(20 days)
The Apex HP M Ph.I.S.I.O. Adult Hollow Fiber Membrane Oxygenator is intended to be used in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to 6 hours.
The Apex HP M Ph.I.S.I.O Adult Hollow Fiber Membrane Oxygenator is a cardiopulmonary bypass blood oxygenator with an integral heat exchanger.
This document describes a 510(k) premarket notification for a medical device called the "Apex HP M Ph.I.S.I.O. Adult Hollow Fiber Membrane Oxygenator". This is a regulatory submission for a device, not a study of an AI algorithm, therefore the requested information fields related to AI, ground truth, expert review, and sample sizes for training/test sets are not applicable.
Here's the relevant information extracted from the provided text:
Device: Apex HP M Ph.I.S.I.O Adult Hollow Fiber Membrane Oxygenator
Indications for Use: Intended to be used in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to 6 hours.
Predicate Device: Apex M Ph.I.S.I.O. Adult Hollow Fiber Membrane Oxygenator (K020997) and Dideco D 903 Avant 2 Ph.I.S.I.O Adult Hollow Fiber Oxygenator (K020351)
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria in a table format. Instead, it refers to compliance with established standards and specifications. The "reported device performance" is described in terms of meeting these specifications and being substantially equivalent to the predicate device.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Meets ISO 10993-1:1997 and FDA May 1, 1995 Memorandum requirements; no new materials used. | Substantially equivalent to unmodified/predicate device; biocompatible according to intended use. |
| Sterility | Meets established specifications. | Met established specifications; production techniques effective. |
| Pyrogenicity | Meets established specifications. | Met established specifications; production techniques effective; non-pyrogenic. |
| EO Residuals | Meets established specifications. | Met established specifications. |
| Package Integrity | Meets established specifications. | Met established specifications. |
| Gas Transfer Characteristics | Meets ISO 7199 and FDA Guidance requirements; meets established specifications. | Met established specifications for 3-year aged devices. |
| Pressure Drop | Meets ISO 7199 and FDA Guidance requirements; meets established specifications. | Met established specifications for 3-year aged devices. |
| Plasma Leakage Data | Meets ISO 7199 and FDA Guidance requirements; meets established specifications. | Met established specifications for 3-year aged devices. |
| Operating Blood Volume | Meets ISO 7199 and FDA Guidance requirements; meets established specifications. | Met established specifications for 3-year aged devices. |
| Heat Exchanger Performance | Meets ISO 7199 and FDA Guidance requirements; meets established specifications. | Met established specifications for 3-year aged devices. |
| Hemolysis/Cell Depletion | Meets ISO 7199 and FDA Guidance requirements; meets established specifications. | Met established specifications for 3-year aged devices. |
| Mechanical Integrity | Meets ISO 7199 and FDA Guidance requirements; meets established specifications. | Met established specifications for 3-year aged devices. |
| Leaking Test | Meets ISO 7199 and FDA Guidance requirements; meets established specifications. | Met established specifications for 3-year aged devices. |
| Overall Performance | Substantially equivalent to predicate devices. | Performs in a manner substantially equivalent to the unmodified device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document refers to "in vitro testing" and "applicable tests" being carried out. It does not provide specific sample sizes (e.g., number of devices tested) for these nonclinical tests. The tests were performed on devices aged to an equivalent of three years real-time aging. The data provenance is implied to be from internal testing conducted by the manufacturer (Sorin Group Italia S.r.I. in Italy), but no explicit country of origin for the data is mentioned, nor is it specified as retrospective or prospective.
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)
Not Applicable. This is a medical device 510(k) submission focusing on nonclinical and in vitro performance, not an AI algorithm study using expert-derived ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable. This is a medical device 510(k) submission focusing on nonclinical and in vitro performance, not an AI algorithm study involving human adjudication of results.
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 a medical device 510(k) submission for a physical medical device (oxygenator), not an AI-assisted diagnostic or clinical decision support system. No human reader studies with or without AI assistance were performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This is a medical device 510(k) submission for a physical medical device (oxygenator), not a standalone AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the nonclinical and in vitro tests, the "ground truth" (or basis for evaluation) was established by recognized industry standards (ISO 10993-1:1997, ISO 7199) and FDA guidance documents (FDA May 1, 1995 Memorandum on biocompatibility, Guidance for Cardiopulmonary Bypass Oxygenators 510(k) submissions - November 13, 2000). The device's performance was compared against the "established specifications" derived from these standards and the performance of the legally marketed predicate device.
8. The sample size for the training set
Not Applicable. This is a medical device 510(k) submission for a physical medical device, not an AI algorithm that requires training data.
9. How the ground truth for the training set was established
Not Applicable. This is a medical device 510(k) submission for a physical medical device, not an AI algorithm that requires ground truth for a training set.
§ 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.”