Kitazato IUI Catheter

K162667 · Kitazato Corporation · MQF · May 11, 2017 · Obstetrics/Gynecology

Device Facts

• Record ID: K162667
• Device Name: Kitazato IUI Catheter
• Applicant: Kitazato Corporation
• Product Code: MQF · Obstetrics/Gynecology
• Decision Date: May 11, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6110
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Kitazato IUI Catheter is used for the introduction of washed spermatozoa into the uterine cavity through the cervix. Kitazato IUI Stylet is used to provide rigidity and assist in maintaining the shape of the catheter shaft.

Device Story

Kitazato IUI Catheter is a single-use, sterile device for intrauterine insemination. It consists of a polyvinyl chloride shaft with an ABS connector and depth markers. Models include Type 4 (no core, optional stylet cannula) and Type 5 (integrated stainless steel core). The device is used by clinicians in a clinical setting to deliver washed spermatozoa into the uterine cavity. The clinician inserts the catheter through the cervix, guided by depth markers; a syringe (not included) is attached to the 6% taper connector to inject the sperm. The stylet or integrated stainless steel core provides rigidity to assist navigation through curved cervices. The device facilitates assisted reproduction by ensuring precise delivery of sperm, potentially increasing the likelihood of conception.

Clinical Evidence

Bench testing only. Testing included mechanical tensile strength, dimensional verification, appearance, endotoxin levels (≤20 EU/device), sterility (USP <71), biocompatibility (ISO 10993-1: cytotoxicity, sensitization, irritation), Human Sperm Survival Assay (HSSA) showing ≥70% motility at 24 hours, color fastness, shelf-life validation, and package integrity (ISO 11607).

Technological Characteristics

Materials: Polyvinyl chloride (shaft), ABS (connector), SUS 304 stainless steel (core/stylet). Dimensions: 10 cm or 18 cm length; 1.7 mm (5 Fr) or 2.0 mm (6 Fr) diameter. Connectivity: 6% taper syringe connector. Sterilization: Ethylene Oxide (EO).

Indications for Use

Indicated for the introduction of washed spermatozoa into the uterine cavity through the cervix in patients undergoing 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

• Kitazato IUI Catheter (K131491)

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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized human profiles facing to the right.

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

May 11, 2017

Kitazato Corporation % Audrey Swearingen, RAC Director, Regulatory Affairs Emergo Global Consulting. LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, TX 78746

Re: K162667 Trade/Device Name: Kitazato IUI Catheter Regulation Number: 21 CFR§ 884.6110 Regulation Name: Assisted Reproduction Catheters Regulatory Class: II Product Code: MOF Dated: April 13, 2017 Received: April 14, 2017

Dear Audrey Swearingen:

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.

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

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-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,

Benjamin R. Fisher -S

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}------------------------------------------------

# Indications for Use

510(k) Number (if known) K162667

Device Name Kitazato IUI Catheter

Indications for Use (Describe)

Kitazato IUI Catheter consists of the following versions:

· Kitazato IUI Catheter with Outer Stiffener with or without Stylet Cannula, 18 cm, model number Type 4-v1 and Type 4v2

· Kitazato IUI Catheter with Outer Stiffener with or without Stylet Cannula, 10 cm, model number Type 4-v3 and Type 4v4

· Kitazato IUI Catheter with Outer Stiffener with Stainless Steel Core, 18 cm, model number Type 5-v1 and Type 5-v2

· Kitazato IUI Catheter with Outer Stiffener with Stainless Steel Core, 10 cm, model number Type 5-v3 and Type 5-v4 Kitazato IUI Catheter is used for the introduction of washed spermatozoa into the uterine cavity through the cervix. Kitazato IUI Stylet is used to provide rigidity and assist in maintaining the shape of the catheter shaft.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

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

# CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

# Kitazato IUI Catheter

# K162667

### 1. Submission Sponsor

KITAZATO Corporation

1-1-8 Shibadaimon, Minato-ku

Tokyo 105-0012

JAPAN

Contact: Ms. Mari YAZAKI

Title: Quality Assurance Manager

Phone number: + (81) 3 - 3434 -2731

## 2. Submission Correspondent

Emergo Global Consulting, LLC

2500 Bee Cave Road

Building 1, Suite 300

Austin, TX 78746

Office Phone: (512) 327 - 9997

Contact: Ms. Audrey Swearingen, RAC

Title: Director, Regulatory Affairs

Email: [e-mail]

#### 3. Date Prepared

May 10, 2017

#### 4. Device Identification

| Trade/Proprietary Name: | Kitazato IUI Catheter |
|-------------------------|------------------------------------------|
| Common/Usual Name: | Intrauterine Insemination (IUI) Catheter |
| Classification Name: | Assisted Reproduction Catheters |
| Classification Number: | 884.6110 |

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

MQF, Assisted Reproduction Catheter Product Code:

Device Class: Class II

Classification Panel: Obstetrics/Gynecology

## 5. Legally Marketed Predicate Device(s)

K131491, Kitazato IUI Catheter, KITAZATO Medical Co., Ltd.

