(177 days)
No
The device description and performance studies focus on mechanical function and biocompatibility, with no mention of AI or ML.
No
The device is an accessory for inserting compatible medical devices, not a therapeutic device itself. Its purpose is to aid in insertion, not to provide therapy.
No
Explanation: The device is described as an aid for inserting compatible devices, specifically infusion sets, into subcutaneous tissue. Its function is mechanical insertion, not the detection, diagnosis, or monitoring of a disease or condition.
No
The device description clearly outlines a physical, hand-held accessory product with mechanical components (plastic barrel, stainless steel spring, handle, buttons) designed for inserting infusion sets. There is no mention of software as part of the device itself.
Based on the provided information, the MiniMed Quick-serter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to aid in the insertion of compatible devices (specifically infusion sets) into the subcutaneous tissue. This is a mechanical action performed on the body, not a test performed on a sample taken from the body.
- Device Description: The description details a mechanical device with a spring and handle designed for insertion. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There are no references to reagents, assays, or diagnostic results.
- Performance Studies: The performance studies focus on biocompatibility and mechanical function, which are typical for devices that interact with the body, not for diagnostic tests.
In summary, the MiniMed Quick-serter is a medical device used for the physical insertion of other medical devices into the body, not for performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The MiniMed Quick-serter is indicated to use as an aid for inserting compatible devices. It is for use by a single patient. It is not for use by multiple patients.
Product codes
KZH
Device Description
The modified MiniMed Quick-serter (MMT-305) is a non-sterile, single patient, multi-use, hand held accessory product designed to be used as an insertion aid for compatible devices, including specific infusion sets. It is used to insert the introducer needle and cannula through the skin and into the subcutaneous tissue. The MiniMed Quick-serter is intended to be used by a patient or clinician as a means to insert an infusion set with minimum discomfort and technique dependency.
The MiniMed Quick-serter consists of a plastic barrel containing a stainless steel spring and a handle. The device user places and securely seats the infusion set into the MiniMed Quick-serter is loaded and locked by pulling the handle (compressing the spring) until it clicks/locks into place. The serter is placed in contact with the insertion site and fired to release the infusion set. This is done by depressing the green side buttons to release the spring, which drives the infusion set forward and the insertion needle and cannula are inserted into the user's subcutaneous tissue. The release button on the top of the device is then pressed to ease the release of the infusion set from the serter.
Devices compatible to MiniMed Quick-serter (MMT-305) include:
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
patient or clinician
Description of the training set, sample size, data source, and annotation protocol
Not Found
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)
Biocompatibility:
The biocompatibility evaluation was conducted in accordance with the FDA #G95-1 "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing"" and international standard EN ISO 10993-1 "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within A Risk Management Process" as recognized by FDA. The battery of testing included the following tests:
- . Chemical Characterization (EN ISO 10993-18)
- . Cytotoxicity (EN ISO 10993-5)
- Sensitization (EN ISO 10993-10)
- . Skin Irritation (EN ISO 10993-10)
The MiniMed Quick-serter has been evaluated for biocompatibility and is acceptable for its intended use by Biological Evaluation.
Verification Testing:
The design of MiniMed Quick-serter (MMT-305) was verified to provide objective evidence that the device retains its mechanical properties and functions with MiniMed Quick-set and MiniMed Pro-set infusion sets.
Performance testing performed to support the design modifications included:
- Cocking Force
- Trigger Force
- Visual/Functional
- Life Cycle testing
- Drop Test ●
- Warehouse Environment Storage ●
- Home Environment Storage
- Operating Temperature
- Operating Humidity ●
- Mechanical Vibration
- Chemical Resistance
- Reliability
- Cleaning ●
- Robust Cleaning Life Test ●
- Usability Evaluation of Quick-set and Pro-set Insertion with Quick-serter
The aforementioned tests were completed to internal standards: - . Ship Test - ASTM D4169 "Distribution Cycle 12, Assurance Level 1-Standard Practice for Performance Testing of Shipping Containers and Systems
- . Cleaning studies- AAMI TIR12 "Designing, testing and labeling reusable medical devices for reprocessing in healthcare facilities. A guide for medical device manufacturers" and AAMI TIR30 "A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices.
Results from performance testing indicate that the product meets the established performance requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
MiniMed Quick-serter (MMT-395), infusion set insertion system (K992300)
Reference Device(s)
MiniMed Quick-set Infusion Set (K991759, K011071), MiniMed Pro-set Infusion Set (K160651)
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 22, 2016
Medtronic MiniMed Noreen Bajwa Sr. Regulatory Affairs Specialist 18000 Devonshire St. Northridge. California 91325
Re: K160860
Trade/Device Name: MiniMed Quick-serter Regulation Number: 21 CFR 880.6920 Regulation Name: Syringe Needle Introducer Regulatory Class: II Product Code: KZH Dated: August 24, 2016 Received: August 25, 2016
Dear Noreen Bajwa:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
1
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. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
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Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
MiniMed Quick-serter
Indications for Use (Describe)
The MiniMed Quick-serter is indicated to use as an aid for inserting compatible devices. It is for use by a single patient. It is not for use by multiple patients.
