(170 days)
Not Found
No
The device description and performance study summary do not mention any AI or ML capabilities. The substantial equivalence is based on design and performance characteristics, not data-driven algorithms.
No.
The device is used for artificial insemination, which is a procedure for conception, and not for treating a disease or condition. While it aids in a medical process, it does not directly treat or cure a disease, which is the primary characteristic of a therapeutic device.
No
This device is described as an insemination catheter used for artificial insemination procedures. While it allows for visualization to "confirm placement of insemination fluid," its primary function is therapeutic (insemination) rather than diagnostic (identifying a condition or disease). The visualization component serves to aid the therapeutic procedure, not to diagnose a uterine condition.
No
The device description clearly describes a physical catheter with a lumen and side ports, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "intrauterine artificial insemination procedures using washed spermatozoa or semen." This is 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 details a catheter used to deliver material into the uterus and potentially visualize the uterine interior. This is a medical device used for a therapeutic/procedural purpose, not for analyzing a biological sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is related to the physical process of insemination and visualization.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
"For use in intrauterine artificial insemination procedures using washed spermatozoa or semen."
Product codes (comma separated list FDA assigned to the subject device)
85 MFD
Device Description
"Malleable catheter with distal side ports and a lumen which can accommodate a fiberoptic device to allow visualization of the interior of the uterus. Allows physician to confirm placement of insemination fluid in the uterine cavity."
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Interior of the uterus, uterine cavity
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)
"Substantial equivalence for this device was based solely on design and performance characteristics; no performance or safety data was included in this premarket notification. The materials, performance specifications and essential design characteristics of the MedWorks Visualization Catheter are equivalent to those of the predicate devices."
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.
Roseff's Double Lumen Standard Intrauterine Insemination Catheter (K884696), Standard Intrauterine Insemination Catheter (K884696), Mini-Embryon Intra Uterine Insemination Catheter (K972823), Jansen-Anderson Insemination Set (K914150), Centurion Vaginal Speculum (K897100), Galileo Disposable Endoscope (K981928), Imagyn MicroSpan Insemination System (970750), MicroSpan Hysteroscope Sheath (K961506), MicroSpan Hysteroscope (K961688)
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
MedWorks Corp. 510(k) Premarket Notification
510(k) Summary
4782630
| Trade Name: | MedWorks Visualization Insemination Catheter |
|---|---|
| Sponsor: | MedWorks Corp. |
| 2400 Crittenden Drive | |
| Louisville, KY 40217 | |
| Registration #1530618 | |
| Device Generic Name: | Intrauterine Insemination Catheter |
| Classification: | According to Section 513 of the Federal Food, Drug, and |
| Cosmetic Act, the device classification is Class II. | |
| Predicate Devices: | Roseff's Double Lumen Standard Intrauterine Insemination Catheter |
| (K884696) | |
| Fertility Technologies, Inc. | |
| Standard Intrauterine Insemination Catheter (K884696) | |
| CCD International | |
| Mini-Embryon Intra Uterine Insemination Catheter (K972823) | |
| A&A Medical, Inc. | |
| Jansen-Anderson Insemination Set (K914150) | |
| Cook Ob/Gyn | |
| Centurion Vaginal Speculum (K897100) | |
| Tri-State Hospital Supply | |
| Galileo Disposable Endoscope (K981928) | |
| Galileo Electro-Optics Corp. | |
| Imagyn MicroSpan Insemination System (970750), MicroSpan Hysteroscope | |
| Sheath (K961506) and MicroSpan Hysteroscope (K961688) | |
| Imagyn Medical, Inc. |
Product Description:
Malleable catheter with distal side ports and a lumen which can accommodate a fiberoptic device to allow visualization of the interior of the uterus. Allows physician to confirm placement of insemination fluid in the uterine cavity.
Indications for Use:
For use in intrauterine artificial insemination procedures using washed spermatozoa or semen.
Safety and Performance:
Substantial equivalence for this device was based solely on design and performance characteristics; no performance or safety data was included in this premarket notification. The materials, performance specifications and essential design characteristics of the MedWorks Visualization Catheter are equivalent to those of the predicate devices.
1
MedWorks Corp. 510(k) Premarket Notification
Conclusion:
Based on the indications for use, technological characteristics, and comparison to currently marketed devices, the MedWorks Visualization Insemination Catheter has been shown to be safe and effective for its intended use.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 4 1999
Pamela L. Papineau President Delphi Medical Device Consulting for MedWorks Corp. 50 Brewster Street Pawtucket, RI 02860
Re: K982630 MedWorks Insemination Catheter Dated: November 8, 1998 Received: November 12, 1998 Regulatory Class: II 21 CFR 884.5250/Procode: 85 MFD
Dear Ms. Papineau:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
J. J. J.
Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: MedWorks Visualization Insemination Catheter
Indications for Use:
For use in intrauterine artificial insemination procedures using washed spermatozoa or semen.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109) X OR Over-the -Counter Use __
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number. K982630/S