(90 days)
The Haemonetics OrthoPAT advance (Orthopedic Perioperative Autotransfusion) System is indicated for use to salvage Red Blood Cells (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 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 advance Perioperative Autotransfusion System is an evolution of the previously cleared OrthoPAT Perioperative Autotransfusion System. The OrthoPAT advance System is designed to salvage Red Blood Cells (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 two liters per hour. Blood shed from the surgical site or wound drain is collected in the reservoir; processed in the Dynamic Disk® separation chamber to pack the RBCs; washed to remove the cell fragments, irrigation fluid, plasma, and other undesirable components that are found in the fluid portion of the shed blood; then transferred to a bag for gravity reinfusion to the patient. The OrthoPAT advance System consists of the following three parts that work together to collect and process the RBCs lost during and after surgery: OrthoPAT advance device: the electro-mechanical device and display screen. Disposable set: the single-use collection material including reservoir, processing set, A&A line, post-op line, and vacuum line. Solutions: solutions for collecting and processing salvaged blood (examples: anticoagulant and wash solutions).
Here's an analysis of the acceptance criteria and supporting study for the Haemonetics OrthoPAT advance Perioperative Autotransfusion System, based on the provided 510(k) summary:
The K122262 submission for the Haemonetics OrthoPAT advance Perioperative Autotransfusion System focuses on demonstrating substantial equivalence to a predicate device (Haemonetics OrthoPAT Perioperative Autotransfusion System, K992723). The "acceptance criteria" in this context are primarily established by showing that the new device performs at least as well as, or better than, the predicate device in relevant performance areas, and that any changes do not raise new questions of safety or effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes "Non-Clinical Testing Summary" which serves as the evidence that the device meets the implied acceptance criteria for substantial equivalence, specifically focusing on the differences from the predicate device. The acceptance criteria are implicit in the "Test Intent" columns, signifying that the device must "Pass" these tests to be considered safe and effective, and substantially equivalent.
| Acceptance Criteria (Implied from Test Intent) | Reported Device Performance |
|---|---|
| Software User Interface (EBL Display) | Passed |
| Validate update to software user interface with display of Estimated Blood Loss (EBL) volume. | Passed |
| Biocompatibility of New Reservoir Materials | Passed |
| Demonstrate the biocompatibility of the new reservoir, containing materials different from the predicate device. | Passed |
| Transportation & Aging Testing for Reservoir (Package Integrity & Device Stability) | Passed |
| Demonstrate the package integrity and device stability of the new reservoir, up to a six-month shelf life. | Passed |
| Electrical Hardware (Increased-Capacity Battery Safety) | Passed |
| Demonstrate the electrical safety of the increased-capacity battery. | Passed |
| EMC (Modified Device Compliance) | Passed |
| Demonstrate the EMC compliance of the modified device. | Passed |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes non-clinical bench testing. It does not specify sample sizes for these tests in terms of patient-derived data or a typical "test set" as one might expect in a clinical study for diagnostic AI. Instead, the tests are primarily engineering and material validation tests.
- Sample Size: Not specified in terms of patient counts or data points in the provided summary. The tests are focused on hardware, software, and material properties. For example, "Biocompatibility Testing" would involve material samples, and "Transportation & Aging Testing" would involve multiple reservoir units.
- Data Provenance: Not applicable in the context of patient data. These are bench testing results, meaning they were generated in a controlled laboratory environment by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable (N/A) for this type of device and submission. The tests performed are engineering and material science evaluations (e.g., software validation, biocompatibility, electrical safety, EMC). They do not involve expert interpretation of medical images or patient data to establish a "ground truth" in the way an AI diagnostic device would.
4. Adjudication Method for the Test Set
This information is not applicable (N/A). Adjudication methods like 2+1 or 3+1 are used in clinical studies where multiple human readers interpret data, and their discrepancies need to be resolved to establish a definitive ground truth. Such a scenario is not described for the non-clinical bench tests reported here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a MRMC comparative effectiveness study was not done or at least not described in this 510(k) summary. This type of study is relevant for diagnostic devices (especially those involving image interpretation by human readers) to assess how an AI system impacts human performance. The OrthoPAT advance is an automated autotransfusion system, not a diagnostic imaging device with human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The document describes standalone performance of device components, particularly the software and hardware. For example, "Bench Testing for Software" validated the software's user interface and its display of Estimated Blood Loss (EBL) volume. The "Bench Testing for Electrical Hardware" demonstrated the electrical safety of the battery. These are effectively standalone tests of the device's functional components. However, this is not an "algorithm only" study in the sense of a machine learning algorithm detecting a condition, but rather a validation of the device's engineered functions.
