(228 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and biological compatibility of a catheter and its accessories for embryo transfer. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML.
No
The device is used for the introduction of embryos, which is a delivery mechanism, not a therapeutic treatment itself for an existing condition.
No
Explanation: The device is a catheter intended for the introduction of embryos into the uterine cavity, which is a therapeutic or interventional procedure, not a diagnostic one. While it uses ultrasound for guidance, the device itself does not perform diagnosis.
No
The device description clearly details physical components such as catheters, guides, obturators, and stylets, along with their materials, sizes, and features (e.g., echo reflective chip, stainless steel core). The performance studies also focus on physical characteristics and biological interactions of these hardware components.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is "ultrasound guided introduction of embryos into the uterine cavity following in vitro fertilization." This describes a procedure performed on the patient's body, not a test performed on a sample taken from the body to diagnose or monitor a condition.
- Device Description: The description details a catheter, guide, obturator, and stylet used for physically delivering embryos. These are instruments used in a medical procedure, not reagents, kits, or instruments used for analyzing biological samples.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples (like blood, urine, tissue, etc.) or to provide information for diagnosis, monitoring, or screening.
IVDs are typically used to perform tests outside of the body on samples to provide information about a patient's health status. This device is used inside the body to facilitate a medical procedure.
N/A
Intended Use / Indications for Use
Kitazato ET Catheters are intended for ultrasound guided introduction of embryos into the uterine cavity following in vitro fertilization.
Product codes (comma separated list FDA assigned to the subject device)
MQF
Device Description
Kitazato ET Catheters are sterile, single-use catheters for use in embryo transfer procedures.
The catheter is used to hold and deliver embryos to the uterine cavity during a procedure. Catheters are available in 3Fr and 4Fr sizes, both of which are provided in lengths of 220 mm and 250 mm, as well as one version that is 3Fr and 400 mm length that has the same uterine insertion depth as the other device versions, but allows the user to be positioned further from the patient during a procedure. Devices also include versions with and without an echo reflective chip in the tip of the catheter. The echo reflective chip aids in visualization of the catheter during a transfer procedure; all transfer procedures are to be done under ultrasound guidance. Both the Type 2 devices also include a stainless steel or polyimide core to provide additional rigidity to the catheter.
The guide is used to navigate the pathway through the cervical canal to allow for easier catheter insertion Guides are provided with a 30° pre-curved distal shaft and are available in lengths of 170 mm and 200 mm. Guides also include a styrene elastomer stopper to aid in positioning the targeted uterine insertion depth. The guides are also available with a straight or bulb tip design, and with and without an echo reflective chip in the tip of the guide. An obturator with a length of 170 mm or 200 mm is provided with the Type 2 versions of the device to prevent ingress of fluid into the guide lumen during guide insertion.
The Stylet is an optional accessory used when additional rigidity is needed during insertion of the guide through the cervix, and is provided in two lengths, 170 mm and 200 mm. The stainless steel core of the Stylet can be shaped to aid in guide delivery through the cervix.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Uterine cavity / Uterus / Cervical canal
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)
The following studies have been performed to support substantial equivalence to the predicate device:
- Sterilization validation per ISO 11137-1:2006(R)2010 &A1:2013 and ISO 11137-2:2013
- Biocompatibility studies conducted in accordance with ISO 10993-1: 2018 and the 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 10993-5:2009
- Sensitization ISO 10993-10:2010
- Intracutaneous reactivity ISO 10993-10:2010
- Endotoxin testing per AAMI/ANSI ST72:2011; USP (
§ 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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 1, 2020
Kitazato Corporation % Audrey Swearingen Regulatory Affairs Manager/Consultant Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, TX 78746
Re: K192540
Trade/Device Name: Kitazato ET Catheters (Type 1 [Versions 1-4], Type 2 [Versions 1-5], and Type 3 [Versions 1-4]) Regulation Number: 21 CFR§ 884.6110 Regulation Name: Assisted Reproduction Catheters Regulatory Class: II Product Code: MQF Dated: April 1, 2020 Received: April 2, 2020
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Monica D. Garcia, Ph.D. Acting Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192540
Device Name
Kitazato ET Catheters (Type 1 [Versions 1-4], Type 2 [Versions 1-5], and Type 3 [Versions 1-4])
Indications for Use (Describe)
Kitazato ET Catheters are intended for ultrasound guided introduction of embryos into the uterine cavity following in vitro fertilization.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☑ 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 Catheter
1. Submission Sponsor
Kitazato Corporation Shibakoen Building 1-1-8 Shibadaimon Minato-ku Tokyo 105-0012 Japan Contact: Mr. Futoshi Inoue Phone: +81 35 800 6055 Title: President and Representative Director
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 Title: Regulatory Affairs Manager/Senior Consultant
3. Date Prepared
April 28, 2020
4. Device Identification
| Trade/Proprietary Name: Kitazato ET Catheters (Type 1 [Versions 1-4], Type 2 [Versions 1-5], and Type
| 3 [Versions 1-4]) | |
|---|---|
| Common/Usual Name: | Embryo Transfer Catheter |
| Regulation Name: | Assisted Reproduction Catheters |
| Regulation Number: | 884.6110 |
| Product Code: | MQF (Catheter, Assisted Reproduction) |
| Class: | Class II |
5. Legally Marketed Predicate Device(s)
4
Guardia™ Access Embryo Transfer Catheter Sets (Cook Incorporated), K173686.
