(272 days)
Not Found
No
The device description and performance studies focus on the physical components, materials, and mechanical properties of the catheters, with no mention of software, algorithms, or data processing related to AI/ML.
No.
The device facilitates the introduction of embryos but does not directly treat a disease or medical condition.
No.
The device is intended for the introduction of embryos into the uterus for in vitro fertilization, which is a treatment procedure, not a diagnostic one. While it includes a "Trial Catheter" used to confirm the curvature of the cervix and if it's passable, this step is part of preparing for the embryo transfer procedure, not diagnosing a medical condition.
No
The device is described as physical catheters and associated components used for embryo transfer, not software.
Based on the provided information, the Kitazato ET Catheters are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the "introduction of embryos into the uterine in vitro fertilisation." This describes a procedure performed on the patient's body (in vivo), not a test performed on a sample taken from the body (in vitro).
- Device Description: The description details a catheter system designed for physical insertion into the uterus to deliver embryos. This is a medical device used for a therapeutic procedure, not for diagnostic testing of a sample.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples (like blood, urine, tissue, etc.) to provide diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on the physical and biological safety and functionality of the catheter for its intended use (insertion and embryo delivery), not on the accuracy or reliability of diagnostic results.
In summary, the Kitazato ET Catheters are a medical device used for a procedure related to in vitro fertilization, not for performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The Kitazato ET Catheters are intended for ultrasound guided introduction of embryos into the uterine in vitro fertilisation.
Kitazato ET Catheters are provided in various configurations (Type 5), which consist of the following components:
- · Transfer Catheter, for delivery of embryos into the uterine cavity;
- · Guide Catheter, to guide the insertion of the Transfer Catheter and reinforce it during use:
- · Trial Catheter, used to confirm the curvature of the cervix and if the cervix is passable;
- · Stylet Sheath, used to increase the strength of the Guide Catheter during insertion.
Product codes (comma separated list FDA assigned to the subject device)
MQF
Device Description
Kitazato ET Catheters are sterile, single-use catheters for embryo transfer. The ET Catheters consist of a transfer catheter, guide catheter, and a stylet sheath. The Transfer catheter (hereafter referred to as 'catheter' or 'ET Catheter') is composed of a catheter shaft, a connector and a shaft protective sleeve (protector). The catheter types include a normal catheter (Type1, EC-PRO Normal), a catheter with a stainless outer stiffener (Type2, EC-PRO Supported), a catheter with Echo Line (Type3, EC-PRO Master), and a catheter that has both the stainless outer stiffener and the echo line (Type4, EC-PRO Master Supported), all of which are offered in lengths of 18cm and 23cm, and various versions (v1-v8). A corresponding Trial catheter of the same length is provided for all four Types of the Kitazato ET Catheters. The Guide catheter is offered both with a straight shaft and a 30° pre-curved distal shaft. The Stylet Cannula (Type5) is an optional accessory used when additional rigidity is needed during insertion of the cannula through the cervix, and is offered in two lengths, 13.5 cm and 18.5 cm.
During the implantation procedure of the embryo into the uterus, the catheter is introduced into the uterine cavity through the cervix, then the embryo is delivered into the uterine cavity by plunging the syringe that is coupled at the connector end of the catheter via a 6% taper luer lock. A syringe is not included with the Kitazato ET Catheters.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound guided
Anatomical Site
uterine cavity
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
As part of demonstrating safety and effectiveness of the Kitazato ET Catheters and in showing substantial equivalence to the predicate devices, Kitazato completed a number of non-clinical tests. The device meets all the requirements for design, sterilization, biocompatibility, and functionality.
The Kitazato ET Catheters passed all the testing in accordance with internal requirements, national standards, and international standards support substantial equivalence:
- . 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."
- Cytotoxicity (ISO Extraction Method, ISO 10993-5:2009) O
- Sensitization (ISO Guinea Pig Maximization Sensitization, ISO 10993-10:2010) O
- Irritation (ISO Intracutaneous Reactivity Test, ISO 10993-10:2010) O
- Mouse Embryo Assay (MEA) ●
- o 1-Cell mouse embryos were incubated in extracts of the subject device at 37°C in an atmosphere containing 5% CO₂. The percent of embryos developed to the expanded blastocyst stage at 96 hours were assessed in comparison with the control group. The acceptance criterion was 1-Cell MEA: ≥80% expanded to blastocyst at 96 hours.
