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

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.

AI/ML Overview

The provided 510(k) summary for the Gyrus ACMI® Invisio® Digital Hysteroscope System (K092278) does not contain information regarding acceptance criteria, performance studies, or clinical trial data to support the device's efficacy or safety.

This 510(k) notification focuses on establishing substantial equivalence to previously cleared predicate devices based on technological characteristics and intended use. The document primarily describes the device, its intended use, and argues for its substantial equivalence to other hysteroscopes and similar digital endoscopes already on the market.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria because it is not present in the provided text.

Here's a breakdown of why the information is absent from the provided document:

510(k) Pathway: The 510(k) premarket notification pathway is typically used for devices that are "substantially equivalent" to already legally marketed devices (predicates). This pathway often relies on demonstrating that the new device has similar technological characteristics and the same intended use as a predicate, rather than requiring extensive new clinical efficacy studies or establishing novel acceptance criteria.
Focus on Substantial Equivalence: The summary extensively details the "Technological Characteristics and Substantial Equivalence" section, comparing the Invisio Digital Hysteroscope System to existing predicate devices like other Gyrus ACMI endoscopes and hysteroscopes from Karl Storz and Olympus. The argument is that because it shares similar technology, design, and patient-contacting materials with already cleared devices, it presents no new questions of safety or efficacy.
Lack of Performance Data: There are no sections describing performance metrics, study designs (e.g., sample sizes, ground truth establishment), or results of any clinical or non-clinical trials demonstrating specific performance against predefined acceptance criteria. This type of data is more common in a Premarket Approval (PMA) application or a 510(k) for a novel device that cannot demonstrate substantial equivalence based on technological characteristics alone.

In summary, none of the requested information (acceptance criteria table, study sample sizes, ground truth details, adjudication methods, MRMC studies, standalone performance, training set details) can be extracted from the provided 510(k) notification.

Summary

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K092278

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.

Diagnostic Hysteroscopy:

Abnormal uterine bleeding o
Infertility & pregnancy wastage o

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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

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

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Page 2 -

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

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 :________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801.109)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE),

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

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.