(227 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and biological compatibility of a catheter and stylet for intrauterine insemination. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
The device is used to introduce washed spermatozoa into the uterine cavity, which is a therapeutic intervention for infertility.
No
The device is described as an IUI catheter used for sperm delivery into the uterine cavity, not for diagnosing any condition.
No
The device description clearly details physical components made of materials like polyvinyl chloride, ABS, and stainless steel, and the performance studies focus on physical and biological characteristics, not software validation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Kitazato IUI Catheter is a device used to introduce material (washed spermatozoa) into the body. It is a delivery system, not a test that analyzes a sample taken from the body.
- Intended Use: The intended use clearly states "introduction of washed spermatozoa into the uterine cavity through the cervix." This is a procedural device, not a diagnostic test.
- Device Description: The description details the physical components and how the device is used for insertion and delivery. It does not describe any analytical or testing capabilities.
- Performance Studies: The performance studies listed are related to the physical and biological compatibility of the device itself (mechanical strength, sterility, biocompatibility, sperm survival after contact with the device), not the analysis of a biological sample for diagnostic purposes.
Therefore, based on the provided information, the Kitazato IUI Catheter is a medical device used for a therapeutic procedure (intrauterine insemination), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Kitazato IUI Catheter is used for the introduction of washed spermatozoa into the uterine cavity through the cervix. Kitazato IUI Stylet is used to provide rigidity and assist in maintaining the shape of the catheter shaft.
Product codes (comma separated list FDA assigned to the subject device)
MOF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Uterine cavity, 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 Performance Data: Mechanical Tensile Testing, Dimensional Testing, Appearance Testing, Endotoxin Testing per ANSI/AAMI ST72:2002/(R)2010, Sterility Testing per USP , 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.", Human Sperm Survival Assay (HSSA), Color fastness of the depth marker bands, Shelf Life Testing, 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.
Key results: The Kitazato IUI Catheter passed all the testing as shown below to support substantial equivalence to the subject device. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Endotoxin: ≤20 EU/device
- HSSA: ≥70% motility at 24 hours
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 11, 2017
Kitazato Corporation % Audrey Swearingen, RAC Director, Regulatory Affairs Emergo Global Consulting. LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, TX 78746
Re: K162667 Trade/Device Name: Kitazato IUI Catheter Regulation Number: 21 CFR§ 884.6110 Regulation Name: Assisted Reproduction Catheters Regulatory Class: II Product Code: MOF Dated: April 13, 2017 Received: April 14, 2017
Dear Audrey Swearingen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
1
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (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
2
Indications for Use
510(k) Number (if known) K162667
Device Name Kitazato IUI Catheter
Indications for Use (Describe)
Kitazato IUI Catheter consists of the following versions:
· Kitazato IUI Catheter with Outer Stiffener with or without Stylet Cannula, 18 cm, model number Type 4-v1 and Type 4v2
· Kitazato IUI Catheter with Outer Stiffener with or without Stylet Cannula, 10 cm, model number Type 4-v3 and Type 4v4
· Kitazato IUI Catheter with Outer Stiffener with Stainless Steel Core, 18 cm, model number Type 5-v1 and Type 5-v2
· Kitazato IUI Catheter with Outer Stiffener with Stainless Steel Core, 10 cm, model number Type 5-v3 and Type 5-v4 Kitazato IUI Catheter is used for the introduction of washed spermatozoa into the uterine cavity through the cervix. Kitazato IUI Stylet is used to provide rigidity and assist in maintaining the shape of the catheter shaft.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
Kitazato IUI Catheter
K162667
1. Submission Sponsor
KITAZATO Corporation
1-1-8 Shibadaimon, Minato-ku
Tokyo 105-0012
JAPAN
Contact: Ms. Mari YAZAKI
Title: Quality Assurance Manager
Phone number: + (81) 3 - 3434 -2731
2. Submission Correspondent
Emergo Global Consulting, LLC
2500 Bee Cave Road
Building 1, Suite 300
Austin, TX 78746
Office Phone: (512) 327 - 9997
Contact: Ms. Audrey Swearingen, RAC
Title: Director, Regulatory Affairs
Email: 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 |
4
MQF, Assisted Reproduction Catheter Product Code:
Device Class: Class II
Classification Panel: Obstetrics/Gynecology
5. Legally Marketed Predicate Device(s)
K131491, Kitazato IUI Catheter, KITAZATO Medical Co., Ltd.
The predicate device has not been subject to a design-related recall.
