The DIR 800 is an accessory for the Aesculap Aeos and is used in viewing intra-operative blood flow in the cerebral vascular area including, but not limited to, assessing cerebral aneurysm and vessel branch occlusion, as well as patency in neurosurgery. It also aids in the visual assessment of intraoperative blood flow and vessel patency in bypass surgical procedures in neurosurgery.

Device Description

The DIR 800 is an accessory to the Aeos Digital Surgical Microscope Class I 510(k) exempt surgical operating microscope. The DIR 800 allows the Aeos to produce excitation light to illuminate the fluorescence properties of the Indocyanine Green (ICG). The generated fluorescence signal depicts the distribution of the infrared dye in the patient's blood vessels during surgery.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the DIR 800 device. This type of FDA submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving direct safety and effectiveness through extensive clinical trials with strict acceptance criteria often seen for novel devices.

Therefore, the information available in this document is primarily related to proving substantial equivalence, not a standalone "performance study" in the sense of a clinical trial with specific diagnostic accuracy metrics. The "performance data" section largely covers verification and validation (V&V) testing to ensure the device performs as intended and is comparable to the predicate.

Here's an attempt to extract the requested information based on the provided text, while acknowledging the limitations of a 510(k) submission in terms of detailed performance criteria and study design:

Device Name: DIR 800
Predicate Device: Carl Zeiss Surgical GmbH, INFRARED 800 with FLOW Option (K100468)
Intended Use: Accessory for viewing intra-operative blood flow in the cerebral vascular area (e.g., assessing cerebral aneurysm, vessel branch occlusion, patency in neurosurgery, bypass procedures).

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission, the "acceptance criteria" are primarily related to demonstrating substantial equivalence and the device performing as intended through verification and validation. There are no explicit quantitative performance metrics like sensitivity/specificity thresholds mentioned for clinical utility in this document.

Acceptance Criteria (related to verification/validation and substantial equivalence)	Reported Device Performance (Summary from Bench and Animal Studies)
No fluorescence detected when DIR 800 mode disabled.	Pass: No fluorescence detected.
Excitation light bandwidth and peak within 700nm-802nm range at all working distances.	Pass: Excitation light bandwidth and peak fall within the specified range.
Total excitation absorption power over the entire ICG excitation spectrum.	Pass. (Specific value not provided).
Visualization of Aeos DIR 800 mode occurs.	Pass.
Fluorescence pixel intensity shows optics and detectors adequately visualize a fluorescent agent.	Pass.
Compliance with IEC 60601-1 and IEC 60601-2 for electrical safety.	Complies.
Compliance with IEC 60601-1-2 for electromagnetic compatibility (EMC).	Complies.
Software verification and validation conducted (Major level of concern).	Conducted; documentation provided.
Capability to visualize blood flow, vascular structures, and aneurysms in animal models.	Confirmed: Test cases and independent scoring assessments showed DIR 800 enabled viewing of intra-operative blood flow.
Overall image quality, brightness, illumination, visual acuity, visual artifacts, depth perception, contrast, and alignment of visible light vs. fluorescent images are acceptable.	Confirmed: Individual assessments of comparative images met pre-established acceptance criteria.
Visualization of intraoperative blood flow and imaging of aneurysms in small vessels equivalent to Digital Subtraction Angiography (DSA).	Confirmed: Visualizations were equivalent to DSA.
Device reflects intended use and provides intraoperative visualization and visual assessment of blood flow compared to DSA.	Confirmed.
No new questions regarding safety and effectiveness compared to predicate.	Confirmed.

2. Sample Sizes Used for the Test Set and Data Provenance

Test Set (Animal Study):
- Sample Size: A porcine model and a rabbit elastase model. The exact number of animals is not specified beyond "a" model for each.
- Data Provenance: The study was conducted specifically to support this submission. The text doesn't specify country of origin for the animals, but the submission is to the US FDA. It was a prospective animal study.
Test Set (Bench Testing): Not applicable for "sample size" in the traditional sense of patient data. Bench tests would involve specific units of the device or test setups according to a protocol.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Animal Study Experts: "Neurosurgeons" were used for independent scoring assessments.
- Number of Experts: Not specified.
- Qualifications: "Neurosurgeons." No further details on years of experience or board certification are provided in this document.

