(88 days)
Not Found
No
The description focuses on the optical and mechanical aspects of the device. There is no mention of AI, ML, image processing, or any software-based analysis of the images. The performance studies are related to the physical integrity and optical properties of the endoscope.
No
The device is described as an endoscope intended for direct visualization for diagnostic procedures, not for therapeutic intervention.
Yes
The first paragraph under "Intended Use / Indications for Use" explicitly states that the endoscopes are "intended for direct visualization of the cervical canal and uterine cavity for diagnostic procedures during gynecological procedures." It also lists specific diagnostic conditions like "abnormal uterine bleeding, infertility and pregnancy wastage," confirming its diagnostic purpose.
No
The device description clearly outlines a physical endoscope with fiber optics, lenses, and a light source, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This testing is performed outside of the body (in vitro).
- Device Function: The Galileo Hysteroscopes are used for direct visualization of the cervical canal and uterine cavity inside the body. They are endoscopes, which are used for internal examination.
- Intended Use: The intended use clearly states "direct visualization" and "diagnostic procedures during gynecological procedures." This involves looking directly at the anatomy, not analyzing samples taken from the body.
The information provided describes a medical device used for internal examination and diagnosis through visualization, which falls under the category of an endoscope, not an IVD.
N/A
Intended Use / Indications for Use
The Galileo Disposable Hysteroscopes are endoscopes intended for direct visualization of the cervical canal and uterine cavity for diagnostic procedures during gynecological procedures. The Hysteroscope diagnostic include abnormal uterine bleeding, infertility and pregnancy wastage, evaluation of abnormal hysterosalpingogram, intrauterine foreign body, amenorrhea and pelvic pain.
Product codes (comma separated list FDA assigned to the subject device)
85 HIH
Device Description
The Galileo Disposable Hysteroscopes are a line of disposable endoscopes based on existing endoscope technology. The Galileo Disposable Hysteroscopes will be available in 2.8 mm OD X 270 mm length size.
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.
Mentions image processing
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K962116, K925968, K880314, K770378
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
P1073
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
Enrique Bernal G. Director of Corporate Product Development
Date of Summary Preparation
November 7, 1997
Device Name 2.
Proprietary Name: Common/Usual Name: Classification Name:
Galileo Disposable Hysteroscopes Hysteroscopes 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 Hysteroscopes (K962116), U.S. Surgical Surgiview Endoscopes, (K925968) and the Richard Wolf Hysteroscopes and Laparoscopes (K880314 and K770378).
4. Device Description
The Galileo Disposable Hysteroscopes are a line of disposable endoscopes based on existing endoscope technology. The Galileo Disposable Hysteroscopes will be available in 2.8 mm OD X 270 mm length size.
1
K 974297
P2073
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.
ડ. Intended Use
The Galileo Disposable Hysteroscopes are endoscopes intended for direct visualization of cervical canal and uterine cavity for diagnostic 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.
6: Comparison of Technological Characteristics
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.
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.
2
K974297 130 }
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.
3
Image /page/3/Picture/0 description: The image shows a black and white logo of the Department of Health. The logo features a stylized bird-like symbol with three curved lines representing the wings or body. The text "DEPARTMENT OF HE" is vertically oriented and curved along the left side of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 3 1998
Galileo Corporation c/o Ms. Mary McNamara-Cullinane, RAC Staff Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760
Re: K974297 Galileo Disposable Hysteroscopes Dated: November 14, 1997 Received: November 17, 1997 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 Devices that have been rechassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 III (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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 531 through 542 of the Act for devices under 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 questions 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/dsmamain.html".
Sincerely yours,
H.M.Liau Yi
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
4
510(k) Number (if known): _
Device Name: Galileo Disposable Hysteroscopes
Indications For Use:
The Galileo Hysteroscopes are endoscopes intended for direct visualization of the cervical canal and uterine cavity for diagnostic procedures during gynecological procedures. The Hysteroscope diagnostic include abnormal uterine bleeding, infertility and pregnancy wastage, evaluation of abnormal hysterosalpingogram, intrauterine foreign body, amenorrhea and pelvic pain.
I
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert R. Ratliff
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 197429 510(k) Number
Prescription Use
(Per 21 CFR 801.109) ✓
OR
Over-The-Counter Use _
(Optional Format 1-2-96)