(29 days)
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No
The document does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML models. The description focuses on the mechanical and electronic functions of the pump.
Yes
The device is designed for the controlled administration of prescribed liquid medicines into patients, which directly relates to treating or managing a medical condition.
No.
The device is described as an ambulatory syringe infusion pump designed for the subcutaneous infusion of prescribed liquid medicines, not for diagnosing conditions.
No
The device description explicitly details a physical pump with a mechanism, display, buttons, and uses dedicated syringes, 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 "subcutaneous infusion of prescribed liquid medicines." This describes a device used to administer substances into the body, not to test samples from the body.
- Device Description: The description details a pump that administers liquids to patients. It focuses on mechanical aspects of delivery, not on analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely for drug delivery.
N/A
Intended Use / Indications for Use
the Crono go has been designed for use in subcutaneous infusion of prescribed liquid medicines.
Product codes
FRN
Device Description
Crono go is an ambulatory syringe infusion pump intended for the controlled administration of liquids into the patients. This means that the pump can be worn during the infusion. Crono go combines high technology with innovative design. Thanks to the small size of the pump Orono go sombinister the drug any time during the day without interrupting daily life or leisure activities. Crono go pump uses dedicated syringes which are available in two sizes: 10 and 20 ml. Crono go has a particular mechanism which pushes directly on the rubber syringe piston, which Orono go has a particular mestignificant thrust force and high accuracy of administration. Additional bolus doses can be easily administered by pressing a dedicated button, and the administered bolus dose is shown on the display screen. In case of occlusion, an innovative infusion control system makes it possible to proceed with the infusion automatically and, after the occlusion is eliminated, to complete it. Crono go is fitted with a liquid crisfal display which shows the time it takes to complete the delivery, the syringe size and the battery charge status.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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.)
Flow rate accuracy: +/-2%.
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
SEP 1 3 2005
Image /page/0/Picture/1 description: The image shows the word "CAINE" in bold, black letters. To the left of the word is a symbol that resembles a plus sign, but with a more geometric and stylized design. The letters are slightly tilted to the right, giving the impression of movement or a dynamic feel.
Canė S.r.l. società unipersonale
P.IVA - Reg. Impr. TO: 04384410017
R.Ε.Α. ΤΟ Ν. 629783
Cap. Soc. Euro 10.400 i.v.
Image /page/0/Picture/4 description: The image shows a logo with the text "CERMET" in bold letters. Below that, there is a smaller box with the text "SISTEMA DI GESTIONE CERTIFICATO". Further down, the text "REG. N. 3506 UNI EN ISO 9001:200 ISO 13485:2002" is displayed, indicating a certification or registration number along with ISO standards.
EXHIBIT 2
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 July 4, 2005
510(k) Summary
1. Identification of the Device:
Proprietary - Trade Name: Crono go. Classification Name: 80 FRN. Common/Usual Name: Ambulatory Infusion Pump.
2. Equivalent legally marketed devices
2: Equivalient regulty marriction and design to the Crono cleared under 510(k) number K041414.
3. Indications for Use (intended use)
or manuallence on ogo infusion devices have been designed for use in subcutaneous infusion of prescribed liquid medicines.
4. Description of the Device
Cane s.r.l., a company that specializes in the production of ambulatory pumps, has now produced Same of miration of compact pumps: Crono, a perfect combination of high technology and innovative design.
Crono go is an ambulatory syringe infusion pump intended for the controlled administration of liquids into the patients. This means that the pump can be worn during the infusion.
Crono go combines high technology with innovative design. Thanks to the small size of the pump Orono go sombinister the drug any time during the day without interrupting daily life or leisure activities.
Crono go pump uses dedicated syringes which are available in two sizes: 10 and 20 ml.
Crono go has a particular mechanism which pushes directly on the rubber syringe piston, which Orono go has a particular mestignificant thrust force and high accuracy of administration.
1
Image /page/1/Picture/1 description: The image shows the word "CAINE" in a stylized font. The letters are bold and have a unique design, with horizontal lines running through them. To the left of the word is a symbol that resembles a plus sign or a cross, also in a bold and stylized design. The overall image has a modern and geometric aesthetic.
Canė S.r.l. società unipersonale
P.IVA - Reg. Impr. TO: 04384410017
R.E.A. ΤΟ Ν. 629783
Cap. Soc. Euro 10.400 i.v.
Image /page/1/Picture/3 description: The image shows a logo with the word "SINCERT" at the top. Below that is a logo with the word "CERMET" inside of it. Underneath the logo, the words "SISTEMA DI GESTIONE CERTIFICATO" are written. The text "REG. N. 3506, UNI EN ISO 9001:2000, ISO 13485:2002" is at the bottom of the image.
