(243 days)
The OrthoPAT Orthopedic Perioperative Autotransfusion system is indicated for use to salvage RBCs from blood lost intraoperatively and postoperatively during orthopedic surgery procedures. Appropriate orthopedic procedures include joint replacement (primary and revision), and spinal fusion and instrumentation. 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.
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.
The acceptance criteria and study proving device performance are detailed below:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Total Cell Recovery | 79% to 88% |
| Washout Efficiency of Contaminants | 95% to 100% |
2. Sample Size and Data Provenance
The study was an in vitro simulation of use test. The specific sample size for this test is not explicitly stated in the provided document. The data provenance is also not explicitly stated beyond being an "in vitro simulation," which implies a controlled laboratory setting rather than patient data from a specific country. Given the nature of a 510(k) submission, it is assumed to be prospective data collected for the purpose of demonstrating device performance for regulatory approval.
3. Number of Experts and their Qualifications for Ground Truth
The provided document does not mention using experts to establish ground truth or their qualifications for the in vitro simulation test. The performance metrics (total cell recovery and washout efficiency) are objective, quantitative measurements derived from the experimental simulation rather than expert interpretation.
4. Adjudication Method for the Test Set
The concept of an adjudication method (e.g., 2+1, 3+1) is typically relevant for studies involving subjective interpretations, such as image analysis by human readers. For the in vitro simulation of use test described, which measured objective performance metrics like cell recovery and washout efficiency, an adjudication method is not applicable and therefore not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The study described is an in vitro performance evaluation of the device itself, not a study assessing the impact of the device on human reader performance.
6. Standalone Performance Study
Yes, a standalone performance study was done. The "in vitro simulation of use test" directly assessed the performance of the OrthoPAT system in terms of total cell recovery and washout efficiency, independent of human operators beyond the execution of the simulation itself. This constitutes an algorithm-only (device-only in this context) performance evaluation.
7. Type of Ground Truth Used
The ground truth used was based on quantitative laboratory measurements from an in vitro simulation. This means the performance metrics (total cell recovery and washout efficiency) were derived from direct experimental measurements of the blood product produced by the OrthoPAT system under simulated conditions, rather than expert consensus, pathology, or outcomes data.
8. Sample Size for the Training Set
The provided document does not mention a training set sample size. The OrthoPAT system is a medical device, not an AI/ML algorithm that typically requires a training set. The performance data presented relates to the functionality of the electromechanical device and its disposable set.
9. How Ground Truth for the Training Set Was Established
As the device is not an AI/ML algorithm, a "training set" and its associated ground truth establishment methods are not applicable and therefore not mentioned in the document. The performance evaluation focuses on the in vitro functionality of the physical device.
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3/30/99
K 982660
Transfusion Technologies Corp.
510(k) Summary of Safety and Effectiveness
OrthoPAT™1 Perioperative Autotransfusion System
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:
July 27, 1998
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
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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 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 OrthoPAT 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-Basle system are intended to collect and reinfuse blood lost postoperatively.
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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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines suggesting movement or progress. The overall design is simple and conveys a sense of professionalism and authority.
MAR 30 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. John J. Sokolowski Vice President, Quality Assurance and Regulatory Affairs Transfusion Technologies Corporation 9 Erie Drive Natick, MA 01760-1312
K982660 Re : OrthoPAT™ Perioperative Autotransfusion System Requlatory Class: II (Two) Product Code: 74 CAC Dated: January 11, 1999 Received: January 12, 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 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 Regulations, 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 requlatory action. In addition, FDA may publish further announcements 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 regulations.
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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. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Intended Use Form
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: OrthoPAT Orthopedic Perioperative Autotransfusion System
Indications for Use:
The OrthoPAT Orthopedic Perioperative Autotransfusion system is indicated for use to salvage RBCs from blood lost intraoperatively and postoperatively during orthopedic surgery procedures. Appropriate orthopedic procedures include joint replacement (primary and revision), and spinal fusion and instrumentation. 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)
Lede Xaver Ce
ision Sign-Off Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K982660
Prescription Use t. (Per 21 CFR 801.192)
OR
Over-the-Counter Use _
§ 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).