(29 days)
the Crono Super PID has been designed for use in subcutaneous infusion of prescribed liquid medicines.
Crono Super PID 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 Super PID combines high technology with innovative design. Thanks to the small size of the pump the patients can administer the drug any time daring the day without interrupting daily life or leisure activities. Crono Super PID pump uses dedicated syringes which are available in two sizes: 10 and 20 ml. Crono Super PID has a particular mechanism which pushes directly on the rubber syringe piston, which makes it possible to reach a significant thrust force and high accuracy of administration. Crono Super PID administers 22 µl per impulse. 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 Super PID is fitted with a liquid cristal display which shows the time it takes to complete the delivery, the syringe size and the battery charge status.
The provided text describes a 510(k) premarket notification for the Crono Super PID ambulatory infusion pump, establishing its substantial equivalence to a predicate device (Crono, K041414). This type of submission focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than proving novel effectiveness through extensive clinical trials.
Here's an analysis of the acceptance criteria and the "study" that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents a comparison table between the predicate device (Crono - K041414) and the new device (Crono Super PID) to demonstrate substantial equivalence. The "acceptance criteria" here are essentially the performance characteristics of the predicate device that the new device must match or improve upon to be considered substantially equivalent.
| Characteristic | Acceptance Criteria (Predicate Device Crono - K041414) | Reported Device Performance (Crono Super PID) | Met? |
|---|---|---|---|
| Intended Use | Subcutaneous infusion of prescribed liquid medicines. | SAME | YES |
| Size | 3" x 1.85" x 1.14" (77 x 48 x 29 mm). | SAME | YES |
| Weight | 4.0 oz (115 g) (battery included). | SAME | YES |
| Battery | Power Source Lithium battery (3V) of the 123 A type. | SAME | YES |
| Infusion per impulse | 22 µl. | SAME | YES |
| Flow rate accuracy | +/-2%. | SAME | YES |
| Max. Occlusion pressure | 4.5 bar +/-1 bar. | SAME | YES |
| Capacity | 10 or 20 ml. | SAME | YES |
Note: The phrase "SAME" in the "Reported Device Performance" column signifies that the Crono Super PID meets or matches the specified characteristic of the predicate device.
2. Sample size used for the test set and the data provenance
The document states, "The results of bench, EMC, and user testing indicates that the new device is as safe and effective as the predicate device." However, specific sample sizes for these tests are not provided. Similarly, the data provenance (e.g., country of origin, retrospective/prospective) for the bench, EMC, and user testing is not explicitly stated. Given that CANE S.r.l. is an Italian company, it's highly probable that some or all of the testing was conducted in Italy, but this is an inference, not stated fact.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable or not specified. For a 510(k) submission demonstrating substantial equivalence for an infusion pump, the "ground truth" for performance characteristics (like flow rate accuracy) would typically be established through instrumental measurements and engineering verification, not through expert consensus on medical images or clinical outcomes. The document does not mention the involvement of medical experts in establishing ground truth for the technical performance parameters.
4. Adjudication method for the test set
Not applicable or not specified. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving interpretation of subjective data (e.g., radiological images) where discrepancies between expert readers need to be resolved. This is not relevant for the type of bench and user testing described for an infusion pump, which focuses on objective physical and functional characteristics.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly those involving AI algorithms, where the performance of human readers (e.g., radiologists) is augmented by AI. The Crono Super PID is an ambulatory infusion pump, not a diagnostic device, and does not involve AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The Crono Super PID is a physical medical device (an infusion pump), not an algorithm. Its performance is inherent to its mechanical and electronic function, not an algorithm's output separate from human interaction in a diagnostic or interpretive context.
7. The type of ground truth used
The ground truth for the performance characteristics of the Crono Super PID would be established through objective engineering measurements and verification. For example:
- Flow rate accuracy: Measured against a calibrated standard using laboratory equipment.
- Max. Occlusion pressure: Measured using pressure sensors.
- Size and Weight: Measured using standard measuring tools.
- Infusion per impulse: Verified through precise volume measurement.
The phrase "bench, EMC, and user testing" suggests these types of objective measurements were performed.
8. The sample size for the training set
Not applicable / Not specified. The concept of a "training set" is primarily relevant for machine learning or AI models. The Crono Super PID is a physical device, and its development and testing do not involve a training set in the AI sense. Its design and manufacturing are based on engineering principles and quality control.
9. How the ground truth for the training set was established
Not applicable. As explained above, there is no "training set" in the context of this device's development as described. The performance data is derived from direct physical and functional testing.
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Kas2217
SEP 1 3 2005
Image /page/0/Picture/2 description: The image contains a partial view of what appears to be a document or form. At the top left corner, the number '3' is visible, followed by '2005' on the same line. The rest of the image is mostly blank, with a horizontal line extending across the width of the frame below the numbers.