7. Type of Ground Truth Used
The "ground truth" for the tests described is based on engineering specifications, regulatory standards, and material science properties.
- For software validation: The ground truth is the expected correct functionality and display of EBL volume according to design specifications.
- For biocompatibility: The ground truth is compliance with recognized biocompatibility standards (e.g., ISO 10993).
- For transportation & aging: The ground truth is maintaining specified package integrity and device stability over time.
- For electrical safety and EMC: The ground truth is compliance with relevant electrical safety and electromagnetic compatibility standards.
8. Sample Size for the Training Set
This information is not applicable (N/A). The Haemonetics OrthoPAT advance System is an automated blood processing device, not an AI/machine learning device that relies on a "training set" of data for algorithm development or learning. Any software development would follow traditional software engineering principles and verification/validation.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable (N/A), as there is no "training set" in the context of machine learning for this device. The software and hardware functionalities are designed and verified against established engineering requirements and safety standards.
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510(k) Summary
Date: July 26, 2012
OCT 25 2012
Submitter: Haemonetics Corporation 400 Wood Road. Braintree MA 02184
Contact: Erica Diaz Regulatory Affairs Specialist Phone: 781-356-9798 Fax: 781-356-3558 Email: erica.gasca@haemonetics.com Alternate Contact: Greg Calder Regulatory Affairs Manager Phone: 781-356-9538 Fax: 781-356-3558 Email: gcalder@haemonetics.com
Device Information: Trade Name: Haemonetics OrthoPAT advance Perioperative Autotransfusion System Regulation Number: 21 CFR 868.5830 Regulation Name: Autotransfusion Apparatus Regulatory Class: Class II (two) Product Code: CAC
Predicate Device Information: Trade Name: Haemonetics OrthoPAT Perioperative Autotransfusion System Regulation Number: 21 CFR 868.5830 Regulation Name; Autotransfusion Apparatus Regulatory Class: Class II (two) Product Code: CAC
Device Characteristics Summary:
The OrthoPAT advance Perioperative Autotransfusion System is an evolution of the previously cleared OrthoPAT Perioperative Autotransfusion System. The OrthoPAT Perioperative Autotransfusion System was most recently cleared via 510(k) K992723 on October 18, 1999.
The OrthoPAT advance System is designed to salvage Red Blood Cells (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 two liters per hour.
Blood shed from the surgical site or wound drain is collected in the reservoir; processed in the Dynamic Disk® separation chamber to pack the RBCs; washed to remove the cell fragments, irrigation fluid, plasma, and other undesirable components that are found in the fluid portion of the shed blood; then transferred to a bag for gravity reinfusion to the patient.
The OrthoPAT advance System consists of the following three parts that work together to collect and process the RBCs lost during and after surgery:
- OrthoPAT advance device: the electro-mechanical device and display screen. .
- Disposable set: the single-use collection material including reservoir, processing set, A&A line, post-op . line, and vacuum line.
- Solutions: solutions for collecting and processing salvaged blood (examples: anticoagulant and wash . solutions).
The OrthoPAT advance device, together with the disposables to be used with the device, is the subject of this 510(k) submission.
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Non-Clinical Testing Summary:
ﻢ
The following non-clinical performance testing was submitted in support of a determination of substantial equivalence between the subject and predicate device. A summary of the performance testing is presented below in Table 1: Summary of Performance Studies. Test data demonstrates that the device met all clinical and performance requirements, and that the subject device is as safe, as effective, and performs as well as or better than the predicate device.
