Slit Lamp Microscope

K152429 · Shanghai Mediworks Precision Instruments Co. , Ltd. · HJO · May 11, 2016 · Ophthalmic

Device Facts

• Record ID: K152429
• Device Name: Slit Lamp Microscope
• Applicant: Shanghai Mediworks Precision Instruments Co. , Ltd.
• Product Code: HJO · Ophthalmic
• Decision Date: May 11, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1850
• Device Class: Class 2

Intended Use

The MediWorks Model S series Slit Lamps are AC-powered slit lamp biomicroscopes intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. They are used to aid in the diagnosis of diseases or trauma which affects the structural properties of the anterior eye segment.

Device Story

MediWorks Model S series Slit Lamp is an AC-powered biomicroscope; used by eye care professionals in clinical settings for examination of anterior eye segment. Device provides magnified, illuminated view of ocular structures; aids clinicians in diagnosing diseases or trauma. Operates via standard optical slit lamp principles; no automated analysis or software-based diagnostic algorithms described. Output is direct visual observation by clinician; informs clinical decision-making regarding ocular health and treatment planning.

Clinical Evidence

Bench testing only.

Technological Characteristics

AC-powered slit lamp biomicroscope; optical magnification system; illumination system for anterior segment visualization. No software, connectivity, or automated processing described.

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 of the anterior eye segment. For prescription use.

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.

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 11, 2016

Shanghai Mediworks Precision Instruments Co., Ltd. Ms. Weida Zhan Management Representative Zone A, 2nd Floor, No. 69, Lane 1985 Chunshen Road, Minhang District Shanghai 200237 China

Re: K152429

Trade/Device Name: Slit Lamp Microscope Regulation Number: 21 CFR 886.1850 Regulation Name: Ac-Powered Slitlamp Biomicroscope Regulatory Class: Class II Product Code: HJO Dated: March 29, 2016 Received: April 7, 2016

Dear Ms. Zhan:

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 [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.

Kesia Alexander

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):

Slit Lamp Microscope Device Name:

N/A

The MediWorks Model S series Slit Lamps are Indications for Use: AC-powered slit lamp biomicroscopes intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. They are used to aid in the diagnosis of diseases or trauma which affects the structural properties of the anterior eye segment.

Prescription Use AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices and Radiological Health (OIR)

> (Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

> > 510(k) _______________________________________________________________________________________________________________________________________________________________________