LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module

K193007 · Lina Medical Aps · HIH · Jan 17, 2020 · Obstetrics/Gynecology

Device Facts

• Record ID: K193007
• Device Name: LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module
• Applicant: Lina Medical Aps
• Product Code: HIH · Obstetrics/Gynecology
• Decision Date: Jan 17, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LiNA OperaScope is intended for use in visualization of the cervical canal and uterine cavity during diagnostic and therapeutic gynecological procedures. The types of procedures where the LiNA OperaScope could offer visualization include: - Assessment of abnormal bleeding, pelvic pain, amenorrhea and abnormal findings from hysterosalpingogram - Assessment of infertility and pregnancy wastage - Confirmation of the presence of intrauterine foreign body - Assist in locating submucosal fibroids and polyps targeted for removal - Provide visual guidance during directed biopsy, submucosal myomectomy, transection of intrauterine adhesions and septa. The LiNA OperaScope can also be used to permit viewing of the adult female urinary bladder through minimally invasive approach by utilizing natural orifices for the purpose of performing diagnostic and therapeutic procedures.

Device Story

Handheld, battery-operated, sterile, single-use hysteroscope/cystoscope; features miniature CMOS camera and LED illumination at tip; includes infusion/outflow channels for irrigation. Captures images/video via optional non-sterile reusable Recording Module connected via HDMI. Used by gynecologists/urologists in hospitals or physician offices. Provides direct visualization on on-board LCD or external monitor. Assists clinicians in locating pathology (fibroids, polyps) and provides visual guidance for biopsies, myomectomies, and adhesion/septa transection. Benefits patient through minimally invasive diagnostic/therapeutic access via natural orifices.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including optical performance (ISO 8600-3/4), biocompatibility (ISO 10993), electrical safety (AAMI/ANSI ES60601-1, EN 60601-2-18), EMC (EN/IEC 60601-1-2), sterilization validation, mechanical testing, and visualization studies using a hysteroscopy simulator.

Technological Characteristics

Handheld, battery-operated rigid hysteroscope/cystoscope. CMOS camera, LED illumination at tip. 4.3 mm insertion width. 20° pre-bend tip. 100° field of view. HDMI connectivity for external display/recording. Biocompatible materials per ISO 10993. Sterilization via Ethylene Oxide (device) and Radiation (batteries). Software validation per IEC 62304.

Indications for Use

Indicated for adult females requiring visualization of the cervical canal, uterine cavity, or urinary bladder for diagnostic and therapeutic procedures, including assessment of abnormal bleeding, pelvic pain, amenorrhea, infertility, pregnancy wastage, foreign bodies, fibroids, and polyps.

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

• LiNA OperaScope (K171113)
• Endosee System (K190639)

Submission Summary (Full Text)

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January 17, 2020

LiNA Medical ApS % Kevin MacDonald Regulatory Consultant MacDonald Consulting 4297 D Street Sacramento, CA 95819

Re: K193007

Trade/Device Name: LiNA OperaScope Regulation Number: 21 CFR 884.1690 Regulation Name: Hysteroscope And Accessories Regulatory Class: Class II Product Code: HIH, FAJ Dated: November 13, 2019 Received: November 18, 2019

Dear Kevin Macdonald:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jason R. Roberts, Ph.D. Acting 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) K193007

Device Name LiNA OperaScope

Indications for Use (Describe)

The LiNA OperaScope is intended for use in visualization of the cervical canal and uterine cavity during diagnostic and therapeutic gynecological procedures. The types of procedures where the LiNA OperaScope could offer visualization include:

- Assessment of abnormal bleeding, pelvic pain, amenorthea and abnormal findings from hysterosalpingogram
- · Assessment of infertility and pregnancy wastage
- · Confirmation of the presence of intrauterine foreign body
- Assist in locating submucosal fibroids and polyps targeted for removal

· Provide visual guidance during directed biopsy, submucosal myomectomy, transection of intrauterine adhesions and septa.

The LiNA OperaScope can also be used to permit viewing of the adult female urinary bladder through minimally invasive approach by utilizing natural orifices for the purpose of performing diagnostic and therapeutic procedures.

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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## 510(k) Summary K193007

### 1. Submitter's Name and Address:

LiNA Medical ApS Formervangen 5 DK-2600 Glostrup, Denmark Jarosław Mrówczyński Regulatory Affairs Manager Email: [e-mail] Tel.: [phone]

### 2. Submission Correspondent

Kevin MacDonald Regulatory Consultant 4297 D Street Sacramento, CA 95819 Office Phone: [phone]

### 3. Date Prepared

January 17, 2020

### 4. Device Identification

| Trade/Proprietary Name: | LiNA OperaScope |
|-------------------------|--------------------------------------------------------------------------------------|
| Common/Usual Name: | Hysteroscope/Cystoscope |
| Classification: | 21 CFR 884.1690 Hysteroscope and Accessories |
| Product Code: | HIH, Hysteroscope and Accessories<br>FAJ, Cystoscope and Accessories, Flexible/Rigid |
| Device Class: | Class II |
| Classification Panel: | Obstetrics/Gynecology<br>Gastroenterology/Urology |

#### 5. Legally Marketed Predicate Devices

- . K171113: LiNA OperaScope
- . K190639: Endosee System

There are no design-related recalls for these legally marketed predicate devices.

