Acu Vu GDT-1000 System is used to permit viewing of the adult cervical canal and uterine cavity for the purpose of performing diagnostic and operative procedures.

Device Description

The AcuVu GDT-1000 System is a single-use hysteroscope intended for gynecologic procedures. It includes a disposable cannula module, a reusable handle module, a tower mounted swivel base medical grade touch screen PC for processing system software, operating the graphical user interface, performing image and video capture and display, as well as report creation for a session.

The Handle Module is reusable. Its distal end has a connecting interface, with self-locking mechanism, for attaching and detaching the disposable cannula. Its proximal end has a USB connection interface and cable length of 2.9 m for attaching the handle to the Display Module.

The disposable cannula module family includes two models. One for the purpose of diagnosis, and the other one for operative/therapeutic procedure. The diagnosis cannula has one water channel with two luers at proximal end, for water inflow and outflow. The therapeutic operative cannula has one shared working channel with three lures at proximal end, for water inflow and outflow, as well as for small operative instrument access. The disposable single-use cannula contains a miniature camera module and a pair of light- emitting diode (LED) illumination module at the tip. The cannula connects to the handle through an electrical connector for image data transfer, camera control and power supply. The disposable cannula has overall length of 300 mm to 350 mm.

AI/ML Overview

This submission pertains to the AcuVu GDT-1000 System, a hysteroscope used for viewing the adult cervical canal and uterine cavity for diagnostic and operative procedures. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical study results for novel acceptance criteria. Therefore, the information typically associated with complex AI/ML device studies (like MRMC studies, detailed ground truth establishment for large datasets, or specific performance metrics like AUC, sensitivity, and specificity for diagnostic tasks) is not entirely applicable or present for this type of medical device submission.

The "acceptance criteria" for this device are primarily related to its compliance with established performance standards and its substantial equivalence to the predicate device, not statistical performance against a specific diagnostic target.

Here's the breakdown of the information requested based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally met through compliance with recognized standards and successful completion of verification and validation activities. The reported "device performance" is primarily confirmation of this compliance, rather than specific numerical metrics for diagnostic accuracy typically seen with AI/ML devices.

Acceptance Criteria Category	Specific Standard/Test	Reported Device Performance Statement
Electrical Safety/EMC	IEC 60601-1:2005 (General requirements for basic safety and essential performance), IEC/EN 60601-1-2:2007 (EMC), IEC 60601-1-6:2010 (Usability), IEC 60601-2-18:2009 (Endoscopic equipment), IEC/EN 61000-3-2:2014, IEC/EN 61000-3-3:2013, IEC 61000-4-2:2008, IEC 61000-4-3:2006, IEC 62366:2007 (Usability), EN 55011:2009, ISO 14971:2007 (Risk Management)	"Test results confirm that GDT-1000 system complies with the applicable standards, and is safe and effective for its intended use."
Software	IEC 62304:2015 (Medical device software lifecycle processes), FDA Software Guidance	"Test results confirm that GDT-1000 system complies with the applicable standards, and is safe and effective for its intended use."
Shelf Life	ASTM D4169-16 (Performance Testing Of Shipping Containers), ASTM F1980-16 (Accelerated Aging), ASTM F2096-11 (Gross Leak Detection), ASTM F88/F88M-15 (Seal Strength)	"Demonstration that device meets package integrity and functional performance requirements following shelf life" and ultimately, "Test results confirm that GDT-1000 system complies with the applicable standards, and is safe and effective for its intended use."
Biocompatibility	ISO 10993:2009 (Biological evaluation of medical devices, including cytotoxicity, sensitization, irritation, and acute systemic toxicity)	"Test results confirm that GDT-1000 system complies with the applicable standards, and is safe and effective for its intended use."
Sterilization/Reprocessing	Sterilization validation, Reprocessing validation	"Test results confirm that GDT-1000 system complies with the applicable standards, and is safe and effective for its intended use."
Mechanical Performance	Dimensional analysis, Fittings/connectors assessment, Stiffness, Deformation angle, Tensile strength, Torque, Fluid Delivery	"Test results confirm that GDT-1000 system complies with the applicable standards, and is safe and effective for its intended use."
Optical Performance	Field of view, Direction of view, Illumination, Resolution, Automatic exposure control, Depth of field, Image distortion	"Test results confirm that GDT-1000 system complies with the applicable standards, and is safe and effective for its intended use."
Overall Substantial Equivalence (Conclusion)	Comparison to predicate device (EndoSee Corporation U-Scope Model 8000, K123151) based on indications for use, technological characteristics, safety and effectiveness.	"The performance data demonstrate that the GDT-1000 System is substantially equivalent to the cited predicate device."

