(63 days)
Not Found
No
The description mentions image processing for brightness, clarity, and color, which are standard digital image processing techniques, not necessarily AI/ML. There is no mention of AI, ML, or related concepts like training/test sets or performance metrics typically associated with AI/ML algorithms.
No
The device is used for diagnostic viewing and surgical procedures (e.g., removal of fibroids), which are therapeutic actions. However, the device itself is a viewing instrument and not applied to the patient to treat or cure a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is used "for the purpose of performing diagnostic and surgical procedures," and then further lists "Diagnostic Hysteroscopy" with specific conditions like "Abnormal uterine bleeding" and "Infertility & pregnancy wastage."
No
The device description explicitly states that the system is comprised of both a digital hysteroscope (hardware with CMOS sensor, wiring, PCB, LED, and electrical cord) and a digital controller (hardware with PCBs, software, power supply, and cables). While the controller contains software for image processing, the overall system includes significant hardware components.
Based on the provided information, the Gyrus ACMI Invisio Digital Hysteroscope is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done in vitro (in glass or outside the body).
- Device Function: The Gyrus ACMI Invisio Digital Hysteroscope is a medical device used for direct visualization of the cervical canal and uterine cavity within the body. It uses a camera (CMOS sensor) to capture images of the internal anatomy.
- 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 looking directly at the tissue, not analyzing a sample taken from the body.
The device is an endoscope used for diagnostic and operative procedures performed in vivo (within the living body).
N/A
Intended Use / Indications for Use
The Gyrus ACMI Invisio Digital Hysteroscope is intended to be used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.
The Gyrus ACMI Invisio Digital Hysteroscope System includes the Invisio Digital Hysteroscope and IDC Invision™ Controller. The IDC Controller is intended to be used to process the video signal from the Invisio Digital Hysteroscope and ensure brightness, image clarity and color.
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
Product codes
HIH
Device Description
The Gyrus ACMI® Invisio® Digital Hysteroscope System is comprised of the Invisio Digital Hysteroscope and Invisio Digital Controller (IDC-1500). The Gyrus ACMI Invisio Digital Hysteroscope is a semi-rigid (rigi-flex) hysteroscope that incorporates CMOS (complimentary medical oxide semi-conductor) sensor technology to generate an image. There is a miniature CMOS sensor located in the distal tip, wiring running through the endoscope shaft, a printed circuit board (PCB), a light-emitting diode (LED) light source located in the handle, and an electrical cord that connects the endoscope to the Camera Control Unit (CCU).. The Invisio Digital Hysteroscope connects to a CCU, (the Invisio Digital Controller (IDC-1500)), that contains printed circuits boards (PCBs), software, power supply and power cables to process and display the images transmitted by the camera.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Video signal from hysteroscope (generated by CMOS sensor)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K060269, K072594, K990411, K022445
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.
0
Gyrus ACMI® Invisio® Digital Hysteroscope System Gyrus ACMI, Inc. 136 Turnpike Road Southborough, MA 01772
Traditional 510(k) Notification Summary of S & E July 24, 2009
510(k) Summary of Safety and Effectiveness Gyrus ACMI, Inc. Gyrus ACMI® Invisio® Digital Hysteroscope System
General Information
Manufacturer:
136 Turnpike Rd. Southborough, MA 01772-2104
Establishment Registration Number:
Contact Person:
3003790304
July 24, 2009
Gyrus ACMI Inc.
Graham A. L. Baillie, MS Sr Regulatory Affairs Specialist Tel. # 508 804-2738 Fax # 508 804-2624
Date Prepared:
Trade Name:
Device Description Classification Name:
Hysteroscope and accessories (21CFR 886.1690). Class II Surgical camera and accessories, (21 CFR 878.4160), Class I
Gyrus ACMI Invisio Digital Hysteroscope System
Endoscope, Video Camera and accessories Hysteroscope and accessories
Predicate Devices
Generic/Common Name:
K060269 ACMI DUR®-Digital Ureteroscope & Choledochoscope, (DUR-D) Gyrus ACMI IPN-2505 Percutaneous Nephroscope K072594 K990411 Karl Storz MVM 7.5French Flexible Hysteroscope K022445 Olympus Visera HFY-V Hysterovideoscope
Intended Use
The Gyrus ACMI Invisio Digital Hysteroscope is intended to be used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.
The Gyrus ACMI Invisio Digital Hysteroscope System includes the Invisio Digital Hysteroscope and IDC Invision™ Controller. The IDC Controller is intended to be used to process the video signal from the Invisio Digital Hysteroscope and ensure brightness, image clarity and color.