6. Indication for Use Statement
Kitazato IUI Catheter consists of the following versions:
- . Kitazato IUI Catheter with Outer Stiffener with or without Stylet Cannula, 18 cm, model number Type 4-v1 and Type 4-v2
- . Kitazato IUI Catheter with Outer Stiffener with or without Stylet Cannula, 10 cm, model number Type 4-v3 and Type 4-v4
- Kitazato IUI Catheter with Outer Stiffener with Stainless Steel Core, 18 cm, model number Type 5-v1 and Type 5-v2
- Kitazato IUI Catheter with Outer Stiffener with Stainless Steel Core, 10 cm, model number Type 5-v3 and Type 5-v4
Kitazato IUI Catheter is used for the introduction of washed spermatozoa into the uterine cavity through the cervix.
Kitazato IUI Stylet is used to provide rigidity and assist in maintaining the shape of the catheter shaft.
7. Device Description
The Kitazato IUI Catheter is a set of intrauterine insemination (IUI) catheters comprised of two different models that include either no stainless steel core (Type 4) or a stainless steel core (Type 5). Each type of catheter has a 10 cm or 18 cm catheter shaft length that incorporates an outer stiffener component and a syringe connector. The distal tip of the catheter shaft is rounded and includes two side holes 3 mm from the tip of the catheter for sperm delivery. The catheter shaft also includes depth marker bands at 5, 6, 7, and 8 cm from the distal tip to aid in delivery of the device to the targeted depth.
The catheter is composed of a polyvinyl chloride shaft and an acrylonitrile butadiene styrene (ABS) connector. The Stylet Cannula (Type 6) used with the Type 4 catheter is composed of a stainless steel cannula (SUS304) and an ABS syringe connector. The Stylet Cannula's stainless steel core provides rigidity and assists in maintaining the shape of the catheter shaft when the uterine cervix is sharply curved. The Stylet Cannula is inserted into the catheter shaft through the connector end and then the IUI Catheter is inserted into the cervix. During an IUI procedure, the catheter is introduced into the uterine cavity through the cervix, and the spermatozoa are injected into the uterine cavity by a syringe (not included) that is coupled at the connector end (6% taper connection) of the catheter shaft.
Model configurations and specifications for the Kitazato IUI Catheters are listed below:
5
| Code | Model | Product Name | Code Catheter Body | Center Core Material | Catheter Length | Outer Diameter | Depth mark | Stylet Cannula |
|---|---|---|---|---|---|---|---|---|
| 131184 | Type4-v1 | Catheter with Outer Stiffener with Stylet | Polyvinyl-chloride | None | 18 cm | 1.70mm/5 Fr | Yes | Yes |
| 131182 | Type4-v2 | Cannula | (not made with DEHP) | None | 18 cm | 2.00mm/6Fr | Yes | Yes |
| 131104 | Type4-v3 | None | None | 10 cm | 1.70mm/5 Fr | Yes | Yes | |
| 131102 | Type4-v4 | None | 10 cm | 2.00mm/6Fr | Yes | Yes | ||
| 131181 | Type5-v1 | Catheter with Outer Stiffener with | Polyvinyl-chloride | S.S. SUS 304 | 18 cm | 2.00mm/6Fr | Yes | No |
| 131186 | Type5-v2 | Stainless Steel Core | (not made with DEHP) | S.S. SUS 304 | 18 cm | 2.00mm/6Fr | Yes | No |
| 131101 | Type5-v3 | S.S. SUS 304 | 10 cm | 2.00mm/6Fr | Yes | No | ||
| 131106 | Type5-v4 | S.S. SUS 304 | 10 cm | 2.00mm/6Fr | Yes | No | ||
| 140918 | Type6-v1 | Stylet cannula | n/a | S.S. SUS 304 | 18 cm | 0.65 mm | n/a | n/a |
| 140118 | Type6-v2 | S.S. SUS 304 | 10 cm | 0.65 mm | n/a | n/a |
8. Substantial Equivalence Discussion
The following table compares the Kitazato IUI Catheter to the predicate device with respect to indications for use, principles of operation, technological characteristics, and performance testing. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. Based on the information below, the subject and predicate device have comparable intended uses, and the differences in technology noted do not raise different questions of safety or effectiveness as compared to the predicate.
