(228 days)
Kitazato ET Catheters are intended for ultrasound guided introduction of embryos into the uterine cavity following in vitro fertilization.
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.
This document describes a 510(k) premarket notification for the Kitazato ET Catheters. The focus of the provided text is on demonstrating the substantial equivalence of the Kitazato ET Catheters to a legally marketed predicate device (Guardia™ Access Embryo Transfer Catheter Sets). As such, the information provided is geared towards comparing the new device to an existing one, rather than establishing the performance of a novel AI/software medical device against defined acceptance criteria in the way a traditional clinical study would for an AI-powered diagnostic.
Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI medical device (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set sample size and ground truth establishment) is largely not applicable to this submission.
This submission is for a physical medical device (catheters) and relies on bench testing and biocompatibility studies to show substantial equivalence, not a clinical study involving human readers and AI performance.
However, I can extract information related to relevant non-clinical performance and "acceptance criteria" where applicable to this physical device, as described in the document.
Acceptance Criteria and Device Performance for Kitazato ET Catheters (Physical Device)
This submission focuses on demonstrating substantial equivalence of a physical medical device (embryo transfer catheters) to a predicate device, primarily through non-clinical performance data. Therefore, the "acceptance criteria" are related to established norms for medical device safety and performance rather than AI-specific metrics like AUC, sensitivity, or specificity in a diagnostic context.
Here's the relevant information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Criterion | Reported Device Performance / Evaluation Method |
|---|---|---|
| Sterilization | Validated per ISO 11137-1:2006(R)2010 &A1:2013 and ISO 11137-2:2013 | Studies performed to support substantial equivalence. |
| Biocompatibility | Evaluated per ISO 10993-1: 2018 and 2016 FDA Guidance | Studies performed to support substantial equivalence. |
| - Cytotoxicity | Met ISO 10993-5:2009 | |
| - Sensitization | Met ISO 10993-10:2010 | |
| - Intracutaneous reactivity | Met ISO 10993-10:2010 | |
| Endotoxin | < 20 EU/device (per AAMI/ANSI ST72:2011; USP <85>) | Met: < 20 EU/device |
| Packaging & Transport | - Transportation Simulation per ASTM D4169-16 | Assessment of packaging and contents after conditioning; bubble leak test per ASTM F2096-11 after conditioning. |
| - Package Integrity (Visual Inspection) | Per ASTM F1866/F1886M-09 | |
| - Package Integrity (Dye Penetration) | Per ASTM F1929-15 | |
| - Package Integrity (Seal Strength) | Per ASTM F88/F88M-15 | |
| Embryo Compatibility | Mouse Embryo Assay (MEA): 1-cell, ≥ 80% blastocyst at 96h (before and after aging) | Met: 1-Cell MEA: ≥80% blastocysts at 96h |
| Bench Performance | All predetermined acceptance criteria were met | Studies performed before and after aging. |
| - Dimensional Verification (against device input requirements) | Met: Devices measured and verified against device input requirements. | |
| - Appearance (no burrs, scratches, or foreign objects) | Met: Devices visually inspected. | |
| - Tensile Strength (greater than pre-determined acceptance criterion) | Met: Testing demonstrated value greater than pre-determined acceptance criterion. | |
| - Luer Taper Inspection (assess connection) | Met: Visual inspection to assess connection. | |
| - Colorfastness (legible depth marking after friction) | Met: Testing demonstrated legible depth marking after friction testing (100 rubs at 200g load weight). | |
| - Echo Test (maintenance of echo chip band) | Met: Testing demonstrated maintenance of echo chip band in accordance with pre-determined acceptance criterion. |
2. Sample Size Used for the Test Set and Data Provenance:
- Not Applicable in the traditional sense of an AI/ML test set. The "tests" here are non-clinical bench and lab experiments on the physical device components and assembled units (e.g., sterilization validation, biocompatibility, mechanical testing, Mouse Embryo Assay).
