Who is the manufacturer of DRSplus?

Centervue S.P.A. filed the 510(k) submission for DRSplus (K213705).

What is the FDA product code for DRSplus?

MYC. It is classified under 21 CFR 886.1570 as a Class 2 device in the Ophthalmic panel.

What is the regulatory pathway for DRSplus?

510(k) clearance (submission type: Special).

Who can help prepare an FDA 510(k) submission like DRSplus?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

DRSplus

K213705 · Centervue S.P.A. · MYC · Dec 21, 2021 · Ophthalmic

Device Facts

Record ID	K213705
Device Name	DRSplus
Applicant	Centervue S.P.A.
Product Code	MYC · Ophthalmic
Decision Date	Dec 21, 2021
Decision	SESE
Submission Type	Special
Regulation	21 CFR 886.1570
Device Class	Class 2

Intended Use

The CenterVue DRSplus is a confocal scanning ophthalmoscope indicated for color and infrared imaging of a human retina without the use of a mydriatic agent.

Device Story

DRSplus is a confocal scanning ophthalmoscope for non-mydriatic retinal imaging. Device uses infrared (825-870 nm) and white (420-675 nm) LEDs to capture retinal images. Software version 2.0 enables acquisition, storage, and review of infrared images, which were previously used only for internal alignment/focusing. Operation is automated, featuring auto-alignment, auto-focus, auto-exposure, and auto-capture. Used in clinical settings by eye care professionals to visualize retinal structures. Output is displayed on a 10.1-inch multi-touch screen for clinician review. Device aids in retinal assessment by providing color, red-free, and infrared imaging modalities without pharmacological dilation, improving workflow efficiency and patient comfort.

Clinical Evidence

No clinical data required. Substantial equivalence supported by bench testing and image comparisons. Compliance with ISO 10940 (fundus cameras), ISO 15004-1 (ophthalmic instruments), and ANSI Z80-36 (light hazard protection) confirmed.

Technological Characteristics

Confocal, line-scanning ophthalmoscope. Light sources: Infrared LED (825-870 nm), White LED (420-675 nm). Field of view: 45° (H) x 40° (V). Sensor: 10 MP. Connectivity: SSD storage. Power: 12V DC. Class I, Type B applied part. IPX0. Software version 2.0.

Indications for Use

Indicated for color and infrared imaging of the human retina in patients without the use of a mydriatic agent.

Regulatory Classification

Identification

An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.

Special Controls

*Classification.* Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, 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

DRSplus (K192113)

Reference Devices

EIDON (K142047)

Related Devices

K192113 — DRSplus · Centervue S.P.A. · Nov 15, 2019
K101935 — CENTERVUE DIGITAL RETINOGRAPHY SYSTEM · Centervue S.P.A. · Oct 27, 2010
K142047 — EIDON · Centervue S.P.A. · Nov 12, 2014
K180526 — EIDON FA · Centervue S.P.A. · Jul 16, 2018
K211328 — EIDON FA, EIDON, EIDON AF, EIDON UWFL · Centervue S.P.A. · Aug 19, 2021

