MICROPUMP MP-101

K051252 · Micrel Medical Devices S.A. · FRN · May 27, 2005 · General Hospital

Device Facts

• Record ID: K051252
• Device Name: MICROPUMP MP-101
• Applicant: Micrel Medical Devices S.A.
• Product Code: FRN · General Hospital
• Decision Date: May 27, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

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.

Device Story

Micropump MP-101 is a battery-operated ambulatory syringe pump; accepts 10 ml to 20 ml syringes. Device features LCD, front-panel keyboard, and magnetic drum with dual hall-effect sensors for flow monitoring. Operates by delivering prescribed liquid medicines via subcutaneous or intravenous routes. Used in clinical or ambulatory settings; operated by healthcare professionals or patients. Provides infusion rate range of 01 to 99 mm/Hr. Safety features include alarm systems for monitoring infusion parameters. Device assists in precise medication delivery, improving patient management of prescribed therapies.

Clinical Evidence

Bench testing only. Performance data confirms device meets specifications and is substantially equivalent to predicates. Testing included software/hardware interaction under single fault conditions, alarm safety verification, and risk assessment using Fault Tree Analysis and ISO 14971.

Technological Characteristics

Battery-operated syringe pump; 10-20 ml syringe capacity; 01-99 mm/Hr infusion rate. Sensing: magnetic drum with dual hall-effect sensors. Interface: LCD and up-down-enter keyboard. Standards: IEC 60601-1 (single fault condition), IEC 60601-2-24, ISO 14971 (risk management).

Indications for Use

Indicated for subcutaneous and intravenous infusion of prescribed liquid medicines in patients requiring infusion therapy. Contraindicated for blood infusion.

Regulatory Classification

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.

Predicate Devices

• A. Cane S.r.l. Crono H
• Smiths Graseby MS-16 (K830423)

Submission Summary (Full Text)

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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: | [phone] |
| Facsimile: | [phone] |
| 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<br>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

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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

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### 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 <span style="text-decoration: overline;">NSE</span> Other (specify): |
| ODE/OIVD final decision: | SE <span style="text-decoration: overline;">NSE</span> 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).

______________________________________________________________________________________________________________________________________________________________________________

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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.

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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 [phone]. 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 [phone] or [phone] 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

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# 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