MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn curved, mini IUI Catheter

K143669 · Medgyn Products, Inc. · MQF · Nov 23, 2015 · Obstetrics/Gynecology

Device Facts

• Record ID: K143669
• Device Name: MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn curved, mini IUI Catheter
• Applicant: Medgyn Products, Inc.
• Product Code: MQF · Obstetrics/Gynecology
• Decision Date: Nov 23, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6110
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MedGyn IUI Catheters are used for the introduction of washed spermatozoa into the uterine cavity through the cervix.

Device Story

MedGyn IUI Catheters (straight, mini, and curved mini) are manual medical devices used by physicians in clinical settings for intrauterine insemination. The device consists of a proximal polypropylene tube connected to a distal polyethylene tube, terminating in an ABS connector for syringe attachment. The straight version features two side holes at the tip; the mini and curved mini versions feature a single tip hole. The curved mini variant includes a distal curvature to facilitate insertion into variably positioned uteri. The device is inserted through the cervix to deliver washed spermatozoa into the uterine cavity. By facilitating the placement of sperm, the device assists in artificial insemination procedures, potentially improving fertility outcomes for patients.

Clinical Evidence

Bench testing only. Performance data includes: accelerated aging (ASTM F1980-07) for 1-year shelf life; Mouse Embryo Assay (MEA); Endotoxin testing (USP <85>); Human Sperm Survival Assay (HSSA) showing no negative impact on sperm motility; and biocompatibility testing including cytotoxicity (grade 0, non-cytotoxic), intracutaneous reactivity (no significant reaction), and skin sensitization (no sensitization reactions).

Technological Characteristics

Materials: Polyethylene (inner tube), Polypropylene (outer tube), ABS (connector). Dimensions: 21.4 cm total length; 1.6 mm or 2.1 mm distal outer diameter. Design: Straight, mini, or curved distal tip configurations. Energy source: None (manual). Sterilization: Not specified. Connectivity: None. Software: None.

Indications for Use

Indicated for the introduction of washed spermatozoa into the uterine cavity through the cervix for intrauterine insemination.

Regulatory Classification

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.

Special Controls

*Classification.* Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).

Predicate Devices

• Select IUI (K954099)

Reference Devices

• Select "The Curve" (K012935)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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: [phone] Ex: 7446 Fax: [phone] Email: [e-mail]

| Device Trade Name: | MedGyn Straight IUI Catheter<br>MedGyn Mini IUI Catheter<br>MedGyn 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 Medical<br>Systems, Inc | MedGyn IUI Catheters<br>comparison to predicate | Comparison of<br>Predicate with<br>MedGyn<br>Candidate Device |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K954099 | N/A | N/A |
| Product Code | MFD | MFD | Same |
| Regulation Number | 884.5250 | 884.5250 | Same |
| Regulation Name | Cannula, intrauterine<br>insemination | Cannula, intrauterine<br>insemination | 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 is<br>used for intrauterine<br>artificial insemination. | The MedGyn straight,<br>mini, and curved,mini IUI<br>catheters are to be used<br>for the introduction of<br>washed spermatozoa into<br>the uterine cavity through<br>the cervix. | Same |
| Overall Design | The Select IUI<br>consists of an 20 cm<br>in length catheter<br>composed of an inner<br>polyethylene tube<br>and an outer<br>polypropylene tube.<br>the exposed<br>polyethylene tube<br>measures 4.5cm in<br>length, and is located<br>at the distal end of<br>the catheter/cannula.<br>The outer diameter of<br>the polypropylene<br>tube and<br>polyethylene tube are<br>2.6 mm and 2.1 mm,<br>respectively. The<br>distal tip has two side<br>holes. There are six<br>(6) colored<br>graduation marks<br>each cm from the<br>distal tip of the<br>catheter starting at 5<br>cm and ending at 10<br>cm. A syringe is not<br>included with the<br>products. | The MedGyn straight,<br>mini, and curved,mini IUI<br>catheters are each 21.4<br>cm in length. The straight<br>catheter has a proximal<br>tube with outer diameter<br>of 2.75 mm and length of<br>16.4 cm. The distal tube<br>has an outer diameter of<br>2.1 mm and is 5 cm in<br>length. The mini IUI<br>catheter has a proximal<br>tube outer diameter of<br>2.75 mm with a length of<br>16.4 cm and a distal tube<br>outer diameter of 1.6 mm<br>of length 5 cm. the<br>curved, mini IUI catheter<br>has a proximal tube<br>length of 16.4 cm with an<br>outer diameter of 2.75<br>mm with a distal tube<br>outer diameter of 1.6 mm<br>of length 5 cm. The distal<br>3mm aspect of this tube is<br>slightly curved for<br>insertion into a variably-<br>positioned uterus<br>(retroverted, etc.). All<br>catheters are smooth in<br>texture down to the tip.<br>The straight catheter has<br>two side holes at the tip.<br>The mini and curved, mini<br>catheters have a single<br>hole at the tip. | The MedGyn<br>cannula/catheter is<br>approximately 1.4<br>cm longer, and the<br>outer diameter is<br>approximately .15<br>mm larger. The<br>distal inner tubes<br>are 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.