(45 days)
Not Found
No
The summary describes a mechanical infusion pump with features focused on size reduction, increased thrust force, and fractionated delivery. There is no mention of AI or ML algorithms for decision-making, data analysis, or adaptive control. The "innovative infusion control system" appears to be a mechanical or basic electronic feedback mechanism for occlusion detection and resolution, not an AI/ML system.
Yes
The device is used for "subcutaneous and intravenous infusion of prescribed liquid medicines," which directly contributes to a therapeutic effect on the patient.
No
The device is an infusion pump designed for delivering prescribed liquid medicines, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly details a physical pump with mechanical components (syringe, piston, mechanism for thrust force, display) and mentions bench, EMC, and user testing, indicating hardware validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "subcutaneous and intravenous infusion of prescribed liquid medicines." This describes a device used to deliver medication into the body, not to perform tests on samples from the body.
- 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 providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances in samples
- Providing diagnostic, prognostic, or screening information
- Using reagents or assays
The device is clearly designed for therapeutic delivery of medication, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Crono F ambulatory infusion pump device have been designed 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 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.
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.
After analyzing both bench and user testing data, it is the conclusion of CANÈ S.r.l. that the new device is as safe and effective as the Crono H, predicate device, thus rendering it substantially equivalent to 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
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
-
- 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
-
- Indications for Use (intended use) The portable Crono infusion devices have been designed 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 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.
1
6. Substantial Equivalence Chart
| Characteristic | Crono H, K013855 | Crono F |
|---|---|---|
| Intended Use: | subcutaneous and | |
| intravenous infusion of | ||
| prescribed liquid medicines. | SAME | |
| Physical characteristics: | ||
| Power Source | Lithium battery (3V) of the | |
| 123 A type | SAME | |
| Infusion per impulse | 22 µl | SAME |
| Size | 3" x 1.85" x 1.14" (77 x 48 | |
| x 29 mm) | SAME | |
| Weight | 4.0 oz (115 g) (battery | |
| included). | 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.
2
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.
3
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
4
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