(88 days)
Not Found
Not Found
No
The device description and performance studies focus on the optical and mechanical characteristics of a rigid fiberoptic hysteroscope and sheath, with no mention of AI or ML capabilities.
No.
The device is used to permit viewing for diagnostic and surgical procedures, but it does not directly treat a disease or condition.
Yes
The "Intended Use / Indications for Use" states that the device is used for "viewing... for the purpose of performing diagnostic and surgical procedures." This explicitly indicates a diagnostic purpose.
No
The device description clearly outlines physical components made of stainless steel, metal, and plastic, and describes a rigid, fiberoptic hysteroscope with an outer shaft, illumination fibers, imaging fiber bundle, distal lens, eyepiece, and light post. It also mentions a sheath with ports and an instrument channel. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures." This describes a device used for direct visualization and intervention within the body, not for testing samples taken from the body.
- Device Description: The description details a rigid, fiberoptic hysteroscope and a sheath used for access. These are instruments used for internal examination and procedures, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), reagents, or any process related to in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a physiological state, health, or disease. This device is an endoscopic instrument used for direct visualization and surgical access.
N/A
Intended Use / Indications for Use
The MicroSpan Gold Hysteroscope is used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.
The MicroSpan Hysteroscope Sheath is used to provide access to the uterine cavity for the MicroSpan Gold Hysteroscope or other hysteroscopic instruments during diagnostic and operative hysteroscopic procedures.
Product codes
85 HIH
Device Description
The MicroSpan-Gold Hysteroscope is a small diameter, rigid, fiberoptic hysteroscope without through lumens. The device consists of an outer stainless steel shaft, inner illumination fibers, and an imaging fiber bundle. At one end of the imaging bundle is the distal lens and at the other is the rotatable eyepiece. An endoscopic light source is connected to the light post of the hysteroscope through compatible light cables. If desired, the eyepiece can be connected through a focusing optical coupler to a camera head which carries the image by cable to the camera.
The MicroSpan Hysteroscope Sheath is offered with irrigation/insufflation and aspiration ports and an instrument channel. The device is provided sterile for single use, and is made from both metal and plastic components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Light from a high intensity light source (e.g. xenon) is transmitted through illumination fibers to the distal end of the hysteroscope in order to illuminate the target object. The distal lens system focuses the image of the object onto image fibers, which then transmits the image to the proximal lens system. The proximal lens system magnifies and focuses the image onto an eyepiece at the proximal end of the hysteroscope for viewing and/or directly to standard video cameras, monitors and recording equipment.
Anatomical Site
cervical canal and the 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
Non-clinical tests were performed to demonstrate that the device performed according to its description. Testing included evaluation of optical and mechanical characteristics of the device and the effect of simulated reuses on these characteristics. The device was also evaluated for its electrical safety, thermal characteristics, and biocompatibility.
Key Metrics
Not Found
Predicate Device(s)
Imagyn MicroSpan Hysteroscope, Imagyn MicroLap-Gold Laparoscope, Optimed Technologies Rigid Fiber Optic Hysteroscope
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
K972426
p192
Imágyn
ﺔ ﻣﻤﻤﻠ
SEP 2 3 1997
510(k) Summary
| Submitter: | Imagyn Medical, Inc.
27651 La Paz Road
Laguna Niguel, CA 92677-3917
(714) 362-2500
Contact: Debra A. Rinderer |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary Preparation: | June 25, 1997 |
| Device: | MicroSpan Gold Hysteroscope and MicroSpan Hysteroscope Sheath |
| Predicate Devices: | Imagyn MicroSpan Hysteroscope
Imagyn MicroLap-Gold Laparoscope
Optimed Technologies Rigid Fiber Optic Hysteroscope |
| Device Description: | The MicroSpan-Gold Hysteroscope is a small diameter, rigid, fiberoptic
hysteroscope without through lumens. The device consists of an outer
stainless steel shaft, inner illumination fibers, and an imaging fiber bundle.
At one end of the imaging bundle is the distal lens and at the other is the
rotatable eyepiece. An endoscopic light source is connected to the light post
of the hysteroscope through compatible light cables. If desired, the eyepiece
can be connected through a focusing optical coupler to a camera head which
carries the image by cable to the camera.
The MicroSpan Hysteroscope Sheath is offered with irrigation/insufflation and aspiration ports and an instrument channel. The device is provided
sterile for single use, and is made from both metal and plastic components. |
| Intended Use of Device: | The MicroSpan Gold Hysteroscope is used to permit viewing of the cervical
canal and the uterine cavity for the purpose of performing diagnostic and
surgical procedures.
The MicrSpan Hysteroscope Sheath is indicated for use in providing access
to the uterine cavity for the Imagyn Hysteroscope or other hysteroscopic
instruments during diagnostic and operative hysteroscopic procedures. |
| Technological Comparisons: | Light from a high intensity light source (e.g. xenon) is transmitted through
illumination fibers to the distal end of the hysteroscope in order to illuminate
the target object. The distal lens system focuses the image of the object onto
image fibers, which then transmits the image to the proximal lens system.
The proximal lens system magnifies and focuses the image onto an eyepiece
at the proximal end of the hysteroscope for viewing and/or directly to
standard video cameras, monitors and recording equipment. The MicroSpan
Gold Hysteroscope and the predicate devices all have equivalent
technological characteristics. |
Imagyn Medical, Inc. 27651 La Paz Road Laguna Niguel, CA 92677 Tel: (714) 362-2500 Fax: (714) 362-2520
1
510(k) Summary MicroSpan Gold Hysteroscope and MicroSpan Hysteroscope Sheath Page 2 of 2
:
K 972426
p292
| Technological Comparisons
(continued) | The MicroSpan Hysteroscope Sheath is identical in all respects except
maximum outer diameter to the previously cleared MicroSpan Hysteroscope
Sheath. The device is designed to achieve hysteroscope and/or hysteroscopic
instrument insertion without loss of uterine distention. |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Summary | Non-clinical tests were performed to demonstrate that the device performed
according to its description. Testing included evaluation of optical and
mechanical characteristics of the device and the effect of simulated reuses on
these characteristics. The device was also evaluated for its electrical safety,
thermal characteristics, and biocompatibility. |
2
Image /page/2/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle or bird-like figure, depicted with flowing lines to suggest movement or flight. The overall design is simple and monochromatic, using black lines on a white background.
SEP 2 3 1997
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Debra A. Rinderer Regulatory Affairs Specialist Imagyn Medical, Inc. 27651 La Paz Road Laguna Niguel, California 92677 Re: K972426
MicroSpan Gold Hysteroscope and MicroSpan Hysteroscope Sheath Dated: June 26, 1997 Received: June 27, 1997 Regulatory class: II 21 CFR §884.1690/Product code: 85 HIH
Dear Ms. Rinderer:
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, 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 (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 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.
William Yu
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
3
INDICATIONS FOR USE
510(k) Number (if known): K972426
Device Name: MicroSpan Gold Hysteroscope and MicroSpan Hysteroscope Sheath
Indications for Use:
The MicroSpan Gold Hysteroscope is used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.
The MicroSpan Hysteroscope Sheath is used to provide access to the uterine cavity for the MicroSpan Gold Hysteroscope or other hysteroscopic instruments during diagnostic and operative hysteroscopic procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert D. Natting/
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number_16972426
Prescription Use
OR
Over-The-Counter Use