PARKONE
Device Facts
| Record ID | K073508 |
|---|---|
| Device Name | PARKONE |
| Applicant | Oculus Optikgerate GmbH |
| Product Code | MXK · Ophthalmic |
| Decision Date | Sep 11, 2008 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.1850 |
| Device Class | Class 2 |
Indications for Use
The PARK 1 is designed to photograph the eye and take Scheimpflug images of the anterior segment to evaluate the thickness of the cornea. The implanted keratometer measures the central radii of the cornea. The implanted Ophthalmic Refractometer measures the refractive power of the eye.
Device Story
PARK 1 is a stationary, AC-powered, non-invasive diagnostic system for anterior eye segment analysis. It utilizes the Scheimpflug principle with blue (UV-free) slit illumination and a CCD camera to capture images of the anterior segment. The device integrates a keratometer for central corneal K-value measurement and an ophthalmic refractometer for refractive power assessment. Operated by clinicians in hospitals or clinics, the device uses a head/chin rest for patient stabilization and a joystick for control. Data is processed by an internal CPU and displayed digitally. The system provides objective measurements of corneal thickness and refractive power, assisting clinicians in diagnostic evaluations of the eye. The device contacts the patient only via the chin and forehead rest.
Clinical Evidence
Bench testing only. An internal study of 46 subjects (92 eyes) evaluated repeatability of pachymetry and keratometry measurements. Pooled standard deviations were: Apical Thickness 4.79 µm, Min. Thickness 5.51 µm, K1 0.11 dpt, and K2 0.12 dpt.
Technological Characteristics
Stationary, AC-powered diagnostic system. Uses Scheimpflug principle for slit image photography. Illumination: 950nm IR LED for pupil, 460nm blue LED (UV-free) for flash. CCD camera sensor. Housing: Polyurethane. Includes head/chin rest, joystick, and internal CPU. Non-invasive. No sterilization required.
Indications for Use
Indicated for patients requiring anterior eye segment imaging, corneal thickness evaluation, central corneal radius measurement, and refractive power assessment.
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.
Predicate Devices
- Pachycam, Scheimpflug Camera, OCULUS Optikgeraete GmbH (K041841)
- Auto-Ref-Keratometer, CANON Inc. (exempted 21CFR886.1760)
Submission Summary (Full Text)
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Description of the PARK 1
# 510(K) SUMMARY Substantially equivalent
## SEP 1 1 2008
## General Information
| Applicant's Name and Address: | OCULUS Optikgeräte GmbH |
|-------------------------------|---------------------------|
| | Münchholzhäuser Straße 29 |
| | D-35582 Wetzlar |
| Date of Summary: | 18 August 2008 |
| Owner/Operator Number: | 8010318 |
| Contact person: | Mr. Joerg Iwanczuk |
| | Product Manager |
| <b>Device Name</b> | |
|----------------------|------------------------------------------|
| Trade Name: | PARK 1 |
| Class: | Class II |
| Classification Name: | Scheimpflug Camera |
| Product Code: | MXK Anterior Eye-Segment Analysis System |
| Regulation Number: | 886.1850 |
## Predicate Devices
The PARK 1 is claimed to be substantially equivalent to the following currently market device:
Pachycam, Scheimpflug Camera, OCULUS Optikgeraete GmbH, Germany; K 041841
Auto-Ref-Keratometer, CANON Inc.; exempted (21CFR886.1760)
## Device Description:
The PARK 1 is a non-invasive, diagnostic system created to:
- ං take photos of the anterior segment of the eye
- measure the refractive power of the eye o
- measure the central corneal K-values. o
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The device is stationary and AC powered. The PARK 1:
- o is based on the Scheimpflug Principle for Slit Image photography. The measuring system uses blue light (UV-free) given to a slit to illuminate the eye, and a CCD-Camera for photography. The device takes a series of images of the anterior segment of the eye from one fixed location (180°) and analyses one, selected by software
- o has a real keratometer to measure directly the central keratometer values as per definition in the 3.1mm ring.
- includes an Ophthalmic Refractometer to measure the refractive power of the eye o (21CFR886.1760)
The device consists of a measurement unit, built in CPU, head and chin rest and an external power supply.
