(75 days)
Not Found
No
The summary describes a mechanical device (sheath) for hysteroscopy and does not mention any software, image processing, or AI/ML terms.
No
The device is a sheath providing access for other instruments, making it an accessory rather than a therapeutic device itself.
Yes
The "Intended Use / Indications for Use" states that the device is used "during diagnostic and operative hysteroscopic procedures." This indicates it facilitates diagnostic activities.
No
The device description explicitly states it is made from both metal and plastic components and is a physical sheath for a hysteroscope, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide access to the uterine cavity for hysteroscopic procedures. This is a surgical/procedural device used within the body, not a device used to examine samples outside the body (in vitro).
- Device Description: The description details a physical sheath with ports and a channel for instruments, consistent with a surgical access device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are typically used to examine specimens such as blood, urine, tissue, etc., to diagnose diseases or conditions. This device is used to facilitate a visual examination and potential intervention within the uterine cavity.
N/A
Intended Use / Indications for Use
The MicroSpan 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.
Product codes
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Device Description
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
Not Found
Anatomical Site
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 and intended use. Leak and flow testing performed showed adequate performance for the intended use.
Key Metrics
Not Found
Predicate Device(s)
Imagyn Hysteroscope Sheaths, Olympus Hysteroscope 4/5 mm System, Circon ACMI Office Operative Hysteroscope Sheath, Karl Storz Mini-Hysteroscopy Operating Sheath
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
| Image: Imagyn logo | ||
|---|---|---|
| 510(k) Summary | ||
| Submitted By: | Imagyn Medical, Inc. | |
| 27651 La Paz Road | ||
| Laguna Niguel, CA 92656-3917 | ||
| (714) 362-2500 | ||
| Contact: Debra A. Rinderer | K961506 |
JUL - 3 1996 |
| Summary Preparation: | February 29, 1996 | |
| Device: | MicroSpan Hysteroscope Sheath | |
| Predicate Devices: | Imagyn Hysteroscope Sheaths
Olympus Hysteroscope 4/5 mm System
Circon ACMI Office Operative Hysteroscope Sheath
Karl Storz Mini-Hysteroscopy Operating Sheath | |
| Device Description: | 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 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: | The device has equivalent technological characteristics to the
predicate devices, as well as to numerous other legally marketed
devices, 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 and intended use. Leak and
flow testing performed showed adequate performance for the
intended use. | |
Imagyn Medical, Inc.
27651 La Paz Road
Laguna Niguel, CA 92677
Tel: (714) 362-2500 Fax:(714) 362-2520