(225 days)
Delivery of approximately 1ml of sperm into the uterus over 3-4 hours using a controlled release pump.
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.
I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria in the context of typical medical device performance evaluation (e.g., accuracy, sensitivity, specificity for diagnostic devices, or specific performance metrics for therapeutic devices).
The document is a US FDA 510(k) clearance letter for a "Fertiligent Slow Release IUI Catheter Kit". The core of this submission (K141666) is to allow for patient self-removal of the device at home, which was a change from a previous predicate device (K092579) that required removal under clinical supervision.
The relevant section states: "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."
Based on this, I can provide the following partial information related to what was studied, but not a table of acceptance criteria or performance metrics as you might expect for an AI algorithm or a device with quantifiable performance output like a diagnostic tool.
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria or performance metrics in a quantifiable sense (e.g., specific thresholds for success/failure rates, accuracy, etc.). The study's reported outcome is qualitative: "The study results demonstrated that a typical IUI patient can self-remove the subject device." This suggests the "acceptance criterion" was likely that a high percentage of patients could successfully and safely self-remove the device, but the specific percentage/threshold is not mentioned.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Patients can safely and effectively self-remove the device. | "The study results demonstrated that a typical IUI patient can self-remove the subject device." |
2. Sample size used for the test set and the data provenance
- Sample Size: n=80 (for the self-removal substudy)
- Data Provenance: The study was a "multi-center, randomized, open-label, cross-over study". The country of origin is not specified but is implied to be within the scope of where such FDA-related studies are conducted (likely US or internationally recognized clinical sites). It was a prospective study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not explicitly provided in the document. For a study on patient self-removal, the assessment of safety and effectiveness would likely be made by the patients themselves (reporting successful removal, adverse events) and potentially by clinicians overseeing the study. The criteria for "successful self-removal" are not detailed.
4. Adjudication method for the test set
This information is not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study was not done. This device is a physical medical device (catheter) for sperm delivery, not an AI or imaging device with "readers."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, this question is not applicable as the device is a physical catheter, not an algorithm.
7. The type of ground truth used
The "ground truth" for the self-removal substudy would likely have been the actual successful or unsuccessful removal of the device by the patient, along with the occurrence or non-occurrence of adverse events related to the removal, as documented by patients and/or clinicians. This would fall under observed outcomes data.
8. The sample size for the training set
This information is not applicable. The device is a physical product, not an AI algorithm that requires a training set. The clinical study was for performance evaluation, not for training a model.
9. How the ground truth for the training set was established
This question is not applicable for the same reason as above.
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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
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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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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary — K141666
| Applicant/Sponsor: | Fertiligent Ltd37 Hashmonaim St.Ra'anana 43256Israel |
|---|---|
| Contact Person: | Babacar Diouf317-872-0074 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
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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.
§ 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).