(21 days)
MiniMed Sof-serter™ infusion set insertion system
Not Found
No
The device description explicitly states it is a "manually operated, spring-loaded infusion set insertion device" and there are no mentions of AI, ML, or related concepts in the provided text.
No
The device is an aid for inserting infusion sets and does not provide therapy itself.
No
Explanation: The device is described as an "infusion set insertion system" and an "aid for insertion of infusion sets," which indicates it is a tool for administering medical treatment, not for diagnosing conditions.
No
The device description explicitly states it is a "manually operated, spring-loaded infusion set insertion device," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to aid in the insertion of infusion sets, which are used to deliver medication into the body. This is a therapeutic or drug delivery function, not a diagnostic one.
- Device Description: The description details a mechanical device for inserting a medical device (infusion set). It does not mention any components or processes related to analyzing biological samples or providing diagnostic information.
- Lack of IVD Indicators: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic results.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely mechanical and related to the delivery of medication.
N/A
Intended Use / Indications for Use
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.
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.
Product codes
KZH
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
MiniMed Sof-serter™ infusion set insertion system
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.6920 Syringe needle introducer.
(a)
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.(b)
Classification. Class II (performance standards).
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MiniMed Inc. Premarket [510(k)] Notification MiniMed® Quick-serter™ Model 395
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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.
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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.
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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
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MiniMed Inc. Premarket [510(k)] Notification MiniMed® Quick-serter™ Model 395
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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