Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, Soft-Trans Malleable Obturator, Guardia™ ETS Embryo-Tested Syringe, Flushing Catheter

K180302 · Cook Incorporated · MQF · Oct 24, 2018 · Obstetrics/Gynecology

Device Facts

• Record ID: K180302
• Device Name: Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, Soft-Trans Malleable Obturator, Guardia™ ETS Embryo-Tested Syringe, Flushing Catheter
• Applicant: Cook Incorporated
• Product Code: MQF · Obstetrics/Gynecology
• Decision Date: Oct 24, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6110
• Device Class: Class 2

Indications for Use

Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, and Soft -Trans Malleable Obturator: Used to supplement and assist uterine access of a cleared, dimensionally compatible embryo transfer device for placement of in vitro fertilized (IVF) embryos into the uterine cavity. GuardiaTM ETS Embryo-Tested Syringe: For use with catheters indicated for intrauterine insemination and embryo transfer. Flushing Catheter: The Flushing Catheter is intended for instillation of sterile medium into the cervical canal prior to embryo transfer.

Device Story

Device family includes malleable obturators, embryo-tested syringe, and flushing catheter; used in clinical settings by physicians during IVF/IUI procedures. Obturators assist uterine access for embryo transfer catheters; flushing catheter instills sterile medium into cervical canal; syringe facilitates fluid delivery. Obturators feature adjustable handles and malleable wires to navigate uterine anatomy. Syringe is two-part (polypropylene barrel, high-density polyethylene plunger). Flushing catheter includes depth indicator and side port. Devices are sterile, single-use. Clinical benefit: facilitates precise placement of embryos and preparation of cervical canal, improving procedural success. Healthcare providers use these tools to guide catheters and manage fluids, directly impacting the accuracy of embryo transfer.

Clinical Evidence

Bench testing only. Studies included: sterilization validation (ISO 11135-1:2007), biocompatibility (ISO 10993-5, -10), endotoxin testing (AAMI/ANSI ST72:2011), package integrity (ASTM F2096-04, F88-09), and transportation simulation (ASTM D4169-05). Mouse Embryo Assay (MEA) confirmed >80% embryo development to blastocyst stage. Bench performance verified dimensions, leak resistance, tensile strength, handle securement, and fracture resistance (ISO 11070:1999).

Technological Characteristics

Materials: Polyurethane, stainless steel, polyethylene, nylon, silicone. Obturators: Malleable wire/stylet, adjustable handles. Flushing catheter: 20 cm tube, 14.9 Fr to 3.5 Fr taper, side port. Syringe: Polypropylene barrel, HDPE plunger. Sterilization: Ethylene oxide (ISO 11135-1). Connectivity: None (mechanical).

Indications for Use

Indicated for patients undergoing in vitro fertilization (IVF) or intrauterine insemination (IUI) procedures requiring uterine access or cervical canal preparation.

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)

Reference Devices

• Insemi-Cath IUI catheter (K172321)
• K101547

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 24, 2018

Cook Incorporated Naomi Funkhouser Regulatory Affairs Specialist 750 Daniels Way P.O. Box 489 Bloomington, Indiana 47402

Re: K180302

> Trade/Device Name: Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, Soft-Trans Malleable Obturator, Guardia™ ETS Embryo-Tested Syringe, Flushing Catheter Regulation Number: 21 CFR 884.6110 Regulation Name: Assisted Reproduction Catheters Regulatory Class: Class II Product Code: MOF Dated: September 26, 2018 Received: September 27, 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. 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Sharon M. Andrews -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) K180302

#### Device Name

Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, Soft -Trans Malleable Obturator, GuardiaTM ETS Embryo-Tested Syringe, Flushing Catheter

#### Indications for Use (Describe)

Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, and Soft -Trans Malleable Obturator:

Used to supplement and assist uterine access of a cleared, dimensionally compatible embryo transfer device for placement of in vitro fertilized (IVF) embryos into the uterine cavity.

GuardiaTM ETS Embryo-Tested Syringe:

For use with catheters indicated for intrauterine insemination and embryo transfer.

#### Flushing Catheter:

The Flushing Catheter is intended for instillation of sterile medium into the cervical canal prior to embryo transfer.

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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Image /page/3/Picture/0 description: The image shows the Cook Medical logo. The logo consists of the word "COOK" in white, bold letters on a red background. Below the word "COOK" is the word "MEDICAL" in white letters on a red background. The red background is shaped like a rectangle with a notch cut out of the upper left corner.

