(66 days)
No
The description focuses on electromechanical and software control of a physical process (blood processing) and does not mention any AI/ML terms or capabilities.
Yes.
The device salvages, concentrates, and washes red blood cells from blood lost during surgery for reinfusion, thereby directly treating or preventing a medical condition (need for allogeneic blood transfusion) or affecting the structure or function of the body.
No
This device is designed to salvage and process blood for autotransfusion, which is a therapeutic function, not a diagnostic one. It does not provide information about a patient's health status or condition.
No
The device description explicitly states that the 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, rechargeable battery, and a display panel with a control keypad. While it contains software, it is not a software-only medical device.
Based on the provided information, the OrthoPAT Perioperative Autotransfusion System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body to provide information for diagnostic purposes. This typically involves tests performed outside the body (in vitro) on samples like blood, urine, tissue, etc., to detect diseases, conditions, or monitor health.
- The OrthoPAT system's intended use is to salvage, process (concentrate and wash), and reinfuse a patient's own blood. It is a system for handling and preparing blood for transfusion back into the same patient. It does not perform diagnostic tests on the blood to identify diseases or conditions.
The system is a medical device used in a surgical setting for blood management, specifically autotransfusion. While it processes blood, its purpose is not diagnostic.
N/A
Intended Use / Indications for Use
The OrthoPAT Orthopedic Perioperative Autotransfusion System is intended for use in surgical procedures to salvage red blood cells lost during and after surgery, where the expected rate of processing of salvaged blood and fluid is less than or equal to two liters per hour. It processes the shed blood to separate and wash the red blood cells (RBCs) and make them available for autologous transfusion to the patient.
The OrthoPAT Perioperative Autotransfusion System is indicated for use to salvage RBCs from blood lost intraoperatively and postoperatively during surgical procedures where the expected rate of processing of salvaged blood and fluid aspirated from the surgical site is less than or equal to 2 liters per hour. Autotransfusion is indicated for patients who meet at least one of the following criteria:
The patient is expected to lose sufficient blood in the perioperative period so as to require RBC transfusion, and autotransfusion will likely reduce or eliminate the need for allogeneic blood transfusion.
Religious beliefs cause the patient to refuse allogeneic transfusion, but accept autologous transfusion.
Compatible allogeneic blood is not available.
The patient is unable to donate sufficient quantities of autologous blood prior to surgery to adequately cover the anticipated transfusion requirement.
The patient or physician prefers perioperative autotransfusion rather than preoperative autologous donation or transfusion of allogeneic blood.
Product codes (comma separated list FDA assigned to the subject device)
74 CAC
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 centrifuge, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
An in vitro simulation of use test of the OrthoPAT system demonstrated the quality of blood product produced by it. Comparative test data were submitted in a prior premarket notification submission (K962475). 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 (Sensitivity, Specificity, PPV, NPV, etc.)
Total cell recovery ranged from 79% to 88%. Washout efficiency of contaminants ranged from 95% to 100%.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
OCT 1 8 1999
510(k) Summary of Safety and Effectiveness
OrthoPAT® Perioperative Autotransfusion System
Expanded Indications for Use
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:
August 18, 1999
Device Name:
Classification name: Autotransfusion Apparatus
Proprietary Name: OrthoPAT® Perioperative Autotransfusion System
Predicate Device:
The OrthoPAT Perioperative Autotransfusion System is substantially equivalent to the Electromedics PAT 500 Portable Autotransfusion System (K910238).
1 OrthoPAT is a registered 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 centrifuge, 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 surgical procedures to salvage red blood cells lost during and after surgery, where the expected rate of processing of salvaged blood and fluid is less than or equal to two liters per hour. 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 OrthoPAT Orthopedic Perioperative Autotransfusion System to be substantially equivalent to the Electromedics PAT 500 Portable Autotransfusion System (K910238), 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 and after surgery.
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.
Performance data
An in vitro simulation of use test of the OrthoPAT system demonstrated the quality of blood product produced by it. Comparative test data were submitted in a prior premarket notification submission (K962475). 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.
3
Image /page/3/Picture/2 description: The image shows a logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a symbol consisting of three stylized human profiles facing to the right, with three curved lines above them.
OCT 1 8 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. John J. Sokolowski Vice President, Quality Assurance and Regulatory Affairs Transfusion Technologies, Inc. 9 Erie Drive Natick, MA 01760
Re: K992723 Autotransfusion System Regulatory Class: II (Two) Product Code: 74 CAC ・ Dated: August 12, 1999 Received: August 13, 1999
Dear Mr. Sokolowski:
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 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). 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 reqistration, 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 Regulations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (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 action. In addition, FDA may publish further announcements concerning your device in the Please note: this response to your premarket Federal Register. 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.
4
Page 2 - Mr. John J. Sokolowski
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 regulation (21 CFR Part 801 and additionally 809.10 for in_vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Thomas J. Callahan
Thomas J. Callanan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
5
Intended Use Form
K 992723 510(k) Number (if known):
Device Name: OrthoPAT® Perioperative Autotransfusion System
Indications for Use:
The OrthoPAT Perioperative Autotransfusion System is indicated for use to salvage RBCs from blood lost intraoperatively and postoperatively during surgical procedures where the expected rate of processing of salvaged blood and fluid aspirated from the surgical site is less than or equal to 2 liters per hour. Autotransfusion is indicated for patients who meet at least one of the following criteria:
The patient is expected to lose sufficient blood in the perioperative period so as to require RBC transfusion, and autotransfusion will likely reduce or eliminate the need for allogeneic blood transfusion.
Religious beliefs cause the patient to refuse allogeneic transfusion, but accept autologous transfusion.
Compatible allogeneic blood is not available.
The patient is unable to donate sufficient quantities of autologous blood prior to surgery to adequately cover the anticipated transfusion requirement.
The patient or physician prefers perioperative autotransfusion rather than preoperative autologous donation or transfusion of allogeneic blood.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular, Respiratory, | |
| and Neurological Devices | |
| 510(k) Number | K 992723 |
| Prescription Use
| (Per 21 CFR 801.192) | OR | Over-the-Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |