(63 days)
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No
The summary describes a mechanical catheter system for fluid delivery and aspiration, with no mention of AI/ML terms, image processing, or data-driven performance metrics.
No
The device is used for intrauterine insemination, aspiration, and instillation of fluids, which are procedural uses rather than direct therapeutic actions to treat a disease or condition.
No
The device is primarily used for intrauterine insemination and for instillation and/or aspiration of media in laparoscopic procedures, which are interventional or therapeutic actions, not diagnostic ones. While it can be used for "cytologic screening and bacteriologic cultures," this is an ancillary function of a device designed for delivery and aspiration, not its primary diagnostic purpose.
No
The device description clearly states it is a sterile device consisting of two physical components: the MicroSpan Access Catheter and the MicroSpan Delivery Catheter. These are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes procedures performed within the body (intrauterine insemination, laparoscopic instillation/aspiration). IVDs are used to examine specimens from the body (like blood, urine, tissue) in vitro (outside the body) to provide information about a person's health.
- Device Description: The device is a catheter system designed for insertion into the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with IVD devices.
The device is a medical device used for therapeutic and diagnostic procedures performed in vivo.
N/A
Intended Use / 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.
Product codes
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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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
0
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510(k) Summary
| 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. |