The "Microjet Crono K" and "Crono go" ambulatory infusion pump device has been designed for use in subcutaneous and intravenous infusion of prescribed liquid medicines.

Device Description

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

AI/ML Overview

Here's an analysis of the provided information regarding the Microjet Crono K and Crono go ambulatory infusion pumps, focusing on acceptance criteria and the study that proves the device meets them:

Disclaimer: The provided document is a 510(k) summary from 2002, which typically focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical trial results with detailed performance metrics and statistical analyses as might be found in a more recent PMA or extensive clinical study report. Therefore, some of the requested information (like specific effect sizes for MRMC studies or detailed ground truth methodologies) is not explicitly present in this type of submission.

Acceptance Criteria and Reported Device Performance

The provided 510(k) summary primarily demonstrates substantial equivalence to a predicate device (Cadd-Legacy 1 Ambulatory Infusion Pump, K982838) by comparing characteristics and showing that the new device is as safe and effective. It does not explicitly list quantified acceptance criteria with specific performance thresholds (e.g., a "must achieve X% accuracy"). Instead, "acceptance criteria" are implied by the comparison to the predicate device, where the new device must perform at least as well as or similarly to the predicate device in aspects like safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance:

Characteristic	Acceptance Criteria (Implied by Predicate)	Reported Device Performance ("Microjet Crono K" & "Crono go")
Intended Use	Subcutaneous and intravenous infusion of prescribed liquid medicines (as per predicate's relevant uses)	Subcutaneous and intravenous only
Safety	As safe as the predicate device	Bench, EMC, and user testing indicate safety comparable to predicate.
Effectiveness	As effective as the predicate device	Bench, EMC, and user testing indicate effectiveness comparable to predicate.
Technological Differences	Minor differences that do not raise new questions of safety or effectiveness	Few technological differences (e.g., battery type, size, weight, capacity, warranty) and no new indications for use.
Flow/Infusion Control	Reliable infusion without frequent occlusions, or with effective occlusion management (implied by predicate's function)	Particular mechanism for high thrust force (up to 3x higher) to address catheter occlusion; innovative infusion control system to proceed automatically after occlusion is eliminated. Infusion up to 3x more fractionated (22 ml per impulse for 10/20ml syringe) for better absorption.
Patient Experience/Usability	User-friendly, portable (implied to avoid "refuse of therapy")	Compact size (3" x 1.85" x 1.14", 4.0 oz) due to special syringe; fitted with LCD showing delivery time and battery status.

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the implied acceptance criteria for substantial equivalence consists of bench testing, EMC (Electromagnetic Compatibility) testing, and user testing.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: The document does not specify the sample size for the bench testing, EMC testing, or user testing. These are typically internal validation studies that are summarized to support the 510(k) rather than detailed clinical trial reports with specific patient numbers.
Data Provenance: The studies were conducted by CANÉ S.r.l. (the manufacturer) in Rivoli-Cascine Vica (Torino), Italy. The data is retrospective in the sense that these tests were performed and summarized to support the 510(k) submission. It's not a prospective, multi-center clinical trial report.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

The document does not provide details on the number of experts, their qualifications, or how ground truth was established specifically for the test sets (bench, EMC, user testing). Such information is generally not required for a 510(k) summary demonstrating substantial equivalence for this type of device. The "user testing" would likely involve medical professionals and/or patients, but their expert role in establishing a formal "ground truth" (as in diagnostic accuracy studies) is not described.

4. Adjudication Method for the Test Set:

The document does not describe any formal adjudication method for the test sets (bench, EMC, user testing). Adjudication methods like '2+1' or '3+1' are typical in diagnostic imaging studies where consensus among multiple readers is needed to define a ground truth for ambiguous cases. This is not applicable to the types of tests mentioned (bench, EMC, user testing) for an infusion pump.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was mentioned or performed as part of this 510(k) submission. MRMC studies are specific to diagnostic devices where human readers interpret medical images or data, and their performance with and without AI assistance is compared. This is not relevant for an infusion pump.

6. Standalone (Algorithm Only) Performance Study:

While the device itself is an "algorithm" in the sense that it controls infusion, no separate "standalone" algorithm-only performance study (without human-in-the-loop performance), as understood in AI/ML medical devices (e.g., an automated diagnostic algorithm without human oversight), was conducted or reported. The device's performance inherently involves its interaction with a user (loading medication, setting parameters) and patient (receiving infusion). The "bench testing" would evaluate the device's mechanical and electrical functions in a controlled environment, which could be considered an "algorithm-only" performance aspect to some extent, but not in the context of an AI-driven diagnostic or interpretative algorithm.

7. Type of Ground Truth Used:

For bench testing: The "ground truth" would be established by engineering specifications, known physical principles, and validated measurement techniques. For example, flow rate accuracy would be compared against a known standard, occlusion detection against intentionally induced blockages, and battery life against expected draw under defined conditions.
For EMC testing: The "ground truth" is established by adherence to international standards and regulatory limits for electromagnetic emissions and immunity (e.g., IEC 60601-1-2 or similar).
For user testing: The "ground truth" or validation would be based on observed functional success, ease of use, and user feedback compared to the predicate device or established usability principles. This is not a pathology or outcomes data type of ground truth.

8. Sample Size for the Training Set:

Not applicable / Not specified. This device is an infusion pump, not an AI/ML-based system that uses a "training set" in the computational learning sense. The device's design and functionality are based on engineering principles and prototypes, not on a machine learning training dataset.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As the concept of a "training set" for an AI/ML model does not apply here, there is no ground truth established for such a set. The "ground truth" for the device's design and engineering would be based on fundamental scientific and engineering principles, functional requirements, and safety standards.

Summary

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EXHIBIT 2

KO23840

CANÉ 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 K" and "Crono go" 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 Microjet Crono K 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 K, 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 K 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 K 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 K 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 K 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 K" and"Crono go"K013840
Intended Use:	IntravenousIntra-arterialSubcutaneousIntraperitonealEpiduralIntrathecal	Subcutaneous andintravenous only
Physical characteristics:
Power Source	2 AA alkaline batteries, ACAdapter	Lithium battery (3V) of theCR-123 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 K 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 & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three abstract shapes resembling birds in flight.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Y 1 4 2002

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

Re: K013840

Trade/Device Name: MicroJet Crono K and Crono GO Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: February 26, 2002 Received: February 28, 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

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Page 2 - Mr. Kamm

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) 594-4618 . Additionally, for questions on the promotion and 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Punner

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 K013840

Device Name: "Microjet Crono K" and "Crono go" ambulatory infusion pump

Indications for Use: The "Microjet Crono K" and "Crono go" 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 (Per 21 CFR 801.109)

Over the Counter Use

Victoria Vicente

(Division Sign-Off) (Division Sign-On)
Division of Dental, Infection Control,
Division of Dental, Infection Dovices and General Hospital Devices 840 01 510(k) Number -

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).