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 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.

AI/ML Overview

This document is a 510(k) summary for the Carl Zeiss Meditec SL 220, an AC-powered slit lamp biomicroscope.

Here's an analysis based on your request:

Acceptance Criteria and Reported Device Performance

The provided document does not contain a table of acceptance criteria nor reported device performance in the context of diagnostic accuracy (e.g., sensitivity, specificity, AUC). This is a submission for a Slit Lamp Biomicroscope, which is a diagnostic tool that physicians use, not an AI or algorithm-driven diagnostic device that would typically have such performance metrics.

Instead, the "acceptance criteria" for a device like this are compliance with recognized performance standards related to safety and effectiveness, and then a comparison to predicate devices for substantial equivalence.

Here's what is presented:

Acceptance Criteria (Compliance with Standards)	Reported Device Performance (Compliance)
IEC 60601-1: 2005 + CORR. 1 (2006) + CORR.2 (2007) + AM 1 (2012) (Medical electrical equipment - General requirements for basic safety and essential performance)	Demonstrated conformance
IEC 60601-1-2: 2007 (Third edition) (Medical electrical equipment - Electromagnetic compatibility)	Demonstrated conformance
ISO 15004-2:2007 (Ophthalmic instruments - Slit-lamp biomicroscopes - Part 2: Ophthalmic instruments and fundamental requirements and test methods)	Demonstrated conformance

Study Information (as per the document)

The document describes non-clinical tests to demonstrate compliance with standards and a comparison to predicate devices. It does not describe a clinical study of diagnostic accuracy or comparative effectiveness in the way an AI/CADe/CADx device would.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for this type of device submission. There is no "test set" in the context of diagnostic accuracy.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. Ground truth for diagnostic accuracy is not discussed.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm-only device. It's a medical instrument used directly by a human.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of diagnostic accuracy. The ground truth for this device's performance is adherence to engineering and safety standards.
The sample size for the training set: Not applicable. This is not a machine learning device.
How the ground truth for the training set was established: Not applicable.

Summary of the Device and Submission:

The SL 220 is a conventional slit lamp biomicroscope intended for eye examination of the anterior eye segment to aid in the diagnosis of diseases or trauma. The submission focuses on demonstrating substantial equivalence to existing predicate devices (Carl Zeiss Meditec (CZM) Slit Lamp SL 130 and C.S.O. SL990) and compliance with relevant international safety and performance standards (IEC 60601-1, IEC 60601-1-2, ISO 15004-2). The main technological differences highlighted are top-illumination versus bottom-illumination and Halogen versus LED illumination. The document concludes that the SL 220 is safe and effective and substantially equivalent to the predicate devices.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

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

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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 AGGoeschwitzer Strasse 51-5207745 JenaGermany
b.	Contact Person:	Mandy AmbrechtStaff Regulatory Affairs SpecialistCarl Zeiss Meditec, Inc.5160 Hacienda DriveDublin, CA 94568mandy.ambrecht@zeiss.comTel: (925) 557-4561
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

Indications for Use

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 INmW/cm²	CONTINUOUS WAVE / PULSED
Slit lamp,LED	412 – 810	58.1	Continuous wave
DigiCamIlluminator,LED	405 – 900	1.18	Continuous wave
Fixation light,LED	540 – 720	<0.03	Pulsed
Fixation light,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.

Regulation Number and Section

§ 886.1850 AC-powered slitlamp biomicroscope.

(a)
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.(b)
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.