RESCAN 700

K233421 · Carl Zeiss Meditec, AG · OBO · Mar 8, 2024 · Ophthalmic

Device Facts

• Record ID: K233421
• Device Name: RESCAN 700
• Applicant: Carl Zeiss Meditec, AG
• Product Code: OBO · Ophthalmic
• Decision Date: Mar 8, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1570
• Device Class: Class 2

Intended Use

RESCAN 700 provides non-contact, high resolution optical coherence tomographic (OCT) and biomicroscopic imaging of the anterior and posterior segment of the eve via an ophthalmic surgical microscope. The RESCAN 700 is indicated for in vivo viewing, axial cross sectional, and three-dimensional imaging of posterior ocular structures, including retina, macula, and optic disc, as well as imaging of anterior ocular structures, including the cornea, lens and anterior chamber angle. RESCAN 700 uses the assistance system (CALLISTO eye) that provides non-diagnostic video documentation and image capture for ophthalmic surgeries. The assistance system allows the remote control of RESCAN 700.

Device Story

RESCAN 700 is an intra-operative Spectral Domain OCT system integrated into ZEISS ophthalmic surgical microscopes (e.g., ARTEVO 750/850). It utilizes a Super Luminescent Diode (840 nm) to capture high-resolution OCT images of anterior and posterior ocular segments. The device operates in conjunction with the CALLISTO eye assistance system, which facilitates remote control, image capture, and non-diagnostic video documentation. Intra-operative images are displayed on a monitor and injected into the surgeon's oculars via the microscope's data injection system (IDIS). The system is operated by surgeons during ophthalmic procedures to provide real-time visualization of ocular structures, aiding surgical decision-making and potentially improving surgical outcomes. Images can be stored for subsequent retrieval via the CALLISTO eye data management system.

Clinical Evidence

No clinical or animal testing was conducted. Substantial equivalence is supported by non-clinical performance testing, including software verification and validation (per IEC 62304 and IEC 62366), and electromagnetic compatibility/electrical safety testing (per IEC 60601-1-2).

Technological Characteristics

Spectral Domain OCT; Super Luminescent Diode (840 nm); 27,000 A-scans/sec; axial resolution 5.5 µm (at 2.9 mm depth); connectivity via CALLISTO eye assistance system; integrated into surgical microscopes (ARTEVO 750/850); IP20 enclosure; Class 1 protection; software-controlled via touch panel or foot control.

Indications for Use

Indicated for in vivo viewing, axial cross-sectional, and 3D imaging of posterior ocular structures (retina, macula, optic disc) and anterior ocular structures (cornea, lens, anterior chamber angle) in patients undergoing ophthalmic surgery.

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

• RESCAN 700 (Software Version 2.0) (K180229)

Reference Devices

• CALLISTO eye 5.0 (K232944)
• CALLISTO eye 3.6 (K180858)
• CALLISTO eye 3.7 (K231676)

Submission Summary (Full Text)

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March 8, 2024

Carl Zeiss Meditec AG % Aditya Rao Regulatory Affairs Specialist - USA Carl Zeiss Meditec, Inc 5300 Central Parkway Dublin, California 94568

Re: K233421

Trade/Device Name: Rescan 700 (SW 3.0) Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: OBO Dated: January 29, 2024 Received: January 30, 2024

Dear Aditya Rao:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Elvin Ng Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices

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Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

K233421

Device Name

RESCAN 700 (SW 3.0)

Indications for Use (Describe)

RESCAN 700 provides non-contact, high resolution optical coherence tomographic (OCT) and biomicroscopic imaging of the anterior and posterior segment of the eve via an ophthalmic surgical microscope. The RESCAN 700 is indicated for in vivo viewing, axial cross sectional, and three-dimensional imaging of posterior ocular structures, including retina, macula, and optic disc, as well as imaging of anterior ocular structures, including the cornea, lens and anterior chamber angle.

RESCAN 700 uses the assistance system (CALLISTO eye) that provides non-diagnostic video documentation and image capture for ophthalmic surgeries. The assistance system allows the remote control of RESCAN 700.

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

In accordance with 21 CFR 807.92 the 510(k) Summary for the RESCAN 700 is provided below.

