(272 days)
The Kitazato ET Catheters are intended for ultrasound guided introduction of embryos into the uterine in vitro fertilisation.
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.
The provided text describes the Kitazato ET Catheters, an embryo transfer catheter, and its substantial equivalence to a predicate device. It includes non-clinical performance data to support its safety and effectiveness.
Here's the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | ||
| Cytotoxicity | Pass (ISO 10993-5:2009) | Passed |
| Sensitization | Pass (ISO 10993-10:2010) | Passed |
| Irritation | Pass (ISO 10993-10:2010) | Passed |
| Mouse Embryo Assay (MEA) | ≥ 80% expanded to blastocyst at 96 hours (1-Cell MEA) | Passed (1-cell mouse embryos, ≥ 80% expanded blastocysts at 96 hrs) |
| Endotoxin | < 20 EU/device | < 20 EU/device (conforms to specification) |
| Sterilization Validation | Conformance to ISO 11135:2014 & ISO 10993-7:2008 | Passed |
| Dimensional Verification | Final sterile devices conform to dimensional specifications; luer connectors conform to ISO 594-1 and ISO 594-2 | Passed |
| Appearance Testing | Pass visual inspection for scratches, burrs, and foreign objects | Passed |
| Mechanical Tensile Testing | Met established specifications | Tensile strength met the established specifications |
| Depth Mark Color-fastness | Clearly legible after soaking in saline for 24 hours and 100 cycles of rubbing | Remained clearly legible |
| Package Integrity | Pass dye penetration, seal strength, and visual inspection per ASTM 1929-15, ASTM 1866/F 1886M-09, and ASTM F88/F88M-15 | Passed |
| Transport Testing | Packaging maintained device integrity | Packaging maintained device integrity |
| Shelf Life Testing | Maintained performance for 3 years (tensile strength, dimension, appearance, sterility, endotoxin, MEA, and color fastness) | Established three (3) year shelf life following real time aging; parameters assessed (tensile strength, dimension, appearance, sterility, endotoxin, MEA, and color fastness) |
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical performance testing of the device itself and does not involve human subjects or clinical data for a "test set" in the context of AI/diagnostic algorithm evaluation. Therefore, details regarding sample size for a test set and data provenance (country of origin, retrospective/prospective) are not applicable here. The testing was performed on the device prototypes and manufactured units.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the study is a non-clinical device performance test and does not involve establishing ground truth from human expert interpretations of data (e.g., medical images).
4. Adjudication Method for the Test Set
This information is not applicable as the study is a non-clinical device performance test and does not involve adjudication of expert interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document describes non-clinical performance testing of a medical device (catheter), not an AI algorithm intended to assist human readers. Therefore, an effect size of human readers' improvement with vs. without AI assistance is not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone performance study in the context of an AI algorithm was not done. This document pertains to the physical performance characteristics of a medical catheter, not an AI or diagnostic algorithm.
7. Type of Ground Truth Used
For the non-clinical performance tests, the "ground truth" used are the defined specifications and standards for the device's physical, chemical, and biological properties. This includes:
- ISO standards (e.g., ISO 10993 for biocompatibility, ISO 11135 for sterilization, ISO 11607 for packaging)
- ANSI/AAMI standards (e.g., ANSI/AAMI ST72 for endotoxin)
- ASTM standards (e.g., ASTM D4169 for transport, ASTM F88/F88M-15 for seal strength)
- JIS standards (e.g., JIS L 0849 / JIS L 0803 for color-fastness)
- Internal established specifications for tensile strength, dimensions, and appearance.
- Biological assays (Mouse Embryo Assay) with specific biological endpoints (blastocyst development rate).
8. Sample Size for the Training Set
This information is not applicable. The document does not describe the development or testing of an AI algorithm, so there is no training set in that context. The "training" for the device would be its design and manufacturing process, and performance is tested against established specifications.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As there is no AI algorithm training set, there is no ground truth established for it in this context.
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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.
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You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
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
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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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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 |
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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:
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| 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.
