(162 days)
FUNDUS MODULE 300 is an ophthalmic camera that is used as an accessory with dedicated slit lamps to capture digital images and video of the fundus of the human eye.
FUNDUS MODULE 300 device set for retinal imaging consists of FUNDUS MODULE 300 Camera with base plate, lens cover, battery and camera USB cable (0.6 m), and FUNDUS MODULE 300 Cradle with power supply and cradle USB cable (1.5 m). FUNDUS MODULE 300 is used with dedicated HAAG-STREIT slit lamps. FUNDUS MODULE 300 is designed to be used in medical environment and it is intended for nonmydriatic imaging of the fundus of the human eve for documentation and consultation. In nonmydriatic imaging no mydriatic is needed because infrared light is used for the targeting image to the fundus and visible light is flashed when an image is taken. The pupil does not respond to the infrared light so examination is convenient for the patient. Constant white light illumination for targeting can be selected from device menu if mydriatic drops are used. Images can also be taken using infrared lightning for both aiming and capturing. The FUNDUS MODULE 300 has 9 internal fixation targets for the patient to fixate at during imaging. The middle fixation target provides a macula centred image. FUNDUS MODULE 300 can be used together with HAAG-STREIT Release Module RM02 and HAAG-STREIT EyeSuite software. Controlling the FUNDUS MODULE 300 can be performed by Camera keys or by Release Module RM02. Captured images and recorded videos are automatically transferred to the PC (EyeSuite software) after imaging. Images and videos are stored on the micro SDHC memory card and can be also transferred to the PC by using Cradle USB connection. FUNDUS MODULE 300 Camera has rechargeable Li-lon battery and the device is charged by using the Cradle. Materials of outer shells of the FUNDUS MODULE 300 are plastic, aluminum and silicon. There is no applied parts (no parts which are designed to come into physical contact with the patient) in FUNDUS MODULE 300.
The provided document does not describe acceptance criteria for a device's clinical performance, nor does it detail a study proving such performance related to accuracy or effectiveness in a clinical context.
This document is a 510(k) summary for a medical device (HAAG-STREIT FUNDUS MODULE 300), which focuses on demonstrating substantial equivalence to a predicate device. The "Performance data" section refers to engineering and regulatory compliance testing rather than clinical performance testing with human subjects or expert assessment of diagnostic capability.
Therefore, most of the requested information regarding acceptance criteria, clinical study specifics, expert involvement, and ground truth establishment cannot be extracted from this document.
However, I can provide the available information from the document based on the categories you provided:
Table of Acceptance Criteria and Reported Device Performance (Non-Clinical/Engineering):
| Acceptance Criteria Category | Reported Device Performance (Compliance) |
|---|---|
| Electrical Safety | Fulfills requirements of IEC 60601-1:2005+A1:2012 |
| Electromagnetic Compatibility | Fulfills requirements of IEC 60601-1-2:2014 |
| Optical Radiation Safety | Classified as Group 2 instrument according to ISO 15004-2:2007 |
| Software Verification/Validation | Fulfills design requirements and specified indications for use; Complies with IEC 60601-1-4:1996+A1:1999 and IEC 62304:2006+A1:2015 |
| Mechanic and Environmental Testing | Fulfills requirements of IEC 60601 and IEC 60068 (suitable clauses) |
| Usability (Human Factors) | Complies with IEC 60601-1-6:2010 and IEC 62366-1:2015 |
| Stability (In-use) | Tested to correspond to expected life time of five years |
| Stability (Shipping) | Tested according to IEC 60068-2-27:2008 |
Here's the breakdown of why the other requested information is not available and what little can be inferred:
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Available. This document describes engineering and regulatory compliance testing (e.g., electrical safety, EMC, software V&V), not clinical efficacy or diagnostic accuracy studies. Therefore, there's no mention of a "test set" in the sense of patient data.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable. As there's no clinical test set with diagnostic outcomes, there's no mention of experts establishing ground truth in this context.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No clinical test set data or adjudication process is described.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This device is an ophthalmic camera, not an AI-powered diagnostic system. It captures images and video. No MRMC study is mentioned, nor any AI assistance.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a hardware device for image capture; there's no "algorithm only" performance reported in a diagnostic context.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable. For the engineering tests, the "ground truth" would be the standard's compliance requirements, not clinical diagnostic ground truth.
-
The sample size for the training set:
- Not Applicable. This document does not describe an AI/machine learning device that would require a "training set."
-
How the ground truth for the training set was established:
- Not Applicable. As above, no training set is described.
In summary, the provided document is a 510(k) summary for an ophthalmic camera, focusing on its technical specifications, changes from a predicate device, and compliance with various engineering and safety standards. It does not contain information about clinical performance studies, diagnostic accuracy, or AI evaluation.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with a design that resembles a bird or a wing above them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 11, 2017
Optomed Oy Mr. Jyri Leskelä Quality Manager Yrttipellontie 1 Oulu. 90230 FI
Re: K163021
Trade/Device Name: HAAG-STREIT FUNDUS MODULE 300 Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic camera Regulatory Class: Class II Product Code: HKI Dated: February 23, 2017 Received: March 1, 2017
Dear Mr. Leskelä:
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.
