ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US)

K240401 · Origyn Medical Technology (Hangzhou) Co., Ltd. · HIH · Jul 26, 2024 · Obstetrics/Gynecology

Device Facts

• Record ID: K240401
• Device Name: ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US)
• Applicant: Origyn Medical Technology (Hangzhou) Co., Ltd.
• Product Code: HIH · Obstetrics/Gynecology
• Decision Date: Jul 26, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1690
• Device Class: Class 2

Intended Use

ClearVision Single Use Hysteroscope & Image Processing System is intended to be used for viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures (EHS-Dx4001) or diagnostic and operative procedures (EHS-Op5001 and EHS-Op6001).

Device Story

Portable hysteroscope system comprising sterile, single-use disposable electronic hysteroscope and reusable Medical Endoscope Image Processor. Hysteroscope tip contains miniature CMOS camera and LED illumination module; includes two channels for fluid infusion and aspiration. Image processor contains control panel, video processor, and microcontrollers. Used in hospitals and physician offices by trained medical professionals. CMOS sensor converts reflected tissue light into electrical signals; transmitted to image processor for conversion to video output on external medical-grade HD monitor. Enables visualization of uterine cavity for diagnostic/operative procedures. Benefits include reduced risk of cross-contamination via single-use design and high-definition visualization for improved clinical decision-making.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including electrical safety, EMC, packaging integrity, sterilization validation, biocompatibility, and optical/mechanical performance testing (field of view, resolution, bending strength, leakage).

Technological Characteristics

System includes disposable CMOS-based hysteroscope (EO sterilized) and reusable image processor. Features LED illumination at tip. Models vary by width (4.1mm-6.4mm) and channel size. Connectivity via HDMI to external HD monitor. Software/firmware controlled. Complies with ISO 8600 series, IEC 60601-1, IEC 60601-2-18, and ISO 10993.

Indications for Use

Indicated for viewing the adult cervical canal and uterine cavity to perform diagnostic or operative procedures.

Regulatory Classification

Identification

A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.

Predicate Devices

• HTx Single Use Hysteroscope System (K211227)

Submission Summary (Full Text)

{0}

FDA U.S. FOOD & DRUG ADMINISTRATION

July 26, 2024

OriGyn Medical Technology (Hangzhou) Co., Ltd.
% Chen Yuling
Official Correspondent
Linnwell International Certification Consulting Co., Ltd.
First Floor, Building 1, No. 333 Wanfang Road,
Minhang District
Shanghai, 201112
CHINA

Re: K240401
Trade/Device Name: ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US)
Regulation Number: 21 CFR 884.1690
Regulation Name: Hysteroscope and accessories
Regulatory Class: II
Product Code: HIH
Received: July 2, 2024

Dear Chen Yuling:

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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

{1}

K240401 - Chen Yuling
Page 2

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" (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 QS 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 (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-reporting-combination-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the

{2}

K240401 - Chen Yuling
Page 3

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-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] 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}

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known)
K240401

Device Name
ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US)

Indications for Use (Describe)
ClearVision Single Use Hysteroscope & Image Processing System is intended to be used for viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures (EHS-Dx4001) or diagnostic and operative procedures (EHS-Op5001 and EHS-Op6001).

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
[e-mail]

"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."

FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]

{4}

K240401
Page 1 of 10

# 510(k) Summary

This summary of 510(k) is submitted in accordance with the requirements of 21 CFR 807.92.

## 1. Submitter Information

| Manufacturer | OriGyn Medical Technology (Hangzhou) Co., Ltd.
688 Bin’An Road, Building 6, Room 310, Hangzhou, Zhejiang Province China |
| --- | --- |
| Contact Person | Yuling Chen
Linnwell International Certification Consulting Co., Ltd.
Email: [e-mail]
Phone: [phone] |
| Date Prepared | July 26, 2024 |

## 2. Device Information

| Trade/Device Name | ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US) |
| --- | --- |
| Proprietary Name | Medical Endoscope Image Processing System |
| Models | EHS-Dx4001, EHS-Op5001, EHS-Op6001 and EHS-IPS01US |
| Regulation Number | 21 CFR 884.1690 |
| Regulation Name | Hysteroscope and accessories |
| Product Code | HIH (Hysteroscope (And Accessories)) |
| Regulatory Class | II |
| Panel | Obstetrics/Gynecology |

## 3. Predicate Device

| Predicate Device | HTx Single Use Hysteroscope System (K211227) |
| --- | --- |
| Legal Manufacturer | Acuvu Humming Scope |

This predicate device has not been subject to a design related or safety recall.