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# 6. Indications for Use Statement

The LiNA OperaScope is intended for use in visualization of the cervical canal and uterine cavity during diagnostic and therapeutic gynecological procedures. The types of procedures where the LiNA OperaScope could offer visualization include:

- . Assessment of abnormal bleeding, pelvic pain, amenorrhea and abnormal findings from hysterosalpingogram
- . Assessment of infertility and pregnancy wastage
- . Confirmation of the presence of intrauterine foreign body
- Assist in locating submucosal fibroids and polyps targeted for removal
- . Provide visual guidance during directed biopsy, submucosal myomectomy, transection of intrauterine adhesions and septa.

The LiNA OperaScope can also be used to permit viewing of the adult female urinary bladder through minimally invasive approach by utilizing natural orifices for the purpose of performing diagnostic and therapeutic procedures.

### 7. Device Description

The LiNA OperaScope is a handheld, battery-operated portable hysteroscope which allows direct viewing of the cervical canal and uterine cavity via the on-board LCD display. If the user wants to capture images and/or record video sequences utilizing a USB stick, a Recording Module is available, which connects to the device via the HDMI cable. The LiNA OperaScope can also be connected to an external monitor via the HDMI cable. External monitors are not provided by LiNA Medical ApS and therefore, monitors are not the subject of this 510(k) submission.

The LiNA OperaScope is supplied as a sterile, single use device and the Recording Module is supplied as a non- sterile reusable unit. The LiNA OperaScope contains a miniature Complimentary Medical Oxide Semiconductor (CMOS) camera and a Light-Emitting Diode (LED) illumination at the tip, a channel for infusion of irrigating fluid and a channel for fluid outflow, a display), microelectronics, firmware and single use batteries for powering the device. The Recording Module contains microelectronics, software, controls for recording pictures and video sequences, USB port for storage of pic/video, HDMI port for connection of the LiNA OperaScope, HDMI port for connecting an external monitor and an input port for external 9V DC power supply.

### Model Numbers

| Ref. number | Description |
|-------------|----------------------------------------------------------------|
| OP-201-6 | LiNA OperaScope™ with HDMI cable and<br>on-board LCD – 6 units |
| OP-RM-1 | LiNA OperaScopeTM Recording Module |

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# 8. Predicate Comparison

The table below compares the LiNA OperaScope to the predicate devices with respect to the indications for use and technological characteristics:

