K Number

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

Manufacturer

LiNA Medical ApS

Date Cleared

2018-01-04

(265 days)

Product Code

HIH

Regulation Number

884.1690

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, 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K132384, K092278

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on basic visualization, image capture, and recording capabilities, with no mention of AI/ML for analysis, interpretation, or enhanced visualization.

Therapeutic

Yes
The device is described as assisting in locating fibroids and polyps targeted for removal and providing visual guidance during directed biopsy, submucosal myomectomy, and transection of intrauterine and septa, all of which are therapeutic procedures.

Diagnostic

Yes

The device's Intended Use explicitly states its purpose in "visualization of the cervical canal and uterine cavity during diagnostic and therapeutic gynecological procedures," and lists several "Assessment" types of procedures, clearly indicating a diagnostic function.

SaMD (Software as a Medical Device)

The device description clearly outlines multiple hardware components including a handheld, battery-operated unit, LCD display, CMOS camera, LED illumination, fluid channels, microelectronics, and a separate Recording Module with its own hardware. While it contains firmware and software, it is not solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, the LiNA OperaScope is not an In Vitro Diagnostic (IVD).

Here's why:

Intended Use: The intended use is for visualization of the cervical canal and uterine cavity during diagnostic and therapeutic gynecological procedures. This is a direct visualization tool used in vivo (within the body), not a device used to examine specimens in vitro (outside the body).
Device Description: The device is a hysteroscope with a camera and display for direct viewing. It facilitates procedures by providing visual guidance.
Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, tissue, etc.) or to provide diagnostic information based on the analysis of such samples.

IVDs are typically used to examine specimens like blood, urine, tissue, etc., to detect diseases, conditions, or infections. The LiNA OperaScope's function is to provide a visual pathway for a medical professional to observe internal anatomy directly.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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, 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.

Product codes (comma separated list FDA assigned to the subject device)

HIH

Device Description

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.

Mentions image processing

Transmits images from CMOS video camera to local LCD display unit on the handpiece and remote monitor

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

CMOS camera

Anatomical Site

cervical canal and uterine cavity

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Intended Users: Trained Medical Professionals
Site of Use: Hospitals and Physician Offices

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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:

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K132384, K092278

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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.

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

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)
-------------------------------------------------------------------------------------

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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

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.

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

7. Device Description

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.
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

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

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).

. 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.