4. Adjudication Method for the Test Set

The text states that in the animal study, "independent scoring assessments which were predefined in the protocol" were performed. It does not specify a formal adjudication method like 2+1 or 3+1. It implies individual assessments were carried out and then likely compared against pre-established criteria or against the DSA gold standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No.

The study described is an animal study comparing the DIR 800 visualization to Digital Subtraction Angiography (DSA), not a human MRMC study to compare human reader performance with and without AI assistance.
The DIR 800 is an imaging accessory that allows visualization, not an AI algorithm that assists in interpretation or diagnosis. Therefore, an MRMC study related to AI assistance for human readers is not relevant to this device's function as described.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done

Yes, in essence, as much as applicable for an imaging accessory.

The "performance data" largely describes the standalone technical performance of the imaging system (DIR 800) in visualizing blood flow when ICG is introduced.
The animal study assessed the device's capability to visualize structures and blood flow independently (compared to DSA) and confirmed it met its pre-established acceptance criteria for visualization, image quality, etc. This is inherently a standalone performance assessment of the device's imaging capabilities.

7. The Type of Ground Truth Used

Animal Study: Digital Subtraction Angiography (DSA) data was collected and used as a comparative "ground truth" to evaluate the DIR 800's visualization of blood flow, vascular structures, and aneurysms in the animal models. DSA is a widely accepted method for visualizing vasculature.

8. The Sample Size for the Training Set

Not applicable.

The DIR 800 is described as an optical imaging accessory that enables visualization of fluorescence. There is no indication in the document that it incorporates a machine learning/AI algorithm that would require a separate "training set" of data in the typical sense for an AI-powered diagnostic device.
The "software" mentioned underwent standard software verification and validation, but not training on a dataset.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no mention of a training set or AI model in the provided description of the DIR 800 device.

Summary

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January 21, 2021

Aesculap, Inc. Ms. Kathy A. Racosky Project Manager I 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K202391

Trade/Device Name: DIR 800 Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic X-ray system Regulatory Class: Class II Product Code: IZI Dated: August 21, 2020 Received: August 21, 2020

Dear Ms. Racosky:

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

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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 (OS) 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 medical devices and radiation-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,

Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine 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) K202391

Device Name DIR 800

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 201 Subpart D)	Over-The-Counter Use (21 CFR 201 Subpart C)
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Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY (as required by 21 CFR 807.92)

DIR 800 January 21, 2021

COMPANY:	Aesculap ®, Inc.3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 291671
CONTACT:	Kathy A. Racosky610-984-9291 (phone)610-791-6882 (fax)kathy.racosky@aesculap.com
TRADE NAME:	DIR 800
COMMON NAME:	Angiographic x-ray system
CLASSIFICATION:	Class II
CLASSIFICATION NAME:	System, X-Ray, Angiographic
REGULATION NUMBER:	892.1600
PRODUCT CODE:	IZI

SUBSTANTIAL EQUIVALENCE

DIR 800 is substantially equivalent to Carl Zeiss Surgical GmbH, INFRARED 800 with FLOW Option (K100468). DIR 800 has similar indications for use and is similar in design and operating principle to the predicate device.

INDICATIONS FOR USE

DEVICE DESCRIPTION

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TECHNOLOGICAL CHARACTERISTICS (compared to Predicate(s))

As established in this submission, the DIR 800 is substantially equivalent to other predicate devices cleared by FDA. The subject device is shown to be substantially equivalent and has the same technological characteristics to its predicate device through comparison in function, design and intended use. The device characteristics comparing the DIR 800 to the predicate device are summarized below.