The predicate device has not been subject to a design-related recall.

# 6. Indication for Use Statement

Kitazato IUI Catheter consists of the following versions:

- . Kitazato IUI Catheter with Outer Stiffener with or without Stylet Cannula, 18 cm, model number Type 4-v1 and Type 4-v2
- . Kitazato IUI Catheter with Outer Stiffener with or without Stylet Cannula, 10 cm, model number Type 4-v3 and Type 4-v4
- Kitazato IUI Catheter with Outer Stiffener with Stainless Steel Core, 18 cm, model number Type 5-v1 and Type 5-v2
- Kitazato IUI Catheter with Outer Stiffener with Stainless Steel Core, 10 cm, model number Type 5-v3 and Type 5-v4

Kitazato IUI Catheter is used for the introduction of washed spermatozoa into the uterine cavity through the cervix.

Kitazato IUI Stylet is used to provide rigidity and assist in maintaining the shape of the catheter shaft.

## 7. Device Description

The Kitazato IUI Catheter is a set of intrauterine insemination (IUI) catheters comprised of two different models that include either no stainless steel core (Type 4) or a stainless steel core (Type 5). Each type of catheter has a 10 cm or 18 cm catheter shaft length that incorporates an outer stiffener component and a syringe connector. The distal tip of the catheter shaft is rounded and includes two side holes 3 mm from the tip of the catheter for sperm delivery. The catheter shaft also includes depth marker bands at 5, 6, 7, and 8 cm from the distal tip to aid in delivery of the device to the targeted depth.

The catheter is composed of a polyvinyl chloride shaft and an acrylonitrile butadiene styrene (ABS) connector. The Stylet Cannula (Type 6) used with the Type 4 catheter is composed of a stainless steel cannula (SUS304) and an ABS syringe connector. The Stylet Cannula's stainless steel core provides rigidity and assists in maintaining the shape of the catheter shaft when the uterine cervix is sharply curved. The Stylet Cannula is inserted into the catheter shaft through the connector end and then the IUI Catheter is inserted into the cervix. During an IUI procedure, the catheter is introduced into the uterine cavity through the cervix, and the spermatozoa are injected into the uterine cavity by a syringe (not included) that is coupled at the connector end (6% taper connection) of the catheter shaft.

Model configurations and specifications for the Kitazato IUI Catheters are listed below:

{5}------------------------------------------------

| Code | Model | Product Name | Code Catheter Body | Center Core Material | Catheter Length | Outer Diameter | Depth mark | Stylet Cannula |
|--------|----------|-------------------------------------------|----------------------|----------------------|-----------------|----------------|------------|----------------|
| 131184 | Type4-v1 | Catheter with Outer Stiffener with Stylet | Polyvinyl-chloride | None | 18 cm | 1.70mm/5 Fr | Yes | Yes |
| 131182 | Type4-v2 | Cannula | (not made with DEHP) | None | 18 cm | 2.00mm/6Fr | Yes | Yes |
| 131104 | Type4-v3 | | None | None | 10 cm | 1.70mm/5 Fr | Yes | Yes |
| 131102 | Type4-v4 | | | None | 10 cm | 2.00mm/6Fr | Yes | Yes |
| 131181 | Type5-v1 | Catheter with Outer Stiffener with | Polyvinyl-chloride | S.S. SUS 304 | 18 cm | 2.00mm/6Fr | Yes | No |
| 131186 | Type5-v2 | Stainless Steel Core | (not made with DEHP) | S.S. SUS 304 | 18 cm | 2.00mm/6Fr | Yes | No |
| 131101 | Type5-v3 | | | S.S. SUS 304 | 10 cm | 2.00mm/6Fr | Yes | No |
| 131106 | Type5-v4 | | | S.S. SUS 304 | 10 cm | 2.00mm/6Fr | Yes | No |
| 140918 | Type6-v1 | Stylet cannula | n/a | S.S. SUS 304 | 18 cm | 0.65 mm | n/a | n/a |
| 140118 | Type6-v2 | | | S.S. SUS 304 | 10 cm | 0.65 mm | n/a | n/a |

