CRONO SUPER PID

K052217 · Cane S.R.L. · FRN · Sep 13, 2005 · General Hospital

Device Facts

• Record ID: K052217
• Device Name: CRONO SUPER PID
• Applicant: Cane S.R.L.
• Product Code: FRN · General Hospital
• Decision Date: Sep 13, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Crono Super PID is an ambulatory syringe infusion pump for controlled subcutaneous delivery of liquid medications. Device is compact, wearable, and intended for use during daily activities. It utilizes dedicated 10 ml or 20 ml syringes. A mechanical pusher acts directly on the rubber syringe piston to provide high thrust force and administration accuracy. The device delivers 22 µl per impulse. An integrated infusion control system manages occlusions by pausing and automatically resuming delivery once the occlusion is cleared. An LCD displays time to completion, syringe size, and battery status. Operated by the patient, the pump allows for continuous medication administration without interrupting daily life or leisure activities. Healthcare providers use the device to facilitate prescribed subcutaneous therapy.

Clinical Evidence

Bench testing only. Testing included evaluation of infusion accuracy, occlusion pressure, battery performance, and EMC compliance. User testing was conducted to verify device operation. No clinical trials were performed.

Technological Characteristics

Ambulatory syringe infusion pump. Materials: not specified. Power: 3V Lithium battery (123A type). Dimensions: 77 x 48 x 29 mm. Weight: 115 g. Mechanism: direct mechanical pusher on syringe piston. Infusion: 22 µl per impulse. Flow accuracy: +/- 2%. Max occlusion pressure: 4.5 bar +/- 1 bar. Display: LCD. Connectivity: none. Sterilization: not specified.

Indications for Use

Indicated for subcutaneous infusion of prescribed liquid medicines in patients requiring ambulatory drug delivery.

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 (K041414)

Submission Summary (Full Text)

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Kas2217

# SEP 1 3 2005

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Image /page/0/Picture/3 description: The image shows a logo with the text "CERMET" in bold letters. Below CERMET, the text "SISTEMA DI GESTIONE CERTIFICATO" is present. Further down, the text "REG. N. 3506 UNI EN ISO 9001:200 ISO 13485:2002" is displayed, indicating compliance with specific ISO standards.

## EXHIBIT 2

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 July 4, 2005

510(k) Summary

### 1. Identification of the Device:

Proprietary - Trade Name: Crono Super PID. 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 K041414.

### 3. Indications for Use (intended use)

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

### 4. Description of the Device

Cane 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.

Crono Super PID is an ambulatory syringe infusion pump intended for the controlled administration of liquids into the patients. This means that the pump can be worn during the infusion.

Crono Super PID combines high technology with innovative design. Thanks to the small size of the pump the patients can administer the drug any time daring the day without interrupting daily life or leisure activities.

Crono Super PID pump uses dedicated syringes which are available in two sizes: 10 and 20 ml.

Crono Super PID has a particular mechanism which pushes directly on the rubber syringe piston, which makes it possible to reach a significant thrust force and high accuracy of administration.

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# SINGERI

Image /page/1/Picture/2 description: The image shows the word "CANE" in a stylized font. To the left of the word is a symbol that looks like two squares with lines extending from the top and bottom. The letters in the word "CANE" are blocky and have a textured appearance. The overall image has a simple, graphic design.

**MEDICAL TECHNOLOGY**

P.IVA - Reg. Impr. TO: 04384410017
R.E.A. TO Ν. 629783
Cap. Soc. Euro 10.400 i.v.

Image /page/1/Picture/5 description: The image shows a logo for CERMET, which is an Italian certification organization. The logo features a stylized "C" shape at the top, followed by the text "CERMET" in a bold font. Below that, there is a rectangle containing the words "SISTEMA DI GESTIONE CERTIFICATO". The text at the bottom of the logo indicates the certifications held, including "REG. N. 3506", "UNI EN ISO 9001:2000", and "ISO 13485:2002".

Crono Super PID administers 22 µl per impulse.

In case of occlusion, an innovative infusion control system makes it possible to proceed with the infusion automatically and, after the occlusion is eliminated, to complete it.

Crono Super PID is fitted with a liquid cristal display which shows the time it takes to complete the delivery, the syringe size and the 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.

| Characteristic | Crono - K041414 | Crono Super PID |
|--------------------------|-------------------------------------------------------------|-----------------|
| Intended Use | Subcutaneous infusion of<br>prescribed liquid<br>medicines. | SAME |
| Physical characteristics | Crono - K041414 | Crono Super PID |
| 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 |
| Battery | Power Source Lithium<br>battery (3V) of the 123 A<br>type. | SAME |
| Infusion per impulse | 22 μl. | SAME |
| Flow rate accuracy | +/-2%. | SAME |
| Max. Occlusion pressure | 4.5 bar +/-1 bar. | SAME |
| Capacity | 10 or 20 ml. | SAME |

### 6. Substantial Equivalence Chart

#### 7. Conclusion

After analyzing both bench and user testing data, it is the conclusion of CANE S.r.l. that Crono pumps are as safe and effective as the predicate device, has few software 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 Department of Health and Human Services, USA. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, which is a common symbol of the United States.

Public Health Service

SEP 1 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Carlo Musso Quality Manager Cane S.R.L., Medical Technology Via Pavia, 105/I 10090 Rivoli-Cascine Vica Torino ITALY

Re: K052217

Trade/Device Name: Crono Super PID Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion pump Regulatory Class: II Product Code: FRN Dated: July 26, 2005 Received: August 15, 2005

Dear Mr. Musso:

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 for abor and a 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. Musso

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be advised that I DT brissants over device complies with other requirements of the Act that I DA has made a acteriminations administered by other Federal agencies. You must of ally receral statures and regaranents ancluding, but not limited to: registration and listing (21 Comply with an the 11et 81e creations) (1) good manufacturing practice requirements as set CI K I at 607); adomig (21 CFR Part 820); and if applicable, the electronic forth in the quality bystems (Sections 531-542 of the Act); 21 CFR 1000-1050. product ladiation control provins (evening your device as described in your Section 510(k) This letter will and in you'ts began finding of substantial equivalence of your device to a legally promative notification: "The started on 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 If you desire spocents arrivaliation of [phone]. Also, please note the regulation entitled, Contact the Office of Companies in (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on Jour Popsumer 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,

Chiu Lin, Ph.D.

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

Enclosure

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Image /page/4/Picture/0 description: The image shows the word "CAINE" next to a symbol that looks like a plus sign. The word and the symbol are both in a bold, sans-serif font. The image is black and white, and the text is black on a white background. The plus sign is made up of thick, rectangular bars.

Canė S.r.l. società unipersonale
P.IVA - Reg. Impr. TO: 04384410017
R.E.A. TO Ν. 629783
Cap. Soc. Euro 10.400 i.v.

Image /page/4/Picture/2 description: The image shows a logo for CERMET, which is a certification organization. The logo includes the text "CERMET" and "SISTEMA DI GESTIONE CERTIFICATO". It also includes the registration number REG. N. 3506 and the standards UNI EN ISO 9001:200 and ISO 13485:2002.

SINCERT

j) Indications for Use

Korzzi7 510(k) Number (if known):

Device Name: Crono Super PID.

Indications For Use: the Crono Super PID has been designed for use in subcutaneous infusion of prescribed liquid medicines.

Prescription Use X . (Part 21 CFR 801 Subpart D)

AND/OR

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)

Ried C. Chopra FOR ACW

(Division Sign-Off Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

KO 510(k) Number:_