AUTOLOGOUS BLOOD MANAGEMENT SYSTEM (ABMS)

K982650 · Dideco S.P.A. · CAC · Dec 16, 1998 · Anesthesiology

Device Facts

• Record ID: K982650
• Device Name: AUTOLOGOUS BLOOD MANAGEMENT SYSTEM (ABMS)
• Applicant: Dideco S.P.A.
• Product Code: CAC · Anesthesiology
• Decision Date: Dec 16, 1998
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 868.5830
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The ABMS 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.

Device Story

ABMS is an autotransfusion system for intraoperative/postoperative blood recovery, washing, and pre-operative sequestration. Hardware includes centrifuge, blood pump, three automatic clamps, control sensors, and user interface. System processes blood via centrifugation in a bowl; integrates automated autotransfusion and sequestration protocols. Used in clinical settings (OR, etc.) by trained personnel. Device provides automated control of blood processing phases (PRIME, WASH, EMPTY, RETURN, CONCentrate). Output allows clinicians to manage autologous blood for transfusion, potentially reducing need for allogeneic blood. Enhances Dideco Compact-A by adding automated sequestration protocols and modifying bowl base thickness.

Clinical Evidence

Clinical study compared automated sequestration (ABMS) to manual sequestration. Results showed ABMS PRP platelet yield mean 0.79 (SD 0.29) vs. manual 0.75 (SD 0.32); PRP platelet collection efficiency mean 69.2% (SD 17.6%) vs. manual 69.4% (SD 20.3%). Data indicates ABMS provides improved consistency and reproducibility. Bench and electrical safety/EMI/EMC testing also provided.

Technological Characteristics

Centrifugal blood processing system; includes centrifuge, blood pump, automatic clamps, and sensors. Features pre-programmable/reprogrammable processing modes (PRIME, WASH, EMPTY, RETURN, CONCentrate). Bowl sizes: 55, 125, 175, 225 ml. Blood pump speed: 25-1000 ml/min; Centrifuge speed: 1500-5600 RPM. Includes air and buffy coat detectors. Connectivity: Standalone unit with user interface control panel.

Indications for Use

Indicated for intraoperative/postoperative blood recovery, washing, and pre-operative sequestration in patients undergoing cardiovascular, orthopedic, thoracic, transplant, trauma, neurosurgical, obstetric/gynecologic, or urologic procedures.

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

• STAT-P (K884564)
• Compact (K910991)
• Compact-A (K940519)
• K963758
• K963759
• AT-1000 (K Number could not be identified)

Submission Summary (Full Text)

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# DEC 16 1988

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## APPENDIX H

- 2017-02-04 11:12:13

・・・

### 510(k) Summary

Dideco S.p.A. Abbreviated 510(k) 7/29/98 Autologous Blood Management System (ABMS)

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# 510(k) Summary Dideco S.p.A. Autologous Blood Management System (per 21 CFR 807.92)

#### SPONSOR/APPLICANT 1.

Mr. Luigi Vecchi Contact: Dideco, S.p.A. via Statale 12 Nord, 86 I-41037 Mirandola (MO), Italy 011 39 535 298 11 Telephone: [phone] Facsimile:

#### DEVICE NAME 2.

| Proprietary Name: | Autologous Blood Management System (ABMS) |
|-----------------------|-------------------------------------------|
| Common/Usual Name: | Autotransfusion Device |
| Classification Names: | Autotransfusion Apparatus |

#### PREDICATE DEVICES 3.

| • STAT-P | K884564 |
|-------------|--------------------------------------------------------------------|
| • Compact | K910991 (under the name Shiley Therapeutic Autotransfusion System) |
| • Compact-A | K940519 |
| | K963758 |
| | K963759 |
| • AT-1000 | K Number could not be identified |

#### 4. INTENDED USE

The ABMS 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.

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#### DEVICE DESCRIPTION 5.

The ABMS consists of hardware and disposables. It is an enhancement of the parent device, the Dideco Compact-A. It integrates the automated autotransfusion protocols of the STAT-P as well as adding automated sequestration protocols. The main elements of the hardware include the centrifuge, blood pump, three automatic clamps, control sensors, and a user interface (control panel). The modifications to the disposables are an increase in the thickness of the base of the bowl and a change in labeling to the new product codes.

#### BASIS FOR DETERMINATION OF EQUIVALENCE 6.

Dideco S.p.A. makes the claim of substantial equivalence based on the intended use, indications for use, design, operational and technological characteristics, materials of construction, and principles of operation.

