(225 days)
Not Found
No
The description focuses on a mechanical pump for controlled release and does not mention any AI/ML components or functions.
Yes
This device is designed to deliver sperm into the uterus for insemination, which is a therapeutic intervention aimed at achieving pregnancy.
No
The device is described as a "balloon catheter for slow release intrauterine insemination" used for "Delivery of approximately 1ml of sperm into the uterus." Its function is to deliver a substance, not to diagnose a condition or disease.
No
The device description clearly outlines physical components including a balloon catheter, syringe, mechanical actuator, and leg strap, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The described device is a catheter and pump system designed to deliver sperm into the uterus for insemination. It is a therapeutic/procedural device, not a device used to analyze specimens in vitro.
- Intended Use: The intended use is the "Delivery of approximately 1ml of sperm into the uterus over 3-4 hours using a controlled release pump." This is a direct intervention within the body, not an in vitro test.
The device is clearly intended for a medical procedure performed in vivo (within the living body), not for testing samples in vitro (in a lab setting).
N/A
Intended Use / Indications for Use
Delivery of approximately 1ml of sperm into the uterus over 3-4 hours using a controlled release pump.
Product codes (comma separated list FDA assigned to the subject device)
MQF
Device Description
The subject device is a balloon catheter for slow release intrauterine insemination. The catheter is placed in the uterus and sperm is injected through the catheter. The subject device is provided with a standard 3 ml syringe, a mechanical actuator, and a leg strap. Sperm is loaded into the syringe, and the syringe is attached to the IUI catheter. The syringe is placed in the mechanical actuator to 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The safety of patient self-removal of the subject device was evaluated as a substudy (n=80) within a multi-center, randomized, open-label, cross-over study comparing the subject device to conventional "bolus" IUI. The study results demonstrated that a typical IUI patient can self-remove the subject device.
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
§ 884.6110 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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol of medicine, with three figures in profile facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circle around the caduceus. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 3, 2015
Fertiligent, Ltd. % Babacar Diouf VP of RA and OS Catheter Research, Inc. 5610 W 82nd Street Indianapolis, IN 46278
Re: K141666
Trade/Device 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: October 30, 2014 Received: November 5, 2015
Dear Babacar Diouf,
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 (reporting of medical
1
device-related 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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Herbert P. Lerner -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K141666
Device Name
Fertiligent Slow Release IUI Catheter Kit
Indications for Use (Describe)
Delivery of approximately 1ml of sperm into the uterus over 3-4 hours using a controlled release pump.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary — K141666
| Applicant/Sponsor: | Fertiligent Ltd
37 Hashmonaim St.
Ra'anana 43256
Israel |
|----------------------|--------------------------------------------------------------------|
| Contact Person: | Babacar Diouf
317-872-0074 x3512 |
| Date: | February 2, 2015 |
| Proprietary Name: | Fertiligent Slow Release IUI Catheter Kit |
| Classification Name: | Assisted Reproduction Catheter; CFR 884.6110;
Product Code: MQF |
Legally Marketed Devices to Which Substantial Equivalence Is Claimed:
Fertiligent Slow Release IUI Catheter Kit K092579
Device Description: The subject device is a balloon catheter for slow release intrauterine insemination. The catheter is placed in the uterus and sperm is injected through the catheter. The subject device is provided with a standard 3 ml syringe, a mechanical actuator, and a leg strap. Sperm is loaded into the syringe, and the syringe is attached to the IUI catheter. The syringe is placed in the mechanical actuator to deliver the sperm over a 3-4 hour period.
The subject device is identical to the predicate device. The purpose of current 510(k) submission was to remove the Precaution statement from the predicate Instructions for Use stating "Use device only under the supervision of a trained clinician in a medical facility," allowing patients to leave the clinic following device placement and remove and dispose of the device at home or other non-clinical site.
Intended Use: Delivery of approximately 1ml of sperm into the uterus over 3 – 4 hours using a controlled release pump
The subject and predicate device have the same intended use.
Summary of Technologies: The subject device has the identical technologies as the predicate device. The proposed device is identical in materials and function to the predicate device. Both devices are assembled in the same
4
environment using the same manufacturing and undergo the same sterilization processes.
Non-clinical/Clinical Testing: Biocompatibility, Endotoxins, HSSA testing, sterilization validation, shelf-life, and performance testing were addressed in K092579.
The safety of patient self-removal of the subject device was evaluated as a substudy (n=80) within a multi-center, randomized, open-label, cross-over study comparing the subject device to conventional "bolus" IUI. The study results demonstrated that a typical IUI patient can self-remove the subject device.
Conclusion: The subject device is substantially equivalent to the predicate device.