Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a simple mechanical catheter for sperm delivery and contains no mention of AI or ML technologies.

Therapeutic

Yes

This device is used for the introduction of washed spermatozoa into the uterine cavity, which is a medical intervention aimed at achieving a therapeutic outcome (pregnancy in cases of infertility).

Diagnostic

No

This device is used for the introduction of washed spermatozoa into the uterine cavity, which is an interventional procedure for treatment (insemination), not for diagnosing a condition.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical catheter composed of a shaft and connector, used for introducing washed spermatozoa. It also details mechanical and dimensional testing, which are relevant to hardware.

IVD (In Vitro Diagnostic)

Based on the provided information, the Kitazato IUI Catheter is not an In Vitro Diagnostic (IVD).

Here's why:

Intended Use: The intended use is the "introduction of washed spermatozoa into the uterine cavity through the cervix." This is a procedure performed directly on the patient's body, not on a sample taken from the body.
Device Description: The device is a catheter used to deliver material (spermatozoa) into the body. This is a delivery device, not a device used to analyze a sample.
Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples, detecting substances, or providing diagnostic information based on in vitro testing.

IVDs are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Kitazato IUI Catheter's function is to facilitate a therapeutic procedure (insemination), not to perform diagnostic testing on a sample.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Kitazato IUI Catheters consist of the following versions:

Kitazato IUI Catheter with Stainless Steel Core Type, 10 cm, model number Type 1-v1 .
Kitazato IUI Catheter with Stainless Steel Core Type, 7 cm, model number Type 1-v2 .
Kitazato IUI Catheter without Stainless Steel Core Type, 10 cm, model number Type 2-v1 .
Kitazato IUI Catheter without Stainless Steel Core Type, 7 cm, model number Type 2-v2 .

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

Product codes

MQF

Device Description

Kitazato IUI Catheters are sterile, single-use catheters for use in infusion of washed spermatozoa into the uterine cavity. Catheters are composed of a catheter shaft and a connector. The connector is connected to a syringe (not included with the catheter), and washed spermatozoa are aspirated through the tip of the catheter shaft connected to the syringe. During the insemination procedure, the shaft of catheter is introduced into the uterine cavity through the cervix, and then spermatozoa are injected into the uterine cavity.

The Kitazato IUI Catheter has the following types; IUI Catheter with Stainless Steel Center Core Type and IUI Catheter without Stainless Steel Center Core Type.

IUI Catheter with Stainless Steel Center Core Type: Catheters of this type consist of a catheter body and the connector. The rounded tip of the catheter shaft has a side hole used for aspiration and delivery of sperm. These catheters incorporate a stainless steel core in the center of the catheter shaft to provide rigidity to the catheter during device placement procedures. The connector has a 6% taper that allows it to be coupled with a standard syringe. One model is offered with the shaft of the catheter containing a depth mark and a stopper that aids in setting catheter insertion depth.

IUI Catheter without Stainless Steel Center Core Type: Catheters of this type consist of a catheter body and the connector. The rounded tip of the catheter shaft has a side hole used for aspiration and delivery of sperm. These catheters do not include a stainless steel center core in the body of the catheter. The connector has a 6% taper that allows it to be coupled with a standard syringe. One model is offered with the shaft of the catheter containing a depth mark and a stopper that aids in setting catheter insertion depth.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

uterine cavity through the cervix

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Testing:

Mechanical Tensile Testing: Tensile strength to withstand 4.9N
Dimensional Testing: Passes outer diameter and length according to specifications
Endotoxin Testing: Endotoxin values conform to the value ≤20 EU/device
Sterility Testing: No microbial growth from sterility testing
Human Sperm Survival Assay: ≥70% motility at 24 hours

The Kitazato IUI Catheters passed all testing and supports the claims of substantial equivalence and safe operation.
The Kitazato IUI Catheters complies with the applicable voluntary standards for biocompatibility and sterilization. The device passed all the testing in accordance with national and international standards.

