(63 days)
Not Found
No
The description focuses on a microprocessor-controlled centrifuge for blood separation and does not mention any AI or ML capabilities.
No.
The device prepares platelet-poor plasma and platelet concentrate for diagnostic tests, not for direct therapeutic application to a patient.
No
The device is described as a system for preparing platelet poor plasma and platelet concentrate from a blood sample. While the resulting plasma and platelets can be used for diagnostic tests, the device itself performs preparation, not diagnosis.
No
The device description explicitly states it consists of a "microprocessor controlled table-top centrifuge and processing disposables," indicating it includes significant hardware components beyond just software.
Based on the provided information, the Magellan™ Autologous Platelet Separator System is not an IVD (In Vitro Diagnostic) device itself, but it produces materials that can be used for diagnostic tests.
Here's why:
- Intended Use: The intended use states that the plasma and concentrated platelets produced can be used for diagnostic tests. This indicates the output of the device is a component or sample for diagnostics, not the diagnostic test itself.
- Device Description: The device is described as a centrifuge and processing disposables for separating blood components. This is a sample preparation device, not a device that performs a diagnostic test on a sample.
- Lack of Diagnostic Function: There is no mention of the device performing any analysis, measurement, or interpretation of the blood components to diagnose a condition.
In summary: The Magellan™ Autologous Platelet Separator System is a sample preparation device that provides materials (plasma and platelet concentrate) that are then used in separate IVD tests.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FMF, JQC
Device Description
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.
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
clinical laboratory or intraoperatively at point of care
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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 N |
| Minneapolis, 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 or |
| promoted for a specific medical use (21 CFR | |
| 862.2050) | |
| Predicate Device: | SmartPREPTM Centrifuge System |
| Harvest Technologies Corp. | |
| K991430 - 05/28/1999 | |
| Device Description: | 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. | |
| Indications for Use: | 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. |
1
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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2
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 Children
CHECK CHE COLLECT COLLECTION CONTRACT COLLECTION CONTRACT CARDER COLLECTION CONTRACT CARDER COLLECTION CONTRACT CARDER COLLECTION CONTRACT CARACT CARACT CARACT CARACT CARACT |
| ---------------------------------------------------------------------- | -- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
| 510(k) Number (if known): | K021902 |
|---|---|
| --------------------------- | --------- |
Device Name:
Indications for Use:
。
:
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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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) |
|------------------------------------------|-----------------------------------------------------|
| ✓ | |