SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G)

K240978 · MacroLux Medical Technology Co., Ltd. · HIH · Aug 16, 2024 · Obstetrics/Gynecology

Device Facts

• Record ID: K240978
• Device Name: SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G)
• Applicant: MacroLux Medical Technology Co., Ltd.
• Product Code: HIH · Obstetrics/Gynecology
• Decision Date: Aug 16, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SeleneView® (model: HC29, HC29-G, HC35, HC35-G) is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures. The SeleneView® (model: HO35, HO35-G, HO42, HO42-G) is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and therapeutic procedures. SeleneView® is intended for use in professional healthcare facility environments such as hospitals and clinics. SeleneView® is designed for use in adults.

Device Story

SeleneView® is a single-use digital hysteroscope consisting of a handle, insertion tube, and endoscope cable. It utilizes a distal-tip LED light source and CMOS image sensor to capture visual data, which is transmitted to the ViewHub® Video Processor (K233779) for signal processing and display. Used in hospitals and clinics by healthcare professionals, the device allows for real-time visualization of the cervical canal and uterine cavity. The output is displayed on a monitor, enabling clinicians to perform diagnostic or therapeutic procedures. The device is provided sterile via ethylene oxide (EO) and is intended for single-use, eliminating reprocessing requirements and reducing cross-contamination risks.

Clinical Evidence

Bench testing only. Performance validated via mechanical testing (tensile, Luer interface, sealing, flow control), optical testing (FOV, resolution, DOF, SNR, dynamic range, intensity uniformity, distortion, color), biocompatibility (ISO 10993-1, -5, -10, -11, -23), electrical safety (IEC 60601-1, -2-18), EMC (IEC 60601-1-2), and photobiological safety (IEC 62471).

Technological Characteristics

Single-use digital hysteroscope; CMOS image sensor; LED illumination; ethylene oxide sterilization. Complies with ISO 8600 (optical), ISO 10993-1 (biocompatibility), IEC 60601-1/2-18 (electrical safety), and IEC 62471 (photobiological). Connectivity via cable to ViewHub® Video Processor. Dimensions vary by model (2.9mm to 4.3mm insertion width).

Indications for Use

Indicated for adult patients requiring visualization of the cervical canal and uterine cavity for diagnostic (all models) or therapeutic (HO35, HO35-G, HO42, HO42-G models) 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

• Single-Use Video Hysteroscope: RP-G-C24, RP-G-C0101 (K232003)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

August 16, 2024

MacroLux Medical Technology Co., Ltd. Linbin Ye Person Responsible for Regulatory Compliance 301, Building 3, NamTai Inno Park In Guang Ming Avenue Guangming Shenzhen, Guangdong CHINA

Re: K240978

Trade/Device Name: SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G) Regulation Number: 21 CFR 884.1690 Regulation Name: Hysteroscope And Accessories Regulatory Class: Class II Product Code: HIH Dated: April 7, 2024 Received: August 5, 2024

Dear Linbin Ye:

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.

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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 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-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 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-devicereporting-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-device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn).

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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/medicaldevices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumereducation-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

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# Indications for Use

510(k) Number (if known) K240978

#### Device Name

SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35-G, HO35, HO35-G, HO42, HO42-G)

Indications for Use (Describe)

The SeleneView® (model: HC29, HC29-G, HC35, HC35-G) is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures.

The SeleneView® (model: HO35, HO35-G, HO42, HO42-G) is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and therapeutic procedures.

Selene View® is intended for use in professional healthcare facility environments such as hospitals and clinics. SeleneView® is designed for use in adults.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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| | | K240978 Page 1 of 3 |
|-----------------------------|------------------------------------------------------------------------------------------------------|-------------------------|
| 510(k) #: K240978 | 510(k) Summary | Prepared on: 2024-08-16 |
| Contact Details | | 21 CFR 807.92(a)(1) |
| Applicant Name | MacroLux Medical Technology Co., Ltd. | |
| Applicant Address | 301, Building 3, NamTai Inno Park In Guang Ming Avenue Guangming Shenzhen Guangdong Shenzhen China | |
| Applicant Contact Telephone | [phone] | |
| Applicant Contact | Mr. Linbin Ye | |
| Device Name | | 21 CFR 807.92(a)(2) |
| Device Trade Name | SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G) | |
| Common Name | Hysteroscope and accessories | |
| Classification Name | Hysteroscope (And Accessories) | |
| Regulation Number | 884.1690 | |

Legally Marketed Predicate Devices
21 CFR 807.92(a)(3)

| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|----------------------------|----------------------------------------------------------|--------------------|
| K232003 | Single-Use Video Hysteroscope: RP-G-C24, RP-G-C0101 | HIH |
| Device Description Summary | | |
| | | 21 CFR 807.92(a)(4 |

# Device Description Summary

SeleneView® Single-Use Digital Hysteroscope consists of a handle, insertion and endoscope cable. SeleneView® is provided sterile (sterilized by ethylene oxide [EO]) and intended to be single-use.

The built-in light emitting diode (LED) at the distal tip of SeleneView® Single-Use Digital Hysteroscope provides a light source, the lens module captures the light signal, then the complementary metal-oxide-semiconductor (CMOS) image module converts the light signal into an electrical signal; the endoscope cable connects SeleneView® Video Processor, which provides power and processes video signal from the endoscope.

The SeleneView® is intended to be used combined with ViewHub® Video Processor to perform its intended function and the ViewHub® has been 510(k) cleared in K233779.

SeleneView® Single-Use Digital Hysteroscope has the following physical and performance characteristics:

- Camera and LED light source at the distal tip
- Sterilized by Ethylene Oxide

- For single-use

# Intended Use/Indications for Use

The SeleneView® (model: HC29, HC29-G, HC35, HC35-G) is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures.

