(163 days)
The CrossBay IVF Embryo Transfer Catheter Set is intended for ultrasound-guided introduction of embryos into the uterine cavity following in vitro fertilization.
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 provided text describes the CrossBay IVF Embryo Transfer Catheter Set and its comparison to a predicate device, the Wallace Sure View™ Embryo Replacement Catheters & Trial Transfer Catheters (K033084), to demonstrate substantial equivalence for regulatory approval.
Here's a breakdown of the acceptance criteria and the study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a consolidated table of acceptance criteria for all aspects of the device in a typical format. Instead, acceptance criteria are embedded within the "Performance Data" section for specific tests.
However, based on the provided text, we can construct the following table for the criteria that are clearly stated:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mouse Embryo Assay (MEA) | |
| ≥ 80% blastocyst formation rate at 96 hours | Met: "demonstrating that devices met the acceptance specification of ≥80% blastocyst formation at 96 hours." "Test articles passed all MEA testing conducted." (Performed on Embryo Transfer Catheter both before and after 6 months of accelerated aging, on three lots of product). |
| Endotoxin Testing | |
| ≤ 20 EU/device | Met: "demonstrating that devices met the acceptance specification of ≤20 EU/device." (Performed on three lots of product). |
| Biocompatibility | |
| No signs of cytotoxicity | Met: "no signs of cytotoxicity... were noted in testing." (Performed on sterile CrossBay Medical IVF devices per ISO 10993-5:2009). |
| No signs of sensitization | Met: "no signs of... sensitization... were noted in testing." (Performed on sterile CrossBay Medical IVF devices per ISO 10993-10:2010). |
| No signs of irritation reactions | Met: "no signs of... irritation reactions were noted in testing." (Performed on sterile CrossBay Medical IVF devices per ISO 10993-10:2010 for Vaginal Irritation). |
| Physical Bench Testing | |
| Performs according to product specifications | Met: "Physical bench testing confirmed that the CrossBay IVF Device performs according to the product specifications." This included dimensional testing, visual inspection, functional testing (eversion/inversion of Delivery Catheter, passage of ET Catheter), bond joint testing, over-pressurization testing, tensile testing on bond joints, membrane integrity and burst testing, and verification testing on catheter prepping procedure. Comparative testing also demonstrated functional equivalence with predicate device (navigating tubing, cantilevering, resistance to deformation, compressive force, fluid pickup/injection). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (for specific tests where mentioned):
- Mouse Embryo Assay (MEA): Three lots of product.
- Endotoxin Testing: Three lots of product.
- Testing for Shelf-Life/Accelerated Aging: "samples exposed to accelerated aging conditions". Specific number not defined beyond "samples".
- Data Provenance: The document does not specify the country of origin of the data. The studies appear to be retrospective bench and lab-based tests conducted on manufactured device samples. There is no mention of prospective clinical studies or human-based data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This section is not applicable as the studies described are bench tests, biocompatibility tests, and sterilization validations, which do not involve expert interpretation or ground truth establishment in the traditional sense of clinical imaging or diagnostic studies. The "ground truth" for these tests is based on established scientific and engineering principles, and the measured physical/biological properties of the device.
4. Adjudication Method for the Test Set
This section is not applicable for the reasons stated in point 3. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which are not present here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. This type of study is used to assess human reader performance, often in diagnostic imaging, which is not relevant to this device's testing.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
This section is not applicable. The device is an embryo transfer catheter set, a physical medical device. It does not involve algorithms or AI. The performance tests described evaluate the physical, chemical, and biological properties of the device itself.
7. Type of Ground Truth Used
The "ground truth" for the various performance tests is based on:
- Established engineering specifications and product design.
- Validated laboratory methods and consensus standards (e.g., ISO, ASTM, USP).
- Direct measurement and observation of physical properties.
- Biological responses (e.g., mouse embryo development for MEA, cellular reactions for biocompatibility).
For example, for MEA, the ground truth is the observable blastocyst formation rate in the mouse embryo cultures, and for endotoxin, it's the measured endotoxin level.
8. Sample Size for the Training Set
This section is not applicable. The device is a physical medical device, not a machine learning or AI model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the reasons stated in point 8.
