(217 days)
The Cytori Celution™ Cell Concentration Device is indicated for the collection, concentration, washing, and reinfusion of autologous cells collected intraoperatively or postoperatively to obtain concentrated blood cells for reinfusion. Such areas of application may include, but are not limited to, the following:
- · General Surgery
- · Cardiovascular Surgery
- · Orthopedic Surgery
- · Vascular Surgery
- · Plastic/Reconstructive Procedures
- Obstetric/Gynecologic Surgery
- · Neurosurgical Procedures
- · Thoracic Surgery
- · Transplantation Surgery
- · Emergency / Trauma Procedures
- Urology Procedures
- · Postoperative Treatment Areas
The Cytori Therapeutics Celution™ Cell Concentration Device consisting of a centrifuge, blood collection canister, peristaltic pumps, pinch valves, sensors, controller and associated vacuum fluorescent display. The Celution Cell Concentration Device weighs approximately 170 lbs, measures 35 inches with a height of 55 inches, and is equipped with lockable caster wheels for portability in the operating room. The Celution Cell Concentration Device is used in conjunction with a sterile disposable set that consists of a blood collection canister, a concentration chamber, a waste bag, and associated tubing. The Disposable Set for the Celution Cell Concentration Device is provided in a separate sterile package and mounted onto the device by the user at the time of use by contacting the tubing with the peristaltic pumps and pinch valves. Various washing solutions are provided by the user and connected to the single-use disposable set through the use of Spike ports attached to the tubing. The user is able to choose between large and small volume disposable sets based on the user's needs. The large volume set (190ml chamber size) is referred to as the "Macro" disposable set while the small volume set (70ml chamber size) is referred to as the "Micro" disposable set. The Macro and Micro disposable sets consists of the same essential configuration of tubing, bags, rotating seal, etc., and operate on the same essential principles of peristaltic pumping to transmit fluids, centrifugation, etc. The Macro and Micro disposable sets differ with respect to their collection chambers and continuous processing capabilities as the 190 ml chamber can only process one time and must have product removed from the chamber with a syringe and needle. The 70 ml chamber can process multiple runs and pump the cellular product to a pull/donif interface. The centrifuge of the Celution Cell Concentration Device concentrates and pellets the cells in the concentration chamber and the peristaltic pumps and associated pinch valves interact with the disposable tubing to remove the superitiation from the pelleted cells and deliver the waste to the waste bag. The Celution Cell Concentration Device then washes the cells by delivering the user-provided washing solutions to the cells through the use of the same peristaltic pumps and pinch valves. After the wash cycles, the pelleted cells are them available for use by the physician. The Celution Cell Concentration Device is operated by the user through use of a menu driven user interface. The device operates on a user interaction principle through use of the key pad by requiring the user to confirm the completion of prompted tasks. The device also comprehends timing on to the next programmed step. The device also comprehends programmed steps as there are sensors built into the device to confirm the execution of critical tasks and/or equipment error conditions.
The provided text describes a 510(k) submission for the Cytori Celution Cell Concentration Device, which is intended for the collection, concentration, washing, and re-infusion of autologous cells. The submission focuses on demonstrating substantial equivalence to predicate devices rather than establishing specific acceptance criteria and detailed performance studies against those criteria.
Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, expert qualifications, and ground truth establishment are not explicitly present in the provided document. The document describes "Design Verification Testing" generally, stating that performance is substantially equivalent to predicate devices with respect to "key cellular components" and that mechanical and safety testing demonstrated substantial equivalence in areas like "sterility, biocompatibility, durability, reliability, electrical safety, and software validation." However, no specific quantitative acceptance criteria or detailed study results are provided for these aspects.
Here's a breakdown of what can and cannot be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance
This information is not explicitly stated in the provided text. The document claims substantial equivalence in performance to predicate devices regarding "key cellular components" and in mechanical/safety aspects, but it does not provide a table with specific, quantifiable acceptance criteria and the device's measured performance against them.
2. Sample size used for the test set and the data provenance
This information is not explicitly stated in the provided text. The document mentions "Design Verification Testing" and "Test results," but it does not provide details on the sample size of the test set, the type of data (e.g., in vitro, animal, human), or its provenance (country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not explicitly stated in the provided text. Given that the submission focuses on substantial equivalence and general performance claims rather than a clinical efficacy study with ground truth established by experts, this detail is not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not explicitly stated in the provided text.
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
An MRMC study is not mentioned or implied in the provided text. This device is an "Autotransfusion Apparatus" for cell concentration, not an AI-assisted diagnostic tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable as the device is a physical cell concentration system, not an algorithm in the typical sense of AI or software-only performance. The device's "Celution firmware logic" and "user interaction principle" are mentioned, implying it operates automatically once initiated by a user, but it's not discussed in terms of standalone "algorithm performance" in the context of diagnostic algorithms or interpretations.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not explicitly stated in the provided text. Given the nature of the device (cell concentration), "ground truth" would likely relate to quantifiable cellular parameters (e.g., cell viability, concentration, purity) rather than diagnostic outcomes. However, the document does not detail how the "key cellular components" performance was benchmarked or what "ground truth" standard was used.
8. The sample size for the training set
This information is not explicitly stated in the provided text. The phrase "training set" typically refers to machine learning. While the device contains "firmware logic" and operates on a "user interaction principle," there's no indication of a machine learning component requiring a training set in the conventional sense detailed in the document.
9. How the ground truth for the training set was established
This information is not explicitly stated in the provided text, and as mentioned for point 8, the concept of a "training set" for machine learning is not discussed in this submission.
Summary of what is available regarding "acceptance criteria" and "study":
The document focuses on demonstrating substantial equivalence to predicate devices rather than meeting specific, predefined acceptance criteria through a detailed performance study with explicit numerical targets.
The study described is "Design Verification Testing" which showed:
- The performance of the Cytori Celution Cell Concentration Device is substantially equivalent to the predicate device in yielding a blood product with respect to key cellular components.
- Mechanical and safety testing demonstrated substantial equivalence to the predicate device with respect to sterility, biocompatibility, durability, reliability, electrical safety, and software validation.
The document does not provide details on the methodologies, specific metrics, or quantitative results of these "Design Verification Testing" studies, nor does it list explicit predefined acceptance criteria that were met.
§ 868.5830 Autotransfusion apparatus.
(a)
Identification. An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.(b)
Classification. Class II (performance standards).