(151 days)
The ON-Q* EchoSpark* Echogenic Catheter is indicated for delivery of medication for regional anesthesia and pain management. Routes of administration may be perineural, intraoperative, or percutaneous.
The ON-Q* EchoSpark* Echogenic Catheter is indicated for patients undergoing continuous regional anesthesia and pain management procedures.
The ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit is indicated for delivery of medication for regional anesthesia and pain management. Routes of administration may be perineural, intraoperative, or percutaneous.
The ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit is indicated for patients undergoing continuous regional anesthesia and pain management procedures.
The ON-Q* Echogenic Catheter is a closed tip catheter composed of polyamide nylon (Pebax) tubing that contains two radiopaque barium sulfate stripes, black pad printed depth markings, and a stainless steel echogenic screw tip that is visible under ultrasound. The catheter assembly will also include a stylet composed of Nitinol wire with an ABS Finger holder and a polypropylene thread assist guide in a sterile Tyvek and polyester pouch.
ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit is designed for the Regional Anesthesia market to deliver medication for regional anesthesia and pain management. The Kit contains multiple components; one being Halyard Health's new Echogenic Catheter. The Echogenic Catheter is a closed tip catheter composed of polvamide nylon (Pebax) tubing that contains two radiopaque barium sulfate stripes, black pad printed depth markings, and a stainless steel echogenic screw tip that is visible under ultrasound. The catheter assembly will also include a stylet composed of Nitinol wire with an ABS Finger holder and a polypropylene thread assist quide in a sterile catheter sleeve composed of Tyvek and polyester.
Here's a breakdown of the acceptance criteria and study information, based on the provided document. It's important to note that this document is a 510(k) summary for medical devices, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel clinical study with explicit acceptance criteria for performance metrics like sensitivity/specificity.
The provided documents describe two devices:
- ON-Q EchoSpark Echogenic Catheter** (K161232)
- ON-Q T-bloc Echogenic Continuous Nerve Block Kit** (K161232)
Both devices reuse part of the same summary. The information provided heavily emphasizes comparison to predicate devices and adherence to standards, rather than defining specific performance metrics against clinical ground truth.
For the ON-Q EchoSpark Echogenic Catheter (K161232):**
The acceptance criteria here are primarily about demonstrating substantial equivalence to the predicate device (ON-Q* Pain Relief System, QuikBloc* Over-the-Needle Catheter Set, K143164) and compliance with relevant performance standards and biocompatibility requirements. There are no explicit quantitative performance metrics like sensitivity/specificity for the echogenic catheter's visibility that are stated as acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Predicate Equivalent / Standard Compliant) | Reported Device Performance (Subject Device) |
|---|---|---|
| Indications for Use | Substantially equivalent to predicate: delivery of medication for regional anesthesia and pain management. Predicate contraindicates epidural space use. | "The ON-Q* EchoSpark* Echogenic Catheter is indicated for delivery of medication for regional anesthesia and pain management. Routes of administration may be perineural, intraoperative, or percutaneous. The ON-Q* EchoSpark* Echogenic Catheter is indicated for patients undergoing continuous regional anesthesia and pain management procedures." Subject device does not have the epidural contraindication (as it is not an over-the-needle catheter). Stated to be "not critical to the intended therapeutic or surgical use... and do not affect the safety and efficacy." |
| Regulation/Product Code | BSO (same as predicate) | BSO (Same) |
| Manufacturer | Halyard Health (same as predicate) | Halyard Health (Same) |
| Sterilization Method | Ethylene Oxide (same as predicate) | Same |
| Catheter Tubing Composition | Pebax (same as predicate) | Same |
| Depth Markings | Graduated depth markings every 10 mm (same as predicate) | Same |
| Radiopaque Stripes | Barium sulfate stripes (same as predicate) | Same |
| Labeling | Case and sterile pack with identification label of catheter type, size etc. and IFU (same as predicate) | Same |
| Single Use Device | Yes (same as predicate) | Yes (Same) |
| Packaging Standards | ASTM F1980-07, ASTM D4169-09, ASTM F 2096-11, ASTM F 1886-09, ISO 15223:2012, ISO 11607-1:2006 (same as predicate) | Same |
| Performance Testing Standards | ISO:10555-1:2013, ASTM F 1980-07, EN-13868:2002, ISO:10555-5:2013 (for predicate) | "All applicable performance standards are the same. ISO 10555-5:2013 does not apply because this is not an over the needle catheter." |
| Biocompatibility Standards | ISO:10993 series (1, 3, 4, 5, 6, 10, 11) compliant (with specific criteria like Grade ≤ 2 for cytotoxicity, Sensitization Index |
§ 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).