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

Device Description

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.

AI/ML Overview

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.

Summary

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Y060482

SEP 2 8 2006

Exhibit 14

Cytori Celution Cell Concentration Device

510(k) Summary

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ADMINISTRATIVE INFORMATION

Manufacturer Name:	Cytori Therapeutics, Inc.3020 Callan RoadSan Diego, CA 92121
Official Contact:	Kenneth K. KleinhenzSr. Director of Regulatory AffairsTelephone (858) 458-0900Fax (858) 458-0994

DEVICE NAME

Classification Name:	Autotransfusion Apparatus
Trade/Proprietary Name:	Cytori Celution™ Cell Concentration Device

ESTABLISHMENT REGISTRATION NUMBER 2031733

DEVICE CLASSIFICATION AND PRODUCT CODE

As shown in 21 CFR 868.5830, Autotransfusion Apparatus devices are defined as a device used to onlied As shown in 21 CFK 806.5630, Autoralististion ripper on traumes. Autotransfusion Apparatus devices are and rentrase the 01002 hev have been assigned Product Code CAC.

INTENDED USE

The Cytori Celution™ Cell Concentration Device is indicated for the collection, concentration, The Cytori Celulton… Cell Collectration Dovice is intraoperatively or postoperatively to obtain washing, and remnusion of autologous ocho corrector and 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

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DEVICE DESCRIPTION

Design Characteristics

Design Characteristics
The Cytori Therapeutics Celution™ Cell Concentration Device consisting of a centrifuge, blood i he Cylon Therapeates Celation - Coll Controller and our sensors, controller and associated collection callister, peristante pumps, phiel vacuum fluorescent display. The Celution firmware logic, user micriated Rey pad and accounted - 170 lbs, measures 35 inches with a Cell Colleentiation Device welgin upprominations for portability in the operaling
height of 55 inches, and is equipped with lockable caster wheels for portability in the oper neign of 35 ments, and is equipped within the weed in conjunction with a sterile disposable set suite. The Centron Con Collection canister, a concentration chamber, a waste bag, and associated that consists of a blood concention Cell Concentration Device is provided in a separate tubing. The Disposable Sec for the Celution Cell Concentration Device by the user at the time sterne package and mounted one the the peristaltic pumps and pinch valves. Various washing of use by contacting the tasing with and connected to the single-use disposable set through the use sofuluins are provided by the asse of the tubing. The user is able to choose between large and of Spire polis anachia to the used 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) size) is referred to as the "Micro" estile set. The Macro and Micro disposable sets consists of the Is releirou to as the "Mitro" disposure of tubing, bags, rotating seal, etc., and operate on the same essential configuration while of fluids, centrifugation, etc. The Macro and Micro salle principies of persuatio pailfying to transmit .
disposable sets differ with respect to their collection chambers and continuous processing disposable sels unfier will respect to sees multiple runs and pump the cellular Capabilities as the 190 mr fracts onails occhamber can only process one time and must have product to a removed from the chamber with a syringe and needle.

The centrifuge of the Celution Cell Concentration Device concentrates and pellets the cells in the The centriting chamber and the peristaltic pumps and associated pinch valves interact with the concentiation enamove the superiation from the pelleted cells and deliver the waste to the disposable tubing to remove the superitiation Device then washes the cells by delivering the userwaste bag. The Contron Con Concentration cells through the use of the same peristaltic provided wasning solutions to the wash cycles, the pelleted cells are them available pullip/donif interrace. Open complex Cell Concentration Device is operated by the user through Iol ase by the prysician. The Column Outs the user to perform various tasks. The device operates use of a meria arrough use of the key pad by requiring the user to confirm the on a user interaction primorple arough timing on to the next programmed step. The device also comprenon of prompled as there are sensors built into the device to confirm the execution of critical tasks and/or equipment error conditions.

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Design Verification Testing

Testing demonstrated that the performance of the Cytori Celution Cell Concentration Device is substantially equivalent to the predicate device as they both yield a blood product that is substantially equivalent with respect to key cellular components. Mechanical and safety testing of the Cytori Celution Cell Concentration Device further demonstrate substantial equivalence to the predicate device with respect to sterility, biocompatibility, durability, reliability, electrical safety, and software validation. Test results indicate that the mechanical properties of the Cytori Celution Cell Concentration Device are substantially equivalent to the mechanical properties of the predicate devices.

EQUIVALENCE TO MARKETED PRODUCT

The Cytori Celution Cell Concentration Device shares indications and design principles with the following predicate devices which have been determined by FDA to be substantially equivalent to pre-amendment devices: Medtronic Autolog Autotransfusion System (K972894), Dideco Electra (K020647), and Dideco Autologous Blood Management System (K982650).

Indications For Use

The Cytori Therapeutics Celution Cell Concentration Device and the predicate devices share substantially equivalent indications for use with the predicate devices as they all share nearly identical language and are all indicated for washing, concentrating, and processing blood for eventual return to the same patient within the same type of surgical procedures.

Design and Materials

The design and materials of Cytori Celution Cell Concentration Device and the predicate devices (Medtronic Autolog Autotransfusion System, Dideco Electa, and Dideco Autologous Blood Management System) are substantially equivalent as they are all free standing devices that perform the same basic function (collect, wash, and concentrate blood for reinfusion) through use of the like technology (centrifugation, peristaltic pumps, pinch valves, sensor, user interface module, etc.) in combination with multiple sterile, single-use disposable sets that utilize standard medical grade materials and associated tubing, waste bags, collection bags, collection reservoirs, and concentration chambers / bowls. The Cytori Celution Cell Concentration Device is also substantially equivalent to the predicate devices with respect to customer-supplied reagents as they all require and subsequently accommodate customer-supplied washing solutions / reagents used during the cell washing and concentration procedure through use of IV bag hooks / poles, spike ports, etc.

The disposables of the Cytori Celution Cell Concentration Device and the predicated devices are substantially equivalent as they are all sterile, single-use disposable sets that are installed onto the device by the user. Additionally, the Cytori Celution Cell Concentration Device and the predicated devices' disposable sets all utilize substantially equivalent designs of waste bags, collection bags, and blood collection reservoirs interconnected through use of small gauge tubing. The Cytori Celution Cell Concentration Device and the predicated devices all employ a substantially equivalent technology of moving fluids throughout the device's disposable set (e.g., from reservoir to reservoir) through the use of pinch valves that contact the tubing to prevent back flow in conjunction with peristaltic pumps that squeeze / compress the tubing and subsequently roll over the tubing to move the fluids in a specific direction.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 8 2006

Cytori Therapeutics, Inc. c/o Mr. Kenneth K. Kleinhenz Senior Director of Regulatory Affairs 3020 Callan Road San Diego, CA 92121

Re: K060482 Celution Cell Concentration Device Regulation Number: 21 CFR 870.5830 Regulation Name: Autotransfusion Apparatus Regulatory Class: Class II (two) Product Code: CAC Dated: August 2, 2006 Received: August 21, 2006

Dear Mr. Kleinhenz:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 – Mr. Kenneth K. Kleinhenz

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Duna R. Vachner

E
R

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K060482

Device Name:_Cytori Celution Cell Concentration Device

Indications For Use:

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

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duma R. Vahner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_Ko60482

Page 1 of 1

Regulation Number and Section

§ 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).