This predicate device has not been subject to any design related recalls.
6. Indication for Use Statement
Kitazato ET Catheters are intended for ultrasound guided introduction of embryos into the uterine cavity following in vitro fertilization.
7. Device Description
Kitazato ET Catheters are sterile, single-use catheters for use in embryo transfer procedures.
The catheter is used to hold and deliver embryos to the uterine cavity during a procedure. Catheters are available in 3Fr and 4Fr sizes, both of which are provided in lengths of 220 mm and 250 mm, as well as one version that is 3Fr and 400 mm length that has the same uterine insertion depth as the other device versions, but allows the user to be positioned further from the patient during a procedure. Devices also include versions with and without an echo reflective chip in the tip of the catheter. The echo reflective chip aids in visualization of the catheter during a transfer procedure; all transfer procedures are to be done under ultrasound guidance. Both the Type 2 devices also include a stainless steel or polyimide core to provide additional rigidity to the catheter.
The guide is used to navigate the pathway through the cervical canal to allow for easier catheter insertion Guides are provided with a 30° pre-curved distal shaft and are available in lengths of 170 mm and 200 mm. Guides also include a styrene elastomer stopper to aid in positioning the targeted uterine insertion depth. The guides are also available with a straight or bulb tip design, and with and without an echo reflective chip in the tip of the guide. An obturator with a length of 170 mm or 200 mm is provided with the Type 2 versions of the device to prevent ingress of fluid into the guide lumen during guide insertion.
The Stylet is an optional accessory used when additional rigidity is needed during insertion of the guide through the cervix, and is provided in two lengths, 170 mm and 200 mm. The stainless steel core of the Stylet can be shaped to aid in guide delivery through the cervix.
| Type | Size | Version Components | ||
|---|---|---|---|---|
| Catheter | Guide | Obturator | ||
| Type1-v1 | 3Fr | 220 mm ET Catheter | 170 mm Guide (curved) bulb tip | |
| Type1-v2 | 3Fr | 250 mm ET Catheter | 200 mm Guide (curved) bulb tip | |
| Type1-v3 | 4Fr | 220 mm ET Catheter | 170 mm Guide (curved) straight tip | |
| Type1-v4 | 4Fr | 250 mm ET Catheter | 200 mm Guide (curved) straight tip |
A summary of the different device versions included in this submission are shown in the tables below:
5
| Type2-v1 | 3Fr | 220 mm ET Catheter | 170 mm Guide (curved) bulb tip | 170 mm Obturator |
|---|---|---|---|---|
| Type2-v2 | 3Fr | 250 mm ET Catheter | 200 mm Guide (curved) bulb tip | 200 mm Obturator |
| Type2-v3 | 4Fr | 220 mm ET Catheter | 170 mm Guide (curved) straight tip | 170 mm Obturator |
| Type2-v4 | 4Fr | 250 mm ET Catheter | 200 mm Guide (curved) straight tip | 200 mm Obturator |
| Type2-v5 | 3Fr | 400 mm ET Catheter | 200 mm Guide (curved) bulb tip | 200 mm Obturator |
| Type | Description |
|---|---|
| Type3-v1 | 3Fr Stylet for 170mm Guide |
| Type3-v2 | 3Fr Stylet for 200mm Guide |
| Type3-v3 | 4Fr Stylet for 170mm Guide |
| Type3-v4 | 4Fr Stylet for 200mm Guide |
8. Substantial Equivalence Comparison
The following table compares the Kitazato ET Catheter to the predicate device.
