(334 days)
MedGyn IUI Catheters are used for the introduction of washed spermatozoa into the uterine cavity through the cervix.
MedGyn straight IUI, mini IUI, and curved, mini IUI catheters are used for intrauterine insemination for delivery of washed spermatozoa through the cervical os. The straight IUI is composed of a 21.4 cm length tube with subparts consisting of a polyethylene tube connecting with a polypropylene tube. The outer diameter of the polyethylene tube is 2.1 mm. That of the polypropylene tube is 2.75 cm. The tube is connected proximally to an ABS connector for attachment to a syringe. The mini IUI is exactly the same as the straight IUI except that the outer diameter of the inner polyethylene tube is 1.6 mm. The curved, mini IUI is exactly the same as the mini IUI except that it is slightly curved at its distal tip.
The provided text describes a 510(k) premarket notification for MedGyn IUI Catheters, asserting their substantial equivalence to a predicate device. The information primarily focuses on demonstrating that the new device does not raise different questions of safety and effectiveness, rather than providing a detailed study proving the device meets specific acceptance criteria in terms of efficacy or performance metrics typical for AI/software devices.
The document discusses various performance tests conducted to support the safety and shelf life of the device, which are physical properties rather than AI model performance metrics.
Here is a breakdown of the requested information based on the provided text, acknowledging that many fields will be "N/A" due to the nature of this medical device (a catheter) as opposed to a software or AI device.
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Material Biocompatibility: | |
| - Cytotoxicity | Grade '0', Non-Cytotoxic |
| - Intracutaneous Reactivity | No significantly greater biological reaction than control |
| - Skin Sensitization | No sensitization reactions |
| Sterility/Safety Function: | |
| - Endotoxin levels (LAL) | Conducted per USP <85> (results implied to be acceptable) |
| - Mouse Embryo Assay (MEA) | Conducted (results implied to be acceptable) |
| - Human Sperm Survival Assay (HSSA) | Motility remained consistent, no sign of affecting motility |
| Shelf Life/Stability: | |
| - Stability (accelerated aging) | Substantiates 1-year shelf life |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in terms of number of catheters or tests, but tests were "conducted on each version of the MedGyn IUI catheters." For biocompatibility tests, specific animal (rabbits, guinea pigs) and cell assays were used, but the exact number of samples or runs is not detailed.
- Data Provenance: Not explicitly stated, but assumed to be from internal lab testing conducted by MedGyn Products, Inc. or their contracted labs. Not applicable to country of origin, retrospective or prospective in the context of clinical data for AI.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. The ground truth for these physical and biological tests (e.g., cytotoxicity, endotoxin levels, sperm motility) is established through standardized laboratory assays and objective measurements, not expert human interpretation.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. The tests are objective laboratory assays with defined pass/fail criteria, not subjective interpretations requiring adjudication.
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
- MRMC Comparative Effectiveness Study: No. This is a physical medical device (catheter), not an AI/software device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: No. This is not an algorithm or AI device.
7. The type of ground truth used
- Type of Ground Truth: The ground truth for the performance tests mentioned (biocompatibility, sterility, sperm survival, stability) is based on objective laboratory measurements and standardized assay results (e.g., USP <85> for endotoxin, ASTM F1980-07 for accelerated aging, microscopic evaluation for cytotoxicity).
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
- How Ground Truth for Training Set was Established: Not applicable, as there is no training set for this type of device.
Summary based on the Provided Text:
The document describes the regulatory submission for IUI catheters, focusing on physical and biological safety testing to demonstrate substantial equivalence to a predicate device. It is not an AI or software-as-a-medical-device (SaMD) submission, so many of the requested criteria (like MRMC studies, AI performance metrics, training sets, and expert adjudication for nuanced interpretations) are not relevant to this document. The "studies" mentioned are laboratory tests designed to ensure device safety, biocompatibility, and functionality according to established medical device standards.
