Who is the manufacturer of IUI CATHETERS?

Kitazato Medical Co., Ltd. filed the 510(k) submission for IUI CATHETERS (K112396).

What is the FDA product code for IUI CATHETERS?

MQF. It is classified under 21 CFR 884.6110 as a Class 2 device in the Obstetrics/Gynecology panel.

What is the regulatory pathway for IUI CATHETERS?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like IUI CATHETERS?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

IUI CATHETERS

K112396 · Kitazato Medical Co., Ltd. · MQF · Nov 2, 2012 · Obstetrics/Gynecology

Device Facts

Record ID	K112396
Device Name	IUI CATHETERS
Applicant	Kitazato Medical Co., Ltd.
Product Code	MQF · Obstetrics/Gynecology
Decision Date	Nov 2, 2012
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 884.6110
Device Class	Class 2
Attributes	Therapeutic

Intended 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.

Device Story

Sterile, single-use catheter for intrauterine insemination (IUI). Device consists of a nylon catheter shaft and a connector with a 6% taper for syringe coupling. Washed spermatozoa are aspirated into the catheter via a syringe and injected into the uterine cavity through the cervix. Models include versions with or without an internal stainless steel core to provide rigidity during placement, similar to a stylet. Some models feature a depth mark and stopper to assist in setting insertion depth. Used by clinicians in a clinical setting. Benefits include controlled delivery of sperm to the uterine cavity to facilitate conception.

Clinical Evidence

No clinical testing performed. Substantial equivalence supported by non-clinical bench testing: mechanical tensile strength (4.9N), dimensional verification, endotoxin levels (≤20 EU/device), sterility, and Human Sperm Survival Assay (≥70% motility at 24 hours).

Technological Characteristics

Materials: 12 Nylon catheter body, stainless steel core (select models). Dimensions: 1.65 mm (5 Fr) outer diameter, 7 cm or 10 cm length. Features: Closed rounded tip with side hole, 6% taper connector. Sterilization: Radiation. Single-use.

Indications for Use

Indicated for intrauterine artificial insemination procedures in patients requiring the introduction of washed spermatozoa into the uterine cavity through the cervix.

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

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

Related Devices

K162667 — Kitazato IUI Catheter · Kitazato Corporation · May 11, 2017
K964848 — WALLACE ARTIFICIAL INSEMINATION CATHETER - 8CM/18CM · Marlow Surgical Technologies, Inc. · Jan 16, 1997
K190522 — Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip Intra Uterine Insemination Catheter, CURVED and CURVED Open Tip Intra Uterine Insemination Catheter, TRACKABLE and TRACKABLE Open Tip Intra Uterine Insemination Catheter, FLEXI and FLEXI Open Tip Intra Uterine Insemination Catheter, STUMPY Intra Uterine Insemination Catheter) · Allwin Medical Devices, Inc. · Nov 14, 2019
K021438 — INSEMINATION CATHETER, MODEL 320301 · Labotect Labor-Technik Gottingen · Jul 16, 2002
K052059 — IUI CATHETER, MODEL 9057 · Inntec, Inc. · Nov 22, 2005

Submission Summary (Full Text)

{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

IUI CATHETERS

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IUI CATHETERS

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