The subject and predicate device each utilizes a surgical stereo microscope imaging system and has the same basic functions for viewing, recording, and replaying fluorescent images. Similar cameras are utilized as sensors and the infrared options are equivalent. Each device utilizes the same type of fluorescent agent, Indocyanine Green (ICG), to visualize blood flow. Using near infared excitation, real-time visualization of images takes place in equivalent transmission ranges.

The indications for use for DIR 800 are similar to the indications for use for the predicate device cited in this file. A technological comparison and testing demonstrate that the DIR 800 is functionally equivalent to the predicate device. An evaluation performed on the DIR 800 supports the indications for use statement and demonstrates that the device is substantially equivalent to the predicate device and does not raise new questions regarding safety and effectiveness. Review of the comparison table below shows that the DIR 800 has similar characteristics compared to the predicate and supports the substantial equivalence determination.

	Aesculap, Inc.DIR 800	PredicateCarl Zeiss Meditec AGINFRARED 800 with FLOW 800option
K#	Pending	K100468
Indications	The DIR 800 is an accessory for theAesculap Aeos and is used in viewingintra-operative blood flow in thecerebral vascular area including, butnot limited to, assessing cerebralaneurysm and vessel branchocclusion, as well as patency inneurosurgery. It also aids in thevisual assessment of intraoperativeblood flow and vessel patency inbypass surgical procedures inneurosurgery.	The Carl Zeiss Surgical INFRARED800 with the FLOW 800 option is asurgical microscope accessory used inviewing and visual assessment ofintraoperative blood flow in thecerebral vascular area including, butnot limited to, assessing cerebralaneurysm and vessel branchocclusion, as well as patency of verysmall perforating vessels. It also aidsin the realtime visualization of bloodflow and visual assessment of vesseltypes before and after ArteriovenousMalformation (AVM) surgery.Likewise, INFRARED 800 with theFLOW 800 option used duringfluorescence guided surgery aids inthe visual assessment ofintraoperative blood flow as well asvessel patency in bypass surgicalprocedures in neurosurgery, plasticand reconstructive procedures andcoronary artery bypass graft surgery.

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K202391, Page 3 of 5

Regulation number	892.1600	892.1600
Product code	IZI	IZI
Regulation Medical Specialty	Radiology	Radiology
Device Description	Accessory to surgical stereomicroscope for intraoperativeimaging.	Accessory to surgical stereomicroscope for intraoperativeimaging.
Basic System Function	View, record, and replay fluorescentimages of blood vessels in thecerebral area, and view blood flowand vessel patency in bypass surgicalprocedures during neurosurgery.	View, record, and replay fluorescentimages of blood vessels in thecerebral area, view bypass graftsduring coronary artery bypass(CABG) surgery, and view bloodflow during plastic and reconstructivesurgery.
Accessory to	The DIR 800 is an accessory to theAesculap Aeos [Class I Exempt]	INFRARED 800 is an accessory tothe OPMI Pentero surgicalmicroscope. [Class I Exempt]FLOW 800 is an accessory toINFRARED 800.
Sensor	CMOS video camera, infrared-sensitive	CCD video cameraInfrared-sensitive video cameraBlack & white camera
Fluorescent Agent	Indocyanine Green (ICG)	Indocyanine Green (ICG)
Activation of the ICG option	The press of a single button on thesurgical microscope activates the ICGfunction.	The press of a single button on thesurgical microscope activates the ICGfunction.
Result	Fluorescent image of the distributionof the infrared dye in the patient'sblood vessels during the operation.	Fluorescent image of the distributionof the infrared dye in the patient'sblood vessels during the operation.FLOW 800 provides overview andcomparison functions of display and asummary of the dynamic of thefluorescent dye.
Visualization of Real-timeImages	Yes	Yes
Display	Video and images are presented onmonitor. Picture-in-picture available.	Video and images are presented onmonitor. Image may also be displayedin the eyepiece. Picture-in-pictureavailable.
Termination of the ICGoption	Determined by surgeon or will turnoff automatically after 100 seconds.	Determined by surgeon or will turnoff automatically after 5 minutes.
Light Source	2x white light LEDs and 13x IRLEDs	2x 300W Xenon lamps
White Light Application	400 nm - 700 nm	400 nm - 700 nm
ICG Excitation	740 nm - 800 nm bandpass filter	700 nm - 780 nm bandpass filter
ICG Detection	Filter with high transmission from820 nm - 900 nm	Filter with high transmission from820 nm - 900 nm
Test Card	Pre-operative check test card	Pre-operative check test card
Distance of Imaging Head toPatient	200 mm - 300 mm	200 mm - 500 mm
Camera adaptation	Integrated into the microscope head	Integrated into the microscope head
Zoom	Motorized 8.9:1	Motorized 6:1
Auto detection of fluorescenceinflux	Yes	Yes
Autofocus	Yes	Yes
Control System	Personal Computer	Personal Computer
Storage	HDD	HDD, DVD

