(168 days)
The SPECTRALIS with Flex Module is a non-contact ophthalmic diagnostic imaging device intended to aid in the visualization of the posterior segment structures of the eye and vasculature of the retina and choroid. SPECTRALIS with Flex Module is intended for imaging of adults and pediatric patients in supine position.
The Heidelberg Engineering SPECTRALIS with Flex Module is based on the predicate SPECTRALIS HRA+OCT consisting of an accessory device mount allowing imaging of patients in supine position. The SPECTRALIS with Flex Module is intended for visualization of the posterior segments of the human eye. The SPECTRALIS with Flex Module is using the identical technologies as the predicate SPECTRALIS tabletop configuration (K223557), i.e. it is a combination of a confocal laser-scanning ophthalmoscope (cSLO, the HRA portion) and a spectral-domain optical coherence tomographer (SD-OCT).
Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
Device Name: SPECTRALIS with Flex Module
Predicate Device: SPECTRALIS HRA+OCT (K223557)
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance (SPECTRALIS with Flex Module) |
|---|---|---|
| Overall Image Quality | Images should have overall image quality sufficient to assess clinically relevant content. | In the effectiveness population (All Eyes):- 100% of OCT images were assessed as having sufficient overall image quality.- 100% of IR cSLO images were assessed as having sufficient overall image quality.- 97.2% of OCTA images were assessed as having sufficient overall image quality. (Page 14) |
| Visibility of Key Anatomic Structures | Key anatomic structures should be clinically acceptably visualized. | In the effectiveness population (All Eyes):- Clinically acceptable visualization of key anatomic structures was achieved on OCT in 100% of assessments.- On OCTA, clinically acceptable visualization was achieved in 94.4% to 97.2% of assessments. (Page 14)The results generally demonstrate that investigational SPECTRALIS with Flex images provide similar visualization as compared to the predicate SPECTRALIS. (Page 14-15) |
| Identification of Pre-specified Abnormalities | The device should have comparable ability to identify pre-specified abnormalities (structural via OCT, vascular via OCTA) compared to the predicate device. | - Agreement rates (between investigational device and predicate for same result): - Structural abnormalities on OCT: ≥ 84.3%. - Vascular abnormalities on OCTA: ≥ 85.1%.- Negative Percent Agreement (NPA) in All Eyes for all pre-specified abnormalities: - On OCT: at least 87.8%. - On OCTA: at least 92.6%.- Positive Percent Agreement (PPA) for All Eyes for all pre-specified abnormalities (with more than 2 cases identified on the predicate): - On OCT: at least 75%. - On OCTA: at least 75%.These results indicate the ability to identify each pre-specified abnormality is similar between devices. (Page 15) |
| Safety | The device should not introduce new safety concerns. | No adverse events occurred during the course of the study. (Page 14) |
| Substantial Equivalence (General) | The device should be as safe and effective as the predicate devices. | The study concludes that the SPECTRALIS with Flex Module is substantially equivalent to the predicate SPECTRALIS with regards to image quality, visibility of key anatomic structures, and identification of structural and vascular abnormalities, and supports its safety. (Page 15) |
| Supine & Pediatric Patients | Demonstrate effective and safe imaging for pediatric and adult patients in the supine position. | The clinical study included adult patients (22 years or older) and the literature review provides evidence for safe and effective use in pediatric conscious or unconscious patients in the supine position. The device shares the patient profile (conscious/unconscious pediatrics and adults in supine position) with the secondary predicate device (Bioptigen ENVISU). (Page 15-16) |
Study Details
-
Sample size used for the test set and the data provenance:
- Subjects Enrolled: 88
- Subjects Completed Study: 84
- Effectiveness Analysis Population: 76 participants (25 Normal subjects, 51 Posterior Segment Abnormality subjects). The exact count varied slightly for each image type based on abnormalities of interest and acceptable acquisitions.
- Data Provenance: Single clinical site, located in the United States. The study was prospective and observational.
- Patient Demographics:
- Mean age: 57.3 ± 19.2 years (overall)
- Gender: 59.2% female, 40.8% male
- Ethnicity: 96.1% did not identify as Hispanic or Latino
- Race: 80% White, 18.4% Black/African American, 2.6% Asian
- Study Populations:
- Adult Normal Eyes (no posterior segment abnormalities)
- Adult Posterior Segment Abnormality Eyes (structural and/or vascular posterior segment abnormalities)
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Three independent readers.
