(198 days)
K091515, 510(k) exempt
No
The summary describes a surgical microscope system with infrared imaging capabilities for viewing blood flow. There is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies. The focus is on optical and imaging hardware.
No
Explanation: The device is described as an instrument for viewing intra-operative blood flow and producing excitation/fluorescence light for observation. Its intended use is diagnostic/observational, not therapeutic.
No
The device is described as a surgical microscope system for viewing intra-operative blood flow and producing excitation/fluorescence light. Its purpose is observation, not to diagnose a condition or disease.
No
The device description explicitly details hardware components (surgical microscope, infrared imaging unit, infrared filter unit, LED light source) and the performance studies include hardware-related testing (electrical safety, EMC, bench testing for optical properties and safety).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "viewing intra-operative blood flow in the cerebral vascular area." This describes a direct observation of physiological processes within the body during surgery.
- Device Description: The device is a "SURGICAL MICROSCOPE SYSTEM ORBEYE with IR" that uses infrared imaging to visualize blood flow. This is a surgical imaging tool used in vivo (within a living organism).
- Lack of IVD Characteristics: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or treatment. This device does not process or analyze such specimens.
The device is clearly a surgical imaging system used during a medical procedure on a patient, which falls under the category of medical devices used in vivo, not in vitro.
N/A
Intended Use / Indications for Use
This instrument has been designed to be used for viewing intra-operative blood flow in the cerebral vascular area and is intended for use in adults only.
Product codes (comma separated list FDA assigned to the subject device)
IZI, EPT
Device Description
The SURGICAL MICROSCOPE SYSTEM ORBEYE with IR is used for viewing intra-operative blood flow in the cerebral vascular area.
When the INFRARED IMAGING UNIT MAJ-2304 and the INFRARED FILTER UNIT MAJ-2307 are mounted on the LED LIGHT SOURCE OME-L200 and the ORBEYE SURGICAL MICROSCOPE OME-V200 respectively, it allows the surgical microscope to produce excitation light and resolve florescence light from the fluorescent ICG. The subject device of this 510(k) submission, ORBEYE with IR system, enables the microscopic observation with IR (Infrared) Imaging.
The ORBEYE with IR system will be marketed as a System and will also be sold as individual components.
The subject system consists of the following primary components:
- ORBEYE SURGICAL MICROSCOPE OME-V200 -
- LED LIGHT SOURCE OME-L200 -
- INFRARED IMAGING UNIT MAJ-2304 -
- -INFRARED FILTER UNIT MAJ-2307
- AUTO FOCUS UNIT MAJ-2303 -
- FOOT SWITCH MAJ-2301 -
- -4K COMBINED CABLE 10M MAJ-2309
- RECORDER REMOTE CABLE 3P MAJ-2310 -
- -POWER CORD US MAJ-2312
- Indocyanine Green for Injection, USP -
ORBEYE SURGICAL MICROSCOPE OME-V200
OME-V200 is a surgical microscope to enlarge the images of the surgical site or enable stereoscopic observation. In the microscope unit, two image sensors in UHD (ultra high definition) resolution are incorporated. Connecting the microscope with an UHD-3D monitor enables displaying enlarged images or viewing stereoscopic images in UHD resolution.
LED LIGHT SOURCE OME-L200
OME-L200 is an LED light source to supply illumination light to the surgical site through the OME-V200.
INFRARED IMAGING UNIT MAJ-2304
MAJ-2304 is a unit that enables IR Imaging.
INFRARED FILTER UNIT MAJ-2307
MAJ-2307 is a unit that switches filters to enable IR Imaging.
AUTO FOCUS UNIT MAJ-2303
MAJ-2303 is a unit that enables Auto Focus.
FOOT SWITCH MAJ-2301
MAJ-2301 is a foot switch and receiver that operates a surgical microscope.
4K COMBINED CABLE 10M MAJ-2309
MAJ-2309 is a video cable for displaying 4K video of a surgical microscope on a monitor.
RECORDER REMOTE CABLE 3P MAJ-2310
MAJ-2310 is a cable for operating the recorder from a surgical microscope.
POWER CORD US MAJ-2312
MAJ-2312 is the power cable for supplying power to the surgical microscope.
