(205 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a syringe, with no mention of AI or ML capabilities.
No
The device is described as being "intended to inject fluids into or withdraw fluids from the body," which are diagnostic or procedural functions rather than therapeutic.
No
The device is a syringe, which is used for injecting or withdrawing fluids from the body. Its intended use does not involve diagnosing medical conditions, but rather performing a therapeutic or sampling action.
No
The device description clearly states it is a physical syringe made of rigid polycarbonate barrels and plungers with a synthetic rubber gasket, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to inject fluids into or withdraw fluids from the body." This describes a device used on or in the body for direct medical procedures, not for testing samples outside the body.
- Device Description: The description details a syringe with a barrel, plunger, and gasket, designed for fluid handling in a clinical setting. This aligns with a general medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information about a patient's health status based on sample analysis
- Reagents or test kits
IVDs are specifically designed to perform tests on samples taken from the body to provide diagnostic information. This syringe is a tool for administering or collecting fluids, which is a different function.
N/A
Intended Use / Indications for Use
The MHC Standard and NRFit™ Tip Syringes are intended to inject fluids into or withdraw fluids from the body.
Product codes
FMF
Device Description
The MHC Standard and NRFit™ Tip Syringes are provided sterile or in bulk non-sterile for further processing (e.g., sterilization). They are single use devices consisting of rigid polycarbonate barrels and plungers with a synthetic rubber gasket. The syringe barrels with neuraxial tips are ISO 80369 - 6 compliant and allow for connections of neuraxial specific applications while reducing the likelihood of misconnections to non-neuraxial devices. The syringe barrels are printed with graduated markings in cc (milliliters) indicating the volume of liquid inside the syringe barrel.
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
Not Found
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
Verification and validation testing was performed with the subject neuraxial (NRFit) Tip Syringes. It was found that subject neuraxial (NRFit) Tip Syringes are in compliance with design and performance requirements according to ISO 80369-6:2016 "Small-bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications," and ISO 80369-20:2016 "Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common Test Methods, including Visual Inspection (burrs, hooks, cracks, foreign contamination, missing components), Stress Cracking per ISO 80369-6 (sec. 6.3) and ISO 80369-20 (Annex E), Fluid Leakage by Pressure Decay per ISO 80369-20 (Annex B), Subatmospheric Pressue Air Leakage per ISO 80369-20 (Annex D), and, Resistance to Separation from Axial Load per ISO 80369-20 (Annex F). Biocompatibility testing has demonstrated the subject devices meet the guidelines as described in the FDA guidance document entitled, "Use of International Standard ISO10993-1, " Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Clinical tests were not required to demonstrate performance of between the subject and predicate devices. Product functionality has been adequately assessed by non-clinical tests.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 8, 2017
Mazza Healthcare, LLC. % Jon Gilbert Regulatory Consultant to Mazza Healthcare, LLC Jon Gilbert 1641 Jeurissen Lane Chanhassen, Minnesota 55317
Re: K171131
Trade/Device Name: MHC Standard and NRFit™ Tip Syringes Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: September 29, 2017 Received: October 2, 2017
Dear Jon Gilbert:
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 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.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Tina
Kiang-S
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) K171131
Device Name
MHC Standard and NRFit™ Tip Syringes
Indications for Use (Describe)
The MHC Standard and NRFitM Tip Syringes are intended to inject fluids into or withdraw fluids from the body.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Section 5. 510(k) Summary
Submitter
| Sponsor: | Mazza Healthcare, LLC
2101 Waukegan Road, Suite 208
Bannockburn, IL 60015
Jon Gilbert, Consultant
+01 (906) 361-3237
igilb.raca@gmail.com | |
|-------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact: | | |
| Date of Preparation: | September 29, 2017 | |
| Subject Device:
Common Name:
Trade Name:
Requlation Number:
Regulation Name:
Review Panel:
Regulatory Class:
Product Code: | Standard and Neuraxial Tip Syringes
MHC Standard and NRFit™ Tip Syringes
21 CFR 880.5860
Piston syringe
General Hospital
Class II
FMF | |
| Primary Predicate:
510(k): | Vesco Medical NRFit™ Tip Syringes
K170218 cleared February 24, 2017 | |
| Predicate Device:
510(k): | DMC Medical Single-Use Polycarbonate Syringe
K103736 cleared June 10, 2011 | |
Device Description:
The MHC Standard and NRFit™ Tip Syringes are provided sterile or in bulk non-sterile for further processing (e.g., sterilization). They are single use devices consisting of rigid polycarbonate barrels and plungers with a synthetic rubber gasket. The syringe barrels with neuraxial tips are ISO 80369 - 6 compliant and allow for connections of neuraxial specific applications while reducing the likelihood of misconnections to non-neuraxial devices. The syringe barrels are printed with graduated markings in cc (millliters) indicating the volume of liquid inside the syringe barrel. The proposed models for the standard and neuraxial devices are listed below in Table 1.
