Search Results
Found 1 results
510(k) Data Aggregation
(251 days)
The Pakter Curved Needle Set is intended for discography, diagnostic sampling, aspiration, and injection.
The Pakter Curved Needle Set is manufactured as a coaxial needle set and includes a preshaped curved needle and an introducer needle. The curved needle consists of a nitinol cannula connected to a polycarbonate hub at the proximal end and is characterized with a distal curve and a 30° bevel distal tip. It also includes a stainless steel stylet that is designed for a transitional fit. The curved needle with stylet is 25 gage in diameter and has a length of 20 or 15 centimeters. The introducer needle consists of a stainless steel cannula connected to an acrylic hub at the proximal end. The introducer needle is also designed with a stainless steel stylet. The introducer needle with stylet is 21 gage in diameter and has a length of 15 or 10 centimeters. When used as intended, the introducer needle and stylet are first inserted percutaneously and advanced adjacent to the target anatomy. After removing the introducer needle stylet, the curved needle is then inserted through the introducer needle cannula and slowly advanced to the target anatomy. The Pakter Curved Needle Set is sterilized by ethylene oxide and intended for one-time use.
This document describes the premarket notification for the Pakter Curved Needle Set (K173155), a Class II medical device intended for discography, diagnostic sampling, aspiration, and injection. The submission aims to demonstrate substantial equivalence to a predicate device, the Atraumatic Standard Sprotte® Needle (K911260).
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Tensile Strength - Curved Needle Cannula Hub-to-Shaft | Peak tensile load ≥ 22 N (in accordance with BS EN ISO 7864:2016 and BS EN ISO 11070:2014) | The acceptance criterion was met. |
| Tensile Strength - Curved Needle Stylet Hub-to-Shaft | Peak tensile load ≥ 11 N (in accordance with BS EN ISO 7864:2016 and BS EN ISO 11070:2014) | The acceptance criterion was met. |
| Tensile Strength - Introducer Needle Cannula Hub-to-Shaft | Peak tensile load ≥ 44 N (in accordance with BS EN ISO 7864:2016 and BS EN ISO 11070:2014) | The acceptance criterion was met. |
| Tensile Strength - Introducer Needle Stylet Hub-to-Shaft | Peak tensile load ≥ 22 N (in accordance with BS EN ISO 7864:2016 and BS EN ISO 11070:2014) | The acceptance criterion was met. |
| Stiffness - Introducer Needle Cannula and Stylet | Deflection < 0.45 mm when a force of 9.6 N is applied (in accordance with BS EN ISO 9626:2016) | The acceptance criterion was met. |
| Resistance to Breakage - Curved Needle Cannula | No visible breakage after cyclic testing (in accordance with BS EN ISO 9626:2016) | The acceptance criterion was met. |
| Resistance to Breakage - Introducer Needle Cannula | No visible breakage after cyclic testing (in accordance with BS EN ISO 9626:2016) | The acceptance criterion was met. |
| Resistance to Corrosion | No visual signs of corrosion after testing (in accordance with Annex B of BS EN ISO 11070) | The acceptance criterion was met. |
| Tensile Strength Post-Corrosion - Curved Needle Cannula Hub-to-Shaft | (Same as pre-corrosion tensile strength) Peak tensile load ≥ 22 N (in accordance with BS EN ISO 7864:2016 and BS EN ISO 11070:2014) | The acceptance criterion was met. |
| Tensile Strength Post-Corrosion - Curved Needle Stylet Hub-to-Shaft | (Same as pre-corrosion tensile strength) Peak tensile load ≥ 11 N (in accordance with BS EN ISO 7864:2016 and BS EN ISO 11070:2014) | The acceptance criterion was met. |
| Tensile Strength Post-Corrosion - Introducer Needle Cannula Hub-to-Shaft | (Same as pre-corrosion tensile strength) Peak tensile load ≥ 44 N (in accordance with BS EN ISO 7864:2016 and BS EN ISO 11070:2014) | The acceptance criterion was met. |
| Tensile Strength Post-Corrosion - Introducer Needle Stylet Hub-to-Shaft | (Same as pre-corrosion tensile strength) Peak tensile load ≥ 22 N (in accordance with BS EN ISO 7864:2016 and BS EN ISO 11070:2014) | The acceptance criterion was met. |
| Liquid Leakage Under Positive Pressure | Maintain a positive pressure of 300 kPa for 30 seconds without leakage (in accordance with BS EN ISO 11070:2014) | The acceptance criterion was met. |
| Patency of Lumen | A stainless steel stylet with a diameter of 0.009 inches (0.23 mm) shall pass through the lumen of the curved needle cannula. | The acceptance criterion was met. |
| Dimensional Analysis and Compatibility | Curved needle and introducer needle dimensions within specified tolerances and components are compatible. | Testing conducted demonstrated the criteria were met. |
| Biocompatibility Testing | Demonstrated biocompatibility (tests for cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity, material mediated pyrogen, and hemolysis) per ISO 10993-1 and FDA guidance. | Testing demonstrated the biocompatibility of the device. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document extensively lists bench testing conducted on the Pakter Curved Needle Set. However, it does not specify the sample size (i.e., number of units tested) for any of the bench tests described. The testing includes "time-zero and five-year accelerated aged testing," indicating a prospective evaluation of device performance over time. The document does not provide information on the country of origin of the data, but based on the FDA submission and reference to BS EN ISO standards, the testing was likely conducted in accordance with international quality standards, possibly in the US or a country adhering to these standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable to the provided document. The studies described are bench tests evaluating the physical and material properties of the device, not clinical performance or diagnostic accuracy that would require expert-established ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This section is not applicable as the studies are bench tests, not clinical studies requiring adjudication of outcomes or interpretations.
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
This section is not applicable. The document describes a traditional 510(k) premarket notification for a physical medical device (needle set), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI performance is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This section is not applicable, as the device is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the bench tests described is based on established engineering and material science standards and specifications. For instance, tensile strength is measured against a quantitative N value, breakage is determined by visual inspection, and corrosion by visual signs after standardized exposure. These are objective physical measurements rather than clinical or diagnostic "ground truth."
8. The sample size for the training set
This section is not applicable. The device is a physical medical instrument, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
This section is not applicable. There is no training set for this device.
Ask a specific question about this device
Page 1 of 1