Clinical Testing:
There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with a proven safety and efficacy for the use of the device. The substantial equivalence of the device is supported by the non-clinical testing. The validation testing of the device biocompatibility and HSSA testing was found to be acceptable and supports the claims of substantial equivalence.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K013501

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

0

510(k) Summary

For

NOV

Kitazato IUI Catheters – K112396

1. Submission Sponsor

KITAZATO Medical Co., Ltd. 2-15-12 Hongo, Bunkyou-ku Tokyo 113-0033 JAPAN Phone: +(81) 3-5800-6055 Fax: +(81) 3-5800-6056 Contact: Mari Yazaki, Quality Assurance Manager

2. Submission Correspondent

Emergo Group 611 West 5th Street, Third Floor Austin, TX 78701 Cell Phone: (508) 838.9139 Office Phone: (512) 327.9997 Fax: (512) 327.9998 Contact: Richard Vincins, Vice President, QA Email: richard@emergogroup.com

3. Date Prepared

30 October 2012

4. Device Name

| Trade/Proprietary Name: | Kitazato IUI Catheter with Stainless Steel Center Core Type, 10
cm, model number Type 1-v1
Kitazato IUI Catheter with Stainless Steel Center Core Type, 7
cm, model number Type 1-v2
Kitazato IUI Catheter without Stainless Steel Center Core Type,
10 cm, model number Type 2-v1
Kitazato IUI Catheter without Stainless Steel Center Core Type,
7 cm, model number Type 2-v2 |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Kitazato Intrauterine Insemination (IUI) Catheter |
| Classification Name: | Assisted Reproduction Catheter |
| Classification Regulation: | 884.6110 |
| Classification Panel: | Obstetrics/Gynecology |

1

Product Code: MQF Device Class: =

5. Predicate Devices

Gynetics Medical Products N.V. – Smooze Model 4225 – K013501

6. Indication for Use

Kitazato IUI Catheters consist of the following versions:

Kitazato IUI Catheter with Stainless Steel Core Type, 10 cm, model number Type 1-v1 .
Kitazato IUI Catheter with Stainless Steel Core Type, 7 cm, model number Type 1-v2 .
Kitazato IUI Catheter without Stainless Steel Core Type, 10 cm, model number Type 2-. v 1
. Kitazato IUI Catheter without Stainless Steel Core Type, 7 cm, model number Type 2v 2

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

7. Device Description

Kitazato IUI Catheters are sterile, single-use catheters for use in infusion of washed spermatozoa into the uterine cavity. Catheters are composed of a catheter shaft and a connector. The connector is connected to a syringe (not included with the catheter), and washed spermatozoa are aspirated through the tip of the catheter shaft connected to the syringe. During the insemination procedure, the shaft of catheter is introduced into the uterine cavity through the cervix, and then spermatozoa are injected into the uterine cavity.

The Kitazato IUI Catheter has the following types; IUI Catheter with Stainless Steel Center Core Type and IUI Catheter without Stainless Steel Center Core Type.

IUI Catheter with Stainless Steel Center Core Type: Catheters of this type consist of a catheter body and the connector. The rounded tip of the catheter shaft has a side hole used for aspiration and delivery of sperm. These catheters incorporate a stainless steel core in the center of the catheter shaft to provide rigidity to the catheter during device placement procedures. The connector has a 6% taper that allows it to be coupled with a standard syringe. One model is offered with the shaft of the catheter containing a depth mark and a stopper that aids in setting catheter insertion depth.

| Model | Trade Name | Catheter
Body | Catheter
Length | Outer
Diameter | Depth
Mark | Stopper |
|-----------|-------------------------------------------------------|------------------|--------------------|-------------------|---------------|---------|
| Type1 -v1 | IUI Catheter with Stainless
Steel Center Core Type | 12 Nylon | 10 cm | 1.65 mm / 5 Fr | Yes @
7 cm | Yes |
| Type1 -v2 | IUI Catheter with Stainless
Steel Center Core Type | 12 Nylon | 7 cm | 1.65 mm / 5 Fr | No | No |

2

IUI Catheter without Stainless Steel Center Core Type: Catheters of this type consist of a catheter body and the connector. The rounded tip of the catheter shaft has a side hole used for aspiration and delivery of sperm. These catheters do not include a stainless steel center core in the body of the catheter. The connector has a 6% taper that allows it to be coupled with a standard syringe. One model is offered with the shaft of the catheter containing a depth mark and a stopper that aids in setting catheter insertion depth.

