(131 days)
K-JETS-6019, K-JETS-7019-INT, K-JETS-7019, K-JETS-6019-ET, K-JETS-7019-ET, K-JET-2823
No
The summary describes a mechanical device for embryo transfer and does not mention any AI or ML components or functionalities.
No.
The device is used to place IVF embryos into the uterine cavity, which is a procedural step in fertility treatment, not a direct therapeutic action on the patient.
No
This device is used for placing IVF embryos, which is a therapeutic/procedural function, not a diagnostic one. While it mentions an "Echotip Band Echogenicity Test" in performance studies, suggesting it can be observed via ultrasound, its primary purpose is not to diagnose a condition.
No
The device description clearly details physical components like catheters, cannulas, and packaging, and the performance studies involve physical testing (sterilization, biocompatibility, tensile testing, etc.), indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Used to place in vitro fertilized (IVF) embryos into the uterine cavity." This describes a procedure performed on the patient's body, not a test performed on a sample taken from the patient's body to diagnose a condition.
- Device Description: The description details a catheter and guide catheter designed for physical insertion into the uterus. It mentions features like length, diameter, depth indicators, and an echogenic band for visualization during the procedure. These are characteristics of a medical device used for a therapeutic or procedural purpose, not for diagnostic testing of a sample.
- Performance Studies: The performance studies focus on aspects like sterilization, biocompatibility, endotoxin levels, packaging integrity, and bench performance tests related to the physical function of the catheter (aspiration, leak, tensile strength). While it includes a Mouse Embryo Assay (MEA), this is a quality control test for the device's compatibility with embryos in vitro before use, not a diagnostic test performed on a patient sample.
- Lack of Diagnostic Elements: There is no mention of analyzing a biological sample (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
In summary, the device is designed for a medical procedure (embryo transfer) and not for performing diagnostic tests on patient samples. Therefore, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter: Used to place in vitro fertilized (IVF) embryos into the uterine cavity.
Product codes
MOF
Device Description
The Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter cover six subject devices from two of COOK's device families, Guardia™ Access and Guardia™, as outlined in the table below:
| Product family | Device | Product Number | Component |
|---|---|---|---|
| Guardia™ Access | Guardia™ Access Embryo Transfer Catheter | K-JETS-6019 | Embryo transfer catheter and guide catheter |
| Guardia™ Access Embryo Transfer Catheter with Internal Supporting Cannula | K-JETS-7019-INT | Embryo transfer catheter and guide catheter | |
| Guardia™ Access | Guardia™ Access Embryo Transfer Catheter | K-JETS-7019 | Embryo transfer catheter and guide catheter |
| Guardia™ AccessET Embryo Transfer Catheter | K-JETS-6019-ET | Embryo transfer catheter and guide catheter | |
| Guardia™ AccessET Embryo Transfer Catheter | K-JETS-7019-ET | Embryo transfer catheter and guide catheter | |
| Guardia™ | Sydney IVF® Embryo Transfer Catheter | K-JET-2823 | Embryo transfer catheter |
All embryo transfer catheters have an outer diameter of 2.8 Fr and range in length from 23 to 25 cm. The transfer catheters have internal or external supporting cannula, depth indicators, and may have an echogenic band. The Guardia™ Access guide catheters are precurved and feature a bulb-shaped tip. They measure 6.6 Fr in outer diameter and are 16.7 to 17.3 cm in length.
All subject devices are single-use devices and sterilized by ethylene oxide exposure. They undergo lot release Mouse Embryo Assay (MEA) testing for embryo toxicity and USP endotoxin (LAL) testing for pyrogenicity. The subject devices are packaged in peel-open sterile barrier pouches with a three-year shelf life.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
uterine cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
- Sterilization Validation testing per ISO 11135-1:2007
- Biocompatibility studies, as follows:
- Cytotoxicity testing per 10993-5:2009
- Guinea Pig Maximization Sensitization testing per ISO 10993-10:2002 or ISO 10993-10:2010
- Intracutaneous Irritation testing per ISO 10993-10:2002 or ISO 10993-10:2010
- Endotoxin testing per USP and AAMI/ANSI ST72:2011/(R)2016 (=80% embryos developed to blastocyst in 96 hours."
