(22 days)
The Dideco D 903 Avant 2 Ph.I.S.I.O. Adult Hollow Fiber Oxygenator with Integral Hardshell Venous Reservoir is intended for use in adults who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation. It provides oxygenation and carbon dioxide removal from venous blood. The integrated heat exchanger provides blood temperature control and allows the use of hypothermia or aids in the maintenance of normothermia during surgery. The venous reservoir with cardiotomy filter is intended to collect blood aspirated from the operating field during surgical procedures and the blood from patient's veins during normal operation to assure the proper oxygenation capability of the device. The device is intended to be used for six hours or less.
The D 903 AVANT Ph.I.S.I.O is a hollow fiber membrane oxygenator with integral heat exchanger and a hardshell cardiotomy venous reservoir.
Here's an analysis of the provided text regarding the acceptance criteria and study for the D 903 AVANT Ph.I.S.I.O. Adult Hollow Fiber Oxygenator:
This document is a 510(k) summary for a medical device seeking substantial equivalence to predicate devices, not a study report describing novel performance claims. Therefore, the device is not demonstrating performance against acceptance criteria in the way an AI/ML device would. Instead, it is demonstrating substantial equivalence to existing devices through a series of tests. Many of the requested categories are not directly applicable to this type of submission.
The "acceptance criteria" here are implicitly that the D 903 AVANT Ph.I.S.I.O. performs equivalently or within acceptable ranges compared to its predicate devices for relevant characteristics. The "study" proving this is a series of in vitro and biocompatibility tests.
1. Table of "Acceptance Criteria" and Reported Device Performance
| "Acceptance Criteria" (Implicit) | Reported Device Performance |
|---|---|
| Biocompatibility: Meet ISO 10993-1:1995 standards for medical devices and FDA May 1, 1995 Memorandum. | Testing Performed: Hemolysis, Cytotoxicity, Irritation, Acute Systemic Toxicity, Mutagenicity, Sterility, Pyrogenicity, ETO residuals. |
| Result: "The results of the testing met established specifications." The phosphorylcholine coating "is biocompatible." | |
| Gas Transfer Characteristics: Comparable to predicate device (D 903 AVANT). | Testing Performed: In vitro gas transfer studies (following "Guidance for in Vitro Testing World Cardiac Sustained 510(k) submissions - Final Guidance" and ISO 7199 (1996)). |
| Result: "The results of in vitro gas transfer studies demonstrate that the D 903 AVANT Ph.I.S.I.O. Adult Hollow Fiber Membrane Oxygenator performs in a manner substantially equivalent to the predicate device." "The results of the study showed the device characteristics between D 903 AVANT Ph.J.S.I.O. and D 903 AVANT were comparable." | |
| Operating Blood Volume: Comparable to predicate device. | Testing Performed: In vitro testing. |
| Result: Included in general statement: "The results of these tests met established specifications." Also inferred from "The results of the study showed the device characteristics between D 903 AVANT Ph.J.S.I.O. and D 903 AVANT were comparable." | |
| Heat Exchanger Performance Evaluation: Comparable to predicate device. | Testing Performed: In vitro testing. |
| Result: Included in general statement: "The results of these tests met established specifications." Also inferred from "The results of the study showed the device characteristics between D 903 AVANT Ph.J.S.I.O. and D 903 AVANT were comparable." | |
| Hemolysis/Cell Depletion: Comparable to predicate device. | Testing Performed: In vitro testing. |
| Result: Included in general statement: "The results of these tests met established specifications." Also inferred from "The results of the study showed the device characteristics between D 903 AVANT Ph.J.S.I.O. and D 903 AVANT were comparable." | |
| Mechanical Integrity: Comparable to predicate device. | Testing Performed: In vitro testing. |
| Result: Included in general statement: "The results of these tests met established specifications." Also inferred from "The results of the study showed the device characteristics between D 903 AVANT Ph.J.S.I.O. and D 903 AVANT were comparable." | |
| Leaking/Flaking Test: Comparable to predicate device. | Testing Performed: In vitro testing. |
| Result: Included in general statement: "The results of these tests met established specifications." Also inferred from "The results of the study showed the device characteristics between D 903 AVANT Ph.J.S.I.O. and D 903 AVANT were comparable." | |
| Sterility: Achieve and maintain sterility. | Testing Performed: Sterilization validation, ETO residuals. |
| Result: "Additional testing has demonstrated the effectiveness of production techniques to assure that the oxygenator is sterile and non-pyrogenic." | |
| Pyrogenicity: Be non-pyrogenic. | Testing Performed: Pyrogenicity test. |
| Result: "Additional testing has demonstrated the effectiveness of production techniques to assure that the oxygenator is sterile and non-pyrogenic." | |
| Shelf Life (Durability): Maintain performance characteristics for the specified shelf life (up to 2 years). | Testing Performed: Biocompatibility and in vitro tests were conducted on the device "aged up to 2 years." |
| Result: Implied that results met specifications for aged devices. |
The following points are mostly not applicable to this type of device submission (a traditional 510(k) for an oxygenator, not an AI/ML diagnostic system):
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in terms of number of devices or "cases." The "tests" here refer to laboratory evaluations on physical devices (e.g., a certain number of oxygenator units were subjected to gas transfer, heat exchange, etc., tests). The specific number of units isn't detailed in this summary.
- Data Provenance: The tests were conducted internally by Dideco S.p.A. (Italy) as part of their submission to the FDA. The data is prospective in the sense that the tests were specifically performed for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. "Ground truth" in the context of expert consensus is relevant for diagnostic interpretations. For this device, "ground truth" refers to established physical and chemical measurement standards (e.g., for gas exchange, blood compatibility), which are measured by laboratory technicians according to specified protocols.
4. Adjudication method for the test set
- Not Applicable. Adjudication methods like 2+1 or 3+1 are for reconciling disagreements among human readers/experts in diagnostic tasks. This device is evaluated by objective physical and chemical tests against predefined specifications.
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
- Not Applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a hardware medical device, not an algorithm. Performance is inherent to the device's physical function.
7. The type of ground truth used
- Physical and Chemical Measurement Standards / Predicate Device Performance: The "ground truth" is based on established engineering and biocompatibility standards (e.g., ISO 10993, ISO 7199, FDA guidance) and the performance characteristics of the legally marketed predicate devices (D 903 AVANT, D 901 Lilliput Ph.I.S.I.O., Monolyth Mimesys). The device is considered "substantially equivalent" if it meets the same functional performance levels.
8. The sample size for the training set
- Not Applicable. This is a hardware device; there is no "training set" in the context of machine learning. The design and manufacturing processes are refined through engineering, but not "trained" with data.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, this question does not apply.
§ 870.4350 Cardiopulmonary bypass oxygenator.
(a)
Identification. A cardiopulmonary bypass oxygenator is a device used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions.”