| MHC Model # | Item Description |
|---|---|
| 09-050-WH | 5cc Polycarbonate Luer Slip Tip Syringe W/Silicone |
| 09-060-WH | 5cc Polycarbonate Luer Lock Tip Syringe W/Silicone |
| 09-055-WHN | 5cc Polycarbonate Neuraxial Slip Tip Syringe W/Silicone |
| 09-010-WH | 10cc Polycarbonate Luer Slip Tip Syringe w/Silicone |
| 09-120-WH | 10cc Polycarbonate Luer Lock Tip Syringe w/Silicone |
| 09-015-WHN | 10cc Polycarbonate Neuraxial Slip Tip Syringe w/Silicone |
Table 1. MCH Models and Description
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A difference between the predicate syringe (K103736) without a neuraxial tip and the subject syringe with a neuraxial tip is the design of the needle s hub. While the predicate devices (K103736) are designed with a luer slip tip (taper) or luer lock connector the subject neuraxial devices are equipped with a NRFit™ neuraxial connection as standardized in ISO 80369-6. Additionally, the NRFit™ Tip Syringe piston is yellow.
The clinical technique, indications for use, technical specifications, materials used, and sterility status (validation and sterility assurance level) are identical between the subject and predicate Standard syringes. As stated above, the NRFit™ tip syringes provides connections of neuraxial specific applications while reducing the likelihood of misconnections to non-neuraxial devices
Indications for Use:
The MHC Standard and NRFit™ Tip Syringes are intended to inject fluids into or withdraw fluids from the body.
Performance Testing:
The performance of the subject MHC Standard Tip Syringes is identical to the predicate devices as no material (with the exception of the yellow piston), manufacturing or technological changes have occurred. The performance of the subject MHC NRFit™ Tip Syringes is similar to the predicate neuraxial syringes (K170218) as both designs are based upon ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications.
Non-Clinical Tests
Verification and validation testing was performed with the subject neuraxial (NRFit) Tip Syringes. It was found that subject neuraxial (NRFit) Tip Syringes are in compliance with design and performance requirements according to ISO 80369-6:2016 "Small-bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications," and ISO 80369-20:2016 "Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common Test Methods, including Visual Inspection (burrs, hooks, cracks, foreign contamination, missing components), Stress Cracking per ISO 80369-6 (sec. 6.3) and ISO 80369-20 (Annex E), Fluid Leakage by Pressure Decay per ISO 80369-20 (Annex B), Subatmospheric Pressue Air Leakage per ISO 80369-20 (Annex D), and, Resistance to Separation from Axial Load per ISO 80369-20 (Annex F). Biocompatibility testing has demonstrated the subject devices meet the guidelines as described in the FDA guidance document entitled, "Use of International Standard ISO10993-1, " Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
Clinical and Animal Tests
Clinical tests were not required to demonstrate performance of between the subject and predicate devices. Product functionality has been adequately assessed by non-clinical tests.
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| Component: | Vesco Medical
K170218 | DMC Medical,
Ltd, K103736 | MHC Standard
and Neuraxial* |
|--------------------------------------|---------------------------------------------|------------------------------|--------------------------------|
| Syringe Barrel: | Polypropylene | Polycarbonate | Polycarbonate |
| Plunger Tip: | Synthetic Rubber | Elastomer | Elastomer |
| Plunger | Polypropylene | ABS polymer | ABS polymer |
| Syringe Piston Lube
Coating | Polydimethylsiloxane,
Silanol Terminated | Medical Grade
Oil | Medical Grade
Oil |
| Calibrated Barrel
Volume: | Yes | Yes | Yes |
| Recommended
Sterilization method: | EtO | EtO | EtO |
| 510(k) Approval | K170218 | K103736 | K171131 |
Table 2 Technological Characteristics & Substantial Equivalence
*Subiect device Standard and NRFit components are comprised of same materials and manufactured using same manufacturing methods. K103736 best represents predicate materials and components while K170218 and ISO 80369-6 represents requisite neuraxial tip dimensional configurations and technological characteristics and standards.
The operational characteristics, when compared to the predicate device, are identical. The user connects the syringe via a standard slip tip or threaded luer lock, then manually advances or withdraws the plunger internal to the barrel to express or withdraw fluids. Fluids are measured via the printed external housing of the barrel: measurements are indicated in cc (milliliters). Operation is similar for most all piston svringes whether fitted with a threaded luer end, a slip-fit tip or neuraxial tip.
The subject device standard syringes are similar in materials and performance to the Sponsor's currently distributed standard svringes cleared in K103736. The technological characteristics of the subject device neuraxial syringes are consistent with ISO standard and are equivalent to the predicate device cleared in K170218.
Conclusion:
The MHC Standard and NRFit™ Tip Syringes are intended to inject fluids into or
withdraw fluids from the body. The materials, intended use, technological and operational characteristics of the subject devices are substantially equivalent to the predicate Standard Syringes of K103736 and the neuraxial syringes cleared in K170218.