(263 days)
Not Found
No
The summary describes a conventional slit lamp with no mention of AI, ML, image processing, or performance metrics typically associated with AI/ML algorithms.
No
The device is used for examination and diagnosis, not for treating a disease or condition.
Yes
The "Intended Use / Indications for Use" section states, "Slit Lamp which is intended for that is used to aid the diagnosis of diseases or traumas which affect the structure or properties of the eye." This explicitly states its purpose in aiding diagnosis.
No
The device description explicitly states it is an "AC powered microscope and accessories" and mentions "electro-optical performance," indicating it is a hardware device with electrical and optical components, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for the "examination of the anterior eye segment" and to "aid the diagnosis of diseases or traumas which affect the structure or properties of the eye." This describes a device used for direct observation and examination of a patient's physical structures, not for testing samples taken from the body (in vitro).
- Device Description: The description refers to it as a "microscope" and "slit lamp biomicroscope," which are instruments used for visual examination of the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. This slit lamp is used for direct visual examination of the eye.
N/A
Intended Use / Indications for Use
The CeeMax™ Slit Lamp (Halogen Lamp Series/LED Illumination series) is an AC powered microscope and accessories intended for the use in the examination of the anterior eye segment, from cornea, endothelium to posterior capsule. Slit Lamp which is intended for that is used to aid the diagnosis of diseases or traumas which affect the structure or properties of the eye.
The CeeMax™ slit-lamp series is an AC-powered slit-lamp biomicroscope intended for use in eye examination of the anterior 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 (comma separated list FDA assigned to the subject device)
HJO
Device Description
The CceMax™ Slit Lamp's (Halogen Lamp Series/LED Illumination series) with models of 801, 802, 901, 902, 8015S, 802SS, 901SS, 902SS are similar in design, function, materials, operation, and electro-optical electro-optical performance to other conventional AC-powered slit lamp biomicroscope.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior eye segment, from cornea, endothelium to posterior capsule
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Testing provided in this premarket notification includes certifications of electrical safety, flammability, and bench test of radiation outputs.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
K 072861
JUN 2 4 2008
510(k) Summary of Safety and Effectiveness for the CeeMax Slit Lamp™ (Halogen Lamp Series/LED Illumination series) (per 21CFR807.92)
1. SPONSOR
CeeMax Ophthalmic Division of Achevé Technology, Inc 17100 Gillette Ave. #113 Irvine, CA 92614 Telephone: 949-885-8875 949-854-2388 Fax: E Mail: choujs@sbcglobal.com Contact Person: Jim-Son Chou, Ph.D.
2. DEVICE NAME and Classification
| Proprietary Name: | CceMax™ Slit Lamp (Halogen Lamp Series/LED
Illumination series) |
|----------------------|--------------------------------------------------------------------|
| Common/Usual Name: | Slit Lamp |
| Classification Name: | AC-powered slit lamp biomicroscope |
| Regulation Number: | 886.1850 |
| Product Code: | HJO |
| Class: | II |
PREDICATE DEVICES 3.
(1) Reichert PSL Slit Lamp ----- FDA 510K K061330 (2) VISION-TECH YZ SLIT LAMP ---- FDA 510K K033190
4. DEVICE DESCRIPTION
The CceMax™ Slit Lamp's (Halogen Lamp Series/LED Illumination series) with models of 801, 802, 901, 902, 8015S, 802SS, 901SS, 902SS are similar in design, function, materials, operation, and electro-optical electro-optical performance to other conventional AC-powered slit lamp biomicroscope.
INTENDED USE 5.
