CrossBay IVF Embryo Transfer Catheter Set

K162064 · Crossbay Medical, Inc. · MQF · Jan 5, 2017 · Obstetrics/Gynecology

Device Facts

• Record ID: K162064
• Device Name: CrossBay IVF Embryo Transfer Catheter Set
• Applicant: Crossbay Medical, Inc.
• Product Code: MQF · Obstetrics/Gynecology
• Decision Date: Jan 5, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6110
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The CrossBay IVF Embryo Transfer Catheter Set is intended for ultrasound-guided introduction of embryos into the uterine cavity following in vitro fertilization.

Device Story

The CrossBay IVF Embryo Transfer Catheter Set is a sterile, single-use device for transferring in vitro fertilized embryos into the uterus. The system includes a delivery catheter with an everting membrane, a 3cc syringe, and a 3 Fr embryo transfer catheter. The clinician uses the syringe to prime the delivery catheter with saline or culture media. The delivery catheter, featuring an acorn tip for exocervical seating, is advanced into the endocervix; pressurization deploys the everting membrane, which advances 5 cm into the uterine cavity. The embryo transfer catheter, containing a stainless steel band for ultrasound echogenicity, is then inserted through the delivery catheter to deposit the embryos. The device is used in a clinical setting by a physician. The procedure allows for precise, ultrasound-guided embryo placement, potentially improving the success of IVF procedures.

Clinical Evidence

Bench testing only. Testing included dimensional, visual, functional, bond joint, and over-pressurization testing. Biocompatibility testing (cytotoxicity, vaginal irritation, sensitization) per ISO 10993. Endotoxin testing per USP <85>. Mouse Embryo Assay (MEA) testing demonstrated ≥80% blastocyst formation at 96 hours. Sterilization validation per ISO 11135-1. Packaging and shelf-life validation per ASTM F88, F2096, and F1980.

Technological Characteristics

Materials: Pellethane polyurethane, polypropylene, Pebax, ABS. Energy: Manual hydraulic (saline/media). Dimensions: 31 cm ET catheter length, 0.91 mm OD. Features: Everting membrane, stainless steel echogenic marker band, acorn tip. Sterilization: Ethylene Oxide (EtO). Connectivity: None.

Indications for Use

Indicated for ultrasound-guided introduction of embryos into the uterine cavity following in vitro fertilization.

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

• Wallace Sure View™ Embryo Replacement Catheters & Trial Transfer Catheters (K033084)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 5, 2017

CrossBay Medical Inc. % Cindy Domecus Principal Domecus Consulting Services, LLC 1171 Barroihet Drive Hillsborough, CA 94010

Re: K162064

> Trade/Device Name: CrossBay IVF Embryo Transfer Catheter Set Regulation Number: 21 CFR 884.6110 Regulation Name: Assisted Reproduction Catheters Regulatory Class: Class II Product Code: MOF Dated: December 5, 2016 Received: December 7, 2016

Dear Cindy Domecus,

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. 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

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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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Benjamin R. Fisher -S

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) K162064

Device Name CrossBay IVF Embryo Transfer Catheter Set

Indications for Use (Describe)

The CrossBay IVF Embryo Transfer Catheter Set is intended for ultrasound-guided introduction of embryos into the uterine cavity following in vitro fertilization.

| Type of Use (Select one or both, as applicable) | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-------------------------------------------|
| <table><tr><td><span style="text-decoration: underline;">☒</span> Residential Use (Per 31 CFR 801 Subpart B)</td></tr><tr><td>□ Owner-Tenant Use (31 CFR 801 Subpart C)</td></tr></table> | <span style="text-decoration: underline;">☒</span> Residential Use (Per 31 CFR 801 Subpart B) | □ Owner-Tenant Use (31 CFR 801 Subpart C) |
| <span style="text-decoration: underline;">☒</span> Residential Use (Per 31 CFR 801 Subpart B) | | |
| □ Owner-Tenant Use (31 CFR 801 Subpart C) | | |

> Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary (21 CFR § 807.92(c)) K162064