Indocyanine Green for Injection, USP
Fluorescent agent for IR imaging, supplied from Diagnostic Green LLC.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Infrared Imaging
Anatomical Site
Cerebral vascular area
Indicated Patient Age Range
Adults only
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Software verification and validation testing: Software verification and validation testing for the SURGICAL MICROSCOPE SYSTEM ORBEYE with IR 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" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices".
- Electrical safety and electromagnetic compatibility (EMC): Electrical safety and EMC testing were conducted on the SURGICAL MICROSCOPE SYSTEM ORBEYE with IR. The system complies with the ANSI/AAMI ES 60601-1:2005/(R)2012 and A1:2012 standards for safety and the IEC 60601-1-2:2014 standards for EMC.
- Performance testing - Bench: Bench testing for the SURGICAL MICROSCOPE SYSTEM ORBEYE with IR as listed below was conducted to ensure that the subject device performs as intended and meet design specifications.
- Verification for the IR illumination light wavelength
- Verification for the optical property of the objective IR optical systems
- Verification for patient safety of the IR illumination light (focusing on patient's thermal injury)
- Verification for patient safety of the IR illumination light (focusing on users' eye injury)
- Verification for the wireless connection mechanism not to be interfered by the radio waves from other equipment
- Performance testing - Animal: In the animal study, indocyanine green (ICG) solution was intravenously administered to 5 male beagle dogs of 7-8 months old. The cerebral tissue, the cerebral surface arteries and veins were observed under near-infrared light (IR) using the subject device system and Leica M525 F50 in combination with the predicate device. The animal testing is performed in accordance to 21 CFR Part 58 - GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES. Neither the subject system nor predicate system induced any gross pathological abnormalities in the observation.
- Performance testing - Clinical: No clinical study was performed to demonstrate substantial equivalence.
- Risk analysis: Risk analysis for the SURGICAL MICROSCOPE SYSTEM ORBEYE with IR was conducted in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K091515, 510(k) exempt
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 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 is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 10, 2019
Olympus Medical Systems Corp. % Sheri Musgnung Manager, Regulatory Affairs Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, Pennsylvania 18034-0610
Re: K190772
Trade/Device Name: SURGICAL MICROSCOPE SYSTEM ORBEYE with IR Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic X-Ray System Regulatory Class: Class II Product Code: IZI, EPT Dated: September 10, 2019 Received: September 11, 2019
Dear Sheri Musgnung:
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
1
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 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 (QS) 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,
Matthew Krueger Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
SURGICAL MICROSCOPE SYSTEM ORBEYE with IR
Indications for Use (Describe)
This instrument has been designed to be used for viewing intra-operative blood flow in the cerebral vascular area and is intended for use in adults only.
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) |
---|---|
------------------------------------------------ | ----------------------------------------------- |
__ 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."
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Indications for Use
510(k) Number (if known)
Device Name INFRARED FILTER UNIT MAJ-2307
Indications for Use (Describe)
This instrument has been designed to be used for viewing intra-operative blood flow in the cerebral vascular area and is intended for use in adults only.
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) |
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."
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б K190772 Page 1 of
Image /page/4/Picture/1 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are a sans-serif font and are closely spaced together. There is a thin, gold line underneath the word, which appears to be a design element.
Traditional 510(k) Notification SURGICAL MICROSCOPE SYSTEM ORBEYE with IR
Date Prepared: September 10, 2019
510(k) Summary
5.1 GENERAL INFORMATION
■ 510(k) Submitter: OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507
- Contact Person: Sheri L. Musgnung Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 484-896-3147 Fax: 484-896-7128 Email: sheri.musgnung(@olympus.com
- Manufacturing Site Olympus Medical Systems Corp. Hinode Plant 34-3 Hirai, Hinode-machi, Nishitama-gun, Tokyo 190-0182, Japan
5.2 DEVICE IDENTIFICATION
| ■ Device Name
■ Model Name | SURGICAL MICROSCOPE SYSTEM ORBEYE with IR |
---|---|
[System components] | |
ORBEYE SURGICAL MICROSCOPE OME-V200 | |
LED LIGHT SOURCE OME-L200 | |
INFRARED IMAGING UNIT MAJ-2304 | |
INFRARED FILTER UNIT MAJ-2307 | |
AUTO FOCUS UNIT MAJ-2303 | |
FOOT SWITCH MAJ-2301 | |
4K COMBINED CABLE 10M MAJ-2309 | |
RECORDER REMOTE CABLE 3P MAJ-2310 | |
POWER CORD US MAJ-2312 | |
Indocyanine Green for Injection, USP | |
■ Common Name | Surgical microscope system |
■ Regulation Number | 892.1600 |
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б K190772 Page 2 of
Image /page/5/Picture/1 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are a sans-serif font and are closely spaced together. Below the word "OLYMPUS" is a horizontal yellow bar. The logo is clean and modern.
