CRONO S-PID 50

K091042 · Cane S.R.L. · FRN · May 12, 2009 · General Hospital

Device Facts

• Record ID: K091042
• Device Name: CRONO S-PID 50
• Applicant: Cane S.R.L.
• Product Code: FRN · General Hospital
• Decision Date: May 12, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The portable Crono S-PID 50 infusion devices have been designed for use in subcutaneous infusion of prescribed liquid medicines.

Device Story

Crono S-PID 50 is a compact, ambulatory syringe infusion pump for subcutaneous delivery of prescribed liquid medicines. Device uses 50 ml dedicated syringes; mechanism pushes directly on rubber syringe piston to provide high thrust force and administration accuracy. Pump is wearable, allowing patients to maintain daily activities during infusion. Features include LCD showing delivery time, syringe size, and battery status. Includes infusion control system for automatic recovery after occlusion. Operated by patient or clinician in various settings. Output is controlled liquid infusion; healthcare providers use device to manage patient medication regimens, potentially improving quality of life by enabling ambulatory treatment.

Clinical Evidence

Bench testing, EMC testing, and user testing were performed. No clinical data provided. Testing confirmed device safety and effectiveness compared to predicate devices.

Technological Characteristics

Ambulatory syringe infusion pump; 50 ml syringe capacity; 20 μl per impulse; 3V Lithium battery (123 A type); LCD interface; mechanical piston drive; occlusion detection system. Dimensions: 3.3" x 2.15" x 1.65".

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 Super PID (K052217)
• Crono PCA 50 (K052218)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the word "CANE" next to a plus sign. The plus sign is made up of two thick black lines that intersect in the middle. The word "CANE" is written in a bold, sans-serif font. The letters are all capitalized and are black in color.

Canė S.p.A. - Socio Unico
Direzione e coordinamento CMF S.r.l.
C.F.-P.IVA - Reg. Impr. TO: 04384410017
R.E.A. ΤΟ Ν. 629783
Cap. Soc. Euro 120.000,00 i.v.

K091042

ea Qualità /

Image /page/0/Picture/5 description: The image shows a logo with a stylized "C" at the top, followed by the word "CERMET" in bold, sans-serif font. Below "CERMET" is a rectangular box containing the words "SISTEMA DI GESTIONE CERTIFICATO" stacked on top of each other. The text "REG N. 3506 UNI EN ISO 9001:2000 ISO 13485:2004" is at the bottom of the logo.

MAY 12 2009

## EXHIBIT 2

CANĖ S.r.l. Via Pavia, 105/l 10090 Rivoli-Cascine Vica (Torino) Italy Tel .: ++39-011-957.48.72 Fax ++39-011-959.88.80 Contact: Mario Cané, President April 1, 2009

510(k) Summary

1. Identification of the Device: Proprietary - Trade Name: Crono S-PID 50. 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 pumps cleared under 510(k) number K052217 (Crono Super PID) and K052218 (Crono PCA 50).

## 3. Indications for Use (intended use)

The portable Crono S-PID 50 infusion devices have been designed for use in subcutaneous 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, a perfect combination of high technology and innovative design.

Crono S-PID 50 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 S-PID 50 combines high technology with innovative design. Thanks to the small size of the pump the patients can administer the drug any time during the day without interrupting daily life or leisure activities.

Crono S-PID 50 pump uses 50 ml dedicated syringes.

Crono S-PID 50 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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Image /page/1/Picture/0 description: The image shows the word "CANE" in bold, block letters next to a symbol that resembles a plus sign. The plus sign is also made of bold, block shapes. The text and symbol are black against a white background.

MEDICAL TECHNOLOGY

Rep. Imar. TO: 0438 TO N 629783 Soc. Euro 120,000.00 f. Area Qualità

Image /page/1/Picture/4 description: The image shows a logo with the text "SINCERT" at the top. Below that is a circular logo with the letters "C" and "Cermet" inside. The text "Sistema di Gestione Certificato" is below the logo. The bottom of the image contains the text "REG N. 3506, UNI EN ISO 9001:2000, ISO 13485:2004".

Crono S-PID 50 administers 20 ul 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 S-PID 50 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.

## 6. Substantial Equivalence Chart

| Characteristic | Crono PCA 50 - K052218 | Crono Super PID - K052217 | Crono S-PID 50 |
|--------------------------|---------------------------------------------------------------------------------------|----------------------------------------------------------|-----------------------------------------|
| Intended Use | Subcutaneous, intravenous<br>and epidural infusion of<br>prescribed liquid medicines. | Subcutaneous infusion of<br>prescribed liquid medicines. | SAME to Crono<br>Super PID -<br>K052217 |
| Physical characteristics | Crono PCA 50 - K052218 | Crono Super PID- K052217 | Crono S-PID 50 |
| Size | 3.3" x 2.15" x 1.65"<br>(84.5 x 55 x 42 mm). | 3" x 1.85" x 1.14"<br>(77 x 48x 29 mm). | SAME to Crono PCA<br>50 - K052218 |
| Weight | 4.85 oz (140 g)<br>(battery included). | 4.0 oz (115 g)<br>(battery included). | SAME to Crono PCA<br>50 - K052218 |
| Battery | Power Source Lithium battery<br>(3V) of the 123 A type. | Power Source Lithium battery<br>(3V) of the 123 A type. | SAME |
| Infusion per impulse | 20 μl. | 22 μl. | SAME to Crono PCA<br>50 - K052218 |
| Flow rate accuracy | +/-3%. | +/-2%. | SAME to Crono PCA<br>50 - K052218 |
| Max. Occlusion pressure | 2.2 bar +/-0.8 bar. | 4.5 bar +/-1 bar. | 3 bar +/-1.5 bar. |
| Capacity | 50 ml. | 10 or 20 ml. | SAME to Crono PCA<br>50 - K052218 |

# 7. Conclusion

After analyzing both bench and user testing data, it is the conclusion of CANÈ S.p.A. 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 U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black against a white background.

#### Public Health Service

MAY 12 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Carlo Musso Quality Manager Cane S.p.A. Via Pavia, 105/I 10090 Rivoli-Cascine Vica (Torino) ITALY

Re: K091042

Trade/Device Name: Crono S-PID 50 Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: April 9, 2009 Received: April 15, 2009

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 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 cither class II (Special Controls) or class III (PMA), it may be subject to 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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/industry/support/index.html.

Sincerely yours,

Anthony D. Minter Sr.

Susan Runner, D.D.S., MA Acting 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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Image /page/4/Picture/0 description: The image shows the word "CANE" in a stylized font. The letters are bold and black, and the word is horizontally oriented. The letters are spaced closely together, and the overall impression is one of a simple, graphic design.

ne e coordinamento CMF 5 Reg. Impr. TO: 04384410017 Area Qualità

Image /page/4/Picture/3 description: The image shows a logo with the text "SINCERT" at the top. Below that is a circular logo with the text "CERMET" below it. Further down, the text "SISTEMA DI GESTIONE CERTIFICATO" is present, followed by "REG. N. 3506", "UNI EN ISO 9001:2000", and "ISO 13485:2004".

j) Indications for Use

510(k) Number (if known): _

Device Name: Crono S-PID 50.

Indications For Use: the Crono S-PID 50 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)

Light Illum. for LCDR, Colburn 05/14/09

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

510(k) Number: KO9 10 42

Canè S.p.A. Via Pavia, 105/110090 RIVOLI Cascine Vica (TO) Tel. [phone] +39.011.9598880 +39.011.9575089 www.canespa.it - [e-mail]