(163 days)
No
The device description and performance studies focus on the physical and functional aspects of a catheter set for embryo transfer, with no mention of AI or ML capabilities.
Yes
The device is used to introduce embryos into the uterine cavity, which is a therapeutic intervention aimed at achieving pregnancy.
No
Explanation: The device is an embryo transfer catheter set used for the introduction of embryos into the uterine cavity, which is a therapeutic rather than a diagnostic procedure. While it uses ultrasound for guidance, the device itself is not performing a diagnostic function.
No
The device description clearly outlines physical components (catheters, syringe, membrane, stainless steel band, markings) and the performance studies focus on physical and biological characteristics of these components, not software functionality.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is "for ultrasound-guided introduction of embryos into the uterine cavity following in vitro fertilization." This describes a procedure performed on the patient's body, not a test performed on a sample taken from the patient's body.
- Device Description: The device is a catheter set designed to physically deliver embryos into the uterus. It's a tool for a medical procedure, not a device for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
- Performance Studies: The performance studies focus on the physical and functional aspects of the catheter (eversion, passage, strength, biocompatibility, sterility, etc.), not on the accuracy or reliability of a diagnostic test.
- Predicate Device: The predicate device is also an embryo transfer catheter, which is a medical device used in a procedure, not an IVD.
In summary, the CrossBay IVF Embryo Transfer Catheter Set is a medical device used in the process of in vitro fertilization to physically transfer embryos into the uterus. It does not perform any diagnostic testing on biological samples, which is the defining characteristic of an IVD.
N/A
Intended Use / 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.
Product codes
MQF
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Uterine cavity / Uterus; Cervix
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Bench Testing:
Physical bench testing confirmed that the CrossBay IVF Device performs according to the product specifications. Device evaluation consisted of dimensional testing, visual inspection, physical and functional testing including: eversion and inversion of the Delivery Catheter, passage of the Embryo Transfer Catheter through the Delivery Catheter, bond joint testing, and over-pressurization testing. Performance testing also included tensile testing on all bond joints to demonstrate component integrity beyond anticipated operational forces. Membrane integrity and burst testing demonstrated their ability to withstand pressurization forces beyond those expected in use. Verification testing was conducted to demonstrate that the catheter prepping procedure provides the expected catheter performance.
Additional comparative testing performed with the subject device and predicate device supported equivalence by demonstrating functional equivalence of the subject device and predicate devices. Demonstrations of functional equivalence included navigating tubing with varying lumen diameters and bend radii with both the subject and predicate devices. The Embryo Transfer Catheters were also comparison tested for cantilevering in free space, ability to withstand radius of curvature without deformation, degree of compressive force recorded when the distal end of the embryo transfer catheters is pressed into a force gauge, and the ability of the subject and predicate embryo transfer catheters to pick up and inject discrete micro-liters of fluid.
Biocompatibility testing:
Biocompatibility testing was conducted on sterile CrossBay Medical IVF devices according to ISO 10993-1- 2009/(R2013) and FDA's recent guidance "Use of International Standard ISO 10993." Testing included: 1) Cytotoxicity (ISO 10993-5:2009); 2) Vaginal Irritation (ISO 10993-10:2010); and, 3) Sensitization (ISO 10993-10:2010). The test articles assessed provided acceptable results as no signs of cytotoxicity, sensitization or irritation reactions were noted in testing.
Endotoxin Testing:
Bacterial Endotoxin (Limulus Amoebocyte Lysate) Assay testing (FDA recognized consensus standard USP and ANSI/AAMI ST72:2011) was performed on three lots of product demonstrating that devices met the acceptance specification of ≤20 EU/device. Endotoxin testing is performed on each lot of product.
Mouse Embryo Assay (MEA) Testing:
Mouse Embryo Assay Testing was performed on the Embryo Transfer Catheter both before and after 6 months of accelerated aging on three lots of product with one cell mouse embryo testing (MEA) demonstrating that devices met the acceptance specification of ≥80% blastocyst formation at 96 hours. Test articles passed all MEA testing conducted. MEA testing is performed on each lot of product.
Sterilization Validation:
The sterilization validation was performed in compliance with ISO 11135-1:2014 and ISO 10993-7:2008.
