Canè s.r.l., a company that specializes in the production of ambulatory pumps, has now produced a new generation of compact pumps: Crono H, 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 H 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 iron chelation 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 H 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 H 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 H is fitted with a liquid crystal display which shows the time it takes to complete the delivery and battery charge status.

AI/ML Overview

This document is a 510(k) summary for the Microjet Crono H ambulatory infusion pump. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner requested (i.e., a study involving AI/machine learning performance assessment).

Here's what can be extracted from the document based on the provided format, with explanations where information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present acceptance criteria for performance metrics (e.g., accuracy, precision of infusion) in a quantitative sense with corresponding reported performance values. Instead, it relies on a comparison to a predicate device to establish substantial equivalence.

Characteristic	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (Microjet Crono H)
Intended Use	Intravenous, Intra-arterial, Subcutaneous, Intraperitoneal, Epidural, Intrathecal (Predicate)	Subcutaneous and intravenous only
Power Source	2 AA alkaline batteries, AC Adapter (Predicate)	Lithium battery (3V) of the 123 A type
Size	4.4 x 3.8 x 1.6 x in (112x 95x41 mm) (Predicate)	3" x 1.85" x 1.14" (77 x 47 x 29 mm)
Weight	13.8 oz (392 grams) (Predicate)	4.0 oz (115 g) (battery included)
Capacity	10 ml (Predicate)	10 or 20 ml
Warranty	1 year (Predicate)	2 years
Safety & Effectiveness	Safety and effectiveness comparable to predicate device in bench, EMC, and user testing.	"The results of bench, EMC, and user testing indicates that the new device is as safe and effective as the predicate device." "After analyzing both bench and user testing data, it is the conclusion... that the Microjet Crono is as safe and effective as the predicate device..."

2. Sample size used for the test set and the data provenance

The document mentions "bench, EMC, and user testing" but does not specify sample sizes for any of these tests, nor does it provide details on the data provenance (e.g., country of origin, retrospective/prospective nature).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. The testing described is for a medical device (infusion pump) and does not involve "ground truth" derived from expert consensus in the way a diagnostic imaging AI algorithm would.

4. Adjudication method for the test set

Not applicable, as the evaluation type does not involve an adjudication process as described (e.g., for expert consensus on images).

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

No such study was mentioned. The device is an ambulatory infusion pump, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. The device is a physical infusion pump, not a standalone algorithm.

7. The type of ground truth used

The concept of "ground truth" as typically applied to AI/machine learning data sets (e.g., expert consensus, pathology, outcome data) is not relevant here. The evaluation relies on engineering tests (bench testing, EMC testing) and user testing to assess the device's functional performance, safety, and effectiveness in comparison to a predicate device.

8. The sample size for the training set

Not applicable. This is a medical device submission, not an AI/machine learning model submission where a "training set" would be used.

9. How the ground truth for the training set was established

Not applicable.

Summary of the K013855 Submission's Approach to Demonstrating Safety and Effectiveness:

The K013855 submission for the Microjet Crono H ambulatory infusion pump focuses on demonstrating substantial equivalence to a previously legally marketed device (Cadd-Legacy 1 Ambulatory Infusion Pump, K982838). The primary method for proving this is through a detailed comparison of characteristics and results from "bench, EMC, and user testing," which reportedly showed the new device to be "as safe and effective as the predicate device."

The document does not detail acceptance criteria in a quantitative, performance-metric-based fashion. Instead, the "acceptance criterion" is implicitly met by showing that the new device's characteristics and performance are comparable to, or better than, the predicate device across various features, particularly in its fundamental function as an infusion pump. The "study" that proves this is the collection of "bench, EMC, and user testing" data, which are not described in detail regarding methodologies, sample sizes, or specific performance outcomes.

Summary

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K013855

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 H 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 and intravenous infusion of prescribed liquid medicines.
1. 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 H, 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 H 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 iron chelation 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 H 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 H 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 H 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 CronoH
Intended Use:	IntravenousIntra-arterialSubcutaneousIntraperitonealEpiduralIntrathecal	Subcutaneous andintravenous only
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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 0 9 2002

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

Re: K013855

Trade/Device Name: MicroJet Crono H Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: February 14, 2002 Received: February 15, 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

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Page 2 - Mr. Kamm

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594 advertising of your device, 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,

Susa Punoy

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 K013855

Device Name: Microjet CronoH ambulatory infusion pump

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use OR P (Per 21 CFR 801.109)

Over the Counter Use

Pulace Licente

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number_4615

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).