(86 days)
No
The summary describes a drug infusion pump with set and variable rates, and explicitly states the device features are identical to the predicate device with only an expanded indication for use. There is no mention of AI, ML, or related concepts.
Yes
The device is a drug infusion pump intended for therapies such as chemotherapy, antibiotic therapy, and controlled analgesia, which are medical treatments designed to alleviate or cure diseases.
No
This device is a drug infusion pump, designed to administer medication, not to diagnose medical conditions.
No
The device description explicitly states it is an "external pump" and a "syringe-reservoir, rate-programmable pump," indicating it is a hardware device with mechanical components for drug infusion.
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 and intrathecal). This is a therapeutic action, not a diagnostic one.
- Device Description: The device is described as a "drug infusion pump" and a "syringe-reservoir, rate-programmable pump designed for infusion of medication." This aligns with a device used for delivering substances into the body.
- Lack of Diagnostic Activities: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such analysis. IVDs are typically used for testing samples in vitro (outside the body) to diagnose, monitor, or screen for diseases or conditions.
Therefore, the Medtronic MiniMed MicroMed 407C Drug Infusion Pump is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
FRN
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Medtronic MiniMed Model 407C Medication Pump, SIMS Deltec CADD-Micro, Model 5900
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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, (818) 576-4198, (818) 576-6273 (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 (301) 594-5618. 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 (800) 638-2041 or (301) 443-6597 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