(49 days)
Not Found
No
The description mentions a microprocessor for image processing and user interface control, but there is no mention of AI, ML, or related terms like deep learning or neural networks. The performance studies focus on standard image quality metrics and electrical safety, not AI/ML performance.
No.
The device is described as a video system center that processes and outputs image signals from endoscopes for diagnosis, treatment, and observation, but it does not directly perform a therapeutic function on the patient.
No
Explanation: The device is described as processing and displaying images from endoscopes for observation and treatment, implying it is an imaging system rather than a diagnostic one that interprets images or data to make a diagnosis. The "Device Description" states it is "intended to be used in conjunction with ancillary equipment for endoscopic diagnosis, treatment and observation," positioning it as equipment used for diagnosis, not a diagnostic device itself.
No
The device description explicitly states that the OLYMPUS OTV-S500 consists of electrical circuit boards, electrical units, harnesses, and optical components, in addition to embedded software. This indicates it is a hardware device with embedded software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to receive and process electronic signals from endoscopes and output image signals to a monitor for endoscopic surgery, diagnosis, treatment, and observation. This is a function related to imaging and visualization within the body, not the analysis of biological samples outside the body.
- Device Description: The description focuses on the hardware and software components that process image signals from endoscopes. It does not mention any components or functions related to analyzing biological specimens like blood, urine, or tissue.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device does not perform such analysis.
The device is clearly intended for use in endoscopic procedures to provide visual information to the user. This falls under the category of medical devices used for imaging and visualization, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500, when used with endoscopes, video endoscopes, camera heads, monitors and other ancillary equipment for endoscopic surgery, is intended to receive and process electronic signals transmitted from a video endoscope/camera head and output image signal to monitor.
Product codes (comma separated list FDA assigned to the subject device)
FET, NTN, NWB
Device Description
The OLYMPUS OTV-S500 is a "universal platform" which offers compatibility with various endoscopes for different medical specialties and enables operation to meet the clinical needs in the fields of urology and gynecology. The Subject device is intended to be used in conjunction with ancillary equipment for endoscopic diagnosis, treatment and observation.
The OLYMPUS OTV-S500 consists of electrical circuit boards, electrical units (cooling fan, unit power supply, and control panel), harnesses between circuit boards, and optical components (lens and optical filter). A microprocessor is built into the OLYMPUS OTV-S500 which controls processing of observation images, user interface (front panel switch, indicator LEDs, warning buzzer etc.) and menu. These functions are implemented in the embedded software. Scopes including flexible videoscopes or fiberscopes and rigid videoscopes with camera heads and light source are directly connected to the Subject system. When connected, the endoscope (fiberscopes and rigid videoscope without camera head) acquires and displays images directly to the user or output onto a monitor when using a flexible endoscope or scope and camera head.
The Subject devices submitted for clearance include one (1) major component: the Video System Center (OLYMPUS OTV-S500); and two (2) auxiliary components: Foot Holder (MAJ-2552) for the OLYMPUS OTV-S500 that are shipped with the Video System Center, and an optional HDMI cable (MAJ-2551).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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)
Results of the following testing support the safety and performance of the Subject device and demonstrate its equivalence to the Predicate device; all testing passed/met the acceptance criteria, demonstrated compliance with the cited standards and FDA Guidance shown below, and supported equivalent safety and performance to the Predicate device:
- Performance Testing Bench (including Subject and Predicate device testing of Field of View [in compliance with ISO 8600-3:2019); Resolution; Image Noise and Dynamic Range [tested according to ISO 15739:2017]; Brightness; Image Intensity Uniformity; Color Performance [including analysis with the FDA Color Performance Review (CPR) Tool for Endoscopy Devices]; Latency; and Contrast Enhancement). The Subject device performed equivalently to the Predicate device, and test results support performance of the Subject device with compatible endoscopes.
- Electrical Safety/EMC Testing (ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]; ANSI AAMI IEC 60601-1-2 [Including AMD 1:2021]; IEC 60601-2-18: Edition 3.0 2009-08; IEC TR 60601-4-2 Edition 1.0 2016-05; IEC 60601-1-6 Edition 3.2 2020-07 Consolidated Version)
- Software Validation/Cybersecurity (IEC 62304 Edition 1.1 2015-06 Consolidated Version; ISO 14971:2019; FDA Guidance Document Content of Premarket Submissions for Device Software Functions – Guidance for Industry and Food and Drug Administration Staff, issued on June 14, 2023; FDA Guidance Document Off-the-Shelf Software Use in Medical Devices – Guidance for Industry and Food and Drug Administration Staff, issued August 11, 2023; FDA Guidance Document Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, issued on September 27, 2023)
No clinical data were collected to support performance of the Subject device.
The results of non-clinical performance testing demonstrate that the Subject device is as safe and effective as the Predicate device to support a substantial equivalence determination.
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.