#### I. SUBMITTER INFORMATION

| Submitter: | CrossBay Medical, Inc. |
|--------------------------------|----------------------------------------------------|
| | 13240 Evening Creek Drive, Suite 304 |
| | San Diego, CA 92128 |
| | Phone: [phone] |
| | Email: [e-mail] |
| Contact: | Cindy Domecus |
| | Regulatory Consultant to CrossBay Medical |
| | Phone: [phone] |
| | Fax: [phone] |
| | Email: [e-mail] |
| Date Summary Prepared: | January 4, 2017 |
| II. SUBJECT DEVICE INFORMATION | |
| Device Trade Name: | CrossBay IVF Embryo Transfer Catheter Set |
| Common Name: | Embryo Transfer Catheter |
| Classification Name: | Assisted Reproduction Catheters (21 CFR §884.6110) |

Regulatory Class: II Traditional 510(k) Submission Type: Product Code: MQF - Catheter, Assisted Reproduction

#### III. PREDICATE DEVICE INFORMATION

Wallace Sure View™ Embryo Replacement Catheters & Trial Transfer Catheters (K033084) .

This predicate has not been subject to a design-related recall.

## IV. DEVICE DESCRIPTION

The CrossBay IVF Embryo Transfer Catheter Set is a sterile, single use device composed of disposable components supporting the transfer of an in vitro fertilized embryo to the uterus.

The CrossBay IVF Embryo Transfer Catheter Set is comprised of a Delivery Catheter with a 6 Fr Inner Catheter and everting membrane that accesses the cervix and uterine cavity; a 3cc syringe for supplying aseptically filtered media or saline to the Delivery Catheter; and a 3 Fr Embryo Transfer Catheter that is supplied in a separately sealed pouch. The Delivery Catheter contains an acorn tip for seating the distal end of the Delivery Catheter at the exocervix. The Embryo Transfer Catheter contains a stainless steel band at the distal end to provide additional echogenicity to the catheter for ultrasound guided

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procedures. The Embryo Transfer Catheter has markings on its proximal end at 1 cm intervals to aid in determining the depth of insertion. The Embryo Transfer Catheter can extend a maximum distance of 4 cm beyond the distal end of the fully everted membrane when completely inserted into the Delivery Catheter. The maximum insertion depth of the Embryo Transfer Catheter and fully everted membrane is 9 cm.

The 3 cc syringe is used for priming the device and supplying aseptically filtered culture media or sterile saline to pressurize the Delivery Catheter for the purposes of membrane deployment. Aseptically filtered culture media or saline is introduced into the Delivery Catheter until hand resistance on the 3 cc syringe is felt. Once loaded with aseptically filtered culture media or saline, the Inner Catheter is manually advanced to introduce the everting membrane and Inner Catheter into the endocervix and uterine cavity. When fully everted, the Inner Catheter advances 5 cm across the cervical canal into the uterine cavity. The 3 Fr Embryo Transfer Catheter loaded with embryo(s) is inserted through the Inner Catheter and into the uterus.

## V. INDICATIONS FOR USE

The CrossBay IVF Embryo Transfer Catheter Set is intended for ultrasound-guided introduction of embryos into the uterine cavity following in vitro fertilization.

## VI. COMPARISON OF INTENDED USE AND TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

## Comparison of Intended Use

The indications for use for the subject and predicate device are shown in Table 1 below:

| CrossBay IVF Embryo Transfer Catheter Set<br>(K162064) | Wallace Sure View™ Embryo Replacement<br>Catheters & Trial Transfer Catheters (K033084) |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| The CrossBay IVF Embryo Transfer Catheter Set is intended for ultrasound-guided introduction of embryos into the uterine cavity following in vitro fertilization. | Embryo Replacement Catheters are sterile, single-use devices for ultrasound guided introduction of embryos into the uterine cavity following in-vitro fertilization.<br>Trial Transfer Catheter are sterile, single-use devices for determining whether the cervix is passable for a Wallace embryo replacement catheter. |

## Table 1: Indications for Use for the Subject and Predicate Device

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As shown in the table above, the indications for use of the CrossBay IVF Embryo Transfer Catheter Set are not the same as the predicate Wallace Sure View™ Embryo Replacement Catheters & Trial Transfer Catheters (K033084). The subject and primary predicate devices do have comparable indication statements in regards to transferring embryos into the uterus under ultrasound guidance. However, the primary predicate device also included trial transfer catheters indicated for use in determining whether the cervix is passable before attempting an embryo transfer procedure. As trial transfer catheters are not required to complete an embryo transfer procedure, this difference does not represent a new intended use for the subject device (i.e., transferring embryos into the uterus under ultrasound guidance).Therefore, the subject and predicate devices have the same intended use.