| Model | Trade Name | Catheter
Body | Catheter
Length | Outer
Diameter | Depth
Mark | Stopper |
|-----------|-------------------------------------------------------------|------------------|--------------------|-------------------|---------------|---------|
| Type2 -v1 | IUI Catheter without
Stainless Steel Center
Core Type | 12 Nylon | 10cm | 1.65 mm / 5 Fr | Yes @
7 cm | Yes |
| Type2 -v2 | IUI Catheter without
Stainless Steel Center
Core Type | 12 Nylon | 7cm | 1.65 mm / 5 Fr | No | No |

Comparison Table - Kitazato IUI Catheter with Stainless Steel Center Core, 10 cm, Type 1-v1

| Manufacturer | KITAZATO Medical Co., Ltd. | Gynetics Medical Products NV | Kitazato IUI Catheter
Comparison to Predicate |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Kitazato IUI Catheter with
Stainless Steel Center Core | Intra-Uterine Insemination and
GIFT Catheters, Smooze #4225 | N/A |
| 510(k) Number | K112396 | K013501 | Same |
| Product Code | MQF | MQF | Same |
| Regulation
Number | 884.6110 | 884.6110 | Same |
| Regulation
Name | Assisted Reproduction Catheter | Assisted Reproduction Catheter | Same |
| Indications for
use: | The Kitazato IUI Catheter with
Stainless Steel Center Core is
used for the introduction of
washed spermatozoa into the
uterine cavity through the
cervix. | The Intra-Uterine Insemination
Cannula is to be used for intra
uterine artificial insemination
procedures utilizing washed
spermatozoa. | Same |
| Overall Design | The device consists of Catheter
with Stainless Steel Center Core.
The catheters are packaged in a
barrier sterilization pouch
/wrapping. A syringe is not
included in the products. | The device consists of Catheter
without Stainless Steel Center
Core. The catheters are
packaged in a barrier
sterilization pouch /wrapping. A
syringe is not included in the
products. | There are slight differences
that are discussed; the
stainless steel core is to add
rigidity for the catheter to
assist if the uterine cervix is
curved. This does not impact
the use of the device and
adds no safety or efficacy
concerns as the Stainless
Center Core is inside the
catheter similar to the
function of a stylet that is
commonly used with invasive
catheters. |
| Sterile | Radiation | Radiation | Same |
| Single-Use | Yes | Yes | Same |
| French Size | 1.65 mm (5 Fr) | 2 mm (6 Fr) | These have similar size outer
diameter of catheter; the
size difference of 0.35 mm or
one French size does not |
| Manufacturer | KITAZATO Medical Co., Ltd. | Gynetics Medical Products NV | Kitazato IUI Catheter
Comparison to Predicate |
| Trade Name | Kitazato IUI Catheter with
Stainless Steel Center Core | Intra-Uterine Insemination and
GIFT Catheters, Smooze #4225 | |
| | | | impact the use of the device
and adds no safety or
efficacy concerns. |
| Length | 10 cm | 7 cm, 14 cm, 20 cm | The length of the Kitazato IUI
catheter is within the range
of the predicate device. |
| Depth Marks | Reference mark is located at 7
cm from tip | No Depth Mark | The mark at 7 cm from the
tip is used as a reference
point; the physician
measures the length of
uterus prior to insertion of
the catheter and the mark is
used as a guide. This does
not impact the use of the
device and adds no safety or
