(90 days)
Not Found
No
The description focuses on the mechanical and software updates for processing blood, with no mention of AI or ML for analysis or decision-making.
Yes.
The device is designed to salvage and reinfuse a patient's own red blood cells during and after surgery, which directly treats or manages the need for allogeneic blood transfusions.
No
The device description clearly states its function: "The OrthoPAT advance System is designed to salvage Red Blood Cells (RBCs) from blood lost intraoperatively and postoperatively... then transferred to a bag for gravity reinfusion to the patient." This describes a therapeutic or processing device, not one used for diagnosis.
No
The device description explicitly states it consists of an "electro-mechanical device and display screen," a "disposable set," and "solutions," indicating it is a hardware-based system with software components, not a software-only device. The performance studies also include testing for electrical hardware and biocompatibility of physical components.
Based on the provided information, the Haemonetics OrthoPAT advance (Orthopedic Perioperative Autotransfusion) System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to salvage and process red blood cells from blood lost during and after surgical procedures for reinfusion into the same patient. This is a therapeutic procedure involving the patient's own blood, not a diagnostic test performed on a sample in vitro (outside the body) to diagnose a condition or provide information about a patient's health status.
- Device Description: The device description details a system for collecting, processing, and preparing blood for reinfusion. It does not describe any components or functions related to analyzing blood or other biological samples for diagnostic purposes.
- Lack of Diagnostic Indicators: The information does not mention any diagnostic parameters, measurements, or analyses performed by the device.
- Performance Studies: The performance studies focus on software validation, biocompatibility, transportation/aging, electrical hardware, and EMC compliance – all related to the functionality and safety of the blood processing system, not diagnostic accuracy.
In summary, the OrthoPAT advance System is a medical device used for a therapeutic procedure (autotransfusion) and does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
CAC
Device Description
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).
The OrthoPAT advance device, together with the disposables to be used with the device, is the subject of this 510(k) submission.
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
Non-Clinical Testing Summary:
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 for Software | TR-SOF-100367 TR-SOF-100377 TR-SOF-100378 | The intent of these studies was to validate an update to the software user interface with display of Estimated Blood Loss (EBL) volume. | Passed |
| Biocompatibility Testing for Reservoir | TR-BIO-100023-A | The intent of this study was to demonstrate the biocompatibility of the new reservoir, containing materials different from the predicate device. | Passed |
| Transportation & Aging Testing for Reservoir | TR-ACG-100094AA TR-DIS-101222A TR-DIS-101338 | The intent of these studies was to demonstrate the package integrity and device stability of the new reservoir, up to a six month shelf life. | Passed |
| Bench Testing for Electrical Hardware | TR-ELE-100445 | The intent of this study was to demonstrate the electrical safety of the increased-capacity battery. | Passed |
| EMC | TR-ELE-100445A | The intent of this testing was to demonstrate the EMC compliance of the modified device. | Passed |
Key Metrics
Not Found
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).
0
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.
