DEKNATEL DSP PLEUR-EVAC AUTOTRANSFUSION BLOOD RECOVERY BAG

K964070 · Deknatel, Inc. · CAC · Dec 31, 1996 · Anesthesiology

Device Facts

• Record ID: K964070
• Device Name: DEKNATEL DSP PLEUR-EVAC AUTOTRANSFUSION BLOOD RECOVERY BAG
• Applicant: Deknatel, Inc.
• Product Code: CAC · Anesthesiology
• Decision Date: Dec 31, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5830
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Pleur-evac® Autotransfusion Blood Recovery Bag is a blood evacuation and collection device for shed mediastinal or pleural drainage, and is intended to be used in conjunction with DSP Pleur-evac® Continuous Reinfusion Autotransfusion Systems.

Device Story

Flexible PVC bag for collection of shed mediastinal/pleural blood; used with Pleur-evac® Continuous Reinfusion Autotransfusion Systems. Device features two spring-loaded plates; unlatching plates creates vacuum to draw blood from thoracic drainage unit into bag for reinfusion. Used in clinical settings by healthcare providers. Benefits include efficient recovery and reinfusion of patient's own blood.

Clinical Evidence

No clinical data provided; substantial equivalence established via identical design and materials to predicate device.

Technological Characteristics

Flexible PVC bag; spring-loaded plate mechanism for vacuum generation; manual operation; non-powered.

Indications for Use

Indicated for patients requiring autotransfusion of shed mediastinal or pleural blood collected via thoracic drainage units.

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

• Atrium Self-filling ATS Blood Bag, model 2450 (K883663)

Submission Summary (Full Text)

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K964070
DEC 31 1996

# 510(k) SUMMARY
## DEKNATEL DSP
### Pleur-evac® Autotransfusion Blood Recovery Bag

1. **DATE PREPARED**
October 8, 1996

2. **SPONSOR INFORMATION**
**Address:** Deknatel DSP Worldwide, Inc.
600 Airport Road
Fall River, Massachusetts 02720
**Telephone:** 508-677-6600
**Contact:** Dean E. Ciporkin
Director of Regulatory Affairs

3. **DEVICE NAME**
**Proprietary Name:** Pleur-evac® Autotransfusion Blood Recovery Bag
**Common/Usual Name:** Autotransfusion blood bag
**Classification Name:** Autotransfusion apparatus

4. **DEVICE DESCRIPTION AND INTENDED USE**
The Pleur-evac® Autotransfusion Blood Recovery Bag is a blood evacuation and collection device for shed mediastinal or pleural drainage, and is intended to be used in conjunction with DSP Pleur-evac® Continuous Reinfusion Autotransfusion Systems. The device is a flexible PVC bag designed to evacuate and collect filtered blood from a thoracic drainage unit for reinfusion to the patient. The bag contains two spring-loaded plates which are latched together prior to device use. During use, the plates are unlatched and the spring acts against the plates to create a vacuum in the bag thereby drawing the blood into the bag from the Pleur-evac® unit.

Deknatel DSP 510(k)
Pleur-evac® Autotransfusion Blood Recovery Bag
10/8/96
Page C-1

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# 5. COMPARISON TO PREDICATE DEVICES

The Pleur-evac® Autotransfusion Blood Recovery Bag is identical in design, materials, manufacturing process, function, and intended use to the predicate device (Atrium Self-filling ATS Blood Bag, model 2450 --K883663). The only difference in the two devices is in the actual product labeling, which identifies the specific trade names and information on the specific distributors. Since the Pleur-evac® Autotransfusion Blood Recovery Bag is identical to the predicate device, no additional performance or biocompatibility testing was provided in this submission in order to establish substantial equivalence of the device to the predicate product.

Deknatel DSP 510(k)
Pleur-evac® Autotransfusion Blood Recovery Bag
10/8/96
Page C-2