MEDTRONIC MICROMED 407C INFUSION PUMP, MODEL MMT-407C

K043600 · Medtronic Minimed · FRN · Mar 29, 2005 · General Hospital

Device Facts

• Record ID: K043600
• Device Name: MEDTRONIC MICROMED 407C INFUSION PUMP, MODEL MMT-407C
• Applicant: Medtronic Minimed
• Product Code: FRN · General Hospital
• Decision Date: Mar 29, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Medtronic MiniMed MicroMed 407C Drug Infusion Pump is indicated for influsion of medication labeled for subcutaneous, and intrather an intraction 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 drug infusion pump. Device delivers medication at set or variable rates for therapies including chemotherapy, antibiotic therapy, and controlled analgesia. Operated by physician prescription; intended for subcutaneous, intravenous, and intrathecal administration. Device does not deliver blood or blood products. Subject device is identical to previously cleared predicate; submission expands indications to include intravenous infusion.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological identity to predicate device.

Technological Characteristics

Syringe-reservoir, rate-programmable external infusion pump. No changes to technological features from predicate. Regulation Number: 880.5725; Product Code: FRN.

Indications for Use

Indicated for infusion of medication (subcutaneous, intravenous, intrathecal) for therapies including chemotherapy, antibiotic therapy, and controlled analgesia. Prescription use only. Not indicated for blood or blood products.

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 MicroMed 407C Drug Infusion Pump (K040061)
• SIMS Deltec CADD-Micro, Model 5900

Submission Summary (Full Text)

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## Section D 510(k) Summary

K 043600

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, Regulatory Affairs, [phone], [phone] (v/f)

Name of Device: MicroMed 407C Drug Infusion Pump

Predicate Device: Medtronic MicroMed 407C Drug Infusion 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, intravenous and intratheral infrathers at set and variable rates, as prescribed by the user's physician. The 407C is restricted to sale by or or the order of a physician. It is not intended nor indicated for the delivery of blood or blood products. The principal features of the MicroMed 407C Drug Infusion Pump described in this submission are:

The features of device that is the subject to this submission are identical to those of the predicate device (K040061). The only change is expansion of the indications for use to include intravenous infusion.

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 MiniMed MicroMed 407C Drug Infusion Pump is indicated for influsion of medication labeled for subcutaneous, and intrather an intraction 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 MicroMed 407C do not differ from the previously cleared MicroMed 407C Drug Infusion Pump. The MicroMed 407C is intended for infusion of medication labout for subcutancous, intravenous and intrathecal infusion, while the predicate MicroMed 407C Drug Infusion Pump is indicated for infusion of medication labeled for subcutaneous and intrathecal administration only. The CADD-Micro, Model 5900 is jutended for infusion of medication labeled for subcutaneous, intravenus, intravenus, intravenus, intravenus, intravenus, intravenus, intravenus, intravenus, intraven intraperifoneal, intrathecal space, or subarachnoid space administration.

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GerdaRe ch, MT (ASCP) RAC Manager. Regulatory Affairs Medtronic MiniMed

12-27-04
Date

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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MAR 2 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K043600

Trade/Device Name: Medtronic MicroMed 407C Drug Infusion Pump Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN : Dated: December 27, 2004 Received: December 29, 2004

Dear Ms. Resch:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed yourse determined the device is substantially equivalent (for the referenced above and 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) that do not require approval of a premarket the Federal I 000; Drag). You may, therefore, market the device, subject to the general approvisions 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 above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1.1.1), it inche be of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Resch

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that PDA 3 issualled on a backers complies with other requirements mean that IDA has made a deceminations administered by other Federal agencies. of the Act of ally receial statutes and regurements, including, but not limited to: registration You must conting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 607), labeling (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality Systems (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) I his letter will anow you to begin mailering your antial equivalence of your device to a premarket notification. THE FDA miams on 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), If you desire specific author for your at [phone]. Also, please note the regulation prease contact the Office or Ochipsian premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the inay other general marers, International and Consumer Assistance at its toll-free Division of 01 638-2041 or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sensitie Michieu Ond.

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

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## INDICATIONS FOR USE

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510(k) Number:

Medtronic MicroMed 407C Drug Infusion Pump Device Name:

The Medtronic MicroMed 407C Drug Infusion Pump is Indications For Use: indicated for infusion of medication labeled subcutaneous, intravenous 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.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V CFR 801.109)

Over-the-Counter Use

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