CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA

K051940 · Sis Ltd., Surgical Instrument Systems · MXK · Sep 28, 2005 · Ophthalmic

Device Facts

• Record ID: K051940
• Device Name: CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA
• Applicant: Sis Ltd., Surgical Instrument Systems
• Product Code: MXK · Ophthalmic
• Decision Date: Sep 28, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1850
• Device Class: Class 2

Intended Use

The CM3910 is a device intended to take images of the anterior segment of the eye which includes the cornea, iris, pupil, anterior chamber and lens, to evaluate and analyse - Corneal shape - Lens shape - Pachymetry (thickness of the cornea) - Pupil size - Lens thickness - Condition of the lens - Location of cataracts (nuclear, subcapsular and or cortical), using Scheimpflug slit imaging with densitometry - State of the lens (opaque crystalline lens) - Condition and position of implants (e.g. iOLs, phakik IOLs, intracorneal rings) - Anterior chamber (size, volume and angle) - Scheimpflug Image - Position of the cornea relative to iris and lens

Device Story

Non-invasive diagnostic system for anterior eye segment analysis; utilizes Scheimpflug principle for slit image photography and Placido disc imaging. System table-mounted; AC-powered; consists of measurement unit and control unit with CPU. Input: blue light (UV-free) slit illumination and infrared LED (810nm) for eye tracking/Placido imaging; CCD camera captures rotating scans of anterior segment. Output: 3D-model and topography of eye displayed on 17" monitor. Operated by clinician in clinic setting. Healthcare provider uses output to evaluate corneal/lens shape, pachymetry, cataract location, and implant position. Benefits patient through non-invasive assessment of ocular structures and pathology.

Clinical Evidence

Bench testing only. No clinical data provided. Effectiveness demonstrated through internal performance tests.

Technological Characteristics

Non-invasive diagnostic system. Materials: metallic heat sinks, glass, non-inflammable encapsulation. Sensing: CCD camera, blue LED (470nm) slit illumination, infrared LED (810nm) observation. Connectivity: CPU-based, 17" monitor. Power: 110/220 VAC. Form factor: table-mounted measurement unit (10kg).

Indications for Use

Indicated for patients requiring anterior eye segment imaging and analysis, including corneal shape, lens condition (cataracts), pachymetry, pupil size, anterior chamber metrics, and implant positioning.

Regulatory Classification

Identification

An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.

Special Controls

*Classification.* Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

Predicate Devices

• Pentacam Scheimpflug Camera of OCULUS Optikgeräte GmbH (K013941)
• Orbscan IITM Keratometer manufactured by Orbtek, Inc. (K984443)

Submission Summary (Full Text)

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# 510(k) Summary for the CM 3910 Rotating Double Scheimpflug Camera

#### Name and Address of Sponsor

SIS Surgical Instrument Systems Ltd. Registration Number: 9614468 Allmendstrasse 11 2502 Port Switzerland Phone: [phone] Fax: [phone] Email: [e-mail]

#### Name and Address of Manufacturer

SIS Surgical Instrument Systems Ltd. Registration Number: 9614468 Allmendstrasse 11 2502 Port Switzerland Phone: [phone] Fax: [phone] Email: [e-mail]

#### Name and Address of Official Correspondent

Kevin Walls, RAC Principal Consultant Regulatory Insight, Inc. 13 Red Fox Lane Littleton, Colorado 80127 Phone: [phone] Fax: [phone] Email: [e-mail]

#### Device Name

Device trade name: CM 3910 Rotating Double Scheimpflug Camera Classification name: Anterior segment analysis device Common name: AC-powered slitlamp biomicroscope

### Classification, Panel and Product Code

| Device Classification: | Class II, MXK |
|------------------------|--------------------|
| Reviewing Panel: | Ophthalmic Devices |

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#### Indications for Use

The CM3910 is a device intended to take images of the anterior segment of the eye which includes the cornea, iris, pupil, anterior chamber and lens, to evaluate and analyse

- · Corneal shape
- · Lens shape
- · Pachymetry (thickness of the cornea)
- · Pupil size
- · Lens thickness
- · Condition of the lens
- o Location of cataracts (nuclear, subcapsular and or cortical), using Scheimpflug slit imaging with densitometry
- State of the lens (opaque crystalline lens) o
- · Condition and position of implants (e.g. iOLs, phakik IOLs, intracorneal rings)
- · Anterior chamber (size, volume and angle)
- · Scheimpflug Image
- · Position of the cornea relative to iris and lens

#### Predicate Devices

The Pentacam Scheimpflug Camera is claimed to be substantially equivalent to the following legally marketed devices:

- . Pentacam Scheimpflug Camera of OCULUS Optikgeräte GmbH
- Orbscan IITM Keratometer manufactured by Orbtek, Inc. .

#### Device Description

The CM 3910 Double-Scheimpflug Camera is a non-invasive, diagnostic system designed for the analysis of the anterior eye segment by means of Scheimpflug and Placido images. The Scheimpflug images are based on the Scheimpflug Principle for Slit Image photography. The system is table mounted and AC powered. The device consists of a measurement unit and a control unit with a CPU. The measuring system uses blue light (UV-free) given to a slit to illuminate the eye, and a CCD-Camera for taking images. The measuring unit takes pictures by a rotating scan of the anterior eye segment. It also includes a top view for eye tracking means and Placido imaging in the near infrared. From the acquired pictures, the control unit calculates a 3D-model and the topography of the eye.