#### 8. Substantial Equivalence Discussion

The following table compares the Kitazato IUI Catheter to the predicate device with respect to indications for use, principles of operation, technological characteristics, and performance testing. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. Based on the information below, the subject and predicate device have comparable intended uses, and the differences in technology noted do not raise different questions of safety or effectiveness as compared to the predicate.

| Table 1 – Comparison of Characteristics |
|-----------------------------------------|
|-----------------------------------------|

| Manufacturer | KITAZATO Corporation | KITAZATO Medical Co., Ltd. | Significant<br>Differences |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Kitazato IUI Catheter | Kitazato IUI Catheter Type<br>3 with Outer Stiffener with<br>Stylet Cannula | |
| 510(k) Number | K162677 | K131491 | N/A |
| Product Code | MQF | MQF | Same |
| Regulation Number | 884.6110 | 884.6110 | Same |
| Regulation Name | Assisted Reproduction<br>Catheter | Assisted Reproduction<br>Catheter | Same |
| Indications for Use | Kitazato IUI Catheter<br>consists of the following | Kitazato IUI Catheter consist | Different. The Stylet is<br>not included separately |
| Manufacturer | KITAZATO Corporation | KITAZATO Medical Co., Ltd. | Significant<br>Differences |
| Trade Name | Kitazato IUI Catheter | Kitazato IUI Catheter Type<br>3 with Outer Stiffener with<br>Stylet Cannula | |
| | versions:<br>Kitazato IUI Catheter<br>with Outer Stiffener<br>with or without Stylet<br>Cannula, 18 cm, model<br>number Type 4-v1 and<br>Type 4-v2 Kitazato IUI Catheter<br>with Outer Stiffener<br>with or without Stylet<br>Cannula, 10 cm, model<br>number Type 4-v3 and<br>Type 4-v4 Kitazato IUI Catheter<br>with Outer Stiffener<br>with Stainless Steel<br>Core, 18 cm, model<br>number Type 5-v1 and<br>Type 5-v2 Kitazato IUI Catheter<br>with Outer Stiffener<br>with Stainless Steel<br>Core, 10 cm, model<br>number Type 5-v3 and<br>Type 5-v4 Kitazato IUI Catheter is used<br>for the introduction of<br>washed spermatozoa into<br>the uterine cavity through<br>the cervix.<br>Kitazato IUI Stylet is used to<br>provide rigidity and assist in<br>maintaining the shape of<br>the catheter shaft. | of the following versions:<br>Kitazato IUI Catheter<br>with Outer Stiffener<br>with Stylet Cannula, 18<br>cm, model number<br>Type 3-v1 Kitazato IUI Catheter<br>with Outer Stiffener<br>without Stylet Cannula,<br>18 cm, model number<br>Type 3-v2 Kitazato IUI Catheter is used<br>for the introduction of<br>washed spermatozoa into<br>the uterine cavity through<br>the cervix. | in the indications for use<br>statement of the<br>predicate device.<br>However, the inclusion<br>of a stylet does not<br>represent a new<br>intended use. |
| Overall Design | The device consists of types<br>of IUI catheters with an<br>outer stiffener with no<br>stainless steel core (Type 4),<br>outer stiffener with<br>stainless steel core (Type 5) | The device consists of types<br>of IUI catheters with an<br>outer stiffener with and<br>without a stylet cannula<br>(Type 3). The catheter has a | Different; the subject<br>device includes a version<br>of the IUI catheter that<br>utilizes a stainless steel<br>core. The inclusion of<br>this stainless steel core |
| Manufacturer | KITAZATO Corporation | KITAZATO Medical Co., Ltd. | Significant |
| Trade Name | Kitazato IUI Catheter | Kitazato IUI Catheter Type<br>3 with Outer Stiffener with<br>Stylet Cannula | Differences |
| | and stylet cannula for Type<br>4 catheters. The catheter<br>has a smooth distal tip with<br>two side holes. All types<br>have a syringe connector<br>hub compatible with a 6%<br>taper syringe (not included).<br>The catheters are packaged<br>in a barrier sterilization<br>package. | side holes. All types have a<br>syringe connector hub<br>compatible with a 6% taper<br>syringe (not included). The<br>catheters are packaged in a<br>barrier sterilization<br>package. | does not raise different<br>questions of safety or<br>effectiveness. |
| Sterile | Ethylene Oxide (EO) | Radiation | Different; however<br>Differences in the<br>sterilization method do<br>not raise different<br>questions of safety and<br>effectiveness. |
| Single-Use | Yes | Yes | Same |
| French Size | Type 4 (catheter shaft):<br>1.7 mm / 5 Fr<br>2 mm / 6 Fr<br>Type 5 (catheter shaft):<br>2 mm / 6 Fr<br>Outer stiffener shaft of<br>catheter: 2.5 mm / 7.5 Fr | Catheter shaft<br>2 mm / 6 Fr<br>Outer stiffener shaft<br>2.5 mm/ 7.5 Fr | Similar |
| Length | 10 and 18 cm | 18 cm | Different; However, no<br>different questions of<br>safety and effectiveness<br>are raised due to a<br>shorter length of the<br>subject device. |
| Depth Marks | Centimeter marks are<br>located at 5, 6, 7, 8 cm from<br>tip on the outer stiffer | Centimeter marks are<br>located at 5, 6, 7, 8 cm from<br>tip on the outer stiffer | Same |
| Tip | Closed and smoothly<br>rounded; two side holes<br>end type | Closed and smoothly<br>rounded; two side holes<br>end type | Same |
| Stainless steel core | Type 4: No | No | Different; the Type 5 |
| Manufacturer | KITAZATO Corporation | KITAZATO Medical Co., Ltd. | Significant<br>Differences |
| Trade Name | Kitazato IUI Catheter | Kitazato IUI Catheter Type<br>3 with Outer Stiffener with<br>Stylet Cannula | |
| | Type 5: Yes | | version of the subject<br>device contains a<br>stainless steel core.<br>However, no different<br>questions of safety and<br>effectiveness are raised<br>by this inclusion. |
| Stylet | Type 4: Yes<br>Type 5: No | Yes | Different; the Type 5<br>model does not utilize<br>the optional Type 6<br>stylet cannula. However,<br>an internal stainless<br>steel core is present to<br>provide additional<br>rigidity during insertion.<br>No different questions<br>of safety and<br>effectiveness are raised. |
| Stylet length | 10 and 18 cm | 18 cm | Different; however, no<br>different questions of<br>safety and effectiveness<br>are raised due to the<br>shorter length. |
| Stylet width | 0.65 mm | 0.65 mm | Same |
| Materials | Polyvinyl chloride, ABS,<br>stainless steel | Polyvinyl chloride, ABS,<br>stainless steel | Same |
| Biocompatible per ISO<br>10993-1 | Yes | Yes | Same |
| HSSA | ≥ 70% motility at 24 hours | ≥ 70% motility at 24 hours | Same |
| Endotoxin | <20 EU/device | <20 EU/device | Same |