- . Endotoxin Testing per ANSI/AAMI ST72:2011: Endotoxin values conform to the specification of ≤20 EU/device
- . Sterilization validation per ISO 11135:2014 and ISO 10993-7:2008
- Dimensional Verification – final sterile devices confirmed to the dimensional specifications, and luer connectors conform to requirements of ISO 594-1 and ISO 594-2.
- Appearance Testing - passes visual inspection for scratches, burrs, and foreign objects
- Mechanical Tensile Testing (shaft and strength between shaft and connector) – Tensile strength met the established specifications.
- . Depth Mark color-fastness testing per JIS L 0849 / JIS L 0803 – The ink depth markings remained clearly legible after soaking in saline for 24 hours and undergoing 100 cycles of rubbing.
- . 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 per ASTM 1929-15, ASTM 1866/F 1886M-09, and ASTM F88/F88M-15.
- . Transport Testing per ASTM D4169-09 – Packaging maintained device integrity.
- . 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, MEA, and color fastness.
10. Statement of Substantial Equivalence
The results of the performance testing described above demonstrate that the Kitazato ET Catheters are as safe and effective as the predicate device and supports a determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Mouse Embryo Assay (MEA): ≥80% expanded to blastocyst at 96 hours.
Endotoxin: ≤20 EU/device
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 features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is composed of three intertwined lines that form the shape of a bird or a human profile. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 13, 2017
Kitazato Corporation % Audrey Swearingen Director, Regulatory Affairs Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, TX 78746
Re: K162878
Trade/Device Name: Kitazato ET Catheters Regulation Number: 21 CFR§ 884.6110 Regulation Name: Assisted Reproduction Catheters Regulatory Class: II Product Code: MQF Dated: June 12, 2017 Received: June 13, 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.
Joyce M. Whang -S
for
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) K162878
Device Name Kitazato ET Catheters
Indications for Use (Describe)
The Kitazato ET Catheters are intended for ultrasound guided introduction of embryos into the uterine in vitro fertilisation.
Kitazato ET Catheters are provided in various configurations (Type 5), which consist of the following components:
- · Transfer Catheter, for delivery of embryos into the uterine cavity;
- · Guide Catheter, to guide the insertion of the Transfer Catheter and reinforce it during use:
- · Trial Catheter, used to confirm the curvature of the cervix and if the cervix is passable;
- · Stylet Sheath, used to increase the strength of the Guide Catheter during insertion.
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 ET Catheters
1. Submission Sponsor
Kitazato Corporation 1-1-8 Shibadaimon, Minato-ku Tokyo 105-0012 JAPAN Ms. Mari Yazaki Quality Assurance Manager Phone: (81) 3-3434-2731 Fax: (81) 3-3434-2732 Email: yazaki@kitazato.co.jp
2. Submission Correspondent
Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Office Phone: (512) 327.9997 Contact: Audrey Swearingen, RAC (US) Title: Director, Regulatory Affairs
3. Date Prepared
July 13, 2017
4. Device Identification
| Trade/Proprietary Name: | Kitazato ET Catheters |
|---|---|
| Common/Usual Name: | Embryo Transfer Catheter |
| Classification Name: | Assisted Reproduction Catheter |
| Regulation Number: | 884.6110 |
| Product Code: | MQF, Assisted Reproduction Catheter |
4
Class II Device Class: Classification Panel: Obstetrics/Gynecology
5. Legally Marketed Predicate Device(s)
K033084 - Portex, Ltd. Wallace Embryo Replacement Catheters and Trial Transfer Catheters
The predicate device was subject to a design-related recall in 2013. However, the recall status for the predicate device is completed, and the predicate device is currently marketed.
6. Indication for Use Statement
The Kitazato ET Catheters are intended for ultrasound guided introduction of embryos into the uterine cavity following in vitro fertilisation.
Kitazato ET Catheters are provided in various configurations (Type 1 through Type 5), which consist of the following components:
- Transfer Catheter, for delivery of embryos into the uterine cavity; .
- . Guide Catheter, to guide the insertion of the Transfer Catheter and reinforce it during use;
- Trial Catheter, used to confirm the curvature of the cervix and if the cervix is passable;
- Stylet Sheath, used to increase the strength of the Guide Catheter during insertion.