- Qualifications: Referred to as "independent readers from a reading center." No specific qualifications (e.g., years of experience, subspecialty) are provided in this extract.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The text states that the "proportion of images graded better than Poor on consensus" was used. For abnormality identification, "agreement rates (based on the abnormalities identified by the reading center on the predicate, percentage of eyes with the same result on the investigational device)" were utilized. This implies that the three readers likely had a consensus process for the overall image quality and visibility assessments, and for abnormality identification, agreement with the predicate's findings by the reading center was important. The specific 2+1 or 3+1 method is not explicitly mentioned, but the term "consensus" suggests an agreed-upon finding among the readers.
-
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:
- This was not an MRMC comparative effectiveness study involving AI assistance. The study was designed to show substantial equivalence between the investigational device (SPECTRALIS with Flex Module) and its predicate (SPECTRALIS HRA+OCT) regarding image quality and ability to identify abnormalities. There is no mention of AI or its impact on human reader performance.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, this was not a standalone (algorithm-only) study. The study involved human readers (three independent readers) to grade images obtained from the device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for image quality, visibility of structures, and identification of abnormalities was established through expert grading by three independent readers from a reading center, likely using expert consensus to interpret findings. The predicate device's findings also served as a reference for agreement in abnormality detection.
-
The sample size for the training set:
- The provided text does not contain information about a training set size. The clinical study described is for validation and comparison to a predicate, not for training a new algorithm.
-
How the ground truth for the training set was established:
- As no training set is mentioned, this information is not applicable based on the provided document.
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October 11, 2024
Image /page/0/Picture/1 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
Heidelberg Engineering GmbH % Lena Sattler Consultant Orasi Consulting, LLC. 226 1st Street Bonita Springs, Florida 34134
Re: K241163
Trade/Device Name: SPECTRALIS with Flex Module Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: OBO, MYC Dated: April 26, 2024 Received: April 26, 2024
Dear Lena Sattler:
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" (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).
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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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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).
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Sincerely,
Elvin Y. Ng -S
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
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Indications for Use
510(k) Number (if known) K241163
Device Name SPECTRALIS with Flex Module
Indications for Use (Describe)
The SPECTRALIS with Flex Module is a non-contact ophthalmic diagnostic imaging device intended to aid in the visualization of the posterior segment structures of the eye and vasculature of the retina and choroid. SPECTRALIS with Flex Module is intended for imaging of adults and pediatric patients in supine position.
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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Image /page/4/Picture/1 description: The image contains the logo for Heidelberg Engineering. The logo consists of two lines of text, with a red square on either side. The first line reads "HEIDELBERG" and the second line reads "ENGINEERING". The text is in a bold, sans-serif font.
510(K) SUMMARY
Date Prepared
September 09, 2024
SPONSOR/510(K) OWNER/ MANUFACTURER
Heidelberg Engineering GmbH Max-Jarecki-Strasse 8 69115 Heidelberg, Germany Telephone: Facsimile: Email: Establishment Registration No.:
+49 6221 / 64 63 0 +49 6221 / 64 63 62 arianna.schoess.vargas@heidelbergengineering.com 8043762
OFFICIAL CONTACT PERSON
Lena Sattler Orasi Consulting, LLC. 226 1st Street Bonita Springs, FL 34134 Telephone: Facsimile: E-mail:
(440) 554-3706 (866) 904-4315 lena@orasiconsulting.com
COMMON/USUAL NAME
Optical Coherence Tomography
PROPRIETARY OR TRADE NAMES
SPECTRALIS with Flex Module
CLASSIFICATION INFORMATION
| Classification Name: | Tomography, Optical CoherenceOphthalmoscope, Laser, Scanning |
|---|---|
| Medical Specialty: | Ophthalmic |
| Device Class: | II |
| Classification Panel: | Ophthalmic Device Panel |
| Product Codes: | OBO, MYC |
PRODUCT CODE: CLASSIFICATION / CFR TITLE
OBO, MYC: Class II § 21 CFR 886.1570
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PRIMARY PREDICATE DEVICE
SPECTRALIS HRA+OCT and variants (K223557), Heidelberg Engineering GmbH
SECONDARY PREDICATE DEVICE
Bioptigen ENVISU Spectral Domain Ophthalmic Imaging System (K120057)
INDICATIONS FOR USE
The SPECTRALIS with Flex Module is a non-contact ophthalmic diagnostic imaging device intended to aid in the visualization of the posterior segment structures of the eye and vasculature of the retina and choroid. SPECTRALIS with Flex Module is intended for imaging of adults and pediatric patients in supine position.
