MICROJET CRONO PCA

K013822 · Cane S.R.L. · MEA · May 8, 2002 · General Hospital

Device Facts

• Record ID: K013822
• Device Name: MICROJET CRONO PCA
• Applicant: Cane S.R.L.
• Product Code: MEA · General Hospital
• Decision Date: May 8, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The portable Crono infusion device has been designed for use in intravenous or subcutaneous infusion of medicines for pain management.

Device Story

Microjet Crono PCA is a portable ambulatory infusion pump for pain management. It delivers medication via intravenous or subcutaneous routes. The device features a microprocessor-controlled electronic circuit that allows users to program infusion flow and duration. Patients can trigger additional bolus doses via a button; the device tracks and displays the number of boluses delivered and the infused volume. A liquid crystal display (LCD) shows programmed data and battery status. A safety system locks the keyboard to prevent unauthorized parameter changes. In the event of catheter occlusion, the device allows administration to resume once the obstruction is cleared. Designed for patient mobility, the device is small and lightweight. It is intended for use in clinical or home settings to facilitate analgesic therapy.

Clinical Evidence

Bench testing, EMC testing, and user testing were performed. No clinical trial data was provided. The device was demonstrated to be as safe and effective as the predicate through comparative bench analysis.

Technological Characteristics

Ambulatory infusion pump; microprocessor-controlled; 3V Lithium battery (123A type); LCD interface; dimensions 77 x 47 x 29 mm; weight 115g; 10 or 20 ml capacity. Features include programmable flow rates, bolus administration, occlusion detection/recovery, and keyboard lockout safety mechanism.

Indications for Use

Indicated for patients requiring intravenous or subcutaneous infusion of pain management medications.

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

• Cadd-Legacy PCA Model 6300 Ambulatory Infusion Pump (K982839)

Submission Summary (Full Text)

{0}------------------------------------------------

## EXHIBIT 2

\$\chi013822\$

CANÈ S.r.I. Via Pavia, 105/1 10090 Rivoli-Cascine Vica (Torino) Italy Tel .: ++39-011-957.48.72 Fax ++39-011-959.88.80 Contact: Mario Cané, President November 13, 2001

## 510(k) Summary of Safety and Effectiveness

- 1. Identification of the Device: Proprietary-Trade Name: Microjet Crono PCA Classification Name: MEA Common/Usual Name: Ambulatory Infusion Pump
- 2. Equivalent legally marketed devices This product is similar in function to the Cadd-Legacy PCA Model 6300 Ambulatory Infusion Pump , Sims Deltec, Inc., K982839
- 3. Indications for Use (intended use) The portable Crono infusion device has been designed for use in intravenous or subcutaneous infusion of medicines for pain management.
- 4. Description of the Device: Microjet Crono PCA has been designed for the analgesic therapy with a flexible and precise drug's administration causing the minimum discomfort to the patient allowing to walking about. Microjet Crono PCA results to be, within its field, the most innovative instrument available in the market due to small dimension and easy-to-use. Outstanding technology degree has allowed to obtain high reliability degree for long time use without maintenance. A microprocessor runs the electronic circuitry allowing to program the flow seeing the duration of the infusion. A button allows the patient to administer an additional bolus as well seeing the infused volume when in process. The screen also allows to indicate the total of bolus that have been delivered within the infusion in course. A safety system is foreseen to unlock the keyboard to avoid unauthorized variation of the programmed parameters. In the event of occlusion of the catheter, Microjet Crono PCA allows to carry on the administration after the occlusion has been removed. This function is capable to highly reduce the risk of infusion not brought to end. Microjet Crono PCA is equipped with a liguid crystal display where the programmed data can be seen as well as the battery status.
- 5. Safety and Effectiveness, comparison to predicate device. The results of bench, EMC, and user testing indicates that the new device is as safe and effective as the predicate device.

{1}------------------------------------------------

# 6. Substantial Equivalence Chart

| Characteristic | Cadd-Legacy PCA Model<br>6300 Ambulatory Infusion<br>Pump , Sims Deltec, Inc.,<br>K982839 | Microjet Crono PCA<br>ambulatory infusion<br>pump |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|
| Intended Use: | Designed for use in<br>intravenous, intra-arterial,<br>subcutaneous,<br>intraperitoneal, epidural,<br>intrathecal infusion of<br>medicines for pain<br>management. | Intravenous or<br>subcutaneous only. |
| Physical characteristics: | | |
| Power Source | 2 AA alkaline batteries, AC<br>Adapter | Lithium battery (3V) of the<br>123 A type |
| Size | 4.4 x 3.8 x 1.6 x in (112x<br>95x41 mm) | 3" x 1.85" x 1.14" (77 x 47<br>x 29 mm) |
| Weight | 13.8 oz (392 grams) | 4.0 oz (115 g) (battery<br>included). |
| Capacity | 50 or 100 ml | 10 or 20 ml |
| Warranty: | 1 year | 2 years |

#### 7. Conclusion

After analyzing both bench and user testing data, it is the conclusion of CANÈ S.r.1. that the Microjet Crono PCA is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device.

{2}------------------------------------------------

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of an abstract human figure, with three lines representing the head, body, and legs.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAY 0 8 2002

Cane S. R. L. C/O Mr. Daniel Kamm Kamm & Associates P. O. Box 7007 Deerfield, Illinois 60015

Re: K013822

Trade/Device Name: MicorJet Crono PCA Regulation Number: 880.5725 Regulation Name: Infusion Pump, PCA Regulatory Class: II Product Code: MEA Dated: February 11, 2002 Received: February 12, 2002

Dear Mr. Kamm:

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 vour 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.

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.

{3}------------------------------------------------

Page 2 -

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 your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

j) Indications for Use

510(k) Number_ KO 13822

Device Name: Microjet Crono PCA ambulatory infusion pump

Indications for Use: The Microjet Crono PCA ambulatory infusion pump device has been designed for use in intravenous or subcutaneous infusion of medicines for pain management.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use \/ OR

Over the Counter Use (Per 21 CFR 801.109)

Patrice Cuscente
(Division Sign-Off)

er Station Gign-Off)
Division of Dental, Infection Control, and General Hospital, Infection C
and General Hospital Devicess 510(k) Number __

7