Image /page/0/Picture/3 description: The image shows a logo with the text "CERMET" in bold letters. Below CERMET, the text "SISTEMA DI GESTIONE CERTIFICATO" is present. Further down, the text "REG. N. 3506 UNI EN ISO 9001:200 ISO 13485:2002" is displayed, indicating compliance with specific ISO standards.
EXHIBIT 2
CANÈ S.r.l. 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 Super PID. Classification Name: 80 FRN. Common/Usual Name: Ambulatory Infusion Pump.
2. Equivalent legally marketed devices
This product is similar in function and design to the Crono cleared under 510(k) number K041414.
3. Indications for Use (intended use)
The portable Crono Super PID 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 a new generation of compact pumps: Crono, a perfect combination of high technology and innovative design.
Crono Super PID 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 Super PID combines high technology with innovative design. Thanks to the small size of the pump the patients can administer the drug any time daring the day without interrupting daily life or leisure activities.
Crono Super PID pump uses dedicated syringes which are available in two sizes: 10 and 20 ml.
Crono Super PID has a particular mechanism which pushes directly on the rubber syringe piston, which makes it possible to reach a significant thrust force and high accuracy of administration.
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SINGERI
Image /page/1/Picture/2 description: The image shows the word "CANE" in a stylized font. To the left of the word is a symbol that looks like two squares with lines extending from the top and bottom. The letters in the word "CANE" are blocky and have a textured appearance. The overall image has a simple, graphic design.
MEDICAL TECHNOLOGY
P.IVA - Reg. Impr. TO: 04384410017
R.E.A. TO Ν. 629783
Cap. Soc. Euro 10.400 i.v.
Image /page/1/Picture/5 description: The image shows a logo for CERMET, which is an Italian certification organization. The logo features a stylized "C" shape at the top, followed by the text "CERMET" in a bold font. Below that, there is a rectangle containing the words "SISTEMA DI GESTIONE CERTIFICATO". The text at the bottom of the logo indicates the certifications held, including "REG. N. 3506", "UNI EN ISO 9001:2000", and "ISO 13485:2002".
Crono Super PID administers 22 µl per impulse.
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 Super PID is fitted with a liquid cristal 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 - K041414 | Crono Super PID |
|---|---|---|
| Intended Use | Subcutaneous infusion ofprescribed liquidmedicines. | SAME |
| Physical characteristics | Crono - K041414 | Crono Super PID |
| Size | 3" x 1.85" x 1.14" (77 x 48x 29 mm). | SAME |
| Weight | 4.0 oz (115 g) (batteryincluded). | SAME |
| Battery | Power Source Lithiumbattery (3V) of the 123 Atype. | 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 CANE 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.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, which is a common symbol of the United States.
Public Health Service
SEP 1 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Carlo Musso Quality Manager Cane S.R.L., Medical Technology Via Pavia, 105/I 10090 Rivoli-Cascine Vica Torino ITALY
Re: K052217
Trade/Device Name: Crono Super PID Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion pump Regulatory Class: II Product Code: FRN Dated: July 26, 2005 Received: August 15, 2005
Dear Mr. Musso:
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 for abor and a 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.
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Page 2 - Mr. Musso
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be advised that I DT brissants over device complies with other requirements of the Act that I DA has made a acteriminations administered by other Federal agencies. You must of ally receral statures and regaranents ancluding, but not limited to: registration and listing (21 Comply with an the 11et 81e creations) (1) good manufacturing practice requirements as set CI K I at 607); adomig (21 CFR Part 820); and if applicable, the electronic forth in the quality bystems (Sections 531-542 of the Act); 21 CFR 1000-1050. product ladiation control provins (evening your device as described in your Section 510(k) This letter will and in you'ts began finding of substantial equivalence of your device to a legally promative notification: "The started on 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), please If you desire spocents arrivaliation of (240) 276-0115. Also, please note the regulation entitled, Contact the Office of Companies in (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on Jour Popsumer Assistance at its toll-free number (800) 638-2041 or (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 of Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the word "CAINE" next to a symbol that looks like a plus sign. The word and the symbol are both in a bold, sans-serif font. The image is black and white, and the text is black on a white background. The plus sign is made up of thick, rectangular bars.
Canė S.r.l. società unipersonale
P.IVA - Reg. Impr. TO: 04384410017
R.E.A. TO Ν. 629783
Cap. Soc. Euro 10.400 i.v.
Image /page/4/Picture/2 description: The image shows a logo for CERMET, which is a certification organization. The logo includes the text "CERMET" and "SISTEMA DI GESTIONE CERTIFICATO". It also includes the registration number REG. N. 3506 and the standards UNI EN ISO 9001:200 and ISO 13485:2002.
SINCERT
j) Indications for Use
Korzzi7 510(k) Number (if known):
Device Name: Crono Super PID.
Indications For Use: the Crono Super PID 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)
Ried C. Chopra FOR ACW
(Division Sign-Off Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
KO 510(k) Number:_
§ 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).