(24 days)
Not Found
No
The device description and the lack of mentions of AI/ML, image processing, training/test sets, and performance metrics typically associated with AI/ML devices strongly suggest the absence of such technology. The basis for substantial equivalence is solely on design and performance characteristics, not AI/ML performance.
No.
The device is used for artificial insemination, which is a procedure to introduce sperm, not to treat a disease or condition. While it may help with conception, it does not fit the definition of a therapeutic device which implies treating or curing a medical issue.
No
Explanation: The device description and intended use clearly state its purpose is for intrauterine artificial insemination procedures, which is a therapeutic or procedural function, not a diagnostic one. It facilitates the introduction of semen, rather than detecting, identifying, or monitoring a disease or condition.
No
The device description clearly describes a physical catheter with a balloon and luer connector, indicating it is a hardware 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 for "intrauterine artificial insemination procedures using washed spermatozoa or semen." This describes a procedure performed on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a catheter designed for insertion into the uterus to deliver fluid. This is a medical device used for a therapeutic or procedural purpose, not for analyzing a biological sample.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (like reagents, detection methods, or measurement of analytes).
IVD devices are specifically designed to examine specimens derived from the human body (such as blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. 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 balloon to help position the catheter at the uterus. Balloon is filled with saline: insemination fluid is introduced using a syringe attached to the proximal luer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intrauterine
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 Insemination 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.
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
AUG 2 1 1998
MedWorks Corp. 510(k) Premarket Notification
July 24, 1998 Insemination Catheter
| 510(k) Summary K982628 | |
|---|---|
| P171 | |
| Trade Name: | MedWorks 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. | |
| Mini-Embryon Intra Uterine Insemination Catheter (K972823) | |
| A&A Medical, Inc. | |
| Standard Intrauterine Insemination Catheter (K884696) | |
| CCD International | |
| Jansen-Anderson Insemination Set (K914150) | |
| Cook Ob/Gyn | |
Product Description:
Malleable catheter with distal side ports and balloon to help position the catheter at the uterus. Balloon is filled with saline: insemination fluid is introduced using a syringe attached to the proximal luer.
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 Insemination Catheter are equivalent to those of the predicate devices.
Conclusion:
Based on the indications for use, technological characteristics, and comparison to currently marketed devices, the MedWorks Insemination Catheter has been shown to be safe and effective for its intended use.
1
Image /page/1/Picture/0 description: The image shows a seal with the words "DEPARTMENT OF HEALTH & HUM" around the left side of the seal. The right side of the seal has a symbol that looks like three curved lines stacked on top of each other. The seal appears to be from the Department of Health and Human Services.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medworks Corporation c/o Ms. Pamela Papineau Delnhi Medical Device Consulting 50 Brewster Street Pawtucket, RI 02860
Re: K982628
Embryon® Intrauterine Insemination Devices and Stylet Dated: July 24, 1998 Received: July 28, 1998 Unclassified/Procode: 85 MFD
Dear Ms. Papineau:
AUG 2 1 1998
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 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 (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 (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 (OS) 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 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/cdrl/dsmaldsmamain.html".
Sincerely yours
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page
510(k) Number (if known):
Device Name: _MedWorks 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)
Dober R. Silling
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K982628
Prescription Use X OR (Per 21 CFR 801.109)
Over-the -Counter Use