Packaging, Shipping Validation, and Shelf-Life:
Packaging and shipping validation studies were conducted according to ASTM F88/F88M - 15, ASTM F 2096-11, and ISTA 2A:2011. The proposed shelf-life of six (6) months is supported by packaging and performance tests conducted on samples exposed to accelerated aging conditions pursuant to ASTM F1980 – 07. The parameters assessed before and after aging included functional, dimensional testing, visual inspection, bond and joint testing, over-pressurization testing, and MEA testing.
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).
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, often associated with medicine and healthcare. The seal is black and white.
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
1
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,
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
2
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) | ||
|---|---|---|
| ☒ Residential Use (Per 31 CFR 801 Subpart B)□ Owner-Tenant Use (31 CFR 801 Subpart C) | ☒ Residential Use (Per 31 CFR 801 Subpart B) | □ Owner-Tenant Use (31 CFR 801 Subpart C) |
| ☒ 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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3
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: 844.722.6462 | |
| Email: info@crossbaymedicalinc.com | |
| Contact: | Cindy Domecus |
| Regulatory Consultant to CrossBay Medical | |
| Phone: 650.343.4813 | |
| Fax: 650.343.7822 | |
| Email: domecusconsulting@comcast.net | |
| 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
4
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
(K162064) | Wallace Sure View™ Embryo Replacement
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.
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
5
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
Characteristics | CrossBay IVF Embryo
Transfer Catheter Set
(K162064) | Wallace Sure View™
Embryo Replacement
Catheters & Trial
Transfer Catheters
(K033084) | Comparison |
|-----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| System
Components | Delivery catheter
(incorporating the inner
catheter and everting
membrane), embryo
transfer (ET)catheter,
and 3 cc syringe | Outer delivery catheter,
ET catheter, trial
transfer catheter. | Different: The subject
device incorporates an
everting membrane that is
deployed as the inner
catheter is advanced
through the cervical canal.
The inclusion of these
components provides a
padded (fluid-filled) layer
around the inner catheter
as it passes through the
cervix. The inclusion of
these components does not
raise different questions of
safety and effectiveness (S
& E) as compared to the
predicate (e.g., ability to
advance through cervix,
ability to support passage |
| | | | of ET catheter, perforation,
etc.). |
| | | | |
| | | | The subject device also
includes a 3 cc syringe for |
| | | | device preparation and |
| | | | deployment. This |
| | | | component is supplied as a |
| | | | convenience to the user
and does not raise different |
| | | | questions of S & E. |
| | | | The predicate includes an |
| | | | optional trial transfer |
| | | | catheter that may be used
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
Embryo Transfer
Catheter | Pellethane polyurethane
tubing, polypropylene
hub | Information is unknown | Different: The materials in
the predicate device are
not known; however,
differences in device
materials do not raise
different S & E questions
(e.g., biocompatibility,
embryo compatibility) |
| Device Materials of
Delivery Catheter | Pebax, polyurethane, low
density polyethylene,
ABS | Information is unknown | Different: The materials in
the predicate devices are
not known; however, these
differences do not raise
different S & E questions
(e.g., biocompatibility) |
| Device Markings | Three (3) marks of 1 cm
increments on proximal
end of Embryo Transfer
Catheter | Four (4) marks of 1 cm
increments on proximal
end of embryo transfer
catheter and five (5)
marks on the distal end
of the outer delivery
catheter. | Different: The ET catheters
both include 1 cm
increment depth marks to
aid in assessing insertion
depth. However, the
subject delivery catheter
does not include depth
marks like the predicate.
The subject device |
| | | | |
| | | | incorporates an acorn tip
on the delivery catheter
that is positioned at the
exocervix to control the
depth of insertion of the
delivery catheter. Lack of
depth marks on the subject
device delivery catheter
does not raise different S &
E questions. |
| Depth of insertion
into the uterine
cavity | The Delivery Catheter is
used to traverse the
cervix for a distance of 5
cm from the acorn tip at
the exocervix with a fully
everted membrane. The
embryo transfer catheter
is inserted through the
fully everted Delivery
Catheter. Four markings
in 1 cm increments on
the proximal end of the
Embryo Transfer
Catheter indicates
insertion beyond the
distal end of the everted
membrane. | The outer delivery
catheter is used to
traverse the cervix.