Not Found
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
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 3, 2024
Olympus Medical Systems Corporation % Wendy Perreault Regulatory Affairs SME Consultant Olympus Surgical Technologies of the Americas 800 West Park Drive Westborough, Massachusetts 01581
Re: K241371
Trade/Device Name: VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FET, NTN, NWB Dated: May 14, 2024 Received: May 15, 2024
Dear Wendy Perreault:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
2
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,
Reginald K. Avery -S
for Jason R. Roberts, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K241371
Device Name VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500)
Indications for Use (Describe)
The VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500, when used with endoscopes, video endoscopes, camera heads, monitors and other ancillary equipment for endoscopic surgery, is intended to receive and process electronic signals transmitted from a video endoscope/camera head and output image signal to monitor.
| 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."
4
Image /page/4/Picture/1 description: The image shows the word "OLYMPUS" in large, bold, dark blue letters. The font is sans-serif and the letters are evenly spaced. A registered trademark symbol is located to the right of the letter "S".
510(k) Summary: K241371
1. COMPANY INFORMATION
• Applicant
OLYMPUS MEDICAL SYSTEMS CORPORATION 2951 Ishikawa-cho, Hachioji-shi Tokyo 192-8507, Japan FDA Establishment Registration #: 8010047
Official Correspondent .
Wendy Perreault c/o Olympus Surgical Technologies of the Americas 800 West Park Drive Westborough, MA 01581 Cell: 404-542-5854 Email: wendy.perreault@olympus.com
. Manufacturing Site
SHIRAKAWA OLYMPUS CO., LTD. 3-1 Okamiyama, Odakura NISHIGO-MURA NISHISHIRAKAWA-GUN Fukushima, JAPAN 961-8061
- Date Prepared: 2-July-2024 .
PRODUCT INFORMATION 2.
Trade Name: VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500)
Common Name: Video System Center
Classification Name: Endoscope and accessories
5
OLYMPUS
Classification Number: 876.1500
Product Code Names: Endoscopic Video Imaging System/Component, Gastroenterology-Urology, LED Light Source, and Endoscope, Accessories, Narrow Band Spectrum
Product Codes: FET, NTN, NWB
Regulatory Class: II
Classification Panel: Gastroenterology / Urology
3. PREDICATE DEVICE
The Subject device is equivalent to the Predicate device listed below in Table 1.
Table 1: Predicate device of OLYMPUS OTV-S500
| Device name | 510(k) Submitter | 510(k) No. |
|---|---|---|
| CV-170 VIDEO SYSTEM CENTER | OLYMPUS MEDICAL SYSTEMS | |
| CORP. | K122831 |
The Predicate device has not been subject to a design-related recall.
DEVICE DESCRIPTION 4.
The OLYMPUS OTV-S500 is a "universal platform" which offers compatibility with various endoscopes for different medical specialties and enables operation to meet the clinical needs in the fields of urology and gynecology. The Subject device is intended to be used in conjunction with ancillary equipment for endoscopic diagnosis, treatment and observation.
The OLYMPUS OTV-S500 consists of electrical circuit boards, electrical units (cooling fan, unit power supply, and control panel), harnesses between circuit boards, and optical components (lens and optical filter). A microprocessor is built into the OLYMPUS OTV-S500 which controls processing of observation images, user interface (front panel switch, indicator LEDs, warning buzzer etc.) and menu. These functions are implemented in the embedded software. Scopes including flexible videoscopes or fiberscopes and rigid videoscopes with camera heads and light source are directly connected to the Subject system. When connected, the endoscope (fiberscopes and rigid videoscope without camera head) acquires and displays images directly to the user or output onto a monitor when using a flexible endoscope or scope and camera head.
The Subject devices submitted for clearance include one (1) major component: the Video System Center (OLYMPUS OTV-S500); and two (2) auxiliary components: Foot Holder (MAJ-2552)
6
OLYMPUS
for the OLYMPUS OTV-S500 that are shipped with the Video System Center, and an optional HDMI cable (MAJ-2551).
న. INDICATIONS FOR USE
The VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500, when used with endoscopes, video endoscopes, camera heads, monitors and other ancillary equipment for endoscopic surgery, is intended to receive and process electronic signals transmitted from a video endoscope/camera head and output image signal to monitor.
6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
Compared to the Predicate device, the Subject device offers the same functions but uses newer technology and incorporates additional features, such as digital HDMI output and additional color tone adjustment. A detailed comparison of the technological characteristics of the devices is provided in the Table below. These differences in technological characteristics do not raise new questions of safety or effectiveness.
