MICROJET CRONO PAR AND CRONO APO-GO

K013840 · Cane S.R.L. · FRN · May 14, 2002 · General Hospital

Device Facts

• Record ID: K013840
• Device Name: MICROJET CRONO PAR AND CRONO APO-GO
• Applicant: Cane S.R.L.
• Product Code: FRN · General Hospital
• Decision Date: May 14, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The portable Microjet Crono K infusion device has been designed only for use in subcutaneous and intravenous infusion of prescribed liquid medicines.

Device Story

Microjet Crono K/Crono go are compact ambulatory infusion pumps for subcutaneous/intravenous delivery of prescribed liquid medicines. Device utilizes proprietary syringe system to reduce size compared to standard commercial syringe pumps. Mechanism pushes rubber syringe piston directly, providing 3x higher thrust force than conventional pumps to overcome catheter occlusions. Features automated infusion control system to resume delivery after occlusion clearance. Infusion is 3x more fractionated (22 ml per impulse) to improve drug absorption. Operated by patients in everyday life settings; includes LCD displaying delivery time and battery status. Benefits include increased patient mobility, improved therapy adherence, and reliable delivery during iron chelation therapy.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and effectiveness established via bench, EMC, and user testing comparing performance to predicate device.

Technological Characteristics

Ambulatory infusion pump; 3V Lithium CR-123A battery; dimensions 77x47x29 mm; weight 115g; 10/20 ml capacity. Features high-thrust mechanical piston drive and automated occlusion recovery system. LCD interface for status monitoring. No software algorithm details provided.

Indications for Use

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

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 1 Ambulatory Infusion Pump (K982838)

Submission Summary (Full Text)

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### EXHIBIT 2

KO23840

CANÉ S.r.l. Via Pavia, 105/I 10090 Rivoli-Cascine Vica (Torino) Italy Tel .: ++39-011-957.48.72 Fax ++39-011-959.88.80 Contact: Mario Cané, President January 30, 2002

# 510(k) Summary of Safety and Effectiveness

- 1. Identification of the Device: Proprietary-Trade Name: "Microjet Crono K" and "Crono go" Classification Name: 80 FRN Common/Usual Name: Ambulatory Infusion Pump
- 2. Equivalent legally marketed devices This product is similar in function to the Cadd-Legacy 1 Ambulatory Infusion Pump , Sims Deltec, Inc., K982838
- 3. Indications for Use (intended use) The portable Microjet Crono K infusion device has been designed only for use in subcutaneous and intravenous infusion of prescribed liquid medicines.
- 4. Description of the Device: Canè s.r.l., a company that specializes in the production of ambulatory pumps, has now produced a new generation of compact pumps: Crono K, a perfect combination of high technology and innovative design. The infusion pumps which use normal commercial syringes are inevitably cumbersome and thus difficult to use in everyday life. This provokes in the patients a refuse of the therapy. A special syringe, an integral part of the Crono K allows an efficient reduction of the pump size. In this way, the patients can freely carry out the therapy at any time of the day, even during their everyday life. Patients who have been following a iron chelation therapy for a long time, often experience difficulties in absorbing the drug subcutaneously; this may lead to a catheter occlusion with consequent interruption of the infusion. Crono K has a particular mechanism which pushes directly the rubber syringe piston: so it is possible to reach a thrust force up to 3 times higher with respect to conventional pumps. In case of catheter occlusion, an innovative infusion control system makes it possible to proceed with the infusion automatically and, after the occlusion is eliminated, to complete it. For a better absorption of the drug, Crono K makes the infusion up to 3 times more fractionated with respect to traditional pumps (22 ml per impulse, using a 10/20 ml syringe). Crono K is fitted with a liquid crystal display which shows the time it takes to complete the delivery and battery charge 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.

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## 6. Substantial Equivalence Chart

| Characteristic | Cadd-Legacy 1<br>Ambulatory Infusion<br>Pump, Sims Deltec, Inc.,<br>K982838 | "Microjet Crono K" and<br>"Crono go"<br>K013840 |
|---------------------------|---------------------------------------------------------------------------------------------|-------------------------------------------------|
| Intended Use: | Intravenous<br>Intra-arterial<br>Subcutaneous<br>Intraperitoneal<br>Epidural<br>Intrathecal | Subcutaneous and<br>intravenous only |
| Physical characteristics: | | |
| Power Source | 2 AA alkaline batteries, AC<br>Adapter | Lithium battery (3V) of the<br>CR-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 | 10 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 K 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.

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### 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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three abstract shapes resembling birds in flight.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Y 1 4 2002

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

Re: K013840

Trade/Device Name: MicroJet Crono K and Crono GO Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: February 26, 2002 Received: February 28, 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 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.

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

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## Page 2 - Mr. Kamm

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 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,

Susan Punner

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

Enclosure

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## j) Indications for Use

510(k) Number K013840

Device Name: "Microjet Crono K" and "Crono go" ambulatory infusion pump

Indications for Use: The "Microjet Crono K" and "Crono go" ambulatory infusion pump device has been designed for use in subcutaneous and intravenous infusion of prescribed liquid medicines.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use OR (Per 21 CFR 801.109)

Over the Counter Use

Victoria Vicente

(Division Sign-Off) (Division Sign-On)
Division of Dental, Infection Control,
Division of Dental, Infection Dovices and General Hospital Devices 840 01 510(k) Number -