Bench and electrical (safety and EMI/EMC) testing presented in this 510(k) demonstrates that the ABMS is substantially equivalent to the Compact-A in these areas. In addition, a clinical study was conducted to compare the results obtained using automated sequestration (ABMS) with those previously submitted to FDA for the manual sequestration process. As shown in Table H-1 below, results for the PRP collected with the ABMS in the automatic mode were similar to those using the manual mode. The lower standard deviations for the ABMS results demonstrate more consistency and overall reproducibility in product collection than that observed with the manual sequestration process.

| Characteristic | ABMS | Manual<br>Process | |
|-------------------------------------------|------|-------------------|------|
| PRP Platelet Yield (1011) | Mean | 0.79 | 0.75 |
| | SD | 0.29 | 0.32 |
| PRP Platelet Collection Efficiency<br>(%) | Mean | 69.2 | 69.4 |
| | SD | 17.6 | 20.3 |

| | Table H-1. Sequestration Results |
|--|----------------------------------|
|--|----------------------------------|

A side by side comparison of the characteristics of the ABMS with cited predicate devices is provided in Table H-2.

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| Characteristic | ABMS | STAT-P | COMPACT | COMPACT-A | AT-1000 |
|-----------------------------------------|-----------------------|----------------------|-----------------------|-----------------------|---------------------------|
| Separation by<br>centrifugation | YES | YES | YES | YES | YES |
| Separation chamber: bowl | YES | YES | YES | YES | YES |
| Available bowl sizes (ml) | 55, 125,<br>175, 225 | 55, 125,<br>175, 225 | 55, 125,<br>175, 225 | 55, 125,<br>175, 225 | 125, 225, 375 |
| Blood source for PPP/PRP | bag or<br>patient | NA | bag or<br>patient | bag or<br>patient | bag or<br>patient |
| Fully and semi-automatic<br>processing | YES | YES | NO | YES | YES |
| Air detector | YES | YES | YES | YES | YES |
| Buffy coat detector | YES | YES | YES | YES | YES |
| Pre-programmable | YES | YES | NO | YES | YES |
| Reprogrammable | YES | YES | NO | YES | YES |
| Tools required for bowl<br>installation | NO | YES | NO | NO | YES |
| Integral vacuum unit | NO | YES | NO | NO | YES |
| Dimensions (inches) | 17 x 22 x<br>18 | 34 x 20 x<br>31 | 17 x 22 x<br>18 | 17 x 22 x 18 | 17 x 31 x 48 |
| Weight (approx. in lbs.) | 73 | 262 | 73 | 73 | 265 |
| Identical tubing diameter | YES | YES | YES | YES | YES |
| Blood pump speed<br>(range in ml/min) | 25-1000 | 25-1000 | 25-1000 | 25-1000 | 0-1000 |
| Centrifuge speed (range in<br>RPM) | 1500-5600 | 1500-4800 | 1500-5600 | 1500-5600 | 2400-5600 |
| PPP collection parameters | 50 ml/min<br>5600 RPM | NA | 50 ml/min<br>5600 RPM | 50 ml/min<br>5600 RPM | 50-100 ml/min<br>5600 RPM |
| PRP collection parameters | 50 ml/min<br>2400 RPM | NA | 50 ml/min<br>2400 RPM | 50 ml/min<br>2400 RPM | 50-100 ml/min<br>2400 RPM |
| Operating Phases | | | | | |
| PRIME mode | YES | YES | YES | YES | YES |
| WASH mode | YES | YES | YES | YES | YES |
| EMPTY mode | YES | YES | YES | YES | YES |
| RETURN mode | YES | YES | YES | YES | YES |
| CONCentrate mode | YES | YES | YES | YES | YES |
| CONTinuous operation | YES | YES | YES | YES | YES |
| BQW (Better Quality<br>Wash feature) | YES | NO | YES | YES | YES (Pulse<br>Wash Mode) |

## Table H-2. Comparison of the ABMS with Predicate Devices

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Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing right, stacked on top of each other. The profiles are rendered in black and have a flowing, abstract design. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a sans-serif font.

### DEC 1 6 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dideco, S.P.A. c/o Ms.Rosina Robinson Senior Staff Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760

K982650 Re : Dideco Autologous Blood Management System (ABMS) Requlatory Class: II (Two) Product Code: CAC November 11, 1998 Dated: November 12, 1998 Received:

Dear Ms. Robinson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally 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). You may, therefore, market the device, subject to the general controls provisions of The general controls provisions of the Act include the Act. 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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### Page 2 - Ms. Rosina Robinson

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Other general information on your responsibilities under 807.97) . . the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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K 98,265 510(k) Number (if known):

Device Name: Dideco Autologous Blood Management System (ABMS)

Indications For Use:

The ABMS is 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)

Sue L. Cooper

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K 98267 510(k) Number _

Prescription Use Use Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

Dideco S.p.A. Abbreviated 510(k) 7/29/98 Autologous Blood Management System (ABMS)