(176 days)
No
The description focuses on mechanical and control system innovations for improved drug delivery and occlusion management, with no mention of AI or ML.
Yes
The device is designed for the "subcutaneous and intravenous infusion of prescribed liquid medicines," which indicates its use in delivering therapy.
No
Explanation: The device is an ambulatory infusion pump designed for the subcutaneous and intravenous infusion of prescribed liquid medicines. Its function is to deliver medication, not to diagnose medical conditions or analyze patient data for diagnostic purposes.
No
The device description clearly details a physical infusion pump with mechanical components (special syringe, piston mechanism) and a liquid crystal display, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "subcutaneous and intravenous infusion of prescribed liquid medicines." This describes a device used to administer substances into the body, not to test samples from the body to diagnose conditions.
- Device Description: The description focuses on the mechanical aspects of the pump, its ability to deliver medication, and features related to infusion control and patient comfort. There is no mention of analyzing biological samples or performing diagnostic tests.
- Lack of IVD Characteristics: IVD devices typically involve reagents, assays, or analysis of biological specimens (blood, urine, tissue, etc.) to provide information about a patient's health status. This device does none of that.
Therefore, the "Microjet Crono K" and "Crono go" ambulatory infusion pump is a therapeutic device used for drug delivery, not a diagnostic device.
N/A
Intended Use / Indications for Use
The portable Microjet Crono K infusion device has been designed only for use in subcutaneous and intravenous infusion of prescribed liquid medicines.
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.
Product codes
FRN
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.
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
0
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
-
- Identification of the Device: Proprietary-Trade Name: "Microjet Crono K" and "Crono go" Classification Name: 80 FRN Common/Usual Name: Ambulatory Infusion Pump
-
- Equivalent legally marketed devices This product is similar in function to the Cadd-Legacy 1 Ambulatory Infusion Pump , Sims Deltec, Inc., K982838
-
- 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.
-
- 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.
-
- 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.
1
6. Substantial Equivalence Chart
| Characteristic | Cadd-Legacy 1
Ambulatory Infusion
Pump, Sims Deltec, Inc.,
K982838 | "Microjet Crono K" and
"Crono go"
K013840 |
|---------------------------|---------------------------------------------------------------------------------------------|-------------------------------------------------|
| Intended Use: | Intravenous
Intra-arterial
Subcutaneous
Intraperitoneal
Epidural
Intrathecal | Subcutaneous and
intravenous only |
| Physical characteristics: | | |
| Power Source | 2 AA alkaline batteries, AC
Adapter | Lithium battery (3V) of the
CR-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 | 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.
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 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
3
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
4
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 -