The Microjet Crono PCA ambulatory infusion pump device has been designed for use in intravenous or subcutaneous infusion of medicines for pain management.

Device Description

Microjet Crono PCA has been designed for the analgesic therapy with a flexible and precise drug's administration causing the minimum discomfort to the patient allowing to walking about. Microjet Crono PCA results to be, within its field, the most innovative instrument available in the market due to small dimension and easy-to-use. Outstanding technology degree has allowed to obtain high reliability degree for long time use without maintenance. A microprocessor runs the electronic circuitry allowing to program the flow seeing the duration of the infusion. A button allows the patient to administer an additional bolus as well seeing the infused volume when in process. The screen also allows to indicate the total of bolus that have been delivered within the infusion in course. A safety system is foreseen to unlock the keyboard to avoid unauthorized variation of the programmed parameters. In the event of occlusion of the catheter, Microjet Crono PCA allows to carry on the administration after the occlusion has been removed. This function is capable to highly reduce the risk of infusion not brought to end. Microjet Crono PCA is equipped with a liguid crystal display where the programmed data can be seen as well as the battery status.

AI/ML Overview

The provided text describes the Microjet Crono PCA ambulatory infusion pump and its substantial equivalence to a predicate device. However, it does not contain information typically found in a study proving a device meets acceptance criteria, such as specific performance metrics with numerical targets, details about a test dataset (sample size, provenance, ground truth establishment), expert qualifications, or MRMC study results.

Instead, the document focuses on:

Device Identification: Name, classification, and common use.
Equivalent Legally Marketed Devices: Comparison to a predicate device (Cadd-Legacy PCA Model 6300).
Indications for Use: Intravenous or subcutaneous infusion of medicines for pain management.
Description of the Device: Physical characteristics, features like microprocessor control, patient bolus button, safety system, and occlusion detection.
Safety and Effectiveness, comparison to predicate device: States that "The results of bench, EMC, and user testing indicates that the new device is as safe and effective as the predicate device."
Substantial Equivalence Chart: Compares functional and physical characteristics with the predicate device.

Given that this is a 510(k) summary, it aims to demonstrate substantial equivalence to a legally marketed predicate device rather than presenting a detailed clinical study with specific acceptance criteria and performance data like a novel device might. The "acceptance criteria" here are implicitly tied to demonstrating equivalence to the predicate device's safety and effectiveness.

Therefore, many of the requested details about acceptance criteria and study particulars cannot be extracted from the provided text.

Here is what can be inferred or directly stated based on the text (with many fields unanswerable):

Acceptance Criteria and Reported Device Performance

The document does not explicitly list numerical acceptance criteria. Instead, the "acceptance criterion" is implicitly demonstrating that the Microjet Crono PCA is "as safe and effective" as the Cadd-Legacy PCA Model 6300, based on "bench, EMC, and user testing." The comparison chart provides the basis for this claim of equivalence.

Characteristic	Acceptance Criteria (Implied by Predicate Device)	Reported Device Performance (Microjet Crono PCA)
Intended Use	Designed for use in intravenous, intra-arterial, subcutaneous, intraperitoneal, epidural, intrathecal infusion of medicines for pain management.	Intravenous or subcutaneous only. (Note: This is a more limited intended use, which can support substantial equivalence as it doesn't introduce new risks.) "Designed for use in intravenous or subcutaneous infusion of medicines for pain management."
Safety & Effectiveness	As safe and effective as the Cadd-Legacy PCA Model 6300.	"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 of CANÈ S.r.1. that the Microjet Crono PCA is as safe and effective as the predicate device, has few technological differences, and has no new indications for use..."
Power Source	2 AA alkaline batteries, AC Adapter	Lithium battery (3V) of the 123 A type
Size	4.4 x 3.8 x 1.6 in (112x 95x41 mm)	3" x 1.85" x 1.14" (77 x 47 x 29 mm) (Smaller)
Weight	13.8 oz (392 grams)	4.0 oz (115 g) (battery included). (Lighter)
Capacity	50 or 100 ml	10 or 20 ml (Smaller capacity)
Warranty	1 year	2 years (Longer)
Technological Features	Basic PCA pump functionality	Microprocessor-controlled, patient bolus button, screen for infused volume/bolus count, keyboard lock, occlusion detection/continuation. (These are described as innovative/outstanding technology, implying they meet or exceed predicate features.)

