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510(k) Data Aggregation
(386 days)
IMD's Lumbar Puncture Needle
IMD's Lumbar Puncture Needle, a single patient use needle; it is intended to gain entry into or puncture the spinal cavity permitting injecting (including anesthesia) / withdrawl of fluids for purpose of diagnostic lumbar puncture, myelography discography procedures.
The device is intended for adult and pediatric patients.
It is to be used only under the direction of a licensed clinician.
The IMD Inc. Lumbar Puncture Needle shares major similarities with the predicate device(s), in as much as the configuration, materials, area of use, and are identical to the IMD reference devices.
It consists of an introducer, stylet, and pencil-point needle, with plastic hubs, and stainless steel cannula. Offered in 18-27 gauges, and 3.5 in. (90 mm) and 5.0 in (124 mm) lengths.
The provided text is a 510(k) summary for a medical device called IMD's Lumbar Puncture Needle. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a study that establishes acceptance criteria and proves the device meets them from scratch.
Therefore, the information typically found in a clinical study report regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not present in this document.
The document primarily relies on the equivalency of its design, materials, manufacturing processes, and sterilization methods to previously cleared devices. The "performance" mentioned refers to the device's functional integrity as a medical instrument, rather than clinical efficacy measured through a traditional study.
Here's an attempt to answer your questions based on the available information, noting where information is not provided:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not define specific clinical acceptance criteria in terms of accuracy, sensitivity, specificity, or other performance metrics typically associated with AI/diagnostic device studies. Instead, it relies on demonstrating that the device is manufactured to established standards and is functionally equivalent to already-cleared devices.
The "performance" referred to here relates to product integrity and manufacturing quality, not clinical outcome or diagnostic accuracy.
| Acceptance Criteria (Implied / Functional) | Reported Device Performance (Implied / Functional) |
|---|---|
| Functional Equivalence: Device shares identical configuration, features, materials, and methods of manufacture/sterilization with reference devices. | The document explicitly states: "IMD's Lumbar Puncture shares the identical configuration, features, materials, methods of manufacture / manufacturer, testing, packaging / packager, and sterilization / sterilizer as the reference needles (IMD's)." It also notes similarity to the predicate device in materials and manufacturing. This forms the core argument for substantial equivalence. |
| Biocompatibility: Device materials are biocompatible. | "Yes, per ISO 10993" for all devices in the comparison table, indicating compliance with recognized standards for biocompatibility. Biocompatibility testing has been provided in reference device submissions. |
| Sterility: Device is sterile. | "100% EtO" sterilization process is used, with validation through Nelson Labs (ISO 11135). Tests referenced include "Product Sterility" (USP General Chapter 71, ANSI/AAMI/ISO 11737-2, EP 2.6.1, JP and 21 CFR 610.12) and "Bacteriostasis and Fungistasis" (USP , EP 2.6.1 and JP XV, and AAMI/ISO 11737-2). |
| Non-pyrogenic: Device is non-pyrogenic. | Stated as "Non-pyrogenic" for the device and reference devices. |
| Manufacturing Quality: Production lots are subject to inspection/testing. | "Production Lots are also subjected to inspection / testing by Incoming QC, in-process QC, and finished goods QC, and monitored in the field by means of our CAPA system." This indicates adherence to a Quality Management System (21 CFR Part 820). |
| Safety and Effectiveness (as predicate): Device is as safe and effective as the predicate when used as intended. | The conclusion states: "It is designed and manufactured to be as safe and as effective as the predicate device when used as intended, under a licensed clinician's supervision." This is an assertion based on the substantial equivalence argument, not on a new clinical study demonstrating safety and effectiveness. "No record of unexpected patient problems or adverse reactions were found in our review of the FDA's MAUDE, Safety Alert, and MDR databases" supports the safety profile of similar devices. |
2. Sample size used for the test set and the data provenance
Not applicable. This is not a study involving a "test set" in the context of diagnostic performance evaluation (e.g., AI algorithms). The document does not describe a clinical study with a patient test set for the device's performance. The "testing" mentioned refers to manufacturing quality control (e.g., sterility, biocompatibility).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No "ground truth" establishment in a diagnostic sense is described. The assessment is mechanical and material equivalency.
4. Adjudication method for the test set
Not applicable. There is no test set or adjudication process 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 physical medical instrument (lumbar puncture needle), not an AI algorithm or an imaging device requiring human reader interpretation, hence an MRMC study is irrelevant for this product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm, it is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. Ground truth for diagnostic accuracy is not relevant here. The ground truth for the "performance" described relates to adherence to manufacturing specifications, material composition, and proven sterilization effectiveness, which are established by standardized laboratory tests and regulatory compliance (e.g., ISO 10993 for biocompatibility, USP/AAMI/ISO standards for sterility).
8. The sample size for the training set
Not applicable. This isn't an AI device requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This isn't an AI device requiring a training set.
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