← Product Code [FRN](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRN) · K013776 # MICROJET MODEL # CD4 AND CD4/20 (K013776) _Cane S.R.I. · FRN · Apr 26, 2002 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRN/K013776 ## Device Facts - **Applicant:** Cane S.R.I. - **Product Code:** [FRN](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRN.md) - **Decision Date:** Apr 26, 2002 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5725 - **Device Class:** Class 2 - **Review Panel:** General Hospital - **Attributes:** Therapeutic ## Indications for Use The portable CD4, CD4/20 infusion devices have been designed only for use in subcutaneous infusion of prescribed liquid medicines. ## Device Story Microjet CD4/CD4/20 is a portable, battery-operated ambulatory infusion pump. Device uses 5 ml, 10 ml, or 20 ml (CD4/20 model) syringes. Micromotor transforms rotary motion into linear pusher motion to advance syringe piston. Electronic circuit controls motor with regular pulses to deliver small, repeated amounts of medicine over time. Used for subcutaneous infusion of prescribed liquid medicines. Operated by patient or clinician. Provides controlled, reliable medication delivery in ambulatory settings. ## Clinical Evidence Bench testing only. No clinical data provided. Safety and effectiveness established through bench, EMC, and user testing comparisons against the predicate device. ## Technological Characteristics Portable, battery-operated (9V alkaline) infusion pump. Dimensions: 170 x 70 x 20 mm. Weight: ~220g. Compatible with 5 ml, 10 ml, or 20 ml disposable syringes. Actuation via micromotor and mechanical linkage. Electronic circuit controls pulse-based delivery. Standalone device. ## Regulatory 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 - Cadd-Legacy 1 Ambulatory Infusion Pump ([K982838](/device/K982838.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ ### 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 January 30, 2002 ## 510(k) Summary of Safety and Effectiveness - 1. Identification of the Device: Proprietary-Trade Name: Microjet CD4, CD4/20 Classification Name: 80 FRN Common/Usual Name: Ambulatory Infusion Pump - 2. Equivalent legally marketed devices This product is similar in function to the Cadd-Legacy 1 Ambulatory Infusion Pump , Sims Deltec, Inc., K982838 - 3. Indications for Use (intended use) The portable CD4, CD4/20 infusion devices have been designed only for use in subcutaneous infusion of prescribed liquid medicines. - 4. Description of the Device: This infusion device has been manufactured since 1978 and has, during all this time, proved to be highly reliable in terms of sturdiness, reliability, accuracy and easy operation. Moreover, it does not require particular maintenance work. Microjet CD4 is a portable, battery-operated infusion device for use with 5 ml and 10 ml syringes (20 ml syringes are used with model CD4/20). A special micromotor actuates mechanical members that transform the motor rotary motion into the pusher linear motion which, in turn, causes the syringe piston to advance. The infusion device operating features enable to make infusions with varying amounts of medicine and different infusion times. During infusion, the motor is controlled by a special electronic circuit with regular pulses; therefore, infusion is carried out by delivering small amounts of medicine repeated with the passing of time. - 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. {1}------------------------------------------------ ### 6. Substantial Equivalence Chart | Characteristic | Cadd-Legacy 1
Ambulatory Infusion
Pump , Sims Deltec, Inc.,
K982838 | Microjet CD4, CD4/20 | |---------------------------|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------| | Intended Use: | Intravenous
Intra-arterial
Subcutaneous
Intraperitoneal
Epidural
Intrathecal | Subcutaneous only | | Physical characteristics: | | | | Power Source | 2 AA alkaline batteries, AC
Adapter | 9 volt Alkaline battery | | Size | 4.4 x 3.8 x 1.6 x in (112x
95x41 mm) | 170 x 70 x 20 mm | | Weight | 13.8 oz (392 grams) | Approximately 220 g
(including alkaline battery) | | Capacity | 10 ml | Disposable 5 ml or 10 ml
syringes (the CD4/20 model
has metal jaws to
accommodate 20 ml
syringes) | | Warranty: | 1 year | SAME | #### 7. Conclusion After analyzing both bench and user testing data, it is the conclusion of CANÈ S.r.1. that the Microjet CD/4, CD4/20 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}------------------------------------------------ ### 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 features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol. #### Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Cane S. R. I C/O Mr. Daniel Kamm Kamm & Associates P.O. Box 7007 Deerfield. Illinois 60015 APR 2 6 2002 Re: K013776 Trade/Device Name: Microjet CD4/20 Ambulatory Infusion Pump Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: April 23, 2002 Received: May 8, 2002 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. {3}------------------------------------------------ Page 2 - Mr. Kamm 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, Susan Runner Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health {4}------------------------------------------------ ## j) Indications for Use ### 510(k) Number K013776 Device Name: Microjet CD4, CD4/20 ambulatory infusion pump Indications for Use: The Microjet CD4, CD4/20 ambulatory infusion pump device has been Indications 101 Overboutaneous infusion of prescribed liquid medicines. # Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) Over the Counter Use Patricia Cucenite (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number X013776 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRN/K013776](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRN/K013776) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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