| Table 1 – Comparison of Characteristics |
|---|
| ----------------------------------------- |
| Manufacturer | KITAZATO Corporation | KITAZATO Medical Co., Ltd. | Significant
Differences |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Kitazato IUI Catheter | Kitazato IUI Catheter Type
3 with Outer Stiffener with
Stylet Cannula | |
| 510(k) Number | K162677 | K131491 | N/A |
| Product Code | MQF | MQF | Same |
| Regulation Number | 884.6110 | 884.6110 | Same |
| Regulation Name | Assisted Reproduction
Catheter | Assisted Reproduction
Catheter | Same |
| Indications for Use | Kitazato IUI Catheter
consists of the following | Kitazato IUI Catheter consist | Different. The Stylet is
not included separately |
| Manufacturer | KITAZATO Corporation | KITAZATO Medical Co., Ltd. | Significant
Differences |
| Trade Name | Kitazato IUI Catheter | Kitazato IUI Catheter Type
3 with Outer Stiffener with
Stylet Cannula | |
| | 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. | of the following versions:
Kitazato IUI Catheter
with Outer Stiffener
with Stylet Cannula, 18
cm, model number
Type 3-v1 Kitazato IUI Catheter
with Outer Stiffener
without Stylet Cannula,
18 cm, model number
Type 3-v2 Kitazato IUI Catheter is used
for the introduction of
washed spermatozoa into
the uterine cavity through
the cervix. | in the indications for use
statement of the
predicate device.
However, the inclusion
of a stylet does not
represent a new
intended use. |
| Overall Design | The device consists of types
of IUI catheters with an
outer stiffener with no
stainless steel core (Type 4),
outer stiffener with
stainless steel core (Type 5) | The device consists of types
of IUI catheters with an
outer stiffener with and
without a stylet cannula
(Type 3). The catheter has a | Different; the subject
device includes a version
of the IUI catheter that
utilizes a stainless steel
core. The inclusion of
this stainless steel core |
| Manufacturer | KITAZATO Corporation | KITAZATO Medical Co., Ltd. | Significant |
| Trade Name | Kitazato IUI Catheter | Kitazato IUI Catheter Type
3 with Outer Stiffener with
Stylet Cannula | Differences |
| | and stylet cannula for Type
4 catheters. The catheter
has a smooth distal tip with
two side holes. All types
have a syringe connector
hub compatible with a 6%
taper syringe (not included).
The catheters are packaged
in a barrier sterilization
package. | side holes. All types have a
syringe connector hub
compatible with a 6% taper
syringe (not included). The
catheters are packaged in a
barrier sterilization
package. | does not raise different
questions of safety or
effectiveness. |
| Sterile | Ethylene Oxide (EO) | Radiation | Different; however
Differences in the
sterilization method do
not raise different
questions of safety and
effectiveness. |
| Single-Use | Yes | Yes | Same |
| French Size | Type 4 (catheter shaft):
1.7 mm / 5 Fr
2 mm / 6 Fr
Type 5 (catheter shaft):
2 mm / 6 Fr
Outer stiffener shaft of
catheter: 2.5 mm / 7.5 Fr | Catheter shaft
2 mm / 6 Fr
Outer stiffener shaft
2.5 mm/ 7.5 Fr | Similar |
| Length | 10 and 18 cm | 18 cm | Different; However, no
different questions of
safety and effectiveness
are raised due to a
shorter length of the
subject device. |
| Depth Marks | Centimeter marks are
located at 5, 6, 7, 8 cm from
tip on the outer stiffer | Centimeter marks are
located at 5, 6, 7, 8 cm from
tip on the outer stiffer | Same |
| Tip | Closed and smoothly
rounded; two side holes
end type | Closed and smoothly
rounded; two side holes
end type | Same |
| Stainless steel core | Type 4: No | No | Different; the Type 5 |
| Manufacturer | KITAZATO Corporation | KITAZATO Medical Co., Ltd. | Significant
Differences |
| Trade Name | Kitazato IUI Catheter | Kitazato IUI Catheter Type
3 with Outer Stiffener with
Stylet Cannula | |
| | Type 5: Yes | | version of the subject
device contains a
stainless steel core.
However, no different
questions of safety and
effectiveness are raised
by this inclusion. |
| Stylet | Type 4: Yes
Type 5: No | Yes | Different; the Type 5
model does not utilize
the optional Type 6
stylet cannula. However,
an internal stainless
steel core is present to
provide additional
rigidity during insertion.
No different questions
of safety and
effectiveness are raised. |
| Stylet length | 10 and 18 cm | 18 cm | Different; however, no
different questions of
safety and effectiveness
are raised due to the
shorter length. |
| Stylet width | 0.65 mm | 0.65 mm | Same |
| Materials | Polyvinyl chloride, ABS,
stainless steel | Polyvinyl chloride, ABS,
stainless steel | Same |
| Biocompatible per ISO
10993-1 | Yes | Yes | Same |
| HSSA | ≥ 70% motility at 24 hours | ≥ 70% motility at 24 hours | Same |
| Endotoxin | : 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.