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 21, 2021 CenterVue SpA Luca Scienza Quality and Regulatory Affairs Manager Via S. Marco 9H Padova, 35129 Italy Re: K213705 Trade/Device Name: DRSplus Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: MYC Dated: November 19, 2021 Received: November 24, 2021 Dear Luca Scienza: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. for Elvin Ng Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K213705 Device Name DRSplus Indications for Use (Describe) The CenterVue DRSplus is a confocal scanning ophthalmoscope indicated for color and infrared imaging of a human retina without the use of a mydriatic agent. 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) | |----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------| |----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------| #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 510(k) Summary | Proprietary Name(s): | DRSplus | |------------------------|------------------------------------------------------------------------| | Type of submission: | Special | | 510(k) submission: | K213705 | | Date of submission: | November 19th, 2021 | | Manufacturer: | CENTERVUE S.p.A. | | | Via San Marco 9H | | | 35129 Padova - ITALY | | Applicant and contact: | Mr. Luca Scienza | | | Centervue S.p.A. | | | Manager of Quality and Regulatory Affairs | | | Via San Marco 9H, 35129 Padova - ITALY | | | Phone: +39 049 501 8399 | | | Fax: +39 049 501 8398 | | | Email: luca.scienza@icare-world.com | | Product Code: | MYC | | Regulation Number: | 886.1570 | | Common Name: | Ophthalmoscope | | Panel: | Ophthalmic | | Class: | Class II | | Indications for Use: | The CenterVue DRSplus is a confocal scanning ophthalmoscope | | | indicated for color and infrared imaging of a human retina without the | | | use of a mydriatic agent. | {4}------------------------------------------------ ### Predicate Device Information | Proprietary name: | DRSplus | |---------------------|--------------------------------------------------------------------| | 510(k): | K192113 | | Product Code: | MYC | | Regulation number: | 886.1570 | | Common name: | Ophthalmoscope | | Panel: | Ophthalmic | | Class: | II | | Indication for use: | The CenterVue DRSplus is a confocal scanning ophthalmoscope | | | indicated for color imaging of a human retina without the use of a | | | mydriatic agent. | #### Reference Device Information | Proprietary name: | EIDON | |---------------------|-------------------------------------------------------------------------------------------------------------------| | 510(k): | K142047 | | Product Code: | MYC | | Regulation number: | 886.1570 | | Common name: | Ophthalmoscope | | Panel: | Ophthalmic | | Class: | II | | Indication for use: | The CenterVue EIDON is intended for taking digital images of a human retina without the use of a mydriatic agent. | The reference device has been included only in the context of image comparison, as no comparison of Infrared Imaging Modality is possible between the subject device and the predicate device. {5}------------------------------------------------ ### Device description The CenterVue DRSplus with Software version 2.0 is a modification of the CenterVue DRSplus (K192113). The DRSplus (K192113) is a scanning ophthalmoscope which uses infrared and white light to obtain confocal images of the retina, without pharmacological dilation. With respect to the previous cleared device, DRSplus with software version 2.0 (subject of this submission) provides one additional software feature that enable to acquire, store and review infrared retinal images, in addition to color and red-free photos which were the only imaging modalities of the previously cleared device. This feature does not require any hardware modification, because the infrared illumination is already present in the previously cleared device: in fact, the infrared retinal pictures were automatically taken by the device for alignment and focusing purposes, but they were not presented in the patient's image collection. In the proposed device modification, the user can decide to acquire also infrared pictures that are stored and displayed amongst the other, color and red-free images. The modified device uses the same base technology and maintains the same Intended Use of the previously cleared device; the Indications for Use of the modified device are amended to add the infrared imaging modality. The fundamental scientific technology of the device is unchanged from the previously cleared device and remains confocal, line scanning, LED-based, imaging. The functional differences between DRSplus with software version 2.0 and the previously cleared device are as follows: - . DRSplus with software 2.0 allows the user to take also IR pictures of the retina; - . DRSplus with software 2.0 allows the user to save and review IR pictures of the retina. No technological differences between DRSplus with software version 2.0 and the previously cleared device exist. In particular: - . DRSplus with software version 2.0 uses the same technological principle of retinal acquisitions of the