(228 days)
Delivery of approximately 1 ml of sperm into the uterus over 3-4 hours using a controlled release pump.
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.
The provided text describes a 510(k) premarket notification for the "Fertiligent Slow Release IUI Catheter Kit". This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed study with specific acceptance criteria and performance metrics typically associated with novel technology or diagnostic devices.
Therefore, the requested information regarding acceptance criteria, a study proving the device meets them, sample sizes for test/training sets, expert qualifications, ground truth, and comparative effectiveness studies cannot be fully extracted from the provided document.
Here's a breakdown of what can be inferred or directly stated, and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Explicitly Stated for this 510(k) submission type. The submission focuses on substantial equivalence to a predicate device. Performance is generally assumed to be comparable to the predicate. | The device completed "Biocompatibility, endotoxin, HSSA, sterility validation, mechanical function, and shelf life testing" to document safety and effectiveness. A "small clinical trial" was also included, which "lent support to the safety and effectiveness of the device." |
Missing: Specific quantitative performance metrics (e.g., success rates, complication rates, time to delivery accuracy) that would constitute "acceptance criteria" for a novel device.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: A "small clinical trial" was performed. The exact sample size is not disclosed.
- Data Provenance: Not explicitly stated, but clinical trials are typically prospective. The country of origin is not specified.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not Applicable/Not Provided: For a device like an IUI catheter, "ground truth" in the diagnostic sense (e.g., disease diagnosis by expert consensus) is not directly relevant. The assessment of safety and effectiveness in a clinical trial would involve medical professionals observing outcomes, but their role isn't described as "establishing ground truth" in the context of an algorithm's performance.
4. Adjudication Method for the Test Set:
- Not Applicable/Not Provided: Adjudication methods (like 2+1 or 3+1) are typically used for evaluating human or AI interpretations of data where ambiguity exists. This is not described for the clinical trial of an IUI catheter.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
- No: The document does not describe an MRMC study or any comparison of human readers with and without AI assistance. This device is a pure medical device (catheter and mechanical actuator), not an AI-powered diagnostic or assistive tool.
6. Standalone (Algorithm Only) Performance:
- No: This device is a physical medical device; there is no standalone algorithm to evaluate.
7. Type of Ground Truth Used:
- Outcomes Data/Clinical Observation: For the
small clinical trial, the "ground truth" would be the observed clinical outcomes related to the safety and effectiveness of the device (e.g., successful sperm delivery, absence of adverse events). This is inferred from the statement "lent support to the safety and effectiveness."
8. Sample Size for the Training Set:
- Not Applicable: There is no "training set" for an AI algorithm, as this is a physical medical device.
9. How Ground Truth for the Training Set Was Established:
- Not Applicable: As there is no training set for an AI algorithm, this question is not relevant.
Summary of Device and Evidence Presented:
The Fertiligent Slow Release IUI Catheter Kit is a balloon catheter for slow-release intrauterine insemination. The 510(k) submission primarily relies on demonstrating substantial equivalence to an existing legally marketed device (K032835 H/S Catheter) by stating identical technologies, materials, and function.
The evidence for safety and effectiveness includes:
- Non-clinical testing: Biocompatibility, endotoxin, HSSA, sterility validation, mechanical function, and shelf-life testing.
- Clinical testing: A "small clinical trial" which "lent support to the safety and effectiveness of the device." No further details on this trial (sample size, specific results, methodology) are provided in the summary.
Key takeaway: This document is a regulatory submission focused on substantial equivalence, not a detailed scientific paper describing the performance of a novel diagnostic or AI-driven medical device against pre-defined acceptance criteria. Therefore, many of the requested details related to AI/diagnostic performance studies are not present.
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SECTION 5 (Rev 4)
510(k) Summary
| Applicant/Sponsor: | Fertiligent LtdP.O.B. 73, Migdal HaEmek 23100ISRAEL | 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.
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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
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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
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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)
§ 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).