- Data Provenance: The studies are described as "performed to support substantial equivalence." The source of the materials and specific lab locations are not specified beyond the manufacturer (Kitazato Corporation) and their correspondent (Emergo Global Consulting, LLC) being based in Japan and the USA respectively. These are prospective tests of the manufactured device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. Ground truth, in the context of expert consensus for image or data interpretation, is not relevant here as this is a physical device submission. The "ground truth" for these tests comes from established international standards (ISO, ASTM, AAMI/ANSI, USP) and verified laboratory procedures.
4. Adjudication Method for the Test Set:
- Not Applicable. Adjudication methods are typically for resolving discrepancies in expert interpretations (e.g., in MRMC studies for AI). Here, the tests follow defined protocols with measurable outcomes.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
- No. An MRMC study is not relevant for this type of physical medical device submission.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used:
- For this physical device, the "ground truth" is derived from:
- Established Industry Standards: Compliance with ISO, ASTM, AAMI/ANSI, and USP standards.
- Laboratory Measurements and Biological Assays: Objective measurements (e.g., dimensions, tensile strength) and biological assays (e.g., Mouse Embryo Assay, cytotoxicity testing) with predefined acceptance limits.
8. The Sample Size for the Training Set:
- Not Applicable. This is not an AI/ML device where a "training set" would be used to develop an algorithm.
9. How the Ground Truth for the Training Set was Established:
- Not Applicable. See point 8.
Summary for this specific FDA Submission (K192540):
The FDA 510(k) clearance for the Kitazato ET Catheters is based on demonstrating substantial equivalence to an existing legally marketed predicate device. This is achieved through a comprehensive set of non-clinical performance tests, including sterilization validation, biocompatibility studies, endotoxin testing, packaging and transportation simulation, and specific bench performance tests (dimensional verification, appearance, tensile strength, Luer taper inspection, colorfastness, echo test). Additionally, a Mouse Embryo Assay (MEA) is performed to confirm the device's compatibility with embryos. The "acceptance criteria" are the successful completion of these tests in accordance with relevant international and national standards, with all predetermined criteria reported as met. The study design is not a clinical AI performance study, but a series of laboratory and bench tests on the physical device.
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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.
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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
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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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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 Type3 [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)
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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:
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| 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 CatheterK192540 | Guardia Access EmbryoTransfer Catheter SetsK173686 | |
| Indications for Use | Kitazato ET Catheters areintended for ultrasoundguided introduction ofembryos into the uterinecavity following in vitrofertilization. | Used to place in vitrofertilized (IVF) embryos intothe uterine cavity. | The indications for usestatements are not identical;however, the intended useof the subject and predicatedevices are the same(delivery of embryos into theuterine cavity). |
| Variations/Models | Type1: Catheter withsupporting core and GuideType2: Catheter withsupporting core and Guidewith ObturatorType3: Stylet | Catheter and Guide –internal supporting cannulaavailable in one version | Different: Both offer transferand guide catheters. All ofthe subject devices includean additional internalsupport, which iscomparable to a version ofthe predicate device. Thesubject device also includesobturators and stylets. The |
| Manufacturer | Kitazato Corporation | Cook Medical, Inc. | Device Comparison |
| Trade Name | Kitazato ET CatheterK192540 | Guardia Access EmbryoTransfer Catheter SetsK173686 | |
| Design Features | Catheter: Open-end withdepth markings, Luer lockhub, with and without echochip marker;Guide: Precurved, depthmarks, styrene elastomerstopper, straight or bulb tip,with and without echo tip | Transfer Catheter: Open-ended with depth markings,Luer lock hub, with andwithout echo tip;Guide: Precurved, bulb tip,stopper, no depth markingsor echo tip | Different. Both offercatheter models and guideswith the same basic designfeatures. The differencesshown do not raise differentquestions of safety andeffectiveness. |
