(228 days)
Not Found
No
The device description details a purely mechanical system for controlled release, with no mention of AI or ML components or functions.
No
The device facilitates the delivery of sperm but does not itself provide a therapeutic effect or treatment of a disease or condition. Its purpose is to aid in the process of insemination.
No
Explanation: The device is described as an IUI Catheter designed for the delivery of sperm into the uterus, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines physical components such as a catheter, syringe, mechanical actuator, and leg strap, indicating it is a hardware device with mechanical function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "Delivery of approximately 1 ml of sperm into the uterus over 3-4 hours using a controlled release pump." This describes a procedure performed on the patient's body (in vivo), not a test performed on a sample taken from the body (in vitro).
- Device Description: The device is a catheter and a mechanical actuator designed to deliver a substance into the uterus. This is a delivery system, not a diagnostic tool that analyzes a sample to provide information about a patient's health status.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.) or providing diagnostic information. The device's function is purely mechanical delivery.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The delivery of sperm into the uterus.
Indications For Use: Delivery of approximately 1 ml of sperm into the uterus over 3-4 hours using a controlled release pump.
Product codes
MQF
Device Description
The IUI Catheter is a balloon catheter for slow release insemination. The catheter is placed in the uterus and sperm is injected through the catheter. The kit includes a standard BD 3 ml syringe and a mechanical actuator, as well as an ancillary component, a leg strap. Sperm is loaded into the syringe which is attached to the IUI catheter. The syringe is placed in a plastic, spring loaded mechanical actuator to press on the syringe plunger and deliver the sperm over a 3-4 hour period.
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
Non-clinical/Clinical Testing: Biocompatibility, endotoxin, HSSA, sterility validation, mechanical function, and shelf life testing were completed to document safety and effectiveness of this device. In addition a small clinical trial was included in the testing results, and which lent support to the safety and effectiveness of the device.
Key Metrics
Not Found
Predicate Device(s)
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
SECTION 5 (Rev 4)
510(k) Summary
| Applicant/Sponsor: | Fertiligent Ltd
P.O.B. 73, Migdal HaEmek 23100
ISRAEL | APR - 2 2010 |
|----------------------|-------------------------------------------------------------|--------------|
| Contact Person: | John A. Steen, Ph.D.
317-872-0074 x17 | |
| Date: | April 2, 2010 | |
| Proprietary Name: | Fertiligent Slow Release IUI Catheter Kit | |
| Classification Name: | Assisted Reproduction Catheters; CFR 884.6110 | |
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
K032835 H/S Catheter
Device Description: The IUI Catheter is a balloon catheter for slow release insemination. The catheter is placed in the uterus and sperm is injected through the catheter. The kit includes a standard BD 3 ml syringe and a mechanical actuator, as well as an ancillary component, a leg strap. Sperm is loaded into the syringe which is attached to the IUI catheter. The syringe is placed in a plastic, spring loaded mechanical actuator to press on the syringe plunger and deliver the sperm over a 3-4 hour period.
Intended Use: The delivery of sperm into the uterus. The predicate device is intended for the delivery of contrast media or saline into the uterus.
Summary of Technologies: The IUI Catheter has the identical technologies as the predicate device. The IUI Catheter is identical in materials and function to CRI's presently marketed product. Cat. No. TMI 1154, without the placement sheath; without the pinch clamp, and with depth marks printed on the catheter shaft.
Non-clinical/Clinical Testing: Biocompatibility, endotoxin, HSSA, sterility validation, mechanical function, and shelf life testing were completed to document safety and effectiveness of this device. In addition a small clinical trial was included in the testing results, and which lent support to the safety and effectiveness of the device. In conclusion, we feel the subject device is substantially equivalent to the predicate.
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle, with its wings spread and its head turned to the left. The eagle is composed of three thick, curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G6 Silver Spring, MD 20993-0002
Fertiligent, Inc. c/o John A. Steen, Ph.D. President Catheter Research, Inc. 5610 W 82" Street INDIANAPOLIS IN 46278
APR - 2 2010
· Re: K092579
Trade Name: Fertiligent Slow Release IUI Catheter Kit Regulation Number: 21 CFR $884.6110 Regulation Name: Assisted reproduction catheters Regulatory Class: II Product Code: MQF Dated: March 25, 2010 Received: March 29, 2010
Dear Dr. Steen:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related
2
adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
SECTION 4 (Rev 3)
Indications for Use
510(k) Number (if known): K092579
Device Name: Fertiligent Slow Release IUI Catheter Kit
Indications For Use: Delivery of approximately 1 ml of sperm into the uterus over 3-4 hours using a controlled release pump.
Prescription Use メ AND/OR
Over - The - Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(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)
or
Over-The-Counter Use
Kestenn
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
Page 4-1 (Rev 3)