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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 (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
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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) | ||
|---|---|---|
| ☒ 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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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
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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(K162064) | Wallace Sure View™ Embryo ReplacementCatheters & 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
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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:
| DesignCharacteristics | CrossBay IVF EmbryoTransfer Catheter Set(K162064) | Wallace Sure View™Embryo ReplacementCatheters & TrialTransfer Catheters(K033084) | Comparison |
|---|---|---|---|
| SystemComponents | Delivery catheter(incorporating the innercatheter and evertingmembrane), embryotransfer (ET)catheter,and 3 cc syringe | Outer delivery catheter,ET catheter, trialtransfer catheter. | Different: The subjectdevice incorporates aneverting membrane that isdeployed as the innercatheter is advancedthrough the cervical canal.The inclusion of thesecomponents provides apadded (fluid-filled) layeraround the inner catheteras it passes through thecervix. The inclusion ofthese components does notraise different questions ofsafety and effectiveness (S& E) as compared to thepredicate (e.g., ability toadvance through cervix,ability to support passage |
| of ET catheter, perforation,etc.). | |||
| The subject device alsoincludes a 3 cc syringe for | |||
| device preparation and | |||
| deployment. This | |||
| component is supplied as a | |||
| convenience to the userand does not raise different | |||
| questions of S & E. | |||
| The predicate includes an | |||
| optional trial transfer | |||
| catheter that may be usedto 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 ofEmbryo TransferCatheter | Pellethane polyurethanetubing, polypropylenehub | Information is unknown | Different: The materials inthe predicate device arenot known; however,differences in devicematerials do not raisedifferent S & E questions(e.g., biocompatibility,embryo compatibility) |
| Device Materials ofDelivery Catheter | Pebax, polyurethane, lowdensity polyethylene,ABS | Information is unknown | Different: The materials inthe predicate devices arenot known; however, thesedifferences do not raisedifferent S & E questions(e.g., biocompatibility) |
| Device Markings | Three (3) marks of 1 cmincrements on proximalend of Embryo TransferCatheter | Four (4) marks of 1 cmincrements on proximalend of embryo transfercatheter and five (5)marks on the distal endof the outer deliverycatheter. | Different: The ET cathetersboth include 1 cmincrement depth marks toaid in assessing insertiondepth. However, thesubject delivery catheterdoes not include depthmarks like the predicate.The subject device |
| incorporates an acorn tipon the delivery catheterthat is positioned at theexocervix to control thedepth of insertion of thedelivery catheter. Lack ofdepth marks on the subjectdevice delivery catheterdoes not raise different S &E questions. | |||
| Depth of insertioninto the uterinecavity | The Delivery Catheter isused to traverse thecervix for a distance of 5cm from the acorn tip atthe exocervix with a fullyeverted membrane. Theembryo transfer catheteris inserted through thefully everted DeliveryCatheter. Four markingsin 1 cm increments onthe proximal end of theEmbryo TransferCatheter indicatesinsertion beyond thedistal end of the evertedmembrane. | The outer deliverycatheter is used totraverse the cervix.Outer delivery catheterhas five (5) 1 cmincrements indicatingdepth of insertion in thecervix. The embryotransfer catheter isinserted into the outerdelivery catheter. Theembryo transfercatheter protrudes fromthe outer deliverycatheter by 4 cm. Fourmarkings in 1 cmincrements on theproximal end of embryotransfer catheterindicates insertionbeyond the distal end ofthe outer deliverycatheter. | Similar |
| Physicaldimensions ofdevicecomponents(length, ID, OD) ofthe EmbryoTransfer Catheter | Length: 31 cmID: 0.56 mmOD: 0.91mm | Length: 18 to 23 cmID: 0.76 mmOD: 1.5 mm | Different: The overalllength of the subject ETcatheter is longer than thepredicate; however, theoverall maximum depth ofinsertion into the uterinecavity is similar due toinclusion of the acorn tip onthe delivery catheter thatlimits ET catheter insertiondepth into the uterine |
| Physicaldimensions ofdevicecomponents(length, ID, OD)and overall devicelength of theDelivery Catheter | Overall Length: 23 cmfully evertedID: 1.17mmOD: 1.55 mm(OD of the inner catheterat the distal end of thedelivery catheter | Overall Length ofDelivery Catheter:UnknownInner diameterunknown, 2.3 mm ODof outer deliverycatheter | cavity. In addition, the IDand OD of the subjectdevice are smaller than thepredicate. Thesedifferences do not raisedifferent S & E questions.Different: The specificlength of the predicatedelivery catheters isunknown, but based ondevice design is anticipatedto be shorter than the ETcatheter (~4 cm shorter).Therefore, the subjectdelivery catheter is longerthan the predicate devices.The subject deviceincorporates an acorn tipon the delivery catheterthat is positioned at theexocervix to control thedepth of insertion of thedelivery catheter.In addition, the subjectdevice has a smaller ODthan the predicate device.These differences do notraise different S & Equestions. |
| Embryo TransferCatheter tipconfiguration | Rounded tip withopening at distal end | Rounded tip withopening at distal end | Same |
| Ultrasoundguidance marker | Stainless steel markerband at distal end ofEmbryo TransferCatheter | Air bubbles enclosedwithin polyurethanematerial | Different: Different types ofechogenic markers used inthe subject and predicatedevices. Differences inultrasound visualizationmethods do not raisedifferent S & E questions. |
| Procedural steps:Placement intouterine cavity | 1. Pressurize DeliveryCatheter | 1. Insert outer deliverycatheter across cervix | Similar |
| Catheter across cervix3. Insert loaded EmbryoTransfer Catheterthrough DeliveryCatheter4. Deposit embryo(s) | transfer catheterthrough outer deliverycatheter3. Deposit embryo(s) | ||
| Sterilizationmethod and use | Ethylene Oxide (EtO)sterilized and single use | EtO sterilized and single use | Same |
| MEA specification | One cell mouse embryotested (MEA) showing a$\ge$ 80% blastocystformation rate at 96hours. | Two cell mouse embryotested (MEA) showing a> 80% survival. | Different: Differentversions of MEA testingused. These differences donot raise different S &Equestions. |
| Endotoxinspecification | Endotoxin (LAL): $\le$ 20EU/device Testing isconducted on a lot-to-lot(batch) basis | Endotoxin (LAL): 0.5EU/ml Testing isconducted on a lot-to-lot (batch) basis | Different: The acceptancespecifications used aredifferent, but do not raisedifferent S & E questions. |
Table 2: Technology Comparison of the Subject Device and Predicate Device
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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.
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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<85> 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").
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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.
§ 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).