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.

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.

AI/ML Overview

The OrthoPAT® Perioperative Autotransfusion System is a medical device designed to salvage and process a patient's own blood lost during and after surgery, making it available for autologous transfusion.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Total Cell Recovery	Ranged from 79% to 88%
Washout Efficiency of Contaminants	Ranged from 95% to 100%
Rate of processing of salvaged blood and fluid	Less than or equal to two liters per hour

2. Sample Size Used for the Test Set and Data Provenance

The document states that "An in vitro simulation of use test of the OrthoPAT system demonstrated the quality of blood product produced by it." However, the specific sample size for this in vitro test is not explicitly mentioned in the provided text.

The data provenance is in vitro simulation of use. The country of origin is not specified, but the submission is to the U.S. Food and Drug Administration (FDA), implying the study might have been conducted or overseen according to U.S. regulatory standards. The study was prospective in the sense that it was a controlled in vitro simulation designed to assess performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The provided text does not mention the use of experts to establish ground truth for the in vitro simulation. Performance metrics like "Total cell recovery" and "Washout efficiency of contaminants" are typically determined through laboratory assays and measurements against established standards for blood product quality, rather than expert consensus on individual "cases."

4. Adjudication Method for the Test Set

The provided text does not mention any adjudication method as would be relevant for subjective assessments. The results appear to be objective measurements from an in vitro test.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically for image-based diagnostic devices where human readers interpret images with and without AI assistance. The OrthoPAT system is an autotransfusion device, not a diagnostic imaging device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

The performance data presented ("Total cell recovery" and "Washout efficiency") are representative of the standalone performance of the OrthoPAT system itself. The device is described as functioning "automatically without a dedicated operator," which supports the idea that the reported performance metrics reflect the algorithm/system's capabilities without direct human intervention in the processing steps.

7. The Type of Ground Truth Used

The ground truth for the performance claims (Total Cell Recovery and Washout Efficiency) was likely established through:

Laboratory assays and analytical techniques: For example, measuring hemoglobin concentration or red blood cell count to determine recovery, and measuring markers of contaminants (e.g., plasma proteins, free hemoglobin) to determine washout efficiency.
Established scientific/medical standards: The quality of blood product is assessed against accepted standards for autologous transfusion, though these specific standards are not detailed in the document.

8. The Sample Size for the Training Set

The provided text does not mention a training set. This is consistent with the nature of the device. The OrthoPAT system is an electromechanical device with software that "monitoring and controlling the operation of the system." It's not an AI/ML device that requires a "training set" in the conventional sense to learn patterns. Its operation is likely based on pre-programmed algorithms and control logic derived from engineering principles and physiological requirements for blood processing.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned or relevant for this type of device, the concept of establishing ground truth for a training set does not apply here. The device's operational parameters and control logic would have been designed and validated through engineering principles and possibly pre-clinical testing, rather than an AI training process.

Summary

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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

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Device Description:

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.

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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.

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.

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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.

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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. Callanan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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Intended Use Form

K 992723 510(k) Number (if known):

Device Name: OrthoPAT® Perioperative Autotransfusion System

Indications for Use:

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
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Regulation Number and Section

§ 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).