DIDECO ELECTA

{0}------------------------------------------------ K020647 # 510(k) Summary Dideco S.p.A. electa (per 21 CFR 807.92) ### 1. SPONSOR/APPLICANT | Contact: | Mr. Luigi Vecchi | |-------------------------|-------------------| | Dideco, S.p.A. | | | via Statale 12 Nord, 86 | | | I-41037 Mirandola (MO) | | | Italy | | | Telephone: | 011 39 535 298 11 | | Facsimile: | 011 39 535 252 29 | #### 2. DEVICE NAME | Proprietary Name: | electa | |-----------------------|---------------------------| | Common/Usual Name: | Autotransfusion Device | | Classification Names: | Autotransfusion Apparatus | ## 3. PREDICATE DEVICES - Cobe Brat II K991986 � #### 4. INTENDED USE The Dideco electa is indicated for intraoperative and postoperative recovery of blood, washing of the processed blood, and pre-operative sequestration (with indirect and direct patient connection). Typical clinical applications of autotransfusion include the following surgical specialties: Cardiovascular, Orthopedics, Thoracic, Transplant Surgery, Emergency (Trauma), Neurosurgery, Obstetrics and Gynecology, and Urology. {1}------------------------------------------------ ## 5. DEVICE DESCRIPTION The Dideco electa consists of hardware and disposables. It is the next generation of the Dideco autotransfusion device family. The main elements of the hardware include the centrifuge, blood pump, automatic clamps, control and monitoring sensors, and a user interface (display panel and keyboard). The modifications to the disposables are the addition of a bar code to the addition of a tubing cassette to simplify disposables installation. # BASIS FOR DETERMINATION OF EQUIVALENCE 6. Dideco makes the claim of substantial equivalence to cited predicates based on intended use, Indications for Use, technological characteristics, and operational characteristics. A side-by-side comparison of the Dideco electa with cited predicates is provided in Table I-1 below. | Characteristic | electa | Dideco ABMS<br>K982650 | COBE BRAT II<br>with CRIT-LINE<br>K991986 | |----------------------------------------|--------|------------------------|-------------------------------------------| | Intended Use | | | | | Pre-operative Sequestration | Yes | Yes | Yes | | Intraoperative recovery of shed blood | Yes | Yes | Yes | | Postoperative collection of shed blood | Yes | Yes | Yes | | PPP | Yes | Yes | Yes | | PRP | Yes | Yes | Yes | | Bag processing for PRP | Yes | Yes | Yes | | Direct Draw processing for PRP | Yes | Yes | Yes | | Typical Clinical Applications | | | | | Cardiovascular Surgery | Yes | Yes | Yes | | Orthopedic Surgery | Yes | Yes | Not specified | | Thoracic Surgery | Yes | Yes | Not specified | | Transplant Surgery | Yes | Yes | Not specified | | Emergency (Trauma) | Yes | Yes | Yes | | Neurosurgery | Yes | Yes | Not specified | | Obstetrics and Gynecologic Surgery | Yes | Yes | Not specified | | Urologic Surgery | Yes | Yes | Not specified | | | | | | Table I-1. Side-by-Side Comparison of the electa and Predicate Devices | |-------------------------------------|--------------------------|--------------------------|-------------------------------------------|------------------------------------------------------------------------| | | | Dideco ABMS | COBE BRAT II<br>with CRIT-LINE | | | Characteristic | electa | K982650 | K991986 | | | Operating Modes | | | | | | Automatic | Yes | Yes | Yes | | | Semi-automatic | Yes | Yes | Yes | | | Manual | Yes | Yes | Yes | | | Pre-programmed and reprogrammable | Yes | Yes | Yes | | | Processing Phases | | | | | | Prime (Fill) | Yes | Yes | Yes | | | Wash | Yes | Yes | Yes | | | Empty | Yes | Yes | Yes | | | Return | Yes | Yes | Yes | | | Concentrate | Yes | Yes | Yes | | | Disposables | | | | | | Bowl sizes | 55, 125, 175,<br>and 225 | 55, 