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

Q: Who is the manufacturer of LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI cable and on-board LCD-6 units, LiNA OperaScope Recording Module?

Lina Medical Aps filed the 510(k) submission for LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI cable and on-board LCD-6 units, LiNA OperaScope Recording Module (K171113).

Q: What is the FDA product code for LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI cable and on-board LCD-6 units, LiNA OperaScope Recording Module?

HIH. It is classified under 21 CFR 884.1690 as a Class 2 device in the Obstetrics/Gynecology panel.

Q: What is the regulatory pathway for LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI cable and on-board LCD-6 units, LiNA OperaScope Recording Module?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI cable and on-board LCD-6 units, LiNA OperaScope Recording Module?

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

Q: Who can help prepare an FDA 510(k) submission like LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI cable and on-board LCD-6 units, LiNA OperaScope Recording Module?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K171113 · Lina Medical Aps · HIH · Jan 4, 2018 · Obstetrics/Gynecology

Device Facts

Record ID	K171113
Device Name	LiNA OperaScope with HDMI cable and on-board LCD-single unit, 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 4, 2018
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 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 and septa.

Device Story

Handheld, battery-operated portable hysteroscope; provides direct visualization of cervical canal and uterine cavity via integrated CMOS camera and LED illumination at distal tip. Features inflow/outflow channels for irrigation. Captures video/images via optional Recording Module (connected via HDMI). Used in hospitals and physician offices by trained medical professionals. Provides real-time visual feedback on on-board LCD or external monitor; assists clinicians in diagnostic assessments and surgical guidance (biopsy, myomectomy). Benefits include portable, single-use sterile design reducing cross-contamination risk and simplifying workflow.

Clinical Evidence

Bench testing only. Performance validated per FDA guidance for hysteroscopes. Testing included optical performance (field of view, spatial resolution, distortion), fluid delivery (inflow/outflow, leak testing), mechanical integrity (bending, tensile, torque), electrical safety (IEC 60601-1, 60601-2-18), EMC (IEC 60601-1-2), biocompatibility (ISO 10993), sterilization validation (ISO 11135, 11137), and software verification/validation (IEC 62304). Visualization and illumination adequacy confirmed via hysteroscopy simulator.

Technological Characteristics

Handheld hysteroscope; CMOS camera; LED illumination; inflow/outflow channels; 4.3-inch LCD display; HDMI connectivity. Materials compliant with ISO 10993. Powered by 3V (2 AA batteries) or 9V DC external supply. Sterilization: Ethylene Oxide (handpiece), Gamma radiation (batteries). Software: Moderate level of concern.

Indications for Use

Indicated for visualization of cervical canal and uterine cavity in adult females undergoing diagnostic or therapeutic gynecological procedures, including assessment of abnormal bleeding, pelvic pain, amenorrhea, infertility, pregnancy wastage, foreign body, fibroids, polyps, and guidance for biopsy, myomectomy, or septa/adhesion transection.

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

U-Scope 8000 System with HSC+EMB Cannula (K132384)
Gyrus ACMI Invisio Digital Hysteroscope System (K092278)

Related Devices

K193007 — LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module · Lina Medical Aps · Jan 17, 2020
K123151 — ENDOSEE MODEL 8000 U-SCOPE · Endosee Corp · Mar 8, 2013
K170660 — Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula · CooperSurgical, Inc. · Jul 13, 2017
K202445 — Hystero-V Hysteroscope · Hysterovue, Inc. · Nov 23, 2021
K240401 — ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US) · Origyn Medical Technology (Hangzhou) Co., Ltd. · Jul 26, 2024