1
The CeeMax™ Slit Lamp (Halogen Lamp Series/LED Illumination series) is an AC powered microscope and accessories intended for the use in the examination of the anterior eye segment, from cornea, endothelium to posterior capsule. Slit Lamp which is intended for that is used to aid the diagnosis of diseases or traumas which affect the structure or properties of the eye.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
Side by Side Comparison of the CeeMax™ Slit Lamp (Halogen Lamp Series/LED Illumination series) with Predicate Devices
| Submission Device | Predicate Device | |
|---|---|---|
| CeeMaxTM Slit Lamp | ||
| (Halogen Lamp Series/LED | ||
| Illumination series) | Slit Lamp's | |
| YZ5F (K033190) | ||
| SL-15 (K061330) | ||
| Indications | ||
| for Use | Same. | AC powered microscope and |
| accessories intended for the | ||
| use in the examination of the | ||
| anterior eye segment, from | ||
| cornea, endothelium to | ||
| posterior capsule. Slit Lamp | ||
| which is intended for that is | ||
| used to aid the diagnosis of | ||
| diseases or traumas which | ||
| affect the structure or | ||
| properties of the eye | ||
| Method of | ||
| operation | Same as the predicate device | |
| YZ5F (K033190) table top | YZ5F (K033190) Table Top | |
| SL-15 (K061330) Hand held | ||
| Exposure | ||
| parameters | The Halogen lamp exposure | |
| parameters are the same as the | ||
| predicate device. | ||
| The LED exposure parameters | ||
| are similar to the predicate | Halogen lamp: | |
| YZ5F (K033190) | ||
| LED: Reichert | ||
| SL-15(K061330) | ||
| device, detailed description | ||
| was also provided. | ||
| Flammability | Thermosetting phenol | |
| formaldehyde resin. | Thermosetting phenol | |
| formaldehyde resin for the | ||
| lamp cap YZ5F (K033190) | ||
| Brightness | ||
| control | From zero to full power | |
| illumination control | Same | |
| Light source | Halogen lamp and white LED | Halogen lamp for the YZ5F |
| (K033190) | ||
| LED for the SL-15(K061330) | ||
| Beam | The same as the YZ5F | The standard slit opening |
| geometry | (K033190) | range YZ5F (K033190) |
| Radiation | ||
| safety | The Halogen lamp exposure | |
| parameters are the same as the | ||
| predicate device. | ||
| The LED exposure parameters | ||
| are similar to the predicate | ||
| device, detailed description | ||
| was also provided. | Halogen lamp: | |
| YZ5F (K033190) | ||
| LED: Reichert | ||
| SL-15(K061330) | ||
| Optical | ||
| radiation | ||
| hazard | No, warning in the manual | |
| regarding the caution and | ||
| particularly for the aphakic | ||
| diagnostic | No | |
| Electrical | Safety: EN(IEC) 60601-1 | Safety: IEC 60601-1 |
| Electrical | EMC: EN(IEC) 60601-1-2 | |
| EN6100-3-2 | ||
| EN6100-3-3 | EMC: EN(IEC) 60601-1-2 | |
| Light Output | ||
| Wavelength | The Halogen Lamp emits | |
| Visible light covers 460nm to | ||
| 700nm. The LED light source | ||
| covers 450nm to 650nm. | The Halogen Lamp emits | |
| Visible light covers 460nm to | ||
| 650nm. The LED light source | ||
| covers 450nm to 650nm. | ||
| Light Source | ||
| Power | Halogen: 12V, 30W | |
| LED: 12V, 10W | Halogen(Vision Tech): | |
| 12V, 30W | ||
| LED(Reichert): 12V, 6W |
2
PERFORMANCE TESTING 7.
Testing provided in this premarket notification includes certifications of electrical safety, flammability, and bench test of radiation outputs.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is written in all capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 4 2008
Jim-Son Chou, Ph.D. President CeeMax Ophthalmic Division of Achevé Technology, Inc 17100 Gillette Ave. #113 Irvine, CA 92614
Re: K072861
Trade/Device Name: CceMax Slit Lamp (Halogen Lamp Series/LED Illumination Series) Regulation Number: 21 CFR 886.1850 Regulation Name: AC-powered slit lamp biomicroscope Regulatory Class: Class II Product Code: HJO Dated: May 22, 2008 Received: May 23, 2008
Dear Dr. Chou:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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Page 2 - Jim-Son Chou, Ph.D.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mahina Eggleston, und
Malvina B. Eydelman, M. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known): K 072861
Device Name: CeeMax™ Slit Lamp (Halogen Lamp Series/LED Illumination series)
Indications For Use:
The CeeMax™ slit-lamp series is an AC-powered slit-lamp biomicroscope intended for use in eye examination of the anterior 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
x 6/18/2008
510(k) Number K072861