(44 days)
Not Found
Not Found
No
The summary describes a physical catheter for artificial insemination and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No
A therapeutic device is one that treats a disease or condition. This device is used for artificial insemination, which is a reproductive assistance procedure, not a treatment for a disease.
No
Explanation: The device is intended for the introduction of spermatozoa into the uterine cavity, which is a therapeutic or interventional purpose, not a diagnostic one.
No
The device description explicitly states it is a "catheter," which is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "insertion of catheters and introduction of washed spermatozoa into the uterine cavity." This describes a procedure performed on the patient's body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description reinforces the intended use as a device for a procedure within the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a tool for a medical procedure.
N/A
Intended Use / Indications for Use
The Family of Wallace Artificial Insemination Catheter are sterile single-use device intended for insertion of catheters and introduction of washed spermatozoa into the uterine cavity.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
uterine cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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)
Not Found
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.
Not Found
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
§ 884.5250 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
SIO(K)
JAN 1 6 1997 SUMMARY OF SAFETY AND EFFECTIVENESS WALLACE ARTIFICIAL INSEMINATION CATHETERS
The Summary of Safety and Effectiveness on Artificial Insemination Catheters reflects data available and resented at the time the submission was prepared, but caution should be exercised in interpreting the data. The results of future studies may require alterations of the conclusions or recommendations set forth.
Intended Use
The Family of Wallace Artificial Insemination Catheter are sterile single-use device intended for insertion of catheters and introduction of washed spermatozoa into the uterine cavity.
Indications
The ability of the Family of Wallace Artificial Insemination Catheter to meet its intended function includes the finely smoothed tip and constant internal lumen to prevent embryo damage and ensure atraumatic technique.
Contraindications
The Wallace Artificial Insemination Catheters are not intended for intrafallopian tube procedures.
Caution
Federal law (U.S.A.) restricts this device to sale by or on the order of a physician.
Substantial Equivalency Information
The Wallace Artificial Insemination Catheter are similar to the Edwards-Wallace Catheters currently offered by Marlow Surgical Technologies, Inc.
| | Edwards-Wallace
Catheters | AIC Catheters |
|---------------|---------------------------------------------------------|---------------------------------------------------------|
| Materials | Polypropylene
Fluorethylenepropylene
Polyurethane | Polypropylene
Fluorethylenepropylene
Polyurethane |
| Sterilization | EO
SAL 10-6 | EO
SAL 10-6 |
The intended use and technological characteristics of these devices do not vary significantly. The safety and effectiveness of the Wallace Artificial Insemination Catheter are comparable to that of the other catheters.