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 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 and septa.

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 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 OperaScope is supplied as a sterile, single use device and the Recording Module is supplied as a nonsterile reusable unit. The OperaScope contains a miniature Complimentary Medical Oxide Semi-conductor (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 unit (LCD 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 OperaScope, HDMI port for connecting an external monitor and an input port for external 9V DC power supply.

AI/ML Overview

The provided text does not contain information about acceptance criteria for device performance, a study proving the device meets these criteria, or details regarding sample sizes, expert involvement, or adjudication methods for such a study.

The document is a 510(k) submission summary for the LiNA OperaScope, which focuses on demonstrating substantial equivalence to predicate devices based on:

Indications for Use: The OperaScope's indications for use are compared to those of two predicate devices, affirming that its clinical use is not expanded.
Technological Characteristics: A detailed comparison table (Table B) outlines features such as product code, regulation number, intended users, site of use, device features and components, optical image technology, image resolution, illumination source, inflow/outflow channel design, cannula tip design, image transmission, maximum insertion diameter, shaft/cannula length, LCD display size, energy source, sterilization methods, and tissue contact materials.
Non-Clinical Performance Data: The submission lists a series of non-clinical performance tests conducted, including those for field of view, maximum width of insertion, biocompatibility, residual testing, electromagnetic compatibility, electrical safety, sterilization validation, mechanical testing, spatial resolution, a visualization and illumination study, in-flow and out-flow fluid delivery, functionality testing, shelf-life, battery lifetime, and software validation. These tests are stated to have been conducted in accordance with internal requirements, national, and international standards, and relevant FDA guidance.

The document asserts that the 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," and that "The OperaScope passed all applicable testing." However, specific numerical acceptance criteria for these tests and their corresponding reported performance values are not provided in the text.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance or details about the specific study proving the device meets these criteria, as this information is not present in the provided document.

Summary

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January 4, 2018

LiNA Medical ApS % Jennifer Tribbett Director of Regulatory Affairs Emergo Global Consulting, LLC 2500 Bee Cave Rd. Bldg. 1. Suite 300 Austin, TX 78746

Re: K171113

Trade/Device Name: LiNA OperaScope Regulation Number: 21 CFR§ 884.1690 Regulation Name: Hysteroscope and Accessories Regulatory Class: II Product Code: HIH Dated: November 22, 2017 Received: November 30, 2017

Dear Jennifer Tribbett:

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.

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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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K171113

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 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 and septa.

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

☑ Prescription Use (Part 21 CFR 801 Subpart D)
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☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary

LiNA OperaScope

K171113

1. Submission Sponsor

LiNA Medical ApS

Formervangen 5

DK-2600 Glostrup, Denmark

Contact: Natalia Szychulska

Title: Regulatory Affairs Officer

Office Phone: +48 61 222 21 43

e-Mail: nhe@lina-medical.com

2. Submission Correspondent

Emergo Global Consulting, LLC

2500 Bee Cave Road

Building 1, Suite 300

Austin, TX 78746

Contact: Jennifer Tribbett

Title: Director of Regulatory Affairs and Quality Assurance

Office Phone: (512) 327.9997

3. Date Prepared

January 2, 2018

4. Device Identification

Trade/Proprietary Name:	LiNA OperaScope
Common/Usual Name:	Hysteroscope
Classification Name:	Hysteroscope and Accessories

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Regulation Number:	884.1690
Product Code:	HIH, Hysteroscope and Accessories
Device Class:	Class II
Classification Panel:	Obstetrics/Gynecology

5. Legally Marketed Predicate Device(s)

. K132384 (Primary Predicate): U-Scope 8000 System with HSC+EMB Cannula
K092278: Gyrus ACMI Invisio Digital Hysteroscope System ●

LiNA Medical performed a search of FDA's Medical Device Recall data base and did not discover any recalls for these legally marketed predicate devices.

6. Indication 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 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.

Table A compares the OperaScope to the predicate devices with respect to the Indications for Use.

The OperaScope Indications for Use statement is basically a combination of the two predicate device Indications for Use. Although the wording is slightly different between the subject and predicate devices, the overall intent is the same and does not expand the clinical use of the subject device.

