(89 days)
Not Found
No
The device description and performance studies focus on traditional optical and electrical components, with no mention of AI/ML, image processing, or data-driven analysis.
No.
The device is used to aid in the diagnosis of diseases or trauma, not to treat them.
Yes
The "Intended Use / Indications for Use" states that the device "is used to aid in the diagnosis of diseases or trauma, which affect the structural properties of the anterior segment of the eye."
No
The device description explicitly details hardware components including a halogen lamp, filters, a stereo microscope, a steel body, and glass lenses. The performance studies also focus on electrical safety, EMC compliance, biocompatibility, and environmental tolerance, which are typical for hardware devices.
Based on the provided information, the Xcel 455 Slit Lamp is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Xcel 455 Function: The Xcel 455 Slit Lamp is used for the direct visual examination of the anterior segment of the eye in vivo (within the living body). It uses light and magnification to allow a healthcare professional to observe the structures of the eye.
The device's intended use and description clearly indicate it's an ophthalmic examination instrument used directly on the patient, not on a sample taken from the patient.
N/A
Intended Use / Indications for Use
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.
Product codes
HJO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior eye segment, from the corneal epithelium to the posterior capsule
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians, optometrists, ophthalmologists and eye care technicians
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
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.
Key Metrics
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
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
1
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)
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
| 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 Avenue
Depew NY, 14043 USA
716-686-4500 |
|---------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Thomas M. Heckmann, P.E.
Quality Assurance/Regulatory Manager
Reichert, Inc.
3362 Walden Avenue Depew
NY, 14043 USA
Tom.heckmann@ametek.com
Tel: 716-686-4503
Fax: 716-686-3027 |
| Date Summary Prepared | July 3, 2014 |
| NAME OF DEVICE | |
| Proprietary Name | Xcel 455 Slit Lamp
also known as: Xcel® 455 Slit Lamp, Xcel™ 455 Slit Lamp, Xcel® 455,
Xcel™ 455, or Xcel 455. |
| Common Name
Regulation Number
Classification Name
Regulatory Class
Product Code | Slit Lamp
21 CFR Part 886.1850
AC-powered slitlamp biomicroscope
II
HJO |
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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
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.
INDICATION FOR USE
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.
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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