## 4. Indications for Use

ClearVision Single Use Hysteroscope & Image Processing System is intended to be used for viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures (EHS-Dx4001) or diagnostic and operative procedures (EHS-Op5001 and

{5}

K240401
Page 2 of 10

EHS-Op6001).

# 5. Device Description

ClearVision Single Use Hysteroscope & Image Processing System is a portable hysteroscope. It includes a sterile single use disposable electronic hysteroscope and a reusable Medical Endoscope Image Processor. The Disposable Electronic Hysteroscope contains a miniature CMOS camera and a light-emitting diode (LED) illumination module at its tip and two channels for infusion of irrigating fluid and aspiration of fluid and debris. The Disposable Electronic Hysteroscope is sterilized by ethylene oxide and is packaged in a sealed pouch with a shelf-life of one year. The Medical Endoscope Image Processor contains a control panel with buttons, a video processor, microcontrollers, software and firmware. The equipment is powered by mains supply with a detachable power cord.

ClearVision Single Use Hysteroscope

Accessories : Power cord and HDMI cable
length: 2.1m

length: 1.7m

Image Processing system: Front and Back panel


The Hysteroscope comes in three models: EHS-Dx4001, EHS-Op5001 and EHS-Op6001 and the specifications are shown as below:

{6}

K240401
Page 3 of 10

| Model Number | EHS-Dx4001 | EHS-Op5001 | EHS-Op6001 |
| --- | --- | --- | --- |
| Maximum insertion portion width | 4.1 mm | 5.1 mm | 6.4 mm |
| Minimum instrument channel width | N/A | 2.0 mm | 3.3 mm |
| Tip bending angle | 10° | | 0° |
| Direction of view | 10° | | 0° |
| Field of view | 120° | | |
| Working length | 200 mm | | |
| Depth of field | ~5 mm to 50 mm | | |

The EHS-Dx4001 model is intended to be used for performing only diagnostic procedures and EHS-Op5001 and EHS-Op6001 are used for both diagnostic and operative procedures.

## 6. Principles of Operation

The CMOS sensor at the tip of the Single Use hysteroscope converts the reflected light from the tissue into electrical signals. These signals are then transmitted through a cable connected to the image processing system. The image processing system converts the electrical signal into a video output to display on a connected monitor.

## 7. Comparison of technological characteristics to predicate device

| Feature | Subject Device | Predicate Device | Comparison |
| --- | --- | --- | --- |
| | K240401
OriGyn Medical Technology
(Hangzhou) Co.,Ltd | K211227
Suzhou Acu-Vu Medical
Technology Co., Ltd. | |
| Device Name | ClearVision Single Use
Hysteroscope & Image
Processing System | HTx Disposable
Hysteroscope System | N/A |
| Regulation | 21 CFR 884.1690 | 21 CFR 884.1690 | Same |
| Product code | HIH | HIH | Same |
| Indications for use | ClearVision Single Use
Hysteroscope & Image
Processing System is intended
to be used for
viewing of the cervical canal
and uterine cavity for the | HTx disposable
hysteroscope system is
intended to be used for
viewing of the cervical
canal and uterine cavity
for the purpose of | Same |