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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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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,
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) K163021
Device Name HAAG-STREIT FUNDUS MODULE 300
Indications for Use (Describe)
FUNDUS MODULE 300 is an ophthalmic camera that is used as an accessory with dedicated slit lamps to capture digital images and video of the fundus of the human 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
| 510(k) submitter: | Optomed Oy |
|---|---|
| Address: | Yrttipellontie 1, FI-90230 Oulu, Finland |
| Company phone: | +358 20 741 3380 |
| Contact person: | Mr. Jyri Leskelä, Quality Manager |
| Date: | April 6, 2017 |
| Subject device: | |
| Trade name: | HAAG-STREIT FUNDUS MODULE 300 |
| 510(k) number: | K163021 |
| Common/usual name: | Ophthalmic camera |
| Classification name: | camera, ophthalmic, ac-powered(21 CFR 886.1120) |
| Regulatory Class: | II |
| Product Code: | HKI |
| Predicate device: | |
| Trade name: | Optomed Smartscope M5 digital camerawith Optomed Smartscope EY4 opticsmodule |
| 510(k) number: | K132186 |
| Regulatory Class: | II |
| Product code: | HKI |
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Description of the device
FUNDUS MODULE 300 device set for retinal imaging consists of FUNDUS MODULE 300 Camera with base plate, lens cover, battery and camera USB cable (0.6 m), and FUNDUS MODULE 300 Cradle with power supply and cradle USB cable (1.5 m). FUNDUS MODULE 300 is used with dedicated HAAG-STREIT slit lamps.
FUNDUS MODULE 300 is designed to be used in medical environment and it is intended for nonmydriatic imaging of the fundus of the human eve for documentation and consultation. In nonmydriatic imaging no mydriatic is needed because infrared light is used for the targeting image to the fundus and visible light is flashed when an image is taken. The pupil does not respond to the infrared light so examination is convenient for the patient. Constant white light illumination for targeting can be selected from device menu if mydriatic drops are used. Images can also be taken using infrared lightning for both aiming and capturing. The FUNDUS MODULE 300 has 9 internal fixation targets for the patient to fixate at during imaging. The middle fixation target provides a macula centred image.
FUNDUS MODULE 300 can be used together with HAAG-STREIT Release Module RM02 and HAAG-STREIT EyeSuite software. Controlling the FUNDUS MODULE 300 can be performed by Camera keys or by Release Module RM02. Captured images and recorded videos are automatically transferred to the PC (EyeSuite software) after imaging. Images and videos are stored on the micro SDHC memory card and can be also transferred to the PC by using Cradle USB connection. FUNDUS MODULE 300 Camera has rechargeable Li-lon battery and the device is charged by using the Cradle.
Materials of outer shells of the FUNDUS MODULE 300 are plastic, aluminum and silicon. There is no applied parts (no parts which are designed to come into physical contact with the patient) in FUNDUS MODULE 300.
Indications for use
FUNDUS MODULE 300 is an ophthalmic camera that is used as an accessory with dedicated slit lamps to capture digital images and video of the fundus of the human eye.
FUNDUS MODULE 300 is classified as prescription device. Federal law restricts this device to sale by or on the order of a physician or licensed practitioner. This equipment must only be operated by qualified and trained personnel. The owner is responsible for the training. This device may only be used in accordance with intended use.
The operating principle and the intended use of the FUNDUS MODULE 300 is the same than Smartscope M5 with Smartscope EY4. The main difference between subject device and predicate device is that FUNDUS MODULE 300 is intended to be used as slit lamp accessory instead of being used as hand-held. There is incremental changes in mechanics, software and hardware. There is no changes in optics. These changes do not affect safety and effectiveness of the product.
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Comparison of technological characteristics with the predicate device
Table 1 below includes a summary of the technical information used in the substantial equivalence discussion.
