(247 days)
Not Found
No
The summary describes a conventional slit lamp biomicroscope and does not mention any AI or ML capabilities, image processing, or data sets typically associated with AI/ML devices.
No
The device is used for examination and diagnosis, not for treating or curing diseases.
Yes
The intended use statement explicitly states that the device "is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment."
No
The device description explicitly states it is an "AC-powered slit lamp biomicroscope," which is a physical hardware device used for eye examination.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the compatibility with potential recipients, or to monitor therapeutic measures.
- Device Function: The description clearly states that the slit lamp biomicroscope is used for the direct examination of the anterior eye segment in a living patient. It is an in vivo diagnostic tool, not an in vitro one.
- No Specimen Examination: The device does not involve the collection or analysis of biological specimens outside of the body.
Therefore, the intended use and device description align with an in vivo diagnostic device used for direct observation of the eye, not an IVD.
N/A
Intended Use / 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 eye segment.
Product codes
HJO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Anterior eye segment, from the cornea epithelium to the posterior capsule.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
ophthalmologists, opticians and optometrists.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key 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 ●
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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)
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) | |
|---|---|
| ☑ 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 AG
Goeschwitzer Strasse 51-52
07745 Jena
Germany |
|----|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| b. | Contact Person: | Mandy Ambrecht
Staff Regulatory Affairs Specialist
Carl Zeiss Meditec, Inc.
5160 Hacienda Drive
Dublin, CA 94568
mandy.ambrecht@zeiss.com
Tel: (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
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 | |
| mW/cm² | CONTINUOUS WAVE / PULSED | ||
| Slit lamp, | |||
| LED | 412 – 810 | 58.1 | Continuous wave |
| DigiCam | |||
| Illuminator, | |||
| LED | 405 – 900 | 1.18 | Continuous wave |
| Fixation light, | |||
| LED | 540 – 720 |