(305 days)
The Jostra Venous Softbag Reservoirs are indicated for use in extracorporeal circuits during cardiopulmonary bypass procedures in the field of open-heart-surgery. The utilization period of this device is restricted to six hours. Blood contact longer than 6 hours is not recommended. Application and use of the softbag reservoir is in the sole responsibility of the respective physician.
The Venous Softbag Reservoir is used in extracorporeal circuits during cardiopulmonary bypass surgery and serves as container for a certain blood volume. It consists of plastic foils which are welded together and between which tubes of different diameters and a polyester mesh are sandwiched. The polyester mesh serves for an improved air removal. Application duration: The utilization period of this device is restricted to six hours. The softbag reservoir is delivered sterile and is determined for single use only.
The group of Venous Softbag Reservoirs consists of a variety of models which differ in size (filling volume) and in the port sizes. The filling volumes of the reservoirs range from 650 ml to 1900 ml depending on the model and the ports are either 3/8" or ½" in size.
The provided text describes a 510(k) submission for the Jostra Venous Softbag Reservoirs. Based on the document, here's a breakdown of the requested information, focusing on what is explicitly stated:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Area | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Integrity | Not explicitly stated, but implies the device should maintain structural integrity and prevent leaks or breakage during the intended six-hour use. | In-vitro testing on safety and effectiveness was executed to demonstrate that the Jostra Venous Softbag Reservoirs... are substantially equivalent to the named predicate devices. (This implies it met the integrity performance of the predicates, though no specific results are given.) |
| Performance | Not explicitly stated, but implies the device should perform its intended function as a venous reservoir in extracorporeal circuits for six hours. | In-vitro testing on safety and effectiveness was executed to demonstrate that the Jostra Venous Softbag Reservoirs... are substantially equivalent to the named predicate devices. (This implies it met the functional performance of the predicates, though no specific results are given.) |
| Stability of the Coating | Not explicitly stated, but implies the Safeline Coating (when present) should remain stable and effective throughout the six-hour use. | In-vitro testing on safety and effectiveness was executed to demonstrate that the Jostra Venous Softbag Reservoirs... are substantially equivalent to the named predicate devices. (This implies the coating stability was comparable to predicates or met industry standards, though no specific results are given.) |
| Biocompatibility | Not explicitly stated, but implies the device materials should be safe for blood contact for six hours, without adverse biological reactions. | In-vitro testing on safety and effectiveness was executed to demonstrate that the Jostra Venous Softbag Reservoirs... are substantially equivalent to the named predicate devices. (This implies it met biocompatibility standards, though no specific results are given.) |
| Sterility | Not explicitly stated, but implies the device should be delivered sterile. | In-vitro testing on safety and effectiveness was executed to demonstrate that the Jostra Venous Softbag Reservoirs... are substantially equivalent to the named predicate devices. (This implies it met sterility standards, though no specific results are given.) The device is described as "delivered sterile." |
Note: The document states that "In-vitro testing on safety and effectiveness was executed to demonstrate that the Jostra Venous Softbag Reservoirs with and without Safeline Coating described in this submission are substantially equivalent to the named predicate devices." This is the primary "proof" of meeting acceptance criteria, meaning the new device performed comparably to already cleared devices in these areas. Specific quantitative acceptance criteria and detailed test results are not provided in this summary.
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: Not specified in the provided text.
- Data Provenance: Not specified. The testing was "in-vitro," meaning in a controlled laboratory environment rather than on human or animal subjects. The company is based in Germany, so it's plausible the testing was conducted there, but this is not explicitly stated.
- Retrospective or Prospective: Not applicable, as the document refers to "in-vitro testing" which typically refers to lab experiments rather than patient data.
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 section is not applicable to this document. The device is a physical medical device (venous reservoir bag) and the testing described is primarily mechanical and material characterization ("Integrity," "Performance," "Stability of the coating," "Biocompatibility," "Sterility"). There is no mention of an "AI device," "image analysis," or "ground truth" derived from human interpretation in the context of diagnostic or clinical assessment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable to this document. As mentioned above, this is not an AI/diagnostic device that would involve human review and adjudication of findings against a "ground truth." The testing methods would have followed established protocols for medical device performance and safety testing.
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 section is not applicable to this document. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable to this document. This is not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This section is not applicable in the AI/diagnostic sense. For the in-vitro testing, the "ground truth" would be established by the predefined specifications, standards, and performance characteristics of the predicate devices, against which the new device was compared for substantial equivalence. For example, for "sterility," the ground truth is "no microbial growth." For "integrity," the ground truth is "no leaks under specified pressure." These are objective measurements rather than subjective expert consensus.
8. The sample size for the training set
This section is not applicable to this document. There is no mention of machine learning or an AI training set.
9. How the ground truth for the training set was established
This section is not applicable to this document for the reasons stated above.
§ 870.4400 Cardiopulmonary bypass blood reservoir.
(a)
Identification. A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.(b)
Classification. Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.