Sony LMD-X310S LCD Monitor, Sony LMD-X310MD LCD Monitor, Sony LMD-X310NB LCD Monitor, Sony LMD-X550S LCD Monitor, Sony LMD-X550MD LCD, Sony LMD-X550NB LCD Monitor

K150377 · Sony Electronics, Inc. · GCJ · Jul 29, 2015 · Gastroenterology, Urology

Device Facts

• Record ID: K150377
• Device Name: Sony LMD-X310S LCD Monitor, Sony LMD-X310MD LCD Monitor, Sony LMD-X310NB LCD Monitor, Sony LMD-X550S LCD Monitor, Sony LMD-X550MD LCD, Sony LMD-X550NB LCD Monitor
• Applicant: Sony Electronics, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Jul 29, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Indications for Use

The LCD Monitor is intended to provide 4K 2D color video displays of images from endoscopic / laparoscopic camera systems and other compatible medical imaging systems. The LCD Monitor is a wide-screen, high-definition, medical grade monitor for real-time use during minimally invasive surgical procedures and is suitable for use in hospital operating rooms, surgical centers, clinics, doctors' offices and similar medical environments.

Device Story

LCD monitors (31-inch and 55-inch) display 4K 2D color video from endoscopic/laparoscopic cameras and medical imaging systems. Used in operating rooms, surgical centers, and clinics by physicians and assistants. Features include OptiContrast Panel for reduced reflection/light dispersion and A.I.M.E. (Advanced Image Multiple Enhancer) for structure and color enhancement. A.I.M.E. provides user-selectable levels to improve outline recognition and color tone clarity. Monitors support multiple display formats (Rotation, Side-by-Side, Picture-in-Picture, Picture-out-Picture). Ergonomic design includes LED-navigated control panels and easy-to-clean surfaces. Output allows clinicians to visualize real-time surgical fields, aiding decision-making during minimally invasive procedures.

Clinical Evidence

No clinical data was collected to support substantial equivalence. Bench testing only.

Technological Characteristics

LCD panel (IPS) with LED backlight. 4K resolution (4096x2160 or 3840x2160). Connectivity: DVI-D, HDMI, 3G/HD/SD-SDI. A.I.M.E. image enhancement algorithm. Standards: ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 62304, ISO 14971. Power: AC 100-240V or DC via AC-300MD adapter.

Indications for Use

Indicated for use in hospital operating rooms, surgical centers, clinics, and doctors' offices to provide 4K 2D color video displays of images from endoscopic/laparoscopic camera systems and other compatible medical imaging systems during minimally invasive surgical procedures.

Regulatory Classification

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.

Special Controls

*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.

In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls: 1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following: 1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures. 2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use. 3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use. 2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes. 3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches 4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. 5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms. (7) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance. (8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and repeatability; (ii) System testing; (iii) Instrument reliability; (iv) Crosstalk; (v) Table motion control; (vi) Thermal effects on tissue; (vii) User-device interface performance; (viii) Workspace access testing; and (ix) Performance testing with compatible devices. (9) Software verification, validation, and hazard analysis must be performed. (10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (11) Performance data must demonstrate the sterility of all patient-contacting device components. (12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (13) Performance data must validate the reprocessing instructions for the reusable components of the device. (14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic. (16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.

Predicate Devices

• SONY LMD-2451MT LCD MONITOR (K113203)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name encircling a stylized emblem. The emblem features three human profiles facing right, layered to create a sense of depth and unity. The profiles are rendered in a simple, elegant style.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 29, 2015

Sony Electronics Incorporated Mr. Amarjit Jowandha Head, Quality Assurance, Regulatory Affairs & Compliance 1 Sony Drive, Mail Stop 3C5 Park Ridge, New Jersey 07656

Re: K150377

Trade/Device Name: Sony LMD-X310S LCD Monitor, Sony LMD-X310MD LCD Monitor, Sony LMD-X310NB LCD Monitor, Sony LMD-X550S LCD Monitor, Sony LMD-X550MD LCD, Sony LMD-X550NB LCD Monitor Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: June 19, 2015 Received: June 22, 2015

Dear Mr. Jowandha:

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. 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

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CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Joshua C. Nipper -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. For Director

> Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31. 2017 See PRA Statement below.

510(k) Number (if known)

K150377

Device Name

Sony LMD-X310S LCD Monitor, Sony LMD-X310MD LCD Monitor, Sony LMD-X310NB LCD Monitor, Sony LMD-X550S LCD Monitor, Sony LMD-X550MD LCD Monitor, Sony LMD-X550NB LCD Monitor

Indications for Use (Describe)

The LCD Monitor is intended to provide 4K 2D color video displays of images from endoscopic / laparoscopic camera systems and other compatible medical imaging systems.

The LCD Monitor is a wide-screen, high-definition, medical grade monitor for real-time use during minimally invasive surgical procedures and is suitable for use in hospital operating rooms, surgical centers, clinics, doctors' offices and similar medical environments.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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### *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:

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FORM FDA 3881 (8/14)

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# 510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807.92.