| Manufacturer | LiNA Medical ApS | LiNA Medical ApS | CooperSurgical, Inc. | Technology<br>Overview | | | |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | OperaScope<br>(K193007) | OperaScope<br>(K171113) | Endosee System<br>(K190639) | | Handheld battery-operated sterile and<br>disposable single-use hysteroscope and<br>cystoscope, which can be used for both<br>diagnostic and therapeutic gynecological<br>procedures.<br>Non-Sterile/Reusable Recording Module<br>with software, USB port for storage of<br>pictures and video, HDMI ports (2) for<br>connection to handpiece (hysteroscope /<br>cystoscope) and external monitor and<br>input port for external 9V DC power<br>supply. | Same as Subject Device | Handheld battery-operated<br>hysteroscope consisting of a reusable<br>handle and a sterile, disposable,<br>diagnostic cannula. |
| Common Name | Hysteroscope, Cystoscope | Hysteroscope | Hysteroscope,Cystoscope | Cannula Type | Rigid | Same as Subject Device | Flexible |
| Product Code | HIH, FAJ | HIH | HIH, FAJ | Patient Contact<br>Materials | Compliant with ISO 10993 | Same as Subject Device | Same as Subject Device |
| Regulation<br>Number | 884.1690<br>876.1500 | 884.1690 | 884.1690<br>876.1500 | Working Channel | Yes | Same as Subject Device | Same as Subject Device |
| Regulation<br>Name | Hysteroscope and Accessories<br>Gastroenterology/Urology Device | Hysteroscope and Accessories | Hysteroscope and Accessories<br>Gastroenterology/Urology Device | Maximum<br>Insertion Portion<br>Width | 4.3 mm | Same as Subject Device | 4.5mm |
| Indications for<br>Use | The LiNA OperaScope is intended for<br>use in visualization of the cervical canal<br>and uterine cavity during diagnostic and<br>therapeutic gynecological procedures.<br>The types of procedures where the LiNA<br>OperaScope could offer visualization<br>include:<br>•<br>Assessment of abnormal bleeding,<br>pelvic pain, amenorrhea and<br>abnormal findings from<br>hysterosalpingogram<br>•<br>Assessment of infertility and<br>pregnancy wastage<br>•<br>Confirmation of the presence of<br>intrauterine foreign body<br>•<br>Assist in locating submucosal<br>fibroids and polyps targeted for<br>removal<br>•<br>Provide visual guidance during<br>directed biopsy, submucosal<br>myomectomy, polypectomy,<br>transection of intrauterine<br>adhesions and septa.<br>The LiNA OperaScope can also be used<br>to permit viewing of the adult female<br>urinary bladder through minimally<br>invasive approach by utilizing natural<br>orifices for the purpose of performing<br>diagnostic and therapeutic procedures. | The LiNA OperaScope is<br>intended for use in<br>visualization of the cervical<br>canal and uterine cavity during<br>diagnostic and therapeutic<br>gynecological procedures.<br>The types of procedures where<br>the OperaScope could offer<br>visualization include:<br>• Assessment of abnormal<br>bleeding, pelvic pain,<br>amenorrhea and abnormal<br>findings from<br>hysterosalpingogram<br>• Assessment of infertility and<br>pregnancy wastage<br>• Confirmation of the presence<br>of intrauterine foreign body<br>• Assist in locating submucosal<br>fibroids and polyps targeted for<br>removal<br>• Provide visual guidance during<br>directed biopsy, submucosal<br>myomectomy, transection of<br>intrauterine adhesions and<br>septa. | The Endosee® System is used to<br>permit viewing<br>of the adult cervical canal and<br>uterine cavity for the purpose of<br>performing diagnostic procedures.<br>Generally recognized indications for<br>diagnostic<br>hysteroscopy include:<br>• Abnormal bleeding<br>• Infertility and pregnancy wastage<br>• Evaluation of abnormal<br>hysterosalpingogram<br>• Intrauterine foreign body<br>• Amenorrhea<br>• Pelvic pain<br>The Endosee® System can also be<br>used to permit viewing of the adult<br>urinary bladder through a minimally<br>invasive approach by utilizing<br>natural orifices to access the<br>diagnostic site. | Illumination Light<br>Source | LED at tip of cannula | Same as Subject Device | Same as Subject Device |
| Intended Users | Trained Medical Professionals -<br>Gynecologists/Urologists | Gynecologists | Same as Subject Device | Field of View | 100° | Same as Subject Device | Same as Subject Device |
| Site of Use | Hospitals and Physician Offices | Same as Subject Device | Same as Subject Device | Pre-bend tip | 20° $\pm$ 5° | Same as Subject Device | 20° $\pm$ 3° |
| Shelf Life | 12 months | Same as Subject Device | 6 months | | | | |
| Image Display | LCD on handheld device and connection<br>to<br>external monitor | Same as Subject Device | LCD on handheld device | | | | |

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The LiNA OperaScope has the same or similar indications for use and technological characteristics as compared to the predicate devices. The are no different questions of safety and effectiveness.

# 9. Non-Clinical Performance Data

As part of demonstrating safety and effectiveness of the LiNA OperaScope and in showing substantial equivalence to the predicate devices that are subject to this 510(k) submission, LiNA completed a number of non-clinical performance tests. The LiNA OperaScope meets all the requirements for overall design, sterilization, biocompatibility, and electrical safety results confirming that the design output meets the design inputs and specifications for the device.

The LiNA OperaScope was subjected to safety and optical performance testing in accordance with the FDA's "Hysteroscopes and Gynecological Laparoscopes Submission Guidance for a 510(k)" (March 7, 1996).

The LiNA OperaScope passed all applicable testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device:

- . Field of view and direction of view per ISO 8600-3
- . Maximum width of insertion portion per ISO 8600-4
- . Biocompatibility testing per ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-12
- . EO and ECH residual testing per ISO 10993-7

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- Electromagnetic Compatibility per EN/IEC 60601-1-2 (EMC and Immunity)
- Electrical Safety per AAMI/ANSI ES60601-1 and EN 60601-2-18
- Sterilization Validation per ISO 11135 (Ethylene Oxide – OperaScope), ISO 11137-1 and ISO 11137-2 (Radiation - OperaScope Batteries) and maintenance of sterilization per ISO 11737-2.
- . Mechanical testing for bending (displacement), tensile strength and torque.
- . Spatial Resolution utilizing ISO 3334 (test chart No. 2)
- . Visualization and illumination study to determine the adequacy of imaging while in use in the uterine cavity utilizing a hysteroscopy simulator.
- . In-flow and out-flow fluid delivery, including leak testing
- . Fuctionality testing to verify compatibility of instruments and accessories with respect to dimensions
- Shelf-Life and Simulated shipping conditions per ASTM D4169
- . Battery lifetime
- Software Validation and Verification per IEC 62304
- FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices [Moderate Level of Concern Applied to the OperaScope]
- . FDA's guidance document Hysteroscopes and Gynecologic Laparoscopes Submission Guidance for 510(K), including section V(E)(6b)/distortion characteristics.

# 10. Clinical Performance Data

Not Applicable

### 11. Conclusion

The LiNA OperaScope, as designed and manufactured, is substantially equivalent to the predicate devices.