- Bench Performance studies before and after aging demonstrated that all predetermined acceptance criteria were met in the following tests:
- Dimensional verification of catheter Catheters are measured and verified against device input requirements.
- Transfer Catheter Aspiration Test Testing ensures there is no air leaking into the syringe through the transfer catheter.
- Transfer Catheter Leak Test Testing ensures that fluid path catheter assembly does not leak under a predetermined injection pressure.
- Tensile Testing (Catheter Hub- shaft) - Testing demonstrates that the tensile strength value is greater than the predetermined acceptance criterion.
- Echotip Band Test Testing ensures that the outer diameter of the band does not impede smooth passage through the guide catheter.
- Echotip Band Echogenicity Test Visual comparison testing by ultrasound imaging of catheters with and without an EchoTip band verified that the band provides increased brightness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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April 11, 2018
Cook Incorporated Naomi Funkhouser, MBA Regulatory Affairs Specialist/Scientist 750 Daniels Way P.O. Box 489 Bloomington, IN 47402
Re: K173686
Trade/Device Name: Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter Regulation Number: 21 CFR§ 884.6110 Regulation Name: Assisted Reproduction Catheters Regulatory Class: II Product Code: MOF Dated: March 9, 2018 Received: March 13, 2018
Dear Naomi Funkhouser:
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 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.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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) K173686
Device Name
Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter
Indications for Use (Describe)
Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter: Used to place in vitro fertilized (IVF) embryos into the uterine cavity.
Type of Use (Select one or both, as applicable)
| Transaction(s) (Per 24 CFR 982.451, Subpart K) | One-Time Exception(s) (Per 24 CFR 982.451, Subpart K) |
|---|---|
| ------------------------------------------------------------------------------------------------------------ | ---------------------------------------------------------------------------------------------------- |
X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, block letters on a red background. Below the word "COOK" is the word "MEDICAL" in smaller, white block letters. The logo is simple and clean, with a focus on the company name.
510(k) Summary – K173686
| Submitted By: | |
|---|---|
| Applicant: | Cook Incorporated |
| Contacts: | Naomi Funkhouser |
| Rohini Patel | |
| Applicant Address: | Cook Incorporated |
| 750 Daniels Way | |
| Bloomington, IN 47404 | |
| Contact Phone: | (812) 339-2235 x104371 |
| Contact Fax: | (812) 332-0281 |
| Date Prepared: | April 9, 2018 |
| Device Information: | |
| Trade Names: | Guardia Access Embryo Transfer Catheter Sets and Sydney |
| IVF® Transfer Catheter | |
| Common Name: | Embryo Transfer Catheter |
| Classification Name: | Assisted Reproduction Catheters (21 CFR 884.6110) |
| Classification Regulation: | MQF (Catheter, Assisted Reproduction) |
| Regulatory Class | II |
Predicate Device:
Embryo Transfer Catheter/Sets (K983594) manufactured by Cook Ob/Gyn. This predicate device has not been subject to any design related recalls.
Device Description:
The Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter cover six subject devices from two of COOK's device families, Guardia™ Access and Guardia™, as outlined in the table below:
| Product family | Device | Product Number | Component |
|---|---|---|---|
| Guardia™ | |||
| Access | Guardia™ Access Embryo Transfer | ||
| Catheter | K-JETS-6019 | Embryo transfer catheter | |
| and guide catheter | |||
| Guardia™ Access Embryo Transfer | |||
| Catheter with Internal Supporting Cannula | K-JETS-7019-INT | Embryo transfer catheter | |
| and guide catheter | |||
| Guardia™ | |||
| Access | Guardia™ Access Embryo Transfer | ||
| Catheter | K-JETS-7019 | Embryo transfer catheter | |
| and guide catheter | |||
| Guardia™ AccessET Embryo Transfer | |||
| Catheter | K-JETS-6019-ET | Embryo transfer catheter | |
| and guide catheter | |||
| Guardia™ AccessET Embryo Transfer | |||
| Catheter | K-JETS-7019-ET | Embryo transfer catheter | |
| and guide catheter | |||
| Guardia™ | Sydney IVF® Embryo Transfer Catheter | K-JET-2823 | Embryo transfer catheter |
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Image /page/4/Picture/0 description: The image shows the Cook Medical logo. The logo has a red background with the word "COOK" in white, sans-serif font. Below the word "COOK" is the word "MEDICAL" in white, sans-serif font, on a red background that is slightly darker than the background behind the word "COOK".
