(90 days)
The Medical Designs Hand Drill is intended for use in Neurosurgical procedures and for use with Medical Designs' Subdural Evacuating Port System Kit (S.E.P.S), Catalog # 11-9901. The Hand Drill is not intended for any use other than that indicated.
The hand drill consists of a black ABS plastic housing, glass filled nylon handle and ABS plastic handle knob. The hand drill has lubricated aluminum gears and a ¼" spring loaded, chrome plated steel, 3-jaw chuck assembly. The hand drill is a single-use disposable device. It is sterilized using gamma radiation.
This document is a 510(k) Premarket Notification for a Hand Drill (Catalog # 11-9901-7) manufactured by Medical Designs, LLC. The primary goal of a 510(k) submission is to demonstrate that a new device is substantially equivalent to a predicate device that is already legally marketed in the U.S. This type of submission generally does not include a formal study with acceptance criteria and device performance as one might find for a PMA (Premarket Approval) or De Novo submission, especially for a Class II manual surgical instrument.
Therefore, the requested information elements related to specific performance acceptance criteria, clinical study details (sample size, ground truth, experts, adjudication, MRMC, standalone performance), and training set information are not applicable or present in this 510(k) summary.
Instead, the demonstration of safety and effectiveness relies on comparison to a predicate device and similarities in design, materials, and intended use.
Here's a breakdown based on the provided text, addressing the points where information is available or indicating its absence:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. This 510(k) submission does not include a formal clinical study with pre-defined acceptance criteria and reported device performance metrics like sensitivity, specificity, accuracy, or other quantitative measures. The criteria for acceptance in a 510(k) are based on demonstrating substantial equivalence to a predicate device, primarily through comparison of intended use, technological characteristics, and safety/effectiveness profiles.
2. Sample Sized used for the test set and the data provenance
Not applicable. No formal test set or clinical data is presented for performance evaluation in this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for a test set is not established as no performance study is detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) 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, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a manual surgical instrument, not an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a manual surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. Ground truth for a performance study is not relevant for this 510(k) submission.
8. The sample size for the training set
Not applicable. This device is a physical instrument, not a learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. Ground truth for a training set is not relevant for this 510(k) submission.
Summary of the 510(k) Approach for this Device:
The 510(k) submission for the Medical Designs Hand Drill establishes substantial equivalence to the Integra NeuroSciences Camino Hand Drill - Model 030 (K862160) by demonstrating:
- Identical Intended Use: Both devices are intended for use in Neurosurgical procedures. The Medical Designs Hand Drill also specifies use with their Subdural Evacuating Port System Kit (S.E.P.S.), which is a further specific application within neurosurgery.
- Similar Technological Characteristics: The submission states that the Medical Designs hand drill is made of "the same materials and components as the predicate device" (ABS plastic housing, glass filled nylon handle, ABS plastic handle knob, lubricated aluminum gears, ¼" spring-loaded, chrome-plated steel, 3-jaw chuck assembly). The device is also a single-use disposable and sterilized using gamma radiation.
- Biocompatibility: The materials are stated to be identical to the predicate device, and neither device comes into direct contact with the body or bodily fluids when used as intended. This addresses biocompatibility concerns by similarity.
- No new issues of safety or effectiveness: By using identical materials and having the same intended use, the submission argues that the device does not raise any new safety or effectiveness concerns compared to the predicate.
The FDA's review and clearance (NOV 12 2002) indicate their agreement that substantial equivalence was demonstrated, allowing the device to be marketed. This regulatory pathway does not typically require an extensive performance study with quantitative acceptance criteria as would be needed for novel or higher-risk devices.
§ 882.4300 Manual cranial drills, burrs, trephines, and their accessories
(a)
Identification. Manual cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments that are used without a power source on a patient's skull.(b)
Classification. Class II (performance standards).