CRONO F

K042085 · Cane S.R.L. · FRN · Sep 17, 2004 · General Hospital

Device Facts

• Record ID: K042085
• Device Name: CRONO F
• Applicant: Cane S.R.L.
• Product Code: FRN · General Hospital
• Decision Date: Sep 17, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The portable Crono infusion devices have been designed for use in subcutaneous and intravenous infusion of prescribed liquid medicines.

Device Story

Crono F is a compact ambulatory infusion pump for subcutaneous and intravenous delivery of liquid medications. Device utilizes a specialized integral syringe to reduce overall size compared to pumps using commercial syringes. Mechanism pushes directly on rubber syringe piston, providing up to 3x higher thrust force than conventional pumps to overcome catheter occlusions. Features an infusion control system that automatically continues delivery after clearing occlusions. Delivers medication in 22 µl increments per impulse (using 10/20 ml syringe) to improve drug absorption. Operated by patients for daily therapy; includes LCD displaying delivery time and battery status. Powered by 3V lithium battery. Designed for portability to facilitate therapy during everyday life.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included bench, EMC, and user testing to verify performance characteristics and safety compared to the predicate device.

Technological Characteristics

Ambulatory infusion pump; 3V lithium battery power; 10/20 ml syringe capacity; 22 µl infusion per impulse; dimensions 77 x 48 x 29 mm; weight 115g. Features high-thrust mechanical piston drive and automated occlusion management system. Includes LCD interface. No software algorithm details provided.

Indications for Use

Indicated for patients requiring subcutaneous or intravenous infusion of prescribed liquid medications. No specific age or gender restrictions provided.

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

• Crono H (K013855)

Submission Summary (Full Text)

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# SEP 17 2004

## EXHIBIT 2

CANÈ 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 July 29, 2004 510(k) Summary

- 1. Identification of the Device: Proprietary-Trade Name: Crono F Classification Name: 80 FRN Classion/Usual Name: Ambulatory Infusion Pump
- Equivalent legally marketed devices This product is similar in function and design to the si Crono cleared under 510(k) number K013855
- 3. Indications for Use (intended use) The portable Crono infusion devices have been designed 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 F, 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 F 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 liquid medicine 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 F 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 F makes the infusion up to 3 times more fractionated with respect to traditional pumps (22 µl per impulse, using a 10/20 ml syringe). Crono F is fitted with a liquid crystal display which shows the time it takes to complete the delivery and battery charge status.

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 | Crono H, K013855 | Crono F |
|---------------------------|-----------------------------------------------------------------------------|---------|
| Intended Use: | subcutaneous and<br>intravenous infusion of<br>prescribed liquid medicines. | SAME |
| Physical characteristics: | | |
| Power Source | Lithium battery (3V) of the<br>123 A type | SAME |
| Infusion per impulse | 22 µl | SAME |
| Size | 3" x 1.85" x 1.14" (77 x 48<br>x 29 mm) | SAME |
| Weight | 4.0 oz (115 g) (battery<br>included). | SAME |
| Capacity | 10 or 20 ml | SAME |
| Warranty: | 2 years | SAME |

#### 7. Conclusion

After analyzing both bench and user testing data, it is the conclusion of CANÈ S.r.l. that the Arel and is as safe and effective as the Crono H, predicate device, has few technological Ciono 1 15 as sare and offective as thus rendering it substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that represent the wings and body of the bird.

SEP 17 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Public Health Service

CANÈ S.R.L. C/O Mr. Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates PO Box 7007 Deerfield, Illinois 60015

Re: K042085

Trade/Device Name: Crono F Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: September 10, 2004 Received: September 15, 2004

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 mendments, or to devices that have been reclassified in accordance with the provisions of Andinonene, of to activelic Act (Act) that do not require approval of a premarket the Foublar F 80a, D. Ag, D. You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provision 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 Wri), it may of such of Federal Regulations, Title 21, Parts 800 to 898. In your device ear be foundsh further announcements concerning your device in the Federal Register.

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### Page 2 - Mr. Kamm

Please be advised that FDA's issuance of a substantial equivalence determination does not Please oe auvrsed that I Dri o lostainst on that your device complies with other requirements mean that IDA has made a deceminations administered by other Federal agencies. of the Act of ally I ederal banks and survey with and limited to: registration f ou must comply with an are Hooding (21 CFR Part 801); good manufacturing practice alld listing (21 CFR Part 807), laceling (21 CFR Pat 820); and if requirents as set form in the quality of the entrol 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) This icity will anow you to one finding of substantial equivalence of your device to a premiarket notification. - The Piere 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), If you desire specific au rios ter Jour 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 may outain other generalianal and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Ques

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

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: Crono F

Indications For Use: The Crono F ambulatory infusion pump device have been Indications For Ose. "The Orono Parkburdery infusion park of prescribed liquid medicines.

AND/OR Prescription Use __ __________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (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)

Anten Dink

Division Sian-Off) Division of Anesthesiology, General Hospital. Infection Control, Dental Devices

510(k) Number:_

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