(332 days)
Not Found
No
The summary describes a standard hysteroscope system with a video processor for image processing. There is no mention of AI, ML, or any advanced algorithms beyond basic image processing. The performance studies focus on standard medical device testing (biocompatibility, sterilization, electrical safety, software V&V, optical, mechanical) and do not include metrics typically associated with AI/ML performance (e.g., sensitivity, specificity, AUC).
No
The device is described as a tool for viewing and accessing the uterine cavity for diagnostic and surgical procedures, but it is not, in and of itself, a method of therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "performing diagnostic and surgical procedures," and lists "Generally recognized indications for diagnostic hysteroscopy." Additionally, the "Device Description" mentions that "Model GSA01-B is intended for diagnostic hysteroscopy only."
No
The device description explicitly states it consists of a "sterile single-use disposable Rigid Hysteroscope and video processor," which are hardware components. While it includes software for image processing, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Hysteroscope System is a medical device used to directly visualize the cervical canal and uterine cavity. It is a tool for performing diagnostic and surgical procedures within the body, not for analyzing samples outside the body.
- Intended Use: The intended use clearly states it's for "viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures." This involves direct visualization and intervention, not laboratory analysis of biological samples.
- Device Description: The description details a rigid hysteroscope with a camera and a video processor. This aligns with an endoscopic device used for internal examination and procedures, not an IVD.
- Performance Studies: The performance studies focus on biocompatibility, sterilization, electrical safety, software validation, optical performance, and mechanical performance. These are typical tests for medical devices used internally, not for validating the analytical performance of an IVD (which would involve metrics like sensitivity, specificity, accuracy, etc., related to detecting analytes in samples).
In summary, the Hysteroscope System is an in vivo diagnostic and surgical tool, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Hysteroscope System is intended to be used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.
Note: Hysteroscopes are used as tools to access the uterine cavity and of themselves, a method of surgery.
Generally recognized indications for diagnostic hysteroscopy include:
- Abnormal bleeding
- · Infertility and pregnancy wastage
- · Evaluation of abnormal hysterosalpingogram
- · Intrauterine foreign body
- · Amenorrhea
- Pelvic pain
Generally recognized indications for operative hysteroscopy include:
- · Directed endometrial biopsy
- · Polypectomy
- Submucous myomectomy
- · Transection of intrauterine adhesions
- · Transection of intrauterine septa
- · Endometrial ablation
Product codes
HIH
Device Description
The Hysteroscope System consists of a sterile single-use disposable Rigid Hysteroscope and video processor for clinical image processing. The Rigid Hysteroscope (available in models GSA01-B, GSB04-B and GSB14-B) are used to permit direct viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures. Model GSA01-B is intended for diagnostic hysteroscopy only, and has a rigid shaft without operative channel (injection channel only). Models GSB04-B and GSB14-B are intended for both diagnostic and operative hysteroscopy, and have an operative (insertion) channel. GSB04-B has a rigid shaft, and GSB14-B has a curved tip. The video processor provides power and processes the images from the Rigid Hysteroscopes. Anatomical images are collected via a CMOS chip at the distal end of the hysteroscope and are transmitted through the video processor to a monitor.
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
Not Found
Intended User / Care Setting
Not Found
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
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing: Biocompatibility of the Hysteroscope System was evaluated in accordance with ISO 10993-1:2009 for the body contact category of "Surface – Mucosal Membrane" with a contact duration of "Limited (
§ 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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Image /page/0/Picture/0 description: The image shows 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 is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
May 10, 2019
Shanghai AnQing Medical Instrument CO., Ltd. Lina Fei Quality Manager 150 Cailun Road, Zhangjiang High-Tech Park Shanghai, 201210 China
Re: K181545
Trade/Device Name: Hysteroscope System Regulation Number: 21 CFR§ 884.1690 Regulation Name: Hysteroscope and Accessories Regulatory Class: II Product Code: HIH Dated: April 3, 2019 Received: April 10, 2019
Dear Lina Fei:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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,
Sharon M. Andrews Assistant Division Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K181545
Device Name Hysteroscope System
Indications for Use (Describe)
The Hysteroscope System is intended to be used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.
Note: Hysteroscopes are used as tools to access the uterine cavity and of themselves, a method of surgery.