GENERAL DEVICE DESCRIPTION
The Heidelberg Engineering SPECTRALIS with Flex Module is based on the predicate SPECTRALIS HRA+OCT consisting of an accessory device mount allowing imaging of patients in supine position. The SPECTRALIS with Flex Module is intended for visualization of the posterior segments of the human eye. The SPECTRALIS with Flex Module is using the identical technologies as the predicate SPECTRALIS tabletop configuration (K223557), i.e. it is a combination of a confocal laser-scanning ophthalmoscope (cSLO, the HRA portion) and a spectral-domain optical coherence tomographer (SD-OCT).
COMPARISON BETWEEN THE SUBJECT AND THE PREDICATE DEVICE
The modifications made to the SPECTRALIS HRA+OCT with the introduction of the optional accessory, the Flex Module do not change the applied technologies (OCT, cSLO) and the imaging modes of SPECTRALIS. The main differences between the SPECTRALIS with Flex Module and the predicate tabletop configuration cleared in K223557 are that the SPECTRALIS with Flex Module is for visualization only and allows imaging of supine patients. The imaging of supine patients expands the patient profile by including patients unable to follow simple instructions (e.g., unconscious, pediatrics). The tabletop SPECTRALIS with headrest requires upright sitting and thus awake patients able to follow simple instructions and provides measurements and includes reference databases.
The application of a non-contact ophthalmic OCT device for imaging of conscious or unconscious pediatrics and adults in supine position is also supported by the secondary predicate device, the Bioptigen ENVISU Imaging System which was cleared in K120057. The Bioptigen ENVISU device consists of a handheld, lightweight camera (scan head) which can be also mounted and provides a mobile cart for the optical engine and power supply. Due to the principle of using a handheld camera the physical dimensions and layout is different for the Bioptigen ENVISU and the subject and predicate SPECTRALIS devices, respectively.
Accordingly, due to its use for imaging supine patients, the mobile Flex Module has a different layout as well as larger dimensions and weight than the fixed camera mount
Heidelberg Engineering
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used for the tabletop. All other components to be used with the SPECTRALIS device are unchanged for the SPECTRALIS with Flex Module and are similar for the Bioptigen ENVISU. The SPECTRALIS with Flex Module uses an identical camera, the same power supply and touch panel as the predicate tabletop SPECTRALIS.
The Substantial Equivalence summary tables below illustrate the comparisons of the subject SPECTRALIS to the predicate devices.
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Image /page/7/Picture/0 description: The image contains the logo for Heidelberg Engineering. The logo consists of two lines of text, with a red square on either side. The first line reads "HEIDELBERG" and the second line reads "ENGINEERING".
INDICATIONS FOR USE STATEMENT CHART
| Subject DeviceSPECTRALIS with Flex Module(K241163) | Primary Predicate DeviceSPECTRALIS(K223557) | Secondary Predicate DeviceBioptigen ENVISUTM SpectralDomain Ophthalmic ImagingSystem (K120057) | Same, similar ordifferent |
|---|---|---|---|
| The SPECTRALIS with Flex Module is a non-contact ophthalmic diagnostic imaging deviceintended to aid in the visualization of the posteriorsegment structures of the eye and vasculature ofthe retina and choroid. SPECTRALIS with FlexModule is intended for imaging of adults andpediatric patients in supine position. | The SPECTRALIS is a non-contact ophthalmicdiagnostic imaging device. It is intended for:• viewing the posterior segment of the eye,including two- and three-dimensional imaging• cross-sectional imaging (SPECTRALISHRA+OCT and SPECTRALIS OCT)• fundus imaging• fluorescence imaging (fluoresceinangiography, indocyanine green angiography;SPECTRALIS HRA+OCT, SPECTRALIS HRA)• autofluorescence imaging (SPECTRALISHRA+OCT, SPECTRALIS HRA andSPECTRALIS OCT with BluePeak)• performing measurements of ocular anatomyand ocular lesions.The device is indicated as an aid in the detectionand management of various ocular diseases,including:• age-related macular degeneration• macular edema• diabetic retinopathy• retinal and choroidal vascular diseases• glaucomaThe device is indicated for viewing