MAGELLAN RATIO DISPENSER KIT/MAGELLAN SPRAY TIP/MAGELLAN CANNULA TIP

K020147 · Medtronic Perfusion Systems · FMF · Apr 3, 2002 · General Hospital

Device Facts

• Record ID: K020147
• Device Name: MAGELLAN RATIO DISPENSER KIT/MAGELLAN SPRAY TIP/MAGELLAN CANNULA TIP
• Applicant: Medtronic Perfusion Systems
• Product Code: FMF · General Hospital
• Decision Date: Apr 3, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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).

Device Story

Magellan Ratio Dispenser Kit consists of 12cc and 1cc disposable piston syringes, dispenser handle, plunger clip, dual-channel tip (spray or cannula), and two medicine cups. Device facilitates simultaneous delivery of two non-homogenous liquids to a specific treatment site. Operated by clinician; used in clinical settings. Mechanical design ensures proportional delivery of two fluids through a single dual-channel tip. Benefits include precise, simultaneous application of dual-component substances.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Manual piston syringe-based dispenser. Components include 12cc and 1cc disposable syringes, handle, plunger clip, and dual-channel tip. Materials, design, and sterilization methods are consistent with legally marketed predicate devices.

Indications for Use

Indicated for users requiring simultaneous delivery of two non-homogenous liquids to a single treatment area.

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

• Surgical Sealant Applicator, Micromedics, Inc (K883338)
• Harvest Technologies Dual Liquid Applicator, Harvest Technologies (K000456)

Submission Summary (Full Text)

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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).

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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 [phone]. Additionally, for devices), please contact the example of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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 ________________________________________________________________________________________________________________________________________________________________