# 510(k) Summary - K180302

### 1. Submitter Information:

| Applicant: | Cook Incorporated |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contacts: | Naomi Funkhouser<br>Rohini Patel |
| Applicant Address: | Cook Incorporated<br>750 Daniels Way<br>Bloomington, IN 47404 |
| Contact Phone: | [phone] x104371 |
| Contact Fax: | [phone] |
| 2. Date Prepared: | October 24, 2018 |
| 3. Device Information: | |
| Trade Names: | Guardia™ Access Malleable Obturator, Guardia™<br>Obturator, Soft-Pass™ Obturator, Soft-Trans Malleable<br>Obturator, Guardia™ ETS Embryo-Tested Syringe,<br>Flushing Catheter |
| Common Name: | Embryo Transfer Obturators and Accessories |
| Classification Name: | Assisted Reproduction Catheters (21 CFR 884.6110) |
| Classification Regulation: | MQF (Catheter, Assisted Reproduction) |
| Regulatory Class | II |

### 4. Predicate Device:

Embryo Transfer Catheter/Sets (K983594) manufactured by Cook Ob/Gyn. This predicate device has not been subject to any design related recalls.

# 5. Device Description:

This 510(k) covers eight devices from five of COOK's device families. These devices, as outlined in the table below, are sold separately.

| Product family | Product name | RPN | Diameter/length or volume |
|----------------|--------------------------------------------------------|------------|---------------------------|
| Guardia Access | Guardia™ Access Malleable<br>Obturator | K-JET-7002 | 4.0 Fr/19.9 cm |
| Guardia | Guardia™ Obturator (Malleable<br>Adjustable Obturator) | J-UOB-2828 | 2.8 Fr/28 cm |
| | Guardia™ Obturator (Malleable<br>Adjustable Obturator) | J-UOB-4028 | 4.0 Fr/28 cm |

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Image /page/4/Picture/0 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, sans-serif font, placed on a red square. Below the red square is a red banner with the word "MEDICAL" in white, sans-serif font. The banner is slightly offset from the square above it.

| | Guardia™ Obturator (Stiff Adjustable<br>Obturator) | J-UOB-4028-ST | 4.0 Fr/28 cm |
|-------------------|----------------------------------------------------|------------------|----------------|
| | Guardia™ ETS Embryo-Tested<br>Syringe | K-ETS-1000 | 1 ml |
| Soft-Pass | Soft-Pass™ Obturator | J-SP-4420 | 4.4 Fr/20.2 cm |
| Soft-Trans | Soft-Trans Malleable Obturator | K-SOFT-4018 | 4.0 Fr/18 cm |
| Flushing Catheter | Flushing Catheter | J-IUIC-352000-CE | 3.5 Fr/20 cm |

The polyurethane obturators are designed to fit dimensionally compatible embryo transfer guide catheters. Some of these devices are designed to be adjustable in length.

The flushing catheter is a 20 cm tube measuring 14.9 Fr at the proximal end and tapering to 3.5 Fr at the distal end. It features a depth indicator and directional side port with an ink mark aligned with the position of the side port. This device is identical to the Insemi-Cath IUI catheter cleared under K172321.

The Guardia Embryo-Tested Syringe is two-part syringe with a polypropylene barrel and a highdensity polyethylene plunger. This device undergoes Mouse Embryo Assay (MEA) and endotoxin testing (LAL) before lot release.

All subject devices are supplied sterile and intended for one-time use. The Guardia Embryo-Tested Syringe has a shelf-life of five years, whereas the remaining subject devices have a shelflife of three years.

# 6. Indications for Use:

Guardia Malleable Obturator, Guardia TM Obturator, Soft-Pass™ Obturator, and Soft-Trans Malleable Obturator:

Used to supplement and assist uterine access of a cleared, dimensionally compatible embryo transfer device for placement of in vitro fertilized (IVF) embryos into the uterine cavity.

# GuardiaTM ETS Embryo-Tested Syringe

For use with catheters indicated for intrauterine insemination and embryo transfer.

### Flushing Catheter

The Flushing Catheter is intended for instillation of sterile medium into the cervical canal prior to embryo transfer.

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Image /page/5/Picture/0 description: The image shows the Cook Medical logo. The word "COOK" is in white, sans-serif font on a red background. Below the word "COOK" is the word "MEDICAL" in white, sans-serif font on a red background. The red background is shaped like a rectangle with a diagonal cut on the bottom left.

