Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a fluorescence imaging accessory for a surgical microscope that visualizes blood flow using ICG. There is no mention of AI, ML, or any form of automated analysis or interpretation of the images beyond visualization. The performance studies focus on the imaging capabilities and comparison to DSA, not on any AI/ML-driven analysis.

Therapeutic

No.
The device functions as an accessory to a surgical microscope to visualize blood flow for assessment by a surgeon, not to directly treat or diagnose a condition.

Diagnostic

Yes

The device aids in the visual assessment of intraoperative blood flow and vessel patency, and views intra-operative blood flow to assess cerebral aneurysm and vessel branch occlusion, which are diagnostic activities.

SaMD (Software as a Medical Device)

No

The device is described as an "accessory" to a surgical microscope and allows the microscope to produce excitation light and detect fluorescence signals. This indicates it includes hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, the DIR 800 is not an In Vitro Diagnostic (IVD).

Here's why:

IVDs are used to examine specimens from the human body. The DIR 800 is used to visualize blood flow within the patient's body during surgery. It does not analyze samples taken from the patient.
The intended use is for intra-operative visualization. The device is used directly on the patient during a surgical procedure to assess blood flow in real-time.
The device description focuses on illuminating and detecting fluorescence within the patient. It describes how the device interacts with the patient's blood vessels after the introduction of a dye, not how it analyzes a sample.

The DIR 800 is a surgical accessory used for in vivo imaging (imaging within a living organism), specifically for visualizing blood flow during neurosurgery. This is distinct from the purpose of an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

IZI

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Fluorescent images, Video

Anatomical Site

cerebral vascular area

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Neurosurgeons

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

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).

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.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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). 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K100468

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

1

devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (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

2

Indications for Use

510(k) Number (if known) K202391

Device Name DIR 800

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

Prescription Use (Part 21 CFR 201 Subpart D)	Over-The-Counter Use (21 CFR 201 Subpart C)
------------------------------------------------------------	-----------------------------------------------------------

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

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

DIR 800 January 21, 2021

| COMPANY: | Aesculap ®, Inc.
3773 Corporate Parkway
Center Valley, PA 18034
Establishment Registration Number: 291671 |
|----------------------|---------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Kathy A. Racosky
610-984-9291 (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

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.

4

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 | Predicate
Carl Zeiss Meditec AG
INFRARED 800 with FLOW 800
option |
|-------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K# | Pending | K100468 |
| Indications | 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. | The Carl Zeiss Surgical INFRARED
800 with the FLOW 800 option is a
surgical microscope accessory used in
viewing and visual assessment of
intraoperative blood flow in the
cerebral vascular area including, but
not limited to, assessing cerebral
aneurysm and vessel branch
occlusion, as well as patency of very
small perforating vessels. It also aids
in the realtime visualization of blood
flow and visual assessment of vessel
types before and after Arteriovenous
Malformation (AVM) surgery.
Likewise, INFRARED 800 with the
FLOW 800 option used during
fluorescence guided surgery aids in
the visual assessment of
intraoperative blood flow as well as
vessel patency in bypass surgical
procedures in neurosurgery, plastic
and reconstructive procedures and
coronary artery bypass graft surgery. |

5

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 stereo
microscope for intraoperative
imaging.	Accessory to surgical stereo
microscope for intraoperative
imaging.
Basic System Function	View, record, and replay fluorescent
images of blood vessels in the
cerebral area, and view blood flow
and vessel patency in bypass surgical
procedures during neurosurgery.	View, record, and replay fluorescent
images of blood vessels in the
cerebral area, view bypass grafts
during coronary artery bypass
(CABG) surgery, and view blood
flow during plastic and reconstructive
surgery.
Accessory to	The DIR 800 is an accessory to the
Aesculap Aeos [Class I Exempt]	INFRARED 800 is an accessory to
the OPMI Pentero surgical
microscope. [Class I Exempt]
FLOW 800 is an accessory to
INFRARED 800.
Sensor	CMOS video camera, infrared-
sensitive	CCD video camera
Infrared-sensitive video camera
Black & white camera
Fluorescent Agent	Indocyanine Green (ICG)	Indocyanine Green (ICG)
Activation of the ICG option	The press of a single button on the
surgical microscope activates the ICG
function.	The press of a single button on the
surgical microscope activates the ICG
function.
Result	Fluorescent image of the distribution
of the infrared dye in the patient's
blood vessels during the operation.	Fluorescent image of the distribution
of the infrared dye in the patient's
blood vessels during the operation.
FLOW 800 provides overview and
comparison functions of display and a
summary of the dynamic of the
fluorescent dye.
Visualization of Real-time
Images	Yes	Yes
Display	Video and images are presented on
monitor. Picture-in-picture available.	Video and images are presented on
monitor. Image may also be displayed
in the eyepiece. Picture-in-picture
available.
Termination of the ICG
option	Determined by surgeon or will turn
off automatically after 100 seconds.	Determined by surgeon or will turn
off automatically after 5 minutes.
Light Source	2x white light LEDs and 13x IR
LEDs	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 from
820 nm - 900 nm	Filter with high transmission from
820 nm - 900 nm
Test Card	Pre-operative check test card	Pre-operative check test card
Distance of Imaging Head to
Patient	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 fluorescence
influx	Yes	Yes
Autofocus	Yes	Yes
Control System	Personal Computer	Personal Computer
Storage	HDD	HDD, DVD

6

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 reference
target fluoresces	No fluorescence is detected by the
Aeos when DIR 800 mode is
disabled	Pass
Verification of the software /
hardware accessory visualization
feature	The excitation light bandwidth and
peak fall within 700nm-802nm
range at all working distances	Pass
	Total excitation absorption power
over the entire ICG excitation
spectrum	Pass
	Visualization of the Aeos DIR 800
mode	Pass
	Fluorescence pixel intensity shows
the optics and detectors adequately
visualize 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).

7

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.