The portable Crono infusion device has been designed only for use in subcutaneous infusion of prescribed liquid medicines.
The Microjet Crono ambulatory infusion pump device has been designed for use in subcutaneous infusion of prescribed liquid medicines.

Device Description

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. The infusion pumps which use normal commercial syringes are inevitably cumbersome and thus difficult to use 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. Patients 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 times higher with respect to conventional pumps. In case of catheter occlusion, an innovative infusion control system makes it possible to proceed with the infusion automatically and, after the occlusion is eliminated, 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 ml 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.

AI/ML Overview

The provided text describes a 510(k) summary for the Microjet Crono Ambulatory Infusion Pump. It does not contain information typically found in acceptance criteria and study designs for evaluating device performance against specific metrics like sensitivity, specificity, or image quality, which are more common in studies for diagnostic devices or AI algorithms.

Instead, this document focuses on demonstrating substantial equivalence to a predicate device (Cadd-Legacy 1 Ambulatory Infusion Pump) by comparing general characteristics and safety/effectiveness conclusions based on "bench, EMC, and user testing."

Therefore, I cannot provide a table of acceptance criteria and reported device performance in the traditional sense, nor can I answer questions related to sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. These types of studies were not conducted or described in the provided submission for this device.

The "acceptance criteria" in this context are implicitly the characteristics listed in the "Substantial Equivalence Chart" and the general safety and effectiveness claims.

Here's a breakdown of what can be extracted based on the provided text, addressing only the relevant points:

1. A table of (implicit) acceptance criteria and the reported device performance

The acceptance criteria here are based on similarity to the predicate device and the successful completion of specified tests.

Characteristic / Acceptance Criterion	Reported Microjet Crono Performance
Intended Use	Subcutaneous only
Physical characteristics:
Power Source	Lithium battery (3V) of the 123 A type
Size	3" x 1.85" x 1.14" (77 x 47 x 29 mm)
Weight	4.0 oz (115 g) (battery included)
Capacity	10 or 20 ml
Warranty	2 years
Safety and Effectiveness	Results of bench, EMC, and user testing indicate safety and effectiveness.
Technological Differences	Few technological differences compared to the predicate.
New Indications for Use	No new indications for use.

2. Sample sized used for the test set and the data provenance: Not applicable. The document mentions "bench, EMC, and user testing" but does not specify sample sizes for these tests or the provenance of any data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment by experts is not described for this type of device submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are not described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is not an AI-powered diagnostic tool, so MRMC studies are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an infusion pump, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the traditional sense. The "ground truth" for this submission is implicitly established by the performance of the predicate device and the successful completion of engineering and usability tests.

8. The sample size for the training set: Not applicable. There is no mention of a training set for an algorithm.

9. How the ground truth for the training set was established: Not applicable. There is no mention of a training set for an algorithm.

Summary

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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 January 30, 2002

510(k) Summary of Safety and Effectiveness

1. Identification of the Device: Proprietary-Trade Name: Microjet Crono Classification Name: 80 FRN Common/Usual Name: Ambulatory Infusion Pump
1. Equivalent legally marketed devices This product is similar in function to the Cadd-Legacy 1 Ambulatory Infusion Pump , Sims Deltec, Inc., K982838
1. Indications for Use (intended use) The portable Crono infusion device has been designed only for use in subcutaneous infusion of prescribed liquid medicines.
1. 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. The infusion pumps which use normal commercial syringes are inevitably cumbersome and thus difficult to use 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. Patients 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 times higher with respect to conventional pumps. In case of catheter occlusion, an innovative infusion control system makes it possible to proceed with the infusion automatically and, after the occlusion is eliminated, 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 ml 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.
1. 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	Cadd-Legacy 1Ambulatory InfusionPump , Sims Deltec, Inc.,K982838	Microjet Crono
Intended Use:	IntravenousIntra-arterialSubcutaneousIntraperitonealEpiduralIntrathecal	Subcutaneous only
Physical characteristics:
Power Source:	2 AA alkaline batteries, ACAdapter	Lithium battery (3V) of the123 A type
Size	4.4 x 3.8 x 1.6 x in (112x95x41 mm)	3" x 1.85" x 1.14" (77 x 47x 29 mm)
Weight	13.8 oz (392 grams)	4.0 oz (115 g) (batteryincluded).
Capacity	10 ml	10 or 20 ml
Warranty:	1 year	2 years

7. Conclusion

After analyzing both bench and user testing data, it is the conclusion of CANÈ S.r.1. that the Microjet Crono is 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with three distinct head profiles layered on top of each other.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cane S.R.L. C/O Mr. Daniel Kamm Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015

Re: K013234

Trade/Device Name: Microjet Crono Ambulatory Infusion Pump Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: January 30, 2002 Received: January 31, 2002

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.

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.

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Page 2 - Mr. Hamm

You must comply with all the Act's requirements, including, but not limited to: registration r od intilet compry was a 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 OF Furt 007), labeling (25) regulation (21 CFR Part 820); and if requirements as set form in the quality sign 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 110(k) premarket notification. The FDA finding of substantial equivalence of your device to 910(t) promaticate 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the and additionally 21 CF (301) 594-4618 . Additionally, for questions on the promotion and Office of Compliance ice, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Punor

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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j) Indications for Use

510(k) Number K013234

Device Name: Microjet Crono ambulatory infusion pump

Indications for Use: The Microjet Crono ambulatory infusion pump device has been designed for use in subcutaneous infusion of prescribed liquid medicines.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ ﺳﮯ ﺳﮯ ﺍﯾﺴﮯ ﻣﯿﮟ ﺍﺱ ﮐﮯ ﺳﺎﺗﮫ ﺍﺱ ﮐﮯ ﺳﺎﺗﮫ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍ (Per 21 CFR 801.109)

Over the Counter Use

Patricia Cussenite

--------------------Divison Of Donal, Infection Control, and General Hospits! Devices

510(k) Number: K013234

Regulation Number and Section

§ 880.5725 Infusion pump.

(a)
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.(b)
Classification. Class II (performance standards).