The Xcel 455 Slit Lamp is an AC-powered slit lamp biomicroscope that is intended for use in examining the anterior eye segment, from the corneal 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 segment of the eye.

Device Description

The Xcel 455 slit lamp is a general purpose examination instrument used in a wide range of eye care practices. Slit lamps are used for ophthalmic observation of the structures of the eye. By controlling the light source, nature of slit, and filters, physicians, optometrists, ophthalmologists and eye care technicians can observe various structures in the eye. The Xcel 455 can be used on any patient; there are no contraindications.

Ophthalmic slit lamp design has not changed in decades, and like most, including the predicate Xcel 255, the Xcel 455 slit lamp consists of two fundamental subsystems, the illumination source to illuminate the eye to be examined, and the microscope to enable the practitioner to view the structures of the eye under magnification.

The Xcel 455 uses a low voltage (6 Volt, 20 Watt) dimmable halogen lamp, and a selection of 4 color filters, or none, to illuminate the eye. The device uses a stereo microscope with 5 selections of magnification ranges, from 6.5x to 40x, to view the structure. There is a mount that allows other devices to attach in line with the optical path, such as a prism type contact tonometer.

Like the predicate Xcel 255 device, the Xcel 455 device uses a steel body and glass lenses. The scientific principle of all slit lamps is to project light onto a patient's eye, so that a doctor may view the eye and its structures through a microscope.

AI/ML Overview

The document describes the Reichert Xcel 455 Slit Lamp, an AC-powered slit lamp biomicroscope intended for examining the anterior eye segment to aid in diagnosing diseases or trauma affecting its structural properties. The submission claims substantial equivalence to the Reichert Xcel 255 Slit Lamp (K063750).

Here's an analysis of the provided information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly list acceptance criteria in a quantitative table with corresponding device performance metrics (e.g., sensitivity, specificity, accuracy for a diagnostic device). Instead, it states that the device was evaluated against several international standards and "passed" them.

Acceptance Criteria (Standard)	Reported Device Performance
IEC 60601-1:2007 (3rd edition) for electrical safety	Passed
IEC 60601-1-2 for EMC compliance	Passed at Class A radiated emissions limits
ISO 10993-1 for biocompatibility of forehead & chinrest materials	Passed
ISO 15004-1 for environmental tolerance of ophthalmic devices	Passed
ISO 15004-2 for photo-biological safety of light intensity limits	Passed
ISO 10939 (which includes ISO 15004-1, 15004-2, and IEC 60601-1)	Passed

2. Sample size used for the test set and the data provenance:

This information is not provided in the document. The tests performed are engineering and safety standard compliance tests, not clinical performance studies involving a test set of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as there was no test set involving patient data requiring expert ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not applicable as there was no test set involving patient data.

5. 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:

This information is not applicable. The device is a physical slit lamp, not an AI-powered diagnostic tool, and no MRMC study was mentioned. The determination of substantial equivalence was based on nonclinical performance data, and did not include clinical data.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

This information is not applicable. The device is an ophthalmic examination instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

This information is not applicable as the studies conducted were engineering and safety compliance tests, not clinical performance studies. The "ground truth" for these tests would be the established specifications and requirements of the various IEC and ISO standards.

8. The sample size for the training set:

This information is not applicable as the device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established:

This information is not applicable as the device is not an AI/ML algorithm that requires a training set.

Summary

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

October 15, 2014

Reichert Inc. % Mr. Thomas M. Heckmann Quality Assurance/Regulatory Manager 3362 Walden Avenue Depew, NY 14043

Re: K141954

Trade/Device Name: Xcel 455 Slit Lamp Regulation Number: 21 886.1850 Regulation Name: AC-powered slitlamp biomicroscope Regulatory Class: Class II Product Code: HJO Dated: September 12, 2014 Received: September 15, 2014

Dear Mr. Heckmann:

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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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" (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 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.

Deborah L. Falls -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) K141954

Device Name Xcel 455 Slit Lamp

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

Submitter/Applicant Owner	Reichert, Inc.3362 Walden AvenueDepew NY, 14043 USA716-686-4500
Contact Person	Thomas M. Heckmann, P.E.Quality Assurance/Regulatory ManagerReichert, Inc.3362 Walden Avenue DepewNY, 14043 USATom.heckmann@ametek.comTel: 716-686-4503Fax: 716-686-3027
Date Summary Prepared	July 3, 2014
NAME OF DEVICE
Proprietary Name	Xcel 455 Slit Lampalso known as: Xcel® 455 Slit Lamp, Xcel™ 455 Slit Lamp, Xcel® 455,Xcel™ 455, or Xcel 455.
Common NameRegulation NumberClassification NameRegulatory ClassProduct Code	Slit Lamp21 CFR Part 886.1850AC-powered slitlamp biomicroscopeIIHJO

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Reichert, Inc. · 3362 Walden Avenue, Depew, New York 14043 USA Telephone: 716-686-4500 · Fax: 716-686-4545 · www.reichert.com · ISO-9001 Registered

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PREDICATE DEVICE

Marketed device claiming equivalence to

Reichert claims the Xcel 455 slit lamp is substantially equivalent to the Reichert Xcel 255 Slit Lamp, 510(k) # K063750.

The proposed indications for use for the Xcel 455 are identical to the indications for use of the Reichert Xcel 255 Slit Lamp.

DEVICE DESCRIPTION

INDICATION FOR USE

TECHNOLOGICAL CHARACTERISTICS

The manufacturing process for the Xcel 455 slit lamp is the same as the process used for the predicate Xcel 255 slit lamp. The fundamental configuration difference of the Xcel 455 slit lamp is that the light source is above the optical path, and reflected into the path from above. In comparison, the Xcel 255 slit lamp has the optical light source below the optical path, and is reflected into the path from below. The devices use the same technology of universal power supply rheostat to control the same halogen light source, use manual adjustment

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of filters, optical settings, and X-Y position. All controls are manual. Neither the Xcel 455 nor its predicate Xcel 255 have data collection, display systems, motors, or software.

DETERMINATION OF SUBSTANTIAL EQUIVALENCE

The determination of substantial equivalence was based upon nonclinical performance data. The determination of substantial equivalence did not include clinical data.

BRIEF SUMMARY OF NONCLINICAL TESTS AND RESULTS

The Xcel 455 was evaluated to IEC 60601-1:2007 (3rd edition) for electrical safety, and passed. The Xcel 455 was evaluated to IEC 60601-1-2 for EMC compliance, and passed at Class A radiated emissions limits.

The Xcel 455 was evaluated to ISO 10993-1 for biocompatibility of the forehead & chinrest materials and passed.

The Xcel 455 was evaluated to ISO 15004-1 for environmental tolerance of ophthalmic devices and passed. The Xcel 455 was evaluated to ISO 15004-2 for assessment of photo-biological safety of light intensity limits, and passed.

The Xcel 455 was evaluated to ISO 10939, which requires assessment to ISO 15004-1. 15004-2. and IEC 60601-1, and passed.

These results support determination of substantial equivalence because they show that the Xcel 455 slit lamp, is a safe device, and an effective device, built to the norms of the industry, just like its predicate.

CONCLUSION

Based upon the test results, and the comparison to the long established predicate Reichert Xcel 255 slit lamp which uses the same technology and indication for use, Reichert believes the Xcel 455 slit lamp is as safe and effective, and performs as well as or better than the predicate device with respect to its intended use.

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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.