Generally recognized indications for diagnostic hysteroscopy include:
- Abnormal bleeding
- · Infertility and pregnancy wastage
- · Evaluation of abnormal hysterosalpingogram
- · Intrauterine foreign body
- · Amenorrhea
- · Pelvic pain
Generally recognized indications for operative hysteroscopy include:
- · Directed endometrial biopsy
- · Polypectomy
- Submucous myomectomy
- · Transection of intrauterine adhesions
- · Transection of intrauterine septa
- · Endometrial ablation
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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3
510(k) Summary – K181545
I. Submitter
Device submitter: Shanghai AnQing Medical Instrument CO., Ltd. Room 202, 2nd Floor, No.7 Building & Room 202, 2nd Floor No.4 Building, 150 Cailun Road, Zhangjiang High-Tech Park, 201210, Shanghai, China
Contact person: Wen Shi Quality Manager Phone: +86 135 8580 5802 Fax: +86 21 5019 1132 – 8004 Email: wenshi@innovexmed.com.cn
Date prepared: May 9, 2019
II. Device
Trade Name of Device: Hysteroscope System Common Name: Hysteroscope (And Accessories) Regulation Number: 21 CFR 884.1690 Regulation Name: Hysteroscope and Accessories Regulatory Class: II Product Code: HIH Product Code Name: Hysteroscope and Accessories
III. Predicate Devices
| Trade name: | LiNA OperaScope |
|---|---|
| Common name: | Hysteroscope |
| Classification: | 21 CFR 884.1690 Hysteroscope and Accessories |
| Product Code: | HIH, Hysteroscope and Accessories |
| Premarket Notification: | K171113 |
The predicate device has not been subject to a design-related recall.
IV. Device description
The Hysteroscope System consists of a sterile single-use disposable Rigid Hysteroscope and video processor for clinical image processing. The Rigid Hysteroscope (available in models GSA01-B, GSB04-B and GSB14-B) are used to permit direct viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures. Model GSA01-B is intended for diagnostic hysteroscopy only, and has a rigid
4
shaft without operative channel (injection channel only). Models GSB04-B and GSB14-B are intended for both diagnostic and operative hysteroscopy, and have an operative (insertion) channel. GSB04-B has a rigid shaft, and GSB14-B has a curved tip. The specifications for the three models are as follows:
| Model | Shape | Scope diameter | Working length | Minimum
insertion
channel
diameter | Injection
channel
Diameter | Tip Curve | Curved Tip
length |
|---------|----------------------|-----------------------|----------------|---------------------------------------------|----------------------------------|------------|----------------------|
| GSA01-B | Straight | Φ4.0mm
+0.0/-0.3mm | 260mm±8mm | N/A | 0.8mm
+0.2/-0.0mm | N/A | N/A |
| GSB04-B | Straight | Φ6.4mm
+0.0/-0.3mm | 260mm±8mm | 2.3mm
+0.2/-0.0mm | 1.1mm
+0.2/-0.0mm | N/A | N/A |
| GSB14-B | Curved
distal tip | Φ6.4mm
+0.0/-0.3mm | 260mm±8mm | 2.3mm
+0.2/-0.0mm | 1.1mm
+0.2/-0.0mm | 22°
±5° | 25mm
±1.3mm |
The video processor provides power and processes the images from the Rigid Hysteroscopes. Anatomical images are collected via a CMOS chip at the distal end of the hysteroscope and are transmitted through the video processor to a monitor.
V. Indications for use
The Hysteroscope System is intended to be used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.
Note: Hysteroscopes are used as tools to access the uterine cavity and are not, in and of themselves, a method of surgery.