Traditional 510(k) Notification SURGICAL MICROSCOPE SYSTEM ORBEYE with IR
878.4700
- Regulation Name Angiographic x-ray system Surgical microscope and accessories
- Regulatory Class Class II
- Product Code IZI, EPT
- Classification Panel Radiology General & Plastic Surgery
5.3 PREDICATE DEVICE
Predicate device
Device name | 510(k) Submitter | 510(k) No. |
---|---|---|
Leica FL800 | LEICA BIOSYSTEMS RICHMOND, Inc | K141136 |
■ Reference device
No. | Device name | 510(k) Submitter | 510(k) No. |
---|---|---|---|
1 | SPY SCOPE INTRA-OPERATIVE | ||
OPERATING SYSTEM | NOVADAQ | ||
TECHNOLOGIES, INC. | K091515 | ||
2 | SURGICAL MICROSCOPE | ||
SYSTEM ORBEYE | OLYMPUS MEDICAL | ||
SYSTEMS CORP. | 510(k) exempt | ||
(under | |||
878.4700 | |||
EPT) |
5.4 DEVICE DESCRIPTION
The SURGICAL MICROSCOPE SYSTEM ORBEYE with IR is used for viewing intra-operative blood flow in the cerebral vascular area.
When the INFRARED IMAGING UNIT MAJ-2304 and the INFRARED FILTER UNIT MAJ-2307 are mounted on the LED LIGHT SOURCE OME-L200 and the ORBEYE SURGICAL MICROSCOPE OME-V200 respectively, it allows the surgical microscope to produce excitation light and resolve florescence light from the fluorescent ICG. The subject device of this 510(k) submission, ORBEYE with IR system, enables the microscopic observation with IR (Infrared) Imaging.
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Image /page/6/Picture/1 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are spaced closely together, creating a strong visual impact. A thin, curved, yellow line is located beneath the word.
Traditional 510(k) Notification SURGICAL MICROSCOPE SYSTEM ORBEYE with IR
The ORBEYE with IR system will be marketed as a System and will also be sold as individual components.
The subject system consists of the following primary components:
- ORBEYE SURGICAL MICROSCOPE OME-V200 -
- LED LIGHT SOURCE OME-L200 -
- INFRARED IMAGING UNIT MAJ-2304 -
- -INFRARED FILTER UNIT MAJ-2307
- AUTO FOCUS UNIT MAJ-2303 -
- FOOT SWITCH MAJ-2301 -
- -4K COMBINED CABLE 10M MAJ-2309
- RECORDER REMOTE CABLE 3P MAJ-2310 -
- -POWER CORD US MAJ-2312
- Indocyanine Green for Injection, USP -
ORBEYE SURGICAL MICROSCOPE OME-V200
OME-V200 is a surgical microscope to enlarge the images of the surgical site or enable stereoscopic observation. In the microscope unit, two image sensors in UHD (ultra high definition) resolution are incorporated. Connecting the microscope with an UHD-3D monitor enables displaying enlarged images or viewing stereoscopic images in UHD resolution.
LED LIGHT SOURCE OME-L200
OME-L200 is an LED light source to supply illumination light to the surgical site through the OME-V200.
INFRARED IMAGING UNIT MAJ-2304
MAJ-2304 is a unit that enables IR Imaging.
INFRARED FILTER UNIT MAJ-2307
MAJ-2307 is a unit that switches filters to enable IR Imaging.
AUTO FOCUS UNIT MAJ-2303
MAJ-2303 is a unit that enables Auto Focus.
FOOT SWITCH MAJ-2301
MAJ-2301 is a foot switch and receiver that operates a surgical microscope.
4K COMBINED CABLE 10M MAJ-2309
MAJ-2309 is a video cable for displaying 4K video of a surgical microscope on a monitor.
