INTRAUTERINE INSEMINATION (IUI) CATHETER

K120154 · Catheter Research, Inc. · MQF · Mar 21, 2012 · Obstetrics/Gynecology

Device Facts

• Record ID: K120154
• Device Name: INTRAUTERINE INSEMINATION (IUI) CATHETER
• Applicant: Catheter Research, Inc.
• Product Code: MQF · Obstetrics/Gynecology
• Decision Date: Mar 21, 2012
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 884.6110
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Delivery of washed sperm into the uterus.

Device Story

IUI Catheter is a sterile, disposable, flexible, two-lumen plastic balloon catheter used for intrauterine insemination. One lumen facilitates balloon inflation; the other allows injection of washed sperm. The device is used in a clinical setting by healthcare professionals to deliver sperm into the uterus via bolus injection in less than several minutes. It eliminates the need for the mechanical actuators, pumps, and leg straps required by slow-release predicate systems. The device benefits patients by providing a simplified, standard method for intrauterine insemination with reduced sperm contact duration compared to controlled-release alternatives.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical testing including biocompatibility, endotoxin testing, HSSA testing, sterilization validation, shelf-life, and performance testing.

Technological Characteristics

Two-lumen flexible plastic catheter with integrated balloon. Sterile, disposable. Identical materials and manufacturing process to predicate. No software or electronic components.

Indications for Use

Indicated for the delivery of washed sperm into the uterus 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

• Fertiligent Slow Release IUI Catheter (K092579)

Submission Summary (Full Text)

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

Pg. 1 of 2

### 510(k) Summary: K120154

MAR 2 1 2012

| Applicant/Sponsor: | Catheter Research, Inc.<br>5610 W. 82nd St.<br>Indianapolis, IN 46278 |
|----------------------|-----------------------------------------------------------------------|
| Contact Person: | John Steen<br>317-872-0074 x3517 |
| Date: | 12/22/2011 |
| Proprietary Name: | IUI Catheter |
| Classification Name: | Assisted Reproduction Catheters; CFR 884.6110.<br>Product Code: MQF |

# Legally Marketed Devices to Which Substantial Equivalence Is Claimed:

Fertiligent Slow Release IUI Catheter K092579

Device Description: The IUI Catheter is a balloon catheter for intrauterine insemination. The catheter is placed in the uterus and sperm is intracted through the catheter in less than several minutes. The IUI Catheter is a packaged , sterile, disposable, flexible, plastic catheter with two lumens, one for inflation of the balloon and one for injection of washed sperm. A balloon inflation syringe is provided with the product.

Intended Use: Delivery of washed sperm into the uterus

The predicate device is intended for the delivery of approximately 1ml of sperm into the uterus over 3 – 4 hours using a controlled release pump,

Summary of Technologies: The IUI Catheter has the identical technologies as the predicate device, IUI catheter component. The IUI Catheter is identioal in materials and function to the predicate. Both devices are assembled in the same environment using the same manufacturing and sterilization process.

Non-clinical/Clinical Testing: Biocompatibility, Endotoxins, HSSA testing, sterilization validation, shelf-life, and performance testing.

{1}------------------------------------------------

KI 20154
Pg. 2 of 2

| Equivalence Summary | | | |
|-----------------------|---------------------------------------------------------------------------------------------------------------------|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | |
| Item | Predicate | Proposed | Comments/Discussion |
| Component | Mechanical Actuator | Not included | Not part of proposed device; required for<br>Slow Release product, not required for<br>bolus injection IUI. |
| Component | Insemination Syringe | Not included | Not part of proposed device. Required for<br>Slow Release product due to syringe fit in<br>pump; not required for bolus injection IUI<br>as a sperm-compatible syringe is chosen<br>by the andrology lab. |
| Component | Leg Strap | Not included | Not part of proposed device; required for<br>Slow Release product, not required for<br>bolus injection IUI. |
| Component | IUI Catheter | IUI Catheter | Identical: No design, manufacturing,<br>material, sterilization, or packaging<br>differences. |
| Indication<br>for Use | Delivery of approximately<br>1 ml of sperm into the<br>uterus over 3-4 hours<br>using a controlled release<br>pump. | Delivery of washed<br>sperm into the uterus. | Proposed device is for standard IUI use,<br>where injection is over a shorter period of<br>time. Comparable use for both products. |
| Use | 3-4 hour insemination | < several minutes | Proposed device is identical to predicate<br>and does not raise any new<br>biocompatibility concerns. The predicate<br>device was cleared for 4 hr sperm contact,<br>whereas the proposed has reduced sperm<br>contact duration, and therefore does not<br>raise any new sperm compatibility<br>concerns. Acceptance criteria are the<br>same for both proposed and predicate<br>devices. |
| Endotoxin<br>Testing | < 20EU/device | < 20EU/device | Proposed and predicate devices are the<br>same. |

ﻬﻤﺎ ﺗﺴﺮ

Conclusion: Since both the proposed and predicate catheters are identical, we feel that the testing performed on the predicate is sufficient to support the safety and effectiveness of the proposed IUI catheter.

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

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

John A. Steen, Ph.D. President Catheter Research, Inc. 5610 West 82 Street INDIANAPOLIS IN 46278

MAR 2 1 2012

Re: K120154

Trade/Device Name: IUI Catheter Regulation Number: 21 CFR§ 884.6110 Regulation Name: Assisted reproduction catheters Regulatory Class: II Product Code: MQF Dated: January 13, 2012 Received: January 19, 2012

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 (reporting of medical

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

Page 2 -

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 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

and all 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

{4}------------------------------------------------

## Indications for Use

510(k) Number (if known): K120154

Device Name: IUI Catheter

Indications For Use:

Delivery of washed sperm into the uterus.

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-------------------------------------------------------------------|---------|
| Division of Reproductive, Gastro-Renal, and<br>Urological Devices | |
| 510(k) Number | K120154 |

Page 1 of 1