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| Manufacturer | Kitazato Corporation | Portex, Ltd. (marketed bySmiths Medical) | Device Comparison |
|---|---|---|---|
| Trade Name | Kitazato ET Catheters,Type1, Type2, Type3,Type4, Type5 | Wallace EmbryoReplacement Cathetersand Trial TransferCatheters | |
| 510(k) Number | K162878 | K033084 | N/A |
| Product Code | MQF | MQF | Same |
| RegulationNumber | 884.6110 | 884.6110 | Same |
| Regulation Name | Assisted ReproductionCatheter | Assisted ReproductionCatheter | Same |
| Indications for Use | The Kitazato ET Cathetersare intended forultrasound guidedintroduction of embryosinto the uterine cavityfollowing in vitrofertilisation.Kitazato ET Catheters areprovided in variousconfigurations (Type 1through Type 5), whichconsist of the followingcomponents:• Transfer Catheter, fordelivery of embryos intothe uterine cavity;• Guide Catheter, toguide the insertion of thetransfer catheter andreinforce it during use;• Trial Catheter, used toconfirm the curvature ofthe cervix and if thecervix is passable;• Stylet Sheath, used toincrease the strength of | Embryo ReplacementCatheters are sterile,single-use devices forultrasound guidedintroduction of embryosinto the uterine cavityfollowing in vitrofertilisation.Trial Transfer Cathetersare sterile, single-usedevices for determiningwhether the cervix ispassable for a Wallaceembryo replacementcatheter | Similar. The subject andpredicate device have thesame intended use -ultrasound guidedintroduction of embryosinto the uterine cavityfollowing in vitrofertilisation. |
| Manufacturer | Kitazato Corporation | Portex, Ltd. (marketed bySmiths Medical | Device Comparison |
| Trade Name | Kitazato ET Catheters,Type1, Type2, Type3,Type4, Type5 | Wallace EmbryoReplacement Cathetersand Trial TransferCatheters | |
| the Guide Catheterduring insertion. | |||
| Variations | Type1: EC-PRO Normal;Type2: EC-PRO Supported– same as Type1 but withouter stiffener on shaft;Type3: EC-PRO Master -same as Type1 but withpre-marked Echo line onshaft for ultrasoundimaging visibility;Type4: EC-PRO MasterSupported - includesboth outer stiffener andEcho line; | Sure View EmbryoReplacement Catheterwith echogenic shaft forultrasound imagingvisibility;Sure View Trial TransferCatheters | Different. However, bothoffer catheter models andguides with the samebasic design features.These differences do notraise different questionsof safety andeffectiveness. |
| Each Type includescatheters of 18cm and23cm length (v1 and v2)with correspondingGuides, and Trials of thesame length (v3 and v4). | Sure View models includeinner catheters of 18cmand 23cm length, withcorresponding outersheath | ||
| Design Overview | Transfer catheter, Guidecatheter, Trial catheter:Transfer Catheter: Open-end shaft with depthmarks and protectivesleeve, luer connector,outer stiffener (somevariations), and echo line(some variations); | Inner catheter (transfer),Outer sheath (guide), Trialcatheter:Transfer Catheter: Open-ended shaft with depthmarkings, luer hub, andecho line. | Similar. The minordifferences in the designdo not raise differentquestions of safety andeffectiveness. |
| Manufacturer | Kitazato Corporation | Portex, Ltd. (marketed bySmiths Medical | Device Comparison |
| Trade Name | Kitazato ET Catheters,Type1, Type2, Type3,Type4, Type5 | Wallace EmbryoReplacement Cathetersand Trial TransferCatheters | |
| Guide: Straight or curvedshaft with depth marks,and handle/ connector;Trial: Identical tocorresponding sizetransfer catheter, butwith closed end. | Guide: Shaft with depthmarks, andhandle/connector;Trial: Same ascorresponding sizetransfer catheter, but withclosed end. | ||
| Stylet | Yes (Type 5) | No | Different. However,different questions ofsafety and effectivenessare not raised by theinclusion of a stylet as it'sused to provide additionalrigidity to the device. |
| Materials | Catheter/Trial shaft:Polyurethane;Guide: Fluoric resin;Luer connector: ABS;Outer stiffener: Stainlesssteel | Shaft: flexible plastic ofunknown type;Remaining materials notknown | Unknown. However,different questions ofsafety and effectivenessare not raised, and can beassessed throughbiocompatibility 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 OuterDiameter | Catheter - 1.55 mm / 4.7Fr | Inner Catheter - 1.52 mm | Similar |
| Depth Markings | Yes | Yes | Same |
| Guide Length | 14cm and 19cm | Unknown (expected to be13 and 18cm, based onavailable information) | Similar |
| Ultrasound Visible | Yes (Type3 and Type4) | Yes | Same |
| Manufacturer | Kitazato Corporation | Portex, Ltd. (marketed bySmiths Medical) | Device Comparison |
| Trade Name | Kitazato ET Catheters,Type1, Type2, Type3,Type4, Type5 | Wallace EmbryoReplacement Cathetersand Trial TransferCatheters | |
| Mouse EmbryoAssay | 1-cell, ≥ 80% expandedblastocysts at 96 hrs | 2-cell, ≥ 80% blastocyst | Similar |
| Endotoxin | < 20 EU/device | <0.5 EU/ml | Same |
Table 1 – Comparison of Characteristics
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9. 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.
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- . 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.
§ 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).