(32 days)
The Harvest SmartPReP™ CENTRIFUGE SYSTEM is designed to be used in the clinical laboratory or intraoperatively at point-of-care for the safe and rapid preparation of platelet poor plasma and platelet concentrate from a small sample of blood. The plasma and concentrated platelets produced can be used for diagnostic tests.
SmartPReP Centrifuge System: Includes a table-top, self-decanting, swinging bucket centrifuge and processing disposable designed to allow for rapid automatic separation of plasma and platelets. The centrifuge spins at a maximum speed of 6000 rpms at a maximum force of approximately 3550g.
Here is an analysis of the provided text regarding the Harvest Technologies SmartPReP Centrifuge System:
1. A table of acceptance criteria and the reported device performance
Based on the provided text, the submission focuses on demonstrating substantial equivalence to a predicate device rather than defining specific acceptance criteria for performance metrics (e.g., specific platelet concentration levels or plasma purity). The "Substantial Equivalence" section states: "The proposed device is substantially equivalent to other table-top centrifuges previously cleared by the FDA via the 510(k) Notification process."
The table below summarizes the comparison of features between the SmartPReP and the predicate centrifuge, effectively acting as the "acceptance criteria" here, where "reported device performance" means demonstrating that the SmartPReP possesses these characteristics as intended.
| Feature | Acceptance Criteria (Predicate Device Characteristic) | Reported Device Performance (SmartPReP Characteristic) |
|---|---|---|
| Principle of Operation | Separation based on density of liquids | Separation based on density of liquids |
| Table-Top | Yes | Yes |
| Refrigerated | No | No |
| Swinging Bucket | Yes | Yes |
| Automatic Decanting | No | Yes |
| Micro-processor Controlled | Yes | Yes |
| User Programmable | Yes | No, program set by manufacturer |
| Speed Control | Selectable | Preset |
| Acceleration and Braking | Current-controlled | Current-controlled |
| Maximum RPM | 4000 RPM | 6000 RPM |
| Maximum RCF | 3077 g | 3550 g |
| Tube Capacity | Variety of sizes and volumes up to 250mL | Two Processing Disposables (50 mL/disposable) |
| Lid Locking, Lid Holding | Yes | Yes |
| Imbalance Detector | Yes | Yes |
| Construction | Anti-torsion construction, metal housing and rotor | Anti-torsion construction, metal housing and rotor |
Notes on Acceptance Criteria:
- The primary "acceptance criterion" for a 510(k) is demonstrating substantial equivalence to a legally marketed predicate device. This is achieved by showing similar intended use, technological characteristics, and safety and effectiveness.
- For quantitative features like 'Maximum RPM' and 'Maximum RCF', the SmartPReP exceeds the predicate, which is generally acceptable as long as it doesn't raise new questions of safety or effectiveness.
- For differences like 'Automatic Decanting', 'User Programmable', and 'Speed Control', the submission implicitly argues that these differences do not alter the fundamental mechanism of action or intended use in a way that would require new clinical data or raise significant safety concerns.
2. Sample size used for the test set and the data provenance
The provided 510(k) summary does not contain information about a test set with a specific sample size, data provenance, or a study to prove performance against specific clinical or analytical targets. The submission is a comparison of technological characteristics to a predicate device, not a performance study with a test set of samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As noted above, there is no mention of a test set or ground truth established by experts in this submission.
4. Adjudication method for the test set
Not applicable. There is no mention of a test set or adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a centrifuge for preparing blood components, not an AI-assisted diagnostic device that would involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical centrifuge, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. This submission is based on a comparison of engineering and design characteristics to a predicate device, not on clinical performance data requiring a ground truth.
8. The sample size for the training set
Not applicable. This device is a centrifuge, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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MAY 2 8 1999
510(k) Summary for the Harvest Technologies SmartPReP Centrifuge System
| 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: | April 22, 1999 |
| Device Trade Name: | SmartPRePTM Centrifuge System |
| Common name: | General Purpose Centrifuge for Clinical Use |
| Classification Name: | General purpose laboratory equipment labeled orpromoted for a specific medical use (21 CFR862.2050) |
| Substantial Equivalence: | The proposed device is substantially equivalentto other table-top centrifuges previously clearedby the FDA via the 510(k) Notification process |
| Device Description: | SmartPReP Centrifuge System: Includes atable-top, self-decanting, swinging bucketcentrifuge and processing disposable designed toallow for rapid automatic separation of plasmaand platelets. The centrifuge spins at amaximum speed of 6000 rpms at a maximumforce of approximately 3550g. |
| Intended Use: | The Harvest SmartPReP Centrifuge System isdesigned to be used in the clinical laboratory orintraoperatively at point-of-care for the safe andrapid preparation of platelet poor plasma andplatelet concentrate from a small sample ofblood. |
| Technological Characteristics: | The proposed device has the same technologicalcharacteristics and is similar in design andconfigurations compared with the predicatedevice (See Table 6-1). |
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TABLE 6-1
COMPARISON OF THE HARVEST SMARTPReP AND PREDICATE CENTRIFUGES
| Features | SmartPReP(This Submission) | Predicate Centrifuge |
|---|---|---|
| Principle of Operation | Separation based on density of liquids | Separation based on density of liquids |
| Table-Top | Yes | Yes |
| Refrigerated | No | No |
| Swinging Bucket | Yes | Yes |
| Automatic Decanting | Yes | No |
| Micro-processor Controlled | Yes | Yes |
| User Programmable | No, program set by manufacturer | Yes |
| Speed Control | Preset | Selectable |
| Acceleration and Braking | Current-controlled | Current-controlled |
| Maximum RPM | 6000 RPM | 4000 RPM |
| Maximum RCF | 3550 g | 3077 g |
| Tube Capacity | Two Processing Disposables(50 mL/disposable) | Variety of sizes and volumesup to 250mL |
| Lid Locking, Lid Holding | Yes | Yes |
| Imbalance Detector | Yes | Yes |
| Construction | Anti-torsion construction, metal housing and rotor | Anti-torsion construction, metal housing and rotor |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 28 1999
Richard Lariviere Operations Manager HARVEST TECHNOLOGIES CORPORATION 77 Accord Park Drive, D-7 Norwell, MA 02061
Re: K991430 Trade Name: SmartPREP Centrifuge System Requlatory Class: I Product Code: JQC April 23, 1999 Dated: Received: April 26, 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 general controls The general controls provisions of the provisions of the Act. Act include requirements for annual registration, 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 Regulations, 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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. this response to your premarket notification Please note: 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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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. 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"(21 CFR 807.97). Other general information on your responsibilities under 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,
Steven Putman
Steven I. Gutman, M.D. M.B.A. Director Division of Clinical Laboratory 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):
Harvest Technologies SmartPRePTM Centrifuge System Device Name:
The Harvest SmartPReP™ CENTRIFUGE SYSTEM is designed to be Indications for Use: used in the clinical laboratory or intraoperatively at point-of-care for the safe and rapid preparation of platelet poor plasma and platelet concentrate from a small sample of blood.
The plasma and concentrated platelets produced can be used for diagnostic tests.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jiter E. Malin
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
t
§ 862.2050 General purpose laboratory equipment labeled or promoted for a specific medical use.
(a)
Identification. General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use.(b)
Classification. Class I (general controls). The device is identified in paragraph (a) of this section and is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.