| Manufacturer | Kitazato Corporation | Cook Medical, Inc. | Device Comparison |
|---|---|---|---|
| Trade Name | Kitazato ET Catheter | ||
| K192540 | Guardia Access Embryo | ||
| Transfer Catheter Sets | |||
| K173686 | |||
| Indications for Use | Kitazato ET Catheters are | ||
| intended for ultrasound | |||
| guided introduction of | |||
| embryos into the uterine | |||
| cavity following in vitro | |||
| fertilization. | Used to place in vitro | ||
| fertilized (IVF) embryos into | |||
| the uterine cavity. | The indications for use | ||
| statements are not identical; | |||
| however, the intended use | |||
| of the subject and predicate | |||
| devices are the same | |||
| (delivery of embryos into the | |||
| uterine cavity). | |||
| Variations/Models | Type1: Catheter with | ||
| supporting core and Guide |
Type2: Catheter with
supporting core and Guide
with Obturator
Type3: Stylet | Catheter and Guide –
internal supporting cannula
available in one version | Different: Both offer transfer
and guide catheters. All of
the subject devices include
an additional internal
support, which is
comparable to a version of
the predicate device. The
subject device also includes
obturators and stylets. The |
| Manufacturer | Kitazato Corporation | Cook Medical, Inc. | Device Comparison |
| Trade Name | Kitazato ET Catheter
K192540 | Guardia Access Embryo
Transfer Catheter Sets
K173686 | |
| Design Features | Catheter: Open-end with
depth markings, Luer lock
hub, with and without echo
chip marker;
Guide: Precurved, depth
marks, styrene elastomer
stopper, straight or bulb tip,
with and without echo tip | Transfer Catheter: Open-
ended with depth markings,
Luer lock hub, with and
without echo tip;
Guide: Precurved, bulb tip,
stopper, no depth markings
or echo tip | Different. Both offer
catheter models and guides
with the same basic design
features. The differences
shown do not raise different
questions of safety and
effectiveness. |
| | | | inclusion of obturators and
stylets do not raise different
questions of safety and
effectiveness. |
| Materials | Transfer Catheter - Silicone,
stainless steel/polyimide
core, ABS, nylon
Guide - Nylon,
polycarbonate, styrene
elastomer, stainless steel
Obturator - Nylon,
polycarbonate
Stylet - Nylon, stainless
steel, polycarbonate | Transfer catheter -
Polyethylene, polyurethane,
stainless steel
Guide - Polyurethane,
silicone, polymethylpentene | Different: Different materials
are used in the subject and
predicate devices; however,
they do not raise different
questions of safety and
effectiveness. |
| Sterilization method | Gamma irradiation | Ethylene oxide | Different: Different
questions of safety and
effectiveness are not raised
by the use of different
sterilization methods. |
| Single-Use | Yes | Yes | Same |
| Shelf Life | 3 years | 3 years | Same |
| Length of Catheters | Transfer catheter - 22 cm,
25 cm and 40cm
Guide catheter - 17 cm, 20
cm | Transfer catheter - 23 - 25
cm
Guide catheter - 16.7 cm,
17.3 cm | Different: The dimensions
are comparable for the
majority of the subject
devices with the exception
of the Type 2 v 5. This
version is longer than the
predicate devices, but it |
| Manufacturer | Kitazato Corporation | Cook Medical, Inc. | Device Comparison |
| Trade Name | Kitazato ET Catheter
K192540 | Guardia Access Embryo
Transfer Catheter Sets
K173686 | |
| | | | does not raise different
questions of safety and
effectiveness as the device
can only be inserted the
same depth as the other
devices. The additional
length is provided to allow
the physician to be
positioned further from the
subject during a procedure. |
| Outer Diameter | Catheter – 1.0mm/3 Fr,
1.35mm/4 Fr
Guide – 1.9mm, 2.2mm | Transfer Catheter – 2.8 Fr
Guide Catheter - 6.6 Fr | Different: The differences
in outer diameter between
the subject and predicate
do not raise different
questions of safety and
effectiveness. |
| Depth Markings | Transfer Catheter - located
at 1, 2, 3 and 4 cm from
connector.
Guide catheter marks -
located at 4, 5, 6, 7 and 8cm
from the tip. | Transfer catheter includes
depth marks (spacing not
known).
No depth markings on Guide
catheter. | Different: The subject and
predicate catheter
components include depth
markings, while only the
subject device Guide
catheter includes depth
markings. Differences in
depth marking between the
subject and predicate device
do not raise different
questions of safety and
effectiveness. |
| Mouse Embryo
Assay | 1-cell, ≥ 80% blastocyst at
96h | ≥ 80%expanded blastocytes
within 96 hours | Similar |
| Endotoxin | (