(11 days)
Not Found
No
The summary describes a standard infusion pump with a basic user interface and safety features, with no mention of AI or ML capabilities.
Yes
The device is an infusion pump designed for subcutaneous and intravenous infusion of prescribed liquid medicines, indicating it directly administers treatment to a patient.
No
The device is an infusion pump designed to administer prescribed liquid medicines, not to diagnose a condition.
No
The device description explicitly states it is a "battery-operated portable infusion pump" with a "LCD and units are displayed on the front panel" and a "keyboard user interface," indicating it is a physical hardware device. The performance studies also mention "software/hardware interaction."
Based on the provided information, the MP 101 Micropump is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the subcutaneous and intravenous infusion of prescribed liquid medicines. This involves delivering substances into the body, not analyzing samples from the body.
- Device Description: The description details an infusion pump that delivers liquids at a set speed using syringes. This is a drug delivery device, not a diagnostic device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The MP 101 Micropump's function is purely therapeutic (drug delivery).
N/A
Intended Use / Indications for Use
The MP 101 Micropump is a battery-operated portable infusion pump designed for use in subcutaneous and intravenous infusion of prescribed liquid medicines.
MP 101 is not indicated to infuse blood.
Product codes (comma separated list FDA assigned to the subject device)
FRN
Device Description
Ambulatory Infusion Pump, battery operated, for use with any syringe type from 10 ml to 20 ml, set at a particular speed. The LCD and units are displayed on the front panel. The Pump has an up-down-enter keyboard user interface
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)
The performance data indicate that the device will meet specified requirements and is substantially equivalent to the predicate devices. Product Softety testing demonstrates single fault condition for software/hardware interaction. Software safety tests demonstrate that alarms meet safety specifications. A risk assessment was performed utilizing Fault Tree Analysis and ISO 14971.
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.
A. Cane S.r.l. Crono H, K830423
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
051252
MAY 2 7 2005
SUMMARY
In accordance with 21 CFR 807.92 Micrel Medical submits the following information:
| Submitter: | Micrel Medical Devices, S.A. |
|---|---|
| 4 Ithakis Street | |
| Pallini 15351 | |
| GREECE | |
| Telephone: | +30210 6032333 |
| Facsimile: | +3-210 6032335 |
| Contact: | Alexandre Tsoukalis, Technical Director |
| Date: | March 12, 2005 |
| Device Name: | Micropump MP-101 |
| Common Name: | Syringe Pump |
| Classification Name: | Infusion Pump (80 FRN) |
| Regulation Number: | 21 CFR 880.5725 |
| Predicate Device: | A. Cane S.r.l. Crono H |
| B. Smiths Graseby MS-16 (K830423) |
Description of the Device: Ambulatory Infusion Pump, battery operated, for use with any syringe type from 10 ml to 20 ml, set at a particular speed. The LCD and units are displayed on the front panel. The Pump has an up-down-enter keyboard user interface
Intended Use: The MP 101 Micropump is a battery-operated portable infusion pump designed for use in subcutaneous and intravenous infusion of prescribed liquid medicines.
MP 101 is not indicated to infuse blood.
The Predicate devices have the same intended use as the Proposed device.
Technological Characteristic Comparison with Predicate Device: The technological features of the Proposed device do not differ significantly from the Predicate devices. The Proposed device MP 101 and the Predicate devices are syringe drivers, are battery operated, have the same intended use; and flow rate reading, accuracy and materials are identical to the Predicate devices. The devices are equal in size and both have a 01 to 99 mm/Hr Infusion Rate range. An enhanced safety feature of the Proposed device uses a magnetic drum and two hall-effect sensors. The devices meet the IEC60601-1 standard covering the single fault condition and IEC60601-2-24, except for clause 54.101 which is addressed by both manufacturer with similar counter measures as described in the
1
comparison table and in the risk analysis for this product in accordance with ISO 14971. The Proposed device and Predicate A use an LCD and keyboard, Predicate B uses rotary switches for each digit
Performance Data: The performance data indicate that the device will meet specified requirements and is substantially equivalent to the predicate devices. Product Softety testing demonstrates single fault condition for software/hardware interaction. Software safety tests demonstrate that alarms meet safety specifications. A risk assessment was performed utilizing Fault Tree Analysis and ISO 14971.
end
2
Third Party Review Quality Assessment
| Section 1 – Submission Information | |
|---|---|
| 510(k) No.: | K051252 |
| Third Party Organization: | TUV American |
| Third Party's Primary Reviewer(s): | Stefan Preiss |
| ODE/OIVD Division: | DAGID |
| Branch/Team: | GHDB |
| Section 2 – 510(k) Decision | |
|---|---|
| Third party recommendation: | SE NSE Other (specify): |
| ODE/OIVD final decision: | SE NSE Other (specify): |
| Section 3 – Assessment of Third Party Review | ||
|---|---|---|
| Review Element | Rating (check one) | |
| Adequate Minor Issue(s) Major Issue(s) | ||
| a. Determination of device eligibility for third party review | ||
| b. Extent of pre-submission consultation with ODE/OIVD division | ||
| c. Organization and format of review documentation | ||
| d. Determination of 510(k) administrative completeness (screening review) | ||
| e. Summary of device characteristics, intended use, and performance (including accessories, if applicable) and reason for 510(k) submission | ||
| f. Comparison to legally marketed devices—identification and analysis of key similarities and differences | ||
| g. Rationale for conclusions and recommendation | ||
| h. Use of guidance documents and standards | ||
| i. Resolution of 510(k) deficiencies and FDA requests for additional information | ||
| j. Scope of reviewer expertise and use of consulting reviewers | ||
| k. Other (specify): |
Comments (explanation of ratings/issues):
Section 4 - ODE/OIVD Assessor Information un & Date: 5/27 Tel. No .: 30/-627-526 2
Assessed by: >>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>
Routing: Division -- Clip completed assessment (this page only) to inside front cover of 510(k). DMC-Forward this page only to Eric Rechen, POS/ODE, Rm. 120J, Corp. Blvd. (HFZ-402).
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
MAY 27 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Micrel Medical Devices S.A. C/O Mr. Stefan Preiss Responsible Third Party Official TUV America, Incorporated 1775 Old Highway 8 New Brighton, Minnesota 55112-1891
Re: K051252
Trade/Device Name: Micropump MP 101 Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: May 13, 2005 Received: May 16, 2005
Dear Mr. Preiss:
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 indications for use stated 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 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 above) 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 Federal Register.
4
Page 2 - Mr. Preiss
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 applicable, the electronic 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 (240) 276-0115. 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/industry/support/index.html.
Sincerely yours,
Sitte y. Michael O. mD.
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
5
Statement of Indications for Use
510(k) Number : Device Name: Micropump MP 101
Indications For Use:
The MP 101 Micropump is a battery-operated portable infusion pump designed for use in subcutaneous and intravenous infusion of prescribed liquid medicines.
MP 101 is not indicated to infuse blood.
Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE: BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runne fin Ann
Civision Sign-Off) ് ivision of Anesthesiology, General Hospital, Intection Control, Dental Devices
510(k) Number: 1051252