2. Sample Size Used for the Test Set and the Data Provenance

This document is a 510(k) summary for a hysteroscope, which is a physical medical device, not an AI/ML diagnostic software. The "test set" and "data provenance" as understood in the context of AI/ML performance evaluation (i.e., a discrete, often large, set of medical data cases used to evaluate an algorithm's diagnostic performance) are not directly applicable or described in this submission.

Instead, testing (verification and validation) for such devices typically involves:

Engineering tests on physical prototypes/production units.
Bench testing for mechanical, electrical, and optical properties.
Biocompatibility testing on materials.
Sterilization and shelf-life validation using batches of products.

The document does not specify sample sizes for these tests in terms of "cases" like an imaging dataset. The provenance of these test results would be internal laboratory testing and external accredited lab testing, as implied by the reference to various IEC, ISO, and ASTM standards. No specific country of origin for clinical data (retrospective or prospective) is mentioned because this is a hardware device review, not a clinical trial summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not applicable to the provided 510(k) submission. The device is a hysteroscope, an imaging tool, not a diagnostic algorithm that interprets images. Therefore, there's no "ground truth" to be established by experts in the sense of labeling a dataset for AI performance evaluation. The "ground truth" for this device's performance relates to its ability to meet engineering and safety standards, confirmed through objective measurements and standard compliance.

4. Adjudication Method for the Test Set

Not applicable. As explained above, this submission does not detail an AI/ML algorithm's performance evaluation against a diagnostic ground truth derived from expert adjudication. "Testing" involves compliance with standards and functional verification.

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 physical hysteroscope, not an AI-powered diagnostic software designed to assist human readers. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed and is not relevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a hysteroscope, which is an imaging device used by a human operator, not a standalone algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" as applied to AI/ML diagnostic algorithms (e.g., pathology reports, long-term outcomes, expert consensus on images) is not directly relevant here. For this hysteroscope, the "ground truth" for its performance is implicitly derived from compliance with a wide range of engineering, safety, and performance standards (e.g., optical resolution is measured objectively, biocompatibility is assessed by chemical tests and biological responses, electrical safety by standardized electrical measurements).

8. The Sample Size for the Training Set

Not applicable. This device is a hardware hysteroscope. It does not involve a "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for an AI/ML algorithm, there is no ground truth to be established for it.

Summary

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510(k) Notification

510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

510(k) Number: K180096 Applicant

Information:

Date Prepared:	April 2, 2018
Manufacturer:	AcuVu Inc.1749 BroadwayRedwood City, CA 94063
Contact Person:	Sam Mostafaviipcs11@ymail.com
Mobile Number:	650-670-6972
Office Number:	650-578-9653
Facsimile Number:	650-578-9653

Device Information:

Trade/Device Name:	GDT-1000 System
Common Name:	Hysteroscope
Regulation Number:	21 CFR § 884.1690
Classification Name:	Hysteroscope and accessories
Product Class:	Class II
Product Code	HIH (Hysteroscope and accessories)
Panel:	Obstetrics/Gynecology

Predicate Device:

EndoSee Corporation U-Scope Model 8000 (K123151)
The predicate device has not been subject to a design related recall.

Indications for Use

Acu Vu GDT-1000 System is used to permit viewing of the adult cervical canal and uterine cavity for the purpose of performing diagnostic and operative procedures.

