(98 days)
As provided in Sec. 870.1340 the PAJUNK®s Vascular Sono cannula/needle is an introducer used to facilitate placing an intravascular or intravenous device for diagnostically or interventional use through the skin into a vein or artery.
The Vascular Sono intravenous introducer cannula/needle is a single use sterile and nonpvrogenic medical device used to gain entry or puncture arteries and veins.
The provided text describes a 510(k) summary for the PAJUNK® Vascular Sono vascular introducer cannula/needle, which is a medical device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through extensive clinical trials. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on demonstrating that the new device performs similarly to existing, cleared devices for the specified functions, primarily via bench testing and biocompatibility assessments, rather than clinical efficacy studies.
Here's an analysis based on your requested information:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail manner for each test. Instead, it describes "standard testing applicable for all cannulas" and concludes that the device is "safe and effective" and "substantially equivalent" to predicate devices. The "reported device performance" is a general statement of compliance rather than specific measured values against thresholds.
However, we can infer the types of criteria based on the tests conducted and the overall conclusion of substantial equivalence.
| Acceptance Criteria (Inferred from tests and claims of equivalence) | Reported Device Performance |
|---|---|
| Packaging Integrity: | |
| DIN EN 868-5:2009-09 compliance (materials, test methods) | Implied compliance to standard requirements. |
| ASTM E 515-05 4a (Bubble Emission test) for seal integrity | Packaging passed this test. |
| DIN 868-1 and ASTM F 1929-98 (Rhodamin-B-Test, DYE-Test) | Packaging passed this test. |
| 868-10:2009-09 Annex C (Peel-Test) | Packaging passed this test, ensuring sterility can be maintained and packaging can be opened effectively. |
| Microbiology/Particulates: | |
| LAL-Testing (Pyrogens) compliance | Passed to ensure non-pyrogenic. |
| Bioburden levels compliance | Passed. |
| Chemical Burden levels compliance | Passed. |
| Ethylene-Oxide Residuals acc. 10993-7 compliance | Passed. |
| Sterility (per batch) | Passed to ensure an SAL of 10^-6, with efficacy proven for a 10-year period (shelf life set to 5 years). |
| Performance (Mechanical/Physical): | |
| Bending Rigidity/Bending Stability requirements | Device passed these tests, demonstrating structural integrity during use. "Subject device is tested the same way as each cannula is tested at PAJUNK® GmbH Medizintechnologie." |
| Hub to needle bonding strength requirements | Device passed this test, ensuring the hub remains securely attached to the needle. "Subject device is tested the same way as each cannula is tested at PAJUNK® GmbH Medizintechnologie." |
| Breakage resistance requirements | Device passed this test, indicating durability. "Subject device is tested the same way as each cannula is tested at PAJUNK® GmbH Medizintechnologie." |
| Insertion force at point of entry requirements | Device passed this test, ensuring appropriate ease of insertion. "Subject device is tested the same way as each cannula is tested at PAJUNK® GmbH Medizintechnologie." |
| Biocompatibility: | |
| ISO 10993-1 compliance | All cannulas comply with ISO 10993-1, 20d and 3rd edition. Components (stainless steel tubing, polycarbonate hub, epoxy resin glue, optional polymeric NanoLine coating) are identical to those cleared in previous 510(k)s (K040965, K000722, K053283) in formulation, processing, and sterilization, with no added chemicals, implying existing biocompatibility. |
| Ultrasound Visibility: | The device is "provided with enhanced ultrasound visibility," similar to a predicate manufactured by BBraun. This is a characteristic, not a performance metric with specific acceptance criteria in this document. |
| Sterilization Process: | |
| Validated sterilization process | Sterilization process is "identical to the process and sterilizer used for all PAJUNK® - manufactured and purchased devices which are already cleared for market or exempt." Validated to ensure an SAL of 10^-6 and compliance with limits for chemical burden, bioburden, and EtO-residuals. Efficacy of sterile product's lifecycle proven for 10 years; shelf life set to 5 years. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document does not specify the exact sample sizes (number of units tested) for individual performance tests (bending, bonding, breakage, insertion force, packaging). It refers to "standard testing applicable for all cannulas" and mentions that the device is "tested the same way as each cannula is tested at PAJUNK® GmbH Medizintechnologie." For sterility, it mentions "test for sterility (per batch)."
- Data Provenance: The testing was conducted by PAJUNK® GmbH Medizintechnologie, located in Geisingen, Germany. This is a prospective evaluation of newly manufactured devices against established internal standards and relevant international standards (ISO, ASTM, DIN).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This type of information (number and qualification of clinical experts for ground truth) is not applicable to this submission. This 510(k) summary focuses on demonstrating mechanical, material, and sterilization equivalence to existing devices through bench testing and biocompatibility assessments, not on clinical performance or diagnostic accuracy that would require expert-established ground truths on patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically used in clinical studies or image-based diagnostic device evaluations where there might be disagreements among expert readers/observers. The tests described here are bench tests with predefined methods and objective measurements (e.g., force, bending angle, chemical levels), which do not require expert adjudication.
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
No. A multi-reader multi-case (MRMC) comparative effectiveness study is designed for evaluating diagnostic or interpretive devices, often involving human readers and AI. This device is a physical medical instrument (introducer cannula/needle), not a diagnostic tool or an AI-assisted system. Therefore, this type of study was not conducted and is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. Standalone algorithm performance is relevant for AI/software as a medical device. The Vascular Sono is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance and material tests, the "ground truth" is implied by the established standards and specifications (e.g., ISO 10993-1 for biocompatibility, DIN and ASTM standards for packaging and sterility, and internal PAJUNK® Medizintechnologie testing standards for mechanical properties). The device's performance is compared against the requirements specified in these standards or the performance of the predicate device.
8. The sample size for the training set
Not applicable. This device submission does not involve machine learning or AI, and therefore, there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set involved.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).