(214 days)
Not Found
No
The description focuses on hardware components, fluid dynamics, and basic electronic monitoring of a sedimentation process, with no mention of AI/ML terms or functionalities.
Yes.
The device is used to process autologous shed blood for reinfusion, which is a therapeutic intervention aimed at restoring blood volume and red blood cell count in a patient.
No
Explanation: The "Intended Use" states that the device is "indicated for the processing of autologous shed blood collected intraoperatively or postoperatively to obtain concentrated red blood cells for reinfusion." This describes a blood processing device for therapeutic purposes (reinfusion), not for diagnosing a disease or condition. The "Device Description" also focuses on the mechanical and electronic aspects of blood processing and containment, not diagnostic functions.
No
The device description explicitly states the system includes "Reusable SC-1000, SmartCell hardware system" with various physical components like pumps, sensors, and processing chambers, in addition to software.
Based on the provided information, the SmartCell™ Processing System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to process autologous shed blood for reinfusion. This is a process performed on blood outside the body, but the purpose is to prepare it for reintroduction into the same patient. IVDs are typically used to examine specimens (like blood, urine, tissue) to provide information about a patient's health status, diagnose conditions, or monitor treatment.
- Device Description: The description details a system for processing blood, including pumps, processing chambers, and disposable components for containing and transferring blood. This aligns with a blood processing system, not a diagnostic test.
- Lack of Diagnostic Function: There is no mention of the device analyzing blood components to provide diagnostic information. Its function is purely mechanical and fluidic for concentrating red blood cells.
- Predicate Device: The predicate device is the Haemonetics Cell Saver 5 Autotransfusion System, which is also a blood processing system for autotransfusion, not an IVD.
In summary, the SmartCell™ Processing System is a device used for blood processing and preparation for reinfusion, which falls under the category of a blood processing or autotransfusion system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SmartCell™ Processing System is indicated for the processing of autologous shed blood collected intraoperatively or postoperatively to obtain concentrated red blood cells for reinfusion.
Product codes
CAC
Device Description
The SmartCell System includes the following two components: Reusable SC-1000, SmartCell hardware system that includes the following major system components: start/stop/clear buttons, process indicator display, process indicator lights, HES and blood pumps, two processing chambers (left and right), fluid sensors, optics and drain controls. The system also includes the electronic components and system software that monitors proper installation of the disposable and the sedimentation process. The SCP-1500, Process Pack: a sterile, disposable device to transfer and contain the blood and sedimentation fluid (HES) during concentration and transfer to the preconnected filtered reinfusion bag. Also a separate disposable Processing Bag (SCP-1550) is provided that is a sub-assembly of the Process Pack. The SCP-1550 is provided to allow for processing of additional volumes of blood.
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)
"In vitro blood quality studies, electrical safety testing and biocompatibility evaluation of the disposable set has been performed to demonstrate substantial equivalence."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Haemonetics Cell Saver 5 Autotransfusion System
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
K98302ว
PART 10 Summary of Safety and Effectiveness Information
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The contents of this 510(k) summary have been provided in conformance with 21 CFR §807.92.
스님들
2 1000
1
510(k) Summary for the Harvest Technologies
| Submitter's Name and Address: | Harvest Technologies Corp.
77 Accord Park Drive, D-7 |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Phone Number: | 781-982-1900 |
| Telefax Number: | 781-982-7288 |
| Contact Person: | Richard Lariviere, Operations Manager |
| Date Summary Prepared: | August 26, 1998 |
| Device Trade Name: | SmartCell Processing System |
| Common name: | Autotransfusion Device |
| Classification Name: | Autotransfusion Apparatus per 21 CFR 868.5830 |
| Substantial Equivalence: | The proposed device is substantially equivalent to devices previously cleared by the FDA via the Premarket Notification process for autotransfusion (i.e., Haemonetics Cell Saver 5 Autotransfusion System) |
| Device Description: | The SmartCell System includes the following two components: Reusable SC-1000, SmartCell hardware system that includes the following major system components: start/stop/clear buttons, process indicator display, process indicator lights, HES and blood pumps, two processing chambers (left and right), fluid sensors, optics and drain controls. The system also includes the electronic components and system software that monitors proper installation of the disposable and the sedimentation process. The SCP-1500, Process Pack: a sterile, disposable device to transfer and contain the blood and sedimentation fluid (HES) during concentration and transfer to the preconnected filtered reinfusion bag. Also a separate disposable Processing Bag (SCP-1550) is provided that is a sub-assembly of the Process Pack. The SCP-1550 is provided to allow for processing of additional volumes of blood. |
2
Intended Use:
The SmartCell™ Processing System is indicated for the processing of autologous shed blood collected intraoperatively or postoperatively to obtain concentrated red blood cells for reinfusion.
Technological Characteristics:
With the SmartCell device, the concentration of red blood cells is accomplished via a nonmechanical, accelerated gravitational sedimentation process using a commercially available sterile 6% hydroxyethyl starch solution (e.g., Hetastarch). Hydroxyethyl starch (HES) promotes red cell aggregation (rouleaux) thereby accelerating the sedimentation and concentration process. This process yields a packed red cell product with a hematocrit and anticoagulant washout equivalent to that of the predicate device. In vitro blood quality studies, electrical safety testing and biocompatibility evaluation of the disposable set has been performed to demonstrate substantial equivalence.
3
2 1999 APR
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Richard Lariviere Operations Manager Harvest Technologies, LLC. 77 Accord Park Drive, D-7 Norwell, MA 02061
Re: K983022 SmartCell™ Processing System II (Two) Requlatory Class: Product Code: 74 CAC Dated: January 7, 1999 Received: January 13, 1999
Dear Mr. Lariviere:
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 qeneral controls provisions of The general controls provisions of the Act include the Act. 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 Requlations, 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 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 Federal Reqister. 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.
4
Page 2 - Mr. Richard Lariviere
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 requlation (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 Other general information on your responsibilities under 807.97) . . 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, Ph.D.
Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE STATEMENT
Page 1 of 1
510(k) Number ( if known):
SmartCell™ Processing System Device Name:
The SmartCell™ Processing System is indicated for the processing of Indications for Use: autologous shed blood collected intraoperatively or postoperatively to obtain concentrated red blood cells for reinfusion
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Seve & Cooperle
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
10(k) Number .________________________________________________________________________________________________________________________________________________________________
Prescription Use ﺎ (Per 21 CFR 801.109) OR
Over-The-Counter Use