All embryo transfer catheters have an outer diameter of 2.8 Fr and range in length from 23 to 25 cm. The transfer catheters have internal or external supporting cannula, depth indicators, and may have an echogenic band. The Guardia™ Access guide catheters are precurved and feature a bulb-shaped tip. They measure 6.6 Fr in outer diameter and are 16.7 to 17.3 cm in length.
All subject devices are single-use devices and sterilized by ethylene oxide exposure. They undergo lot release Mouse Embryo Assay (MEA) testing for embryo toxicity and USP endotoxin (LAL) testing for pyrogenicity. The subject devices are packaged in peel-open sterile barrier pouches with a three-year shelf life.
Indications for Use:
Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter:
Used to place in vitro fertilized (IVF) embryos into the uterine cavity.
| Parameter | K173686 (subject device) | K983594 (predicate device) |
|---|---|---|
| Indication for Use | Used to place in vitro | |
| fertilized (IVF) embryos | ||
| in the uterine cavity. | The embryo transfer catheters/sets are | |
| used to place embryos in the uterine | ||
| cavity. | ||
| Design - transfer catheter | Same as predicate | • Graduation marks |
| • Open end | ||
| • Locking hub | ||
| • With or without echotip | ||
| Design - guide catheter | Same as predicate | • No graduation marks |
| • Positioner | ||
| • Bulb tip | ||
| • Precurved | ||
| • No echotip | ||
| Dimension - transfer catheter | OD 2.8 Fr / Length 23-25 cm | OD 2-8 Fr / Length 12-30 cm |
| Dimensions – guide catheter | OD 6.6 Fr / Length 16.7 or 17.3 cm | OD 5-8.5 Fr / Length 12-30 cm |
| Materials - transfer catheter | Polyethylene, polyurethane, | |
| stainless steel | Polyethylene, teflon, stainless steel | |
| Materials - guide catheter | Polyurethane, silicone, | |
| polymethylpentene | Polyethylene, echosight polyethylene, | |
| teflon, stainless steel |
Comparison of Intended Use and Technological Characteristics with the Predicate Device:
The subject and predicate devices have the same intended use. They also have the comparable designs. There are differences in dimensions and materials between the subject and predicate devices, but these differences do not raise different questions of safety and effectiveness. The difference in dimensions can be addressed by bench performance testing. The differences in materials can be evaluated by biocompatibility testing and Mouse Embryo Assay Testing.
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Image /page/5/Picture/0 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, uppercase letters on a red background. Below the word "COOK" is the word "MEDICAL" in white, uppercase letters on a red background. The red background for the word "MEDICAL" is in a rectangular shape with a diagonal cut on the left side.
Summary of Non-Clinical Performance Testing:
The following studies have been performed to support substantial equivalence to the predicate device:
- . Sterilization Validation testing per ISO 11135-1:2007
- Biocompatibility studies, as follows: ●
- Cytotoxicity testing per 10993-5:2009 o
- Guinea Pig Maximization Sensitization testing per ISO 10993-10:2002 or ISO 10993o 10:2010
- Intracutaneous Irritation testing per ISO 10993-10:2002 or ISO 10993-10:2010 o
- Endotoxin testing per USP and AAMI/ANSI ST72:2011/(R)2016 (