Diagnostic Hysteroscopy:
- Abnormal uterine bleeding o
- Infertility & pregnancy wastage o
1
Gyrus ACMI® Invisio® Digital Hysteroscope Gyrus ACMI, Inc. 136 Turnpike Road Southborough, MA 01772
Traditional 510(k) Notification Truthfuiness Statement July 24, 2009
- Evaluation of abnormal hysterosalpingogram �
- Intrauterine foreign body o
- Amenorrhea �
- Pelvic pain �
Operative Hysteroscopy:
- Directed biopsy a
- Removal of fibroids and polyps �
- Transection of intrauterine adhesions .
- Transection intrauterine septa �
Product Description
The Gyrus ACMI® Invisio® Digital Hysteroscope System is comprised of the Invisio Digital Hysteroscope and Invisio Digital Controller (IDC-1500). The Gyrus ACMI Invisio Digital Hysteroscope is a semi-rigid (rigi-flex) hysteroscope that incorporates CMOS (complimentary medical oxide semi-conductor) sensor technology to generate an image. There is a miniature CMOS sensor located in the distal tip, wiring running through the endoscope shaft, a printed circuit board (PCB), a light-emitting diode (LED) light source located in the handle, and an electrical cord that connects the endoscope to the Camera Control Unit (CCU).. The Invisio Digital Hysteroscope connects to a CCU, (the Invisio Digital Controller (IDC-1500)), that contains printed circuits boards (PCBs), software, power supply and power cables to process and display the images transmitted by the camera.
Technological Characteristics and Substantial Equivalence
The Gyrus ACMI® Invisio® Digital Hysteroscope System, utilizes features included in the predicate Gyrus ACMI Invisio Digital, IPN-2505 Percutaneous Nephroscope K072594, and the ACMI DUR®-Digital Ureteroscope & Choledochoscope, DUR®-D K060269. The proposed device incorporates the same CMOS video imaging technology located in the endoscope as the aforementioned Invisio predicates. The subject Invisio Digital Hysteroscope System utilizes the same model Invisio Controller loaded with the same Invisio digital software. The internal shaft construction and flexible/articulating distal section contains similarly designed defection pulleys/wires, and electrical wiring as the predicate Invisio DUR®-D. The subject and two aforementioned Invisio predicates also incorporate similarly designed bifurcated fiber optic illumination bundles that carry/transmit light from the same design LEDs, located in the handles of each device, through the shaft to the distal tip. The subject hysteroscope and predicate DUR®-D also share the same patient contacting materials used in the distal tip, working channel and deflection cover.
Like other predicate hysteroscopes: the Karl Storz MVM 7.5 Fr Flexible Hysteroscope (K99041 1); and the Olympus Visera HFY-V Hysterovideoscope (K022445); the proposed hysteroscope has similar shaft diameter and working length and is intended for viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.
In summary, the Gyrus ACMI® Invisio® Digital Hysteroscope System is substantially equivalent to the four predicate devices and presents no new questions of safety or efficacy.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract, curved shapes that resemble human figures or flowing lines. The symbol is positioned in the center of the seal.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
SEP 2 9 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Graham A. L. Baillie, MS Sr. Regulatory Affairs Specialist Gyrus ACMI, Inc. 136 Turnpike Road SOUTHBOROUGH MA 01772-2104
Re: K092278
Trade/Device Name: Invisio Digital Hysteroscope System Regulation Number: 21 CFR 8884,1690 Regulation Name: Hysteroscope and accessories Regulatory Class: II Product Code: HIH Dated: July 24, 2009 Received: July 28, 2009
Dear Mr. Baillie:
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.
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 (reporting of medical
3
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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Gyrus ACMI® Invisio® Digital Hysteroscope System Gyrus ACMI, Inc. 136 Turnpike Road Southborough, MA 01772
Traditional 510(k) Notification Intended Use Statement July 24, 2009
Indications for Use
K092278 510(k) Number: Device Name: Invisio Digital Hysteroscope System
Indications for Use
The Gyrus ACMI Invisio Digital Hysteroscope is intended to be used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.
The Gyrus ACMI Invisio Digital Hysteroscope System includes the Invisio Digital Hysteroscope and IDC InvisionM Controller. The IDC Controller is intended to be used to process the video signal from the Invisio Digital Hysteroscope and ensure brightness, image clarity and color.
Diagnostic Hysteroscopy:
- 0 Abnormal uterine bleeding
- Infertility & pregnancy wastage .
- Evaluation of abnormal hysterosalpingogram �
- Intrauterine foreign body 0
- � Amenorrhea
- � Pelvic pain
ð
Operative Hysteroscopy:
- � Directed biopsy
- Removal of fibroids and polyps ね
- Transection of intrauterine adhesions 0
- Transection intrauterine septa
Prescription Use: X
Over-the-Counter Use :________________________________________________________________________________________________________________________________________________________
7
(Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE),
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number