| Test Name | Test Report # | Test Intent | Test Result |
|---|---|---|---|
| Bench Testing forSoftware | TR-SOF-100367TR-SOF-100377TR-SOF-100378 | The intent of these studies wasto validate an update to thesoftware user interface withdisplay of Estimated Blood Loss(EBL) volume. | Passed |
| BiocompatibilityTesting for Reservoir | TR-BIO-100023-A | The intent of this study was todemonstrate the biocompatibilityof the new reservoir, containingmaterials different from thepredicate device. | Passed |
| Transportation &Aging Testing forReservoir | TR-ACG-100094AATR-DIS-101222ATR-DIS-101338 | The intent of these studies wasto demonstrate the packageintegrity and device stability ofthe new reservoir, up to a sixmonth shelf life. | Passed |
| Bench Testing forElectrical Hardware | TR-ELE-100445 | The intent of this study was todemonstrate the electrical safetyof the increased-capacity battery. | Passed |
| EMC | TR-ELE-100445A | The intent of this testing was todemonstrate the EMCcompliance of the modifieddevice. | Passed |
Table 1: Summary of Performance Studies
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Comparison to Predicate Summary:
The OrthoPAT advance Perioperative Autotransfusion System is an evolution of the OrthoPAT Perioperative Autotransfusion System. The OrthoPAT Perioperative Autotransfusion System was most recently cleared via 510(k) K992723 on October 18, 1999. The OrthoPAT advance System is designed to perform the same types of procedures as the previously-cleared OrthoPAT system, utilizing identical disposable sets as well as additional disposables designed for the new system. The previously-cleared OrthoPAT System to the subject OrthoPAT advance System include a software user interface update, a change in reservoir material and orientation of the reservoir filter, and an increase in battery capacity.
A summary of the OrthoPAT advance System comparison to the predicate OrthoPAT System is presented in Table 2: Comparison of the OrthoPAT advance System to the Previously-Cleared Predicate OrthoPAT System.
| Predicate OrthoPAT Device (K992723) | Subject OrthoPAT advance Device | |
|---|---|---|
| Indications for Use | The Haemonetics OrthoPAT(Perioperative AutoTransfusion) Systemis indicated for use to salvage Red BloodCells (RBCs) from blood lostintraoperatively and postoperativelyduring surgical procedures where theexpected rate of processing of salvagedblood and fluid aspirated from thesurgical site is less than or equal to 2liters per hour. Autotransfusion isindicated for patients who meet at leastone of the following criteria:• The patient is expected to losesufficient blood in the perioperativeperiod so as to require RBC transfusion,and autotransfusion will likely reduceor eliminate the need for allogeneicblood transfusion.• Religious beliefs cause the patient.torefuse allogeneic transfusion, but acceptautologous transfusion.• Compatible allogeneic blood is notavailable.• The patient is unable to donatesufficient quantities of autologousblood prior to surgery to adequatelycover the anticipated transfusionrequirement.• The patient or physician prefersperioperative autotransfusion ratherthan preoperative autologous donation | Same |
| Table 2: Comparison of the OrthoPAT advance System to the Previously-Cleared Predicate OrthoPAT | ||||||
|---|---|---|---|---|---|---|
| System | ||||||
| Table 2 (cont.): | ||||||
| Hardware Device: | Predicate OrthoPAT Device (K992723) | Subject OrthoPAT advance Device | ||||
| Display unit | • Keypad | Contains seven membrane switches and corresponding LED indicator lights | Contains thirteen buttons that provide pressed status to the display processor. Seven of the buttons shall provide associated key lights that can be turned on and off by software The SELECT button shall provide three key lights associated with it that can be turned off by the Display Processor | |||
| • Display | LCD (480x640 pixel) | Same | ||||
| Base Unit | • Centrifuge | 0 to 5500 rpmPneumatic control of disposable disk diaphragm | Same | |||
| • Header Arm | The header arm holds the header portion of the disk stationary during operation | Same | ||||