geographicatrophy.The SPECTRALIS OCT Angiography Module isindicated as an aid in the visualization of vascularstructures of the retina and choroid. TheSPECTRALIS HRA+OCT and SPECTRALISOCT include the following reference databases:• a retinal nerve fiber layer thickness reference | Bioptigen ENVISUTM Spectral DomainOphthalmic Imaging System (SDOIS) isintended to acquire, process, display andsave depth-resolved images of oculartissue microstructure using SpectralDomain Optical Coherence Tomography(SD-OCT). The ENVISU SDOIS isindicated for use as an aid in thediagnosis of physiologic and pathologicconditions of the eye through non-contactoptical imaging. Imaging of the varioustissues of the eye is supported throughthe use of interchangeable lenses. It isindicated for use on patient populationsfrom premature and neonatal infants toadult, and is suitable for patientsambulatory or confined. The system isindicated for use in upright or supineimaging, handheld or mounted, and issuited for imaging patients underanesthesia. | K223557: Different(measurements,upright patients)K120057: Similar(visualization only,pediatric andsupine patients) |
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| compare the retinal nerve fiber layer in thehuman retina to values of Caucasian normalsubjects – the classification result being validonly for Caucasian subjects• a reference database for retinal nerve fiberlayerthickness and optic nerve head neuroretinal rimparameter measurements, which is used toquantitatively compare the retinal nerve fiberlayer and neuroretinal rim in the human retina tovalues of normal subjects of different races andethnicities representing the population mix of theUSA (Glaucoma Module Premium Edition) | |
|---|---|
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TECHNOLOGICAL CHARACTERISTICS COMPARISON CHART
| Feature | Subject DeviceSPECTRALIS with FlexModule | Primary Predicate DeviceSPECTRALIS(K223557) | Secondary PredicateDeviceBioptigen ENVISU SpectralDomain Ophthalmic ImagingSystem (K120057) | Same, similar or different |
|---|---|---|---|---|
| Deviceclassificationname | Optical Coherence Tomographer(OCT) | Optical Coherence Tomographer(OCT) | Optical Coherence Tomographer(OCT) | K223557, K120057: Same |
| Technology andoptical setup | Confocal Scanning LaserOphthalmoscope (SLO) andSpectral-Domain OpticalCoherence Tomograph (OCT) | Confocal Scanning LaserOphthalmoscope (SLO) andSpectral-Domain OpticalCoherence Tomograph (OCT) | Spectral-Domain OpticalCoherence Tomograph (OCT) | K223557: SameK120057: Similar (OCT only) |
| PhysicalDimensions | Laser scanning camera: 235 mm x100 mm x 205 mmWeight camera head: 5.6 kgFlex Module:Height 1690 plus 300 swivel rangein mm, width 1467 mm maximumOperation panel:170 mm x 185 mm x 100 mm | Laser scanning camera: 235 mm x100 mm x 205 mmWeight camera head: 5.6 kgCamera Mount:470 mm x 325 mm x 550 mmOperation panel:170 mm x 185 mm x 100 mm | OCT Scan head: 170 mm high x 80mm wide x 230 mm long (incl. lens)Scan head weight: 1.6 kgCart footprint:Height 953 mm alone, 1549 mm withmonitor, width 787 mm, depth 559mm | K223557: DifferentK120057: Different:The Flex Module for supinepatients has otherdimensions than thepredicate tabletop mount withheadrest (K223557). Thepredicate Bioptigen(K120057) is a handheld |
| Feature | Subject DeviceSPECTRALIS with FlexModule | Primary Predicate DeviceSPECTRALIS(K223557) | Secondary PredicateDeviceBioptigen ENVISU SpectralDomain Ophthalmic ImagingSystem (K120057) | Same, similar or different |
| Power supply includingspectrometer:180 mm x 335 mm x 165 mm | Power supply includingspectrometer: 180 mm x 335mm x165 mm | mountable camera with amobile cart. | ||
| Lights sourcesand wavelengthof light emitted | Near infrared reflectance images:diode laser, 815 nm,Blue light reflectance images: diodelaser, 486 nm, or optically pumpedsemiconductor laser, 488 nmGreen light reflectanceimages: diode laser, 518 nmFluorescein angiography: diodelaser, 486 nm, or optically pumpedsemiconductor laser, 488nmIndocyanine green angiography:diode laser, 786 nmOptical coherence tomography:superluminescence diode, 840 nmto 920 nm (weighted average 880nm) | Near infrared reflectance images:diode laser, 815 nm,Blue light reflectance images: diodelaser, 486 nm, or optically pumpedsemiconductor laser, 488 nmGreen light reflectanceimages: diode laser, 518 nmFluorescein angiography: diodelaser, 486 nm, or optically pumpedsemiconductor laser, 488nmIndocyanine green angiography:diode laser, 786 nmOptical coherence tomography:superluminescence diode, 840 nmto 920 nm (weighted average 880nm) | No Laser Scanning (cSLO)availableOptical coherence tomography:superluminescence diode, 760 nmto 930 nm (860 nm) | K223557: Same (cSLO)K120057: N/A (cSLO)K223557: Same (OCT)K120057: Similar (OCT) |