efficacy concerns. |
| Tip | Closed and smoothly rounded;
one side hole end type | Closed and smoothly rounded;
one side hole end type | Same |
| Stylet | No; inner stainless steel center
core | No | The stainless steel core is to
add rigidity for the catheter
to assist if the uterine cervix
is curved. This does not
impact the use of the device
and adds no safety or
efficacy concerns as the
Stainless Steel Center Core is
inside the catheter similar to
the function of a stylet that is
commonly used with invasive
catheters. |
| Stopper | Yes | No | The stopper is used as a
reference point; the
physician measures the
length of uterus prior to
insertion of the catheter and
utilizes the stopper as a
guide. This does not impact
the use of the device and
adds no safety or efficacy
concerns |
| Manufacturer | KITAZATO Medical Co., Ltd. | Gynetics Medical Products NV | Kitazato IUI Catheter Comparison to Predicate |
| Trade Name | Kitazato IUI Catheter with
Stainless Steel Center Core | Intra-Uterine Insemination and
GIFT Catheters, Smooze #4225 | N/A |
| 510(k) Number | K112396 | K013501 | N/A |
| Product Code | MQF | MQF | Same |
| Regulation
Number | 884.6110 | 884.6110 | Same |
| Regulation
Name | Assisted Reproduction Catheter | Assisted Reproduction Catheter | Same |
| Indications for
use: | The Kitazato IUI Catheter with
Stainless Steel Center Core is
used for the introduction of
washed spermatozoa into the
uterine cavity through the
cervix. | The Intra-Uterine Insemination
Cannula is to be used for intra
uterine artificial insemination
procedures utilizing washed
spermatozoa. | Same |
| Overall Design | The device consists of Catheter
with Stainless Steel Center Core.
The catheters are packaged in a
barrier sterilization pouch
/wrapping. A syringe is not
included in the products. | The device consists of Catheter
without Stainless Steel Center
Core. The catheters are
packaged in a barrier
sterilization pouch /wrapping. A
syringe is not included in the
products. | There are slight differences
that are discussed; the
stainless steel core is to add
rigidity for the catheter to
assist if the uterine cervix is
curved. This does not impact
the use of the device and
adds no safety or efficacy
concerns as the Stainless
Steel Center Core is inside
the catheter similar to the
function of a stylet that is
commonly used with invasive
catheters. |
| Sterile | Radiation | Radiation | Same |
| Single-Use | Yes | Yes | Same |
| French Size | 1.65 mm (5 Fr) | 2 mm (6 Fr) | These have similar size outer
diameter of catheter; the
size difference of 0.35 mm or
one French size does not
impact the use of the device
and adds no safety or
efficacy concerns. |
| Length | 7 cm | 7 cm, 14 cm, 20 cm | The length of the Kitazato IUI
catheter is within the range
of the predicate device. |
| Depth Marks | No Depth Mark | No Depth Mark | Same |
| Tip | Closed and smoothly rounded;
one side hole end type | Closed and smoothly rounded;
one side hole end type | Same |
| Stylet | No; inner stainless steel center
core | No | The stainless steel core is to
add rigidity for the catheter
to assist if the uterine cervix
is curved. This does not
impact the use of the device
and adds no safety or
efficacy concerns as the |

