SL 220

K162684 · Carl Zeiss Meditec, AG · HJO · May 31, 2017 · Ophthalmic

Device Facts

• Record ID: K162684
• Device Name: SL 220
• Applicant: Carl Zeiss Meditec, AG
• Product Code: HJO · Ophthalmic
• Decision Date: May 31, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1850
• Device Class: Class 2

Intended Use

An AC-powered slit lamp biomicroscope is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.

Device Story

The SL 220 is an AC-powered slit lamp biomicroscope used by ophthalmologists, opticians, and optometrists in clinical settings. It provides magnified visualization of the anterior eye segment, including the cornea and posterior capsule. The device utilizes adjustable illumination, transitioning between slit-type and full-field illumination via beam-forming elements. It employs LED light sources for the slit lamp and illuminator, and both LED and tungsten bulb options for fixation. The clinician observes the eye through the biomicroscope to assess structural properties, aiding in the diagnosis of ocular diseases or trauma. The device functions as a diagnostic aid, allowing the provider to visually inspect the eye to inform clinical decision-making and patient management.

Clinical Evidence

Bench testing only. The device demonstrated conformance to recognized performance standards, including IEC 60601-1 (general safety), IEC 60601-1-2 (electromagnetic compatibility), and ISO 15004-2 (light hazard protection for ophthalmic instruments).

Technological Characteristics

AC-powered slit lamp biomicroscope. Illumination sources: LED (slit lamp, illuminator, fixation) and tungsten bulb (fixation). Wavelength ranges: 412–810 nm (slit lamp LED), 405–900 nm (DigiCam LED), 540–720 nm (fixation LED), 380–1700 nm (fixation tungsten). Beam-forming elements adjust illumination from slit to full-field. Conforms to IEC 60601-1, IEC 60601-1-2, and ISO 15004-2.

Indications for Use

Indicated for eye examination of the anterior eye segment (cornea epithelium to posterior capsule) to aid in the diagnosis of diseases or trauma affecting structural properties in patients requiring ophthalmic evaluation.

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

• Carl Zeiss Meditec (CZM) Slit Lamp SL 130 (K133476)
• C.S.O. SL990 (K992836)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 31, 2017

Carl Zeiss Meditec, Inc. Mandv Ambrecht Staff Regulatory Affairs Specialist Carl Zeiss Meditec, Inc. 5160 Hacienda Drive Dublin. CA 94568

Re: K162684

Trade/Device Name: SL 220 Regulation Number: 21 CFR 886.1850 Regulation Name: AC-Powered Slitlamp Biomicroscope Regulatory Class: Class II Product Code: HJO Dated: April 21, 2017 Received: April 24, 2017

Dear Mandy Ambrecht:

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.

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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 devicerelated adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free 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" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Denise L. Hampton -S

for Malvina B. Eydelman, M.D. 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)

K162684

Device Name SL 220

Indications for Use (Describe)

An AC-powered slit lamp biomicroscope is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| <div> <span> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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## 510(K) SUMMARY

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(a).

Submitter's name, address, telephone number, contact person, and date summary prepared

| a. | Applicant: | Carl Zeiss Meditec AG<br>Goeschwitzer Strasse 51-52<br>07745 Jena<br>Germany |
|----|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| b. | Contact Person: | Mandy Ambrecht<br>Staff Regulatory Affairs Specialist<br>Carl Zeiss Meditec, Inc.<br>5160 Hacienda Drive<br>Dublin, CA 94568<br>[e-mail]<br>Tel: [phone] |
| c. | Date Submitted: | April 21, 2017 |

| a. | Trade/Proprietary Name: | SL 220 |
|----|-------------------------|------------------------------------|
| b. | Common/Usual Name: | Slit Lamp |
| c. | Classification Name: | AC-powered slit lamp biomicroscope |
| d. | Product Code and Class: | HJO – Class II |
| e. | Regulation Number: | 886.1850 |

#### Predicate Devices

Name

The SL 220 is substantially equivalent to the predicate devices Carl Zeiss Meditec (CZM) Slit Lamp SL 130 (K133476), and C.S.O. SL990 (K992836).

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### Device Description

The SL 220 can be used in performing a wide range of conventional eye care applications. It is used for ophthalmic observation of structural properties of the eye. The illumination can be adjusted from slit type illumination to a full-field type illumination by beam forming elements. The instrument is primarily used by ophthalmologists, opticians and optometrists.

### Indications for Use

An AC-powered slit lamp biomicroscope is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eve segment.

### Comparison of Technological Characteristics

The SL 220 predicate devices, Carl Zeiss Meditec (CZM) Slit Lamp SL 130 (K133476) and C.S.O. SL990 (K992836), share similar functional features and operating modes.

The following main technological differences existing between the subject and predicate devices are:

- Top-illumination versus bottom-illumination -
- -Halogen versus LED illumination

The technical specifications of the SL 220 light sources are as follows:

| | OPERATING CHARACTERISTICS | | EXPOSURE CONDITIONS |
|----------------------------------|---------------------------|-----------------------------|--------------------------|
| LIGHT SOURCE | WAVELENGTH IN nm | MAXIMUM OUTPUT IN<br>mW/cm² | CONTINUOUS WAVE / PULSED |
| Slit lamp,<br>LED | 412 – 810 | 58.1 | Continuous wave |
| DigiCam<br>Illuminator,<br>LED | 405 – 900 | 1.18 | Continuous wave |
| Fixation light,<br>LED | 540 – 720 | <0.03 | Pulsed |
| Fixation light,<br>Tungsten bulb | 380 - 1700 | 0.03 | Continuous wave |

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### Brief Summary of Nonclinical Tests and Results

The SL 220 has demonstrated conformance to the following recognized performance standards:

- IEC 60601-1: 2005 + CORR. 1 (2006) + CORR.2 (2007) + AM 1 (2012) ●
- IEC 60601-1-2: 2007 (Third edition) ●
- ISO 15004-2:2007 ●

### Conclusion

Based on the test results and the comparison to the predicate devices, the SL 220 including its accessories, is safe and effective with respect to its intended use when used in accordance with its Instructions for Use and substantially equivalent to, and performs as well as, the predicate devices.