MEDTRONIC MINIMED MMT-407C AMBULATORY INFUSION PUMP, MODEL MMT-407C

K040061 · Medtronic Minimed · FRN · Apr 8, 2004 · General Hospital

Device Facts

• Record ID: K040061
• Device Name: MEDTRONIC MINIMED MMT-407C AMBULATORY INFUSION PUMP, MODEL MMT-407C
• Applicant: Medtronic Minimed
• Product Code: FRN · General Hospital
• Decision Date: Apr 8, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Medtronic MiniMcd MicroMed 407C Drug Infusion Pump is indicated for infusion of medication labeled for subculancous and intratheral infusion. The pump is intended for therapies at set and variable rates, for therapies including, but not limited to chemotherapy, antibiotic therapy, and controlled analgesia.

Device Story

MicroMed 407C is a syringe-reservoir, rate-programmable external infusion pump. It delivers medication at set or variable rates for therapies such as chemotherapy, antibiotics, and analgesia. Operated by clinicians or patients under physician prescription; used in clinical or home settings. Device transforms programmed rate settings into mechanical infusion of medication via subcutaneous or intrathecal routes. Output is the controlled delivery of therapeutic agents. Benefits include precise, programmable medication administration for chronic or acute conditions.

Clinical Evidence

No clinical data provided; substantial equivalence is based on identical technological characteristics to the predicate device.

Technological Characteristics

Syringe-reservoir, rate-programmable external infusion pump. Supports subcutaneous and intrathecal infusion. No changes to technological features from predicate. Regulatory Class II, Product Code FRN.

Indications for Use

Indicated for patients requiring subcutaneous or intrathecal infusion of medications, including chemotherapy, antibiotics, and analgesics. Not indicated for blood product delivery. Restricted to prescription use.

Regulatory Classification

Identification

An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.

Predicate Devices

• Medtronic MiniMed Model 407C Medication Pump (K991013)
• SIMS Deltec CADD-Micro, Model 5900

Submission Summary (Full Text)

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

K040061

## Section D 510(k) Summary

In accordance with the requirements of SMDA 1990 and 21 CFR 807,92, this 510(k) Summary is provided:

Submitter: Medtronic MiniMed, 18000 Devonshire Street, Northridge CA 91325

Contact: Gerda Resch, Department Regulatory Affairs, [phone], [phone] (v/f)

Name of Device: MicroMed 407C

Predicate Device: Medtronic MiniMed Model 407C Medication Pump; and SIMS Deltec CADD-Micro, Model 5900

Description of the Device: The MicroMed 407C external pump is a syringe-reservoir, rate-programmable pump designed for infusion of medication labeled for subcutaneous and, intratheral infusion, at set and variable rates, as prescribed by the user's physician. The 407C is restricted to sale by or on the order of a physician, It is not intended nor indicated for the delivery of blood products. The principal features of the 407C Medication Pump also known as the MicroMed 407C described in this submission are:

The features of device that is the subject to this submission are identical to those of the predicate device (K991013). The only change is expansion of the indications for use to include intrathecal in fusion.

This change to the indications for use will have no untoward effect on the safety and effectiveness of the device.

Intended Use of the Device: The Medtronic MiniMcd MicroMed 407C Drug Infusion Pump is indicated for infusion of medication labeled for subculancous and intratheral infusion. The pump is intended for therapies at set and variable rates, for therapies including, but not limited to chemotherapy, antibiotic therapy, and controlled analgesia.

Comparison of the Technological Features of the Device and Predicate Devices: The technological features of the MicroMcd 407C do not differ from the previously cleared 407C Medication Pump. The MicroMed 407C is intended for infusion of medication labeled for subculaneous and intrathecal infusion, while the 407C Medication Pump is indicated for infusion labeled for subcutaneous administration only. The CADD-Micro, Model 5900 is intended for infusion of medication labeled for subcutanegus, intravenous, intra-arterial, intraperitoneal, intrathecal space, or subarachnoid space administration.

Verrn

Gerda Resch, MT (ASCP) RAC Manager, Regulatory Affairs Medtfonic MiniMed

3/24/05
Date

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

Image /page/1/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 8 2004

Mr. Gerda Resch, RAC Manager, Regulatory Affairs Medtronic MiniMed 18000 Devonshire Street Northridge, California 91325-1219

Re: K040061

Trade/Device Name: Medtronic Minimed Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: March 26, 2004 Received: March 29, 2004

Dear Ms. Resch:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the inclications for use stated in the enclosure) to legally marketed prodicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see ahove) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Ecderal Register.

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

Page 2 - Ms. Resch

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirence as lectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 vour 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,

JoH Waterhousn

UN.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

## INDICATIONS FOR USE

510(k) Number:

Device Name: MicroMed 407C

Indications For Use: The Medtronic MiniMed MicroMed 407C Drug Infusion Pump is inclicated for infusion of medication labeled subcutaneous and intrathecal infusion. The pump is intended for therapies at set and variable rates, for therapies including, but not limited to chemotherapy, antibiotic therapy, and controlled analgesia.

Prescription Use X (Per 21 CFR 801. Subpart D) or

Over-the-Counter Use (Pcr 21 CFR807 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jm On

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital,
Charline Control Dental Devices Division of Anesthesiology, De

510(k) Number: K1940061

CONFIDENTIAL

000009