(90 days)
Not Found
No
The description focuses on the hardware components, image capture/display, and basic system functions without mentioning any AI/ML capabilities for image analysis, diagnosis, or procedural guidance.
Yes
The device description explicitly mentions that the disposable cannula module family includes models for "operative/therapeutic procedure," and the therapeutic operative cannula has a "shared working channel" for "small operative instrument access," directly indicating its use in therapeutic interventions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is used "for the purpose of performing diagnostic and operative procedures." Additionally, the "Device Description" mentions that one of the disposable cannula models is "for the purpose of diagnosis."
No
The device includes significant hardware components such as a disposable cannula module with a camera and LEDs, a reusable handle module, and a tower-mounted PC. While software is part of the system, it is not the sole component.
Based on the provided information, the Acu Vu GDT-1000 System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "permit viewing of the adult cervical canal and uterine cavity for the purpose of performing diagnostic and operative procedures." This describes a device used for direct visualization and intervention within the body, not for examining specimens in vitro (outside the body).
- Device Description: The description details a hysteroscope, which is an endoscopic device used to visualize the inside of the uterus. It involves a camera, light source, and channels for fluid and instruments, all designed for use in vivo.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (like blood, urine, tissue, etc.) or to provide information about a patient's health status based on the analysis of such samples.
In summary, the Acu Vu GDT-1000 System is a medical device used for direct visualization and procedures within the body, which falls under the category of an endoscopic device, not an IVD.
N/A
Intended Use / 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.
Product codes
HIH
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical canal and uterine cavity
Indicated Patient Age Range
adult
Intended User / Care Setting
Trained Medical Professionals.
Hospitals and physicians 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)
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.
Test results confirm that GDT-1000 system complies with the applicable standards, and is safe and effective for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
EndoSee Corporation U-Scope Model 8000 (K123151)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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1
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 Broadway | |
| Redwood City, CA 94063 | |
| Contact Person: | Sam Mostafavi |
| ipcs11@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
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
2
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.
3
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
AcuVu Inc.
GDT-1000 System | Predicate Device
EndoSee
U-Scope Model 8000 (K123151) | Subject Device
to Predicate
Device |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| Classification | Class II | Class II | Same as
predicate device |
| Regulation Name | 21 CFR § 884.1690 | 21 CFR § 884.1690 | Same as
predicate device |
| Classification Panel | Obstetrics and Gynecology | Obstetrics and Gynecology | Same as
predicate device |
| Product code | HIH | HIH | Same as
predicate device |
| Indications for use | AcuVu GDT-1000 System is used to
permit viewing of the adult cervical canal
and uterine cavity for the purpose of
performing diagnostic and operative
procedure. | The U-Scope device is used to permit viewing
of the cervical canal and uterine cavity for the
purpose of performing diagnostic procedures.
Generally recognized indications for
diagnostic hysteroscopy include: Abnormal
uterine bleeding, infertility and pregnancy
wastage; evaluation of abnormal | Similar to
predicate device |
| Procedures | Viewing of the adult cervical canal and
uterine cavity for the purpose of
performing diagnostic or operative
procedures | Viewing of the cervical canal and uterine
cavity for the purpose of performing
diagnostic procedures. | Similar to
predicate device |
| Site of use | Hospitals and physicians offices. | Hospitals and physicians offices. | Same as predicate
device |
4
510(k)
| ) Notification | K180096
Page 4 of 7 |
| ---------------- | ------------------------ |
|---|
| Intended users | Trained Medical Professionals. | Trained Medical Professionals. | Similar to
predicate device |
|-------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| Clinical application | Viewing of the adult cervical canal and
uterine cavity for the purpose of
performing diagnostic and operative
hysteroscope. | Diagnostic hysteroscopy. | Similar to
predicate device |
| Device Features:
- Components | (1) image-capturing hand piece and tower;
(2) attachable cannula configuration with
inflow and outflow ports. | (1) image-capturing hand tower; (2) attachable
cannula with inflow port. | Similar to
predicate device |
| - Cannula outer
diameter | 4.8 - 5.3 mm (operative)
4.8 - 5.3 mm (diagnostic) | 3.8 x 4.6 mm (oval). | Similar to
predicate device |
| Cannula length
। | Working length: 220 - 240 mm
Overall length: 300 - 350 mm | 260 mm. | Similar to
predicate device |
| - Cannula | Two (2) attachable cannula:
Operative cannula
Diagnostic cannula -
| Two (2) separate components (cannula and
handle) | Similar to
predicate device |
| - Illumination light
source | LEDs | LEDs | Same as predicate
device |
| - Image
transmission | Image transmitted from a video camera to
a video monitor on the display module. | Transmit images from a video camera to a
video monitor. | Same as predicate
device |
| - LCD display size | 19 inches (diagonal) | 3 inches (diagonal) | Different from
predicate device.
See discussion
below |
| - Image resolution | The CMOS sensor consists of 400 x 400
(160,000) pixels. | The CMOS sensor consists of approximately
160,000 pixels. | Same as predicate
device |
| - Optical image | Digital CMOS | Digital CMOS technology | Same as predicate
device |
| - Disposable/
Reusable | Cannula is provided sterile for single use
and the handle and tower is reusable. | Cannula is provided sterile for single use and
the handle is reusable. | Same as predicate
device |
| - Battery operated | No | Yes | Different. Subject
device is not
battery operated |
| - Battery charge
indication | NA | Charge indication as an icon on the LCD
monitor | NA |
| | | | |
| - Battery power | NA | 3.3 V | NA |
| - Adjust brightness
of LEDs | Adjust by depressing a button on a hand piece | Adjust by depressing a button on a hand piece | Same as predicate
device |
| - Capture still or
video image
during procedure | Capture still or video during procedure by
depressing a camera button on the hand
piece or by pressing the icons on GUI | Capture still or video during procedure by
depressing a camera button on the hand piece | Different. Subject
device captures
still and video
during procedure |
| - Enter patient ID
information before
procedure | User interface on monitor allows physician
to add patient information | User interface on monitor on hand piece allows
physician to add patient information | Different. Subject
device allows
physician to input
patient
information |
| Duration of use |