(90 days)
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 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, 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 510(k) submission (K043600) is for a modification to an existing drug infusion pump, the MicroMed 407C, specifically an expansion of its indications for use to include intravenous infusion. Therefore, the study details you are requesting for device performance in meeting acceptance criteria typically associated with new device clearance or significant modifications are not present in this document.
The provided 510(k) summary explicitly states:
"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."
And further:
"This change to the indications for use will have no untoward effect on the safety and effectiveness of the device."
This indicates that the manufacturer is asserting that the device's fundamental performance characteristics (accuracy of infusion, safety features, etc.) remain unchanged and were already established by the predicate device (K040061). The focus of this 510(k) is the equivalence of the device with the expanded indication to existing legally marketed devices, rather than a new study to prove device performance against acceptance criteria for a novel functionality.
Therefore, I cannot provide the requested information in the format given because a comprehensive study with new acceptance criteria and performance data for this specific 510(k) modification is not described in the provided text. The document relies on the established performance of the predicate device.
However, based on the principle of substantial equivalence for which this 510(k) was submitted, we can infer the basis of acceptance. The "acceptance criteria" here are essentially that the device, with its expanded indication, is as safe and effective as a legally marketed predicate device for intravenous infusion.
Here's how we can frame a response based on the provided text, assuming the "reported device performance" is the established performance of the existing device and predicate devices.
Acceptance Criteria and Study for K043600 (Medtronic MicroMed 407C Drug Infusion Pump)
This 510(k) submission (K043600) is for an expansion of the indications for use of an already cleared device, the Medtronic MicroMed 407C Drug Infusion Pump, to include intravenous infusion. The manufacturer states that the device features are identical to the predicate device (K040061) and that the change will have no untoward effect on safety and effectiveness. Therefore, the "acceptance criteria" and "study" are implicitly tied to demonstrating substantial equivalence to legally marketed predicate devices for intravenous infusion.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied for Intravenous Infusion) | Reported Device Performance (Inherited/Reference from Predicate and Similar Devices) |
|---|---|
| Safety and Effectiveness for Intravenous Infusion: | The device's features are identical to the previously cleared MicroMed 407C Drug Infusion Pump (K040061) which has established safety and effectiveness for subcutaneous and intrathecal infusion. The manufacturer asserts that the expansion to intravenous infusion will have no untoward effect on safety and effectiveness. |
| Functional Equivalence: Ability to infuse medication at set and variable rates reliably and accurately in an intravenous context. | The MicroMed 407C Drug Infusion Pump is already a "syringe-reservoir, rate-programmable pump designed for infusion of medication labeled for subcutaneous, intravenous and intratheral infrathers at set and variable rates." The functional capability for rate-programmable infusion is inherent. The predicate device SIMS Deltec CADD-Micro, Model 5900, is cited as a device intended for infusion of medication labeled for subcutaneous, intravenous, and other routes. This implies that similar functionality for IV use has been previously demonstrated and accepted for a predicate device. |
| Alarm Mechanisms and Safety Features: Adequate alarms for occlusion, air in line, low battery, etc., applicable to intravenous use. | (Not explicitly detailed in the provided summary, but as the device itself is identical to its predicate, it is assumed to possess all existing safety features and alarm functionalities. These would have been evaluated during the initial clearance of the predicate device). |
| Biocompatibility: Materials in contact with infusate are suitable for intravenous use. | (Not explicitly detailed, but as the device is identical to its predicate, the material composition remains unchanged and would have been previously evaluated). |
2. Sample Size Used for the Test Set and Data Provenance
This 510(k) does not describe a new clinical or performance test set with a specific sample size. The substantial equivalence argument is based on the identity of the device's features to its predicate and the equivalence of the expanded indication to other legally marketed devices.
- Test Set Sample Size: Not applicable/not specified for a new study. The submission relies on the established performance of the predicate device (K040061) and other similar devices, such as the SIMS Deltec CADD-Micro, Model 5900.
- Data Provenance: Not applicable/not specified for a new study. Historical performance data and regulatory clearances of predicate devices form the basis of the claim.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. This submission doesn't detail a new study requiring expert-established ground truth. The decision is based on regulatory review of the device's design, intended use, and comparison to predicates.
4. Adjudication Method for the Test Set
Not applicable. No new test set or study requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This type of study is not relevant for an infusion pump's indication expansion based on identical features and substantial equivalence.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
This refers to a software algorithm's performance, which is not directly applicable to an electromechanical drug infusion pump. The device itself is the "standalone" entity in terms of its function (delivering medication). Its performance is inherent to its mechanical and electronic design, which is stated to be identical to the predicate.
7. The Type of Ground Truth Used
The "ground truth" in this context is the safety and effectiveness data and regulatory clearances for the predicate device (K040061) and other legally marketed infusion pumps used for intravenous administration (e.g., SIMS Deltec CADD-Micro, Model 5900). The manufacturer asserts that the identical design of the pump ensures similar performance characteristics for the expanded indication.
8. The Sample Size for the Training Set
Not applicable. This device is not a machine learning or AI-driven system that would have a "training set" in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the reason stated above. The "ground truth" for the device's inherent design and functionality was established through the rigorous testing and regulatory clearance processes for the original device (K040061) and similar predicate devices.
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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, (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.
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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
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.
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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 (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
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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
§ 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).