← Product Code [KZH](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KZH) · K992300 # QUICK-SERTER, MODEL 395 (K992300) _Medtronic Minimed · KZH · Jul 29, 1999 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KZH/K992300 ## Device Facts - **Applicant:** Medtronic Minimed - **Product Code:** [KZH](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KZH.md) - **Decision Date:** Jul 29, 1999 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.6920 - **Device Class:** Class 2 - **Review Panel:** General Hospital ## Indications for Use The Quick-serter infusion set insertion system (Quickserter), model 395, is indicated for use as an aid for insertion of the Maersk Medical A/S Contour infusion sets. ## Device Story The MiniMed Quick-serter (Model 395) is a manually operated, spring-loaded insertion device designed to assist in the placement of Maersk Medical A/S Contour infusion sets. The device functions by having the user load an infusion set into a carrier, compress an internal metal spring, and trigger the mechanism to insert the set. It is intended to simplify the insertion process, minimize discomfort, and improve consistency of placement. The device is used by the patient or clinician; it is contraindicated for use with any infusion sets other than the specified Contour models. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Manually operated, spring-loaded insertion device. Materials: plastic housing with metal springs. Dimensions/form factor: handheld. Connectivity: none. Sterilization: not specified. Software: none. Energy source: mechanical (spring-driven). ## Regulatory Identification A syringe needle introducer is a device that uses a spring-loaded mechanism to drive a hypodermic needle into a patient to a predetermined depth below the skin surface. ## Predicate Devices - MiniMed Sof-serter infusion set insertion system ## 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}------------------------------------------------ MiniMed Inc. Premarket [510(k)] Notification MiniMed® Quick-serter™ Model 395 Image /page/0/Picture/2 description: The image shows the MiniMed logo. The logo consists of a black square with white curved lines on the left and the word "MiniMed" in black font on the right. Above the logo is the number "K992300". ## Part C. 510(k) Summary Submitter: MiniMed® Inc. 12744 San Fernando Rd., Sylmar, California 91342 Contact: Don Selvey, Regulatory Affairs (818) 362-5958, ext. 3011; (480) 704-8070 (v/f) Name of Device: MiniMed Quick-serter™ infusion set insertion system Predicate Device: MiniMed Sof-serter™ infusion set insertion system Description of the New Device: The MiniMed Quick-serter is a manually operated, spring-loaded infusion set insertion device. It is similar in features and intended use to the MiniMed Sof-serter infusion set insertion system. The device has been designed for use exclusively with the Maersk Medical A/S Contour infusion sets. The device is contraindicated for use with other infusion sets. Intended Use of the New Device: The MiniMed Quick-serter infusion system is intended to help make insertion of the Contour infusion sets simpler and with minimal discomfort. Use of the device may improve the user's consistency of infusion set insertion. Comparison of the Technological Features of the New Device and Predicate Device: Technologically, both insertion devices are spring-driven devices that require the user to load the infusion set into a carrier, compress a spring, then activate the device by depressing the release or trigger buttons. Both devices are made of plastic with metal springs. The differences between the new device and the predicate device are limited to differences required for compatibility with the specific infusion set to be inserted. These modifications do not affect the safety or effectiveness of the device. Signed, Don Selvey 7-6-99 date Senior Regulatory Affairs Specialist Department of Clinical Research and Regulatory Affairs MiniMed Inc. @MiniMed is a Registered Trademarks of MiniMed Inc. "Sof-serter and Quick-serter are Trademarks of MiniMed Inc. Image /page/0/Picture/15 description: The image shows the number 000004 in a bold, sans-serif font. The numbers are black against a white background. The number is evenly spaced and the same size. {1}------------------------------------------------ Image /page/1/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 an abstract symbol that resembles a stylized caduceus, a symbol often associated with healthcare. The symbol is composed of three intertwined figures. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUL 29 1999 Mr. Don Selvey Senior Regulatory Affairs Specialist Department of Clinical and Regulatory Affairs MiniMed® Technologies, Incorporated 12744 San Fernando Road Sylmar, California 91342 K992300 Re : MiniMed® Quick-serter™ Infusion Set Trade Name: Insertion System, Model 395 Requlatory Class: II Product Code: KZH Dated: July 7, 1999 Received: July 8, 1999 Dear Mr. Selvey: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಕ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. {2}------------------------------------------------ Page 2 - Mr. Selvey Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda/gov/cdrh/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 {3}------------------------------------------------ MiniMed Inc. Premarket [510(k)] Notification MiniMed® Quick-serter™ Model 395 Image /page/3/Picture/1 description: The image shows the logo for MiniMed. The logo consists of a black square with white curved lines on the left and the word "MiniMed" in black font on the right. There is a registered trademark symbol next to the "d" in "MiniMed". ## INDICATIONS FOR USE 510(k) Number: Device Name: MiniMed Quick-serter infusion set insertion system Indications for Use: The Quick-serter infusion set insertion system (Quickserter), model 395, is indicated for use as an aid for insertion of the Maersk Medical A/S Contour infusion sets. Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) or Over-the-Counter Use Thola Hubbard for Pat Cuicci 510(k) Numb 000007 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KZH/K992300](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KZH/K992300) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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