(78 days)
Not Found
No
The device description and performance studies focus on the optical and mechanical characteristics of a traditional rigid laparoscope. There is no mention of image processing, AI, ML, or any related concepts.
No
The device is a visual tool (laparoscope) used for viewing and diagnosis, not for treating a disease or condition.
Yes
The device is described as being used for "performing diagnostic and surgical procedures," indicating its involvement in the diagnostic process.
No
The device description clearly outlines physical components like a stainless steel shaft, illumination fibers, imaging fiber bundle, distal lens, eyepiece, and light post, 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 "permit viewing of the abdominal cavity for the purpose of performing diagnostic and surgical procedures." This describes a device used for direct visualization within the body, not for testing samples of biological material outside the body.
- Device Description: The description details a rigid, fiberoptic laparoscope used for imaging the abdominal cavity. This aligns with a surgical or diagnostic imaging tool used in vivo.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process that would involve testing in vitro.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. This device is used for direct observation and potentially surgical intervention within the body.
N/A
Intended Use / Indications for Use
The MicroLap ™ and MicroLap Gold Laparoscopes are used to permit viewing of the abdominal cavity for the purpose of performing diagnostic and surgical procedures.
Product codes
Not Found
Device Description
The MicroLap ™ and MicroLap Gold Laparoscopes are small diameter, rigid, fiberoptic laparoscopes without through lumens. The devices consist 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 laparoscopes 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal 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 thermal characteristics and biocompatibility.
Key Metrics
Not Found
Predicate Device(s)
Imagyn MicroLap Laparoscope, Medical Dynamics Optical Catheter, Optimed Technologies Model F18-200 Laparoscope, Origin Medsystems, Inc. Small Diameter Endoscope, Galileo Endoscope
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. 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
Iriágyn
510(k) Summary
MAR – 6 1997
| Submitter: | Imagyn Medical, Inc.
27651 La Paz Road
Laguna Niguel, CA 92656-3917
(714) 362-2500
Contact: Debra A. Rinderer |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary Preparation: | December 17, 1996 |
| Device: | MicroLap ™ and MicroLap Gold Laparoscopes |
| Predicate Devices: | Imagyn MicroLap Laparoscope
Medical Dynamics Optical Catheter
Optimed Technologies Model F18-200 Laparoscope
Origin Medsystems, Inc. Small Diameter Endoscope
Galileo Endoscope |
| Device Description: | The MicroLap ™ and MicroLap Gold Laparoscopes are small diameter,
rigid, fiberoptic laparoscopes without through lumens. The devices consist
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 laparoscopes 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. |
| Intended Use of Device: | The MicroLap ™ and MicroLap Gold Laparoscopes are used to permit
viewing of the abdominal cavity for the purpose of performing diagnostic
and surgical procedures. |
| Technological Comparisons: | Light from a high intensity light source (e.g. xenon) is transmitted through
illumination fibers to the distal end of the laparoscope 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 laparoscope for viewing and/or directly to
standard video cameras, monitors and recording equipment. The
MicroLap ™ and MicroLap Gold Laparoscopes and the predicate devices all
have equivalent technological characteristics. |
| 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 thermal
characteristics and biocompatibility. |
Imagyn Medical, Inc. 27651 La Paz Road Laguna Niguel, CA 92677 Tel: (714) 362-2500 Fax: (714) 362-2520