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Manufacturer	LiNA Medical ApS	EndoSee Corporation	Gyrus ACMI Inc.
Trade Name	OperaScope	U-Scope 8000 HSC+EMBCannula	Gyrus ACMI InvisioDigital HysteroscopeSystem
510(k) Number	K171113	K132384	K092278
Indications for Use	The LiNA OperaScope isintended for use invisualization of thecervical canal and uterinecavity during diagnosticand therapeuticgynecological procedures.The types of procedureswhere the OperaScopecould offer visualizationinclude:• Assessment of abnormalbleeding, pelvic pain,amenorrhea andabnormal findings fromhysterosalpingogram;• Assessment of Infertilityand pregnancy wastage;• Confirmation of thepresence of intrauterineforeign body;• Assist in locatingsubmucosal fibroids andpolyps targeted forremoval;• Provide visual guidanceduring directed biopsy,submucosalmyomectomy, transectionof intrauterineadhesions and septa.	Intended to be used topermit viewing of thecervical canal and uterinecavity for the purpose ofperforming diagnosticprocedures and to obtainan endometrial tissuesample (biopsy).The sample is used forcytologic and histologicdiagnosis. Generallyrecognized indicationsfor diagnostichysteroscopy include:abnormal bleeding,infertility and pregnancywastage, evaluation ofabnormalhysterosalpingogram,intrauterine foreignbody, amenorrhea andpelvic pain.	Intended to be used topermit viewing of thecervical canal and uterinecavity for the purpose ofperforming diagnosticand surgical procedures.Diagnostic Hysteroscopy:• Abnormal uterinebleeding• Infertility &pregnancy wastage• Evaluation ofabnormalhysterosalpingogram• Intrauterine foreignbody• Amenorrhea• Pelvic painOperative Hysteroscopy:• Directed biopsy• Removal of fibroidsand polyps• Transection ofintrauterineadhesions• Transectionintrauterine septa

Table A – Comparison of Indications for Use

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7. Device Description

Ref. number	Description
OP-201-1	LiNA OperaScope™ with HDMI cable andon-board LCD – single unit
OP-201-6	LiNA OperaScope™ with HDMI cable andon-board LCD – 6 units
OP-RM-1	LiNA OperaScope™ Recording Module

Model Numbers

8. Substantial Equivalence Discussion

1. U-Scope 8000 HSC + EMB Cannula (K132384)
  The OperaScope is substantially equivalent to the EndoSee Corporation's U-Scope 8000 HSC+EMB Cannula (K132384) in terms of technological characteristics and intended use.
1. Gyrus ACMI Invisio Digital Hysteroscope System (K092278)
  The OperaScope is substantially equivalent to the Gyrus ACMI Invisio Digital Hysteroscope System (K092278) in terms of indication for use.

Table B compares the OperaScope to the predicate devices with respect to the mode of operation, technological characteristics, materials, and performance testing. The OperaScope is substantially equivalent to the U-Scope 8000 HSC+EMB Cannula (K132384) in terms of intended use and technological

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characteristics such as the CMOS camera, LED illumination, inflow/outflow channel, image capturing features and LCD display unit and to the Gyrus ACMI Invisio Digital Hysteroscope System (K092278) in terms of indication for use.