## Technological Characteristics

A detailed comparison of the technological characteristics of the subject and predicate device is provided in Table 2 below:

| Design<br>Characteristics | CrossBay IVF Embryo<br>Transfer Catheter Set<br>(K162064) | Wallace Sure View™<br>Embryo Replacement<br>Catheters & Trial<br>Transfer Catheters<br>(K033084) | Comparison |
|-----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| System<br>Components | Delivery catheter<br>(incorporating the inner<br>catheter and everting<br>membrane), embryo<br>transfer (ET)catheter,<br>and 3 cc syringe | Outer delivery catheter,<br>ET catheter, trial<br>transfer catheter. | Different: The subject<br>device incorporates an<br>everting membrane that is<br>deployed as the inner<br>catheter is advanced<br>through the cervical canal.<br>The inclusion of these<br>components provides a<br>padded (fluid-filled) layer<br>around the inner catheter<br>as it passes through the<br>cervix. The inclusion of<br>these components does not<br>raise different questions of<br>safety and effectiveness (S<br>& E) as compared to the<br>predicate (e.g., ability to<br>advance through cervix,<br>ability to support passage |
| | | | of ET catheter, perforation,<br>etc.). |
| | | | |
| | | | The subject device also<br>includes a 3 cc syringe for |
| | | | device preparation and |
| | | | deployment. This |
| | | | component is supplied as a |
| | | | convenience to the user<br>and does not raise different |
| | | | questions of S & E. |
| | | | The predicate includes an |
| | | | optional trial transfer |
| | | | catheter that may be used<br>to assess whether the |
| | | | cervix is passable before |
| | | | delivering the ET catheter. |
| | | | Lack of a trial transfer |
| | | | catheter does raise |
| | | | different questions of S & E. |
| Device Materials of<br>Embryo Transfer<br>Catheter | Pellethane polyurethane<br>tubing, polypropylene<br>hub | Information is unknown | Different: The materials in<br>the predicate device are<br>not known; however,<br>differences in device<br>materials do not raise<br>different S & E questions<br>(e.g., biocompatibility,<br>embryo compatibility) |
| Device Materials of<br>Delivery Catheter | Pebax, polyurethane, low<br>density polyethylene,<br>ABS | Information is unknown | Different: The materials in<br>the predicate devices are<br>not known; however, these<br>differences do not raise<br>different S & E questions<br>(e.g., biocompatibility) |
| Device Markings | Three (3) marks of 1 cm<br>increments on proximal<br>end of Embryo Transfer<br>Catheter | Four (4) marks of 1 cm<br>increments on proximal<br>end of embryo transfer<br>catheter and five (5)<br>marks on the distal end<br>of the outer delivery<br>catheter. | Different: The ET catheters<br>both include 1 cm<br>increment depth marks to<br>aid in assessing insertion<br>depth. However, the<br>subject delivery catheter<br>does not include depth<br>marks like the predicate.<br>The subject device |
| | | | |
| | | | incorporates an acorn tip<br>on the delivery catheter<br>that is positioned at the<br>exocervix to control the<br>depth of insertion of the<br>delivery catheter. Lack of<br>depth marks on the subject<br>device delivery catheter<br>does not raise different S &<br>E questions. |
| Depth of insertion<br>into the uterine<br>cavity | The Delivery Catheter is<br>used to traverse the<br>cervix for a distance of 5<br>cm from the acorn tip at<br>the exocervix with a fully<br>everted membrane. The<br>embryo transfer catheter<br>is inserted through the<br>fully everted Delivery<br>Catheter. Four markings<br>in 1 cm increments on<br>the proximal end of the<br>Embryo Transfer<br>Catheter indicates<br>insertion beyond the<br>distal end of the everted<br>membrane. | The outer delivery<br>catheter is used to<br>traverse the cervix.<br>Outer delivery catheter<br>has five (5) 1 cm<br>increments indicating<br>depth of insertion in the<br>cervix. The embryo<br>transfer catheter is<br>inserted into the outer<br>delivery catheter. The<br>embryo transfer<br>catheter protrudes from<br>the outer delivery<br>catheter by 4 cm. Four<br>markings in 1 cm<br>increments on the<br>proximal end of embryo<br>transfer catheter<br>indicates insertion<br>beyond the distal end of<br>the outer delivery<br>catheter. | Similar |