| Amount of lightirradiated toretina (exposure) | Low amount, does not exceedClass I laser accessible emissionlimits | Low amount, does not exceedClass I laser accessible emissionlimits | Class 1 LED | K223557, K120057: Same |
| Lateral opticalresolution (OCT) | 14 μm (standard objective), 24 μm(WFO2) | 14 μm (standard objective), 24 μm(WFO2) | Retina: 20 μm in tissue | K223557: SameK120057: Similar |
| Focusadjustmentrange | Correction of patient's refractiveerrors: minimum range: -12 to +12diopters | Correction of patient's refractiveerrors: minimum range: -12 to +12diopters | Not known | K223557: SameK120057: N/A |
| Optical depthresolution (OCT) | 7 μm | 7 μm | ≤ 6 μm (High Resolution, HR)< 4 μm (Very High Resolution,VHR) | K223557: SameK120057: Similar |
| OCT acquisitionspeed (MaximumA-scan rate) | 40 kHz (Firewire),85 kHz (Thunderbolt) | 40 kHz (Firewire),85 kHz (Thunderbolt) | 32 kHz | K223557: SameK120057: Similar |
| Feature | Subject DeviceSPECTRALIS with FlexModule | Primary Predicate DeviceSPECTRALIS(K223557) | Secondary PredicateDeviceBioptigen ENVISU SpectralDomain Ophthalmic ImagingSystem (K120057) | Same, similar or different |
| OCT acquisitionmodes | Standard, Enhanced Depth Imaging(EDI), Enhanced Vitreous Imaging(EVI) | Standard, Enhanced Depth Imaging(EDI), Enhanced Vitreous Imaging(EVI) | N/A, no different acquisition modesavailable | K223557: SameK120057: N/A |
| cSLO imagingmodes forartifactsuppression | Reflectance (R), Cross-Polarization(XP), Widefield Reflectance (WR) | Reflectance (R), Cross-Polarization(XP), Widefield Reflectance (WR) | N/A, no cSLO imaging available | K223557: SameK120057: N/A |
| OCTA scantypes | Volume OCTA, Scout OCTA, DARTVolume OCTA, DART Line | Volume OCTA, Scout OCTA, DARTVolume OCTA, DART Line | N/A, no OCT-Angiography available | K223557: SameK120057: N/A |
| Lateral field ofview (SLO) | SO (standard objective):15°x15° to 30 x30°HMM: 8°x8°WFO2: 25°x25° to Ø 55°UWF Objective: 51°x 1° to Ø102° | SO (standard objective):15°x15° to 30 x30°HMM: 8°x8°WFO2: 25°x25° to Ø 55°UWF Objective: 51°x 1° to Ø102° | N/A, no cSLO imaging available | K223557: SameK120057: N/A |
| Lateral field ofview (OCT) | Standard objective lens: 15°-30°,WFO2: 25°-55° | Standard objective lens: 15°-30°,WFO2: 25°-55° | Posterior retina: 70° | K223557: SameK120057: Different |
| Lateral digitalresolution (SLO) | High speed mode: 3 um (HMM), 11um (SO) to 40 µm (UWF), Highresolution mode: 1.5µm (HMM), 6um (SO) to 20 µm (UWF) | High speed mode: 3 um (HMM), 11um (SO) to 40 µm (UWF), Highresolution mode: 1.5µm (HMM), 6um (SO) to 20 um (UWF) | N/A, no cSLO imaging available | K223557: SameK120057: N/A |
| Lateral digitalresolution (OCT) | Standard and WFO2 objectivelenses: same as SLO | Standard and WFO2 objectivelenses: same as SLO | Posterior retina: 11 µm | K223557: SameK120057: Similar |
| Axial digitalimage size | 496 pixels | 496 pixels | 512 pixels or 1024 pixles | K223557: SameK120057: Similar |
| Digital axialresolution (pixelsize OCT) | 3.9 µm | 3.9 µm | 1.6 µm or 2.4 µm (1024 pixels) | K223557: SameK120057: Similar |
| Scan depth | 1.9 mm | 1.9 mm | 1.7 mm (High Resolution) or 2.5mm (Very High Resolution) | K223557: SameK120057: Different |
| Acquisition ofthree-dimensionalimages | Yes, HRA: stacks of confocalsection images; OCT: OCT volumescan | Yes, HRA: stacks of confocalsection images; OCT: OCT volumescan | Yes, OCT volume scan | K223557, K120057: Same |
| Feature | Subject DeviceSPECTRALIS with FlexModule | Primary Predicate DeviceSPECTRALIS(K223557) | Secondary PredicateDeviceBioptigen ENVISU SpectralDomain Ophthalmic ImagingSystem (K120057) | Same, similar or different |
| Measurements | Measured data points are notdisplayed | Measured data points are displayed | No measurements | K223557: DifferentK120057: Same(visualization only) |
| Imagecompression | No | No | No | K223557, K120057: Same |
| Display of thedata | Images are visible on a standardPC-Monitor | Images are visible on a standardPC-Monitor | Images are visible on a standardPC-Monitor | K223557, K120057: Same |