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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" in blue, with the word "ADMINISTRATION" underneath. 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ ## 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) | |--------------------------------------------------------------------------------------| |--------------------------------------------------------------------------------------| | ☐ 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 PRAStaff@fda.hhs.gov "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." {3}------------------------------------------------ # 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 | {4}------------------------------------------------ | 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. {5}------------------------------------------------ | Manufacturer | LiNA Medical ApS | EndoSee Corporation | Gyrus ACMI Inc. | |---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name | OperaScope | U-Scope 8000 HSC+EMB Cannula | Gyrus ACMI Invisio Digital Hysteroscope System | | 510(k) Number | K171113 | K132384 | K092278 | | Indications for 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 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. | Intended to be used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures and to obtain an endometrial tissue sample (biopsy). The sample is used for cytologic and histologic diagnosis. Generally recognized indications for diagnostic hysteroscopy include: abnormal bleeding, infertility and pregnancy wastage, evaluation of abnormal hysterosalpingogram, intrauterine foreign body, amenorrhea and pelvic pain. | Intended to be used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures. Diagnostic Hysteroscopy: • Abnormal uterine bleeding • Infertility & pregnancy wastage • Evaluation of abnormal hysterosalpingogram • Intrauterine foreign body • Amenorrhea • Pelvic pain Operative Hysteroscopy: • Directed biopsy • Removal of fibroids and polyps • Transection of intrauterine adhesions • Transection intrauterine septa | ## Table A – Comparison of Indications for Use {6}------------------------------------------------ #### 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 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. | Ref. number | Description | |-------------|--------------------------------------------------------------------| | OP-201-1 | LiNA OperaScope™ with HDMI cable and on-board LCD – single unit | | OP-201-6 | LiNA OperaScope™ with HDMI cable and on-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. - 2) 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 {7}------------------------------------------------ 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+EMB Cannula | Gyrus ACMI Invisio Digital Hysteroscope System | | 510(k) Number | K171113 | K132384 | K092278 | | Product Code | HIH | SAME | SAME | | Regulation Number | 884.1690 | SAME | SAME | | Regulation Name | Hysteroscope and Accessories | SAME | SAME | | Intended Users | Trained Medical Professionals | SAME | SAME | | Site of Use | Hospitals and Physician Offices | SAME | SAME | | Device Features and Components | ● Sterile/Single-Use Handpiece (Hysteroscope) with CMOS camera, LED illumination, LCD display unit, channel for infusion of irrigating fluid, channel for fluid outflow, microelectronics, firmware and single use batteries for powering the device. ● Non-Sterile/Reusable Recording Module with software, microelectronics and controls for recording pictures/video sequences. USB port for storage of pictures/video, HDMI ports (2) for | ● Sterile/Single-Use Biopsy Cannula with CMOS camera, LED illumination, channel for irrigating fluid, channel for aspiration of tissue. ● Non-Sterile/Reusable HandTower with connector and locking mechanism to attach/detach cannula, LCD display unit, power button, illumination brightness adjuster, video processor, electronics, microcontrollers, firmware for capture of single image/video procedures, rechargeable battery. | ● Non-Sterile (sterilization by the user)/Reusable Hysteroscope with CMOS sensor, LED light source, electrical wiring, printed circuit board (PCB), electrical cord to connect to the Camera Control Unit (CCU) ● Non-Sterile/Reusable Camera Control Unit (CCU) with PCBs, software, power supply, power cables to process and display images transmitted by the camera. | | Manufacturer | LiNA Medical ApS | EndoSee Corporation | Gyrus ACMI Inc. | | Trade Name | OperaScope | U-Scope 8000 HSC+EMB Cannula | Gyrus ACMI Invisio Digital Hysteroscope System | | | connection to handpiece (hysteroscope) and external monitor and input port for external 9V DC power supply. | | | | Optical Image | Digital CMOS Technology | SAME | SAME | | Image Resolution | CMOS camera consists of approximately 160,000 pixels | SAME | Approximately 50,000 pixels | | Illumination Light Source | LED at tip of cannula | SAME | LED integrated in handle | | Light at 20mm from target. Range high to low level [LUX] | 322 - 66 LUX | 325 - 74 LUX | 675 - 670 LUX | | Inflow/outflow channel design | Inflow: Inflow channel and working channel combined in one channel above the camera. Outflow: One outflow channel with two entrances placed on top and bottom of distal tip. | Inflow: Inflow occurs through two smaller inflow channels on each side of the camera. Outflow: No outflow channel. | Inflow: Inflow channel and working channel combined in one channel below the camera. Outflow: No outflow channel. | | Cannula tip design | Rounded polymer tip. Angled shaft proximal to tip (~20°). Steerable by rotation knob. | Rounded polymer tip. 25° angled shaft proximal to tip. Steerable by rotation of device. | Rounded stainless steep tip. Flexible. Sideward steerable 0 - 30° by control means on handle. | | Image Transmission | Transmits images from CMOS video camera to local LCD display unit on the handpiece and remote monitor | Transmits images from CMOS video camera to local LCD display unit on the HandTower | Transmits images from CMOS video camera to remote monitor | | Maximum Insertion Diameter (Tip) | 4.3 mm | 4.8 mm | 5.5 mm with continuous flow sheath | | Shaft/Cannula Length | 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+EMB Cannula | Gyrus ACMI Invisio Digital Hysteroscope System | | 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 Contact Materials | Compliant with ISO 10993 | SAME | SAME | #### Table B – Comparison of Characteristics {8}------------------------------------------------ {9}------------------------------------------------ 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: {10}------------------------------------------------ - . 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.