{7}

K240401
Page 4 of 10

| Feature | Subject Device | Predicate Device | Comparison |
| --- | --- | --- | --- |
| | K240401
OriGyn Medical Technology
(Hangzhou) Co.,Ltd | K211227
Suzhou Acu-Vu Medical
Technology Co., Ltd. | |
| | purpose of performing
diagnostic procedures (EHS-
Dx4001) or diagnostic and
operative procedures (EHS-
Op5001 and EHS-Op6001). | performing diagnostic
and operative procedures. | |
| Procedures | Viewing of the adult cervical
canal and uterine cavity for the
purpose of performing
diagnostic or operative
procedures | Viewing of the adult
cervical canal and uterine
cavity for the purpose of
performing diagnostic or
operative procedures | Same |
| Environment of use | Hospitals and physician’s office | Hospitals and physician’s
office | Same |
| Intended users | Trained Medical Professionals | Trained Medical
Professionals | Same |
| System Components | Disposable Cannula and Image
Capture System | Disposable Cannula and
Image Capture System | Same |
| Sterilization | Cannula is provided sterile
(Ethylene Oxide).
The image processor and other
modules are provided non-sterile. | Cannula is provided
sterile (Ethylene Oxide).
The image processor and
other modules are
provided non-sterile. | Same |
| Clinical Application | Diagnostic and Operative
Hysteroscopy | Diagnostic and Operative
Hysteroscopy | Same |
| Scope Outer Diameter | EHS-Dx4001: 4.1 +0/-5% mm
EHS-Op5001 : 5.1 +0/-5% mm
EHS-Op6001: 6.4 +0/-5% mm | 4.5mm (HTx40)
6.2mm (HTx60) | Different
* See Note 1 |
| Inner Diameter/Tool
Size | 5 Fr (EHS-Op5001)
9 Fr (EHS-Op6001) | 5 Fr (HTx40)
9 Fr (HTx60) | Same |
| Scope Working Length | 200 mm | 240 mm
Overall: 330 mm | Different
* See Note 2 |
| Field of View | 120° | >115° | Different
* See Note 3 |
| Direction of View | EHS-Dx4001 : 10°
EHS-Op5001 : 10°
EHS-Op6001 : 0° | HTx60: 12°
HTx40: 8° | Different
* See Note 4 |
| Light Source | LEDs at cannula tip | LEDs at cannula tip | Same |

{8}

K240401
Page 5 of 10

| Feature | Subject Device | Predicate Device | Comparison |
| --- | --- | --- | --- |
| Image Resolution | K240401
OriGyn Medical Technology
(Hangzhou) Co.,Ltd | K211227
Suzhou Acu-Vu Medical
Technology Co., Ltd. | Different
* See Note 5 |
| | 1280 x 720 pixels | 400 x 400 pixels | |
| Disposable/Reusable | Cannula/Hysteroscope:
Disposable
Image System: Reusable | Cannula/Hysteroscope:
Disposable
Image System: Reusable | Same |
| Image Transmission | CMOS | CMOS | Same |
| LCD Display Size | 19-24 inches, any medical grade
HD monitor. | 24 inches | Different
*See Note 5 |
| Image and Video
Capture | Image and Video | Image and Video | Same |
| Battery- powered mode | No | No | Same |

Note 1: The outer diameter of the EHS-Dx4001 and EHS-Dx6001 is within the range of the predicate device. The difference does not raise different questions of safety and effectiveness.

Note 2: Shorter scope working length and does not raise different questions of safety and effectiveness.

Note 3: The field of view is (120°) is within the range of the predicate device does not raise different questions of safety and effectiveness.

Note 4: The subject device has a direction of view of 10° for the two models, which is different than the predicate, but it is consistent with previously cleared devices and does not raise different questions of safety or effectiveness for the device.

Note 5: The subject device is recommended to be used with a medical grade HD monitor with similar LCD display size range as predicate and with a higher pixel resolution and does not raise different questions of safety and effectiveness.

The differences in these technological characteristics do not raise different questions of safety and effectiveness.

## 8. Summary of Non-Clinical Performance Testing

The following performance data were provided to support substantial equivalence to the predicate

{9}

K240401
Page 6 of 10

device.

## 8.1 Electrical Safety and Performance testing

The ClearVision Single Use Hysteroscope & Image Processing System was tested according to ES60601-1 and IEC 60601-2-18. The Safety and Performance results meet the requirements.

- ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)];
- IEC 60601-2-18 Medical electrical equipment - Part 2-18:2009 Particular requirements for the basic safety and essential performance of endoscopic equipment.

## 8.2 EMC testing

The ClearVision Single Use Hysteroscope & Image Processing System has been tested on according to IEC 60601-1-2. The EMC performance meets or exceeds the IEC 60601-1-2 requirements.

- IEC 60601-1-2:2020 General requirements for basic safety and essential performance-Collateral standard: Electromagnetic Disturbances-Requirements and tests.

## 8.3 Packaging verification

ClearVision Single Use Hysteroscope is individually packaged in a sterile package, which consists of a blister box and a Tyvek film.

Package Integrity testing included visual inspection, seal strength and dye penetration testing per the standards as below:

- ASTM F1980-21, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- ASTM D4169-22, Standard Practice for Performance Testing of Shipping Containers and Systems
- ASTM F1886/F1886M-16, Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection

{10}

K240401
Page 7 of 10

- ASTM F1929-2015, Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- ASTM F88/F88M-2021, Standard Test Method for Seal Strength of Flexible Barrier Materials

The transportation testing was conducted in accordance with ASTM D4169-22 (DC 13 – Level II) and accelerated aging per ASTM F1980-21 to support a 1-year shelf-life.

