FERTILIGENT SLOW RELEASE IUI CATHETER KIT

K141666 · Fertiligent, Ltd. · MQF · Feb 3, 2015 · Obstetrics/Gynecology

Device Facts

• Record ID: K141666
• Device Name: FERTILIGENT SLOW RELEASE IUI CATHETER KIT
• Applicant: Fertiligent, Ltd.
• Product Code: MQF · Obstetrics/Gynecology
• Decision Date: Feb 3, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6110
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Delivery of approximately 1ml of sperm into the uterus over 3-4 hours using a controlled release pump.

Device Story

Balloon catheter system for slow-release intrauterine insemination (IUI); includes 3ml syringe, mechanical actuator, and leg strap. Clinician places catheter in uterus; sperm loaded into syringe; syringe inserted into mechanical actuator for controlled delivery over 3-4 hours. Patient leaves clinic post-placement; patient performs self-removal and disposal of device at home. System facilitates prolonged sperm exposure to uterus compared to traditional bolus IUI. Benefits include potential for improved clinical outcomes via extended delivery duration.

Clinical Evidence

Safety of patient self-removal evaluated in a multi-center, randomized, open-label, cross-over study (n=80) comparing subject device to conventional bolus IUI. Results demonstrated that typical IUI patients can safely self-remove the device. Other performance and biocompatibility data were previously established in K092579.

Technological Characteristics

Balloon catheter, 3ml syringe, mechanical actuator, and leg strap. Identical to predicate device. Sterilization and manufacturing processes remain unchanged.

Indications for Use

Indicated for intrauterine insemination (IUI) in patients requiring controlled delivery of approximately 1ml of sperm into the uterus over a 3-4 hour period. The device is intended for use under clinician supervision for placement, with patient self-removal permitted.

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

• Fertiligent Slow Release IUI Catheter Kit (K092579)

Submission Summary (Full Text)

{0}------------------------------------------------

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 [phone] or [phone] 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 [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

{2}------------------------------------------------

#### 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.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 510(k) Summary — K141666

| Applicant/Sponsor: | Fertiligent Ltd<br>37 Hashmonaim St.<br>Ra'anana 43256<br>Israel |
|----------------------|--------------------------------------------------------------------|
| Contact Person: | Babacar Diouf<br>317-872-0074 x3512 |
| Date: | February 2, 2015 |
| Proprietary Name: | Fertiligent Slow Release IUI Catheter Kit |
| Classification Name: | Assisted Reproduction Catheter; CFR 884.6110;<br>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.