## 1. SUBMITTER

| Applicant: | Carl Zeiss Meditec AG<br>Goeschwitzer Strasse 51-52<br>D-07745 Jena<br>Germany |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant Contact | Dr. Katrin Faber<br>Head of RA/CA SPS<br>[phone] Phone <br>E-mail: [e-mail] |
| Primary Correspondent | Aditya Rao<br>Regulatory Affairs Specialist - USA<br>Carl Zeiss Meditec, Inc.<br>5300 Central Parkway Dublin, CA 94568<br>[phone] Phone [phone] Fax<br>E-mail: [e-mail] (preferred) |
| Date Prepared: | March 08, 2024 |

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Page 2 of 8

RESCAN 700 (SW 3.0) Device Trade Name: 510(k) Number: K233421 21CFR886.1570 Tomography, Optical coherence Classification: Regulatory Class: Ⅱ OBO Product Code:

### 3. PREDICATE DEVICE

Predicate Device: RESCAN 700 (Software Version 2.0) 510(k) number K180229 Classification: 21CFR886.1570 Tomography, Optical coherence Regulatory Class: II Product Code: OBO

### 4. DEVICE DESCRIPTION

RESCAN 700 brings Spectral Domain OCT technology to the ZEISS ophthalmic surgical microscopes (e.g. ARTEVO 800). Used in conjunction with the assistance system, CALLISTO eye, OCT images taken intra-operatively are presented on the monitor and may also be seen within the surgeon's oculars using the surgical microscopes integrated data injection system (IDIS). OCT images may be stored for subsequent retrieval using CALLISTO eye's data management system. RESCAN 700 can be controlled via the touch panel of the assistance system or via the foot control panel of an ophthalmic surgical microscope

### INDICATIONS FOR USE ડ.

RESCAN 700 provides non-contact, high resolution, optical coherence tomographic (OCT) and biomicroscopic imaging of the anterior and posterior segment of the eye via an ophthalmic surgical microscope. The RESCAN 700 is indicated for in vivo viewing, axial cross sectional, and threedimensional imaging of posterior ocular structures, including retina, macula, and optic disc, as well as imaging of anterior ocular structures, including the cornea, lens and anterior chamber angle.

RESCAN 700 uses the assistance system (CALLISTO eye) that provides non-diagnostic video documentation and image capture for ophthalmic surgeries. The assistance system allows the remote control of RESCAN 700.

This device is for Prescription Use (Rx) only.

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## SUBSTANTIAL EQUIVALENCE 6.

## Primary Predicate 6.1.

Table 1. Subject to Predicate Device Comparison Table – Indications for Use

| Subject Device (K233421) | Predicate Device (K180229) | Equivalency<br>Analysis |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| RESCAN 700 provides non-<br>contact, high resolution, optical<br>coherence tomographic (OCT) and<br>biomicroscopic imaging of the<br>anterior and posterior segment of<br>the eye via an ophthalmic surgical<br>microscope. The RESCAN 700 is<br>indicated for in vivo viewing, axial<br>cross sectional, and three-<br>dimensional imaging of posterior<br>ocular structures, including retina,<br>macula, and optic disc, as well as<br>imaging of anterior ocular<br>structures, including the cornea,<br>lens and anterior chamber angle. | RESCAN 700 provides non-<br>contact, high resolution, optical<br>coherence tomographic (OCT) and<br>biomicroscopic imaging of the<br>anterior and posterior segment of<br>the eye via an ophthalmic surgical<br>microscope. The RESCAN 700 is<br>indicated for in vivo viewing, axial<br>cross sectional, and three-<br>dimensional imaging of posterior<br>ocular structures, including retina,<br>macula, and optic disc, as well as<br>imaging of anterior ocular<br>structures, including the cornea,<br>lens and anterior chamber angle. | Identical |
| RESCAN 700 uses the assistance<br>system (CALLISTO eye) that provides<br>non-diagnostic video documentation<br>and image capture for ophthalmic<br>surgeries. The assistance system allows<br>the remote control of RESCAN 700 | RESCAN 700 uses the assistance<br>system (CALLISTO eye) that provides<br>non-diagnostic video documentation<br>and image capture for ophthalmic<br>surgeries. The assistance system allows<br>the remote control of RESCAN 700 | |

Table 2. Subject to Predicate Device Comparison Table – Technical Characteristics