# 7. Comparison of Intended Use and Technological Characteristics with the Predicate Device:

# Comparison of obturators with the predicate device

| Device | Subject device (K180302) | Predicate device (K983594) |
|--------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Same as the predicate device | Used to supplement and assist uterine access of<br>cleared, dimensionally compatible embryo transfer<br>devices for placement of in vitro fertilized (IVF)<br>embryos into the uterine cavity. |
| Design | • Adjustable handles to be sized<br>to fit inside guide catheters<br>• Polyethylene over soft<br>stainless or stylet wire for<br>malleability<br>• Smooth and rounded distal tip | • Sized to fit inside guide catheters<br>• Malleability not specified<br>• Tip characteristic not specified |
| Dimension | • OD: 2.8-4.4 Fr<br>• Length: 18-28 cm | • OD: Matched to fit within guide catheter<br>• Length: matched with guide catheter at tip |
| Materials | Same as the predicate device | Polyethylene, stainless steel |

Both subject and predicate devices are used to supplement and assist uterine access of cleared, dimensionally compatible embryo transfer devices for placement of IVF embryos into the uterine cavity. Therefore, they have the same intended use.

The subject and predicate devices use the same materials but have different design and dimensions. However, the differences are commonly seen in cleared devices and therefore, do not raise different questions of safety and effectiveness. The differences can be assessed by biocompatibility and bench performance testing.

### Comparison of Guardia™ ETS Embryo-Tested Syringe with the predicate device

The predicate device (K983594) includes a syringe intended for aiding in embryo transfer procedures. Therefore, the subject device and predicate devices have the same intended use. In addition, these two devices have comparable technological characteristics. The Guardia™ ETS Embryo-Tested Syringe is identical to a cleared device intended for general injection use. To ensure biological safety, the subject syringe is evaluated for embryotoxicity and endotoxin.

| Device | Subject device (K180302) | Predicate device (K983594) |
|-----------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Design | • Without graduation marks<br>• Close end with side port<br>• Without hubs<br>• With positioner | • With or without graduation marks<br>• Open end with side port<br>• With or without hubs<br>• Without positioner |
| Dimension | OD 3.5 Fr / Length 20 cm | OD 2-8 Fr / Length 12-30 cm |
| Materials | Nylon, silicone | Polyethylene, Teflon, stainless steel |

### Comparison of Flushing Catheter with the predicate device

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Image /page/6/Picture/0 description: The image shows the Cook Medical logo. The logo consists of the word "COOK" in white, sans-serif font, stacked on top of the word "MEDICAL" in a smaller, white, sans-serif font. Both words are set against a red background. The "COOK" has a trademark symbol next to it.

The subject and predicate devices have similarity in design (e.g., side port, hubless, no graduation marks and comparable dimensions). There are differences in design, materials, and dimensions, but these differences do not raise different questions of safety or effectiveness as compared to the predicate device and are commonly seen in other comparable cleared Assisted Reproduction Technology devices. The differences can be assessed by biocompatibility and bench performance testing.

# 8. 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 10993-10:2002/2010 o
- Intracutaneous Irritation testing per ISO 10993-10:2002/2010 o
- Endotoxin testing per AAMI/ANSI ST72:2011 (<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°C in an atmosphere containing 5% CO2. The percent of embryos developed to the expanded blastocyst stage within 96 hours were assessed. 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 demonstrated that all predetermined acceptance criteria were met in the following tests:
- Obturator/Flushing Catheter dimensional verification Devices are measured and o verified against device input requirements.
- Flushing Catheter Leak Test Testing ensures that fluid path does not leak under a o predetermined injection pressure.

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Image /page/7/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 white, block letters on a red background. The red background extends further to the left than the word "COOK".

- Obturator/Flushing Catheter Tensile Test Testing demonstrates that the tensile o strength value is greater than the predetermined acceptance criterion.
- Obturator Handle Securement Test Testing demonstrates the adjustment o mechanism does not allow the obturator to move from its set position under worst case handling under the predetermined acceptance criterion.
- Obturator Fracture Test This testing demonstrated that the test articles do not o facture, loosen, or fail when tested in accordance with ISO 11070:1999

In addition, performance data in K172321 and K101547 are leveraged to support substantial equivalence of Flushing Catheter and Guardia™ ETS Embryo-Tested Syringe, respectively.

### 9. 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.