(63 days)
Not Found
No
The device description and summary of performance studies do not mention any AI or ML components or capabilities. The device is a simple mechanical catheter.
No.
The device facilitates the delivery of washed sperm for intrauterine insemination, which is a procedure rather than direct therapy for a medical condition. It is an instrument used in a therapeutic process.
No
Explanation: The device is described as a catheter for delivering washed sperm into the uterus for intrauterine insemination, which is a therapeutic or interventional procedure, not a diagnostic one. There is no mention of it being used to detect or identify a condition.
No
The device description clearly describes a physical catheter with lumens, a balloon, and a syringe, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Delivery of washed sperm into the uterus." This is a procedure performed on the patient's body, not a test performed on a sample taken from the body to diagnose or monitor a condition.
- Device Description: The device is a catheter designed for physical delivery of material into the uterus. It does not involve analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of detecting markers, measuring substances, or providing diagnostic information based on sample analysis.
Therefore, this device falls under the category of a medical device used for a therapeutic or procedural purpose, not an in vitro diagnostic purpose.
N/A
Intended Use / Indications for Use
Delivery of washed sperm into the uterus.
Product codes (comma separated list FDA assigned to the subject device)
MQF
Device Description
The IUI Catheter is a balloon catheter for intrauterine insemination. The catheter is placed in the uterus and sperm is intracted through the catheter in less than several minutes. The IUI Catheter is a packaged , sterile, disposable, flexible, plastic catheter with two lumens, one for inflation of the balloon and one for injection of washed sperm. A balloon inflation syringe is provided with the product.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
uterus
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical/Clinical Testing: Biocompatibility, Endotoxins, HSSA testing, sterilization validation, shelf-life, and performance testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 884.6110 Assisted reproduction catheters.
(a)
Identification. Assisted reproduction catheters are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to introduce or remove gametes, zygote(s), preembryo(s), and/or embryo(s) into or from the body. This generic type of device may include catheters, cannulae, introducers, dilators, sheaths, stylets, and component parts.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).
0
Pg. 1 of 2
510(k) Summary: K120154
MAR 2 1 2012
| Applicant/Sponsor: | Catheter Research, Inc.
5610 W. 82nd St.
Indianapolis, IN 46278 |
|----------------------|-----------------------------------------------------------------------|
| Contact Person: | John Steen
317-872-0074 x3517 |
| Date: | 12/22/2011 |
| Proprietary Name: | IUI Catheter |
| Classification Name: | Assisted Reproduction Catheters; CFR 884.6110.
Product Code: MQF |
Legally Marketed Devices to Which Substantial Equivalence Is Claimed:
Fertiligent Slow Release IUI Catheter K092579
Device Description: The IUI Catheter is a balloon catheter for intrauterine insemination. The catheter is placed in the uterus and sperm is intracted through the catheter in less than several minutes. The IUI Catheter is a packaged , sterile, disposable, flexible, plastic catheter with two lumens, one for inflation of the balloon and one for injection of washed sperm. A balloon inflation syringe is provided with the product.
Intended Use: Delivery of washed sperm into the uterus
The predicate device is intended for the delivery of approximately 1ml of sperm into the uterus over 3 – 4 hours using a controlled release pump,
Summary of Technologies: The IUI Catheter has the identical technologies as the predicate device, IUI catheter component. The IUI Catheter is identioal in materials and function to the predicate. Both devices are assembled in the same environment using the same manufacturing and sterilization process.
Non-clinical/Clinical Testing: Biocompatibility, Endotoxins, HSSA testing, sterilization validation, shelf-life, and performance testing.
1
KI 20154
Pg. 2 of 2
| Equivalence Summary | |||
|---|---|---|---|
| Item | Predicate | Proposed | Comments/Discussion |
| Component | Mechanical Actuator | Not included | Not part of proposed device; required for |
| Slow Release product, not required for | |||
| bolus injection IUI. | |||
| Component | Insemination Syringe | Not included | Not part of proposed device. Required for |
| Slow Release product due to syringe fit in | |||
| pump; not required for bolus injection IUI | |||
| as a sperm-compatible syringe is chosen | |||
| by the andrology lab. | |||
| Component | Leg Strap | Not included | Not part of proposed device; required for |
| Slow Release product, not required for | |||
| bolus injection IUI. | |||
| Component | IUI Catheter | IUI Catheter | Identical: No design, manufacturing, |
| material, sterilization, or packaging | |||
| differences. | |||
| Indication | |||
| for Use | Delivery of approximately | ||
| 1 ml of sperm into the | |||
| uterus over 3-4 hours | |||
| using a controlled release | |||
| pump. | Delivery of washed | ||
| sperm into the uterus. | Proposed device is for standard IUI use, | ||
| where injection is over a shorter period of | |||
| time. Comparable use for both products. | |||
| Use | 3-4 hour insemination |