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PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Bench testing

The following bench testing was performed to demonstrate that the DIR 800 performs as intended and is substantially equivalent to the predicate device.

Test	Test Summary	Results
Verification that the referencetarget fluoresces	No fluorescence is detected by theAeos when DIR 800 mode isdisabled	Pass
Verification of the software /hardware accessory visualizationfeature	The excitation light bandwidth andpeak fall within 700nm-802nmrange at all working distances	Pass
	Total excitation absorption powerover the entire ICG excitationspectrum	Pass
	Visualization of the Aeos DIR 800mode	Pass
	Fluorescence pixel intensity showsthe optics and detectors adequatelyvisualize a fluorescent agent	Pass

Biocompatibility

None of the components come into contact with a patient; therefore, no biocompatibility data is required.

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the Aeos System. The DIR 800 module was tested as part of the Aeos System. The system complies with the IEC 60601-1. and IEC 60601-2 standards for safety and the IEC 60601-1-2 standard for EMC.

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.

Animal Study

Animal studies using a porcine model and a rabbit model were conducted to confirm the DIR 800 enabled viewing of intra-operative blood flow in the cerebrovascular area. Testing was completed by Neurosurgeons using test cases and independent scoring assessments which were predefined in the protocol. Comparative image sets of the same cerebrovascular anatomy in either a non-occluded (before clipping), occluded (clipped) and non-occluded (after removal of clip) were visualized by the DIR 800 and digital subtraction angiography (DSA).

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Data was collected using Indocyanine Green (ICG) introduced into the vascular system of a porcine model and a rabbit elastase model. Evidence regarding the capability to visualize blood flow, vascular structures and aneurysms was collected and compared directly to data collected with a DSA on the same porcine and rabbit elastase model.

The device performance was evaluated for overall image quality, brightness and illumination, visual acuity, visual artifacts, depth perception, contrast and alignment of visible light images versus fluorescent images.

The testing confirmed that the DIR 800 reflects the intended use and provides intraoperative visualization and visual assessment of blood flow when compared to the DSA. The individual assessments of comparative images verify that the DIR 800 allowed visualization of intraoperative blood flow in the cerebrovascular area and imaging of aneurysms in small sized vessels in an equivalent manner to the DSA.

The individual assessments of comparative images to verify the device performance met their pre-established acceptance criteria.

CONCLUSION

The subject device and predicate device have the same intended use, for viewing internal surgical sites during general surgical procedures. The specifications and functionality of the subject device is similar to the predicate device. Any differences between the devices do not raise new questions of safety and effectiveness. Performance data demonstrated that the device meets its specifications and intended uses and support the device. The hardware and software verification and validation demonstrate that the DIR 800 should perform as intended in the specified use conditions. Therefore, the subject device can be found substantially equivalent to the Carl Zeiss Surgical INFRARED 800 with the FLOW 800 option as cleared in K100468.

Regulation Number and Section

§ 892.1600 Angiographic x-ray system.

(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.