7. Device Description
Kitazato ET Catheters are sterile, single-use catheters for embryo transfer. The ET Catheters consist of a transfer catheter, guide catheter, and a stylet sheath. The Transfer catheter (hereafter referred to as 'catheter' or 'ET Catheter') is composed of a catheter shaft, a connector and a shaft protective sleeve (protector). The catheter types include a normal catheter (Type1, EC-PRO Normal), a catheter with a stainless outer stiffener (Type2, EC-PRO Supported), a catheter with Echo Line (Type3, EC-PRO Master), and a catheter that has both the stainless outer stiffener and the echo line (Type4, EC-PRO Master Supported), all of which are offered in lengths of 18cm and 23cm, and various versions (v1-v8). A corresponding Trial catheter of the same length is provided for all four Types of the Kitazato ET Catheters. The Guide catheter is offered both with a straight shaft and a 30° pre-curved distal shaft. The Stylet Cannula (Type5) is an optional accessory used when additional rigidity is needed during insertion of the cannula through the cervix, and is offered in two lengths, 13.5 cm and 18.5 cm.
During the implantation procedure of the embryo into the uterus, the catheter is introduced into the uterine cavity through the cervix, then the embryo is delivered into the uterine cavity by plunging the syringe that is coupled at the connector end of the catheter via a 6% taper luer lock. A syringe is not included with the Kitazato ET Catheters.
Model configurations and specifications for the Kitazato ET Catheters (Types 1 – 4) are listed below:
5
| Version | Version Components | ||
|---|---|---|---|
| Catheter | Guide | Trial | |
| Version 1 (v1) | 18 cm ET Transfer Catheter | 14 cm Guide Catheter | |
| (straight) | n/a | ||
| Version 2 (v2) | 23 cm ET Transfer Catheter | 19 cm Guide Catheter | |
| (straight) | n/a | ||
| Version 3 (v3) | n/a | 14 cm Guide Catheter | |
| (straight) | 18 cm Trial Catheter | ||
| Version 4 (v4) | n/a | 19 cm Guide Catheter | |
| (straight) | 23 cm Trial Catheter | ||
| Version 5 (v5) | 18 cm ET Transfer Catheter | n/a | n/a |
| Version 6 (v6) | 23 cm ET Transfer Catheter | n/a | n/a |
| Version 7 (v7) | 18 cm ET Transfer Catheter | 14 cm Guide Catheter | |
| (curved) | n/a | ||
| Version 8 (v8) | 23 cm ET Transfer Catheter | 19 cm Guide Catheter | |
| (curved) | n/a |
Model configurations and specifications for the Type 5 stylet are listed below:
| Type 5-v1 | 13.5 cm | Used with 14 cm Guide Catheter and 18 cm ET Transfer Catheter |
|---|---|---|
| Type 5-v2 | 18.5 cm | Used with 19 cm Guide Catheter and 23 cm ET Transfer Catheter |
8. Substantial Equivalence Discussion
The following tables compare the Kitazato ET Catheters to the predicate devices with respect to indications for use, principles of operation, technological characteristics, materials, and performance. 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.
6
| Manufacturer | Kitazato Corporation | Portex, Ltd. (marketed by
Smiths Medical) | Device Comparison |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Kitazato ET Catheters,
Type1, Type2, Type3,
Type4, Type5 | Wallace Embryo
Replacement Catheters
and Trial Transfer
Catheters | |
| 510(k) Number | K162878 | K033084 | 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 ET Catheters
are intended for
ultrasound guided
introduction of embryos
into the uterine cavity
following in vitro
fertilisation.
Kitazato ET Catheters are
provided in various
configurations (Type 1
through Type 5), which
consist of the following
components:
• Transfer Catheter, for
delivery of embryos into
the uterine cavity;
• Guide Catheter, to
guide the insertion of the
transfer catheter and
reinforce it during use;
• Trial Catheter, used to
confirm the curvature of
the cervix and if the
cervix is passable;
• Stylet Sheath, used to
increase the strength of | Embryo Replacement
Catheters are sterile,
single-use devices for
ultrasound guided
introduction of embryos
into the uterine cavity
following in vitro
fertilisation.