The "study" refers to "bench, EMC, and user testing." No specific details about the methodology, sample sizes, or results of these tests beyond the general conclusion are provided.

Unanswerable Information (Based on provided text):

Sample size used for the test set and the data provenance: Not specified. The document mentions "bench, EMC, and user testing" but no details on sample size (e.g., number of devices tested, number of users, number of cases/simulations). Data provenance is not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/specified. This is not a diagnostic device or a study involving expert interpretation of data. The "ground truth" for a pump's function typically comes from engineering specifications and objective measurements (bench testing) and user feedback/performance in simulated or actual (but controlled) use.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/specified.
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 is not a diagnostic device involving human readers or AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, and its function involves both the device itself and human interaction (programming, patient use of bolus). The "bench" testing could be considered "standalone" in a technical sense, but it's not specific to an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a device like an infusion pump, "ground truth" would likely involve engineering specifications, calibration standards, and objective measurements (e.g., flow rate accuracy, occlusion pressure thresholds, battery life, structural integrity). For "user testing," ground truth would relate to usability and performance as expected by users and design requirements. The document does not specify.
The sample size for the training set: Not applicable/specified. This is not a machine learning or AI-based device that typically has a "training set."
How the ground truth for the training set was established: Not applicable/specified.

Summary

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EXHIBIT 2

$\chi013822$

CANÈ S.r.I. Via Pavia, 105/1 10090 Rivoli-Cascine Vica (Torino) Italy Tel .: ++39-011-957.48.72 Fax ++39-011-959.88.80 Contact: Mario Cané, President November 13, 2001

510(k) Summary of Safety and Effectiveness

1. Identification of the Device: Proprietary-Trade Name: Microjet Crono PCA Classification Name: MEA Common/Usual Name: Ambulatory Infusion Pump
1. Equivalent legally marketed devices This product is similar in function to the Cadd-Legacy PCA Model 6300 Ambulatory Infusion Pump , Sims Deltec, Inc., K982839
1. Indications for Use (intended use) The portable Crono infusion device has been designed for use in intravenous or subcutaneous infusion of medicines for pain management.
1. Description of the Device: Microjet Crono PCA has been designed for the analgesic therapy with a flexible and precise drug's administration causing the minimum discomfort to the patient allowing to walking about. Microjet Crono PCA results to be, within its field, the most innovative instrument available in the market due to small dimension and easy-to-use. Outstanding technology degree has allowed to obtain high reliability degree for long time use without maintenance. A microprocessor runs the electronic circuitry allowing to program the flow seeing the duration of the infusion. A button allows the patient to administer an additional bolus as well seeing the infused volume when in process. The screen also allows to indicate the total of bolus that have been delivered within the infusion in course. A safety system is foreseen to unlock the keyboard to avoid unauthorized variation of the programmed parameters. In the event of occlusion of the catheter, Microjet Crono PCA allows to carry on the administration after the occlusion has been removed. This function is capable to highly reduce the risk of infusion not brought to end. Microjet Crono PCA is equipped with a liguid crystal display where the programmed data can be seen as well as the battery 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 PCA Model6300 Ambulatory InfusionPump , Sims Deltec, Inc.,K982839	Microjet Crono PCAambulatory infusionpump
Intended Use:	Designed for use inintravenous, intra-arterial,subcutaneous,intraperitoneal, epidural,intrathecal infusion ofmedicines for painmanagement.	Intravenous orsubcutaneous 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	50 or 100 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 PCA 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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of an abstract human figure, with three lines representing the head, body, and legs.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 0 8 2002

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

Re: K013822

Trade/Device Name: MicorJet Crono PCA Regulation Number: 880.5725 Regulation Name: Infusion Pump, PCA Regulatory Class: II Product Code: MEA Dated: February 11, 2002 Received: February 12, 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 vour 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 -

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,

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_ KO 13822

Device Name: Microjet Crono PCA ambulatory infusion pump

Indications for Use: The Microjet Crono PCA ambulatory infusion pump device has been designed for use in intravenous or subcutaneous infusion of medicines for pain management.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use / OR

Over the Counter Use (Per 21 CFR 801.109)

Patrice Cuscente
(Division Sign-Off)

er Station Gign-Off)
Division of Dental, Infection Control, and General Hospital, Infection C
and General Hospital Devicess 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).