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.

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.

AI/ML Overview

The provided document is a 510(k) summary for the LiNA OperaScope, which is a medical device for visualizing the cervical canal, uterine cavity, and adult female urinary bladder. Notably, the document states "10. Clinical Performance Data: Not Applicable". This indicates that a clinical study, with human subjects, was not conducted to compare the device's performance against specific acceptance criteria.

Instead, substantial equivalence was demonstrated through non-clinical performance data, comparing the device to legally marketed predicate devices and against established standards. Therefore, I cannot provide a table of acceptance criteria with reported device performance from a clinical study, nor answer questions related to sample sizes for test/training sets, expert consensus, adjudication methods, or MRMC studies, as these types of studies were explicitly stated as "Not Applicable."

However, I can extract information regarding the non-clinical performance acceptance criteria and the methods used to prove the device met these criteria.

Summary of Acceptance Criteria and Device Performance (Non-Clinical):

Since no clinical performance data was deemed applicable, the device's performance was evaluated against non-clinical criteria. The acceptance criteria were met by passing various tests aligned with internal requirements, national standards, and international standards.

Table of Non-Clinical Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criterion (Standard/Test)	Reported Device Performance
Overall Design & Safety	Overall design, sterilization, biocompatibility, electrical safety.	Meets all requirements and confirms design output meets design inputs/specifications.
Optical Performance	Field of view and direction of view (ISO 8600-3)	Passed applicable testing.
	Spatial Resolution (ISO 3334, test chart No. 2)	Passed applicable testing.
	Visualization and illumination study (in uterine cavity using hysteroscopy simulator)	Demonstrated adequacy of imaging.
	Distortion characteristics (FDA Guidance Hysteroscopes and Gynecologic Laparoscopes Submission Guidance for 510(K), section V(E)(6b))	Passed applicable testing.
Physical Dimensions	Maximum width of insertion portion (ISO 8600-4)	Passed applicable testing.
Biocompatibility	Biocompatibility testing (ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-12)	Passed applicable testing.
	EO and ECH residual testing (ISO 10993-7)	Passed applicable testing.
Electrical Safety & EMC	Electromagnetic Compatibility (EN/IEC 60601-1-2)	Passed applicable testing.
	Electrical Safety (AAMI/ANSI ES60601-1 and EN 60601-2-18)	Passed applicable testing.
Sterilization & Shelf Life	Sterilization Validation (ISO 11135 for EO, ISO 11137-1 and ISO 11137-2 for Radiation - OperaScope Batteries)	Passed applicable testing.
	Maintenance of sterilization (ISO 11737-2)	Passed applicable testing.
	Shelf-Life and Simulated shipping conditions (ASTM D4169)	Passed applicable testing.
Mechanical & Functionality	Mechanical testing (bending (displacement), tensile strength and torque)	Passed applicable testing.
	In-flow and out-flow fluid delivery, including leak testing	Passed applicable testing.
	Functionality testing (compatibility of instruments and accessories with respect to dimensions)	Passed applicable testing.
	Battery lifetime	Passed applicable testing.
Software Validation	Software Validation and Verification (IEC 62304)	Passed applicable testing.
	FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (Moderate Level of Concern)	Compliant with guidance.

Regarding a "study that proves the device meets the acceptance criteria":

Based on the document, the "study" was a series of non-clinical performance tests that are detailed in section "9. Non-Clinical Performance Data". The device passed all these tests.

Based on the provided text, the following information cannot be extracted or is explicitly stated as "Not Applicable":

2. Sample sizes used for the test set and the data provenance:

No human clinical test set was used for performance evaluation, as indicated by "Clinical Performance Data: Not Applicable". The "test set" in the context of non-clinical data would refer to the samples used for physical, electrical, and optical testing, but specific sample sizes for each non-clinical test are not provided. Data provenance would be from internal lab testing based on the referenced standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable as no human clinical test set was used requiring expert ground truth establishment for performance.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable as no human clinical test set was used.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a direct visualization tool, not an AI-assisted diagnostic tool, and no clinical study was conducted.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a medical device, not an algorithm/AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the non-clinical tests, the "ground truth" was established by the specifications and parameters defined within the relevant national and international standards (e.g., ISO, EN/IEC, ASTM) and the device's design inputs. For instance, for "Field of view," the ground truth is the specified range defined by ISO 8600-3.