1
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 for | |||
| Software | TR-SOF-100367 | ||
| TR-SOF-100377 | |||
| TR-SOF-100378 | The intent of these studies was | ||
| to validate an update to the | |||
| software user interface with | |||
| display of Estimated Blood Loss | |||
| (EBL) volume. | Passed | ||
| Biocompatibility | |||
| Testing for Reservoir | TR-BIO-100023-A | The intent of this study was to | |
| demonstrate the biocompatibility | |||
| of the new reservoir, containing | |||
| materials different from the | |||
| predicate device. | Passed | ||
| Transportation & | |||
| Aging Testing for | |||
| Reservoir | TR-ACG-100094AA | ||
| TR-DIS-101222A | |||
| TR-DIS-101338 | The intent of these studies was | ||
| to demonstrate the package | |||
| integrity and device stability of | |||
| the new reservoir, up to a six | |||
| month shelf life. | Passed | ||
| Bench Testing for | |||
| Electrical Hardware | TR-ELE-100445 | The intent of this study was to | |
| demonstrate the electrical safety | |||
| of the increased-capacity battery. | Passed | ||
| EMC | TR-ELE-100445A | The intent of this testing was to | |
| demonstrate the EMC | |||
| compliance of the modified | |||
| device. | Passed |
Table 1: Summary of Performance Studies
2
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) 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 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 | 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 rpm | ||||
| Pneumatic 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 as | |||||
| pneumatics, centrifuge, reservoir, etc. | New software for the CD camera | |||||
| calibration and detection algorithm; | ||||||
| Added memory storage area for | ||||||
| calibration data, machine recovery | ||||||
| information data, and procedure | ||||||
| summary and event data | ||||||
| • Display Unit | Control LCD display, keypad, key lights, | |||||
| and tone generator | Additional functionality utilizing a new | |||||
| keypad to add AC volume, process | ||||||
| volume trigger, process time trigger, | ||||||
| interval timer reset and display toggling | ||||||
| between graphic and text messages; | ||||||
| A new audible alarm will be generated | ||||||
| and a visual text message will be | ||||||
| displayed when the reservoir volume | ||||||
| reaches the process volume trigger | ||||||
| volume or process time trigger set by | ||||||
| operator; | ||||||
| Additional icons will be generated and | ||||||
| displayed for use with the battery and | ||||||
| charging system | ||||||
| Disposables: | ||||||
| Integrated Processing Set | Collects blood in reservoir, processes | |||||
| blood from collection reservoir and | ||||||
| separates into RBC's and waste | Designed to use Quickconnect collection | |||||
| reservoir and processing set. | ||||||
| • | Anticoagulant line | Delivers anticoagulant to shed blood | Component of Aspiration and | |||
| Anticoagulation line | ||||||
| • | Anticoagulant | |||||
| Roller Clamp | Allows the operator to adjust the flow rate | |||||
| of the anticoagulant | Component of Aspiration and | |||||
| Anticoagulation line | ||||||
| • | Anticoagulant | |||||
| Spike | Incorporates a drip chamber to allow the | |||||
| operator to visually monitor the | ||||||
| anticoagulant flow rate | Component of Aspiration and | |||||
| Anticoagulation line | ||||||
| • | Anticoagulant Y | |||||
| Adapter | Allows the anticoagulant to flow into the | |||||
| aspiration line and mix with the blood as | ||||||
| it flows toward the reservoir | Component of Aspiration and | |||||
| Anticoagulation line | ||||||
| • | Aspiration | |||||
| Connector | Connector to either the wound drain set or | |||||
| the intraoperative suction set | Component of Aspiration and | |||||
| Anticoagulation line | ||||||
| • | Aspiration Line | Connects the suction tip or wound drain | ||||
| to the reservoir | Same | |||||
| • | Effluent Stopcock | Diverts fluid from the rotor into either the | ||||
| waste bag or the RBC bag | Same | |||||
| • | Inlet Stopcock | Diverts fluid into the rotor from either the | ||||
| reservoir or the saline bag | Same | |||||
| • | Saline line | Runs between inlet stopcock and saline | ||||
| spike | Same | |||||
| • | Separation | |||||
| Chamber (rotor, | ||||||
| disk) | Spins in the centrifuge to separate the | |||||
| shed blood and process the RBCs | Same | |||||
| Aspiration and | ||||||
| Anticoagulant line | ||||||
| HAR-A-1003 | N/A | Connects suction tip to reservoir, | ||||
| anticoagulates shed blood | ||||||
| • | Anticoagulant | N/A | Allows the operator to adjust the flow |
3
.
:
and the comments of the comments of the comments of
4
.
5
Table 2 (cont.):
・・
·
.
.