Type of Use (Select one or both, as applicable)| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY (21 CFR 807.92)
K160860
l. SUBMITTER [807.92(a)(1)]
Medtronic MiniMed, Inc. 18000 Devonshire Street Northridge, CA USA 91325
| Telephone: | (818) 576-5224 |
|---|---|
| Fax: | (818) 576-6273 |
| Contact Person: | Noreen Bajwa |
|---|---|
| Email: | noreen.bajwa@medtronic.com |
| Date Prepared: | September 21, 2016 |
II. DEVICE [807.92(a)(2)]
| Trade Name: | MiniMed Quick-serter |
|---|---|
| Common or Usual Name: | Syringe Needle Introducer |
| Regulation Name: | Introducer, Syringe Needle |
| Regulation Number: | 21 CFR §880.6920 |
| Product Code: | KZH |
| Regulatory Class: | II |
| Reviewing Product Branch: | General Hospital Devices Branch (GHDB) |
III. PREDICATE DEVICE [807.92(a)(3)]
MiniMed Quick-serter (MMT-395), infusion set insertion system (K992300)
Reference Devices
Purpose of Submission
The scope of this 510(k) submission includes modifications to the device design and additional compatibility to MiniMed Pro-set infusion set.
IV. DEVICE DESCRIPTION [807.92(a)(4)]
The modified MiniMed Quick-serter (MMT-305) is a non-sterile, single patient, multi-use, hand held accessory product designed to be used as an insertion aid for compatible devices, including specific
4
infusion sets. It is used to insert the introducer needle and cannula through the skin and into the subcutaneous tissue. The MiniMed Quick-serter is intended to be used by a patient or clinician as a means to insert an infusion set with minimum discomfort and technique dependency.
The MiniMed Quick-serter consists of a plastic barrel containing a stainless steel spring and a handle. The device user places and securely seats the infusion set into the MiniMed Quick-serter is loaded and locked by pulling the handle (compressing the spring) until it clicks/locks into place. The serter is placed in contact with the insertion site and fired to release the infusion set. This is done by depressing the green side buttons to release the spring, which drives the infusion set forward and the insertion needle and cannula are inserted into the user's subcutaneous tissue. The release button on the top of the device is then pressed to ease the release of the infusion set from the serter.
Devices compatible to MiniMed Quick-serter (MMT-305) include:
V. INDICATIONS FOR USE [807.92(a)(5)]
The MiniMed Quick-serter is indicated to use as an aid for inserting compatible devices. It is for use by a single patient. It is not for use by multiple patients.
The Indications for Use statement for the MiniMed Quick-serter is not identical to the predicate device. However, the differences do not affect the intended use of the device, nor does it affect the safety and effectiveness of the device relative to the predicate.
The predicate MiniMed Quick-serter (MMT-395) is indicated for use with MiniMed Quick-set family of infusion sets. The subject MiniMed Quick-serter (MMT-305) is indicated for use with compatible infusion sets including both MiniMed Quick-set and MiniMed Pro-set families of infusion sets. Both the predicate and subject MiniMed Quick-serter are indicated for single patient, multi-use and have the same intended use for automatic insertion of infusion sets.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS [807.92(a)(6)]
The MiniMed Quick-serter has similar technological characteristics as the predicate device.
The energy source for both the predicate (MMT-395) and subject (MMT-305) MiniMed Quick-serter devices is spring driven. The predicate and subject devices operational principle and there are no different questions of safety and effectiveness as the subject MiniMed Quick-serter (MMT-305) falls within the same classification regulation, has the same intended use and retains the same fundamental scientific technology of the predicate MiniMed Quick-serter (MMT-395).
5
A comparison of the technological characteristics of the predicate (MMT-395) and subject (MMT-305) MiniMed Quick-serter are provided below:
| Description | (Predicate) MiniMed Quick-serter
(MMT-395) | (Modified) MiniMed Quick-serter
(MMT-305) |
|------------------------------|--------------------------------------------------------------|----------------------------------------------------------------|
| Classification | Class II | Identical |
| Product Code | KZH | Identical |
| Type of Use | Over the Counter | Identical |
| Compatibility | Maersk Medical A/S Contour infusion
sets | MiniMed Quick-set Infusion Set
MiniMed Pro-set Infusion Set |
| Condition of use | Single patient, multi-use | Identical |
| Energy Source | Spring Driven | Identical |
| Mode of action | Manual operation | Identical |
| Cocking Force |