(89 days)
The MiniMed 407C Infusion Pump is indicated for infusion of medications For USC. The Ministration, at set and variable rates, for therapies including chemotherapy, antibiotic therapy, and controlled analgesia.
The 407C cxtcmal pump is a syringe-reservoir, rate-programmable pump designed for infusion of medication appropriately labeled for subcutancous administration, 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 is, not intended nor indicated for the delivery of blood or blood products. The principal modifications described in this, submission are: 1) The device is indicated for use with medication labeled for subcutancous administration. 7) A Low Reservoir Alert feature has been incorporated that will sound when the reservoir plunger reaches the point where approximately 0.200 ml of medication remains. 3) A 'Take a Break' Bolus feature has been added to deliver a bolus before disconnecting from the pump to help the patient remain above the minimum therapeutic lovel of the medication for the duration of the break. 4) Three lockout levels have been incorporated so that some for etturns will not be accessible to the patient. 5) The Bolus feature and the 'Take a Break' Bolus feature can be turned on and off. 6) A Suspend/Storage Mode has been incorporated in which no recurring alcrt will remind the user of that condition. 7) The medication concentration feature has been eliminated. The medication rate will be adapted by delivery rate of the pump only. 8) The square wave bolus and dual wave bolus have bolus have been climinated. A normal bolus can be administered. 9) The temporary basal rate feature has been eliminated. 10) Forty-cight basal rates have been replaced by a single rate. 11) The Auto Off and Audio Dolus features have been climinated. 12) The LCD has been revised so that the word RATE will replace BASAI., PROG will replace SET, and ML will replace U for the anount of medication displayed. 13) Two new icons, a low reservoir icon and a lock icon, have been incorporated.
The provided text does not contain information about acceptance criteria and a study proving device performance in the format requested. The document is a 510(k) summary for the MiniMed Model 407C Infusion Pump, focusing on its substantial equivalence to predicate devices and its intended use. It describes modifications to the device and makes a general statement about safety and effectiveness, but it does not detail specific acceptance criteria or report on a study designed to meet them.
Therefore, I cannot extract the requested information from the provided text.
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Image /page/0/Picture/1 description: The image shows the MiniMed logo. The logo consists of a black square with white lines inside, and the word "MiniMed" in a bold, sans-serif font. Above the logo is the text "K99/013". The MiniMed logo is a registered trademark, as indicated by the "®" symbol.
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: MiniMed® Inc. 12744 San Fernando Road, Sylmar, California 91342
Contact: Don Selvey, Department of Clinical and Regulatory Affairs, (818) 362-5958, 3011: (520) 527-0107 (v/f)
Name of Device: MiniMcd Model 407C Infusion Pump
Predicate Device: MiniMed Model 507C Insulin Pump; MiniMed 404-SP Infusion Pump
Description of the Device, The 407C cxtcmal pump is a syringe-reservoir, rate-programmable pump designed for infusion of medication appropriately labeled for subcutancous administration, 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 is, not intended nor indicated for the delivery of blood or blood products. The principal modifications described in this, submission are:
- The device is indicated for use with medication labeled for subcutancous administration. 7) A Low Reservoir Alert feature has been incorporated that will sound when the reservoir plunger reaches the point where approximately 0.200 ml of medication remains. 3) A 'Take a Break' Bolus feature has been added to deliver a bolus before disconnecting from the pump to help the patient remain above the minimum therapeutic lovel of the medication for the duration of the break. 4) Three lockout levels have been incorporated so that some for etturns will not be accessible to the patient. 5) The Bolus feature and the 'Take a Break' Bolus feature can be turned on and off. 6) A Suspend/Storage Mode has been incorporated in which no recurring alcrt will remind the user of that condition. 7) The medication concentration feature has been eliminated. The medication rate will be adapted by delivery rate of the pump only. 8) The square wave bolus and dual wave bolus have bolus have been climinated. A normal bolus can be administered. 9) The temporary basal rate feature has been eliminated. 10) Forty-cight basal rates have been replaced by a single rate. 11) The Auto Off and Audio Dolus features have been climinated. 12) The LCD has been revised so that the word RATE will replace BASAI., PROG will replace SET, and ML will replace U for the anount of medication displayed. 13) Two new icons, a low reservoir icon and a lock icon, have been incorporated.
The modifications which are the subject of this promarket notification have no untoward effect on the salety and effectiveness of the device.
Intended Use of the Device: The MiniMed 407C Infusion Pump is intended for infusion of medication labelcd for subcutancous administration, at set and variable rates, for therapies including chemotherapy, antibiotic therapy, and controlled analgesia. It is not intended for use with blood or blood products.
Comparison of the Technological Features of the New Device and Predicate Device: The technological features of the 407C do not differ significantly from the 404-SP and the 507C infinsion pumps. The devices have similar materials, product design, and energy source. The 407C and the 404-SP are intended for infusion of medication labeled for subcutancous administration, while the 507C is intended only for subcurance in nisulin delivery
Don Solvey 3-24-99
Date
Senior Regulatory Affairs Specialist Department of Clinical and Regulatory Affairs MiniMed Inc.
iv
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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, stacked on top of each other.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 23 1999
Mr. Don Selvey Senior Regulatory Affairs Specialist Department of Clinical and Regulatory Affairs MiniMed, Incorporated 12744 San Fernando Road Sylmar, California 91342-3728
Re : K991013 Trade Name: MiniMed® Model 407C Infusion Pump Regulatory Class: II Product Code: FRN Dated: March 25, 1999 Received: March 26, 1999
Dear Mr. Selvey:
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 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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practicc, 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
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Page 2 - Mr. Selvey
the Act for devices under the Electronic 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) 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other gener Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely Yours
Timothy A. Ulatowski
thy A. 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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MiniMed Inc. Premarket Notification - 510(k) 407C Infusion Pump
INDICATIONS FOR USE
510(k) Number:
Device Name: MiniMcd 407C Infusion Pump
Indications For Use: The MiniMed 407C Infusion Pump is indicated for infusion of medications For USC. The Ministration, at set and variable rates, for therapies including chemotherapy, antibiotic therapy, and controlled analgesia.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use م (Per 21 CFR 801.109)
or
Over-the-Counter Usc
Patuxent Research
§ 880.5725 Infusion pump.
(a)
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.(b)
Classification. Class II (performance standards).