(82 days)
No
The device description and intended use describe a mechanical blood collection bag with no mention of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is described as a blood evacuation and collection device, not a device intended for treating a disease or condition. It works in conjunction with a reinfusion system, but its primary function is collection, not therapy.
No
The device is described as a blood evacuation and collection device for reinfusion, not for diagnosing conditions.
No
The device description clearly describes a physical PVC bag with spring-loaded plates, indicating it is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Pleur-evac® Autotransfusion Blood Recovery Bag is designed to collect and store blood that has drained from the chest cavity for the purpose of reinfusion back into the same patient. It's a collection and storage device for a therapeutic procedure (autotransfusion), not a device used for diagnostic testing of a specimen.
- Intended Use: The intended use clearly states it's for "blood evacuation and collection" for "reinfusion to the patient." This is a therapeutic process, not a diagnostic one.
The device is used in conjunction with a system for reinfusion, which is a medical treatment, not a diagnostic test.
N/A
# Intended Use / Indications for 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.
# Product codes
Not Found
# Device Description
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.
# Mentions image processing
Not Found
# Mentions AI, DNN, or ML
Not Found
# Input Imaging Modality
Not Found
# Anatomical Site
mediastinal or pleural
# Indicated Patient Age Range
Not Found
# Intended User / Care Setting
Not Found
# Description of the training set, sample size, data source, and annotation protocol
Not Found
# Description of the test set, sample size, data source, and annotation protocol
Not Found
# Summary of Performance Studies
Since the Pleurevac® 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.
# Key Metrics
Not Found
# Predicate Device(s)
[K883663](https://510k.innolitics.com/search/K883663)
# Reference Device(s)
Not Found
# Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
DEC 31 1996
510(k) SUMMARY DEKNATEL DSP Pleur-evac® Autotransfusion Blood Recovery Bag
-
- DATE PREPARED
October 8, 1996
- DATE PREPARED
SPONSOR INFORMATION 2.
Deknatel DSP Worldwide, Inc. Address: 600 Airport Road Fall River, Massachusetts 02720
Telephone: 508-677-6600
Contact: Dean E. Ciporkin Director of Regulatory Affairs
3. DEVICE NAME
Pleur-evac® Autotransfusion Blood Recovery Bag Proprietary Name: Common/Usual Name: Autotransfusion blood bag Classification Name: Autotransfusion apparatus
DEVICE DESCRIPTION AND INTENDED USE 4.
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.
10/8/96
1
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 Pleurevac® 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.
.