GDT-1000 System

K180096 · Acuvu, Inc. · HIH · Apr 16, 2018 · Obstetrics/Gynecology

Device Facts

• Record ID: K180096
• Device Name: GDT-1000 System
• Applicant: Acuvu, Inc.
• Product Code: HIH · Obstetrics/Gynecology
• Decision Date: Apr 16, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1690
• Device Class: Class 2

Intended 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 Story

GDT-1000 System is a single-use hysteroscope for gynecologic procedures in hospitals and physician offices. System comprises a disposable cannula module (diagnostic or operative), a reusable handle module, and a tower-mounted 19-inch touch screen PC. Cannula tip contains a miniature CMOS camera and LED illumination. Handle connects to cannula via self-locking interface and to display tower via USB. Physician operates device to visualize cervical canal and uterine cavity; captures still images and video via hand-piece buttons or GUI; inputs patient information. System processes image data for display and report creation. Enables diagnostic and operative hysteroscopy; provides real-time visualization to assist clinical decision-making and procedural guidance.

Clinical Evidence

Bench testing only. No clinical data presented. Performance verified via electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), biocompatibility (ISO 10993), and mechanical/optical performance testing (field of view, resolution, automatic exposure control, etc.).

Technological Characteristics

Single-use cannula with CMOS sensor (400x400 pixels) and LED illumination. Reusable handle and tower-mounted 19-inch touch screen PC. Connectivity via USB. Materials compliant with ISO 10993. Sterilization validation performed for disposable components. Software lifecycle per IEC 62304.

Indications for Use

Indicated for adult patients requiring visualization of the cervical canal and uterine cavity for diagnostic and operative gynecologic procedures.

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

• EndoSee Corporation U-Scope Model 8000 (K123151)

Submission Summary (Full Text)

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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.<br>1749 Broadway<br>Redwood City, CA 94063 |
| Contact Person: | Sam Mostafavi<br>[e-mail] |
| 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

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

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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.

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.

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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 Device<br>AcuVu Inc.<br>GDT-1000 System | Predicate Device<br>EndoSee<br>U-Scope Model 8000 (K123151) | Subject Device<br>to Predicate<br>Device |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| Classification | Class II | Class II | Same as<br>predicate device |
| Regulation Name | 21 CFR § 884.1690 | 21 CFR § 884.1690 | Same as<br>predicate device |
| Classification Panel | Obstetrics and Gynecology | Obstetrics and Gynecology | Same as<br>predicate device |
| Product code | HIH | HIH | Same as<br>predicate device |
| Indications for use | AcuVu GDT-1000 System is used to<br>permit viewing of the adult cervical canal<br>and uterine cavity for the purpose of<br>performing diagnostic and operative<br>procedure. | The U-Scope device is used to permit viewing<br>of the cervical canal and uterine cavity for the<br>purpose of performing diagnostic procedures.<br>Generally recognized indications for<br>diagnostic hysteroscopy include: Abnormal<br>uterine bleeding, infertility and pregnancy<br>wastage; evaluation of abnormal | Similar to<br>predicate device |
| Procedures | Viewing of the adult cervical canal and<br>uterine cavity for the purpose of<br>performing diagnostic or operative<br>procedures | Viewing of the cervical canal and uterine<br>cavity for the purpose of performing<br>diagnostic procedures. | Similar to<br>predicate device |
| Site of use | Hospitals and physicians offices. | Hospitals and physicians offices. | Same as predicate<br>device |

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510(k)

| ) Notification | K180096<br>Page 4 of 7 |
|----------------|------------------------|
|----------------|------------------------|

| Intended users | Trained Medical Professionals. | Trained Medical Professionals. | Similar to<br>predicate device |
|-------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| Clinical application | Viewing of the adult cervical canal and<br>uterine cavity for the purpose of<br>performing diagnostic and operative<br>hysteroscope. | Diagnostic hysteroscopy. | Similar to<br>predicate device |
| Device Features:<br>- Components | (1) image-capturing hand piece and tower;<br>(2) attachable cannula configuration with<br>inflow and outflow ports. | (1) image-capturing hand tower; (2) attachable<br>cannula with inflow port. | Similar to<br>predicate device |
| - Cannula outer<br>diameter | 4.8 - 5.3 mm (operative)<br>4.8 - 5.3 mm (diagnostic) | 3.8 x 4.6 mm (oval). | Similar to<br>predicate device |
| Cannula length<br>। | Working length: 220 - 240 mm<br>Overall length: 300 - 350 mm | 260 mm. | Similar to<br>predicate device |
| - Cannula | Two (2) attachable cannula:<br>Operative cannula<br>Diagnostic cannula<br>- | Two (2) separate components (cannula and<br>handle) | Similar to<br>predicate device |
| - Illumination light<br>source | LEDs | LEDs | Same as predicate<br>device |
| - Image<br>transmission | Image transmitted from a video camera to<br>a video monitor on the display module. | Transmit images from a video camera to a<br>video monitor. | Same as predicate<br>device |
| - LCD display size | 19 inches (diagonal) | 3 inches (diagonal) | Different from<br>predicate device.<br>See discussion<br>below |
| - Image resolution | The CMOS sensor consists of 400 x 400<br>(160,000) pixels. | The CMOS sensor consists of approximately<br>160,000 pixels. | Same as predicate<br>device |
| - Optical image | Digital CMOS | Digital CMOS technology | Same as predicate<br>device |
| - Disposable/<br>Reusable | Cannula is provided sterile for single use<br>and the handle and tower is reusable. | Cannula is provided sterile for single use and<br>the handle is reusable. | Same as predicate<br>device |
| - Battery operated | No | Yes | Different. Subject<br>device is not<br>battery operated |
| - Battery charge<br>indication | NA | Charge indication as an icon on the LCD<br>monitor | NA |
| | | | |
| - Battery power | NA | 3.3 V | NA |
| - Adjust brightness<br>of LEDs | Adjust by depressing a button on a hand piece | Adjust by depressing a button on a hand piece | Same as predicate<br>device |
| - Capture still or<br>video image<br>during procedure | Capture still or video during procedure by<br>depressing a camera button on the hand<br>piece or by pressing the icons on GUI | Capture still or video during procedure by<br>depressing a camera button on the hand piece | Different. Subject<br>device captures<br>still and video<br>during procedure |
| - Enter patient ID<br>information before<br>procedure | User interface on monitor allows physician<br>to add patient information | User interface on monitor on hand piece allows<br>physician to add patient information | Different. Subject<br>device allows<br>physician to input<br>patient<br>information |
| Duration of use | < 24 hours | < 24 hours | Same as predicate<br>device |
| Reusable/disposable | Hand Tower is reusable. Display tower is<br>equipment. Cannula is single patient use | Hand Tower is reusable. Diagnostic cannula is<br>single patient use. | Similar to<br>predicate 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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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 ([e-mail]) or phone [phone] 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