SMARTCELL PROCESSING SYSTEM

K983022 · Harvest Technologies, LLC · CAC · Apr 2, 1999 · Anesthesiology

Device Facts

• Record ID: K983022
• Device Name: SMARTCELL PROCESSING SYSTEM
• Applicant: Harvest Technologies, LLC
• Product Code: CAC · Anesthesiology
• Decision Date: Apr 2, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5830
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

SmartCell Processing System concentrates autologous shed blood for reinfusion. System comprises reusable SC-1000 hardware and sterile, disposable SCP-1500 Process Pack. Hardware includes pumps, fluid sensors, optics, and drain controls. Operation involves non-mechanical, accelerated gravitational sedimentation using 6% hydroxyethyl starch (HES) to promote red cell aggregation (rouleaux). System monitors disposable installation and sedimentation process via electronic components and software. Output is packed red cell product with hematocrit and anticoagulant washout levels comparable to predicate devices. Used in clinical settings (intraoperative/postoperative) by trained personnel. Benefits patient by providing concentrated autologous red blood cells, reducing need for allogeneic transfusion.

Clinical Evidence

Bench testing only. In vitro blood quality studies were performed to compare the hematocrit and anticoagulant washout of the red cell product produced by the SmartCell system against the predicate device. Biocompatibility evaluation and electrical safety testing were also conducted.

Technological Characteristics

Non-mechanical, accelerated gravitational sedimentation using 6% hydroxyethyl starch (HES). System includes SC-1000 hardware (pumps, sensors, optics) and SCP-1500 disposable process pack. Software monitors disposable installation and sedimentation process. Biocompatible materials used in disposable set.

Indications for Use

Indicated for processing autologous shed blood collected intraoperatively or postoperatively to obtain concentrated red blood cells for reinfusion in patients requiring autotransfusion.

Regulatory Classification

Identification

An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.

Predicate Devices

• Haemonetics Cell Saver 5 Autotransfusion System

Submission Summary (Full Text)

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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.

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# 510(k) Summary for the Harvest Technologies

| Submitter's Name and Address: | Harvest Technologies Corp.<br>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: <p> 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. </p> <p> 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. </p> |

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#### 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.

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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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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#### INDICATIONS FOR USE STATEMENT

Page 1 of 1

510(k) Number ( if known):

K983022

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