(173 days)
Not Found
Not Found
No
The summary describes a simple insemination catheter and contains no mention of AI, ML, image processing, or performance studies typically associated with AI/ML devices.
Yes
The device is used for transferring spermatozoa into the uterine cavity, which is a medical procedure to achieve pregnancy, hence it is a therapeutic device.
No
Explanation: The device, an "Insemination Catheter," is described as being used for "transferring spermatozoa into the uterine cavity," which is a therapeutic or interventional function, not a diagnostic one. There is no mention of it identifying, detecting, or monitoring a disease or condition.
No
The device is described as an "Insemination Catheter," which is a physical medical device used for transferring spermatozoa. The summary does not mention any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "transferring spermatozoa into the uterine cavity." This is a direct intervention on the patient's body, not a test performed on a sample taken from the body to diagnose or monitor a condition.
- Device Description: While the description is "Not Found," the intended use clearly indicates a physical device used for a procedure.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
Insemination catheters are considered medical devices used for a therapeutic or procedural purpose, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Insemination Catheters are used for transferring spermatozoa into the uterine cavity.
Product codes
85 MOF
Device Description
Morton IUI Catheter
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
Prescription Use
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an abstract symbol. The symbol resembles a stylized caduceus, featuring three wavy lines emanating from a central point, representing health and well-being. The text is arranged around the perimeter of the circle, with "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" clearly visible.
NOV 2 2 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Constance W. Sturgeon President Fertility Technology Resources, Inc. 4343 Shallowford Road Suite D-4 MARIETTA GA 30062
Re: K041470
Trade/Device Name: Morton IUI Catheter Regulation Number: 21 CFR 884.6110 Regulation Name: Assisted reproduction catheters
Regulatory Class: II Product Code: 85 MOF Dated: September 23, 2004 Received: September 24, 2004
Dear Ms. Sturgeon:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 (Act), that do not require approval of a premarket approval application (PMA). 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
1
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/dsma/dsmamain.html
Sincerely yours,
Nancy C. brogdon
Nancy C. Brogdon Director. Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Attachment A
Indications for Use
| 510(k): Number | K041470 |
|---|---|
| Device Name: | Morton IUI Catheters |
| Intended Use: | Insemination Catheters are used for transferring spermatozoa into |
| the uterine cavity. |
Prescription Use __ X (Per CFR 801.109) AND/OR
Over-the-counter use (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Brogdon
(Division Sign-Off Division of Reproductive, Abdominal, and Radiological Devices 041470 510(k) Number __