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a caduceus, often associated with healthcare.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Medgyn Products, Inc. Amar Agadi Chief Medical Officer 100 W. Industrial Rd. Addison, Illinois 60101
Re: K143669
Trade/Device Name: MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn Curved, Mini IUI Catheter Regulation Number: 21 CFR 884.6110 Regulation Name: Assisted Reproduction Catheters Regulatory Class: Class II Product Code: MQF Dated: October 20, 2015 Received: October 26, 2015
Dear Amar Agadi:
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 device
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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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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) K143669
Device Name
MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn Curved,Mini IUI Catheter.
24.589
Indications for Use (Describe)
MedGyn IUI Catheters are used for the introduction of washed spermatozoa into the uterine cavity through the cervix.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
MedGyn IUI Catheters
(MedGyn straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn curved,mini IUI catheter)
This 510(k) Summary is provided in accordance with the requirements of 21 CFR 807.92
Prepared on: December 26, 2014
Submitter:
MedGyn Products, Inc. 100 W Industrial Road, Addison, Il 60101, USA
Contact Person :
Dr. Amar Agadi M.D. MedGyn Products, Inc. 100 W Industrial Rd Addison, IL 60101 Tel: 630 6274105 Ex: 7446 Fax: 630 6270127 Email: amar@medgyn.com
| Device Trade Name: | MedGyn Straight IUI CatheterMedGyn Mini IUI CatheterMedGyn Curved,Mini IUI Catheter |
|---|---|
| Common Name: | Intrauterine Insemination (IUI) Cannula |
| Device Classification: | II |
| Classification Name | Assisted reproduction catheters |
| Product Code: | MFQ |
| Regulation Number: | 21 CFR 884.6110 |
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Predicate Devices:
510(K) Number: K954099 Product Name: Select IUI Manufacturer: Select Medical Systems, Inc.
Device description:
MedGyn straight IUI, mini IUI, and curved, mini IUI catheters are used for intrauterine insemination for delivery of washed spermatozoa through the cervical os.
The straight IUI is composed of a 21.4 cm length tube with subparts consisting of a polyethylene tube connecting with a polypropylene tube. The outer diameter of the polyethylene tube is 2.1 mm. That of the polypropylene tube is 2.75 cm. The tube is connected proximally to an ABS connector for attachment to a syringe.
The mini IUI is exactly the same as the straight IUI except that the outer diameter of the inner polyethylene tube is 1.6 mm. The curved, mini IUI is exactly the same as the mini IUI except that it is slightly curved at its distal tip.
The materials used in this device are the same materials used in predicate devices. The combination of an inner polyethylene tube with an outer polypropylene tube is the exact same material and the same concept as that used in the "Select IUI" and "The Curve", (K954099 and K012935, respectively). Additionally, the dimensions of the MedGyn IUI catheters are almost identical with those of the Select IUI and the Select "The Curve" catheters.
(Note syringe is not included with catheters)
Indications for Use:
MedGyn IUI Catheters are used for the introduction of washed spermatozoa into the uterine cavity through the cervix
Technological Comparison to Predicate Devices:
The indication for use and technology of the MedGyn IUI catheters are substantially equivalent to the identified predicate devices.