## 8.4 Sterilization Validation

The ClearVision Single-Use Hysteroscope was sterilized using Ethylene Oxide and validated according to the following applicable standards:

- ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
- ISO 11737-2:2019 Sterilization of Medical Device-Microbiological methods part 2: Tests of sterility performed in the validation of a sterilization process
- ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals

Reprocessing of the image processor was conducted per AAMI TIR30, A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices.

## 8.5 Optical performance and mechanical performance test

The proposed system underwent testing for mechanical and optical performance listed in the table according to the standards listed below. The results indicate that the system meets the associated acceptance criteria and provides performance equivalent the Predicate Device.

| Test category | Test Item |
| --- | --- |
| Optical and color performance | • Photobiological safety
• Field of view
• Direction of view
• Resolution
• Depth of field
• Noise and dynamic range
• Geometric distortion
• Image intensity uniformity |
| Mechanical Performance | • Bending strength |

{11}

K240401
Page 8 of 10

| Test category | Test Item |
| --- | --- |
| | • Tensile test
• Function knob
• Water tightness
• Leakage
• Flow |

**Standards used:**

- Hysteroscopes and Gynecologic Laparoscopes Submission Guidance for a 510(k) ; March 7, 1996
- ISO 8600-1 Fourth Edition 2015-10-15 Endoscopes — Medical endoscopes and endotherapy devices — Part 1: General requirements
- ISO 8600-3:2019 Endoscopes — Medical endoscopes and endotherapy devices — Part 3: Determination of field of view and direction of view of endoscopes with optics
- ISO 8600-4:2014 Endoscopes — Medical endoscopes and endotherapy devices — Part 4: Determination of maximum width of insertion portion
- ISO 8600-5:2020 Optics and photonics — Medical endoscopes and endotherapy devices — Part 5: Determination of optical resolution of rigid endoscopes with optics
- ISO 15739:2017 Photography-Electronic still-picture imaging -noise measurements
- ISO 12233-2017 Photography-Electronic still picture imaging-Resolution and Spatial frequency responses
- IEC 62471 : 2006 Photobiological safety of lamps and lamp systems

**8.6 Shelf life**

After 1 year of accelerated aging, the EHS-Dx4001、EHS-Op5001、and EHS-Op6001 Single Use hysteroscopes meet design input and packaging requirements for sterile barrier systems as outlined in the associated standards. The shelf life for the single use hysteroscopes is set at 1 year.

The EHS-IPS01US Image Processing System underwent accelerated aging in accordance with ASTM F1980-21 to validate its performance for a shelf life of 5 years.

- ASTM F1980-21 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

{12}

K240401
Page 9 of 10

## 8.7 Biocompatibility testing

The product was tested for cytotoxicity, acute toxicity, pyrogenicity, sensitization, and intracutaneous irritation in accordance with the FDA guidance document “Use of International Standard ISO 10993-1, ‘Biological evaluation of medical device – Part 1: Evaluation and testing within a risk management process’” and a device with limited (<24 hours) contact with breached or compromised tissue. The results demonstrate that the product's biocompatibility meets the required criteria. The following standards were used to complete the testing:

- ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- ISO 10993-2:2022 Biological evaluation of medical devices-Part 2: Animal welfare requirements
- ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- ISO 10993-12:2021 Biological evaluation of medical devices-Part 12: Sample preparation and reference materials
- ISO 10993-10:2021 Biological evaluation of medical devices-Part 10: Tests for skin sensitization
- ISO 10993-23:2021 Biological evaluation of medical devices-Part 23: Tests for irritation
- ISO 10993-11: 2017 Biological evaluation of medical devices—Part 11: Tests for systemic toxicity & material mediated pyrogenicity

The test results demonstrate that the subject device is non-cytotoxic, non-sensitizing, a non-irritant, not acutely systemically toxic, and non-pyrogenic.

## 8.8 Software and Cybersecurity

The software of the subject device was validated as Basic Documentation Level in accordance with FDA’s Guidance for Industry and FDA Staff, Content of Premarket Submissions for Device Software Functions, issued on June 14, 2023. Cybersecurity documentation is provided in support of the subject device per FDA guidance document, Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, September 2023.

{13}

K240401
Page 10 of 10

# 9. Conclusions

The performance testing summarized above support that the subject device is as safe and effective as the predicate device. Therefore, the subject device is substantially equivalent to the predicate device.