Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter
Device Facts
| Record ID | K173686 |
|---|---|
| Device Name | Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter |
| Applicant | Cook Incorporated |
| Product Code | MQF · Obstetrics/Gynecology |
| Decision Date | Apr 11, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.6110 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
Used to place in vitro fertilized (IVF) embryos into the uterine cavity.
Device Story
Guardia Access Embryo Transfer Catheter Sets and Sydney IVF Transfer Catheter are single-use devices used by clinicians to place IVF embryos into the uterine cavity. The system consists of a transfer catheter (with or without internal/external supporting cannula) and, for the Guardia Access family, a precurved guide catheter with a bulb-shaped tip. The transfer catheters feature depth indicators and optional echogenic bands for ultrasound visualization. The device is manually operated by a clinician. The clinician uses the guide catheter to navigate the cervical canal and the transfer catheter to deliver the embryo. The device benefits the patient by facilitating precise embryo placement during assisted reproduction procedures. All devices are sterilized via ethylene oxide.
Clinical Evidence
Bench testing only. Studies included sterilization validation (ISO 11135-1:2007), biocompatibility (ISO 10993-5, -10), endotoxin testing (USP <85>), package integrity (ASTM F2096-04, F88-09), and transportation simulation (ASTM D4169-05). Mouse Embryo Assay (MEA) confirmed no embryo toxicity (≥80% development to blastocyst). Bench performance testing verified dimensions, aspiration, leak resistance, tensile strength, and echogenicity.
Technological Characteristics
Materials: Polyethylene, polyurethane, stainless steel, silicone, polymethylpentene. Transfer catheters: 2.8 Fr OD, 23-25 cm length. Guide catheters: 6.6 Fr OD, 16.7-17.3 cm length. Features: Depth indicators, echogenic bands, precurved guide catheters. Sterilization: Ethylene oxide. Single-use.
Indications for Use
Indicated for patients undergoing in vitro fertilization (IVF) requiring embryo placement into the uterine cavity.
Regulatory Classification
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.
Special Controls
*Classification.* Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).
Predicate Devices
- Embryo Transfer Catheter/Sets (K983594)
Submission Summary (Full Text)
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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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
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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 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
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# 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)
| <div> <input checked="true" type="checkbox"/> Transaction(s) (Per 24 CFR 982.451, Subpart K) </div> | <div> <input type="checkbox"/> One-Time Exception(s) (Per 24 CFR 982.451, Subpart K) </div> |
|------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
|------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
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<br>Rohini Patel |
| Applicant Address: | Cook Incorporated<br>750 Daniels Way<br>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<br>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™<br>Access | Guardia™ Access Embryo Transfer<br>Catheter | K-JETS-6019 | Embryo transfer catheter<br>and guide catheter |
| | Guardia™ Access Embryo Transfer<br>Catheter with Internal Supporting Cannula | K-JETS-7019-INT | Embryo transfer catheter<br>and guide catheter |
| Guardia™<br>Access | Guardia™ Access Embryo Transfer<br>Catheter | K-JETS-7019 | Embryo transfer catheter<br>and guide catheter |
| | Guardia™ AccessET Embryo Transfer<br>Catheter | K-JETS-6019-ET | Embryo transfer catheter<br>and guide catheter |
| | Guardia™ AccessET Embryo Transfer<br>Catheter | K-JETS-7019-ET | Embryo transfer catheter<br>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<br>fertilized (IVF) embryos<br>in the uterine cavity. | The embryo transfer catheters/sets are<br>used to place embryos in the uterine<br>cavity. |
| Design - transfer catheter | Same as predicate | • Graduation marks<br>• Open end<br>• Locking hub<br>• With or without echotip |
| Design - guide catheter | Same as predicate | • No graduation marks<br>• Positioner<br>• Bulb tip<br>• Precurved<br>• 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,<br>stainless steel | Polyethylene, teflon, stainless steel |
| Materials - guide catheter | Polyurethane, silicone,<br>polymethylpentene | Polyethylene, echosight polyethylene,<br>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 <85> and AAMI/ANSI ST72:2011/(R)2016 (<20 EU/device) ●
- Transportation Simulation study per ASTM D4169-05
- . Package Integrity testing after real-time aging:
- Bubble Leak test per ASTM F2096-04 o
- Seal Strength testing per ASTM F88-09 o
- Visual Inspection: No package displayed damage (tears, folds, puncture holes, etc.) o
- Mouse Embryo Assay (MEA) before and after aging: .
One-cell mouse embryos were exposed to subject devices and cultured at 37℃ in an atmosphere containing 5% CO2. The percent of embryos developed to the expanded blastocyst stage within 96 hours were assessed in comparison with the control group. The testing demonstrated that the devices met acceptance criterion of "1-cell MEA ≥80% embryos developed to blastocyst in 96 hours."
- Bench Performance studies before and after aging demondtrated that all predetermined acceptance criteria were met in the following tests:
- Dimensional verification of catheter Catheters are measured and verified against o device input requirements.
- Transfer Catheter Aspiration Test Testing ensures there is no air leaking into the O syringe through the transfer catheter.
- Transfer Catheter Leak Test Testing ensures that fluid path catheter assembly O does not leak under a predetermined injection pressure.
- o Tensile Testing (Catheter Hub- shaft) - Testing demonstates 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 O impede smooth passage through the guide catheter.
- Echotip Band Echogenicity Test Visual comparison testing by ultrasound imaging O of catheters with and without an EchoTip band verified that the band provides increased brightness.
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Image /page/6/Picture/0 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is written in large, white, sans-serif font. Below "COOK" is the word "MEDICAL" in a smaller, white, sans-serif font, set against a dark red background.
COOK INCORPORATED 750 DANIELS WAY BLOOMINGTON, IN 47404 USA 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM
## Conclusion:
The subject and predicate devices have the same intended use. Although there are differences in technological characteristics between the subject and predicate devices, these differences do not raise different questions of safety or effectiveness. The performance data demonstrate that the subject devices are substantially equivalent to the predicate device.