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Table :1 Comparison of Predicates with MedGyn Candidate Device
| Manufacturer | Select MedicalSystems, Inc | MedGyn IUI Catheterscomparison to predicate | Comparison ofPredicate withMedGynCandidate Device |
|---|---|---|---|
| 510(k) Number | K954099 | N/A | N/A |
| Product Code | MFD | MFD | Same |
| Regulation Number | 884.5250 | 884.5250 | Same |
| Regulation Name | Cannula, intrauterineinsemination | Cannula, intrauterineinsemination | Same |
| Anatomical Site | Uterine Cervix | Uterine Cervix | Same |
| Intended Use | Artificial insemination | Artificial insemination | Same |
| Where Used: | Physician's Office | Physician's Office | Same |
| Indications for use: | The Select IUI isused for intrauterineartificial insemination. | The MedGyn straight,mini, and curved,mini IUIcatheters are to be usedfor the introduction ofwashed spermatozoa intothe uterine cavity throughthe cervix. | Same |
| Overall Design | The Select IUIconsists of an 20 cmin length cathetercomposed of an innerpolyethylene tubeand an outerpolypropylene tube.the exposedpolyethylene tubemeasures 4.5cm inlength, and is locatedat the distal end ofthe catheter/cannula.The outer diameter ofthe polypropylenetube andpolyethylene tube are2.6 mm and 2.1 mm,respectively. Thedistal tip has two sideholes. There are six(6) coloredgraduation markseach cm from thedistal tip of thecatheter starting at 5cm and ending at 10cm. A syringe is notincluded with theproducts. | The MedGyn straight,mini, and curved,mini IUIcatheters are each 21.4cm in length. The straightcatheter has a proximaltube with outer diameterof 2.75 mm and length of16.4 cm. The distal tubehas an outer diameter of2.1 mm and is 5 cm inlength. The mini IUIcatheter has a proximaltube outer diameter of2.75 mm with a length of16.4 cm and a distal tubeouter diameter of 1.6 mmof length 5 cm. thecurved, mini IUI catheterhas a proximal tubelength of 16.4 cm with anouter diameter of 2.75mm with a distal tubeouter diameter of 1.6 mmof length 5 cm. The distal3mm aspect of this tube isslightly curved forinsertion into a variably-positioned uterus(retroverted, etc.). Allcatheters are smooth intexture down to the tip.The straight catheter hastwo side holes at the tip.The mini and curved, minicatheters have a singlehole at the tip. | The MedGyncannula/catheter isapproximately 1.4cm longer, and theouter diameter isapproximately .15mm larger. Thedistal inner tubesare the same |
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The comparison of the above mentioned in Table 1 the predicates devices the outer diameter IUI straight is 2.6mm and 2.1mm respectively, the curved 2.6mm and 1.6mm in diameter. The MedGyn cannula/catheter is approximately 1.4 cm longer, and the outer diameter is approximately .15 mm larger. The distal inner tubes are the same. The differences in dimensions between the subject and predicate device do not raise different questions of safety and effectiveness.
Summary of Performance Testing:
Stability testing was conducted in accordance with ASTM F1980-07 (accelerated aging) to substantiate a shelf life of 1 year.
Mouse Embryo Assay (MEA) testing was conducted on each version of the MedGyn IUI catheters.
Endotoxin Testing (LAL) was conducted per USP <85> for each version of the MedGyn IUI catheters.
Human Sperm Survival Assay (HSSA) testing has been performed on the device the test results shows that the motility remained consistent, both the test and control samples showed no sign of affecting motility during the course of the assay.
The biocompatibility of the device includes cytotoxicity, Intracutaneous Reactivity and sensitization of the final device tests were performed on the IUI device;
a. Cytotoxicity: Microscopic evaluation of the cells showed that the extract from the test article received a cytotoxicity grade of '0' at 24 ± 3, 48 ± 3 and 72 ± 3 hours and was considered Non-Cytotoxic.
b. Intracutaneous Reactivity: The USP 0.9% Sodium chloride for injection ( NaCl) and Cottonseed Oil (CSO) extracts of the test article, IUI catheters, were evaluated for their potential to produce irritation after intracutaneous injection in white rabbits. The test article sites did not show a significantly greater biological reaction than the sites injected with the control article.
c. Skin Sensitization: A comparison of the biological responses seen following guinea pig sensitization of the test item extracts and solvents were reported and interpreted, results of
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the IUI Catheter did not show any sensitization reactions..
The above test reports data proven that device is safe for the use.
Substantially Equivalent Conclusion
By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise different questions regarding its safety and effectiveness as compared with the predicate device.
The MedGyn IUI Catheters are substantially equivalent to the proposed 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).