| OLYMPUS OTV-S500 | OLYMPUS CV-170 | |
|---|---|---|
| (Subject Device) | (Predicate Device) | |
| Indications for Use | The VISERA S VIDEO SYSTEM | |
| CENTER OLYMPUS OTV-S500, | ||
| when used with endoscopes, | ||
| video endoscopes, camera heads, | ||
| monitors and other ancillary | ||
| equipment for endoscopic surgery, | ||
| is intended to receive and process | ||
| electronic signals transmitted from | ||
| a video endoscope/camera head | ||
| and output image signal to monitor. | This video system center is intended to be | |
| used with OLYMPUS video converter, | ||
| camera heads, endoscopes, monitors, | ||
| EndoTherapy accessories, and other | ||
| ancillary equipment for endoscopic | ||
| diagnosis, treatment, and video | ||
| observation. | ||
| Front panel (Operation) | Available | Available |
| Analog HDTV signal | ||
| output | Not available | Either RGB (1080/60I) or YPbPr |
| (1080/60I) output | ||
| Analog SDTV signal | ||
| output | Not available | VBS composite (480/60I: NTSC), Y/C |
| (480/60I: NTSC), and RGB (480/60I: | ||
| NTSC); simultaneous outputs possible. | ||
| Digital signal output | SDI (HD-SDI or 3G-SDI) | |
| HDMI (1080P) | SDI (HD-SDI or SD-SDI) | |
| DVI (WUXGA,1080P or SXGA can be | ||
| selected) | ||
| White balance adjustment | Available | Available |
| Standard color chart output | The "Color bar" can be displayed. | The "Color bar" or the "50% white" screen |
| can be displayed. | ||
| Color tone adjustment | Color Hue / Saturation adjustment ±5 | |
| steps for Magenta/ Red/ Orange/ | ||
| Yellow color | Red adjustment: ±8 steps | |
| Blue adjustment: ±8 steps | ||
| Chroma adjustment: ±8 steps | ||
| Automatic Gain control | ||
| (AGC) | Available | Available |
7
TRADITIONAL 510(k) VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OTV-S500) (compatible with URO/GYN Endoscopes) 510(k) SUMMARY
| OLYMPUS OTV-S500 | OLYMPUS CV-170 | |
|---|---|---|
| (Subject Device) | (Predicate Device) | |
| Contrast | Image contrast enhancement can be set (ON, OFF) | The image contrast can be set to one of the following three modes (Normal, High, Low) |
| Noise reduction | Available | Available |
| Image enhancement setting | Structural enhancement | |
| Edge enhancement | Structural enhancement | |
| Edge enhancement | ||
| Switching the | ||
| enhancement modes | Available | Available |
| Image size selection | Available | Available |
| Freeze | Available | Available |
| Pre-freeze | Available | Available |
| Optical-digital observation | NBI observation | NBI observation |
| Compatible scopes/Camera | ||
| head | Video endoscopes for | |
| · Urology | ||
| · Obstetrics and gynecology |
Camera head for
· Urology
· Obstetrics and gynecology
Telescope/Fiber scope for
· Urology
· Obstetrics and gynecology | · Flexible video scopes including, but not limited to,
Gastroscope
Colonoscope
Duodenoscope
Small intestinal scope
Sigmoidoscope
Bronchoscope
Cysto-nephro scope
Choledochoscope
Rhino-laryngo scope
Esophagoscope
Ureteroscope
Ureterorenoscope
· Rigid scopes
· Fiber scopes
· Video converter
· Camera head |
| Dimensions (maximum) | 308(W) x 157(H) x 461(D) mm | 309(W) x 156(H) x 442(D) mm |
| Weight | 10.6kg | 11.0kg |
| Examination Lamp | LED
(White LED: 1 and Violet LED: 1) | LED
(White LED: 1 and Violet LED: 1) |
| Rated input | 150VA | 200VA |
SUMMARY OF NON-CLINICAL PERFORMANCE DATA 7.
Results of the following testing support the safety and performance of the Subject device and demonstrate its equivalence to the Predicate device; all testing passed/met the acceptance criteria, demonstrated compliance with the cited standards and FDA Guidance shown below, and supported equivalent safety and performance to the Predicate device:
- · Performance Testing Bench (including Subject and Predicate device testing of Field of View [in compliance with ISO 8600-3:2019); Resolution; Image Noise and Dynamic Range [tested according to ISO 15739:2017]; Brightness; Image Intensity Uniformity; Color Performance [including analysis with the FDA Color Performance Review (CPR) Tool for
8
Image /page/8/Picture/1 description: The image shows the word "OLYMPUS" in a bold, sans-serif font. The word is in all capital letters and is a dark blue color. The registered trademark symbol is located to the right of the word.
Endoscopy Devices]; Latency; and Contrast Enhancement). The Subject device performed equivalently to the Predicate device, and test results support performance of the Subject device with compatible endoscopes.
- · Electrical Safety/EMC Testing (ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]; ANSI AAMI IEC 60601-1-2 [Including AMD 1:2021]; IEC 60601-2-18: Edition 3.0 2009-08; IEC TR 60601-4-2 Edition 1.0 2016-05; IEC 60601-1-6 Edition 3.2 2020-07 Consolidated Version)
- · Software Validation/Cybersecurity (IEC 62304 Edition 1.1 2015-06 Consolidated Version; ISO 14971:2019; FDA Guidance Document Content of Premarket Submissions for Device Software Functions – Guidance for Industry and Food and Drug Administration Staff, issued on June 14, 2023; FDA Guidance Document Off-the-Shelf Software Use in Medical Devices – Guidance for Industry and Food and Drug Administration Staff, issued August 11, 2023; FDA Guidance Document Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, issued on September 27, 2023)
8. SUMMARY OF CLINICAL PERFORMANCE DATA
No clinical data were collected to support performance of the Subject device.
9. CONCLUSION
The results of non-clinical performance testing demonstrate that the Subject device is as safe and effective as the Predicate device to support a substantial equivalence determination.