(64 days)
The sterile single-use device is to be used for the introduction of embryo(s) the uterine cavity during assisted reproductive procedures.
The subject devices are single-use, sterile, disposable, flexible catheters with rounded smooth distal ends, provided for the introduction of embryos into the uterine cavity during in vitro fertilization or Embryo Transfer procedures. The subject devices are available in working lengths of 18cm including Luer Lock adaptors that are affixed at their proximal ends. The inner catheter is a clear tube with a 1.8mm outer and a 0.8mm inner diameter. The inner catheter is surrounded by an outer sheath with a 2.3mm outer diameter. This inner catheter has a series of graduated markings that are placed 1cm apart at the proximal end to provide reference to the degree of inner catheter insertion to the uterus during embryo placement. The distal of the outer sheath possesses a gradual taper and is shorter than the inner catheter. Jeaving the distal 5cm of the inner catheter exposed. The proximal circumference of the outer sheath and inner catheter are molded directly into the distal end of the Luer Lock adaptor. Five black graduation markings are located on the distal portion of the outer sheath at 1cm increments to indicate the degree of advancement into the cervix.
The provided 510(k) summary for the CooperSurgical Embryo Transfer Catheter (K023379) does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically associated with AI/software performance studies.
This 510(k) is for a physical medical device (catheter), and the "performance data" section focuses on physical and material properties rather than diagnostic performance or efficacy for medical image analysis.
Therefore, I cannot provide the requested information in the format of a table outlining acceptance criteria and reported device performance for an AI/software device, nor can I answer the questions related to sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance.
However, based on the information provided, I can infer the types of "acceptance criteria" and "studies" relevant to this specific device:
Types of "Acceptance Criteria" and "Studies" Applicable to this Device (Based on the 510(k) Summary):
The acceptance criteria for this physical medical device are related to its material properties, dimensions, and manufacturing processes to ensure safety and equivalence to a predicate device. The "studies" are tests conducted to demonstrate these properties.
Here's how aspects of the request align with the provided document for this physical device:
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A table of acceptance criteria and the reported device performance:
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Acceptance Criteria (Implied from the document):
- Biocompatibility (equivalent to ISO 10993-1)
- Conical fittings comply with ISO 594-1 1986 (6% luer taper)
- Sterility (SAL 10^-6) via validated Ethylene Oxide cycle
- Mechanical integrity (e.g., sufficient stiffness for AR-ET23F, flexible with rounded smooth distal ends)
- Dimensional specifications (working lengths, inner/outer diameters, luer dimensions)
- Material composition identical to stated components
- Packaging integrity
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Reported Device Performance (as stated):
- "The subject device has been subject to biocompatibility testing (for the materials that is equivalent to ISO 10993-1 Biocompatibility requirements."
- "The subject device also complies with ISO 594-1 1986 Conical fittings with a 6% (luer) taper requirements."
- "The subject devices will be sterilized using validated Ethylene Oxide cycle affording an SAL 10^-6 to sterility level."
- The device characteristics (materials, dimensions) are listed as designed.
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Sample size used for the test set and the data provenance: This is not applicable. The "tests" mentioned are for physical device properties (biocompatibility, luer taper, sterility), not for evaluating diagnostic or algorithmic performance with a "test set" of clinical data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical properties is based on established engineering standards and material science, not clinical expert consensus on a test set.
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Adjudication method for the test set: Not applicable.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is not applicable to a physical embryo transfer catheter. MRMC studies are for assessing diagnostic performance of imaging systems or AI algorithms.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No, this is not applicable. This is a physical device, not an algorithm.
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The type of ground truth used: For this device, the "ground truth" for compliance would be established through:
- Laboratory testing against ISO standards (e.g., for biocompatibility, luer taper).
- Chemical/material analysis to verify stated composition.
- Physical measurements to verify dimensions.
- Microbiological testing for sterility.
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The sample size for the training set: Not applicable. This is a manufactured medical device, not an AI model requiring a training set.
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How the ground truth for the training set was established: Not applicable.
In summary, the 510(k) for the CooperSurgical Embryo Transfer Catheter (K023379) demonstrates substantial equivalence through adherence to existing standards for physical devices and material compatibility, not through clinical performance studies against a 'ground truth' as one would expect for an AI/software 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).