Search Results
Found 1 results
510(k) Data Aggregation
(163 days)
CrossBay IVF Embryo Transfer Catheter Set
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.
Ask a specific question about this device
Page 1 of 1