| Physical layout | • Mobile instrumentation mountwith swivel arms for camera andaccessories• Optical camera head• Power supply and spectrometerunit• Touch panel• Computer with monitor, keyboard,mouse, and printer | • Fixed camera mount withheadrest and joystick• Optical camera head• Power supply and spectrometerunit• Touch panel• Computer with monitor, keyboard,mouse, and printer | • Mobile cart• Handheld or mounted scanning(camera) head• Power supply, optical engine(spectromerter, LED light)• Computer with monitor | K223557:Different (tabletop mount)Same (other components)K120057:Different (handheld camera,mobile cart),Similar (other components) |
| Patient Profile | • No special assumptions aboutthe ethnicity, body weight,biological sex, or age of thepatient• Patients in supine position• Patients, able to follow simpleinstructions including pediatricsand adults• Patients not able to follow simpleinstructions (unconscious andanesthetized patients patients)including pediatrics and adults | • No special assumptions about theethnicity, body weight, biologicalsex, or age of the patient• Patients sitting upright in front ofthe device• Awake patients, able to followsimple instructions includingpediatrics and adults | • Pediatric patients• Adult patients• Supine patients• Upright sitting patients• Any patient that finds it difficult tosit upright or where it is clinicallypreferable to image without theconstraint of a chin• Anesthetized patients | K223557:Different (awake, upright)K120057:Similar (pediatric, supine) |
| ThunderboltInterface | Thunderbolt-3 Interface | Thunderbolt-3 Interface | N/A (not known) | K223557: SameK120057: N/A |
| Flammability ofthe materials | The metal housing of the deviceprevents flammability | The metal housing of the deviceprevents flammability | The metal housing of the deviceprevents flammability | K223557: SameK120057: Similar |
| Feature | Subject DeviceSPECTRALIS with FlexModule | Primary Predicate DeviceSPECTRALIS(K223557) | Secondary PredicateDeviceBioptigen ENVISU SpectralDomain Ophthalmic ImagingSystem (K120057) | Same, similar or different |
| StandardObjective Lens | 19.5 mm working distance, 31 mmlength, 49 outer mm diameter | 19.5 mm working distance, 31 mmlength, 49 outer mm diameter | 13 mm working distance (posteriorretina) | K223557: SameK120057: Different |
| HighMagnificationModule (HMM) | 50 mm working distance, 29 mmlength, 49 mm outer diameter; notused for measurements; | 50 mm working distance, 29 mmlength, 49 mm outer diameter; notused for measurements; | N/A | K223557: SameK120057: N/A |
| AnteriorSegment Module(ASM) ObjectiveLens | Not available | 12 mm working distance, 65 mmlength, 49.5 mm outer diameter, 30° field of view, not used formeasurements | 15 mm,17 mm or 20 mm workingdistance | K223557: DiferentK120057: Different |
| Wide FieldObjective(WFO2) | 10 mm working distance, 46 mmlength, 49 mm outer diameter; 55°field of view; not used formeasurements; WFO2 has thesame design and optical layout asWFO, but an improved anti-reflective coating | 10 mm working distance, 46 mmlength, 49 mm outer diameter; 55°field of view; not used formeasurements; WFO2 has thesame design and optical layout asWFO, but an improved anti-reflective coating | N/A | K223557: SameK120057: N/A |
| Ultra-Widefield(UWF)AccessoryObjective Lens | 7.8 mm working distance, 167 mmlength, 80 mm outer diameter; 102°field of view; not used formeasurements | 7.8 mm working distance, 167 mmlength, 80 mm outer diameter; 102°field of view; not used formeasurements | N/A | K223557: SameK120057: N/A |
| Objective lensprotection caps | For standard and widefieldobjective lens | N/A | N/A | K223557, K120057: Different |
| SupportedOperatingSystem | Windows 10, Windows 11 | Windows 10, Windows 11 | Windows XP | K223557: SameK120057: Similar |
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NON-CLINICAL PERFORMANCE TESTING
Software documentation was provided, and software verification and validation were conducted as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
Documentation regarding cybersecurity was submitted as recommended by FDA's Guidance for Industry and FDA Staff, "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" and an overall risk assessment regarding security and safety of the device was conducted due to ISO 14971:2019.
