(170 days)
Not Found
No
The description focuses on mechanical and control system innovations, with no mention of AI or ML.
Yes
The device is used for the "subcutaneous and intravenous infusion of prescribed liquid medicines," which are treatments for medical conditions, thus making it a therapeutic device.
No
The device is an infusion pump designed to deliver prescribed liquid medicines, not to diagnose a medical condition.
No
The device description clearly describes a physical infusion pump with mechanical components (syringe, piston, catheter) and a liquid crystal display, indicating it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "subcutaneous and intravenous infusion of prescribed liquid medicines." This describes a device used on a patient to deliver medication, not a device used in vitro (outside the body) to examine specimens for diagnostic purposes.
- Device Description: The description focuses on the mechanical aspects of the pump, its size, thrust force, infusion control, and display. It describes a device for delivering therapy, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. There is no mention of diagnostic markers, assays, or any process related to diagnosing a condition.
Therefore, the Crono infusion device is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The portable Crono infusion device has been designed only for use in subcutaneous and intravenous infusion of prescribed liquid medicines.
Product codes (comma separated list FDA assigned to the subject device)
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 H, 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 H 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 H 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 H 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 H 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): 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).
0
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 January 30, 2002
510(k) Summary of Safety and Effectiveness
-
- Identification of the Device: Proprietary-Trade Name: Microjet Crono H 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 Crono 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 H, 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 H 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 H 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 H 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 H 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 CronoH |
|----------------|---------------------------------------------------------------------------------------------|-------------------------------------------|
| Intended Use: | Intravenous
Intra-arterial
Subcutaneous
Intraperitoneal
Epidural
Intrathecal | Subcutaneous and
intravenous only |
| 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 | 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 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
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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 0 9 2002
Cane S. R. I C/O Mr. Daniel Kamm Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015
Re: K013855
Trade/Device Name: MicroJet Crono H Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: February 14, 2002 Received: February 15, 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
3
Page 2 - Mr. Kamm
requirements 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 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.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susa Punoy
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 K013855
Device Name: Microjet CronoH ambulatory infusion pump
Indications for Use: The Microjet Crowo 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 P (Per 21 CFR 801.109)
Over the Counter Use
Pulace Licente
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number_4615