Outer delivery catheter
has five (5) 1 cm
increments indicating
depth of insertion in the
cervix. The embryo
transfer catheter is
inserted into the outer
delivery catheter. The
embryo transfer
catheter protrudes from
the outer delivery
catheter by 4 cm. Four
markings in 1 cm
increments on the
proximal end of embryo
transfer catheter
indicates insertion
beyond the distal end of
the outer delivery
catheter. | Similar |
| Physical
dimensions of
device
components
(length, ID, OD) of
the Embryo
Transfer Catheter | Length: 31 cm
ID: 0.56 mm
OD: 0.91mm | Length: 18 to 23 cm
ID: 0.76 mm
OD: 1.5 mm | Different: The overall
length of the subject ET
catheter is longer than the
predicate; however, the
overall maximum depth of
insertion into the uterine
cavity is similar due to
inclusion of the acorn tip on
the delivery catheter that
limits ET catheter insertion
depth into the uterine |
| | | | |
| Physical
dimensions of
device
components
(length, ID, OD)
and overall device
length of the
Delivery Catheter | Overall Length: 23 cm
fully everted
ID: 1.17mm
OD: 1.55 mm
(OD of the inner catheter
at the distal end of the
delivery catheter | Overall Length of
Delivery Catheter:
Unknown
Inner diameter
unknown, 2.3 mm OD
of outer delivery
catheter | cavity. In addition, the ID
and OD of the subject
device are smaller than the
predicate. These
differences do not raise
different S & E questions.
Different: The specific
length of the predicate
delivery catheters is
unknown, but based on
device design is anticipated
to be shorter than the ET
catheter (~4 cm shorter).
Therefore, the subject
delivery catheter is longer
than the predicate devices.
The subject device
incorporates an acorn tip
on the delivery catheter
that is positioned at the
exocervix to control the
depth of insertion of the
delivery catheter.
In addition, the subject
device has a smaller OD
than the predicate device.
These differences do not
raise different S & E
questions. |
| Embryo Transfer
Catheter tip
configuration | Rounded tip with
opening at distal end | Rounded tip with
opening at distal end | Same |
| Ultrasound
guidance marker | Stainless steel marker
band at distal end of
Embryo Transfer
Catheter | Air bubbles enclosed
within polyurethane
material | Different: Different types of
echogenic markers used in
the subject and predicate
devices. Differences in
ultrasound visualization
methods do not raise
different S & E questions. |
| Procedural steps:
Placement into
uterine cavity | 1. Pressurize Delivery
Catheter | 1. Insert outer delivery
catheter across cervix | Similar |
| | Catheter across cervix
3. Insert loaded Embryo
Transfer Catheter
through Delivery
Catheter
4. Deposit embryo(s) | transfer catheter
through outer delivery
catheter
3. Deposit embryo(s) | |
| Sterilization
method and use | Ethylene Oxide (EtO)
sterilized and single use | EtO sterilized and single use | Same |
| MEA specification | One cell mouse embryo
tested (MEA) showing a
$\ge$ 80% blastocyst
formation rate at 96
hours. | Two cell mouse embryo
tested (MEA) showing a
80% survival. | Different: Different
versions of MEA testing
used. These differences do
not raise different S &E
questions. |
| Endotoxin
specification | Endotoxin (LAL): $\le$ 20
EU/device Testing is
conducted on a lot-to-lot
(batch) basis | Endotoxin (LAL): 0.5
EU/ml Testing is
conducted on a lot-to-
lot (batch) basis | Different: The acceptance
specifications used are
different, but do not raise
different S & E questions. |
Table 2: Technology Comparison of the Subject Device and Predicate Device
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7
8
9
As noted in the table above, the subject and predicate device are similar in that they are both EtOsterilized, single-use, polymer-based catheters consisting of an outer delivery system used to traverse the vaginal cavity and cervix, and a transfer catheter used to hold and deliver embryos into the uterine cavity. Both the subject and predicate devices include depth markers on the embryo transfer catheter to assess insertion depth into the uterine cavity. However, differences do exist as described in the table above (e.g., inclusion of an everting membrane, dimensions, specific device materials, etc.). The differences identified do not raise different questions of safety and effectiveness as discussed in Table 2.
