(281 days)
The Over-the-needle (OTN) Catheter System is indicated for delivery of medication for regional anesthesia and pain management. Route of administration may be intraoperative, percutaneous, or perineural. The Over-the-needle (OTN) Catheter System is contraindicated for the epidural space.
The Over-the-needle (OTN) Catheter Systems are available in different designs with cannula and catheter in different sizes. The system includes: SonoPlex cannula, permanent cannula. E-Cath catheter, filter, FixoLong or FixoCath, locking cap and optional ultrasound cover.
The provided text describes a 510(k) premarket notification for a medical device, the "Over-the-Needle (OTN) Catheter System E-Cath." The purpose of the document is to demonstrate that this new device is substantially equivalent to legally marketed predicate devices, meaning it is as safe and effective.
The supplied text pertains to a medical device, specifically an anesthesia conduction catheter, not an AI/imaging device. Therefore, many of the requested criteria for AI/imaging device studies (like MRMC studies, expert consensus for imaging, training set details) are not applicable to this document. The "tests" described are engineering and material property tests to ensure the physical device meets relevant standards and performs comparably to its predicate.
However, I can extract the relevant acceptance criteria and study information that is present in the document for this specific type of medical device:
Device Acceptance Criteria and Performance
The document demonstrates substantial equivalence by comparing the new device against predicate devices and relevant international standards through various bench tests.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Specific Test / Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Intended Use | Indication for Use | Substantially Equivalent to predicate device K143164 regarding delivery of medication for regional anesthesia and pain management (intraoperative, percutaneous, or perineural administration), and contraindicated for epidural space. | The subject device's Indications for Use are identical to the predicate device K143164. |
| Needle Stability | Bending Rigidity | ≤ 0.48mm under an applied force of 15N by a span width of 17.5mm (according to EN ISO 9626). | The bending rigidity of both the predicate device's needles and the subject device's needles is less than 0.46mm. Additionally, the tested cannulas did not break during the breaking resistance test (bent at a defined angle for 20 periods, meaning bent in two directions), meeting the acceptance criterion of "not to break." |
| Bonding to Hub | ≥ 44N pull-off force (according to EN ISO 7864). | For both the subject device's and predicate device's needles, a force significantly higher than 44N was required to achieve pull-off. The cannula meets this acceptance criterion. | |
| Penetration Force | Not explicitly defined (objective comparison only per EN 13097). | The subject device's needles as well as the predicate device's needles show equivalent penetration/insertion forces. | |
| Catheter Performance | Leak Tightness | Defined through internal protocols based on risk assessment and clinical evaluation (standard DIN EN 1618 does not define criteria). | The catheters of both the subject device and the predicate device meet the acceptance criterion for tightness (i.e., both are tight during the test for a defined period and pressure). |
| Tensile Strength | Defined through internal protocols based on risk assessment and clinical evaluation; "internally defined acceptable value to be met without tear off" (standard DIN EN 10555-1 and DIN EN 1618 do not define criteria). | The catheters of both the subject device and the predicate device meet the acceptance criterion (i.e., they meet the internally defined "must-value" without tear off). | |
| Flow Rate | Defined through internal protocols based on risk assessment and clinical evaluation; "internally defined must-value" (standard DIN EN 10555-1 and DIN EN 1618 do not define criteria). | The catheters of both the subject device and the predicate device meet the acceptance criterion and have proven to have equivalent flow rates. | |
| Sterilization | Sterility Assurance Level (SAL) | 10⁻⁶ | Achieved using Ethylene Oxide sterilization (validated according to ISO 11135-1 Overkill Approach: 1 sublethal, 2 half, 1 full cycle). |
| Residuals | EO: 25ppm (25µg/g/device); ECH: 25ppm (25µg/g/device); Pyroburden/endotoxin: 0.06 EU/ml and 2.15 EU/device (acc. to FDA GUIDELINE ON VALIDATION OF LIMULUS AMEBOCYTE LYSATE TEST). | All limits for residuals (EO, ECH) and pyroburden/endotoxin are met. | |
| Shelf Life | Sterility & Performance | Remains sterile and performs as intended for 5 years. | Sterility tests after 5 years on worst-case devices showed they remained sterile. Performance tests (LUER connection, bonding stability, tensile strength, bending rigidity) on real-time aged components showed no decrease in performance after 5 years. |
| Biocompatibility | Biocompatibility ISO 10993-1 | Compliant with ISO 10993-1, 2nd and 3rd edition. | Components meet biocompatibility requirements, evidenced by successful completion of tests including: In vitro Cytotoxicity (ISO 10993-5), Irritation (ISO 10993-10), In vitro Haemolysis Test (ISO 10993-04), Acute Systemic Toxicity (ISO 10993-11), Test for delayed type hypersensitivity (ISO 10993-10), Reverse Mutation Assay (ISO 10993-03), Implantation (ISO 10993-06), Implantation Histopathology (ISO 10993-06). |
Study Details (as applicable to a non-AI medical device 510k submission)
2. Sample size used for the test set and the data provenance:
- The document does not explicitly state the sample sizes for the "bench tests" performed. It refers to standard test procedures (e.g., EN ISO 9626, EN ISO 7864, EN 13097, DIN EN 1618, DIN EN 10555-1). These standards typically specify minimum sample sizes for material and performance testing.
- The data provenance is from Germany (PAJUNK GmbH Medizintechnologie is based in Baden-Wuerttemberg, Germany, and the contract sterilizer is in Wiesbaden, Germany).
- The studies were prospective bench tests comparing the new device to the predicate and to established international standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as the "ground truth" for this device is based on compliance with engineering and material standards and direct comparison of physical properties with an already FDA-cleared predicate device. It does not involve subjective expert assessment of medical images or clinical outcomes in the same way as an AI diagnostic tool. Compliance is proven by laboratory testing measurements.
4. Adjudication method for the test set:
- This is not applicable. The "tests" are objective measurements against defined engineering standards and comparisons to a physical predicate device, not subjective assessments requiring 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:
- This is not applicable. This is a physical medical device (catheter system), not an AI-assisted diagnostic tool. No human reader studies (MRMC or otherwise) were conducted or relevant for this type of submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable. This question pertains to AI algorithms. The device is a physical catheter system, not an algorithm. Bench tests were performed on the physical device itself.
7. The type of ground truth used:
- The "ground truth" (or basis for acceptance) for this submission is:
- International Engineering Standards: e.g., EN ISO 9626, EN ISO 7864, EN 13097, DIN EN 10555-1, DIN EN 1618 for physical properties, ISO 11135-1 for sterilization, ISO 10993-1/4/5/6/7/10/11 for biocompatibility.
- Comparison to a Legally Marketed Predicate Device: Direct comparison of physical and performance characteristics to the Halyard - Irvine: On-Q QuikBloc Over-the-Needle (OTN) Catheter Set (K143164).
- Internal Protocols and Clinical Evaluation: For some properties where international standards did not define specific pass/fail criteria (e.g., catheter leak tightness, tensile strength, flow rate), PAJUNK® established internal acceptable values based on risk assessment and clinical evaluation.
8. The sample size for the training set:
- This is not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
- This is not applicable. As above, no training set for an AI model was used.
§ 868.5120 Anesthesia conduction catheter.
(a)
Identification. An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.(b)
Classification. Class II (performance standards).