| • Red blood cell sensor | Light source and sensor to differentiate between air, waste, fluid, and red blood cells | Same | ||||
| • Spill containment system | Spill containment well and spill containment ring | Spill containment well drain and spill collection bag | ||||
| Rotary Valves | • Inlet Valve | Controls the flow of fluid into the disk | Same | |||
| • Effluent Valve | Controls the flow of fluid out of the disk | Same | ||||
| Pneumatic System | ||||||
| • Vacuum | 0 to -350mmHG[0 to -39.99 kPA;0 to -399.9 mbar] | Same | ||||
| • Pressure | 0 to 250mmHG[0 to 33 kPA;0 to 333 mbar] | Same | ||||
| • Pump | Maintains selected vacuum range | Same | ||||
| Reservoir Optics System | ||||||
| • Light Bar | Emits light towards the light reflector located in the reservoir | Same | ||||
| • CCD Camera | Tracks the movement of the float and monitors the fluid level of the reservoir | Same | ||||
| Power Supply | ||||||
| • AC Power | AC power accommodates worldwide voltage and frequencies from 100V to 240V, 50/60Hz | Same | ||||
| • Battery power | Nickel Metal hydride 7.2 volts and provides 1800mAH | Lithium Ion 8.4V 4600mAH | ||||
| Rear panel | Predicate OrthoPAT Device (K992723) | Provides mechanism for mounting an IV | Subject OrthoPAT advance Device | Same | ||
| Software | ||||||
| Base Unit | Controls device subsystems such aspneumatics, centrifuge, reservoir, etc. | New software for the CD cameracalibration and detection algorithm;Added memory storage area forcalibration data, machine recoveryinformation data, and proceduresummary and event data | ||||
| • Display Unit | Control LCD display, keypad, key lights,and tone generator | Additional functionality utilizing a newkeypad to add AC volume, processvolume trigger, process time trigger,interval timer reset and display togglingbetween graphic and text messages;A new audible alarm will be generatedand a visual text message will bedisplayed when the reservoir volumereaches the process volume triggervolume or process time trigger set byoperator;Additional icons will be generated anddisplayed for use with the battery andcharging system | ||||
| Disposables: | ||||||
| Integrated Processing Set | Collects blood in reservoir, processesblood from collection reservoir andseparates into RBC's and waste | Designed to use Quickconnect collectionreservoir and processing set. | ||||
| • | Anticoagulant line | Delivers anticoagulant to shed blood | Component of Aspiration andAnticoagulation line | |||
| • | AnticoagulantRoller Clamp | Allows the operator to adjust the flow rateof the anticoagulant | Component of Aspiration andAnticoagulation line | |||
| • | AnticoagulantSpike | Incorporates a drip chamber to allow theoperator to visually monitor theanticoagulant flow rate | Component of Aspiration andAnticoagulation line | |||
| • | Anticoagulant YAdapter | Allows the anticoagulant to flow into theaspiration line and mix with the blood asit flows toward the reservoir | Component of Aspiration andAnticoagulation line | |||
| • | AspirationConnector | Connector to either the wound drain set orthe intraoperative suction set | Component of Aspiration andAnticoagulation line | |||
| • | Aspiration Line | Connects the suction tip or wound drainto the reservoir | Same | |||
| • | Effluent Stopcock | Diverts fluid from the rotor into either thewaste bag or the RBC bag | Same | |||
| • | Inlet Stopcock | Diverts fluid into the rotor from either thereservoir or the saline bag | Same | |||
| • | Saline line | Runs between inlet stopcock and salinespike | Same | |||
| • | SeparationChamber (rotor,disk) | Spins in the centrifuge to separate theshed blood and process the RBCs | Same | |||
| Aspiration andAnticoagulant lineHAR-A-1003 | N/A | Connects suction tip to reservoir,anticoagulates shed blood | ||||
| • | Anticoagulant | N/A | Allows the operator to adjust the flow |
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.
:
and the comments of the comments of the comments of
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Table 2 (cont.):
・・
·
.
.
.
