← Product Code [MFD](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/MFD) · K970750 # MICROSPAN INSEMINATION SYSTEM (K970750) _Imagyn Medical, Inc. · MFD · May 5, 1997 · Obstetrics/Gynecology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/MFD/K970750 ## Device Facts - **Applicant:** Imagyn Medical, Inc. - **Product Code:** [MFD](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/MFD.md) - **Decision Date:** May 5, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 884.5250 - **Device Class:** Class 2 - **Review Panel:** Obstetrics/Gynecology - **Attributes:** Therapeutic ## Indications for Use 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. ## Device Story MicroSpan Insemination System comprises two sterile components: MicroSpan Access Catheter (introducer) and MicroSpan Delivery Catheter. System functions via introduction through MicroSpan Hysteroscope Sheath for intrauterine insemination or through laparoscope operative channel for fluid management. Clinician-operated; used for delivery of washed spermatozoa to uterine cavity or laparoscopic aspiration/irrigation of fluids (ascitic, cul-de-sac, ovarian, blood) and irrigation of operative fields. Facilitates reproductive procedures and diagnostic fluid collection; improves procedural access during laparoscopic interventions. ## Clinical Evidence Bench testing only. Non-clinical tests performed to demonstrate device performance according to description and intended uses; results confirmed adequate performance. ## Technological Characteristics Sterile, two-component catheter system (Access Catheter and Delivery Catheter). Designed for coaxial use. Mechanical fluid delivery and aspiration device. No electronic, software, or energy-based components. ## Regulatory 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. ## Predicate Devices - Imagyn Intrauterine Insemination Device - Cook OB/GYN Coaxial Catheter Set - Cook OB/GYN Shepard Intrauterine Insemination Catheter - Cook OB/GYN Jansen-Anderson Insemination Set - Cook OB/GYN Spirtos Coaxial Catheter Set ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} MAY - 5 1997 # 510(k) Summary K970750 | Submitter: | Imagyn Medical, Inc. 27651 La Paz Road Laguna Niguel, CA 92677-3917 (714) 362-2500 Contact: Debra A. Rinderer | | --- | --- | | Summary Preparation: | April 18, 1997 | | Device: | MicroSpan Insemination System | | Predicate Device(s): | Imagyn Intrauterine Insemination Device Cook OB/GYN Coaxial Catheter Set Cook OB/GYN Shepard Intrauterine Insemination Catheter Cook OB/GYN Jansen-Anderson Insemination Set Cook OB/GYN Spirtos Coaxial Catheter Set | | Device Description: | 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. | | Intended Use of Device: | 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. | | Technological Comparisons: | The MicroSpan Insemination System has equivalent technological characteristics to the predicates to achieve intrauterine insemination or laparoscopic instillation and/or aspiration of media. | | Performance Summary: | Non-clinical tests were performed to demonstrate that the device performed according to its description and intended uses. All tests showed adequate performance of the device for its intended uses. | --- **Source:** [https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/MFD/K970750](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/MFD/K970750) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com