(46 days)
The Galileo Disposable Hysteroscopes are endoscopes intended for visualization of the cervical canal and uterine cavity for diagnostic and surgical procedures during gynecological procedures. The Hysteroscope diagnostic indications include abnormal uterine bleeding, infertility and pregnancy wastage, evaluation of abnormal hysterosalpingogram, intrauterine foreign body, amenorrhea and pelvic pain. The Hysteroscope is indicated for surgical procedures such as directed biopsy, removal of submucous fibroids and large polyps, submucous myomectomy, transection of intrauterine adhesions and septa and endometrial ablation.
The Galileo Disposable Hysteroscopes are a line of disposable endoscopes based on existing endoscope technology. The Galileo Disposable Hysteroscopes will be available in several sizes and lengths. The Galileo Disposable Hysteroscopes are fiber optic design endoscopes that are offered in disposable configurations only. Fiberoptic design endoscopes function by light being transmitted from a standard external high intensity light source through optical fibers to the distal tip of the endoscope. The image of the target is then transmitted from the distal end via an objective lens and a fiberoptic imaging bundle to a proximal eyepiece. The image can be viewed directly or it may be transmitted through a video camera to a video monitor. The Disposable Hysteroscopes are offered with a coupler that includes a light source which is provided by Galileo Electro-Optics Corporation. The Galileo coupler is compatible only with the Galileo Disposable Hysteroscopes and the other cleared commercially available Galileo endoscopes.
Galileo Disposable Hysteroscopes (K981828) - Acceptance Criteria and Study Findings
The provided document describes the acceptance criteria and study findings for the Galileo Disposable Hysteroscopes, primarily focusing on optical performance and thermal safety.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Optical Acceptance Criteria (after deflection tests): | Passed. "The results of this testing showed that both the stainless steel and the polyimide sheathed sample scopes showed no change in any tested optical performance criteria. These results demonstrate that both samples maintained structural integrity of the optics assembly when subjected to the test protocol." This includes: - Field of view - Angle of view - Resolution on axis - Uniformity of illumination |
| Thermal Safety (per IEC 601-2-18) | Passed. "The Disposable Hysteroscopes passed the Thermal Safety Testing." |
Note: Electrical safety testing was planned but not detailed in this submission as being completed prior to commercial distribution.
2. Sample Size and Data Provenance
- Test Set Sample Size: "Samples of each type of hysteroscope containing the lens, image fiber, and illumination fiber were used for this testing." The exact number of samples is not specified beyond "samples of each type."
- Data Provenance: The study was conducted by Galileo Corporation, a U.S. company. The data is based on laboratory testing of their manufactured devices. This is a prospective study in the sense that the testing was performed specifically to evaluate the performance of the new disposable hysteroscopes against their internal acceptance criteria.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. The ground truth for this study was established through objective engineering and optical measurements, not expert human assessment.
4. Adjudication Method
Not applicable. The study involved objective measurements and comparisons against predefined optical and safety standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This study focuses on the intrinsic performance of the device's optical and thermal properties, not on human reader performance with or without AI assistance.
6. Standalone Performance Study
Yes, a standalone study was performed. The testing described (optical performance after deflection, thermal safety) evaluated the device itself without human interaction or interpretation as part of the primary outcome. The optical properties (field of view, angle of view, resolution, uniformity of illumination) were objective measurements of the device's capabilities.
7. Type of Ground Truth Used
The ground truth used was based on objective engineering measurements and predefined technical standards/specifications. Specifically:
- Optical Performance: Established prior to and after mechanical stress (deflection) by measuring field of view, angle of view, resolution on axis, and uniformity of illumination. The "ground truth" was that these pre- and post-stress measurements should meet the optical acceptance criteria and show no significant change.
- Thermal Safety: Established by compliance with the IEC 601-2-18 standard.
8. Sample Size for the Training Set
Not applicable. This device is a mechanical/optical medical device, not an AI or algorithm-driven system that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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K981828
7 1998 JUL
Proy
510(k) Summary Galileo Corporation Galileo Disposable Hysteroscopes
SPONSOR/APPLICANT NAME AND ADDRESS 1.
Galileo Corporation Galileo Park P.O. Box 550 Sturbridge, MA 01566 Telephone: (508) 347-9191
Contact Person
Debby Iampetro Director of Quality Assurance and Regulatory Affairs
Date of Summary Preparation
May 20, 1998
-
- DEVICE NAME
| Proprietary Name: | Galileo Disposable Hysteroscopes |
|---|---|
| Common/Usual Name: | Hysteroscopes |
| Classification Name: | Hysteroscopes and accessories |
IDENTIFICATION OF PREDICATE OR LEGALLY MARKETED DEVICE(S) 3.
The Galileo Hysteroscopes are substantially equivalent to several legally marketed endoscopes including the Galileo Disposable Diagnostic Hysteroscopes (K974297), Galileo Reusable Hysteroscopes (K962116), U.S. Surgical Surgiview Endoscopes, (K925968) and the Richard Wolf Hysteroscopes and Laparoscopes (K880314 and K770378).
