(27 days)
The portable Quark infusion device has been designed only for use in subcutaneous infusion for insulin infusion therapy. Canè S.r.l. declines all responsibility for the administration of drugs in treatments and with methods other than the above.
The Microjet Quark U-100 ambulatory infusion pump has been designed only for use in subcutaneous infusion of insulin for the treatment of diabetes mellitus. (Home use. prescription device)
Microjet Quark U-100 is an ambulatory insulin pump using syringe, battery powered and available to employ 2 ml syringes. A special micromotor acting the mechanical parts transforming the rotating movement of the motor into a linear movement of the slider which determines the moving of the syringe piscon. The characteristics of the pump working allow w administer insuling to two infusion ways: the fust one, basal rate, cnsure an insulin basal feed within 24 hours, the second one, bolus, allows to administer insulin additional doses and finds its most common use at meal-time. During the basal rate, the motor is driven with impulses at regular intervals by mean of a particular clectronic circuit and the infusion is effected by administering of small quantities repeated over the time. The programmed insulin quantity is distributed with 304 administrations within 24 hours, one every 4 minutes and 44 seconds. The bolus is delivered with fast insulin administrations of 0.5 International Units (U1) each time, with intervals of 10 seconds pauses. The administration of the insulin basal quantity is programmed operating on a specific selector allowing an accurate delivery of insulin, depending on the various daily needs. Insulin delivery as bolus is programmed using a specific button. The pump starts delivering insulin in basal speed to the sclected value. It remains operating until, by mean of manual command, the administration of the bolus is primed; after it returns automatically to work again. The pump is equipped of safety systems, acoustic signals for different operating functions and acoustic alert signals in the event of irregular working.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:
Device: Microjet Quark Model U-100 (Insulin Infusion Pump)
Predicate Device: Dana Diabecare infusion pump, K001604
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by comparing the Microjet Quark to the predicate device, the Dana Diabecare infusion pump. The study aims to demonstrate substantial equivalence to the predicate device.
| Characteristic | Acceptance Criteria (Predicate Device K001604) | Reported Device Performance (Microjet Quark) |
|---|---|---|
| Intended Use | Insulin infusion therapy, subcutaneous | SAME |
| Physical Characteristics: | ||
| Power Source | 2 AA batteries | Varta 2800XL, lithium 6V (6 weeks life) |
| Size | 75 x 45 x 19 mm | 110 x 60 x 20 mm |
| Weight | 61 gr (battery included) | 135 gr. (battery included) |
| Capacity | 3ml (300 units) | 2 ml (200 units) |
| Insulin concentration | U-100 (default) | SAME |
| Warranty | 4 years | 1 year |
Conclusion from Study: The conclusion states that "Microjet Quark 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. Sample Size Used for the Test Set and Data Provenance
The provided submission materials do not explicitly state the sample size for any testing.
The document mentions "bench, clinical, and user testing," but no specifics on the number of samples or participants for each.
The data provenance (country of origin, retrospective/prospective) is not specified in the provided text. Given that the manufacturer, CANÈ S.r.l., is based in Italy, it is plausible that some testing occurred there, but this is not confirmed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the submission. There is no mention of expert involvement in establishing ground truth for any test sets.
4. Adjudication Method for the Test Set
This information is not provided in the submission. There is no mention of an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or described.
The study's focus was on demonstrating substantial equivalence through "bench, clinical, and user testing" against a predicate device, rather than comparing human reader performance with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device described is an insulin infusion pump, a hardware device, not an AI algorithm. Therefore, the concept of "standalone (algorithm only)" performance and "human-in-the-loop" is not applicable in this context. The device itself performs the function (insulin delivery).
7. The Type of Ground Truth Used
The primary "ground truth" for this substantial equivalence determination is the performance and characteristics of the predicate device (Dana Diabecare, K001604).
The studies conducted (bench, clinical, and user testing) would have generated data to demonstrate that the Microjet Quark performs safely and effectively in a manner comparable to the predicate. For example:
- Bench testing: Involves objective measurements of device performance, such as accuracy of insulin delivery, battery life, alarm functionality, etc., compared to specifications or the predicate's known performance.
- User testing: Likely involved evaluating ease of use, alarm comprehension, and overall user experience, often in comparison to the predicate device or established usability principles.
