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510(k) Data Aggregation
(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 <3, etc., as detailed for predicate) | Same (implied full compliance to the listed ISO 10993 standards and their acceptance criteria). |
| Sterilization Standards | ISO 10993-7:2008, ISO 11135-1:2007 (same as predicate) | Same |
| Echogenic Screw Tip | N/A (predicate lacked this feature) | Stainless Steel (present) |
| Echogenic Property | N/A (predicate lacked this feature) | Yes (present) |
| MRI Compatibility | MR Safe (predicate) | MR UnSafe (subject device, noted as a difference but not framed as a failure to meet acceptance, likely due to a change in material for echogenicity). |
2. Sample Size for the Test Set and Data Provenance
The document does not describe a clinical "test set" in the sense of patient data for evaluating diagnostic performance. The testing described is primarily engineering performance testing (e.g., against ISO standards, biocompatibility).
- Sample Size: Not specified for any clinical or image-based test set, as such a study is not detailed. For engineering tests, the sample sizes would be described within the individual test protocols (e.g., number of catheters tested for tensile strength, number of animals in biocompatibility).
- Data Provenance: Not applicable for a clinical test set from this document. The engineering tests likely originate from the manufacturer's labs.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. No clinical test set with human-established ground truth is described.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set with expert adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a MRMC comparative effectiveness study is not mentioned. The device is a physical medical device (catheter) for drug delivery, not an AI diagnostic algorithm. The primary "improvement" is the echogenic tip for better visibility under ultrasound, which is a design feature rather than an AI-driven enhancement.
6. Standalone (Algorithm Only) Performance
Not applicable. The device is a physical catheter, not a standalone algorithm.
7. Type of Ground Truth Used
The "ground truth" used for this device's acceptance is based on adherence to recognized international and national standards for medical devices (ISO, ASTM, EN), biocompatibility testing results, and the safety and performance characteristics of its predicate device. For the "echogenic" attribute, the ground truth would be the physical property of being visible under ultrasound, demonstrated through product design and potentially in vitro/in vivo bench testing.
8. Sample Size for the Training Set
Not applicable. There is no AI algorithm being trained.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
For the ON-Q T-bloc Echogenic Continuous Nerve Block Kit (K161232):**
Similar to the individual catheter, the acceptance criteria are predominantly about demonstrating substantial equivalence to its predicate device (Peripheral Nerve Block Tray, K073187) and compliance with relevant standards. The key distinguishing feature is the inclusion of the new Echogenic Catheter.
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: "administration of regional or local anesthesia to a patient." | "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 document notes expansion to identify routes and patient population, but states these are "not critical to the intended therapeutic or surgical use... and do not affect the safety and efficacy." |
| Regulation/Product Code | CAZ (same as predicate) | CAZ (Same) |
| Sterilization Method | Ethylene Oxide (same as predicate) | SAME |
| Single Use Device | Yes (same as predicate) | SAME |
| Packaging | Sterile Tyvek Pouch, Sterile .035" HDPE tray with Tyvek Lid (same as predicate) | SAME |
| Catheter Component (Key Difference) | 20 GA x 24 in (61 cm) Spirol® Catheter, with Inner Stylet and Thread Assist Guide (predicate) | 20 GA x 24 in (61 cm) Echogenic Catheter, with Inner Stylet and Thread Assist Guide (subject device - includes the previously described echogenic catheter) |
| Stylet Material (Key Difference) | Stainless Steel (predicate) | Nitinol (subject device) |
2. Sample Size for the Test Set and Data Provenance
Not applicable for a clinical "test set" in the AI sense. Primarily engineering and component-level testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable.
4. Adjudication Method for the Test Set
Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a MRMC comparative effectiveness study is not mentioned.
6. Standalone (Algorithm Only) Performance
Not applicable.
7. Type of Ground Truth Used
The "ground truth" for this kit's acceptance is based on adherence to recognized standards, biocompatibility, and the safety and performance of its predicate device, incorporating the design and testing of the Echogenic Catheter component.
8. Sample Size for the Training Set
Not applicable.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
Overall Summary regarding AI/Software Performance:
The provided documents are for physical medical devices (an anesthesia catheter and a nerve block kit). They do not describe an AI or software device, nor do they detail clinical studies with human readers or AI algorithms for diagnostic performance. Therefore, many of the requested points related to AI performance metrics, training/test sets, expert ground truth, and reader studies are not applicable to this submission. The focus is on demonstrating substantial equivalence in terms of intended use, technology, materials, and compliance with general device safety and performance standards.
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