(86 days)
The Medtronic MiniMed MicroMed 407C Drug Infusion Pump is indicated 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.
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 document is a 510(k) summary for the Medtronic MiniMed MicroMed 407C infusion pump. It details a request for an expanded indication for use to include intrathecal infusion, in addition to the previously cleared subcutaneous infusion.
Here's an analysis of the provided text in relation to your questions, noting that this particular document mostly focuses on regulatory submission and equivalency, and therefore lacks significant detail regarding a device performance study with acceptance criteria.
1. A table of acceptance criteria and the reported device performance
Based on the provided text, there is no specific table of acceptance criteria or performance metrics reported for this device in the context of a new study. The submission focuses on demonstrating substantial equivalence to a predicate device for an expanded "indications for use."
The document states: "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 infusion. This change to the indications for use will have no untoward effect on the safety and effectiveness of the device."
This implies that because the device itself hasn't changed structurally or functionally from its predicate, and the expanded indication is for a similar type of infusion route (just a different anatomical location), a detailed new performance study with specific acceptance criteria beyond simply demonstrating "no untoward effect on safety and effectiveness" for the new route might not have been
deemed necessary or explicitly documented within this summary. It relies on the existing safety and effectiveness profile of the identical predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document does not describe a clinical performance study with a test set. It relies on demonstrating substantial equivalence to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No test set or ground truth establishment by experts is described in this regulatory summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set or adjudication method is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an infusion pump, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an infusion pump, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. No ground truth is described as part of a performance study. The "ground truth" for the regulatory submission is based on the previously cleared predicate device's established safety and effectiveness.
8. The sample size for the training set
Not applicable. The document does not describe the development or training of a software algorithm or model.
9. How the ground truth for the training set was established
Not applicable. No training set or ground truth establishment for a training set is described.
Summary of what the document does provide:
- Device Name: MicroMed 407C
- Predicate Device: Medtronic MiniMed Model 407C Medication Pump (K991013) and SIMS Deltec CADD-Micro, Model 5900.
- Key Change: Expansion of Indications for Use from "subcutaneous administration only" to include "subcutaneous and intrathecal infusion."
- Reason for Substantial Equivalence: The technological features of the device are "identical" to the previously cleared 407C Medication Pump. The change is solely in the indication for use, with the assertion that this change will have "no untoward effect on the safety and effectiveness."
- Intended Use: Infusion of medication labeled for subcutaneous and intrathecal infusion, at set and variable rates, for therapies including chemotherapy, antibiotic therapy, and controlled analgesia.
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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
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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.
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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
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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
§ 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).