(240 days)
No
The description focuses on electromechanical control, software for monitoring and controlling operation, and automatic function. There is no mention of AI, ML, or learning from data.
Yes.
The device is used to process shed blood into red blood cells for autologous transfusion to the patient, which is a therapeutic intervention.
No
The device is described as an autotransfusion system intended to salvage and process red blood cells for reinfusion, not to diagnose a condition or disease.
No
The device description explicitly states that the OrthoPAT™ system consists of a single-use disposable set and an electromechanical device, which includes hardware components like a centrifuge, pneumatic system, valve system, electronic circuitry, and a rechargeable battery, in addition to software.
Based on the provided information, the OrthoPAT™ Orthopedic Perioperative Autotransfusion System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to salvage, process, and reinfuse the patient's own red blood cells lost during surgery. This is a therapeutic procedure involving the processing of blood within the patient's body (or shed from it) for reintroduction into the same patient.
- Device Description: The device processes blood physically (separation and washing) and does not perform any diagnostic tests or analyses on the blood to provide information about a patient's health status.
- Lack of Diagnostic Function: There is no mention of the device analyzing blood components for diagnostic purposes, detecting diseases, or providing any information used for diagnosis, monitoring, or screening.
IVD devices are typically used to examine specimens (like blood, urine, tissue) outside the body to provide information for diagnostic purposes. The OrthoPAT system's function is to prepare blood for transfusion, which is a treatment, not a diagnostic activity.
N/A
Intended Use / Indications for Use
The OrthoPAT™ Orthopedic Perioperative Autotransfusion System is intended for use in major orthopedic surgical procedures, such as joint replacement or spinal fusion to salvage red blood cells lost during and after surgery. It processes the shed blood to separate and wash the red blood cells (RBCs) and make them available for autologous transfusion to the patient.
Product codes
Not Found
Device Description
The OrthoPAT™ system consists of a single-use disposable set and an electromechanical device. The patient's blood is contained within the disposable set, is used for both intraoperative and postoperative processing (concentration and washing) of shed blood. The concentrated red blood cells are deposited into a bag. The bag is removed from the OrthoPAT system prior to the blood being reinfused.
The electromechanical device controls the collection process, the separation and washing process and the flow of fluids through the disposable. It contains a centrifige, a pneumatic system, a valve system, electronic circuitry, a rechargeable battery, software for monitoring and controlling the operation of the system, and a separately-mounted display panel with a control keypad.
The system is compact, light weight, can be mounted on an IV pole or bed frame, and is designed to follow the patient from the operating room, to the recovery room, and, if necessary, to the hospital floor. The on-board rechargeable battery provides power to the system to maintain suction while the patient is being transported. The system functions automatically without a dedicated operator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
An in vitro simulation of use test of the OrthoPAT system demonstrated the quality of blood product produced by it. Total cell recovery ranged from 79% to 88%. Washout efficiency of contaminants ranged from 95% to 100%. This performance is substantially equivalent to the Electromedics PAT 500 system.
Key Metrics
Total cell recovery ranged from 79% to 88%. Washout efficiency of contaminants ranged from 95% to 100%.
Predicate Device(s)
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).
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Image /page/0/Picture/0 description: The image shows the logo for Transfusion Technologies. The logo consists of a geometric design on the left and the words "TRANSFUSION TECHNOLOGIES" on the right. The word "TRANSFUSION" is on the top line, and the word "TECHNOLOGIES" is on the bottom line.
Transfusion Technologies Corporation ▪ 9 Erie Drive ▪ Natick, MA 017ο0-1312 Tel 508-655-2277 ▪ Fax 508-655-2292
FEB 2 0 1997
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510(k) Summary of Safety and Effectiveness
OrthoPATTM1 Perioperative Autotransfusion System K962475
Submitter:
Transfusion Technologies Corporation 9 Erie Drive Natick, MA 02760
(508) 655-2277 (phone) (508) 655-2292 (fax)
Contact person: John J. Sokolowski
Date Prepared:
October 28, 1996
Device Name:
Classification name: Autotransfusion Apparatus
Proprietary Name: OrthoPAT™ Perioperative Autotransfusion System
Predicate Devices:
The OrthoPAT Perioperative Autotransfusion System is substantially equivalent to the Electromedics PAT 500 Portable Autotransfusion System (K910238), the IBM Model 2991 Blood Cell Processor (K812355), and the Solco-Basle Solcotrans® SI Orthopedic Autotransfusion Set (K913177).
1 OrthoPAT is a trademark of Transfusion Technologies Corporation
1
Device Description:
The OrthoPAT™ system consists of a single-use disposable set and an electromechanical device. The patient's blood is contained within the disposable set, is used for both intraoperative and postoperative processing (concentration and washing) of shed blood. The concentrated red blood cells are deposited into a bag. The bag is removed from the OrthoPAT system prior to the blood being reinfused.
The electromechanical device controls the collection process, the separation and washing process and the flow of fluids through the disposable. It contains a centrifige, a pneumatic system, a valve system, electronic circuitry, a rechargeable battery, software for monitoring and controlling the operation of the system, and a separately-mounted display panel with a control keypad.
The system is compact, light weight, can be mounted on an IV pole or bed frame, and is designed to follow the patient from the operating room, to the recovery room, and, if necessary, to the hospital floor. The on-board rechargeable battery provides power to the system to maintain suction while the patient is being transported. The system functions automatically without a dedicated operator.
Intended Use:
The OrthoPAT™ Orthopedic Perioperative Autotransfusion System is intended for use in major orthopedic surgical procedures, such as joint replacement or spinal fusion to salvage red blood cells lost during and after surgery. It processes the shed blood to separate and wash the red blood cells (RBCs) and make them available for autologous transfusion to the patient.
Basis for Claim of Substantial Equivalence:
Transfusion Technologies Corporation claims its Orthopedic Perioperative Autotransfusion System to be substantially equivalent to the Electromedics PAT 500 Portable Autotransfusion System (K910238), the IBM Model 2991 Blood Cell Processor (K812355), and the Solco-Basle Solcotrans® SI Orthopedic Autotransfusion Set (K913177) based on the following:
Intended Use
The OrthoPAT system and the Electromedics PAT 500 system are intended to collect and concentrate shed blood lost during surgery. The OrthoPAT system and the Solco-Bashe system are intended to collect and reinfuse blood lost postoperatively.
2
Design
The OrthoPAT system and the Electromedics PAT 500 system are a combination of hardware, software and sterile disposables.
In both systems, the shed blood is stored in a sterile collection reservoir until the blood is processed. The red blood cells are concentrated by centrifugation and stored in a bag for subsequent reinfusion to the patient.
The materials used in the disposable sets of both systems are well accepted in the industry for this application
The OrthoPAT system does not utilize air to move fluids within the disposable set, and therefore does not require an air sensor to detect the end of an emptying cycle. In addition, a variable volume rotor moves fluid through the disposable set by way of an elastic diaphragm. which expands and contracts by external air pressure or vacuum. This design eliminates the need for a peristaltic pump. The movement of fluid by an elastic diaphragm is substantially equivalent to the flexible membrane used by the IBM Model 2991.
Performance data
An in vitro simulation of use test of the OrthoPAT system demonstrated the quality of blood product produced by it. Total cell recovery ranged from 79% to 88%. Washout efficiency of contaminants ranged from 95% to 100%. This performance is substantially equivalent to the Electromedics PAT 500 system.