CRONO GO.

K052219 · Cane S.R.L. · FRN · Sep 13, 2005 · General Hospital

Device Facts

• Record ID: K052219
• Device Name: CRONO GO.
• 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 Crono go has been designed for use in subcutaneous infusion of prescribed liquid medicines.

Device Story

Crono go is an ambulatory syringe infusion pump for controlled subcutaneous administration of liquid medications. Device is worn by patient during infusion, allowing administration without interrupting daily activities. Pump uses dedicated 10 ml or 20 ml syringes; mechanism pushes directly on rubber syringe piston to provide thrust force and administration accuracy. Features include bolus dose administration via dedicated button, occlusion detection system with automatic recovery, and LCD display showing time to completion, syringe size, and battery status. Operated by patient or caregiver in home or clinical settings. Output allows patients to receive prescribed therapy while mobile; healthcare providers use pump to ensure accurate, controlled drug delivery.

Clinical Evidence

Bench testing only. Results indicate flow rate accuracy of +/-2%, max occlusion pressure of 4.5 bar +/-1 bar, and successful performance in EMC and user testing compared to the predicate device.

Technological Characteristics

Ambulatory syringe infusion pump. Dimensions: 77 x 48 x 29 mm. Weight: 115 g. Power: 3V Lithium battery (123 A type). Infusion per impulse: 22 μl. Flow rate accuracy: +/-2%. Max occlusion pressure: 4.5 bar +/-1 bar. Capacity: 10 or 20 ml. LCD display. Occlusion detection system.

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 go (K013840)

Submission Summary (Full Text)

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SEP 1 3 2005

Image /page/0/Picture/1 description: The image shows the word "CAINE" in bold, black letters. To the left of the word is a symbol that resembles a plus sign, but with a more geometric and stylized design. The letters are slightly tilted to the right, giving the impression of movement or a dynamic feel.

Canė S.r.l. società unipersonale

P.IVA - Reg. Impr. TO: 04384410017

R.Ε.Α. ΤΟ Ν. 629783

Cap. Soc. Euro 10.400 i.v.

Image /page/0/Picture/4 description: The image shows a logo with the text "CERMET" in bold letters. Below that, there is a smaller box with the text "SISTEMA DI GESTIONE CERTIFICATO". Further down, the text "REG. N. 3506 UNI EN ISO 9001:200 ISO 13485:2002" is displayed, indicating a certification or registration number along with ISO standards.

## EXHIBIT 2

CANÈ S.r.I. 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 go. Classification Name: 80 FRN. Common/Usual Name: Ambulatory Infusion Pump.

#### 2. Equivalent legally marketed devices

2: Equivalient regulty marriction and design to the Crono cleared under 510(k) number K041414.

## 3. Indications for Use (intended use)

or manuallence on ogo 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 Same of miration of compact pumps: Crono, a perfect combination of high technology and innovative design.

Crono go 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 go combines high technology with innovative design. Thanks to the small size of the pump Orono go sombinister the drug any time during the day without interrupting daily life or leisure activities.

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

Crono go has a particular mechanism which pushes directly on the rubber syringe piston, which Orono go has a particular mestignificant thrust force and high accuracy of administration.

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Image /page/1/Picture/1 description: The image shows the word "CAINE" in a stylized font. The letters are bold and have a unique design, with horizontal lines running through them. To the left of the word is a symbol that resembles a plus sign or a cross, also in a bold and stylized design. The overall image has a modern and geometric aesthetic.

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

Image /page/1/Picture/3 description: The image shows a logo with the word "SINCERT" at the top. Below that is a logo with the word "CERMET" inside of it. Underneath the logo, the words "SISTEMA DI GESTIONE CERTIFICATO" are written. The text "REG. N. 3506, UNI EN ISO 9001:2000, ISO 13485:2002" is at the bottom of the image.

Additional bolus doses can be easily administered by pressing a dedicated button, and the administered bolus dose is shown on the display screen.

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 go is fitted with a liquid crisfal 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 go - K013840 | Crono go |
|--------------------------|-------------------------------------------------------|----------|
| Intended Use | Subcutaneous infusion of prescribed liquid medicines. | SAME |
| Physical characteristics | Crono go - K013840 | Crono go |
| Size | 3" x 1.85" x 1.14" (77 x 48 x 29 mm). | SAME |
| Weight | 4.0 oz (115 g) (battery included). | SAME |
| Battery | Power Source Lithium battery (3V) of the 123 A 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 CANÈ 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the caduceus. The seal is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 3 2005

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

Re: K052219

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

Dear Mr. Musso:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your bocaon by (1) person the device is substantially equivalent (for the referenced above and have determined the arrest and the marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mersuale collimence prior to ritay 20, 1970, accordance with the provisions of Amendinents, on to devroes that have of the Act (Act) that do not require approval of a prematic the Fedelar Pood, Drug, und Conners , therefore, market the device, subject to the general approval application (1 Mir). The general controls provisions of the Act include controls provisions of the Fea. "The garries, 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 II your device is classified (see above) into exontrols. Existing major regulations affecting (FMA), it may be subject to back addinf Federal Regulations, Title 21, Parts 800 to 898. In your device can oc found in the Seas nouncements 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 Please be advised that FDA S Issualled of a baseaux and as the other requirements
mean that FDA has made a determination that your device the Federal agencies mean that FDA has made a decemmance and regulations administered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by seciences and of the Act of any Federal statutes and regulaents, including, but not limited to: registration
You must comply with all the Act's requirements, and manufacturing protice You must comply with an the Fee s requirements and 801); good manufacturing practices
and listing (21 CFR Part 807); labeling (21 CFR Part 801); gED Box 800); and i and listing (21 CFR I art 607), lacemig (21 CFR Part 820); and if requirements as set form in the quality by 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 5 10(k) I his letter will anow you to begin maticemly your substantial equivalence of your device to a premarket nothleation. The I Dr Imaling of basemans of 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 Patt 801), If you desire specific auvice for your device at [phone]. Also, please note the regulation please comact the Other or Comphanes are (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may outain other general miormational and Consumer Assistance at its toll-free Division of Division of [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 for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/0 description: The image shows a logo with a cross symbol on the left and the word "CAINE" on the right. The cross symbol is made up of thick black lines, and the word "CAINE" is written in bold, sans-serif letters. The logo appears to be for a company or organization with the name "CAINE".

Cané S.r.l. società unipersonale
P.IVA - Reg. Impr. TO: 04384410017
R.Ε.Α. ΤΟ Ν. 629783
Cap. Soc. Euro 10.400 ί.ν.

Image /page/4/Picture/2 description: The image shows a logo with the text "CERMET" in bold letters. Below that, it says "SISTEMA DI GESTIONE CERTIFICATO". Further down, it reads "REG. N. 3506" followed by "UNI EN ISO 9001:2000" and "ISO 13485:2002". The logo includes a stylized symbol at the top.

SINGERT

j) Indications for Use

Kos 2219 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Crono go.

Indications For Use: the Crono go 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)

Rihd C Chapman for ACw

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

510(k) Number:_