Trial Transfer Catheters
are sterile, single-use
devices for determining
whether the cervix is
passable for a Wallace
embryo replacement
catheter | Similar. The subject and
predicate device have the
same intended use -
ultrasound guided
introduction of embryos
into the uterine cavity
following in vitro
fertilisation. |
| Manufacturer | Kitazato Corporation | Portex, Ltd. (marketed by
Smiths Medical | Device Comparison |
| Trade Name | Kitazato ET Catheters,
Type1, Type2, Type3,
Type4, Type5 | Wallace Embryo
Replacement Catheters
and Trial Transfer
Catheters | |
| | the Guide Catheter
during insertion. | | |
| Variations | Type1: EC-PRO Normal;
Type2: EC-PRO Supported
– same as Type1 but with
outer stiffener on shaft;
Type3: EC-PRO Master -
same as Type1 but with
pre-marked Echo line on
shaft for ultrasound
imaging visibility;
Type4: EC-PRO Master
Supported - includes
both outer stiffener and
Echo line; | Sure View Embryo
Replacement Catheter
with echogenic shaft for
ultrasound imaging
visibility;
Sure View Trial Transfer
Catheters | Different. However, both
offer catheter models and
guides with the same
basic design features.
These differences do not
raise different questions
of safety and
effectiveness. |
| | Each Type includes
catheters of 18cm and
23cm length (v1 and v2)
with corresponding
Guides, and Trials of the
same length (v3 and v4). | Sure View models include
inner catheters of 18cm
and 23cm length, with
corresponding outer
sheath | |
| Design Overview | Transfer catheter, Guide
catheter, Trial catheter:
Transfer Catheter: Open-
end shaft with depth
marks and protective
sleeve, luer connector,
outer stiffener (some
variations), and echo line
(some variations); | Inner catheter (transfer),
Outer sheath (guide), Trial
catheter:
Transfer Catheter: Open-
ended shaft with depth
markings, luer hub, and
echo line. | Similar. The minor
differences in the design
do not raise different
questions of safety and
effectiveness. |
| Manufacturer | Kitazato Corporation | Portex, Ltd. (marketed by
Smiths Medical | Device Comparison |
| Trade Name | Kitazato ET Catheters,
Type1, Type2, Type3,
Type4, Type5 | Wallace Embryo
Replacement Catheters
and Trial Transfer
Catheters | |
| | Guide: Straight or curved
shaft with depth marks,
and handle/ connector;
Trial: Identical to
corresponding size
transfer catheter, but
with closed end. | Guide: Shaft with depth
marks, and
handle/connector;
Trial: Same as
corresponding size
transfer catheter, but with
closed end. | |
| Stylet | Yes (Type 5) | No | Different. However,
different questions of
safety and effectiveness
are not raised by the
inclusion of a stylet as it's
used to provide additional
rigidity to the device. |
| Materials | Catheter/Trial shaft:
Polyurethane;
Guide: Fluoric resin;
Luer connector: ABS;
Outer stiffener: Stainless
steel | Shaft: flexible plastic of
unknown type;
Remaining materials not
known | Unknown. However,
different questions of
safety and effectiveness
are not raised, and can be
assessed through
biocompatibility testing |
| Sterile | Yes – Ethylene oxide | Yes – Ethylene oxide | Same |
| Single-Use | Yes | Yes | Same |
| Catheter Length | 18 cm and 23 cm | 18 cm and 23 cm | Same |
| Catheter Outer
Diameter | Catheter - 1.55 mm / 4.7
Fr | Inner Catheter - 1.52 mm | Similar |
| Depth Markings | Yes | Yes | Same |
| Guide Length | 14cm and 19cm | Unknown (expected to be
13 and 18cm, based on
available information) | Similar |
| Ultrasound Visible | Yes (Type3 and Type4) | Yes | Same |
| Manufacturer | Kitazato Corporation | Portex, Ltd. (marketed by
Smiths Medical) | Device Comparison |
| Trade Name | Kitazato ET Catheters,
Type1, Type2, Type3,
Type4, Type5 | Wallace Embryo
Replacement Catheters
and Trial Transfer
Catheters | |
| Mouse Embryo
Assay | 1-cell, ≥ 80% expanded
blastocysts at 96 hrs | 2-cell, ≥ 80% blastocyst | Similar |
| Endotoxin |