(116 days)
The Dimeda Obstetrical Forceps are intended to grasp and apply traction to the fetal head to facilitate vaginal delivery, provided that the cervix is fully dilated and the fetal head is positioned appropriately in the vagina. Use of the forceps is indicated for:
- 0 prolonged second stage
- 0 suspicion of immediate or potential fetal compromise
- shortening of the second stage for maternal benefit 0
The Dimeda Obstetrical Forceps is a surgical medical device for medical procedure to grasp the fetal head when it is in the vagina and bring about delivery by traction and guidance without causing injury to the mother or baby. The forceps consists of two arms which are movable. The device is manufactured from surgical stainless steel.
This submission for Dimeda Obstetrical Forceps (K092827) is a 510(k) premarket notification, which establishes substantial equivalence to previously cleared devices. It does not present a study with specific acceptance criteria and detailed device performance metrics in the way a clinical trial or performance study for a novel device would. Instead, it relies on demonstrating equivalence in intended use, design, materials, and performance to predicate devices already on the market.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts, MRMC study, training set details) are not applicable or cannot be extracted from this type of submission.
Here's a breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a substantial equivalence submission for a traditional surgical instrument, there are no explicit "acceptance criteria" for novel performance features or quantitative reported device performance in the document. The acceptance criterion is the determination of "substantial equivalence" to the predicate devices, implying that the Dimeda Obstetrical Forceps perform as safely and effectively as the predicates.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and Effectiveness (implicit acceptance criterion for substantial equivalence) | The Dimeda Obstetrical Forceps are "absolutely safe and effective for their intended use and do not raise any questions regarding safety and effectiveness" based on comparison to predicate devices and long market presence in Europe. |
| Intended Use Equivalence | Identical to predicate devices (grasp and apply traction to fetal head to facilitate vaginal delivery). |
| Indications for Use Equivalence | Identical to predicate devices (prolonged second stage, suspicion of fetal compromise, shortening of second stage for maternal benefit). |
| Target Population Equivalence | Identical to predicate devices. |
| Hospital Use Equivalence | Identical to predicate devices. |
| Material Equivalence | Manufactured from surgical stainless steel, well-researched materials, identical to predicate devices. |
| Design Equivalence | Consists of two movable arms, identical to predicate devices. |
| Biocompatibility Equivalence | Identical to predicate devices. |
| Sterilization Method Equivalence | Identical to predicate devices. |
| Performance Equivalence | Identical to predicate devices (no modifications regarding design, method of operation, mechanical performance affecting safety and effectiveness). |
| Mechanical Safety Characteristics Equivalence | Identical to predicate devices. |
| Sizes Equivalence | "Partly" identical to predicate devices. (No further detail provided on differences). |
| No Modifications Made (compared to predicates affecting safety/effectiveness) | "By the Dimeda Obstetrical Forceps have been no modification made (regarding to design, method of operation, mechanical performance)." |
| No Device Failures Recorded in Europe (for models covered by 510(k)) | "All models that are covered by this 510(k) premarket notification have been on the market in Europe for many years with no device failures." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. No specific test set with a defined sample size for performance evaluation is mentioned in the document. The submission relies on comparative data and market history.
- Data Provenance: The statement "All models that are covered by this 510(k) premarket notification have been on the market in Europe for many years with no device failures" refers to retrospective market data from Europe.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. No ground truth establishment by experts for a specific test set is described.
4. Adjudication Method for the Test Set
Not applicable. No test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. This type of study is more typical for diagnostic imaging AI systems, not generally for surgical instruments demonstrating substantial equivalence.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This device is a manual surgical instrument and does not involve an algorithm or AI.
7. The Type of Ground Truth Used
Not applicable in the usual sense of a diagnostic or algorithmic device. The "ground truth" for demonstrating safety and effectiveness relies on:
- Predicate Device Performance: The established safety and efficacy of the legally marketed predicate devices (K013747 - Tekno-Medical Obstetrical Forceps and K951529 - V. MUELLER Obstetrical (OB) Forceps).
- Market History: The lack of device failures over many years of use in Europe.
8. The Sample Size for the Training Set
Not applicable. This device is a manual surgical instrument and does not involve a training set for an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 884.4400 Obstetric forceps.
(a)
Identification. An obstetric forceps is a device consisting of two blades, with handles, designed to grasp and apply traction to the fetal head in the birth passage and facilitate delivery.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.