Device Description

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510(k) Notification

system software, operating the graphical user interface, performing image and video capture and display, as well as report creation for a session.

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K180096 Page 3 of 7

The table below includes firnctional and technological comparison between AcuVu GDT-1000 System and the predicate device, EndoSee Corporation U-Scope Model 8000 (K123151).

Feature	Subject DeviceAcuVu Inc.GDT-1000 System	Predicate DeviceEndoSeeU-Scope Model 8000 (K123151)	Subject Deviceto PredicateDevice
Classification	Class II	Class II	Same aspredicate device
Regulation Name	21 CFR § 884.1690	21 CFR § 884.1690	Same aspredicate device
Classification Panel	Obstetrics and Gynecology	Obstetrics and Gynecology	Same aspredicate device
Product code	HIH	HIH	Same aspredicate device
Indications for use	AcuVu GDT-1000 System is used topermit viewing of the adult cervical canaland uterine cavity for the purpose ofperforming diagnostic and operativeprocedure.	The U-Scope device is used to permit viewingof the cervical canal and uterine cavity for thepurpose of performing diagnostic procedures.Generally recognized indications fordiagnostic hysteroscopy include: Abnormaluterine bleeding, infertility and pregnancywastage; evaluation of abnormal	Similar topredicate device
Procedures	Viewing of the adult cervical canal anduterine cavity for the purpose ofperforming diagnostic or operativeprocedures	Viewing of the cervical canal and uterinecavity for the purpose of performingdiagnostic procedures.	Similar topredicate device
Site of use	Hospitals and physicians offices.	Hospitals and physicians offices.	Same as predicatedevice

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510(k)

) Notification	K180096Page 4 of 7
----------------	------------------------

Intended users	Trained Medical Professionals.	Trained Medical Professionals.	Similar topredicate device
Clinical application	Viewing of the adult cervical canal anduterine cavity for the purpose ofperforming diagnostic and operativehysteroscope.	Diagnostic hysteroscopy.	Similar topredicate device
Device Features:- Components	(1) image-capturing hand piece and tower;(2) attachable cannula configuration withinflow and outflow ports.	(1) image-capturing hand tower; (2) attachablecannula with inflow port.	Similar topredicate device
- Cannula outerdiameter	4.8 - 5.3 mm (operative)4.8 - 5.3 mm (diagnostic)	3.8 x 4.6 mm (oval).	Similar topredicate device
Cannula length।	Working length: 220 - 240 mmOverall length: 300 - 350 mm	260 mm.	Similar topredicate device
- Cannula	Two (2) attachable cannula:Operative cannulaDiagnostic cannula-	Two (2) separate components (cannula andhandle)	Similar topredicate device
- Illumination lightsource	LEDs	LEDs	Same as predicatedevice
- Imagetransmission	Image transmitted from a video camera toa video monitor on the display module.	Transmit images from a video camera to avideo monitor.	Same as predicatedevice
- LCD display size	19 inches (diagonal)	3 inches (diagonal)	Different frompredicate device.See discussionbelow
- Image resolution	The CMOS sensor consists of 400 x 400(160,000) pixels.	The CMOS sensor consists of approximately160,000 pixels.	Same as predicatedevice
- Optical image	Digital CMOS	Digital CMOS technology	Same as predicatedevice
- Disposable/Reusable	Cannula is provided sterile for single useand the handle and tower is reusable.	Cannula is provided sterile for single use andthe handle is reusable.	Same as predicatedevice
- Battery operated	No	Yes	Different. Subjectdevice is notbattery operated
- Battery chargeindication	NA	Charge indication as an icon on the LCDmonitor	NA

