(227 days)
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.
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.
This document describes the Kitazato IUI Catheter. Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Tensile Testing | Passed established specifications | Passed |
| Dimensional Testing | Conforms to outer diameter and length specifications | Passed |
| Appearance Testing | Passes visual inspection for scratches, burrs, and foreign objects | Passed |
| Endotoxin Testing (per ANSI/AAMI ST72:2002/(R)2010) | ≤ 20 EU/device | Conforms to specification |
| Sterility Testing (per USP <71>) | No microbial growth | No microbial growth |
| Biocompatibility Testing (per ISO 10993-1:2009 and 2016 FDA guidance) | Cytotoxicity: Passed Sensitization: Passed Irritation: Passed | Passed cytotoxicity, intracutaneous reactivity (irritation), and sensitization |
| Human Sperm Survival Assay (HSSA) | ≥ 70% motility at 24 hours | ≥ 70% motility at 24 hours |
| Color fastness of the depth marker bands | No change in appearance after conditioning | No change in appearance |
| Shelf Life Testing | Established three (3) year shelf life | Established three (3) year shelf life |
| Package Integrity Testing (per ISO 11607-1:2006(R)2014, ISO 11607-2:2006) | Passed dye penetration, seal strength, and visual inspection | Passed dye penetration, seal strength, and visual inspection |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each individual non-clinical performance test (e.g., number of catheters tested for tensile strength, number of samples for HSSA, etc.). It only states that the device "passed all the testing."
Data provenance is not explicitly mentioned as country of origin, however, the submission sponsor is KITAZATO Corporation in Japan, and the predicate device is from KITAZATO Medical Co., Ltd. This implies the studies were likely conducted or overseen by the Japanese manufacturer. The studies are non-clinical, implying they are laboratory-based tests rather than human studies, therefore the retrospective or prospective nature is not applicable in the same way it would be for clinical trials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The reported studies are non-clinical performance tests for a medical device (catheter), not diagnostic studies requiring expert interpretation of results to establish ground truth.
4. Adjudication Method for the Test Set
Not applicable, as these are non-clinical performance tests with objective pass/fail criteria, not subjective human-interpreted data requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No. An MRMC comparative effectiveness study is designed for evaluating diagnostic tools where human readers are involved in interpreting results. This document describes non-clinical performance tests of a physical medical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, standalone performance was done in the sense that the device itself was subjected to a series of tests to verify its physical, chemical, and biological properties without human intervention in the device's function during the test itself (e.g., tensile strength, sterility, biocompatibility).
7. The Type of Ground Truth Used
The ground truth for these non-clinical tests is established by recognized international standards and specifications (e.g., ANSI/AAMI, USP, ISO 10993, ISO 11607). For instance:
- Mechanical properties: Engineering specifications for tensile strength, dimensions.
- Sterility: Absence of microbial growth, as defined by USP <71>.
- Endotoxin: Endotoxin levels below a specified threshold, as defined by ANSI/AAMI ST72.
- Biocompatibility: Absence of cytotoxicity, sensitization, and irritation as evaluated against ISO 10993 standards and FDA guidance.
- HSSA: A specific percentage of sperm motility after a defined period (≥70% at 24 hours).
- Package Integrity: Meeting requirements of ISO 11607.
8. The Sample Size for the Training Set
Not applicable. This report details acceptance criteria and performance data for a medical device based on non-clinical testing, not a machine learning or AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reason as above (no training set for a non-AI medical device).
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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.
