MICROJET QUARK, MODEL U100 OR U40

K013807 · Cane S.R.L. · LZG · Dec 12, 2001 · General Hospital

Device Facts

• Record ID: K013807
• Device Name: MICROJET QUARK, MODEL U100 OR U40
• Applicant: Cane S.R.L.
• Product Code: LZG · General Hospital
• Decision Date: Dec 12, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Ambulatory insulin pump; uses 2 ml syringes; battery-powered. Micromotor transforms rotating movement into linear slider movement to actuate syringe piston. Delivers insulin via two modes: basal rate (continuous feed via 304 small impulses over 24 hours, one every 4 minutes 44 seconds) and bolus (additional doses at meal-time, 0.5 IU per administration with 10-second pauses). Operated by patient; basal rate programmed via selector; bolus delivered via manual button. Includes safety systems, acoustic signals for operating functions, and alerts for irregular operation. Benefits patient by providing automated, programmable insulin delivery for diabetes management.

Clinical Evidence

Bench and user testing performed. No clinical trial data provided. Results indicate the device is as safe and effective as the predicate.

Technological Characteristics

Ambulatory insulin pump; micromotor-driven linear slider mechanism; 6V lithium battery (Varta 2800XL); 2 ml syringe capacity; electronic circuit for impulse-based basal delivery; acoustic alarm system for safety/malfunction alerts.

Indications for Use

Indicated for subcutaneous insulin infusion therapy in patients with diabetes mellitus. Prescription device for home use.

Regulatory Classification

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.

Predicate Devices

• Dana Diabecare infusion pump (K001604)

Submission Summary (Full Text)

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# DEC 1 2 2001

#### EXHIBIT 2

K013807

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

- 1. 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.
- 3. 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.
- 4. 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,<br>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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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 _________________________________________________________________________________________________________________________________________________________________