(17 days)
Not Found
No
The summary describes a mechanical device for laparoscopic access and does not mention any software, algorithms, or data processing that would indicate AI/ML.
No
The device is used for providing access, not for therapy.
No
Explanation: The device is an introducer used to provide access for diagnostic and operative instruments, but it does not perform diagnostic functions itself.
No
The device description explicitly states it is made from both metal and plastic components and is a physical introducer device, not software.
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 peritoneal cavity for surgical instruments during laparoscopic procedures. This is a surgical device used in vivo (within the body), not a device used in vitro (outside the body) to examine specimens like blood, urine, or tissue.
- Device Description: The description details a surgical introducer with a valve system for maintaining insufflation during surgery. This aligns with a surgical instrument, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, the Imagyn Expandable Laparoscopic Introducer is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The Imagyn Expandable Laparoscopic Introducer is indicated for use in providing access to the peritoneal cavity for diagnostic and operative instruments during laparoscopic procedures.
Product codes
Not Found
Device Description
The Imagyn Expandable Laparoscopic Introducer is a single use, sterile device made from both metal and plastic components. For second-site use during laparoscopic procedures, the device incorporates a valve system that maintains adequate insufflation pressures while diagnostic or operative instruments are in use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peritoneal 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. These included visual, dimensional, leak, puncture, instrument passage, and mechanical testing and demonstrated adequate performance for the intended use.
Key Metrics
Not Found
Predicate Device(s)
Imagyn MicroLap Introducer, Innerdyne, Inc. Step Trocar Expandable Port
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
K971255 510(k) Summary
| Submitted By: | Imagyn Medical, Inc.
27651 La Paz Road
Laguna Niguel, CA 92677-3917
(714) 362-2500
Contact: Debra A. Rinderer |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary Preparation: | April 2, 1997 |
| Device: | Imagyn Expandable Laparoscopic Introducer |
| Predicate Devices: | Imagyn MicroLap Introducer
Innerdyne, Inc. Step Trocar Expandable Port |
| Device Description: | The Imagyn Expandable Laparoscopic Introducer is a single use,
sterile device made from both metal and plastic components. For
second-site use during laparoscopic procedures, the device
incorporates a valve system that maintains adequate insufflation
pressures while diagnostic or operative instruments are in use. |
| Intended Use of Device: | The Imagyn Expandable Laparoscopic Introducer is indicated for
use in providing access to the peritoneal cavity for diagnostic and
operative instruments during laparoscopic procedures. |
| Technological Comparisons | The device has equivalent technological characteristics to the
predicate devices to achieve laparoscope and/or laparoscopic
instrument insertion without loss of pneumoperitoneum. |
| Performance Summary: | Non-clinical tests were performed to demonstrate that the device
performed according to its description and intended use. These
included visual, dimensional, leak, puncture, instrument passage,
and mechanical testing and demonstrated adequate performance for
the intended use. |