CRONO FIVE AND CRONO PCA 50

K052218 · Cane S.R.L. · FRN · Nov 23, 2005 · General Hospital

Device Facts

• Record ID: K052218
• Device Name: CRONO FIVE AND CRONO PCA 50
• Applicant: Cane S.R.L.
• Product Code: FRN · General Hospital
• Decision Date: Nov 23, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The portable Crono Five and Crono PCA 50 infusion devices have been designed for use in subcutaneous infusion of prescribed liquid medicines. The Crono Five and Crono PCA 50 has been designed for use in subcutaneous, intravenous, epidural and intrathecal infusions of prescribed liquid medicines.

Device Story

Crono Five and Crono PCA 50 are ambulatory infusion pumps for controlled drug delivery; used in hospital or home settings by clinicians or patients. Devices accept dedicated 10, 20, or 50 ml syringes. Operation modes include continuous, bolus on request (PCA), clinician bolus, and combined. Pumps feature keypad lock-out to prevent unauthorized reprogramming and an LCD for displaying delivery status, programmed values, and remaining time. Devices provide precise drug administration; benefit patients by enabling portable, controlled therapy. Healthcare providers use output data to monitor therapy progress and ensure correct dosage delivery.

Clinical Evidence

Bench testing, EMC testing, and user testing were performed. No clinical trial data provided. Testing confirmed flow rate accuracy (+/-2% for Crono Five, +/-3% for Crono PCA 50) and occlusion pressure performance (2.2 bar +/- 0.5 bar).

Technological Characteristics

Ambulatory infusion pump; battery-powered (3V Lithium 123A). Infusion modalities: continuous, PCA, clinician bolus, combined. Features LCD interface and keypad lock-out. Dedicated syringe sizes: 10, 20, 50 ml. Flow rate accuracy +/-2-3%. Max occlusion pressure 2.2 bar +/- 0.5 bar.

Indications for Use

Indicated for subcutaneous, intravenous, epidural, and intrathecal infusion of prescribed liquid medicines in patients requiring controlled drug administration in hospital or home settings.

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)
• Crono PCA (K013822)
• Crono go (K013840)

Submission Summary (Full Text)

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NOV 2 3 2005

MEDICAL TECHNOLOGY

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 for CERMET, which is a certification organization. The logo includes the text "CERMET" in bold letters, along with the phrase "SISTEMA DI GESTIONE CERTIFICATO". Below this, it indicates compliance with standards REG. N. 3506, UNI EN ISO 9001:2000, and ISO 13485:2003.

## 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 4, 2005

## 510(k) Summary

1. Identification of the Device: Proprietary - Trade Name: Crono Five and Crono PCA 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 Crono cleared under 510(k) number K041414.

## 3. Indications for Use (intended use)

The portable Crono Five and Crono PCA 50 infusion devices have been designed for use in subcutaneous infusion of prescribed liquid medicines.

## 4. Description of the Device

Crono Five is a new, innovative ambulatory infusion pump that is very appreciated by health care professionals and patients due to its small size and technical features.

Crono Five is especially suited for controlled drug administration on patients in hospital or undergoing a therapy at home. The pump is suitable for subcutaneous, intra-venous, epidural and intrathecal infusions allowing 4 different administration modalities:

## 1. Continuous

- 2. Bolus dose upon request (PCA)
- 3. Clinician bolus (managed by clinician)
- 4. Combined (continuous + bolus upon request + clinician bolus)

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

## SINGERI

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# SINGERT

Image /page/1/Picture/2 description: The image shows a logo or wordmark that includes a stylized cross-like symbol on the left, followed by the word "CANE" in bold, sans-serif font. The cross symbol is formed by thick, black bars arranged to create a symmetrical shape with a white space in the center. The letters in "CANE" are also constructed from thick, black bars, giving them a blocky and modern appearance. The overall design is simple, bold, and visually striking.

MEDICAL TECHNOLOGY
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/1/Picture/4 description: The image shows a logo for CERMET, which is a certification organization. The logo includes the text "CERMET" in a bold font, along with the phrase "SISTEMA DI GESTIONE CERTIFICATO". Below this, it states "REG. N. 3506" and "UNI EN ISO 9001:2000". The logo is contained within a rounded rectangular shape.

The pump is provided with key-pad lock-out functions in order to avoid un-authorized reprogramming of the drug administration protocol.

The liquid crystal display (LCD) can show relevant information to caregivers and patients like programmed values, amount of drug delivered, remaining delivery time etc.

Crono PCA 50 is essentially the same as the Crono Five, but has a 50 ml infusion capacity.

## 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 PCA - K013822 | Crono Five<br>Crono PCA 50 |
|--------------------------|---------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Intended Use | subcutaneous, intra-venous,<br>epidural and intrathecal<br>infusions of prescribed<br>liquid medicines. | SAME |
| Physical characteristics | Crono go - K013840 | Crono Five<br>Crono PCA 50 |
| Size | 3" x 1.85" x 1.14" (77 x 48<br>x 29 mm). | SAME<br>For Crono PCA 50: 84.5 x<br>55 x 42 mm. |
| Weight | 4.0 oz (115 g) (battery<br>included). | SAME<br>For Crono PCA 50: 140 g<br>(battery included). |
| Battery | Power Source Lithium<br>battery (3V) of the 123 A<br>type. | SAME |
| Infusion per impulse | 22 μl. | Crono Five: 5 μl.<br>Crono PCA 50: 20 μl. |
| Flow rate accuracy | +/-2%. | Crono Five: +/-2%.<br>Crono PCA 50: +/-3%. |
| Max. Occlusion pressure | 4.5 bar +/-1 bar. | Crono Five: 2.2 bar +/-0.5<br>bar.<br>Crono PCA 50: 2.2 bar +/-<br>0.5 bar. |
| Capacity | 10 or 20 ml. | 10, 20 ml or 50 ml. |

## 6. Substantial Equivalence Chart

## 7. Conclusion

After analyzing both bench and user testing data, it is the conclusion of CANÈ S.r.I. 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 the predicated 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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 3 2005

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

Re: K052218

Trade/Device Name: CRONO FIVE AND CRONO PCA 50 Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion pump Regulatory Class: II Product Code: FRN and MEA Dated: September 21, 2005 Received: September 26, 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 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. 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); 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/industry/support/index.html.

Sincerely yours,

Sulta y. Mckin Omd

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 the word "CANE" in bold, black letters. To the left of the word is a symbol that looks like two mirrored "C" shapes, also in bold black. The letters are sans-serif and appear to be part of a logo or title. The background is plain and white, which makes the black text stand out.

VED CAL TECHNOLOGY

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/4/Picture/2 description: The image shows a logo with the word "CERMET" in bold letters. Below the word CERMET are the words "SISTEMA DI GESTIONE CERTIFICATO" stacked on top of each other. At the bottom of the logo are the words "REG. N. 3506" followed by "UNI EN ISO 9001:2000" and "ISO 13485:2002".

SINGERT

j) Indications for Use

Koszug 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Crono Five and Crono PCA 50.

Indications For Use: the Crono Five and Crono PCA 50 has been designed for use in subcutaneous, intravenous, epidural and intrathecal infusions 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)

Joon Lir. For ADW al

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

Koszus 510(k) Number:_