| Physical<br>dimensions of<br>device<br>components<br>(length, ID, OD) of<br>the Embryo<br>Transfer Catheter | Length: 31 cm<br>ID: 0.56 mm<br>OD: 0.91mm | Length: 18 to 23 cm<br>ID: 0.76 mm<br>OD: 1.5 mm | Different: The overall<br>length of the subject ET<br>catheter is longer than the<br>predicate; however, the<br>overall maximum depth of<br>insertion into the uterine<br>cavity is similar due to<br>inclusion of the acorn tip on<br>the delivery catheter that<br>limits ET catheter insertion<br>depth into the uterine |
| | | | |
| Physical<br>dimensions of<br>device<br>components<br>(length, ID, OD)<br>and overall device<br>length of the<br>Delivery Catheter | Overall Length: 23 cm<br>fully everted<br>ID: 1.17mm<br>OD: 1.55 mm<br>(OD of the inner catheter<br>at the distal end of the<br>delivery catheter | Overall Length of<br>Delivery Catheter:<br>Unknown<br>Inner diameter<br>unknown, 2.3 mm OD<br>of outer delivery<br>catheter | cavity. In addition, the ID<br>and OD of the subject<br>device are smaller than the<br>predicate. These<br>differences do not raise<br>different S & E questions.<br>Different: The specific<br>length of the predicate<br>delivery catheters is<br>unknown, but based on<br>device design is anticipated<br>to be shorter than the ET<br>catheter (~4 cm shorter).<br>Therefore, the subject<br>delivery catheter is longer<br>than the predicate devices.<br>The subject device<br>incorporates an acorn tip<br>on the delivery catheter<br>that is positioned at the<br>exocervix to control the<br>depth of insertion of the<br>delivery catheter.<br>In addition, the subject<br>device has a smaller OD<br>than the predicate device.<br>These differences do not<br>raise different S & E<br>questions. |
| Embryo Transfer<br>Catheter tip<br>configuration | Rounded tip with<br>opening at distal end | Rounded tip with<br>opening at distal end | Same |
| Ultrasound<br>guidance marker | Stainless steel marker<br>band at distal end of<br>Embryo Transfer<br>Catheter | Air bubbles enclosed<br>within polyurethane<br>material | Different: Different types of<br>echogenic markers used in<br>the subject and predicate<br>devices. Differences in<br>ultrasound visualization<br>methods do not raise<br>different S & E questions. |
| Procedural steps:<br>Placement into<br>uterine cavity | 1. Pressurize Delivery<br>Catheter | 1. Insert outer delivery<br>catheter across cervix | Similar |
| | Catheter across cervix<br>3. Insert loaded Embryo<br>Transfer Catheter<br>through Delivery<br>Catheter<br>4. Deposit embryo(s) | transfer catheter<br>through outer delivery<br>catheter<br>3. Deposit embryo(s) | |
| Sterilization<br>method and use | Ethylene Oxide (EtO)<br>sterilized and single use | EtO sterilized and single use | Same |
| MEA specification | One cell mouse embryo<br>tested (MEA) showing a<br>$\ge$ 80% blastocyst<br>formation rate at 96<br>hours. | Two cell mouse embryo<br>tested (MEA) showing a<br>> 80% survival. | Different: Different<br>versions of MEA testing<br>used. These differences do<br>not raise different S &E<br>questions. |
| Endotoxin<br>specification | Endotoxin (LAL): $\le$ 20<br>EU/device Testing is<br>conducted on a lot-to-lot<br>(batch) basis | Endotoxin (LAL): 0.5<br>EU/ml Testing is<br>conducted on a lot-to-<br>lot (batch) basis | Different: The acceptance<br>specifications used are<br>different, but do not raise<br>different S & E questions.…