Generally recognized indications for diagnostic hysteroscopy include:
- Abnormal bleeding
- Infertility and pregnancy wastage
- Evaluation of abnormal hysterosalpingogram
- Intrauterine foreign body
- Amenorrhea
- Pelvic pain
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Generally recognized indications for operative hysteroscopy include:
- · Directed endometrial biopsy
- · Polypectomy
- · Submucous myomectomy
- Transection of intrauterine adhesions
- · Transection of intrauterine septa
- Endometrial ablation
VI. Comparison of technological characteristics with the predicate devices
The Hysteroscope System has the same intended use as the predicate device. The Hysteroscope System and the predicate device are designed to provide real-time images to the physician in order to facilitate diagnostic and therapeutic procedures in the cervical canal and uterus. As summarized in the table below, there are differences in technological characteristics between the subject and predicate device. The technological differences between the Hysteroscope System and predicate device do not raise different questions of safety or effectiveness.
| Device Feature | Hysteroscope
System (subject
device) | LiNA OperaScope
K171113 | Discussion |
|-------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
use | The Hysteroscope
System is intended
to be used to permit
viewing of the
cervical canal and
uterine cavity for the
purpose of
performing
diagnostic and
surgical procedures.
Note: Hysteroscopes
are used as tools to
access the uterine
cavity and are not, in
and of themselves, a
method of surgery.
Generally
recognized
indications for
diagnostic
hysteroscopy
include:
• Abnormal bleeding | 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 | Similar; the difference
in wording of the
indications does not
alter the intended use. |
| | | | |
| | • Infertility and
pregnancy wastage
• Evaluation of
abnormal
hysterosalpingogram
• Intrauterine foreign
body
• Amenorrhea
• Pelvic pain
Generally
recognized
indications for
operative
hysteroscopy
include:
• Directed
endometrial biopsy
• Polypectomy
• Submucous
myomectomy
• Transection of
intrauterine
adhesions
• Transection of
intrauterine septa
• Endometrial
ablation | removal;
• Provide visual guidance
during directed biopsy,
submucosal
myomectomy,
transection of intrauterine
adhesions and septa. | |
| System
Components | The Hysteroscope
System consists of a
sterile single-use
disposable Rigid
Hysteroscope and
video processor for
clinical image
processing. | 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, HDMI
ports (2) for connection to | Similar;
the basic system
composition is
identical (single use
scope with video
processor). |
| | | | |
| | | | |
| Optical Image | CMOS | handpiece
(hysteroscope) and
external monitor and
input port for external 9V
DC power supply. | Identical |
| Image Resolution | 100,000 pixels | Digital CMOS
Technology
CMOS camera consists
of approximately 160,000
pixels | Different; the
difference does not
raise different
questions of safety or
effectiveness. |
| Illumination
Light Source | LED | LED at tip of cannula | Identical |
| Inflow and
outflow channel
for saline
instillation | Inflow and outflow
channels separately | 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. | Different; The
difference does not
raise different
questions of safety or
effectiveness. |
| Cannula tip
design | Angled shaft
proximal to tip:
Straight: 0°
Curved tip:22° | Rounded polymer tip.
Angled shaft proximal to
tip (~ 20°C). Steerable by
rotation knob. | Different; the
predicate device is
steerable by rotation
knob. The difference
does not raise
different questions of
safety or
effectiveness. |
| Image
Transmission | Transmits images
are transmitted to
the user by the video
processor with a
CMOS chip at the
distal end of the
endoscope and the
image showing on a
monitor. | Transmits images from
CMOS video camera to
local LCD display unit on
the handpiece and
remote monitor. | Identical |
| Maximum | 4.0 to 6.4mm | 4.3 mm | Different; the |
| | | | |
| Insertion
Diameter (Tip) | depending on model | | difference in diameter
does not raise
different questions of
safety or
effectiveness. |
| Shaft/Cannula
Length | 260mm | 240mm (24cm) | Different; the
difference in length
does not raise
different questions of
safety and
effectiveness. |
| Energy Source | Hysteroscope: 5V
Video Processor: 5V
2A | Handpiece: 3V (2 AA
batteries)
Recording Module: 9V
DC external power
adapter | Similar;
Different output
formats do not raise
different safety or
effectiveness. |
| Sterilization | The Rigid
Hysteroscope is
provided sterilized
by EO. No
re-sterilization is
permitted.
Video Processor:
Non-Sterile | Handpiece
(Hysteroscope):
Ethylene Oxide (EO)
Handpiece Batteries:
Radiation (Gamma)
Recording Module:
Non-Sterile | Identical |
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K181545 Page 6 of 7
VII. Performance data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
Biocompatibility of the Hysteroscope System was evaluated in accordance with ISO 10993-1:2009 for the body contact category of "Surface – Mucosal Membrane" with a contact duration of "Limited (