3

and the control control of the control of the control of

1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 -

4

:

.

	Comparison Table – Kitazato IUI Catheter with Stainless Steel Center Core, 7 cm, Type 1-v2
--	--------------------------------------------------------------------------------------------	--	--	--

.

·

5

| Manufacturer | KITAZATO Medical Co., Ltd. | Gynetics Medical Products NV | Kitazato IUI Catheter
Comparison to Predicate |
|--------------|-----------------------------------------------------------|----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Kitazato IUI Catheter with
Stainless Steel Center Core | Intra-Uterine Insemination and
GIFT Catheters, Smooze #4225 | |
| | | | Stainless Steel Center Core is
inside the catheter similar to
the function of a stylet that is
commonly used with invasive
catheters. |
| Stopper | No | No | Same |

Comparison Table – Kitazato IUI Catheter without Stainless Steel Center Core Type, 10 cm, Type 2-v1

Manufacturer	KITAZATO Medical Co., Ltd.	Gynetics Medical Products NV	Kitazato IUI Catheter Comparison to Predicate
Trade Name	Kitazato IUI Catheter without
Stainless Steel Center Core	Intra-Uterine Insemination and
GIFT Catheters, Smooze #4225	N/A
510(k) Number	K112396	K013501	Same
Product Code	MQF	MQF	Same
Regulation
Number	884.6110	884.6110	Same
Regulation
Name	Assisted Reproduction Catheter	Assisted Reproduction Catheter	Same
Indications for
use:	The Kitazato IUI Catheter is used
for the introduction of washed
spermatozoa into the uterine
cavity through the cervix.	The Intra-Uterine Insemination
Cannula is to be used for intra
uterine artificial insemination
procedures utilizing washed
spermatozoa	Same
Overall Design	The device consists of Catheter
without Stainless Steel Center
Core. The catheters are
packaged in a barrier
sterilization pouch /wrapping. A
syringe is not included in the
products.	The device consists of Catheter
without Stainless Center Core.
The catheters are packaged in a
barrier sterilization pouch
/wrapping. A syringe is not
included in the products.	Same
Sterile	Radiation	Radiation	Same
Single-Use	Yes	Yes	Same
French Size	1.65 mm (5 Fr)	2 mm (6 Fr)	These have similar size outer
diameter of catheter; the
size difference of 0.35 mm or
one French size does not
impact the use of the device
and adds no safety or
efficacy concerns.

.

•

6

| Manufacturer
Trade Name | KITAZATO Medical Co., Ltd.
Kitazato IUI Catheter without
Stainless Steel Center Core | Gynetics Medical Products NV
Intra-Uterine Insemination and
GIFT Catheters, Smooze #4225. | Kitazato IUI Catheter
Comparison to Predicate |
|----------------------------|--------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Length | 10 cm | 7 cm, 14 cm, 20 cm | The length of the Kitazato IUI
catheter is within the range
of the predicate device. |
| Depth Marks | Reference mark is located at 7
cm from tip | No Depth Mark | The mark at 7 cm from the
tip is used as a reference
point; the physician
measures the length of
uterus prior to insertion of
the catheter and the mark is
used as a guide. This does
not impact the use of the
device and adds no safety or
efficacy concerns. |
| Tip | Closed and smoothly rounded;
one side hole end type | Closed and smoothly rounded;
one side hole end type | Same |
| Stylet | No | No | Same |
| Stopper | Yes | No | The stopper is used as a
reference point; the
physician measures the
length of uterus prior to
insertion of the catheter and
utilizes the stopper as a
guide. This does not impact
the use of the device and
adds no safety or efficacy
concerns. |

Comparison Table – Kitazato IUI Catheter without Stainless Steel Center Core Type, 7 cm, Type 2-v2

| Manufacturer | KITAZATO Medical Co., Ltd. | Gynetics Medical Products NV | Kitazato IUI Catheter
Comparison to Predicate |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|
| Trade Name | Kitazato IUI Catheter without
Stainless Steel Center Core | Intra-Uterine Insemination and
GIFT Catheters, Smooze #4225 | |
| 510(k) Number | K112396 | K013501 | N/A |
| Product Code | MQF | MQF | Same |
| Regulation
Number | 884.6110 | 884.6110 | Same |
| Regulation
Name | Assisted Reproduction Catheter | Assisted Reproduction Catheter | Same |
| Indications for
use: | The Kitazato IUI Catheter is used
for the introduction of washed
spermatozoa into the uterine
cavity through the cervix. | The Intra-Uterine Insemination
Cannula is to be used for intra
uterine artificial insemination
procedures utilizing washed
spermatozoa | Same |
| Overall Design | The device consists of Catheter
without Stainless Steel Center
Core. The catheters are
packaged in a barrier
sterilization pouch /wrapping. A
syringe is not included in the | The device consists of Catheter
without Stainless Center Core.
The catheters are packaged in a
barrier sterilization pouch
/wrapping. A syringe is not
included in the products. | Same |

·

7

Manufacturer	KITAZATO Medical Co., Ltd.	Gynetics Medical Products NV	Kitazato IUI Catheter Comparison to Predicate
Trade Name	Kitazato IUI Catheter without
Stainless Steel Center Core
products.	Intra-Uterine Insemination and
GIFT Catheters, Smooze #4225
Sterile	Radiation	Radiation	Same
Single-Use	Yes	Yes	Same
French Size	1.65 mm (5 Fr)	2 mm (6 Fr)	These have similar size outer
diameter of catheter; the
size difference of 0.35 mm or
one French size does not
impact the use of the device
and adds no safety or
efficacy concerns.
Length	7 cm	7 cm, 14 cm, 20 cm	The length of the Kitazato IUI
catheter is within the range
of the predicate device.
Depth Marks	No Depth Mark	No Depth Mark	Same
Tip	Closed and smoothly rounded;
one side hole end type	Closed and smoothly rounded;
one side hole end type	Same
Stylet	No	No	Same
Stopper	No	No	Same

8. Technological Characteristics

The indication for use and technology of the Kitazato IUI Catheters is substantially equivalent to the identified predicate devices.

