The Magellan™ Ratio Dispenser Kit is intended for the application of fluids, as deemed necessary by the surgeon's determination of the clinical use requirements, to facilitate the preparation of soft tissue prior to repair.

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

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Magellan Ratio Dispenser Kit." This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed de novo clinical study with specific acceptance criteria and performance data.

Therefore, many of the requested categories for device performance and study design cannot be fully addressed from the provided text. The document explicitly states that the performance data is unchanged from the predicate device (K020147). This indicates that no new, independent study was conducted for this specific 510(k) submission to establish new performance criteria.

Here's a breakdown of what can and cannot be extracted:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in the provided text. In a 510(k) for a device like this, acceptance criteria would typically revolve around demonstrating that the device performs as intended and is as safe and effective as the predicate. This would likely involve testing of material compatibility, sterility, dispensing accuracy (if applicable), and mechanical integrity. However, specific quantitative targets are not given.
Reported Device Performance: Not reported as new data for this submission. The text states: "Performance data that supports the safety and effectiveness of the use of Magellan Ratio Dispenser Kit is included in the submission. This data is unchanged from the predicate, which is our currently marketed Magellan Ratio Dispenser kit (K020147)." This implies that the performance established for the prior K020147 device is being referenced. Without access to the K020147 submission, specific performance metrics for this device cannot be outlined here.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified for this submission. Since the performance data is stated to be "unchanged from the predicate," this information would reside within the K020147 submission.
Data Provenance: Not specified for this submission. As above, this information would be tied to the predicate device's performance data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This type of information is typically relevant for studies involving subjective interpretation (e.g., medical imaging, pathology slides). The Magellan Ratio Dispenser Kit is a mechanical device for fluid application, not an interpretative diagnostic tool. Its performance would be evaluated through engineering and functional testing rather than expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. See explanation for #3.

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 mechanical fluid dispenser, not an AI-assisted diagnostic or interpretative tool. MRMC studies are used for evaluating reader performance in diagnostic accuracy tasks.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a mechanical device, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. For a device of this nature, "ground truth" would be objective measurements of its mechanical and functional performance (e.g., fluid volume dispensed, spray pattern consistency, material integrity, sterility).

8. The sample size for the training set

Not applicable. This is a mechanical device, not an AI/ML model that requires a "training set."

9. How the ground truth for the training set was established

Not applicable. See explanation for #8.

Summary of what is known from the provided text:

Device Name: Magellan Ratio Dispenser Kit
Indications for Use: "The Magellan™ Ratio Dispenser Kit is intended for the application of fluids, as deemed necessary by the surgeon's determination of the clinical use requirements, to facilitate the preparation of soft tissue prior to repair."
Predicate Devices:
1. Magellan Ratio Dispenser Kit, Medtronic, Inc (K020147 - 04/03/2002)
2. Harvest Technologies Dual Liquid Applicator, Harvest Technologies (K020252 - 04/05/2002)
Performance Data: The submission states that performance data supports safety and effectiveness, and this data is "unchanged from the predicate, which is our currently marketed Magellan Ratio Dispenser kit (K020147)." This implies that the current submission relies on the existing performance data of the K020147 device to demonstrate substantial equivalence, rather than providing new performance studies.
Basis for Substantial Equivalence: Product design, materials, packaging, and sterilization are considered substantially equivalent to the predicate devices.

Summary

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K041830 1/2

SEP 2 9 2004

510(k) Summary

(as required by 21 CFR 807.92)

A. Submitter Information

Submitter's Name:	Medtronic Perfusion Systems
Address:	7611 Northland Drive NMinneapolis, Minnesota55428-1088 U.S.A.
Telephone Number:	763.391.9000
Contact Person:	Bruce Backlund
Date Submission Prepared:	July 02, 2004
B. Device Information
Common or usual Name:	Syringe
Classification Name:	Piston Syringe
Predicate Device:	1) Magellan Ratio Dispenser Kit,Medtronic, IncK020147 - 04/03/20022) Harvest Technologies Dual Liquid Applicator,Harvest TechnologiesK020252 - 04/05/2002
Device Description:	The Magellan Ratio Dispenser Kit consists of thefollowing components:12 cc legally marketed disposable piston syringe1 cc legally marketed disposable piston syringeDispenser HandlePlunger clipDual channel tip (spray or cannula)Two medicine cups

{1}------------------------------------------------

K041830 2/2

Indications for Use:

C. Comparison of Required Technological Characteristics

The technological characteristics of the Magellan™ Ratio Dispenser Kit are substantially equivalent to the predicate devices 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. This data is unchanged from the predicate, which is our currently marketed Magellan Ratio Dispenser kit (K020147).

E. 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/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized image of a caduceus, a symbol often associated with medicine and healthcare. The caduceus features a staff with two snakes entwined around it, topped with a pair of wings.

SEP. 2 9 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Bruce Backlund Senior Regulatory Affairs Specialist Medtronic Perfusion Systems 7611 Northland Drive N Minneapolis, Minnesota 55428

Re: K041830

K641656
Trade/Device Name: Magellan Ratio Dispenser Kit Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: II Product Code: FMF Dated: July 2, 2004 Received: July 7, 2004

Dear Mr. Backlund:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 310(x) premaint is substantially equivalent (for the indications
referenced above and have determined the device is substanted in interstate referenced above and nave uelemined the devices marketed in interstate for use stated in the enclosure) to tegally manced produced Device Amendments, or to
commerce prior to May 28, 1976, the enactment of the Medical of the Federal Food. Drug. commerce prior to May 28, 1970, the charger with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval assesses provisions of the Act . The and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The Act. The
You may, therefore, market the device, subject to the general controls prov You may, therefore, market the device, subject to the general registration, listing of
general controls provisions of the Act include required withings arginst misbranding a general controls provisions of the Act mender requirements of the management misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see aover) mis Cities in expeculations affecting your device can
may be subject to such additional controls. Existing major regulations EDA I may be subject to such additional controlist Extrume major s 99% In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to Register be found in the Code of Peacharies, oncerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualice or a substitive requirements of the Act
that FDA has made a determination that your device complies with of che must that FDA has made a delefinination that your as research agencies. You must and or any Federal statutes and regulations and unities to: registration and listing (21 l
comply with all the Act's requirements, including, but not be registration and listing comply with all the Act S requirements, meriams, wartice requirements as set
CFR Part 807); labeling (21 CFR Part 801); end if smileshle, the electronic CFR Part 807); labemig (21 CFR Part 001); good and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, 1000-1050 forth in the quality systems (QD) regulation (21-55-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Bruce Backlund

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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.

Sincerely yours,

for

Mark N. Maffern

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number (if known): K041830 Device Name: Magellan Ratio Dispenser Kit Indications For Use: Indications For OSC.
The Magellan Ratio Dispenser Kit is intended for the application of fluids, as deemed I he Mageltan' Rano Dispenser III is the clinical use requirements, to facilitate the preparation of soft tissue prior to repair.

AND/OR Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(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 General, Restorative,
and Neurological Devices

Page 1 of __

510(k) Number. K041830

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).