(275 days)
SPS-1TM is intended for the flushing and cold storage of kidney, liver, and pancreas organs at the time of organ removal from the donor in preparation for storage, transportation and eventual transplantation into a recipient.
SPS-1 TM is a clear to light yellow, sterile, non-pyrogenic solution for hypothermic flushing and storage of organs. The solution has an approximate calculated osmolality of 320 mOsm, a sodium concentration of 29 mEq/L, a potassium concentration of 125 mEq/L, and a pH of approximately 7.4 at 20°C.
The provided document (K091656) does not contain information about a study proving the device meets acceptance criteria. Instead, it is a 510(k) summary for a "Static Preservation Solution" that establishes substantial equivalence to predicate devices based on shared manufacturing processes, chemical composition, and intended use.
Therefore, many of the requested details about acceptance criteria, device performance, sample sizes, expert involvement, and ground truth establishment are not available in this document.
Here's a breakdown of what can be extracted and what is missing:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for a study. The "functional and safety testing" mentions verifying device design met its requirements through biocompatibility, sterility, chemical identification, and particle enumeration in accordance with standards. However, the specific acceptance criteria (e.g., maximum allowable particle count, sterility pass/fail definition) and the results against these are not detailed.
- Reported Device Performance: Not provided in terms of outcome statistics from a study (e.g., organ viability rates, post-transplant function). The document states the primary evidence for equivalence is that the device and predicate devices "are manufactured by the same process, with exactly the same chemical composition and have the same intended use." This implies performance is assumed to be equivalent due to these factors, rather than directly measured in a comparative study.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not applicable. No clinical or comparative study data is presented. The "testing" mentioned refers to laboratory tests (biocompatibility, sterility, etc.), not a test set of patient or organ data.
- Data Provenance: Not applicable.
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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. No ground truth establishment for a test set is described.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No test set requiring adjudication is described.
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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 device is a static preservation solution, not an AI-assisted diagnostic tool or system that involves human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a medical solution, not a software algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable in the context of a performance study. For the laboratory testing (biocompatibility, sterility, chemical ID, particle enumeration), the "ground truth" would be the established industry standards and validated test methods for these specific properties.
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The sample size for the training set:
- Not applicable. This device is a medical solution, not a machine learning model requiring a training set.
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How the ground truth for the training set was established:
- Not applicable.
Summary of Device Acceptance Rationale from the Document:
The acceptance of the SPS-1™ Static Preservation Solution (K091656) by the FDA is based on demonstrating substantial equivalence to existing legally marketed predicate devices (CoStorSol® K083453, K073693, and ViaSpan® K944866).
The key arguments for substantial equivalence are:
- The SPS-1™ is manufactured by the same process as the predicate devices.
- It has exactly the same chemical composition as the predicate devices.
- It has the same intended use (flushing and cold storage of kidney, liver, and pancreas organs for transplantation).
Functional and safety testing mentioned includes biocompatibility, sterility, chemical identification, and particle enumeration, all performed "in accordance with applicable industry standards and/or FDA guidance documents." However, specific results or acceptance criteria for these tests are not detailed in this summary. The primary evidence presented for equivalence relies on the identical nature of the product to already approved devices.
§ 876.5880 Isolated kidney perfusion and transport system and accessories.
(a)
Identification. An isolated kidney perfusion and transport system and accessories is a device that is used to support a donated or a cadaver kidney and to maintain the organ in a near-normal physiologic state until it is transplanted into a recipient patient. This generic type of device may include tubing, catheters, connectors, an ice storage or freezing container with or without bag or preservatives, pulsatile or nonpulsatile hypothermic isolated organ perfusion apparatus with or without oxygenator, and disposable perfusion set.(b)
Classification. Class II (performance standards).