RECORDER REMOTE CABLE 3P MAJ-2310
MAJ-2310 is a cable for operating the recorder from a surgical microscope.
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Image /page/7/Picture/1 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are slightly shadowed, giving them a three-dimensional appearance. A thin, horizontal, gradient line in shades of yellow and orange is located beneath the word.
Traditional 510(k) Notification SURGICAL MICROSCOPE SYSTEM ORBEYE with IR
POWER CORD US MAJ-2312
MAJ-2312 is the power cable for supplying power to the surgical microscope.
Indocvanine Green for Iniection. USP
Fluorescent agent for IR imaging, supplied from Diagnostic Green LLC.
5.5 INDICATIONS FOR USE
SURGICAL MICROSCOPE SYSTEM ORBEYE with IR
This instrument has been designed to be used for viewing intra-operative blood flow in the cerebral vascular area and is intended for use in adults only.
INFRARED FILTER UNIT MAJ-2307
This instrument has been designed to be used for viewing intra-operative blood flow in the cerebral vascular area and is intended for use in adults only.
5.6 COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE DEIVCE
The SURGICAL MICROSCOPE SYSTEM ORBEYE with IR has the same technological characteristics and design as the predicate device except for the following new features:
-
- Image sensor
-
- Software
-
- Excitation light
-
- UHD (Ultra High Definition) technology
All other technological characteristics of both the subject and predicate devices are identical.
Validation from non-clinical testing demonstrated that these technological features do not raise any new issues of safety or effectiveness of the subject device.
5.7 PERFORMANCE DATA
510(k) Summary Page 4 of 6
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Image /page/8/Picture/1 description: The image shows the word "OLYMPUS" in large, bold, dark blue letters. The letters are closely spaced and fill most of the frame. A thin, horizontal yellow bar is visible beneath the word, adding a subtle color contrast to the composition. The registered trademark symbol is visible to the right of the word.
The following performance data were provided in support of the substantial equivalence determination.
1) Software verification and validation testing
Software verification and validation testing for the SURGICAL MICROSCOPE SYSTEM ORBEYE with IR 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" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices".
2) Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the SURGICAL MICROSCOPE SYSTEM ORBEYE with IR. The system complies with the ANSI/AAMI ES 60601-1:2005/(R)2012 and A1:2012 standards for safety and the IEC 60601-1-2:2014 standards for EMC.
3) Performance testing - Bench
Bench testing for the SURGICAL MICROSCOPE SYSTEM ORBEYE with IR as listed below was conducted to ensure that the subject device performs as intended and meet design specifications.
- । Verification for the IR illumination light wavelength
- Verification for the optical property of the objective IR optical systems ।
- Verification for patient safety of the IR illumination light (focusing on patient's । thermal injury)
- Verification for patient safety of the IR illumination light (focusing on users' eye । injury)
- Verification for the wireless connection mechanism not to be interfered by the । radio waves from other equipment
4) Performance testing - Animal
In the animal study, indocyanine green (ICG) solution was intravenously administered to 5 male beagle dogs of 7-8 months old. The cerebral tissue, the cerebral surface arteries and veins were observed under near-infrared light (IR) using the subject device system and Leica M525 F50 in combination with the predicate device. The animal testing is performed in accordance to 21 CFR Part 58 - GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES.
Neither the subject system nor predicate system induced any gross pathological abnormalities in the observation.
9
Image /page/9/Picture/1 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are slightly shadowed, giving them a three-dimensional appearance. A thin, horizontal gold line is underneath the word. A registered trademark symbol is located to the right of the word.
Traditional 510(k) Notification SURGICAL MICROSCOPE SYSTEM ORBEYE with IR
5) Performance testing - Clinical
No clinical study was performed to demonstrate substantial equivalence.
6) Risk analysis
Risk analysis for the SURGICAL MICROSCOPE SYSTEM ORBEYE with IR was conducted in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.
5.8 CONCLUSIONS
Based on the indications for use, technological characteristics, performance testing and technological comparison to the predicate devices, the SURGICAL MICROSCOPE SYSTEM ORBEYE with IR raises no new issue of safety and effectiveness and are substantially equivalent to the predicate device in terms of safety, efficacy and performance.