MAGELLAN RATIO DISPENSER KIT

K041830 · Medtronic Perfusion Systems · FMF · Sep 29, 2004 · General Hospital

Device Facts

• Record ID: K041830
• Device Name: MAGELLAN RATIO DISPENSER KIT
• Applicant: Medtronic Perfusion Systems
• Product Code: FMF · General Hospital
• Decision Date: Sep 29, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2

Intended 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.

Device Story

Magellan Ratio Dispenser Kit is a manual fluid application system used by surgeons in clinical settings. The device consists of a dispenser handle, plunger clip, dual-channel tip (spray or cannula), medicine cups, and two disposable piston syringes (12 cc and 1 cc). The system allows for the controlled delivery of fluids to soft tissue sites. It is a mechanical device requiring no external power or software. The surgeon operates the device to apply fluids as needed for tissue preparation. The device provides a manual method for dispensing, which assists the surgeon in preparing the surgical site for subsequent repair procedures.

Clinical Evidence

Bench testing only.

Technological Characteristics

Manual piston syringe system. Components include 12 cc and 1 cc disposable syringes, dispenser handle, plunger clip, dual-channel tip (spray or cannula), and medicine cups. Non-powered, mechanical device. Sterilization method not specified.

Indications for Use

Indicated for the application of fluids to facilitate soft tissue preparation prior to repair, as determined by a surgeon.

Regulatory Classification

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.

Predicate Devices

• Magellan Ratio Dispenser Kit (K020147)
• Harvest Technologies Dual Liquid Applicator (K020252)

Submission Summary (Full Text)

{0}------------------------------------------------

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 N<br>Minneapolis, Minnesota<br>55428-1088 U.S.A. |
| Telephone Number: | 763.391.9000 |
| Contact Person: | Bruce Backlund |
| Date Submission Prepared: | July 02, 2004 |
| <b>B. Device Information</b> | |
| Common or usual Name: | Syringe |
| Classification Name: | Piston Syringe |
| Predicate Device: | 1) Magellan Ratio Dispenser Kit,<br>Medtronic, Inc<br>K020147 - 04/03/2002<br><br>2) Harvest Technologies Dual Liquid Applicator,<br>Harvest Technologies<br>K020252 - 04/05/2002 |
| Device Description: | The Magellan Ratio Dispenser Kit consists of the<br>following components:<br>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:

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.

#### 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.

{2}------------------------------------------------

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.

{3}------------------------------------------------

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 [phone]. 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 [phone] or [phone] 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