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).

Device Description

The Magellan Ratio Dispenser Kit consists of the following components: 12 cc legally marketed disposable piston syringe 1, 1 cc legally marketed disposable piston syringe 1, Dispenser Handle 1, Plunger clip 1, Dual channel tip (spray or cannula) 1, Two medicine cups.

AI/ML Overview

The provided text is a 510(k) summary for the Medtronic Magellan™ Ratio Dispenser Kit. It explicitly states that performance data supporting the safety and effectiveness of the device is included in the submission but does not detail the acceptance criteria or the specific study that proves the device meets those criteria.

Based on the information provided, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated in the provided text.
Reported Device Performance: Not explicitly stated in the provided text. The document broadly states "Performance data that supports the safety and Effectiveness of the use of Magellan Ratio Dispenser Kit is included in the submission." without providing any specifics.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not specified.
Data Provenance: Not specified.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications:

Number of Experts: Not applicable, as no ground truth establishment is described for a test set.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

Not applicable, as no test set evaluation with adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Study Conducted: No MRMC study is mentioned.
Effect Size: Not applicable.

6. Standalone Performance Study (Algorithm Only):

Study Conducted: This device is a physical medical device (syringe dispenser kit), not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable. The performance data would relate to the physical and functional aspects of the dispenser.

7. Type of Ground Truth Used:

Not applicable, as the document refers to performance data for a physical device, not an AI algorithm requiring ground truth in the typical sense (e.g., expert consensus, pathology for diagnostic tasks). Performance data for such a device would likely involve measurements of dispensing accuracy, consistency, ease of use, material compatibility, etc.

8. Sample Size for the Training Set:

Not applicable. This is a physical medical device, not an AI model requiring a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable.

Summary of Missing Information:

The provided 510(k) summary is a high-level overview. It declares that performance data exists and supports the substantial equivalence claim but does not provide any specifics regarding:

The actual performance criteria the device was intended to meet.
The results of any performance testing in quantitative terms.
Details about the studies conducted (e.g., design, sample sizes, methodology, data sources).

To obtain this detailed information, one would typically need to review the full 510(k) submission document, which is generally not publicly available in its entirety but summarized in documents like this. The 510(k) summary is designed to provide just enough information to support the substantial equivalence claim without revealing proprietary details of the tests.

Summary

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K020147

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

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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.

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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

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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

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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 ________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 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).