- Clinical testing: Would assess actual physiological impact in patients, though details here are sparse.
8. The Sample Size for the Training Set
This information is not applicable as the device is a mechanical/electronic medical device, not an AI/machine learning algorithm requiring a training set in the typical sense.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as point 8.
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DEC 1 2 2001
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 October 9, 2001 Rev December 5, 2001
510(k) Summary of Safety and Effectiveness
-
- Identification of the Device: Proprietary-Trade Name: Microjet Quark Model U-100 Classification Name: LZG Common/Usual Name: Pump, Infusion, Insulin
- Equivalent legally marketed devices This product is similar in function to the 2. Dana Diabecare infusion pump, K001604.
-
- Indications for Use (intended use) The portable Quark infusion device has been designed only for use in subcutaneous infusion for insulin infusion therapy. Canè S.r.l. declines all responsibility for the administration of drugs in treatments and with methods other than the above.
-
- Description of the Device: Microjet Quark U-100 is an ambulatory insulin pump using syringe, battery powered and available to employ 2 ml syringes. A special micromotor acting the mechanical parts transforming the rotating movement of the motor into a linear movement of the slider which determines the moving of the syringe piscon. The characteristics of the pump working allow w administer insuling to two infusion ways: the fust one, basal rate, cnsure an insulin basal feed within 24 hours, the second one, bolus, allows to administer insulin additional doses and finds its most common use at meal-time. During the basal rate, the motor is driven with impulses at regular intervals by mean of a particular clectronic circuit and the infusion is effected by administering of small quantities repeated over the time. The programmed insulin quantity is distributed with 304 administrations within 24 hours, one every 4 minutes and 44 seconds. The bolus is delivered with fast insulin administrations of 0.5 International Units (U1) each time, with intervals of 10 seconds pauses. The administration of the insulin basal quantity is programmed operating on a specific selector allowing an accurate delivery of insulin, depending on the various daily needs. Insulin delivery as bolus is programmed using a specific button. The pump starts delivering insulin in basal speed to the sclected value. It remains operating until, by mean of manual command, the administration of the bolus is primed; after it returns automatically to work again. The pump is equipped of safety systems, acoustic signals for different operating functions and acoustic alert signals in the event of irregular working.
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- Safety and Effectiveness, comparison to prodicate device. The results of heach, FMC , and v user testing indicates that the new device is as safe and effective as the predicate device.
| Characteristic | Dana Diabecare, K001604 | Microjet Quark |
|---|---|---|
| Intended Use: | Insulation infusion therapy,subcutaneous. | SAME |
| Physical characteristics: | ||
| Power Source | 2 AA batteries | Varta 2800XL, lithium 6V (6 weeks life) |
| Size | 75 x 45 x 19 mm | 110 x 60 x 20 mm |
| Weight | 61 gr (battery included) | 135 gr. (battery included). |
| Capacity | 3ml (300 units) | 2 ml (200 units) |
| Insulin concentration | U-100 (default) | SAME |
| Warranty: | 4 years | 1 year |
6. Substantial Equivalence Chart
7. Conclusion
After analyzing both bench and user testing data, it is the conclusion of CANÈ S.r.l. that the Microjet Quark 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.
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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 human profiles facing to the right, with flowing lines beneath them that resemble water or fabric.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 2 2001
Cane SRL C/O Ms. Daniel Kamm Regulatory Engineer Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015
Re: K013807
Trade/Device Name: Microjet Quark, Model U100 Regulation Number: 880.5725 Regulation Name: Pump, Infusion, Insulin, LZG Regulatory Class: II Product Code: LZG Dated: November 14, 2001 Received: November 15, 2001
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 of the Act or any Federal statutes and regulations administered by other Federal agencies.
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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.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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j) Indications for Use
510(k) Number_j3013807
Device Name: Microjet Quark ambulatory infusion pump
Indications for Use: The Microjet Quark U-100 ambulatory infusion pump has been designed only for use in subcutaneous infusion of insulin for the treatment of diabetes mellitus. (Home use. prescription device)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use レ OR
Over the Counter Use (Per 21 CFR 801.109)
Patricia Cuscerite
(Division Sign-Off) E-olsion of Dental, Infection Control, a reneral Hospital Deyices I The 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).