| inclusion of obturators andstylets do not raise differentquestions of safety andeffectiveness. | |||
| Materials | Transfer Catheter - Silicone,stainless steel/polyimidecore, ABS, nylonGuide - Nylon,polycarbonate, styreneelastomer, stainless steelObturator - Nylon,polycarbonateStylet - Nylon, stainlesssteel, polycarbonate | Transfer catheter -Polyethylene, polyurethane,stainless steelGuide - Polyurethane,silicone, polymethylpentene | Different: Different materialsare used in the subject andpredicate devices; however,they do not raise differentquestions of safety andeffectiveness. |
| Sterilization method | Gamma irradiation | Ethylene oxide | Different: Differentquestions of safety andeffectiveness are not raisedby the use of differentsterilization methods. |
| Single-Use | Yes | Yes | Same |
| Shelf Life | 3 years | 3 years | Same |
| Length of Catheters | Transfer catheter - 22 cm,25 cm and 40cmGuide catheter - 17 cm, 20cm | Transfer catheter - 23 - 25cmGuide catheter - 16.7 cm,17.3 cm | Different: The dimensionsare comparable for themajority of the subjectdevices with the exceptionof the Type 2 v 5. Thisversion is longer than thepredicate devices, but it |
| Manufacturer | Kitazato Corporation | Cook Medical, Inc. | Device Comparison |
| Trade Name | Kitazato ET CatheterK192540 | Guardia Access EmbryoTransfer Catheter SetsK173686 | |
| does not raise differentquestions of safety andeffectiveness as the devicecan only be inserted thesame depth as the otherdevices. The additionallength is provided to allowthe physician to bepositioned further from thesubject during a procedure. | |||
| Outer Diameter | Catheter – 1.0mm/3 Fr,1.35mm/4 FrGuide – 1.9mm, 2.2mm | Transfer Catheter – 2.8 FrGuide Catheter - 6.6 Fr | Different: The differencesin outer diameter betweenthe subject and predicatedo not raise differentquestions of safety andeffectiveness. |
| Depth Markings | Transfer Catheter - locatedat 1, 2, 3 and 4 cm fromconnector.Guide catheter marks -located at 4, 5, 6, 7 and 8cmfrom the tip. | Transfer catheter includesdepth marks (spacing notknown).No depth markings on Guidecatheter. | Different: The subject andpredicate cathetercomponents include depthmarkings, while only thesubject device Guidecatheter includes depthmarkings. Differences indepth marking between thesubject and predicate devicedo not raise differentquestions of safety andeffectiveness. |
| Mouse EmbryoAssay | 1-cell, ≥ 80% blastocyst at96h | ≥ 80%expanded blastocyteswithin 96 hours | Similar |
| Endotoxin | < 20 EU/device | < 20 EU/device | Same |
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9. Non-Clinical Performance Data
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."
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K192540 Page 6 of 6
- Cytotoxicity ISO 10993-5:2009 O
- O Sensitization ISO 10993-10:2010
- Intracutaneous reactivity ISO 10993-10:2010 O
- Endotoxin testing per AAMI/ANSI ST72:2011; USP <85> (<20 EU/device) ●
- . Transportation Simulation study per ASTM D4169-16
- Assessment of packaging and contents after conditioning o
- Bubble leak test per ASTM F2096-11 after conditioning O
- . Package Integrity testing:
- Visual Inspection per ASTM F1866/F1886M-09 o
- Dye Penetration test per ASTM F1929-15 O
- O Seal Strength test per ASTM F88/F88M-15
- Mouse Embryo Assay (MEA) before and after aging (1-Cell MEA: ≥80% blastocysts at 96h)
- . Bench Performance studies before and after aging demonstrated that all predetermined acceptance criteria were met in the following tests:
- Dimensional Verification Devices were measured and verified against device input o requirements.
- Appearance Devices were visually inspected to ensure that no burrs, scratches, or foreign o objects observed.
- o Tensile Strength: Testing demonstrates that the tensile strength value is greater than the pre-determined acceptance criterion.
- Luer Taper Inspection: Testing is visual inspection to assess connection of the shaft to a 6% o tapered female connector.
- O Colorfastness – Testing demonstrates that the depth marking is legible undergoing friction testing (100 rubs at 200 g load weight).
- o Echo Test: Testing demonstrates maintenance of the echo chip band on the catheter and guide in accordance with a pre-determined acceptance criterion.
10. Statement of Substantial Equivalence
The subject and predicate devices have the same intended use and comparable technological characteristics. The differences in technological characteristics between the subject and predicate devices do not raise different questions of safety and effectiveness. The performance data demonstrate that the subject device is substantially equivalent to the predicate device.
§ 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).