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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
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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)
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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: project.management@emergogroup.com
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 |
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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:
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| 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. | SignificantDifferences |
|---|---|---|---|
| Trade Name | Kitazato IUI Catheter | Kitazato IUI Catheter Type3 with Outer Stiffener withStylet Cannula | |
| 510(k) Number | K162677 | K131491 | N/A |
| Product Code | MQF | MQF | Same |
| Regulation Number | 884.6110 | 884.6110 | Same |
| Regulation Name | Assisted ReproductionCatheter | Assisted ReproductionCatheter | Same |
| Indications for Use | Kitazato IUI Catheterconsists of the following | Kitazato IUI Catheter consist | Different. The Stylet isnot included separately |
| Manufacturer | KITAZATO Corporation | KITAZATO Medical Co., Ltd. | SignificantDifferences |
| Trade Name | Kitazato IUI Catheter | Kitazato IUI Catheter Type3 with Outer Stiffener withStylet Cannula | |
| versions:Kitazato IUI Catheterwith Outer Stiffenerwith or without StyletCannula, 18 cm, modelnumber Type 4-v1 andType 4-v2 Kitazato IUI Catheterwith Outer Stiffenerwith or without StyletCannula, 10 cm, modelnumber Type 4-v3 andType 4-v4 Kitazato IUI Catheterwith Outer Stiffenerwith Stainless SteelCore, 18 cm, modelnumber Type 5-v1 andType 5-v2 Kitazato IUI Catheterwith Outer Stiffenerwith Stainless SteelCore, 10 cm, modelnumber Type 5-v3 andType 5-v4 Kitazato IUI Catheter is usedfor the introduction ofwashed spermatozoa intothe uterine cavity throughthe cervix.Kitazato IUI Stylet is used toprovide rigidity and assist inmaintaining the shape ofthe catheter shaft. | of the following versions:Kitazato IUI Catheterwith Outer Stiffenerwith Stylet Cannula, 18cm, model numberType 3-v1 Kitazato IUI Catheterwith Outer Stiffenerwithout Stylet Cannula,18 cm, model numberType 3-v2 Kitazato IUI Catheter is usedfor the introduction ofwashed spermatozoa intothe uterine cavity throughthe cervix. | in the indications for usestatement of thepredicate device.However, the inclusionof a stylet does notrepresent a newintended use. | |
| Overall Design | The device consists of typesof IUI catheters with anouter stiffener with nostainless steel core (Type 4),outer stiffener withstainless steel core (Type 5) | The device consists of typesof IUI catheters with anouter stiffener with andwithout a stylet cannula(Type 3). The catheter has a | Different; the subjectdevice includes a versionof the IUI catheter thatutilizes a stainless steelcore. The inclusion ofthis stainless steel core |
| Manufacturer | KITAZATO Corporation | KITAZATO Medical Co., Ltd. | Significant |
| Trade Name | Kitazato IUI Catheter | Kitazato IUI Catheter Type3 with Outer Stiffener withStylet Cannula | Differences |
| and stylet cannula for Type4 catheters. The catheterhas a smooth distal tip withtwo side holes. All typeshave a syringe connectorhub compatible with a 6%taper syringe (not included).The catheters are packagedin a barrier sterilizationpackage. | side holes. All types have asyringe connector hubcompatible with a 6% tapersyringe (not included). Thecatheters are packaged in abarrier sterilizationpackage. | does not raise differentquestions of safety oreffectiveness. | |
| Sterile | Ethylene Oxide (EO) | Radiation | Different; howeverDifferences in thesterilization method donot raise differentquestions of safety andeffectiveness. |
| Single-Use | Yes | Yes | Same |
| French Size | Type 4 (catheter shaft):1.7 mm / 5 Fr2 mm / 6 FrType 5 (catheter shaft):2 mm / 6 FrOuter stiffener shaft ofcatheter: 2.5 mm / 7.5 Fr | Catheter shaft2 mm / 6 FrOuter stiffener shaft2.5 mm/ 7.5 Fr | Similar |
| Length | 10 and 18 cm | 18 cm | Different; However, nodifferent questions ofsafety and effectivenessare raised due to ashorter length of thesubject device. |
| Depth Marks | Centimeter marks arelocated at 5, 6, 7, 8 cm fromtip on the outer stiffer | Centimeter marks arelocated at 5, 6, 7, 8 cm fromtip on the outer stiffer | Same |
| Tip | Closed and smoothlyrounded; two side holesend type | Closed and smoothlyrounded; two side holesend type | Same |
| Stainless steel core | Type 4: No | No | Different; the Type 5 |
| Manufacturer | KITAZATO Corporation | KITAZATO Medical Co., Ltd. | SignificantDifferences |
| Trade Name | Kitazato IUI Catheter | Kitazato IUI Catheter Type3 with Outer Stiffener withStylet Cannula | |
| Type 5: Yes | version of the subjectdevice contains astainless steel core.However, no differentquestions of safety andeffectiveness are raisedby this inclusion. | ||
| Stylet | Type 4: YesType 5: No | Yes | Different; the Type 5model does not utilizethe optional Type 6stylet cannula. However,an internal stainlesssteel core is present toprovide additionalrigidity during insertion.No different questionsof safety andeffectiveness are raised. |
| Stylet length | 10 and 18 cm | 18 cm | Different; however, nodifferent questions ofsafety and effectivenessare raised due to theshorter length. |
| Stylet width | 0.65 mm | 0.65 mm | Same |
| Materials | Polyvinyl chloride, ABS,stainless steel | Polyvinyl chloride, ABS,stainless steel | Same |
| Biocompatible per ISO10993-1 | Yes | Yes | Same |
| HSSA | ≥ 70% motility at 24 hours | ≥ 70% motility at 24 hours | Same |
| Endotoxin | <20 EU/device | <20 EU/device | Same |
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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.
§ 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).