9. Non-Clinical Testing

The catheter mechanical tensile testing, dimension testing, endotoxin testing, sterility testing and Human Sperm Survival Assay results support that all the specifications have met the acceptance criteria for the device.

. Mechanical Tensile Testing: Tensile strength to withstand 4.9N
. Dimensional Testing: Passes outer diameter and length according to specifications
Endotoxin Testing: Endotoxin values conform to the value ≤20 EU/device
. Sterility Testing: No microbial growth from sterility testing
. Human Sperm Survival Assay: ≥70% motility at 24 hours

The Kitazato IUI Catheters passed all testing and supports the claims of substantial equivalence and safe operation.

The Kitazato IUI Catheters complies with the applicable voluntary standards for biocompatibility and sterilization. The device passed all the testing in accordance with national and international standards.

8

10. Clinical Testing

There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with a proven safety and efficacy for the use of the device. The substantial equivalence of the device is supported by the non-clinical testing. The validation testing of the device biocompatibility and HSSA testing was found to be acceptable and supports the claims of substantial equivalence.

11. 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 to the predicate device.

It has been shown in this 510(k) submission that any differences between the Kitazato IUI Catheters and the predicate device do not raise any questions regarding its safety and effectiveness. The Kitazato IUI Catheters, as designed and manufactured, are substantially equivalent to the referenced predicate devices.

9

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/9/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 a stylized image of an eagle with its wings spread, with three wavy lines below the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Letter Date: November 2, 2012

KITAZATO Medical Co., Ltd. % Mr. Richard Vincins, CQA, CBA, RAC (US, EU) Vice President, QA Emergo Group, Inc. 611 West 5th Street, Third Floor AUSTIN TX 78701

Re: K112396

Trade/Device Name: Kitazato IUI Catheter with Stainless Steel Core Type, 10 cm, model number Type 1-v1 and 7 cm, model number Type 1-v2 Kitazato IUI Catheter without Stainless Steel Core Type, 10 cm, model number Type 2-v1 and 7 cm, model number Type 2-v2 Regulation Number: 21 CFR§ 884.6110 Regulation Name: Assisted reproduction catheters Regulatory Class: II

Product Code: MQF

Dated: October 22, 2012

Received: October 22, 2012

Dear Mr. Vincins:

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 for answer of 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 rublish further announcements concerning your device in the Federal Register.

10

Page 2 - Mr. Richard Vincins, CQA, CBA, RAC (US, EU)

Please be advised that FDA's issuance of a substantial equivalence determination does not mean 1 lease be advised that I Drisean.teat your device complies with other requirements of the Act that I Dr has Intact a and regulations administered by other Federal agencies. You must or any 1 outlated and 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 Of it Fart 60 7), accember (21 CFR 803); good manufacturing practice requirements as set de recording systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (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 n you desire specific advisiboutFDA/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 note the regulation untiled, "Mischange 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 I ou may other baller generational and Consumer Assistance 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,

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

11

Indications for Use Statement

510(k) Number (if known): K112396

Device Name: Kitazato IUI Catheter

Indications for Use:

Kitazato IUI Catheters consist of the following versions:

Kitazato IUI Catheter with Stainless Steel Core Type, 10 cm, model number Type 1-v1 .
Kitazato IUI Catheter with Stainless Steel Core Type, 7 cm, model number Type 1-v2 .
Kitazato IUI Catheter without Stainless Steel Core Type, 10 cm, model number Type 2-v1 .
Kitazato IUI Catheter without Stainless Steel Core Type, 7 cm, model number Type 2-v2 .

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

(Part 21 CFR 801 Subpart D) Prescription Use _____________________________________________________________________________________________________________________________________________________________ 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)
--------------------------------------------------------

	Benjamin R. Fisher -S
	2012.11.02 16:12:25-04'00'

Division Sign-Off)

Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K112396