(63 days)
The Magellan™ Autologous Platelet Separator 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 (platelet rich plasma) from a small sample of blood. The plasma and concentrated platelets produced can be used for diagnostic tests.
Magellan Autologous Platelet Separator system consists of a microprocessor controlled table-top centrifuge and processing disposables designed to allow for safe and rapid automatic separation of plasma and platelets. The centrifuge spins at a maximum speed of 3800 rpms at the maximum g-force of approximately 1300g.
The Magellan™ Autologous Platelet Separator System is a general-purpose centrifuge for clinical use, designed for the safe and rapid preparation of platelet poor plasma and platelet concentrate from a small blood sample for diagnostic tests.
Here's an analysis of the provided information, addressing your questions:
1. Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly list numerical acceptance criteria or detailed device performance metrics (e.g., platelet yield, purity, processing time) in a table format. It states that "Performance data that supports the safety and effectiveness of the use of Magellan Autologous Platelet Separator System is included in this 510(k) premarket notification." However, this data itself is not presented in the provided text excerpts.
The conclusion states: "Magellan Autologous Platelet Separator System is substantially equivalent to the noted predicate device based on the similarities of technological characteristics, the identical indications for use and the results of performance comparative testing." This implies that the device's performance was compared to the predicate SmartPREPTM Centrifuge System (K991430) and found to be substantially equivalent, meaning it meets the performance expectations set by the predicate device for its intended use.
Therefore, for this specific submission, the "acceptance criteria" appear to be meeting or demonstrating equivalence to the predicate device's performance as established in its prior clearance. Without access to the full 510(k) submission, specific quantitative acceptance criteria cannot be provided.
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It simply mentions "performance comparative testing" was conducted.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable as the device is a centrifuge for separating blood components, not an AI or diagnostic device that requires expert ground truth for interpretation of images or patient data. Its performance is assessed through laboratory metrics of separation efficiency and product quality.
4. Adjudication Method
This information is not applicable for the reasons stated above (not an AI/diagnostic device requiring expert interpretation).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable. The device is a medical instrument (centrifuge) for preparing blood components, not a medical imaging or diagnostic AI tool that would typically involve human readers for interpretation.
6. Standalone Performance Study
Yes, a standalone performance assessment was conducted for the device. The summary states: "Performance data that supports the safety and effectiveness of the use of Magellan Autologous Platelet Separator System is included in this 510(k) premarket notification." The conclusion further confirms that the device was deemed substantially equivalent based on "results of performance comparative testing." This indicates that the device's ability to separate plasma and platelets was evaluated independently. However, the details of this study (e.g., specific metrics, experimental design) are not provided in the given text.
7. Type of Ground Truth Used
The "ground truth" for this type of device would typically involve established laboratory methods for:
- Platelet count: To determine platelet yield in the concentrate and platelet removal in the plasma.
- White Blood Cell (WBC) count: To assess the purity of the platelet concentrate (i.e., minimal WBC contamination).
- Red Blood Cell (RBC) count/hematocrit: To assess red cell contamination in the plasma and platelet concentrate.
- Volume measurements: To determine recovery efficiency.
These would be measured using standard clinical laboratory analyzers and techniques. The goal is to demonstrate that the device effectively separates blood components into platelet-rich plasma and platelet-poor plasma, meeting predefined biological and physical parameters.
8. Sample Size for the Training Set
This information is not applicable. The Magellan Autologous Platelet Separator System is a physical device (centrifuge) with automated processing, not an AI/machine learning algorithm that requires a "training set" in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated above.
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AUG 1 2 2002
Appendix II
510(k) Summary Magellan™ Autologous Platelet Separator System (as required by 21 CFR 807.92)
Submitter Information A.
| Submitter's Name: | Medtronic Perfusion Systems |
|---|---|
| Address: | 7611 Northland Drive NMinneapolis, Minnesota 55428-1088 U.S.A. |
| Telephone Number: | 763.391.9000 |
| Contact Person: | Lucy Tan |
| Date Submission Prepared: | June 07, 2002 |
| B. Device Information | |
| Device Trade Name: | Magellan™ Autologous Platelet Separator System |
| Common or usual Name: | General Purpose Centrifuge for Clinical Use |
| Classification Name: | General purpose laboratory equipment labeled orpromoted for a specific medical use (21 CFR862.2050) |
| Predicate Device: | SmartPREPTM Centrifuge SystemHarvest Technologies Corp.K991430 - 05/28/1999 |
| Device Description: | Magellan Autologous Platelet Separator systemconsists of a microprocessor controlled table-topcentrifuge and processing disposables designed toallow for safe and rapid automatic separation ofplasma and platelets. The centrifuge spins at amaximum speed of 3800 rpms at the maximum g-force of approximately 1300g. |
| Indications for Use: | The Magellan Autologous Platelet SeparatorSystem is designed to be used in the clinicallaboratory or intraoperatively at point of care for thesafe and rapid preparation of platelet poor plasmaand platelet concentrate (platelet rich plasma) froma small sample of blood. |
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C. Comparison of Required Technological Characteristics
The technological characteristics of the Magellan Platelet Separator system are substantially equivalent to the noted predicate device.
D. Performance Data
Performance data that supports the safety and effectiveness of the use of Magellan Autologous Platelet Separator System is included in this 510(k) premarket notification.
D. Conclusion
Magellan Autologous Platelet Separator System is substantially equivalent to the noted predicate device based on the similarities of technological characteristics, the identical indications for use and the results of performance comparative testing.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of three abstract human figures, possibly representing a family or community, with their heads overlapping and facing to the right.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 1 2 2002
Ms. Lucy Tan Senior Regulatory Affairs Specialist Medtronic Perfusion Systems 7611 Northland Drive N. Minneapolis, Minnesota 55428-1088
Re: K021902
Trade/Device Name: Magellan™ Autologous Platelet Separator System Regulation Number: 21 CFR § 862.2050 Regulation Name: General purpose laboratory equipment labeled or promoted for a specific medical use Regulatory Class: II Product Code: FMF, JQC Dated: June 7, 2002 Received: June 10, 2002
Dear Ms. Tan:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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); 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.
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Page 2
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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer 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 Sutman
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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Appendix III Indications for Use Statement
| -------------------------------------------------------------------- | The Comments of ChildrenCHECK CHE COLLECT COLLECTION CONTRACT COLLECTION CONTRACT CARDER COLLECTION CONTRACT CARDER COLLECTION CONTRACT CARDER COLLECTION CONTRACT CARACT CARACT CARACT CARACT CARACT | |
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| 510(k) Number (if known): | K021902 |
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| --------------------------- | --------- |
Device Name:
Indications for Use:
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The Magellan™ Autologous Platelet Separator 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 (platelet rich plasma) from a small sample of blood. The plasma and concentrated platelets produced can be used for diagnostic tests.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K021902 |
| Prescription Use(Per 21 CFR 801.109) | OR Over-The-Counter Use(Optional Format 1-2-96) |
|---|---|
| ✓ |
§ 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.