(173 days)
Not Found
No
The description mentions a microprocessor and electronic circuitry for programming and control, but there is no mention of AI, ML, or related concepts like learning, adaptation, or complex data analysis beyond basic programming and monitoring.
Yes
The device is described as "designed for the analgesic therapy" and for "pain management" through intravenous or subcutaneous infusion of medicines, indicating its role in treatment.
No
The device is an infusion pump designed for administering medication for pain management. It does not perform any diagnostic functions like detecting, identifying, or analyzing medical conditions.
No
The device description clearly details hardware components such as a microprocessor, electronic circuitry, a button, a screen, a safety system, and a liquid crystal display, indicating it is a physical medical device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "intravenous or subcutaneous infusion of medicines for pain management." This describes a device used to deliver substances into the body for therapeutic purposes.
- Device Description: The description focuses on the mechanical and electronic aspects of a pump designed to administer drugs, including features like flow programming, bolus administration, and safety systems.
- Lack of IVD Characteristics: An IVD device is used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological samples.
Therefore, the Microjet Crono PCA ambulatory infusion pump is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MEA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The results of bench, EMC, and user testing indicates that the new device is as safe and effective as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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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
-
- Identification of the Device: Proprietary-Trade Name: Microjet Crono PCA Classification Name: MEA Common/Usual Name: Ambulatory Infusion Pump
-
- Equivalent legally marketed devices This product is similar in function to the Cadd-Legacy PCA Model 6300 Ambulatory Infusion Pump , Sims Deltec, Inc., K982839
-
- 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.
-
- 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.
-
- 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 Model
6300 Ambulatory Infusion
Pump , Sims Deltec, Inc.,
K982839 | Microjet Crono PCA
ambulatory infusion
pump |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|
| Intended Use: | Designed for use in
intravenous, intra-arterial,
subcutaneous,
intraperitoneal, epidural,
intrathecal infusion of
medicines for pain
management. | Intravenous or
subcutaneous only. |
| Physical characteristics: | | |
| 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 x in (112x
95x41 mm) | 3" x 1.85" x 1.14" (77 x 47
x 29 mm) |
| Weight | 13.8 oz (392 grams) | 4.0 oz (115 g) (battery
included). |
| 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.
2
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
4
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 __
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