Canè s.r.l., a company that specializes in the production of ambulatory pumps, has now produced a new generation of compact pumps: Crono F, 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 F 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 F 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 F makes the infusion up to 3 times more fractionated with respect to traditional pumps (22 µl per impulse, using a 10/20 ml syringe). Crono F 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 document is a 510(k) premarket notification for a medical device called Crono F, an ambulatory infusion pump. The document focuses on demonstrating substantial equivalence to a predicate device (Crono H, K013855) rather than providing extensive details on a comprehensive clinical study with specific acceptance criteria and detailed performance data often seen for novel devices.

Here's an analysis of the provided text based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in the sense of predefined thresholds for performance metrics. Instead, it relies on demonstrating that the Crono F device is "as safe and effective as" the predicate device, Crono H. The demonstration of equivalence is the primary "acceptance criterion."

Characteristic / Test	Acceptance Criteria (Implied)	Reported Device Performance	Comments by AI
Intended Use	Same as predicate device (subcutaneous and intravenous infusion of prescribed liquid medicines)	SAME	Crono F has the same intended use as Crono H.
Physical Characteristics	Same as predicate device	SAME	Power source, infusion per impulse, size, weight, and capacity are the same as Crono H.
Safety and Effectiveness	As safe and effective as the predicate device (Crono H)	"The results of bench, EMC, and user testing indicates that the new device is as safe and effective as the predicate device."	This is a general statement. Specific performance data from these tests are not provided in the summary.
Technological Characteristics	Few technological changes/improvements compared to the predicate without raising new questions of safety/effectiveness.	"has few technological Ciono 1 15 as sare and offective as thus rendering it substantially equivalent to the predicate device." (This sentence appears to be a slight typo in the original document, but the intent is clear).	Crono F has a new design for a "special syringe" allowing reduction of pump size, a mechanism for higher thrust force, and an innovative infusion control system for occlusion. These are presented as improvements that do not negate substantial equivalence.

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

Test Set Sample Size: Not specified. The document mentions "bench, EMC, and user testing" but does not provide the number of devices or subjects used in these tests.
Data Provenance: Not explicitly stated. Given that Canè S.r.l. is an Italian company (Via Pavia, 105/I 10090 Rivoli-Cascine Vica (Torino) Italy), it's reasonable to infer that some testing might have occurred in Italy or by an associated European entity. The documentation is for FDA clearance in the USA. The data is retrospective in the sense that it's being submitted for a device already developed, not from a new prospective clinical trial designed for primary endpoint assessment for this 510(k).

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. This type of information is usually relevant for diagnostic devices that rely on expert interpretation (e.g., radiology images). For an infusion pump, the "ground truth" for performance would be objective measurements (e.g., flow rate accuracy, pressure limits, battery life, alarm functionality) typically evaluated through bench testing and, potentially, user studies for usability. Expert consensus on diagnoses is not relevant here.

4. Adjudication Method for the Test Set:

Not applicable. As noted above, this mainly applies to diagnostic assays or image interpretation where human experts might disagree.

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

No, an MRMC study was not done, as this is an infusion pump, not a diagnostic device involving multiple readers interpreting cases.

6. Standalone Performance:

Yes, the "bench, EMC, and user testing" implicitly evaluates the standalone performance of the device without human-in-the-loop assistance for its core function (infusion). However, the specific metrics and results of these tests are summarized very broadly ("as safe and effective") rather than detailed.

7. Type of Ground Truth Used:

The "ground truth" for an infusion pump would involve:

Bench Test Results: Objective measurements of fluid delivery accuracy, pressure capabilities, alarm thresholds, battery performance, etc., against predefined engineering specifications.
EMC (Electromagnetic Compatibility) Test Results: Verification that the device performs within electromagnetic standards.
User Testing Observations: Data on usability, ease of programming, alarm recognition, and overall user experience.
Predicate Device Data: Performance data from the Crono H would serve as a crucial reference for substantial equivalence.

The document does not detail specific ground truth data but relies on the statement that these tests demonstrate equivalency.

8. Sample Size for the Training Set:

Not applicable. This device is an electromechanical infusion pump, not an AI/ML algorithm that requires a "training set" in the context of machine learning.

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

Not applicable, as there is no "training set" for an AI/ML algorithm involved in this device submission.

Summary

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SEP 17 2004

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 29, 2004 510(k) Summary

1. Identification of the Device: Proprietary-Trade Name: Crono F Classification Name: 80 FRN Classion/Usual Name: Ambulatory Infusion Pump
Equivalent legally marketed devices This product is similar in function and design to the si Crono cleared under 510(k) number K013855
1. Indications for Use (intended use) The portable Crono infusion devices have been designed 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 F, 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 F 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 F 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 F makes the infusion up to 3 times more fractionated with respect to traditional pumps (22 µl per impulse, using a 10/20 ml syringe). Crono F is fitted with a liquid crystal display which shows the time it takes to complete the delivery and battery charge status.

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	Crono H, K013855	Crono F
Intended Use:	subcutaneous andintravenous infusion ofprescribed liquid medicines.	SAME
Physical characteristics:
Power Source	Lithium battery (3V) of the123 A type	SAME
Infusion per impulse	22 µl	SAME
Size	3" x 1.85" x 1.14" (77 x 48x 29 mm)	SAME
Weight	4.0 oz (115 g) (batteryincluded).	SAME
Capacity	10 or 20 ml	SAME
Warranty:	2 years	SAME

7. Conclusion

After analyzing both bench and user testing data, it is the conclusion of CANÈ S.r.l. that the Arel and is as safe and effective as the Crono H, predicate device, has few technological Ciono 1 15 as sare and offective as thus rendering it substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that represent the wings and body of the bird.

SEP 17 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Public Health Service

CANÈ S.R.L. C/O Mr. Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates PO Box 7007 Deerfield, Illinois 60015

Re: K042085

Trade/Device Name: Crono F Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: September 10, 2004 Received: September 15, 2004

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 mendments, or to devices that have been reclassified in accordance with the provisions of Andinonene, of to activelic Act (Act) that do not require approval of a premarket the Foublar F 80a, D. Ag, D. You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provision 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 (1 Wri), it may of such of Federal Regulations, Title 21, Parts 800 to 898. In your device ear be foundsh further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Kamm

Please be advised that FDA's issuance of a substantial equivalence determination does not Please oe auvrsed that I Dri o lostainst on that your device complies with other requirements mean that IDA has made a deceminations administered by other Federal agencies. of the Act of ally I ederal banks and survey with and limited to: registration f ou must comply with an are Hooding (21 CFR Part 801); good manufacturing practice alld listing (21 CFR Part 807), laceling (21 CFR Pat 820); and if requirents as set form in the quality of the entrol 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) This icity will anow you to one finding of substantial equivalence of your device to a premiarket notification. - The Piere 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), If you desire specific au rios ter Jour at (301) 594-4618. 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 may outain other generalianal 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,

Ques

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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Indications for Use

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: Crono F

Indications For Use: The Crono F ambulatory infusion pump device have been Indications For Ose. "The Orono Parkburdery infusion park of prescribed liquid medicines.

AND/OR Prescription Use __ __________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

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)

Anten Dink

Division Sian-Off) Division of Anesthesiology, General Hospital. Infection Control, Dental Devices

510(k) Number:_

Page 1 of 1

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).