.
| Predicate OrthoPAT Device (K992723) | Subject OrthoPAT advance Device | ||
|---|---|---|---|
| • | Anticoagulant | ||
| Spike | N/A | Incorporates a drip chamber to allow the | |
| operator to visually monitor the | |||
| anticoagulant flow rate | |||
| • | Anticoagulant Y | ||
| Adapter | N/A | Allows the anticoagulant to flow into the | |
| aspiration line and mix with the blood as | |||
| it flows toward the reservoir | |||
| Material: PVC | |||
| Aspiration and | |||
| Anticoagulant line | |||
| 1400T | Connects suction tip to reservoir, | ||
| anticoagulates shed blood | Same | ||
| • | Anticoagulant | ||
| Roller Clamp | Allows the operator to adjust the flow rate | ||
| of the anticoagulant | Same | ||
| • | Anticoagulant | ||
| Spike | Incorporates a drip chamber to allow the | ||
| operator to visually monitor the | |||
| anticoagulant flow rate | Same | ||
| • | Anticoagulant Y | ||
| Adapter | Allows the anticoagulant to flow into the | ||
| aspiration line and mix with the blood as | |||
| it flows toward the reservoir | |||
| Material: PVC | Same | ||
| Post-op Suction set | Connects to wound drain tubing and | ||
| collects blood postoperatively from | |||
| wound drain | Same | ||
| Reservoir | Serves four functions: Transmission of | ||
| vacuum, storage of salvaged blood, | |||
| filtration of salvaged blood, and fluid | |||
| volume measurement | Same | ||
| • | Body | Material: ABS Plastic | Material: Polycarbonate |
| SABIC HP4R | |||
| • | Cover | Material: ABS Plastic | Material: Polycarbonate |
| Lexan HP4NR with 8H9D266 White | |||
| • | Mesh filter | Removes clots and large debris from the | |
| shed blood | |||
| Material: ABS frame frame/copolyester | |||
| mesh | Material: Polypropylene | ||
| Frame: TOTAL 3620 WZ | |||
| Screen: Polyester, Saati | |||
| PES 200/43 with Plasma Treatment | |||
| • | Hydrophobic | ||
| Filter | Material: PVDF sheet | Frame: HP4R | |
| Filter: 1um ePTFE, CVL-HC1 with Pre- | |||
| Filter 4.3 um HOVOGLAS HC4011 | |||
| • | Grommet | Material: Silicone rubber | OrthoPAT advance does not use a |
| grommet | |||
| • | Float ball | Floats on the blood as it fills the reservoir, | |
| monitored by reservoir light bar. | |||
| Material: Polypropylene GR2 | Material: Polypropylene | ||
| Plasma treated then pad printed with | |||
| MARIBU TPU 980 Black | |||
| • | Light reflector | Material: ABS with white clariant | Same |
| Material: ABS Terlux 2802 HD with | |||
| white clariant UN0001 | |||
| • | Tubing | Material: PVC | Same |
| • | Pre-filter | Capture and retain debris as fluid enters | |
| the reservoir | |||
| Material: Thermally reticulated | |||
| polyester/polyurethane foam | OrthoPAT advance does not use a Pre- | ||
| Filter | |||
| Predicate OrthoPAT Device | |||
| (K992723) | Subject OrthoPAT advance | ||
| Device | |||
| • Straw | Pulls fluid from the bottom of the | ||
| reservoir | |||
| Material: PVC | Same | ||
| • Reservoir Ports | Shorts line which end in a connector | ||
| Material: 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 cover | |
| for connection to outlet line or | |||
| reservoir | |||
| Silicone | |||
| Vernay PN VL1001M12 | |||
| Waste bag | Stores the waste fluid and saline | ||
| wash that are separated from the | |||
| concentrated RBCs | |||
| PVC | Same | ||
| RBC bag | Stores the concentrated RBCs for | ||
| transfusion back to the patient | |||
| PVC | 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 |
.
:
6
Table 2 (cont.):
, '
Erica Diaz
Regulatory Affairs Specialist
Haemonetics Corporation
7-26-12
Date
7
7
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.
8
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
9
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 |