{6}------------------------------------------------

{7}------------------------------------------------

{8}------------------------------------------------

{9}------------------------------------------------

### 9. Non-Clinical Performance Data

As part of demonstrating safety and effectiveness of the Kitazato IUI Catheter that are subject to this 510(k) submission and in showing substantial equivalence to the predicate device, Kitazato Corporation completed a number of non-clinical performance tests.

The Kitazato IUI Catheter passed all the testing as shown below to support substantial equivalence to the subject device:

- . Mechanical Tensile Testing: Tensile strength of the shaft and connector passed the established specifications
- . Dimensional Testing: Passes outer diameter and length according to specifications
- . Appearance Testing: Passes visual inspection for scratches, burrs, and foreign objects
- . Endotoxin Testing per ANSI/AAMI ST72:2002/(R)2010: Endotoxin values conform to the specification of ≤20 EU/device
- . Sterility Testing per USP <71>: No microbial growth
- . Biocompatibility Testing per ISO 10993-1:2009 and 2016 FDA guidance document Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1:Evaluation and testing within a risk management process."
- O Cytotoxicity (ISO Extraction Method, ISO 10993-5:2009
- O Sensitization (ISO Guinea Pig Maximization Sensitization, ISO 10993-10:2010
- Irritation (ISO Intracutaneous Reactivity Test, ISO 10993-10:2010 o

The subject device passed testing for cytotoxicity, intracutaneous reactivity, and sensitization.

- Human Sperm Survival Assay (HSSA): ≥70% motility at 24 hours
- Color fastness of the depth marker bands: no change in appearance of depth marks following conditioning
- . Shelf Life Testing: Established three (3) year shelf life following real time aging. The following parameters were assessed during shelf life testing: tensile strength, dimension, appearance, sterility, endotoxin, HSSA, and color fastness.
- . Package Integrity Testing per ISO 11607-1:2006(R)2014, Packaging for Terminally Sterilized Medical Devices – Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging systems and ISO 11607-2:2006, Packaging for Terminally Sterilized Medical Devices – Part 2: Validation Requirements for Forming, Sealing, and Assembly Processes: passed dye penetration, seal strength, and visual inspection.

## 10. Statement of Substantial Equivalence

The results of the performance testing described above demonstrate that the Kitazato IUI Catheter is as safe and effective as the predicate device and supports a determination of substantial equivalence.