(65 days)
INSTRUMED Obstetrical Forceps are intended to grasp and apply traction to the fetal head to facilitate delivery for the following indications, provided that the fetal head is positioned appropriately in the vagina: · prolonged second stage - · suspicion of immediate or potential fetal compromise - · shortening of the second stage for maternal benefit
Instrumed obstetrical forceps are instruments designed to aid in the delivery of the fetus. Many different types of forceps have been described and developed. Generally, forceps consist of 2 mirror image metal instruments that are manoeuvred to cradle the fetal head and are articulated, after which traction is applied to effect delivery. Forceps have 4 major components, as follows: - Blades: The blades grasp the fetus. Each blade has a curve to fit around the fetal head. The . blades are oval or elliptical and can be fenestrated (with a hole in the middle) or solid. Many blades are also curved in a plane 90° from the cephalic curve to fit the maternal pelvic curve). - Shanks: The shanks connect the blades to the handles and provide the length of the device. They . are either parallel or crossing. - Lock: The lock is the articulation between the shanks. Many different types have been designed. . - Handles: The handles are where the operator holds the device and applies traction to the fetal . head. The surgeon chooses the obstetrical/gynaecological forceps based on the anatomy of the site and the type desired, based on the type of the surgical procedure. Instrumed obstetrical forceps are made of the ASTM F 899-09 standardized Stainless Steel. The instruments are offered in non-sterile condition.
The provided text describes a 510(k) submission for Instrumed Obstetrical Forceps. It details the device's description, indications for use, and a comparison to predicate devices to establish substantial equivalence.
Based on the content provided, the acceptance criteria and the study proving the device meets them are articulated in terms of equivalence to predicate devices, rather than specific performance metrics.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly based on Predicate Device Equivalence) | Reported Device Performance |
|---|---|---|
| Technical Characteristics | Comparable to predicate devices (TEKNO-MEDICAL OBSTETRICAL FORCEPS K013747, V. MUELLER OBSTETRICAL (OB) FORCEPS K951529) | "The Instrumed product is similar to the predicate device in terms of technical characteristics, design..." |
| Design | Comparable to predicate devices | "The Instrumed product is similar to the predicate device in terms of technical characteristics, design..." |
| Indications for Use | Identical or substantially similar to predicate devices | Identical indications for use: "to grasp and apply traction to the fetal head to facilitate delivery for... prolonged second stage, suspicion of immediate or potential fetal compromise, shortening of the second stage for maternal benefit." |
| Target Population | Comparable to predicate devices | "The Instrumed product is similar to the predicate device in terms of... Target population..." |
| Usage Environment | Comparable to predicate devices | "The Instrumed product is similar to the predicate device in terms of... where it is used..." |
| Performance | Comparable to predicate devices | "The Instrumed product is similar to the predicate device in terms of... performance..." |
| Biocompatibility | Acceptable in comparison to predicate devices | "Biocompatibility and sterilization studies were successfully completed." "The used materials are well researched and do not raise new questions regarding safety and effectiveness of the finished product." |
| Sterilization Method | Acceptable in comparison to predicate devices | "The Instrumed product is similar to the predicate device in terms of... sterilisation method..." (Offered in non-sterile condition, implying sterilization by the user is required/expected, similar to predicate). |
| Mechanical Safety | Comparable to predicate devices | "The Instrumed product is similar to the predicate device in terms of... mechanical safety characteristics..." |
| Materials | ASTM F 899-09 standardized Stainless Steel, deemed safe and effective | "Instrumed obstetrical forceps are made of the ASTM F 899-09 standardized Stainless Steel." "The used materials are well researched and do not raise new questions regarding safety and effectiveness of the finished product." |
| New Safety/Effectiveness Questions | No new questions regarding safety or effectiveness should be raised. | "The presented data that was conducted on the Instruments shows... that the products are absolutely safe and effective for their intended use and do not raise any new questions regarding safety and effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a test set or data provenance in the context of clinical studies with human participants. The evaluation relies on non-clinical and bench testing to demonstrate similarity to predicate devices. Therefore, traditional "sample size" for a clinical test set is not applicable here.
- Sample Size for Test Set: Not applicable as no human clinical test set is described. The evaluation is primarily based on non-clinical and bench testing of the device itself and comparison to predicate devices.
- Data Provenance: Not explicitly stated as the evaluation focuses on the physical device and its properties, materials, and design in comparison to existing devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. Given that the submission is for substantial equivalence based on non-clinical and bench testing and comparison to predicate devices, there's no mention of a ground truth established by medical experts for a test set of patient data.
4. Adjudication Method for the Test Set
This information is not provided in the document. As no human clinical test set requiring expert ground truth or adjudication is described, this section is not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in this submission. The device is a surgical instrument (forceps), and its evaluation is based on material properties, design, and functional similarity to already marketed predicate devices, not on the interpretation of medical images by multiple readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device is a manual surgical instrument, not an algorithm or AI system. Its performance inherently involves a human operator (the surgeon).
7. The Type of Ground Truth Used
The "ground truth" in this context is implicitly established by the known safety and effectiveness of the predicate devices and the standards for material properties (e.g., ASTM F 899-09 for stainless steel). The claim is that the Instrumed Obstetrical Forceps functions equivalently to these well-established devices and uses appropriate materials, thus achieving safety and effectiveness.
- Implicit Ground Truth: Safety and effectiveness of legally marketed predicate devices and compliance with material standards.
8. The Sample Size for the Training Set
This information is not applicable as there is no mention of an algorithm or AI system that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no mention of an algorithm or AI system that requires a "training set" or its associated ground truth establishment.
§ 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.