MICROSPAN INSEMINATION SYSTEM

K970750 · Imagyn Medical, Inc. · MFD · May 5, 1997 · Obstetrics/Gynecology

Device Facts

• Record ID: K970750
• Device Name: MICROSPAN INSEMINATION SYSTEM
• Applicant: Imagyn Medical, Inc.
• Product Code: MFD · Obstetrics/Gynecology
• Decision Date: May 5, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5250
• Device Class: Class 2
• 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.

Indications for Use

Indicated for intrauterine insemination, laparoscopic instillation, and aspiration of fluids (ascitic, cul-de-sac, ovarian tumor, post-operative/tubal pregnancy blood) and irrigation of the operative field.

Regulatory Classification

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)

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MAY - 5 1997

# 510(k) Summary K970750

| Submitter: | Imagyn Medical, Inc.
27651 La Paz Road
Laguna Niguel, CA 92677-3917
[phone]
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. |