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K Number
K030691
Device Name
FETAL SPIRAL ELECTRODE, MODEL FSE07000
Manufacturer
CLINICAL INNOVATIONS, INC.
Date Cleared
2003-09-17

(196 days)

Product Code
HGP
Regulation Number
884.2675
Type
Traditional
Panel
OB
Reference & Predicate Devices
K943732,K792669,K771553,K904745,K872057,K844608
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

For patients requiring fetal heart rate monitoring during labor.

Device Description

The device consists of a stainless steel spiral needle electrode. It is fixed to the fetal scalp by penetration of the skin by the spiral needle and thereby obtains the fetal ECG signal. A guide tube and a drive tube are required to place the electrode and are then removed before monitoring is begun. A stainless steel reference electrode is included close to the body housing the spiral electrode. The electrode is connected to the fetal monitor using a reusable adapter cable. A disposable maternal reference electrode connection is built into the adapter cable.

AI/ML Overview

The provided text is a 510(k) summary for a Fetal Spiral Electrode. While it mentions safety and effectiveness, it does not contain a detailed study report that proves the device meets specific acceptance criteria.

The document primarily focuses on establishing substantial equivalence to previously marketed devices based on shared intended use, basic technological characteristics, and material biocompatibility. It states that "The laboratory testing verified the performance," but it does not provide details of this testing, specific performance metrics, or acceptance criteria.

Therefore, many of the requested details about acceptance criteria, study specifics, ground truth, and expert involvement cannot be extracted from this document.

Here's a breakdown of what can be inferred or directly stated from the provided text, and what is missing:

  1. Table of acceptance criteria and the reported device performance:

    • Acceptance Criteria: Not explicitly stated in terms of measurable performance parameters. The general acceptance criterion is "safety and effectiveness are similar to existing devices" and "performance verified by laboratory testing."
    • Reported Device Performance: Not provided with specific metrics or results. The document states "Effectiveness is the same as the predicate devices" and "The laboratory testing verified the performance," but without any quantitative data to support this.

  2. Sample size used for the test set and the data provenance, etc.:

    • Sample Size (Test Set): Not mentioned. "Laboratory testing" is referenced, but no details about participants or test cases.
    • Data Provenance: Not mentioned (e.g., country of origin, retrospective/prospective).

  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

    • Not mentioned, as no specific clinical study with ground truth establishment is detailed.

  4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

    • Not mentioned.

  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

    • No. This is a physical medical device (Fetal Spiral Electrode), not an AI/software device. Therefore, MRMC studies or AI assistance are not relevant to this submission.

  6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

    • No. Not applicable to this type of physical device.

  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

    • Not mentioned, as no detailed clinical study with ground truth is provided. The evaluation appears to be based on "laboratory testing" for performance and biocompatibility.

  8. The sample size for the training set:

    • Not applicable, as this is not an algorithm/AI device that requires a training set. The device's "effectiveness" is stated as being "the same as the predicate devices."

  9. How the ground truth for the training set was established:

    • Not applicable.

In summary, the provided 510(k) notification focuses on demonstrating substantial equivalence to predicate devices through similarities in intended use, technological characteristics, materials, and general safety/effectiveness claims based on internal laboratory testing (the details of which are not disclosed in this summary). It does not present a detailed clinical study with specific acceptance criteria, performance metrics, ground truth establishment, or expert involvement in the way an AI/software medical device submission might.

§ 884.2675 Fetal scalp circular (spiral) electrode and applicator.

(a)
Identification. A fetal scalp circular (spiral) electrode and applicator is a device used to obtain a fetal electrocardiogram during labor and delivery. It establishes electrical contact between fetal skin and an external monitoring device by a shallow subcutaneous puncture of fetal scalp tissue with a curved needle or needles. This generic type of device includes nonreusable spiral electrodes and reusable circular electrodes.(b)
Classification. Class II (performance standards).