira LED series minor surgery lights is to provide high intensity, shadow free illumination to the patient surgical field during minor surgery procedures

Prescription Use X (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Lona H. Chen - M for MXM A Page I of I ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(Division Sign-Off) Division of Surgical Devices 510(k) Number: K131893