CRONO AND CRONO, MODEL 30

K041414 · Cane S.R.L. · FRN · Jul 8, 2004 · General Hospital

Device Facts

• Record ID: K041414
• Device Name: CRONO AND CRONO, MODEL 30
• Applicant: Cane S.R.L.
• Product Code: FRN · General Hospital
• Decision Date: Jul 8, 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 subcutancous infusion of prescribed liquid medicines.

Device Story

Ambulatory infusion pump for subcutaneous delivery of prescribed liquid medicines; utilizes specialized syringe integral to pump design to reduce size; features high-thrust mechanism to push rubber syringe piston directly, enabling higher thrust force than conventional pumps to overcome catheter occlusions; includes automated infusion control system to resume delivery after occlusion clearance; provides fractionated infusion (22 µl or 33 µl per impulse) for improved drug absorption; powered by 3V lithium battery; includes LCD for delivery time and battery status; intended for patient use during everyday life; enables patient mobility; reduces therapy refusal due to cumbersome equipment.

Clinical Evidence

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

Technological Characteristics

Ambulatory infusion pump; 3V lithium battery power; uses specialized syringes (10, 20, or 30 ml); high-thrust mechanical piston drive; LCD interface; fractionated delivery (22 µl or 33 µl per impulse); compact form factor (approx. 80 x 48 x 35 mm max).

Indications for Use

Indicated for subcutaneous infusion of prescribed liquid medicines in patients requiring long-term 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

• Crono (K013234)

Submission Summary (Full Text)

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K041414

## EXHIBIT 2

JUL 0 8 2004

CANÈ S.r.l. 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 May 24, 2004 510(k) Summary

- 1. Identification of the Device: Proprietary-Trade Name: Crono and Crono 30 Classification Name: 80 FRN Common/Usual Name: Ambulatory Infusion Pump
- 2. Equivalent legally marketed devices This product is similar in function and design to the Crono cleared under 510(k) number K013234
- 3. Indications for Use (intended use) The portable Crono infusion devices have been designed for use in subcutancous infusion of prescribed liquid medicines.
- 4. Description of the Device: Canc s.r.l., a company that specializes in the production of ambulatory pumps, has now produced a new generation of compact pumps: Crono, a perfect combination of high technology and innovative design. The infusion pumps witch use normal commercial syringes are inevitably cumbersome and thus difficult to mee in everyday life. This provokes in the patients a refuse of the therapy. A special syringe, an integral part of the Crono 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. Points 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 has a particular mechanism which pushes directly the rubber syringe piston: so it is possible to reach a thrust force up to 3 timss ligher with respect to conventional pumps. In case of catheter occlusion, an innovative influsion control system makes it possible to proceed with the infusion automatically and, after the occlusion is climinated, to complete it. For a better absorption of the drug, Crono makes the infusion up to 3 times more fractionated with respect to traditional pumps (22 ul per impulse, using a 10/20 ml syringe). Crono is fitted with a liquid crystal display which shows the time it takes to complete the delivery and battery charge status. The Crono 30 is essenially the same as the Crono, but has a 30 ml infusion capacity. It infuses at a rate of 3 ml per impulse.
- 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 | Crono, K013234 | Crono and Crono 30 |
|---------------------------|----------------------------------------------------------|---------------------------------------------------------------------|
| Intended Use: | subcutaneous 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 | 22µl or 33 µl for Crono 30<br>with 30 ml syringe |
| Size | 3" x 1.85" x 1.14" (77 x 48<br>x 29 mm) | SAME<br>For Crono 30: 3.15" x<br>1.89" x 1.38" (80 x 48 x 35<br>mm) |
| Weight | 4.0 oz (115 g) (battery<br>included). | SAME<br>Crono 30: 125 g. (battery<br>included) |
| Capacity | 10 or 20 ml | 10, 20, or 30 ml |
| 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 Crono and Crono 30 pumps are 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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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 an eagle with three wavy lines below it, representing water.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 0 8 2004

Cane S.r.l. C/O Mr. Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015

Re: K041414

Trade/Device Name: Crono and Crono 30 Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: June 28, 2004 Received: July 1, 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 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. Kamm

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 your 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/dsma/dsmamain.html

Sincerely yours.

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):_____________________________________________________________________________________________________________________________________________________

Crono and Crono 30 Device Name:

Indications For Use: The Crono and Crono 30 ambulatory infusion pump devices have been designed for use in subcutaneous infusion of prescribed liquid medicines.

Prescription Use _ X _ AND/OR (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)

Cun

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital, Division of Antoon Dental Devices

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