Tests for electrical safety (IEC 60601-1:2020) and electromagnetic compatibility (IEC 60601-1- 2:2020 and IEC TR 60601-4-2: 2016) were performed with the SPECTRALIS HRA+OCT device and passed the relevant requirements of the applied standards.
Laser safety testing for the light sources used in the SPECTRALIS HRA+OCT device was provided and showed that the requirements according to FDA recognized standard ANSI Z80.36:2021 was fulfilled.
Biocompatibility of the device was previously demonstrated by cytotoxicity testing, skin sensitization testing and chemical analysis according to ISO 10993-5:2009. ISO 10993-10:2021 and ISO 10993-18:2005, respectively, and supported by biocompatibility assessment according to 10993-1:2018. The test results remain valid for the subject SPECTRALIS.
CLINICAL PERFORMANCE TESTING
One clinical, prospective, observational case study (S-2018-3) was performed at a single clinical site, located in the United States, to collect data in support of a 510(k) submission to obtain marketing clearance of the SPECTRALIS with Flex Module, where the Flex Module is an optional accessory to the SPECTRALIS device consisting of an adjustable camera arm mounted on a wheeled instrument base to enable in-vivo imaging in the supine position for visualization only. The predicate used in the study was the cleared SPECTRALIS HRA+OCT (and variants) with a tabletop-mounted instrumentation base.
There were two study populations, the Adult Normal Eyes population (those without posterior segment abnormalities) and the Adult Posterior Segment Abnormality Eyes population (those with structural and/or vascular posterior segment abnormalities). Randomization was performed for eye selection (if applicable), acquisition type (i.e. OCT and/or OCTA) order (if applicable) and device order. The first acceptable acquisition of each applicable acquisition type (OCTA and/or Standard OCT) from each device was submitted for grading. The IR cSLO image extracted from the first acquisition type for each device (either OCTA or Standard OCT based on randomization order, if applicable) was also separately submitted for grading.
Three independent readers from a reading center graded the IR cSLO, OCT and OCTA images on overall image quality, and for OCT and OCTA only, the readers assessed visibility of key anatomic structures, and identified the presence of abnormalities (or lack
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thereof). The analyses were based on the grading results from the effectiveness analysis population, which included all eligible study eyes with an image result for at least one acquisition from the investigational device (SPECTRALIS with Flex) from the reading center.
Data were collected for agreement analysis to show substantial equivalence between the investigational study device and stated predicate. Eighty-eight (88) subjects signed the informed consent form and were enrolled in the study. Of the 88 subjects enrolled, 84 completed the study and 4 were discontinued (2 subjects were unable to complete required scans, 1 subject withdrew voluntarily and for 1 subject there was a device deficiency that occurred prior to attempting any imaging). There were 9 subjects (5 Normal, 4 Posterior Segment Abnormality) who completed the study but subsequently identified as having failed to meet inclusion/exclusion criteria during study monitoring. One Normal subject who was unable to complete required scans was included in the effectiveness population as they had acceptable scans from both devices on at least one acquisition type.
The safety population consisted of 87 subjects, 30 Normal subjects and 57 Posterior Segment Abnormality subjects. No adverse events occurred during the course of the study. The effectiveness population consisted of 25 Normal subjects and 51 Posterior Segment Abnormality subjects. The effectiveness population count differed for each image type based on the Abnormalities of Interest specified and availability of acceptable acquisitions.