The SeleneView® (model: HO35, HO35-G, HO42, HO42-G) is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and therapeutic procedures.

SeleneView® is intended for use in professional healthcare facility environments such as hospitals and clinics. SeleneView® is designed for use in adults.

# 21 CFR 807.92(a)(5)

21 CFR 807.92(a)(3)

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# Indications for Use Comparison

21 CFR 807.92(a)(5)

The indications for use of the subject device and the predicate device are the same.

# Technological Comparison

21 CFR 807.92(a)(6)

| Item | Subject device | Predicate device (K232003) |
|-----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The SeleneView® (model: HC29, HC29-G, HC35, HC35-G) is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures.<br>The SeleneView® (model: HO35, HO35-G, HO42, HO42-G) is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and therapeutic procedures.<br>SeleneView® is intended for use in professional healthcare facility environments such as hospitals and clinics.<br>SeleneView® is designed for use in adults. | The Single-Use Video Hysteroscope is intended to be used for viewing of the adult cervical canal and uterine cavity for the purpose of performing diagnostic and operative procedures. The device is suitable for professional healthcare facility environments such as hospitals and clinics. |
| Population | Adult | Adult |
| Prescription/over-the-counter use | Prescription | Prescription |
| Route of advancement | Advanced to uterine cavity via the cervical canal | Advanced to uterine cavity via the cervical canal |
| Maximum insertion portion width | HC29/HC29-G: 2.9mm;<br>HC35/HC35-G: 3.85mm;<br>HO35/HO35-G: 3.8mm;<br>HO42/HO42-G: 4.3mm | RP-G-C24: 5.5mm;<br>RP-G-C0101: 4.8mm |
| Minimum working channel width | HC29/HC29-G: none;<br>HC35/HC35-G: none;<br>HO35/HO35-G: ≥1.8mm;<br>HO42/HO42-G: ≥2.0mm | RP-G-C24: 2.3mm;<br>RP-G-C0101: 2.0mm |
| Working length | 220 mm | 270 mm |
| Type of image sensor | CMOS | CMOS |
| Image resolution | HC29/HC29-G/HO35/HO35-G: 400*400 pixels<br>HC35/HC35-G/HO42/HO42-G: 1280*720 pixels | 160,000 pixels |
| Direction of view | 15° | RP-G-C24: 22°<br>RP-G-C0101: 30° |
| Field of view | HC29/HC29-G/HO35/HO35-G: 120°;<br>HC35/HC35-G/HO42/HO42-G: 140° | 120° |
| Depth of field | 3mm~100mm | RP-G-C24: 3~50 mm<br>RP-G-C0101: 5~50 mm |
| Illumination source | LED | LED |
| Image transmission | The images are transmitted through the endoscope with a CMOS image module at the distal end and video processor. | The images are transmitted through the endoscope with a CMOS image module at the distal end and video processor. |
| Capture still images or video images during the procedure | Capture images or video during procedure by the video processor | Capture images or video during procedure by the video processor |
| Sterilization | The Hysteroscope is sterile after sterilization with ethylene oxide (EO) | The Hysteroscope is sterile following exposure to ethylene oxide (EO) |
| Performance | Comply with ISO 8600 | Comply with ISO 8600 |
| Biocompatibility | Comply with ISO 10993-1 | Comply with ISO 10993-1 |
| Electrical performance | Comply with IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-18 | Comply with IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-18 |

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## K240978 Page 2 of 3

The subject and predicate devices have Indications for use, Population, Prescription, Route of advancement, Illumination source, Image transmission, Capture still images during the procedure, Sterilization, Performance, Biocompatibility and Electrical performance. The subject device differs from the predicate in Maximum insertion portion width, Minimum working channel width, Working length, Image resolution, Direction of view, Field of view and Depth of field. These differences do not raise different questions of safety and effectiveness as compared to the predicate.

#### Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

## Mechanical Performance

Mechanical characteristics were tested and include:

- · Tensile stress testing of the joints
- · Performance tests for Luer interface (per ISO 80369-7:2021)
- · Sealing performance of working channel
- · Performance tests for inlet/outlet channels and flow control valve
- · Strength and stiffness of insertion portion

### Optical Performance

Comparative testing was performed for the and predicate device to support substantial equivalence, including: · Field of view (FOV)

- Resolution
- Depth of field (DOF)
- · Signal-to-noise ratio (SNR)
- · Dynamic range
- · Image intensity uniformity (IIU)
- · Geometric distortion
- · Color performance

### Sterilitv

The sterilization validation was conducted according to ISO 11135:2014/A1:2018.

### Biocompatibility

The biocompatibility was assessed according to 2023 FDA guidance document "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process" and the standard ISO 10993-1.

The following tests were conducted based contact category of "Surface – Mucosal Membrane" with a contact duration of "Limited (< 24 hours):

- · Cytotoxicity (ISO 10993-5:2009)
- · Sensitization (ISO 10993-10:2010)
- · Intracutaneous reactivity (ISO 10993-23:2021)
- · Material-mediated pyrogenicity (ISO 10993-11:2017)
- · Acute systemic toxicity (ISO 10993-11:2017)

### EMC

The EMC was assessed according to the 2022 FDA guidance document "Electromagnetic Compatibility (EMC) of Medical Devices" and tested according to IEC 60601-1-2:2020 and IEC 60601-2-18:2009.

#### Electrical Safety

The electrical safety was tested according to IEC 60601-1:2020 and IEC 60601-2-18:2009.

### Photobiological Safety

The photobiological safety was tested according to IEC 62471:2006.

It is concluded form the nonclinical tests that the subject devices are as safe, as effective, and perform as well as thelegally marketed predicate device identified above to support a substantial equivalence determination.