510(k) Number: K150377

## 5.1 Applicant Information

| Date Prepared: | March 12, 2015 |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Name and<br>Address: | Sony Electronics, Inc.<br>Sony Medical Systems Division<br>1 Sony Drive, Mail Stop 3C5<br>Park Ridge, NJ 07656<br>United States |
| Contact Person: | Mr. Amarjit "Andy Singh" Jowandha<br>Head, Quality Assurance, Regulatory Affairs & Compliance<br>Phone: [phone]<br>FAX: [phone]<br>Email: [e-mail] |

# 5.2 Device Information

| Device Type: | LCD Monitor |
|-------------------------|-------------------------------------------------------------------------|
| Regulation Description: | Endoscope and Accessories |
| Review Panel: | General & Plastic Surgery |
| Regulation Number: | 21 CFR 876.1500 |
| Product Code: | GCJ |
| Device Class: | II |
| Device Name: | LMD-X310S, LMD-X310MD, LMD-X310NB, LMD-X550S, LMD-X550MD and LMD-X550NB |

## 5.3 Predicate Devices

The legally marketed devices to which substantial equivalence is being claimed are:

| 510(k) Number: | K113203 |
|--------------------|-----------------------------|
| Applicant: | Sony Electronics Inc. |
| Device Name: | SONY LMD-2451MT LCD MONITOR |
| Regulation Number: | 21 CFR 876.1500 |
| Product Code: | GCJ |
| Device Class: | II |

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### 5.4 Device Description

The Sony LMD-X310S. LMD-X310MD and LMD-X310NB are 31 inches LCD monitors, and LMD-X550S. LMD-X550MD and LMD-X550NB are 55 inches LCD monitors with an advanced display technology, designed for use in medical environments. These monitors provide 4K resolution 2D color video displays of images from a surgical endoscope, laparoscopic camera system, and other compatible medical imaging systems. They are suitable for environments such as operating rooms. surgical centers, clinics, doctor's offices, and similar locations.

LMD-X310S、LMD-X310MD and LMD-X310NB are operated by DC power supply and supplied with a dedicated AC adaptor, AC-300MD. LMD-X310MD is SONY brand model, LMD-X310S is a model for a specified customer and LMD-X310NB is for unspecified customers.

MD-X550S, LMD-X550MD and LMD-X550NB are operated by AC power supply. LMD-X550MD is SONY brand model, LMD-X550S is a model for a specified customer and LMD-X550NB is for unspecified customers.

Key features include:

- A Large and 4K Screen
The 4K ultra high resolution on 31 inch and 55 inch size large screen offers high picture quality.

- > Wide color qamut
The LCD panel and signal processing technology realize wide color gamut.

- > Clear and High-contrast View
The OptiContrast Panel™ achieves clear, high-contrast images by controlling reflection and minimizing light dispersion in the LCD panel. It also helps to eliminate dew condensation in the panel.

- A A.I.M.E.™ (Advanced Image Multiple Enhancer)
There are two modes in A.I.M.E function, named as "Structure Enhancement mode" and "Color Enhancement mode". Users can select four levels for Structure Enhancement mode and eight levels for Color Enhancement mode, depending on user's preference. Bv utilizina A.I.M.E function, users can expect the following effectiveness on display image.

- > Color Enhancement Function
- Color Enhancement Function clarifies color tone of the specific color (such as red) object. .
- > Structure Enhancement Function
- Structure Enhancement Function improves recognition of the object's outline.
- Visibility gets clear to easily see objects. .
- > Narrow Bezel

The narrow bezel achieves a wider display area, even with the compact body.

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### 5.0 510(k) Summary

#### Ergonomic Design A

The easy-to-hold design enables the user to adjust monitor position easily.

- > User-friendly Control Panel
LED navigated operation enables easy setting. The user can assign CUSTOM buttons to commonly used functions.

- A Variety of Display Format
A variety of display format - including Rotation Image, Side-by-Side, Picture-in-Picture, and Picture-out-Picture - can be selected easily by simply pressing buttons.

- > Easy to Clean
The flat surface allows the user to easily wipe liquids and gels off the LCD panel and control buttons, facilitating cleanliness and disinfection.

- A Installation-friendly Cabling
All the connectors face downwards, allowing for easy and organized cable connection.

# 5.5 Intended Use/Indications for Use

The LCD Monitor is intended to provide 4K 2D color video displays of images from endoscopic / laparoscopic camera systems and other compatible medical imaging systems. The LCD Monitor is a wide-screen, high-definition, medical grade monitor for real-time use during minimally invasive surgical procedures and is suitable for use in hospital operating rooms, surgical centers, clinics, doctors' offices and similar medical environments.

