(14 days)
The Jostra HLM Tubing Sets are designed to be used in extracorporeal circulation during cardiopulmonary bypass procedures lasting six hours or less.
The Jostra HLM Tubing Set is indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours.
The Jostra HLM Tubing Set is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The product consists of tubing and connectors with connected oxygenators, reservoirs, fifters, and other cardiopulmonary bypass components assembled into user specified circuits for procedures requiring extracorporeal support up to six hours.
Tubing with a 3/32 inch wall thickness may also be used in a roller type displacement blood pump to propel the blood/fluid through the circuit.
The Maquet tubing is made of polyvinyl chloride (PVC) and ranges in size from 1/8" diameter to 1/2" diameter.
The following generic types of barbed connectors will be used: straight with or without luer locks, reducer with or without luer port, Y with or without luer port, male or female luer locks. Connectors may range in size from 1/8 to 1/2 inch.
The Maquet Cardiopulmonary AG Jostra HLM Tubing Set is a sterile, non-pyrogenic device intended for single use in extracorporeal circulation during cardiopulmonary bypass procedures lasting up to six hours. This summary outlines the acceptance criteria and the study that demonstrates the device meets these criteria.
The acceptance criteria for the Jostra HLM Tubing Set revolved around demonstrating that its components (tubing and connectors) are safe and effective for their intended use and are substantially equivalent to currently marketed devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | Tubing and connectors met biocompatibility standards. The submission states, "The tubing and connectors have undergone biocompatibility...testing to demonstrate safety...for their intended use." This implies that the materials and their interaction with blood and tissues are deemed safe and non-toxic for the intended duration of use (up to six hours). |
| Performance | The device demonstrated performance equivalence to predicate devices. The submission specifies, "The tubing and connectors have undergone...performance testing to demonstrate...equivalence for their intended use." Specific tests performed include: |
- Bond strength: Performed on the tubing and connectors.
- Burst pressure: Performed on the tubing and connectors.
- Effects upon cellular components (hemolysis): Performed on the tubing and connectors, indicating a measure of blood compatibility.
- Spallation: Performed on the tubing and connectors, assessing resistance to shedding particles.
The non-clinical tests' overall conclusion was that the materials "are safe and effective for their intended use." Additionally, the data supported that "Maquet tubing and connectors are substantially equivalent to the tubing and connectors that currently hold market clearance." This also extended to the complete "Jostra HLM Tubing Sets," which were deemed "substantially equivalent to the Custom Tubing Packs that currently hold market clearance." |
| Intended Use | The device is suitable for extracorporeal circulation during cardiopulmonary bypass procedures lasting six hours or less. The "Indications for Use" explicitly state: "The Jostra HLM Tubing Sets are designed to be used in extracorporeal circulation during cardiopulmonary bypass procedures lasting six hours or less." |
| Sterility | The device is provided sterile. The device description states, "The Jostra HLM Tubing Set is a sterile, non-pyrogenic device for single use only." |
| Non-pyrogenicity | The device is non-pyrogenic. The device description states, "The Jostra HLM Tubing Set is a sterile, non-pyrogenic device for single use only." |
| Single Use Only | The device is designed for single use and not to be re-sterilized. The device description states, "The Jostra HLM Tubing Set is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user." |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the exact sample size for each performance or biocompatibility test performed (e.g., number of tubing segments for burst pressure, number of samples for hemolysis). The data provenance is also not explicitly stated in terms of country of origin or whether the studies were retrospective or prospective. Given the nature of a 510(k) submission for a physical medical device, these tests would typically be laboratory-based and conducted in a controlled environment, likely by the manufacturer or a contract testing lab.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to the type of device and study described. The ground truth for this device is established through objective, standardized engineering and biological tests (e.g., measuring bond strength, burst pressure, hemolysis rates) against predefined criteria or comparison to predicate devices, rather than expert interpretation of data.
4. Adjudication Method
Not applicable. The "adjudication method" usually refers to a process of resolving discrepancies in expert interpretations, which is not relevant for objective laboratory and physical performance tests of a device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is not an AI-powered diagnostic tool or a device that involves human interpretation of output. Therefore, an MRMC study and the concept of human readers improving with AI assistance are not relevant.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device is a physical medical device (tubing set) and does not involve an algorithm or AI.
7. Type of Ground Truth Used
The ground truth used for this device's evaluation is primarily objective, quantifiable laboratory measurements and performance metrics according to standardized protocols. This includes:
- Engineering specifications (e.g., bond strength and burst pressure measurements).
- Biological responses (e.g., hemolysis and spallation tests).
- Comparison to established performance characteristics of predicate devices.
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 870.4390 Cardiopulmonary bypass pump tubing.
(a)
Identification. A cardiopulmonary bypass pump tubing is polymeric tubing which is used in the blood pump head and which is cyclically compressed by the pump to cause the blood to flow through the cardiopulmonary bypass circuit.(b)
Classification. Class II (performance standards).