| Attribute | Subject Device<br>(K422421) | Primary Predicate<br>Device (K180229) | Equivalency<br>Analysis |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Device name | RESCAN 700 (SW 3.0) | RESCAN 700 (SW2.0) | N/A |
| Software Version | 3.0 | 2.0 | N/A |
| Manufacturer | Carl Zeiss Meditec AG | Carl Zeiss Meditec AG | Identical |
| 510(k) | TBD | K180229 | N/A |
| Classification Product<br>Code | OBO | OBO | Identical |
| Regulation # | 21CFR886.1570 | 21CFR886.1570 | Identical |
| | Tomography, Optical<br>Coherence | Tomography, Optical<br>Coherence | |
| Review Panel | Ophthalmic | Ophthalmic | Identical |
| Patient Contact | No | No | Identical |
| OCT methodology | Spectral Domain OCT | Spectral Domain OCT | Identical |
| 510(k) Summary<br>Attribute | Subject Device<br>(K422421) | Primary Predicate<br>Device (K180229) | Page<br>Equivalency<br>Analysis |
| Optical source | Super Luminescent<br>Diode (SLD) | Super Luminescent<br>Diode (SLD) | Identical |
| Wavelength | 840 nm | 840 nm | Identical |
| Bandwith | 3 dB: 32 nm | 3 dB: 32 nm | Identical |
| Radiation power | < 4 mW | < 4 mW | Identical |
| Emission duration | > 16 min | > 16 min | Identical |
| Beam divergence | Colliminated beam | Colliminated beam | Identical |
| Optical power | 620 µW on cornea | 620 µW on cornea | Identical |
| OCT Scan Speed | 27,000 A-Scans per<br>second | 27,000 A-Scans per<br>second | Identical |
| OCT Scan Area | Scan area, after OCT<br>telescope,<br>max. 38 x 36° x 38 x 36° | Scan area, after OCT<br>telescope,<br>max. 38 x 36° x 38 x 36° | Identical |
| OCT Scan Dimensions<br>(Posterior Segment) | 16 x16 mm (Cube scans)<br>3 to 16 mm for line scans<br>(in steps of 1 mm) | 16 x16 mm (Cube scans)<br>3 to 16 mm for line scans<br>(in steps of 1 mm) | Identical |
| A-Scan depth | 2.9 mm (in the tissue)<br>5.8 mm (in the tissue) | 2.9 mm (in the tissue)<br>5.8 mm (in the tissue) | Identical |
| Axial Resolution | 5.5 µm (in the tissue)<br>at 2.9 mm scan depth<br>11.0 µm (in the tissue)<br>at 5.8mm scan depth | 5.5 µm (in the tissue)<br>at 2.9 mm scan depth<br>11.0 µm (in the tissue)<br>at 5.8mm scan depth | Identical |
| Signal to noise ratio | >=26 dB | >=26 dB | Identical |
| Sensitivity noise level | <10 dB | <10 dB | Identical |
| Camera Resolution | 2048 pixel * 200<br>microns | 2048 pixel * 20<br>microns | Equivalent<br>The pixel width of<br>200 microns<br>compared to 20<br>microns does not<br>impact the axial<br>resolution or signa<br>quality |
| Traversal Resolution<br>(OCT Scan) | 15 µm (in the tissue) | 15 µm (in the tissue) | Identical |
| Scan rotation | Adjustable 0 – 360° (step<br>with 1°) | Adjustable 0 – 360° (step<br>with 1°) | Identical |
| Scan Patterns<br>(OCT Scan) | Single line, cross hair, 5-<br>line scan, cube scan | Single line, cross hair, 5-<br>line scan, cube scan | Identical |
| Scan Types | Live Capture | Live Capture | Identical for<br>RESCAN 700 |
| 510(k) Summary | | | Page 5 of 8 |
| | HD 1 Line HD 1 Line | HD 1 Line HD 1 Line | |
| Abbreviation: | SD 1 Line SD 1 Line | SD 1 Line SD 1 Line | IFU reflects Scan |
| HD: High Definition | | | Mode that can be used |
| SD: Standard | HD 5 Line HD 5 Line | HD 5 Line HD 5 Line | within the whole |
| | SD 5 Line SD 5 Line | SD 5 Line SD 5 Line | system |
| | HD 2 Line Cube Scan | HD 2 Line Cube Scan | |
| | SD 2 Line 200x200 | SD 2 Line 200x200 | |
| | Cube Scan | Cube Scan | |
| | 512x128 | 512x128 | |
| | | | |
| | (Note: The 2<br>Line scan = | (Note: The 2<br>Line scan = | |
| | Middle | Middle | |
| | Vertical &<br>Middle | Vertical &<br>Middle | |
| | Horizontal<br>B-scans) | Horizontal<br>B-scans) | |
| Refresh rate | 5 Hz for each line in scan<br>type | 5 Hz for each line in scan<br>type | Identical |
| OCT focus | Adjustable independent | Adjustable independent | Identical |
| Attribute | Subject Device<br>(K422421)<br>of the microscope focus | Primary Predicate<br>Device (K180229)<br>of the microscope focus | Equivalency<br>Analysis |
| OCT Scan Pixels | 1024 axial, 200 - 4096<br>transverse | 1024 axial, 200 - 4096<br>transverse | Identical |
| Measurement of ocular<br>structures | No | No | Identical |
| Normative<br>Databases | No | No | Identical |
| Configuration | OCT System (Box and<br>OCT Scanning Unit)<br>integrated into a surgical<br>Microscope (e.g.<br>ARTEVO 750/850).<br>Connected to<br>assistance system,<br>CALLISTO eye,<br>for display of images on<br>monitor<br>and integrated<br>touchscreen with PC. | OCT System (Box and<br>OCT Scanning Unit)<br>integrated into a surgical<br>Microscope (e.g.<br>ARTEVO 800).<br>Connected to<br>assistance system,<br>CALLISTO eye,<br>for display of images on<br>monitor<br>and integrated<br>touchscreen with PC. | Identical |
| Surgical<br>Microscopes+Software | ARTEVO 750/850<br>CALLISTO eye 5.0<br>(K232944) | OPMI LUMERA 700 or Equivalent.<br>ARTEVO 800<br>CALLISTO eye 3.6<br>(K180858)/ CALLISTO eye 3.7 (K231676) | (Connectivity to OPMI<br>LUMERA 700 /<br>ARTEVO 800 and<br>previous CALLISTO<br>eye versions is no<br>longer supported<br>in RESCAN700 SW3.0 |
| Materials - Patients<br>Contacting | None | None | Identical |
| 510(k) Summary | | | Page 6 of 8 |
| Electrical Requirements | Supplied by surgical<br>microscope:<br>(115): 100 - 125 VAC,<br>50-60 Hz<br>(230): 220 - 240 VAC,<br>50-60Hz<br>Power consumption:<br>Max. 1200 VA | Supplied by surgical<br>microscope:<br>(115): 100 - 125 VAC,<br>50-60 Hz<br>(230): 220 - 240 VAC,<br>50-60Hz<br>Power consumption:<br>Max. 1200 VA | Identical |
| Electrical Safety<br>Parameters | Enclosure Protection:<br>IP20<br>Protection Class: 1<br>Device Type (IEC | Enclosure Protection:<br>IP20<br>Protection Class: 1<br>Device Type (IEC<br>60601-1): no applied part 60601-1): no applied part | Identical |
| Ambient conditions for<br>storage and transport | Temp. -20° to +60° C<br>Relative Humidity 10%<br>to 90% (without<br>condensation)<br>Atmospheric Pressure<br>500 to 1060 hPa | Temp. -20° to +60° C<br>Relative Humidity 10%<br>to 90% (without<br>condensation)<br>Atmospheric Pressure<br>500 to 1060 hPa | Identical |
| Ambient conditions for<br>operation | Temp. +10 °C to +40 °C<br>Relative Humidity 30 %<br>to 75 % (excluding<br>condensation)<br>700 to 1060 hPa<br>Altitude up to 3,000m<br>above sea level | Temp. +10 °C to +40 °C<br>Relative Humidity 30 %<br>to 75 % (excluding<br>condensation)<br>700 to 1060 hPa<br>Altitude up to 3,000m<br>above sea level | Identical for<br>RESCAN 700.<br>IFU reflects ambient<br>conditions for the<br>whole system. |