Additional bolus doses can be easily administered by pressing a dedicated button, and the administered bolus dose is shown on the display screen.
In case of occlusion, an innovative infusion control system makes it possible to proceed with the infusion automatically and, after the occlusion is eliminated, to complete it.
Crono go is fitted with a liquid crisfal display which shows the time it takes to complete the delivery, the syringe size and the battery charge status.
5. 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.
| Characteristic | Crono go - K013840 | Crono go |
|---|---|---|
| Intended Use | Subcutaneous infusion of prescribed liquid medicines. | SAME |
| Physical characteristics | Crono go - K013840 | Crono go |
| Size | 3" x 1.85" x 1.14" (77 x 48 x 29 mm). | SAME |
| Weight | 4.0 oz (115 g) (battery included). | SAME |
| Battery | Power Source Lithium battery (3V) of the 123 A type. | SAME |
| Infusion per impulse | 22 μl. | SAME |
| Flow rate accuracy | +/-2%. | SAME |
| Max. Occlusion pressure | 4.5 bar +/-1 bar. | SAME |
| Capacity | 10 or 20 ml. | SAME |
6. Substantial Equivalence Chart
7. Conclusion
After analyzing both bench and user testing data, it is the conclusion of CANÈ S.r.l. that Crono pumps are as safe and effective as the predicate device, has few software 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 seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the caduceus. The seal is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 3 2005
Mr. Carlo Musso Quality Manager Cane S.R.L. Via Pavia, 105/I 10090 Rivoli-Cascine Vica (Torino) ITALY
Re: K052219
Trade/Device Name: Crono Go Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: July 15, 2005 Received: August 15, 2005
Dear Mr. Musso:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your bocaon by (1) person the device is substantially equivalent (for the referenced above and have determined the arrest and the marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mersuale collimence prior to ritay 20, 1970, accordance with the provisions of Amendinents, on to devroes that have of the Act (Act) that do not require approval of a prematic the Fedelar Pood, Drug, und Conners , therefore, market the device, subject to the general approval application (1 Mir). The general controls provisions of the Act include controls provisions of the Fea. "The garries, 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 II your device is classified (see above) into exontrols. Existing major regulations affecting (FMA), it may be subject to back addinf Federal Regulations, Title 21, Parts 800 to 898. In your device can oc found in the Seas nouncements concerning your device in the Federal Register.
3
Page 2 - Mr. Musso
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA S Issualled of a baseaux and as the other requirements
mean that FDA has made a determination that your device the Federal agencies mean that FDA has made a decemmance and regulations administered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by seciences and of the Act of any Federal statutes and regulaents, including, but not limited to: registration
You must comply with all the Act's requirements, and manufacturing protice You must comply with an the Fee s requirements and 801); good manufacturing practices
and listing (21 CFR Part 807); labeling (21 CFR Part 801); gED Box 800); and i and listing (21 CFR I art 607), lacemig (21 CFR Part 820); and if requirements as set form in the quality by 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 5 10(k) I his letter will anow you to begin maticemly your substantial equivalence of your device to a premarket nothleation. The I Dr Imaling of basemans of 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 Patt 801), If you desire specific auvice for your device at (240) 276-0115. Also, please note the regulation please comact the Other or Comphanes are (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may outain other general miormational and Consumer Assistance at its toll-free Division of Division of (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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
Image /page/4/Picture/0 description: The image shows a logo with a cross symbol on the left and the word "CAINE" on the right. The cross symbol is made up of thick black lines, and the word "CAINE" is written in bold, sans-serif letters. The logo appears to be for a company or organization with the name "CAINE".
Cané S.r.l. società unipersonale
P.IVA - Reg. Impr. TO: 04384410017
R.Ε.Α. ΤΟ Ν. 629783
Cap. Soc. Euro 10.400 ί.ν.
Image /page/4/Picture/2 description: The image shows a logo with the text "CERMET" in bold letters. Below that, it says "SISTEMA DI GESTIONE CERTIFICATO". Further down, it reads "REG. N. 3506" followed by "UNI EN ISO 9001:2000" and "ISO 13485:2002". The logo includes a stylized symbol at the top.
SINGERT
j) Indications for Use
Kos 2219 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Crono go.
Indications For Use: the Crono go has been designed for use in subcutaneous infusion of prescribed liquid medicines.
Prescription Use X . (Part 21 CFR 801 Subpart D) AND/OR
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)
Rihd C Chapman for ACw
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Denta
510(k) Number:_