125, 175, and<br>225 | 135, 250 | | | Sterile, single use, and disposable | X | X | X | | | Features | | | | | | Cardiotomy weighing system | Yes | No | No | | | Hematocrit sensor | Yes | No | Yes | | | Air bubble sensor | Yes | Yes | Yes | | | Free hemoglobin sensor | Yes | No | No | | | Pressure occlusion sensor | Yes | No | No | | | Blood loss sensor | Yes | No | No | | | Buffy coat sensor | Yes | Yes | Yes | | | Bar code reader | Yes | No | No | | | Level sensor | Yes | No | No | | | Vacuum pump | Yes | No | Yes | | | Smart card | Yes | No | RS232 Option | | | Printer | Yes | No | Yes | | | Continuous operation capability | Yes | No | Up to three cycles | | | Better quality wash option | Yes | Yes | No | | | Emergency wash option | Yes | Yes | No | | | Characteristic | <i>electa</i> | Dideco ABMS<br>K982650 | COBE BRAT II<br>with CRIT-LINE<br>K991986 | | | Operating Parameters | | | | | | Centrifuge speeds (RPM) | 1500-5600 | 1500-5600 | 4400 | | | Pump speeds (mL/min) | 25-1000 | 25-1000 | 25-1300 | | | Blood source for PPP/PRP | Patient or bag | Patient or bag | Patient or bag | | | PPP collection parameters | 50 mL/min<br>5600 RPM | 50 mL/min<br>5600 RPM | 50 mL<br>4400 RPM | | | PRP collection parameters | 50 mL/min<br>2400 RPM | 50 mL/min<br>2400 RPM | 50 mL<br>4400 RPM | | | Vacuum level | 0 to 300<br>mmHg | NA | 50 – 300 mmHg | | {2}------------------------------------------------ Table I-1. Side-by-Side Comparison of the electa and Predicate Devices (Continued) {3}------------------------------------------------ Table I-1. Side-by-Side Comparison of the electa and Predicate Devices (Continued) Dideco S.p.A. believes that the electa is substantially equivalent to the Dideco ABMS, COBE Brat II, and other currently marketed automated autotransfusion devices, that any differences are minor, and raise no new issues of safety and effectiveness. ## 7. TESTING Testing supplied in the 510(k) premarket notification for the Dideco electa includes electrical testing, electromagnetic compatibility testing, and performance testing that demonstrate compliance with performance specifications. {4}------------------------------------------------ Public Health Service Image /page/4/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three parallel lines that curve and merge to form a shape suggestive of a human profile. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 5 2002 SEP Dideco S.p.A. electa Ms. Rosina Robinson c/o Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760 Re: K020647 Dideco electa Regulation Number: 868.5830 Regulation Name: Autotransfusion Apparatus Regulatory Class: Class II (two) Product Code: CAC Dated: June 24, 2002 Received: June 25, 2002 Dear Ms. Robinson: 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 - Ms. Rosina Robinson 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 vour device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html Sincerely yours, Bram D. Zuckerman, M.D. ickerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ 510(k) Number (if known): Device Name: Dideco electa Indications for Use: The Dideco electais indicated for intraoperative recovery of blood, washing of blood collected in the post-operative period, and pre-operative sequestration ( with indirect and direct patient connection). Typical clinical applications of autotransfusion include the following surgical specialties: - Cardiovascular - Orthopedics - > Thoracic - Transplant Surgery - Emergency (Trauma) - Neurosurgery - > Obstetrics and gynecology - Urology (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY) Concurrence of CDRH, Office of Device Evaluation (ODE) OR Division of Carliovascular & Respiratory Devices 510(k) Number K020647 Prescription Use (Per 21 CFR 801.109) : Over-The-Counter Use **__**