(63 days)
Used for intrauterine insemination. The MicroSpan Delivery Catheter is designed to fit through the larger diameter MicroSpan Access Catheter for delivery of washed spermatozoa to the uterine cavity or for laparoscopic instillation and/or aspiration of media. Laparoscopically, the device is specifically intended for use to aspirate ascitic fluids, aspirate fluid from the cul-de-sac for cytologic screening and bacteriologic cultures, irrigation and aspiration of larger volumes of fluid from ovarian tumors, irrigation and rinsing of the operative field, aspiration of bloody fluid resulting from a tubal pregnancy or post operative bleeding, and instillation of sterile saline or Ringer's solution.
The MicroSpan Insemination System is a sterile device consisting of two components: the MicroSpan Access Catheter (introducer) and the MicroSpan Delivery Catheter. The MicroSpan Insemination System is designed to be introduced through the MicroSpan Hysteroscope Sheath for intrauterine insemination procedures or introduced through the operative channel of a laparoscope for laparoscopic instillation and/or aspiration of media.
The provided text is a 510(k) summary for the MicroSpan Insemination System. It describes the device, its intended use, and states that non-clinical tests were performed to demonstrate adequate performance. However, it does not contain any information about acceptance criteria, a study proving device performance against those criteria, or any of the detailed aspects requested in the prompt.
Therefore, I cannot provide the requested information based on the input text.
The input document is a regulatory submission summary document, which typically focuses on describing the device and its intended use, and asserting that testing was performed, rather than providing the detailed results and methodologies of those tests. To answer your questions, one would need to refer to the actual test reports, study protocols, and results that would have been part of the full 510(k) submission.
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510(k) Summary
| Submitter: | Imagyn Medical, Inc.27651 La Paz RoadLaguna Niguel, CA 92677-3917(714) 362-2500Contact: Debra A. Rinderer |
|---|---|
| Summary Preparation: | April 18, 1997 |
| Device: | MicroSpan Insemination System |
| Predicate Device(s): | Imagyn Intrauterine Insemination DeviceCook OB/GYN Coaxial Catheter SetCook OB/GYN Shepard Intrauterine Insemination CatheterCook OB/GYN Jansen-Anderson Insemination SetCook OB/GYN Spirtos Coaxial Catheter Set |
| Device Description: | The MicroSpan Insemination System is a sterile device consisting oftwo components: the MicroSpan Access Catheter (introducer) andthe MicroSpan Delivery Catheter. The MicroSpan InseminationSystem is designed to be introduced through the MicroSpanHysteroscope Sheath for intrauterine insemination procedures orintroduced through the operative channel of a laparoscope forlaparoscopic instillation and/or aspiration of media. |
| Intended Use of Device: | Used for intrauterine insemination. The MicroSpan DeliveryCatheter is designed to fit through the larger diameter MicroSpanAccess Catheter for delivery of washed spermatozoa to the uterinecavity or for laparoscopic instillation and/or aspiration of media.Laparoscopically, the device is specifically intended for use toaspirate ascitic fluids, aspirate fluid from the cul-de-sac for cytologicscreening and bacteriologic cultures, irrigation and aspiration oflarger volumes of fluid from ovarian tumors, irrigation and rinsing ofthe operative field, aspiration of bloody fluid resulting from a tubalpregnancy or post operative bleeding, and instillation of sterilesaline or Ringer's solution. |
| Technological Comparisons: | The MicroSpan Insemination System has equivalent technologicalcharacteristics to the predicates to achieve intrauterine inseminationor laparoscopic instillation and/or aspiration of media. |
| Performance Summary: | Non-clinical tests were performed to demonstrate that the deviceperformed according to its description and intended uses. All testsshowed adequate performance of the device for its intended uses. |
§ 884.5250 Cervical cap.
(a)
Identification. A cervical cap is a flexible cuplike receptacle that fits over the cervix to collect menstrual flow or to aid artificial insemination. This generic type of device is not for contraceptive use.(b)
Classification. Class II (performance standards).