- Battery power	NA	3.3 V	NA
- Adjust brightnessof LEDs	Adjust by depressing a button on a hand piece	Adjust by depressing a button on a hand piece	Same as predicatedevice
- Capture still orvideo imageduring procedure	Capture still or video during procedure bydepressing a camera button on the handpiece or by pressing the icons on GUI	Capture still or video during procedure bydepressing a camera button on the hand piece	Different. Subjectdevice capturesstill and videoduring procedure
- Enter patient IDinformation beforeprocedure	User interface on monitor allows physicianto add patient information	User interface on monitor on hand piece allowsphysician to add patient information	Different. Subjectdevice allowsphysician to inputpatientinformation
Duration of use	< 24 hours	< 24 hours	Same as predicatedevice
Reusable/disposable	Hand Tower is reusable. Display tower isequipment. Cannula is single patient use	Hand Tower is reusable. Diagnostic cannula issingle patient use.	Similar topredicate device
Contact materials	Compliant with ISO 10993 for	Compliant with ISO 10993.	Same as predicate

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device

The subject and predicate device have intended use. The subject and predicate device have different technological characteristics as evidenced by the table above. The differences in technological characteristics do not raise different questions of safety and effectiveness.

cytotoxicity, sensitization, irritation, and

acute systemic toxicity.

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Performance Data

Non-clinical tests were performed in accordance with the applicable requirements of the following standards to evaluate compliance with electrical safety, electromagnetic compatibility, sterilization biocompatibility, shelf life, and packaging.

Additionally, verification and validation activities were also performed to ensure that product performance meets design requirements.

Electrical Safety/EMC

. IEC 60601-1:2005, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC/EN 60601-1-2:2007/AC:2010. Medical electrical equipment Part 1-2: General ● requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-1-6:2010+A1:2013, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
IEC 60601-2-18:2009, Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
IEC/EN 61000-3-2:2014, Electromagnetic compatibility (EMC) Part 3-2: Limits Limits for ● harmonic current emissions (equipment input current ≤ 16 A per phase)
IEC/EN 61000-3-3:2013, Electromagnetic compatibility (EMC) Part 3-3: Limits Limitation of ● voltage changes, voltage fluctuations and flicker in public low-voltage supply systems, for equipment with rated current ≤16 A per phase and not subject to conditional connection
IEC 61000-4-2:2008, Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test
IEC 61000-4-3:2006, Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test
IEC 62366:2007+ A1:2014, Medical devices - Part 1: Application of usability engineering to medical devices
EN 55011:2009+A1:2010, CISPR 11:2009+A1:2010, Industrial, scientific and medical (ISM) radio-frequency equipment - Electromagnetic disturbance characteristics - Limits and methods of measurement
ISO 14971:2007, Medical devices, Application of risk management to medical devices

Software

IEC 62304:2015, Medical device software - Software lifecycle processes
FDA Software Guidance

Shelf Life

ASTM D4169-16, Standard Practice For Performance Testing Of Shipping Containers And Systems
ASTM F1980-16, Accelerated Aging
ASTM F2096-11, Gross Leak Detection
ASTM F88/F88M-15, Seal Strength
Demonstration that device meets package integrity and functional performance requirements following shelf life

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Biocompatibility

. ISO 10993:2009, Biological evaluation of medical devices, including cytotoxicity, sensitization, irritation, and acute systemic toxicity
Sterilization/Reprocessing
Sterilization validation ●
Reprocessing validation

Mechanical Performance

Dimensional analysis ●
Fittings/connectors assessment
Stiffness
Deformation angle ●
Tensile strength
Torque ●
Fluid Delivery ●

Optical Performance

Field of view
Direction of view
Illumination
. Resolution
Automatic exposure control
Depth of field
Image distortion

Test results confirm that GDT-1000 system complies with the applicable standards, and is safe and effective for its intended use.

510(k) Summary Conclusion:

The performance data demonstrate that the GDT-1000 System is substantially equivalent to the cited predicate device.

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Image /page/8/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the words "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue text.

April 16, 2018

AcuVu, Inc. Sam Mostafavi Director of Regulatory 1749 Broadway Street Redwood City, CA 94063

Re: K180096

Trade/Device Name: GDT-1000 System Regulation Number: 21 CFR§ 884.1690 Regulation Name: Hysteroscope and Accessories Regulatory Class: II Product Code: HIH Dated: January 11, 2018 Received: January 16, 2018

Dear Sam Mostafavi:

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. Iisting 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,

For 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

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.