# 5.6 Technological Characteristics

The subject device compares to the legally marketed devices as follows:

| Device | Subject Device | Predicate device | | |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| | LMD-X310S | LMD-X550S | SONY LMD-2451MT LCD | |
| | LMD-X310MD | LMD-X550MD | MONITOR | |
| | LMD-X310NB | LMD-X550NB | | |
| Intended | Hospital operating rooms, surgical centers, clinics, | | Hospital operating | |
| environment | doctors' offices and similar medical environments | | rooms, surgical centers,<br>clinics, doctors' offices<br>and similar medical<br>environments | |
| Intended<br>users | Doctors and assistants | | Doctors and assistants | |
| Compatibility<br>with other<br>devices | Surgical endoscopic/laparoscopic camera systems and<br>other compatible medical imaging systems | | Surgical<br>endoscopic/laparoscopic<br>camera systems and<br>other compatible<br>medical imaqinq | |
| Device | Subject Device | | Predicate device | |
| | LMD-X310S<br>LMD-X310MD<br>LMD-X310NB | LMD-X550S<br>LMD-X550MD<br>LMD-X550NB | SONY LMD-2451MT LCD<br>MONITOR | |
| | | | systems | |
| Power | AC 100-240 V/50-60 Hz | | AC 100-240 V/50-60 Hz | |
| Dimensions<br>(excluding<br>maximum<br>protrusions) | 753.8×456.4×69.3mm | | 1264.6×771.5×85.5mm | 602.4/386.2/110 mm |
| Display<br>dimension | | | 2D | 2D / 3D |
| Input signals | DVI-D, HDMI, 3G/HD/SD-SDI | | DVI-D, HD15,<br>RGB/Component, Y/C,<br>Composite<br>SDI 4:2:2 (optional)<br>HD/D1-SDI (optional)<br>NTSC/PAL :Y/C,<br>Composite (optional)<br> | |
| Output<br>signals | DVI-D, 3G/HD/SD-SDI | | Composite output<br>connector<br>Y/C output connector<br>RGB/component output<br>connectors<br>External synchronized<br>output connector | |
| Display<br>device | LCD panel (IPS) | | LCD panel (IPS) | |
| Backlight<br>device | LED | | CCFL | |
| Viewing<br>angle | Right>89[deg] (CR>10)<br>Left>89[deg] (CR>10)<br>Up>89[deg] (CR>10)<br>Down>89[deg] (CR>10) | | Right>89[deg] (CR>10)<br>Left>89[deg] (CR>10)<br>Up>89[deg] (CR>10)<br>Down>89[deg] (CR>10) | |
| Active<br>screen size | 697.958(H)×368.064(V)<br>mm | | 1209.573(H)×680.385(V)<br>mm | 518.4(H)×324.0(V) mm |
| Resolution | 4096×2160 pixels | | 3840×2160 pixels | 1920×1200 pixels |
| Maximum<br>Luminance | ≥550[cd/m2] | | ≥330[cd/m2] | ≥200[cd/m2] |
| Color Gamut | Avg. 135% of sRGB | | Avg. 135% of sRGB | Avg. 102% of sRGB |
| Picture<br>enhancement | A.I.M.E. function | | NA | |
| Device | Subject Device | | Predicate device | |
| | LMD-X310S<br>LMD-X310MD<br>LMD-X310NB | LMD-X550S<br>LMD-X550MD<br>LMD-X550NB | SONY LMD-2451MT LCD<br>MONITOR | |
| Refresh rate | 50/60 [Hz] | 100/120 [Hz] | 50/60 [Hz] | |
| Frame rate | 50/60 [fps] | | 50/60 [fps] | |
| Display<br>format | Normal | | Normal | |
| | Multi display | | Multi display | |
| | Flip display | | Mirror image | |
| Performance<br>Standards | ANSI/AAMI ES60601-1<br>IEC 60601-1-2<br>IEC 62304<br>ISO 14971 | | IEC 60601-1<br>EN 60601-1-2<br>ISO 14971 | |

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# 5.0 510(k) Summary

ry

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### 5.0 510(k) Summary

Sony Electronics Inc. LCD Monitor LMD-X310S, LMD-X310MD, LMD-X310NB, LMD-X550S, LMD-X550MD and LMD-X550NB

As demonstrated in the above comparison table , the subject and predicate devices have similar technological characteristics such as intended environments, intended users, compatibility with other endoscopic/laparoscopic devices, power ratings, video input and output signals, frame rate, display format and performance standards.

The subject and predicate devices also have differences in technological characteristics, such as dimensions and active screen size, display dimension, video input signals, backlight devices, resolution, refresh rate, and standards. We do not consider these differences to make the subject devices less safe and effective than the predicate device for their intended use and we do not consider these differences to raise different questions of safety and effectiveness.

## 5.7 Non-Clinical Performance Data

The subject devices demonstrate conformance with the following recognized standards:

- . ANSI/AAMI ES60601-1
- IEC 60601-1-2
- IEC 62304
- . ISO 14971

The subject devices have additionally undergone bench testing as part of required performance verification and validation activities. Results show that the subject device has met pre-defined design and performance acceptance criteria. Results of all non-clinical testing support the safety and effectiveness of the subject devices.

### 5.8 Clinical Performance Data

No clinical data was collected to support substantial equivalence between the subject and predicate devices.

## 5.9 Conclusions

Based on the above information and all data provided in this submission, the comparison of intended uses, technological characteristics, and non-clinical performance testing demonstrates that the subject devices are substantially equivalent to the predicate device identified in this submission.