| Predicate OrthoPAT Device (K992723) | Subject OrthoPAT advance Device | ||
|---|---|---|---|
| • | AnticoagulantSpike | N/A | Incorporates a drip chamber to allow theoperator to visually monitor theanticoagulant flow rate |
| • | Anticoagulant YAdapter | N/A | Allows the anticoagulant to flow into theaspiration line and mix with the blood asit flows toward the reservoirMaterial: PVC |
| Aspiration andAnticoagulant line1400T | Connects suction tip to reservoir,anticoagulates shed blood | Same | |
| • | AnticoagulantRoller Clamp | Allows the operator to adjust the flow rateof the anticoagulant | Same |
| • | AnticoagulantSpike | Incorporates a drip chamber to allow theoperator to visually monitor theanticoagulant flow rate | Same |
| • | Anticoagulant YAdapter | Allows the anticoagulant to flow into theaspiration line and mix with the blood asit flows toward the reservoirMaterial: PVC | Same |
| Post-op Suction set | Connects to wound drain tubing andcollects blood postoperatively fromwound drain | Same | |
| Reservoir | Serves four functions: Transmission ofvacuum, storage of salvaged blood,filtration of salvaged blood, and fluidvolume measurement | Same | |
| • | Body | Material: ABS Plastic | Material: PolycarbonateSABIC HP4R |
| • | Cover | Material: ABS Plastic | Material: PolycarbonateLexan HP4NR with 8H9D266 White |
| • | Mesh filter | Removes clots and large debris from theshed bloodMaterial: ABS frame frame/copolyestermesh | Material: PolypropyleneFrame: TOTAL 3620 WZScreen: Polyester, SaatiPES 200/43 with Plasma Treatment |
| • | HydrophobicFilter | Material: PVDF sheet | Frame: HP4RFilter: 1um ePTFE, CVL-HC1 with Pre-Filter 4.3 um HOVOGLAS HC4011 |
| • | Grommet | Material: Silicone rubber | OrthoPAT advance does not use agrommet |
| • | Float ball | Floats on the blood as it fills the reservoir,monitored by reservoir light bar.Material: Polypropylene GR2 | Material: PolypropylenePlasma treated then pad printed withMARIBU TPU 980 Black |
| • | Light reflector | Material: ABS with white clariant | SameMaterial: ABS Terlux 2802 HD withwhite clariant UN0001 |
| • | Tubing | Material: PVC | Same |
| • | Pre-filter | Capture and retain debris as fluid entersthe reservoirMaterial: Thermally reticulatedpolyester/polyurethane foam | OrthoPAT advance does not use a Pre-Filter |
| Predicate OrthoPAT Device(K992723) | Subject OrthoPAT advanceDevice | ||
| • Straw | Pulls fluid from the bottom of thereservoirMaterial: PVC | Same | |
| • Reservoir Ports | Shorts line which end in a connectorMaterial: PVC | Same | |
| • Aspiration connector | Polypropylene | Component of A&A Line HAR-A-1003 Anticoagulant Y Adapter | |
| • Relief Valve | Not a part of the system | Additional part assembled to coverfor connection to outlet line orreservoirSiliconeVernay PN VL1001M12 | |
| Waste bag | Stores the waste fluid and salinewash that are separated from theconcentrated RBCsPVC | Same | |
| RBC bag | Stores the concentrated RBCs fortransfusion back to the patientPVC | Same | |
| Sterilization | Gamma | EtO | |
| Shelf Life | |||
| • Processing Set | |||
| 1150H (Integrated) | 3 years | N/A - See below for OPT-P-1000 | |
| OPT-P-1000 | N/A | 3 years | |
| • HAR-A-10003 | N/A | 3 years | |
| • 1400T | 3 years | 3 years | |
| • Post-op Suction Set | 3 years | Same | |
| • Reservoir | N/A | 6 months | |
| • Waste Bag | 3 years | Same | |
| • RBC Bag | 3 years | Same |
.
:
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Table 2 (cont.):
, '
Erica Diaz
Regulatory Affairs Specialist
Haemonetics Corporation
7-26-12
Date
7
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 25 2012
Haemonetics Corporation c/o Ms. Erica Diaz Regulatory Affairs Specialist 355 Wood Road Braintree, MA 20184
Re: K122262
OrthoPAT advance system Perioperative Autotransfusion System Regulation Number: 21 CFR 868.5830 Regulation Name: Autotransfusion Apparatus Regulatory Class: Class II Product Code: CAC Dated: July 26, 2012 Received: July 27, 2012
Dear Ms. Diaz:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Erica Diaz
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known):
Device Name: Haemonetics OrthoPAT advance (Orthopedic Perioperative Autotransfusion) System
Indications for Use:
The Haemonetics OrthoPAT advance (Orthopedic Perioperative Autotransfusion) System is indicated for use to salvage Red Blood Cells (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 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.
Prescription Use _ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Page 1 of 1 | |
| (Division Sign-Off) | |
| Division of Cardiovascular Devices | |
| 510(k) Number | K122 262 |
§ 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).