| Point ofcomparison | FUNDUS MODULE 300 | Optomed Smartscope M5 withSmartscope EY4 |
|---|---|---|
| 510(k) number | K163021 | K132186 |
| Indications of use | FUNDUS MODULE 300 is anophthalmic camera that is used as anaccessory with dedicated slit lampsto capture digital images and videoof the fundus of the human eye. | Optomed Smartscope M5 digitalcamera with optics moduleSmartscope EY4 is intended tocapture digital images and video ofthe fundus of the human eye. |
| Usage | Prescription use | Prescription use |
| Use condition | Intended to be used withoutmydriatic but can be used also withmydriatic. | Intended to be used withoutmydriatic but can be used also withmydriatic. |
| Observation lightsource | Visible and infrared LEDs:White: OSRAM Oslon LUW-H9GPNIR: OSRAM Oslon SFH-4715Target LEDs: OSRAM LR QH9F | Visible and infrared LEDs:White: OSRAM Oslon LUW-H9GPNIR: OSRAM Oslon SFH-4715Target LEDs: OSRAM LR QH9F |
| Observation anddisplay system | 3.97", TFT-LCD, 800x480 pixels, 16.7M colors, anti-glare coating | 2.4", TFT-LCD, active matrix color,antireflective coating |
| Photographinglight source | Visible and infrared LED | Visible and infrared LED |
| Cameraspecification | Color CMOS camera maximumresolution 5 Mp. Optics uses 1.77Mp. | Color CMOS camera maximumresolution 5 Mp. EY4 uses 1.77 Mp. |
| Dioptercompensation | at least from –20 D to +20 D | at least from -20 D to +20 D |
| Table 1. Summary of technical information used in the substantial equivalence discussion. | |
|---|---|
| ------------------------------------------------------------------------------------------- | -- |
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| Picture angle | 40 degrees | 40 degrees |
|---|---|---|
| Storage media | MicroSDHC memory card | MicroSDHC memory card |
| Image data format | JPEG, MPEG-4 | JPEG, MPEG-1, MPEG-4 |
| Weight | 1200 g | M5: 400g,EY4: 300g |
| Powerconsumption | Re-chargeable Li-Ion battery,NCA103450, 3.6 V, 2350 mAh | Re-chargeable Ni-MH Battery,HR4U700AAA, 4.8V, 1000 mAh;Charging unit 44 VA |
| Output terminalsand data collection | USB (1.1) terminal (B-connector).Compatible with Windows®VISTA/7/8.1/10 | USB (1.1) terminal (B-connector).Compatible with Windows®VISTA/7/8.1/10. |
| Exposureparameters | "Exempt Group" (no risk) LEDproduct according to IEC 62471:2006Group 2 instrument according to ISO15004-2:2007 | "Exempt Group" (no risk) LEDproduct according to EN 62471:2008Group 2 instrument according to ISO15004-2:2007 |
| Standards | IEC 60601-1:2005 (edition 3.1)IEC 60601-1-2:2014 (edition 4.0)IEC 62471:2006ISO 15004-1:2006ISO 15004-2:2007ISO 10940:2009IEC 62366-1:2015 | IEC 60601-1:2005 (edition 3.0)IEC 60601-1-2:2007 (edition 3.0)IEC 62471:2006ISO 15004-1:2006ISO 15004-2:2007ISO 10940:2009ISO 10993-5:2009 |
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The modifications in FUNDUS MODULE 300 compared to Smartscope M5 with Smartscope EY4 optics are:
● Mechanics
- FUNDUS MODULE 300 has new structure where camera and optics are integrated. o
- FUNDUS MODULE 300 has shaft: electronics and mechanics interface part to base O plate.
- o FUNDUS MODULE 300 has base plate: mechanical interface part to slit lamp, electrical interface to medical PC.
- Optics ●
- No changes. o
- . SW
- FUNDUS MODULE 300 only supported optics is EY4. о
- FUNDUS MODULE 300 GUI is different: Display is larger with higher resolution o (800x480). Colors and fonts differ.
- FUNDUS MODULE 300 has no patient list support. O
- FUNDUS MODULE 300 can be controlled with Haag-Streit Release Module RM02. O
- FUNDUS MODULE 300 has slit lamp USB mode support: Images are transferred right O after capture to the PC.
- FUNDUS MODULE 300 is used together with Haag-Streit EyeSuite software. o
- HW ●
- FUNDUS MODULE 300 has camera board (main board, sensor board and AF board O combined) and also shaft board and base plate board.
- FUNDUS MODULE 300 battery is different (Li-ion) O
- FUNDUS MODULE 300 display is different O
- FUNDUS MODULE 300 cradle board is different o
- FUNDUS MODULE 300 AF module different O
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Performance data
The following performance data were provided in support of the substantial equivalence determination.
Electrical safety and electromagnetic compatibility (EMC)
FUNDUS MODULE 300 was tested according to all suitable clauses of IEC 60601-1:2005+A1:2012 (safety) and IEC 60601-1-2:2014 (EMC). FUNDUS MODULE 300 fulfills the requirements of the standards.
Optical radiation safety
Smartscope EY4 was tested according to the standard ISO 15004-2:2007 (optical radiation safety) and FUNDUS MODULE 300 (identical to Smartscope EY4 optics module) is classified as Group 2 instrument.
Software Verification and Validation testing
The level of concern of software included in the FUNDUS MODULE 300 is moderate. Software verification and validation testing was conducted to ensure that design requirements and specified indications for use were fulfilled. FUNDUS MODULE 300 complies with standards IEC 60601-1-4:1996+A1:1999 and IEC 62304:2006+A1:2015.
Mechanic and environmental testing
FUNDUS MODULE 300 was tested according to all suitable clauses of IEC 60601 and IEC 60068. FUNDUS MODULE 300 fulfills the requirements of the standards.
Usability (Human factors)
FUNDUS MODULE 300 was designed according to the usability engineering process. FUNDUS MODULE 300 complies with standards IEC 60601-1-6:2010 and IEC 62366-1:2015.
Stability
FUNDUS MODULE 300 was tested for in use stability to correspond the expected life time of five years. Shipping stability was tested according to IEC 60068-2-27:2008.
Conclusions
Based on the comparison and supportive information, the FUNDUS MODULE 300 is substantially equivalent to the predicate device.
§ 886.1120 Ophthalmic camera.
(a)
Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.(b)
Classification. Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.