Manufacturer	LiNA Medical ApS	EndoSee Corporation	Gyrus ACMI Inc.
Trade Name	OperaScope	U-Scope 8000 HSC+EMBCannula	Gyrus ACMI InvisioDigital HysteroscopeSystem
510(k) Number	K171113	K132384	K092278
Product Code	HIH	SAME	SAME
Regulation Number	884.1690	SAME	SAME
Regulation Name	Hysteroscope andAccessories	SAME	SAME
Intended Users	Trained MedicalProfessionals	SAME	SAME
Site of Use	Hospitals and PhysicianOffices	SAME	SAME
Device Features andComponents	● Sterile/Single-UseHandpiece(Hysteroscope) withCMOS camera, LEDillumination, LCDdisplay unit, channelfor infusion ofirrigating fluid,channel for fluidoutflow,microelectronics,firmware and singleuse batteries forpowering the device.● Non-Sterile/ReusableRecording Modulewith software,microelectronics andcontrols for recordingpictures/videosequences. USB portfor storage ofpictures/video, HDMIports (2) for	● Sterile/Single-UseBiopsy Cannula withCMOS camera, LEDillumination, channelfor irrigating fluid,channel foraspiration of tissue.● Non-Sterile/ReusableHandTower withconnector andlocking mechanismto attach/detachcannula, LCD displayunit, power button,illuminationbrightness adjuster,video processor,electronics,microcontrollers,firmware for captureof single image/videoprocedures,rechargeable battery.	● Non-Sterile(sterilization by theuser)/ReusableHysteroscope withCMOS sensor, LEDlight source,electrical wiring,printed circuit board(PCB), electrical cordto connect to theCamera Control Unit(CCU)● Non-Sterile/ReusableCamera Control Unit(CCU) with PCBs,software, powersupply, power cablesto process anddisplay imagestransmitted by thecamera.
Manufacturer	LiNA Medical ApS	EndoSee Corporation	Gyrus ACMI Inc.
Trade Name	OperaScope	U-Scope 8000 HSC+EMBCannula	Gyrus ACMI InvisioDigital HysteroscopeSystem
	connection tohandpiece(hysteroscope) andexternal monitor andinput port for external9V DC power supply.
Optical Image	Digital CMOS Technology	SAME	SAME
Image Resolution	CMOS camera consists ofapproximately 160,000pixels	SAME	Approximately 50,000pixels
Illumination LightSource	LED at tip of cannula	SAME	LED integrated in handle
Light at 20mm fromtarget. Range highto low level [LUX]	322 - 66 LUX	325 - 74 LUX	675 - 670 LUX
Inflow/outflowchannel design	Inflow: Inflow channel andworking channelcombined in one channelabove the camera.Outflow: One outflowchannel with twoentrances placed on topand bottom of distal tip.	Inflow: Inflow occursthrough two smallerinflow channels on eachside of the camera.Outflow: No outflowchannel.	Inflow: Inflow channeland working channelcombined in one channelbelow the camera.Outflow: No outflowchannel.
Cannula tip design	Rounded polymer tip.Angled shaft proximal totip (~20°). Steerable byrotation knob.	Rounded polymer tip. 25°angled shaft proximal totip. Steerable by rotationof device.	Rounded stainless steeptip. Flexible. Sidewardsteerable 0 - 30° bycontrol means on handle.
Image Transmission	Transmits images fromCMOS video camera tolocal LCD display unit onthe handpiece and remotemonitor	Transmits images fromCMOS video camera tolocal LCD display unit onthe HandTower	Transmits images fromCMOS video camera toremote monitor
Maximum InsertionDiameter (Tip)	4.3 mm	4.8 mm	5.5 mm with continuousflow sheath
Shaft/CannulaLength	240mm (24 cm)	270mm (27 cm)	Information not available
Manufacturer	LiNA Medical ApS	EndoSee Corporation	Gyrus ACMI Inc.
Trade Name	OperaScope	U-Scope 8000 HSC+EMBCannula	Gyrus ACMI InvisioDigital HysteroscopeSystem
LCD Display Size	4.3 inches (diagonal)	3.5 inches (diagonal)	Not applicable
Energy Source	Handpiece: 3V (2 AA batteries) Recording Module: 9V DC external power adapter	3.7V Battery	CCU: 110-240V
Sterilization	Handpiece (Hysteroscope): Ethylene Oxide (EO) Handpiece Batteries: Radiation (gamma) Recording Module: Non-Sterile	Cannula: Ethylene Oxide (EO) HandTower: Non-Sterile	Hysteroscope: Non-Sterile CCU: Non-Sterile
Tissue ContactMaterials	Compliant with ISO 10993	SAME	SAME

Table B – Comparison of Characteristics

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The OperaScope shares the same or similar mode of operall technical and functional capabilities as the predicate devices. In addition, the OperaScope is similar in design and function to the U-Scope 8000 HSC + EMB Cannula (K132384) in terms of mode of operation and use. The minor differences in the image transmission, cannula length and battery voltage do not raise any new issues of safety or effectiveness.

9. Non-Clinical Performance Data

As part of demonstrating safety and effectiveness of the 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 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 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 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:

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. 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 10993-10, ISO 10993-10, ISO 10993-12
. EO and ECH residual testing per ISO 10993-7
. 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. Statement of Substantial Equivalence

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

Regulation Number and Section

§ 884.1690 Hysteroscope and accessories.

(a)
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.(b)
Classification. (1) Class II (performance standards).(2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.