CYTORI CELUTION CELL CONCENTRATION DEVICE

K060482 · Cytori Therapeutics, Inc. · CAC · Sep 28, 2006 · Anesthesiology

Device Facts

• Record ID: K060482
• Device Name: CYTORI CELUTION CELL CONCENTRATION DEVICE
• Applicant: Cytori Therapeutics, Inc.
• Product Code: CAC · Anesthesiology
• Decision Date: Sep 28, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5830
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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

Device Story

Device processes autologous blood intraoperatively or postoperatively; utilizes centrifuge, peristaltic pumps, pinch valves, and sensors to concentrate and wash cells. User mounts sterile, single-use disposable set (Macro or Micro volume) onto device; connects to patient and washing solutions. System operates via firmware-controlled logic; user interacts through keypad and vacuum fluorescent display. Sensors confirm task execution and monitor for error conditions. Device removes supernatant, pellets cells, and delivers waste to bag; final concentrated product retrieved by physician for reinfusion. Benefits include efficient autologous blood management; reduces need for donor blood. Used in clinical/surgical settings by trained personnel.

Clinical Evidence

Bench testing only. Performance verified through mechanical and safety testing, including sterility, biocompatibility, durability, reliability, and electrical safety. Software validation performed. No clinical data presented.

Technological Characteristics

Freestanding device; 170 lbs; 35" x 55". Components: centrifuge, peristaltic pumps, pinch valves, sensors, keypad, vacuum fluorescent display. Disposables: sterile, single-use sets (Macro 190ml/Micro 70ml chambers) with tubing, waste/collection bags. Technology: centrifugation for cell concentration; peristaltic pumps/pinch valves for fluid movement. Connectivity: standalone. Sterilization: sterile disposables.

Indications for Use

Indicated for patients undergoing surgical procedures requiring autologous blood cell collection, concentration, washing, and reinfusion. Applicable across general, cardiovascular, orthopedic, vascular, plastic/reconstructive, OB/GYN, neurosurgical, thoracic, transplant, urology, and emergency/trauma surgery settings.

Regulatory Classification

Identification

An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.

Predicate Devices

• Medtronic Autolog Autotransfusion System (K972894)
• Dideco Electra (K020647)
• Dideco Autologous Blood Management System (K982650)

Submission Summary (Full Text)

{0}------------------------------------------------

Y060482

SEP 2 8 2006

# Exhibit 14

Cytori Celution Cell Concentration Device

510(k) Summary

{1}------------------------------------------------

# ADMINISTRATIVE INFORMATION

| Manufacturer Name: | Cytori Therapeutics, Inc.<br>3020 Callan Road<br>San Diego, CA 92121 |
|--------------------|--------------------------------------------------------------------------------------------------------------|
| Official Contact: | Kenneth K. Kleinhenz<br>Sr. Director of Regulatory Affairs<br>Telephone [phone]<br>Fax [phone] |

#### 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

{2}------------------------------------------------

### 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.

{3}------------------------------------------------

#### 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.

{4}------------------------------------------------

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.

{5}------------------------------------------------

## 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 [phone]. 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 [phone] or [phone] 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

{6}------------------------------------------------

# 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