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# Product Comparison between PARK 1 and Pachycam
| | OCULUS Pachycam | New device, PARK 1 |
|---------------------------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Manufacturer | OCULUS Optikgeräte GmbH | OCULUS Optikgeräte<br>GmbH |
| Measuring Principle | Scheimpflug Principle for Slit<br>Image photography | Scheimpflug Principle for<br>Slit Image photography |
| Observation<br>Illumination | Infrared LED 800nm for pupil<br>illumination | Infrared LED 950nm for<br>pupil illumination |
| Flash Output<br>Illumination | Blue LED Light (UV-free)<br>455nm, max. 2.5W Power<br>Input | Blue LED Light (UV-free)<br>460nm, max. 2.5W Power<br>Input |
| Camera | CCD-Camera | CCD-Camera |
| Display | Data digital, displayed on a<br>CPU | Data digital, displayed on<br>a CPU |
| Image resolution | 640 x 480 pixel | 640 x 480 pixel |
| Measuring points | 600 per image | 600 per image |
| Image size | 4.8mm x 3.6mm | 4.8mm x 3.6mm |
| Photographic range | Fixed slit position in 180° | Fixed slit position in 180° |
| Photographic Series | 5 images | 5 images |
| Exposure Control | Fixed during calibration, max<br>2.5Wsec. Power input | Fixed during calibration,<br>max 2.5Wsec. Power<br>input |
| Slit Length | 5mm fixed | 5mm fixed |
| Illumination time during<br>alignment | Limited to 300 seconds | Limited to 300 seconds |
| Where used | Hospital, ambulance | Hospital, ambulance |
| Intended use | Please refer to the detailed description | |
| Sterilisation | Not necessary | Not necessary |
| Materials | Housing is made of<br>Polyurethane, specially<br>treated, not inflammable | Housing is made of<br>Polyurethane, specially<br>treated, not inflammable |
| Mechanical safety | Please refer to the detailed description | |
| Power supply | External, 110/220 VAC | External, 110/230 VAC |
| | 50/60Hz | 50/60Hz |
| Power Consumption | 27 VA | 49,5 VA |
| Power requirement | 9 VDC, 3A | 15VDC, 3,3A see test<br>certificate |
| Weight | 1 kg | 12 kg |
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## Basics for Substantial Equivalence
The PARK 1 utilizes same or similar operating systems.
In comparison to the device Pachycam, Oculus Optikgeräte GmbH, it contains:
- . same Scheimpflug optical system,
- . same source of illumination for observation and photography.
- . same CCD-Camera as photographic medium,
- . same Keratometer for the central corneal keratometer readings
- . same alignment system
In comparison to the Ophthalmic Refractometer, Canon Inc, exempted (21CFR886.1760), it contains
- . same measurement principle
The PARK 1 has same intended use:
In comparison to PACHYCAM:
to photograph the eye and take Scheimpflug images of the anterior segment of the eye to evaluate the thickness of the cornea. The implanted keratometer measures the central radii of the cornea.
In comparison to the Ophthalmic Refractometer: to measure the refractive power of the eye (21CFR886.1760).
The PARK 1 and the Pachycam uses same device features like a
- head stabilizing device .
- . external fixation target
- . joy stick for control mechanism.
The PARK 1 and the Pachycam are considered "Non Invasive" as defined in 21 CFR §812.3(k) and considered not to be a "Significant Risk Device" as defined in 21 CFR §812.3(m).
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#### Indications for Use
#### Intended Use:
The PARK 1 is designed to photograph the eye and take Scheimpflug images of the anterior segment to evaluate the thickness of the implanted keratometer measures the central radii of the cornea. The implanted Ophthalmic Refractometer measures the refractive power of the eye (21CFR886.1760)
### Safety
The PARK 1 is a non-invasive diagnostic system, which contacts the patient only on his/her chin and forehead. The PARK 1 does not present or pose any new or additional effects for risk on the safety prescribed intended uses. The light output is of an eye safe intensity and wavelength. The electrical safety requirements for medical devices are met. The PARK 1 is proven effective for its intended uses through internal company studies.
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#### Brief summary of nonclinical tests and results
In an internally performed study 46 subjects (92 eyes) were examined with an OCULUS PARK 1 by the same operator to determine the repeatability of the measurement results of the Pachymetry and Keratometry. Both eyes of a patient were measured and every eye was measured three times with the same device. The measurement ranges of the examined eyes were: Apical Thickness [460 .. 636um]; Min. Thickness [453 .. 635μm] ; K1 [38.66 .. 46.04dpt] ; K2 [39.02 .. 47.14dpt]. For this study design repeatability is a pooled standard deviation across subjects and eyes calculated in the following manner: For each set of triplicate results per eye per subject, the variance (standard deviation squared) had been calculated. Then these variances were averaged and the square root of the average had been taken.
| Measurement | Value | Repeatability | SD1 | |
|-------------|---------------------|---------------|----------|----------|
| | | | Min. | Max. |
| Pachymetry | Apical<br>Thickness | 4.79 µm | 0.00 µm | 14.74 µm |
| | Min.<br>Thickness | 5.51 µm | 0.58 µm | 14.93 µm |
| Keratometry | K1 | 0.11 dpt | 0.00 dpt | 0.35 dpt |
| | K2 | 0.12 dpt | 0.00 dpt | 0.31 dpt |
1 : SD : Standard Deviation (across triplicate results)
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Image /page/7/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Public Health Service
SEP 1 1 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Oculus Optikgeräte GmbH c/o Joerg Iwanczuk Product Manager OCULUS Optikgeräte GmbH Muenchholzhaeuser Strasse 29 Wetzlar D-35582 Germany
Re: K073508
Trade Name: PARKONE Regulation Number: 21 CFR 886.1850 Regulation Name: AC-powered slitlamp biomicroscope Regulatory Class: Class II Product Code: MXK, HLQ, HKO Dated: May 13, 2008 Received: June 30, 2008
Dear Mr. Iwanczuk:
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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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,
Malvina B. Edwards, and
Malvina B. Eydelman, M.I 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: K073508 Device Name: PARK 1
Indications For Use:
The PARK 1 is designed to photograph the eye and take Scheimpflug images of the anterior segment to evaluate the thickness of the cornea. The implanted keratometer measures the central radii of the cornea. The implanted Ophthalmic Refractometer measures the refractive power of the eye.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Tean.
Division Sign-Off) on of Onhthalmic Ear. lose and Throat Devises
510(k) Number K073508