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Image /page/1/Picture/0 description: The image shows handwritten text on a white background. The first line of text appears to be a series of numbers and letters, possibly a code or identifier, reading 'K981828'. The second line contains another sequence of numbers and letters, which reads 'P2074'. The handwriting is somewhat stylized, with some characters slightly distorted or connected.
DEVICE DESCRIPTION 4.
The Galileo Disposable Hysteroscopes are a line of disposable endoscopes based on existing endoscope technology. The Galileo Disposable Hysteroscopes will be available in several sizes and lengths.
The Galileo Disposable Hysteroscopes are fiber optic design endoscopes that are offered in disposable configurations only. Fiberoptic design endoscopes function by light being transmitted from a standard external high intensity light source through optical fibers to the distal tip of the endoscope. The image of the target is then transmitted from the distal end via an objective lens and a fiberoptic imaging bundle to a proximal eyepiece. The image can be viewed directly or it may be transmitted through a video camera to a video monitor.
The Disposable Hysteroscopes are offered with a coupler that includes a light source which is provided by Galileo Electro-Optics Corporation. The Galileo coupler is compatible only with the Galileo Disposable Hysteroscopes and the other cleared commercially available Galileo endoscopes.
5. INTENDED USE
The Galileo Disposable Hysteroscopes are endoscopes intended for direct visualization of cervical canal and uterine cavity for diagnostic and surgical. procedures during gynecological procedures. The Galileo Disposable Hysteroscopes are designed to be introduced through natural body cavities or through introducers, catheters, sheaths or other devices with thru-lumens having inside diameters larger than the outside diameter of the endoscope. The surgical indications include directed biopsy, removal of submucous fibroids and large polyps, submucous myomectomy, transection of intrauterine adhesions and septa and endometrial ablation.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS 6.
The Galileo Disposable Hysteroscopes and the substantially equivalent devices are identical in intended use in that they are all endoscopes intended to be passed through a lumen of an introducer or into natural body cavities for visualization of body cavities, tissues, organs or canals.
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K 981828 1204
The Galileo Disposable Hysteroscopes and the substantially equivalent devices are similar in designs in that they all offer various configurations including rod/lens or fiberoptic design, optional working channels, several OD's and lengths, and use external light sources, and similar stainless steel materials.
The Galileo Disposable Hysteroscopes and the substantially equivalent devices are similar in technological characteristics in that they offer a channel for either viewing body cavities, tissues, organs or canals and an optional channel for passing instruments into the desired anatomical sites.
Testing was performed to:
- determine the capability of the units to transmit image after deflection of the . sheath portion of the device through a specific set of distances, and
- demonstrate that the polyimide sheath is equivalent to the stainless steel sheath . in the framework of the rigid scope.
Samples of each type of hysteroscope containing the lens, image fiber, and illumination fiber were used for this testing. A baseline optical test was performed prior to the deflection test. The deflection test was performed by holding the shaft of one sample in one of the jaws of an Instron Tensile Tester and applying weight at the other end of the shaft until a desired deflection was obtained or until the tube is damaged at the plane it is held at in the fixture. All samples were tested ensuring the distance from the point of hold to the point of application of weight is constant. The hysteroscope assemblies were then retested for the desired image conduction properties.
The acceptance criteria for this testing were all optical tests performed before and after the deflection test of the sample must pass the optical acceptance criteria.
The field of view, angle of view, resolution on axis and uniformity of illumination were evaluated for acceptance criteria. The results of this testing showed that both the stainless steel and the polyimide sheathed sample scopes showed no change in any tested optical performance criteria. These results demonstrate that both samples maintained structural integrity of the optics assembly when subjected to the test protocol.
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1981828 VY04
Testing was also performed to determine thermal safety of the Galileo Disposable Hysteroscopes according to IEC 601-2-18. The Disposable Hysteroscopes passed the Thermal Safety Testing. Electrical safety testing will also be performed on the Disposable Hysteroscopes prior to commercial distribution.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
7 1998 JUL
Galileo Corporation c/o Ms. Mary McNamara-Cullinane, RAC Staff Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760
Re: K981828 Galileo Corporation Disposable Hysteroscopes Dated: May 20, 1998 Received: May 22, 1998 Regulatory Class: II 21 CFR 884.1690/Procode: 85 HIH
Dear Ms. McNamara-Cullinane:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions of 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number. (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmadsmam.html".
Sincerely yours
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K98| 828
Device Name: Galileo Disposable Hysteroscopes
Indications For Use:
The Galileo Disposable Hysteroscopes are endoscopes intended for visualization of the cervical canal and uterine cavity for diagnostic and surgical procedures during gynecological procedures. The Hysteroscope diagnostic indications include abnormal uterine bleeding, infertility and pregnancy wastage, evaluation of abnormal hysterosalpingogram, intrauterine foreign body, amenorrhea and pelvic pain. The Hysteroscope is indicated for surgical procedures such as directed biopsy, removal of submucous fibroids and large polyps, F seconders myomectomy, transection of intrauterine adhesions and septa and endometrial ablation.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Peter R. Sattling/
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 9818 510(k) Number _
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
CONFIDENTIAL
§ 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.