All 76 participants in the effectiveness analysis population were 22 years of age or older, met eligibility criteria in at least one eye and were enrolled into either the Normal population or the Posterior Segment Abnormality population.
The mean age was 57.3 ± 19.2 years overall, with the Posterior Segment Abnormality population subjects being older. The study population had more female subjects (59.2%) than male (40.8%). A majority (96.1%) did not identify as Hispanic or Latino, while 80% identified as White, 18.4% identified as Black/African American and 2.6% identified as Asian.
The Normal population had normal (or non-clinicant) eye examination findings for all study eyes, while 100% of the Posterior Segment Abnormality population study eyes had abnormal (or clinically significant) retina, macular and/or periphery eye examination findings. Posterior Segment Abnormality population study eyes also had abnormal (or clinically significant) ophthalmoscopy findings for 13.8% (undilated) to 22.7% (dilated) of eyes when assessing the optic nerve, and 34.5% (undilated) to 36.4% (dilated) of eyes when assessing the vitreous.
The results of this study found that, based on the proportion of images graded better than Poor on consensus in the effectiveness population in All Eyes, 100% of OCT, 100% of IR cSLO, and 97.2% of OCTA images from the investigational SPECTRALIS with Flex were assessed as having overall image quality sufficient to assess the clinically relevant content. Additionally, in All Eyes, clinically acceptable visualization of key anatomic structures on the investigational SPECTRALIS with Flex was achieved on OCT in 100% of assessments, and on OCTA in 94.4% to 97.2% of assessments. In general, the results
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demonstrate that the investigational SPECTRALIS with Flex images provide similar visualization as compared to the predicate SPECTRALIS.
For identification of pre-specified abnormalities, the agreement rates (based on the abnormalities identified by the reading center on the predicate, percentage of eyes with the same result on the investigational device) for all study populations indicate that the predicate and investigational device have similar outcomes for detecting structural abnormalities on OCT (agreement rate ≥ 84.3%) and vascular abnormalities on OCTA (aqreement rate ≥ 85.1%). Similarly, negative percent agreement (NPA) was also high in All Eyes, with NPA at least 87.8% on OCT and at least 92.6% on OCTA for all prespecified abnormalities. Positive percent agreement (PPA) for All Eyes was at least 75% for all pre-specified abnormalities on OCT and OCTA with more than 2 cases identified on the predicate. The results are similar between the investigational SPECTRALIS with Flex and the predicate SPECTRALIS, indicating that the ability to identify each pre-specified abnormality is similar between the devices.
Summary:
The results of this study show that overall image quality for OCT, OCTA and IR cSLO, and visibility of key anatomic structures for OCT and OCTA, are similar between the predicate SPECTRALIS and investigational SPECTRALIS with Flex in all study populations. Additionally, outcomes are similar between the predicate and investigational devices for identification of each abnormality seen on the investigational device when compared to the predicate. There were also no adverse events that occurred. Therefore, the study results support safety of the investigational SPECTRALIS with Flex and substantial equivalence between the predicate SPECTRALIS and investigational SPECTRALIS with Flex Module with regards to image quality, visibility of key anatomic structures, and identification of structural and vascular abnormalities.
LITERATURE REVIEW
The results of a systematic literature review showed that SPECTRALIS with Flex Module is effective and safe for ophthalmic imaging of the posterior segment in pediatric conscious or unconscious patients in the supine position.
CONCLUSION
The subject SPECTRALIS with Flex Module uses the same imaging technologies as the legally marketed SPECTRALIS (K223557). The results of the non-clinical performance testing demonstrate that the SPECTRALIS with Flex Module functions as intended. The outcome of the clinical performance testing supports substantial equivalence to the subject SPECTRALIS with Flex Module and for the predicate SPECTRALIS tabletop configuration. Furthermore, the results of the systematic literature review provide evidence for the safe and effective use of SPECTRALIS with Flex Module in pediatric conscious or unconscious patients. The application of a non-contact ophthalmic OCT device for supine and pediatric patients is also supported by the secondary predicate device, the Bioptigen ENVISU Imaging System (K120057). The SPECTRALIS with Flex Module shares the patient profile with Bioptigen ENVISU which includes conscious or unconscious pediatrics and adults in the supine position.
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The non-clinical and clinical performance testing as well as the outcome of the literature review demonstrate that the subject SPECTRALIS device is as safe, as effective, and thus substantially equivalent to the predicate devices.
§ 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.