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Bench Testing
Physical bench testing confirmed that the CrossBay IVF Device performs according to the product specifications. Device evaluation consisted of dimensional testing, visual inspection, physical and functional testing including: eversion and inversion of the Delivery Catheter, passage of the Embryo Transfer Catheter through the Delivery Catheter, bond joint testing, and over-pressurization testing. Performance testing also included tensile testing on all bond joints to demonstrate component integrity beyond anticipated operational forces. Membrane integrity and burst testing demonstrated their ability to withstand pressurization forces beyond those expected in use. Verification testing was conducted to demonstrate that the catheter prepping procedure provides the expected catheter performance.
10
Additional comparative testing performed with the subject device and predicate device supported equivalence by demonstrating functional equivalence of the subject device and predicate devices. Demonstrations of functional equivalence included navigating tubing with varying lumen diameters and bend radii with both the subject and predicate devices. The Embryo Transfer Catheters were also comparison tested for cantilevering in free space, ability to withstand radius of curvature without deformation, degree of compressive force recorded when the distal end of the embryo transfer catheters is pressed into a force gauge, and the ability of the subject and predicate embryo transfer catheters to pick up and inject discrete micro-liters of fluid.
Biocompatibility testing
Biocompatibility testing was conducted on sterile CrossBay Medical IVF devices. Biocompatibility testing was conducted according to ISO 10993-1- 2009/(R2013) "Biological Evaluation of Medical Devices" and FDA's recent guidance "Use of International Standard ISO 10993." Testing included the following: 1) Cytotoxicity (ISO 10993-5:2009); 2) Vaginal Irritation (ISO 10993-10:2010); and, 3) Sensitization (ISO 10993-10:2010). The test articles assessed provided acceptable results as no signs of cytotoxicity, sensitization or irritation reactions were noted in testing.
Endotoxin Testing
Bacterial Endotoxin (Limulus Amoebocyte Lysate) Assay testing (FDA recognized consensus standard USP and ANSI/AAMI ST72:2011) was performed on three lots of product demonstrating that devices met the acceptance specification of ≤20 EU/device. Endotoxin testing is performed on each lot of product.
Mouse Embryo Assay (MEA) Testing
Mouse Embryo Assay Testing was performed on the Embryo Transfer Catheter both before and after 6 months of accelerated aging on three lots of product with one cell mouse embryo testing (MEA) demonstrating that devices met the acceptance specification of ≥80% blastocyst formation at 96 hours. Test articles passed all MEA testing conducted. MEA testing is performed on each lot of product.
Sterilization Validation
The sterilization validation was performed in compliance with the requirements in the applicable standards for ethylene oxide sterilization (ISO 11135-1:2014 "Sterilization of health care products --Ethylene oxide -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices" and ISO 10993-7:2008 "Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals").
11
Packaging, Shipping Validation, and Shelf-Life
Packaging and shipping validation studies were conducted on sterilized CrossBay IVF Devices pursuant to the applicable ASTM guidelines (ASTM F88/F88M - 15 "Standard Test Method for Seal Strength of Flexible Barrier Materials"; and, ASTM F 2096-11 "Standard Test Methods for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble leaks)"; ISTA 2A:2011 "Preshipment Testing procedures – Combination tests for Packaged Products Weighing 150lbs (68kg) or less"). The proposed shelf-life of six (6) months is supported by packaging and performance tests conducted on samples exposed to accelerated aging conditions pursuant to ASTM F1980 – 07 "Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices". The parameters assessed before and after aging included functional, dimensional testing, visual inspection, bond and joint testing, over-pressurization testing, and MEA testing.
VIII: CONCLUSIONS
The subject and predicate devices have the same intended use and technological characteristics. Based on the intended use, technological characteristics, and bench performance data provided in this premarket notification, the CrossBayIVF Embryo Transfer Catheter Set has been shown to be substantially equivalent to the predicate device.