(150 days)
No
The summary describes standard OCT and biomicroscopic imaging technology with data management and remote control features, but does not mention any AI or ML capabilities.
No.
The device is indicated for imaging and viewing, which are diagnostic functions, not therapeutic.
No
The "Intended Use" section explicitly states that RESCAN 700 "provides non-contact, high resolution optical coherence tomographic (OCT) and biomicroscopic imaging" and is "indicated for in vivo viewing, axial cross sectional, and three-dimensional imaging". It also states that the "assistance system (CALLISTO eye) that provides non-diagnostic video documentation and image capture for ophthalmic surgeries." This indicates the device is for imaging and documentation, not diagnosis.
No
The device description explicitly states it "brings Spectral Domain OCT technology to the ZEISS ophthalmic surgical microscopes" and is used "in conjunction with the assistance system, CALLISTO eye". It also mentions control via a "touch panel" and "foot control panel". This indicates the device is integrated with and relies on significant hardware components (OCT technology, surgical microscope, assistance system, control panels) and is not solely software.
Based on the provided information, the RESCAN 700 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- RESCAN 700's Function: The RESCAN 700 is an imaging device that performs non-contact, in vivo imaging of the eye. It directly images the structures of the eye within the living patient.
- Intended Use: The intended use clearly states "in vivo viewing, axial cross sectional, and three-dimensional imaging of posterior ocular structures... as well as imaging of anterior ocular structures." This is direct imaging of the patient, not analysis of a specimen taken from the patient.
Therefore, the RESCAN 700 falls under the category of an in vivo imaging device, not an IVD.
N/A
Intended Use / Indications for 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.
Product codes
OBO
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
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical Coherence Tomography (OCT), Biomicroscopic imaging
Anatomical Site
anterior and posterior segment of the eye, including retina, macula, optic disc, cornea, lens and anterior chamber angle.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Rx) only, ophthalmic surgeons in surgical settings.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Software Verification and Validation Testing: RESCAN 700 was tested according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (June 2023) and Carl Zeiss Meditec internal software development procedure (IEC 62304:2006+AC:2008 + AC:2015 and IEC 62366). Testing passed.
Electromagnetic compatibility (EMC) and Electrical Safety Testing: Conducted in accordance with IEC 60601-1-2, IEC 60601-1-2 6 standards. Testing passed.
Animal/Clinical Performance Testing: Not conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.1570 Ophthalmoscope.
(a)
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.(b)
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a seal on the left and the FDA acronym with the agency's name on the right. The seal features an eagle with outstretched wings, surrounded by text that reads "Department of Health & Human Services - USA". To the right of the seal, the acronym "FDA" is displayed in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
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"
1
(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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Elvin Ng Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known)
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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4
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
Goeschwitzer Strasse 51-52
D-07745 Jena
Germany |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant Contact | Dr. Katrin Faber
Head of RA/CA SPS
+49 7364 20 1606 Phone
E-mail: katrin.faber@zeiss.com |
| Primary Correspondent | Aditya Rao
Regulatory Affairs Specialist - USA
Carl Zeiss Meditec, Inc.
5300 Central Parkway Dublin, CA 94568
(925) 549-9579 Phone (925) 557-4259 Fax
E-mail: aditya.rao@zeiss.com (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.
6
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
Analysis |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| 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 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 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 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. | Identical |
| 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 | 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 | |
Table 2. Subject to Predicate Device Comparison Table – Technical Characteristics
| Attribute | Subject Device
(K422421) | Primary Predicate
Device (K180229) | Equivalency
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
Code | OBO | OBO | Identical |
| Regulation # | 21CFR886.1570 | 21CFR886.1570 | Identical |
| | Tomography, Optical
Coherence | Tomography, Optical
Coherence | |
| Review Panel | Ophthalmic | Ophthalmic | Identical |
| Patient Contact | No | No | Identical |
| OCT methodology | Spectral Domain OCT | Spectral Domain OCT | Identical |
| 510(k) Summary
Attribute | Subject Device
(K422421) | Primary Predicate
Device (K180229) | Page
Equivalency
Analysis |
| Optical source | Super Luminescent
Diode (SLD) | Super Luminescent
Diode (SLD) | Identical |
| Wavelength | 840 nm | 840 nm | Identical |
| Bandwith | 3 dB: 32 nm | 3 dB: 32 nm | Identical |
| Radiation power | 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
second | 27,000 A-Scans per
second | Identical |
| OCT Scan Area | Scan area, after OCT
telescope,
max. 38 x 36° x 38 x 36° | Scan area, after OCT
telescope,
max. 38 x 36° x 38 x 36° | Identical |
| OCT Scan Dimensions
(Posterior Segment) | 16 x16 mm (Cube scans)
3 to 16 mm for line scans
(in steps of 1 mm) | 16 x16 mm (Cube scans)
3 to 16 mm for line scans
(in steps of 1 mm) | Identical |
| A-Scan depth | 2.9 mm (in the tissue)
5.8 mm (in the tissue) | 2.9 mm (in the tissue)
5.8 mm (in the tissue) | Identical |
| Axial Resolution | 5.5 µm (in the tissue)
at 2.9 mm scan depth
11.0 µm (in the tissue)
at 5.8mm scan depth | 5.5 µm (in the tissue)
at 2.9 mm scan depth
11.0 µm (in the tissue)
at 5.8mm scan depth | Identical |
| Signal to noise ratio | >=26 dB | >=26 dB | Identical |
| Sensitivity noise level |