All light sources used (Slit lamp, Placido Disc illumination, Top view illumination) are Light Emitting Diodes (LED) which produce little heat. Excess heat is conducted by appropriate metallic heat sinks. The encapsulation of the light sources consists of non-inflammable materials (metals, glass). The device does not contain any incandescent lamp.

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Product Comparison

| Characteristics | CM 3910 | Pentacam Scheimpflug Camera (Predicate) | Orbscan II™ Keratometer (Predicate) |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| References<br>Intended use | Taking photos of the anterior segment of the eye which includes the cornea, pupil, anterior chamber and lens of the eye. | 510(k): K013941<br>Taking photos of the anterior segment of the eye which includes the cornea, pupil, anterior chamber and lens of the eye. | 510(k): K984443<br>Scan, map and display the geometry of the anterior segment of the eye. |
| Measuring Principle | Rotational scan of Double-Scheimpflug slit images merged with Placido Disc images. | Rotational scan of Scheimpflug slit images. | Parallel scanned slit images and Placido Disc images |
| Optical<br>Viewing Means | Three Apertures<br>LCD on Measurement Unit, 17" monitor on table | Single Aperture<br>15" Coloured Screen | Single Aperture<br>15" Coloured Screen |
| Observation<br>Illumination | Infrared LED 810nm | Infrared LED 800nm | White flash light |
| Flash Output<br>Illumination | Blue LED Light (UV-free) 470 nm, max. 15 mWsec | Blue LED Light (UV-free) 475nm, max. 2.5 Wsec | |
| Photography<br>Camera | CCD Camera | CCD Camera | CCD Camera |
| Display<br>Image Resolution | Data digital, displayed on a CPU<br>1004 x 1004 pixels | Data digital, displayed on a CPU<br>800 x 600 pixels | Data digital, displayed on a CPU<br>0.25 diopters |
| Image Size | 7.4 x 7.4 mm | 5.6 x 4.5 mm | Parallel scan |
| Photographic Range | Eligible 0 to 180° | Eligible 0 to 180° | 2x 20 images from two sides |
| Photographic Series | 1 to 60 images | 1 to 50 photos | |
| Slit Length | 15 mm | 14 mm | |
| Power Requirement | 110/220 VAC, 50/60 Hz | 110/220 VAC, 50/60 Hz | 110/220 VAC, 50/60 Hz<br>220/240 VAC, 50/60 Hz |
| Weight | 10 kg (Measurement Unit) | 9 kg | 15kg |

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# K051990

### Rationale for Substantial Equivalence

- . The devices have the same intended use
- The devices utilize the same measuring principles (Slit Scan and Placido Disc) .
- The devices utilize the same photographic medium (CCD Camera) .
- The CM 3910 and one predicate device use light sources of comparable wavelength and intensity . .
- The devices use the same features like a
- o Head stabilizing device
- Fixation target o
- Joy stick for measurement head adjustment o
- All devices are considered "non invasive" as defined in 21 CFR §812.3(k) .

#### Safety

The CM 3910 is a non-invasive diagnostic system, which contacts the patient only on his/her chin and forehead. The CM 3910 does not present or pose any new or additional risks for the prescribed intended uses. The light output is of an eye safe intensity and wavelength. The electrical safety requirements for medical devices are met. The CM 3910 is proven effective for its intended uses through internal performance tests.

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Image /page/4/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 a stylized symbol resembling a caduceus, with three angled lines representing the staff and a wavy line at the bottom representing the serpent.

SEP 2 8 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Surgical Instrument Systems c/o Kevin Walls, RAC Principal Consultant Regulatory Insight, Inc. 13 Red Fox Lane Littleton, CO 80127

Re: K051940

Trade/Device Name: CM 3910 Rotating Double Scheimpflug Camcra Regulation Number: 21 CFR 886.1850 Regulation Name: Anterior Eye-Segment Analysis Device Regulatory Class: Class II Product Code: MXK Dated: July 15, 2005 Received: July 20, 2005

Dear Mr. Walls:

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 10 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 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.

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Page 2- Kevin Walls, RAC

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 2 legal) v 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/industry/support/index.html

Sincerely yours,

David M. Whizzle

David M. Whipple Acting Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): ______________________

Device Name: CM 3910 Rotating Double Scheimpflug Camera

Indications for Usc: The CM3910 is a device intended to take images of the anterior segment of the eye which includes the cornea, iris, pupil, anterior chamber and lens, to evaluate and analyse

- · Corneal shape
- Lens shape
- · Pachymetry (thickness of the cornea)
- · Pupil size
- · Lens thickness
- · Condition of the lens
- > Location of cataracts (nuclear, subcapsular and or cortical), using Scheimpflug slit imaging with densitometry
- > State of the lens (opaque crystalline lens)
- · Condition and position of implants (e.g. IOLs, phakik IOLs, intracorneal rings)
- · Anterior chamber (size, volume and angle)
- · Scheimpflug Image
- · Position of the cornea relative to iris and lens

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Senio L. M'Carthy

(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

510(k) Number

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