cleared device; - . DRSplus with software version 2.0 uses the same illuminator, illumination optics and viewing optics of the cleared device. Other than the above, no other differences exist between the DRSplus with software version 2.0 and the previously cleared device, in particular the principle of operation, mechanism of action and interaction with the patient are unchanged. {6}------------------------------------------------ ### TECHNICAL SPECIFICATIONS of the DRSplus with Software version 2.0 #### Class and type of applied part - Class I, Type B (according to IEC 60601-1). #### IP classification: - IPX0 (according to the degree of protection provided by the enclosure with respect to harmful penetration of particulate matter or water). #### Image acquisition: - . Minimum pupil size: 3.2 mm (non-mydriatic use) - 45° (H) x 40° (V) captured in a single exposure ● Field of view: - 3600 x 2910 (10 MP) ● Sensor size: - infrared LED (825-870 nm), white LED (420-675 nm) ● Light source: - color, red-free, infrared . Imaging modalities: - 25 mm ● Working distance: - 3.7 μm ● Pixel pitch: #### Other features: - Automatic operation: auto-alignment, auto-focus, auto-exposure, auto-capture - . Focus adjustment range: -15 D to +15 D - . Internal fixation target: 10 positions - Display: 10.1″ multi-touch, color . - Hard disk: SSD, 512 GB . #### Dimensions: - 11 Kg (24 lbs) · Weight: • Size (W x H x D): 300 X 450 X 650 mm (11.8" x 17.7" x 25.6") #### Power supply: - · Voltage: 12 V DC . Power consumption: 60 W {7}------------------------------------------------ ### Comparison with previously cleared device The previously cleared device is identified as follows: | Proprietary Name: | DRSplus | |----------------------|---------------------------------| | Manufacturer: | CenterVue S.p.A. | | 510(k) Number: | K192113 | | Clearance Date: | 25 November 2019 | | FDA Product Code: | MYC | | Classification Name: | Ophthalmoscope, Laser, Scanning | | Regulation Number: | 886.1570 | The Subject Device and the Predicate Device share many identical or similar properties and features. In particular, the fundamental scientific technology of the subject device is unchanged from the predicate and remains confocal, line scanning, LED-based, ophthalmoscopy. Also, the principle of operation, mechanism of action and interaction with the patient are unchanged. With respect to the previous cleared device, DRSplus with software version 2.0 (subject of this submission) provides one additional software feature that enable to acquire, store and review infrared retinal images, in addition to color and red-free photos which were the only imaging modalities of the previously cleared device. The functional differences between DRSplus with software version 2.0 and the previously cleared device are as follows: - . DRSplus with software 2.0 allows the user to take also IR pictures of the retina; - . DRSplus with software 2.0 allows the user to save and review IR pictures of the retina. No technological differences between DRSplus with software version 2.0 and the previously cleared device exist. In particular: - DRSplus with software version 2.0 uses the same technological principle of retinal acquisitions of the . cleared device; - . DRSplus with software version 2.0 uses the same illumination optics and viewing optics of the cleared device. Other than the above, no other differences exist between the DRSplus with software version 2.0 and the previously cleared device, in particular the principle of operation, mechanism of action and interaction with the patient are unchanged. None of these differences have any significant effect on safety or effectiveness of the Subject Device. Notably, with respect to the impact of these design modifications on a key part of the product's risk analysis (i.e. optical radiation safety), Centervue has confirmed conformance with the applicable recognized standard, ANSI Z80-36:2016, as no modification has been introduced in the illumination and viewing systems. 4 Neither the CenterVue DRSplus with software 2.0 contain lasers but rather use LEDs for confocal imaging {8}------------------------------------------------ ### Performance data Continued conformance with the following standards has been confirmed in support of the substantial equivalence determination: #### ANSI Z80-26 (light Hazard Protection) DRSplus with software version 2.0 fulfills the requirements for a Group 1 determination according to ANSI Z80-36. #### ISO 15004-1 The subject device complies with the ISO 15004-1:2006 standard for ophthalmic instruments. #### IEC 62304 The subject device software complies with IEC 62304. #### ISO 10940 DRSplus with software version 2.0 fully complicable requirements of ISO 10940 - Ophthalmic instruments — Fundus Cameras. #### Clinical data No clinical data required to evaluate the proposed change, only image comparisons are provided. #### Conclusion Based on the information contained within this submission, it is concluded that the CenterVue DRSplus with software version 2.0 is substantially equivalent to the previously cleared device already in interstate commerce within the USA.