(214 days)
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.
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.
The provided text describes a 510(k) summary for the Harvest Technologies SmartCell Processing System. This document focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study proving the device meets those criteria.
Therefore, many of the requested categories cannot be fully answered from the provided text.
Here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Expected Output: Hematocrit equivalent to predicate device | Achieved: "a packed red cell product with a hematocrin... equivalent to that of the predicate device." |
| Expected Output: Anticoagulant washout equivalent to predicate device | Achieved: "a packed red cell product with... anticoagulant washout equivalent to that of the predicate device." |
| Expected Output: Biocompatibility | Achieved: "biocompatibility evaluation of the disposable set has been performed to demonstrate substantial equivalence." |
| Expected Output: Electrical Safety | Achieved: "electrical safety testing... has been performed to demonstrate substantial equivalence." |
| Missing: Quantitative targets for hematocrit, anticoagulant washout, biocompatibility, and electrical safety. The text only states "equivalent." | Missing: Specific numerical results for hematocrit, anticoagulant washout, and other performance metrics. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in the provided text. The text mentions "In vitro blood quality studies" but does not give a sample size.
- Data Provenance: Not specified. It's implied to be laboratory-based ("In vitro blood quality studies"), but country of origin or whether it's retrospective/prospective is not mentioned.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Number of Experts: Not applicable/Not mentioned. The study described is an in vitro blood quality study comparing the device's output to a predicate device, not involving expert interpretation of medical images or conditions to establish ground truth.
- Qualifications of Experts: Not applicable/Not mentioned.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable/Not mentioned. This typically refers to resolving disagreements among experts when establishing ground truth, which is not relevant for the type of study described here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- MRMC Study: No, an MRMC study was not done. The described studies are in vitro comparisons of blood product quality and safety, not studies involving human readers or comparative effectiveness in a clinical setting with AI assistance.
- Effect Size of AI Improvement: Not applicable.
6. If a Standalone (algorithm only without human-in-the-loop performance) study was done:
- Standalone Study: Yes, in a way. The studies described (in vitro blood quality, electrical safety, biocompatibility) are assessing the device's performance directly, independent of a human operator's assessment of its output in a diagnostic context. However, it's not an "algorithm-only" study in the typical AI sense, as the device is a mechanical processing system.
7. The Type of Ground Truth Used:
- Type of Ground Truth: The "ground truth" implicitly used is the performance of the legally marketed predicate device (Haemonetics Cell Saver 5 Autotransfusion System) for metrics like hematocrit and anticoagulant washout. For safety aspects, standard regulatory testing for biocompatibility and electrical safety would serve as the "ground truth" for compliance.
8. The Sample Size for the Training Set:
- Sample Size for Training Set: Not applicable. This device is a mechanical processing system and does not rely on machine learning or AI models with training data in the traditional sense that would require a "training set."
9. How the Ground Truth for the Training Set was established:
- How Ground Truth for Training Set was Established: Not applicable, as there is no training set in the context of this device.
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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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2 1000
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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. |
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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 (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
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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
§ 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).