8. The sample size for the training set:

Not applicable, as this device does not involve a machine learning algorithm requiring a training set.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for a machine learning algorithm.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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.

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: jmr@lina-medical.com Tel.: +48 61 222 8643

2. Submission Correspondent

Kevin MacDonald Regulatory Consultant 4297 D Street Sacramento, CA 95819 Office Phone: (415) 609-9875

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 AccessoriesFAJ, Cystoscope and Accessories, Flexible/Rigid
Device Class:	Class II
Classification Panel:	Obstetrics/GynecologyGastroenterology/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

. 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.

7. Device Description

Model Numbers

Ref. number	Description
OP-201-6	LiNA OperaScope™ with HDMI cable andon-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.	TechnologyOverview
Trade Name	OperaScope(K193007)	OperaScope(K171113)	Endosee System(K190639)		Handheld battery-operated sterile anddisposable single-use hysteroscope andcystoscope, which can be used for bothdiagnostic and therapeutic gynecologicalprocedures.Non-Sterile/Reusable Recording Modulewith software, USB port for storage ofpictures and video, HDMI ports (2) forconnection to handpiece (hysteroscope /cystoscope) and external monitor andinput port for external 9V DC powersupply.	Same as Subject Device	Handheld battery-operatedhysteroscope consisting of a reusablehandle and a sterile, disposable,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 ContactMaterials	Compliant with ISO 10993	Same as Subject Device	Same as Subject Device
RegulationNumber	884.1690876.1500	884.1690	884.1690876.1500	Working Channel	Yes	Same as Subject Device	Same as Subject Device
RegulationName	Hysteroscope and AccessoriesGastroenterology/Urology Device	Hysteroscope and Accessories	Hysteroscope and AccessoriesGastroenterology/Urology Device	MaximumInsertion PortionWidth	4.3 mm	Same as Subject Device	4.5mm
Indications forUse	The LiNA OperaScope is intended foruse in visualization of the cervical canaland uterine cavity during diagnostic andtherapeutic gynecological procedures.The types of procedures where the LiNAOperaScope could offer visualizationinclude:•Assessment of abnormal bleeding,pelvic pain, amenorrhea andabnormal findings fromhysterosalpingogram•Assessment of infertility andpregnancy wastage•Confirmation of the presence ofintrauterine foreign body•Assist in locating submucosalfibroids and polyps targeted forremoval•Provide visual guidance duringdirected biopsy, submucosalmyomectomy, polypectomy,transection of intrauterineadhesions and septa.The LiNA OperaScope can also be usedto permit viewing of the adult femaleurinary bladder through minimallyinvasive approach by utilizing naturalorifices for the purpose of performingdiagnostic and therapeutic procedures.	The LiNA OperaScope isintended for use invisualization of the cervicalcanal and uterine cavity duringdiagnostic and therapeuticgynecological procedures.The types of procedures wherethe OperaScope could offervisualization include:• Assessment of abnormalbleeding, pelvic pain,amenorrhea and abnormalfindings fromhysterosalpingogram• Assessment of infertility andpregnancy wastage• Confirmation of the presenceof intrauterine foreign body• Assist in locating submucosalfibroids and polyps targeted forremoval• Provide visual guidance duringdirected biopsy, submucosalmyomectomy, transection ofintrauterine adhesions andsepta.	The Endosee® System is used topermit viewingof the adult cervical canal anduterine cavity for the purpose ofperforming diagnostic procedures.Generally recognized indications fordiagnostichysteroscopy include:• Abnormal bleeding• Infertility and pregnancy wastage• Evaluation of abnormalhysterosalpingogram• Intrauterine foreign body• Amenorrhea• Pelvic painThe Endosee® System can also beused to permit viewing of the adulturinary bladder through a minimallyinvasive approach by utilizingnatural orifices to access thediagnostic site.	Illumination LightSource	LED at tip of cannula	Same as Subject Device	Same as Subject Device
Intended Users	Trained Medical Professionals -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 connectiontoexternal 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.

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.