(90 days)
Not Found
No
The document describes a drug infusion pump with programmable rates and expanded indications for use, but there is no mention of AI, ML, or related concepts. The description focuses on the mechanical and programmable aspects of the device.
Yes
The device is a drug infusion pump used to deliver medications for various therapies, including chemotherapy and antibiotic therapy, which are treatments for medical conditions.
No
The device is described as a drug infusion pump, designed for delivering medication, not for diagnosing conditions.
No
The device description explicitly states it is an "external pump" and a "syringe-reservoir, rate-programmable pump," indicating it is a physical hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the infusion of medication into the body (subcutaneous, intravenous, and intrathecal). This is a therapeutic function, not a diagnostic one.
- Device Description: The description details a drug infusion pump, which is a device used to deliver substances into the body. This aligns with a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens from the human body to provide information for diagnosis, monitoring, or compatibility testing, which are the hallmarks of an IVD.
Therefore, the Medtronic MiniMed MicroMed 407C Drug Infusion Pump is a therapeutic device, not an IVD.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
FRN
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous, intravenous and intratheral / intrathecal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Medtronic MicroMed 407C Drug Infusion Pump; and SIMS Deltec CADD-Micro, Model 5900
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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, (818) 576-4198, (818) 576-6273 (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.
hm
GerdaRe ch, MT (ASCP) RAC Manager. Regulatory Affairs Medtronic MiniMed
12-27-04
Date
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol that resembles an abstract eagle or bird in flight, composed of three curved lines.
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.
2
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 (240) 276-0115. 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 (301) 443-6597 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
3
INDICATIONS FOR USE
のできるとなったり、その後にはないというとなるとなるなんて
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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CONFIDENTIAL