(77 days)
Not Found
No
The device description and intended use focus on the mechanical delivery of two liquids. There is no mention of AI, ML, image processing, or data-driven decision making.
No
The device is intended to assist in delivering two non-homogenous liquids to a treatment area, which is a delivery mechanism, not a therapeutic action itself. It is also compared to predicate devices like "Surgical Sealant Applicator" and "Dual Liquid Applicator," reinforcing its function as a tool for application.
No
The device is described as assisting in simultaneously delivering two non-homogenous liquids to a treatment area, which points to a therapeutic or delivery function rather than a diagnostic one. Its components and intended use do not suggest any form of detection, analysis, or diagnosis of a condition. Furthermore, the absence of mentions of image processing, AI, or performance metrics related to diagnostic accuracy supports this conclusion. The predicate devices are also applicators rather than diagnostic tools.
No
The device description lists multiple physical components (syringes, dispenser handle, plunger clip, dual channel tip, medicine cups), indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "assist the user in simultaneously delivering two non-homogenous liquids to the same treatment area(s)." This describes a device used for applying substances directly to a patient or treatment site, not for testing samples in vitro (outside the body).
- Device Description: The components listed (syringes, dispenser handle, tip, cups) are consistent with a device used for dispensing liquids, not for performing diagnostic tests on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on testing.
Therefore, the Medtronic Magellan™ Ratio Dispenser Kit is a device for delivering liquids, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Medtronic Magellan™ Ratio Dispenser Kit including tip is intended to assist the user in simultaneously delivering two non-homogenous liquids to the same treatment area(s).
Product codes
FMF
Device Description
The Magellan Ratio Dispenser Kit consists of the following components: 12 cc legally marketed disposable piston syringe, 1 cc legally marketed disposable piston syringe, Dispenser Handle, Plunger clip, Dual channel tip (spray or cannula), Two medicine cups.
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
user
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 Ratio Dispenser Kit is included in the submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).
0
Appendix II
APR 0 3 2002
510(k) Summary (as required by 21 CFR 807.92)
Submitter Information A.
Medtronic Perfusion Systems Submitter's Name: 7611 Northland Drive N Address: Minneapolis, Minnesota 55428-1088 U.S.A. 763.391.9000 Telephone Number: Contact Person: Lucy Tan Date Submission Prepared: January 15, 2002 B. Device Information Syringe Common or usual Name: Piston Syringe Classification Name: Predicate Device: 1) Surgical Sealant Applicator, Micromedics, Inc K883338 - 8/23/1988 2) Harvest Technologies Dual Liquid Applicator, Harvest Technologies K000456 - 6/1/2000 Device Description: The Magellan Ratio Dispenser Kit consists of the following components: 12 cc legally marketed disposable piston syringe I 트 1 cc legally marketed disposable piston syringe l Dispenser Handle 1 Plunger clip 1 Dual channel tip (spray or cannula) 할 Two medicine cups The Magellan Ratio Dispenser kit is intended to Indications for Use: assist the user in simultaneously delivery two nonhomogeneous liquids to the same treatment area(s).
Page 27 of 28
1
Comparison of Required Technological Characteristics C.
The technological characteristics of the Magellan™ Ratio Dispenser Kit are substantially equivalent to the predicate device including product design, materials, packaging, and sterilization.
D. Performance Data
Performance data that supports the safety and Effectiveness of the use of Magellan Ratio Dispenser Kit is included in the submission.
D. Conclusion
Medtronic Perfusion Systems considers the Magellan Ratio Dispenser Kit to be substantially equivalent to the noted predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, composed of three wavy lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lucy Tan Senior Product Regulations Manager Medtronic Perfusion Systems 7611 Northland Drive N Minneapolis, Minnesota 55428
APR 0 3 2002
Re: K020147
Trade/Device Name: Magellan™ Ratio Dispenser Kit Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: January 15, 2002 Received: January 16, 2002
Dear Ms. Tan:
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 provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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
3
Page 2 - Ms. Tan
Current Good Manufacturing Practice requirements, as set forth in the Quality System Current Good Manafacture : General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug the Own Tegulation may room in reguration.
Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does r coord regions for gotion you might have under sections 531 through 542 of the Act for not arry our gareen you Product Radiation Control provisions, or other Federal Laws or Regulations.
This letter will allow you to begin marketing your device as described in your 510(k) Finis letter will anow your be obja. finding of substantial equivalence of your device to a premative notification. - 11 device results in a classification for your device and thus, permits legally maxted proceed to the market. If you desire specific advice for your device on the your device to proved to and additionally 809.10 for in vitro diagnostic laboring regaration (2) Che Office of Compliance at (301) 594-4618. Additionally, for devices), please contact the example of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by compliante at (2017) 21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Icsponsional 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
Kittatrud
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page __ 1
510(k) Number (if known): K 020 147
Device Name: Magellan™ Ratio Dispenser Kit
Indications for Use:
The Medtronic Magellan™ Ratio Dispenser Kit including tip is intended to assist the user in simultaneously delivering two non-homogenous liquids to the same treatment area(s).
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)
Palutto Lucente
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Dev 510(k) Number ________________________________________________________________________________________________________________________________________________________________