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# 510(k) Summary

Page 7 of 8

The proposed product, RESCAN 700, will be used with CALLISTO eye, Software version 5.0 (K232944). The predicate device, RESCAN 700, was used with CALLISTO eye Software version 3.6 (K180858) & CALLISTO eye Software version 3.7 (K231676).

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### SUMMARY OF STUDIES 7.

## Non-Clinical Performance Testing

## Software Verification and Validation Testing

Rescan 700 is a cyber device per 524B(c) of the Food, Drug & Cosmetic Act. ZEISS has followed the recommendations in the Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (fda.gov) (https://www.fda.gov/media/119933/download) guidance document (September 27, 2023). RESCAN 700 was tested according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (June 2023). In addition, the software testing also followed the Carl Zeiss Meditec internal software development procedure that follows the IEC 62304:2006+AC:2008 + AC:2015 - Medical device software life cycle processes. Validation has been conducted according to IEC 62366. Testing passed.

## Electromagnetic compatibility (EMC) and Electrical Safety Testing

Electrical safety and EMC testing were conducted in accordance with IEC 60601-1-2, IEC 60601-1-2 6 standards. Testing passed.

## Animal/Clinical Performance Testing

Animal and Clinical testing was not conducted.

### 8. REASONS FOR 510(k)

The subject device qualifies as a class II medical device and is therefore subject to a premarket notification.

The main purpose of this 510(k) is to bring FDA up to date on non-significant changes implemented since the last 510(k) clearance for RESCAN 700 SW 2.0 (K180229).

In summary, the changes include:

- Minor Software changes
- Changes to components and parts on the RESCAN 700 due to obsolescence reason, cost issues and minor improvements
- . Minor changes to the instruction for use.

### 9. CONCLUSION

The indications for use are equivalent to the indications for use of the predicate device and therefore, are deemed to be equivalent in their relationship to safety and effectiveness.

The technological characteristics and risk profile of the subject device are equivalent to the predicate device and reference device; and therefore, are deemed to be equivalent in their relationship to safety and effectiveness.

Testing methods are equivalent to those of the predicate device; and therefore, and therefore, are deemed to be equivalent in their relationship to safety and effectiveness.

Therefore, the subject device meets the requirements for substantial equivalence.