(240 days)
The NRFit® cap is a sterile, single-use device intended to provide positive closure to prevent fluid loss and contamination in Neuraxial devices CADD Cassettes or Syringes utilizing NRFit® connections. The NRFit® cap is intended to be used for less than 24 hours on any single application.
The NRFit® Caps (abbreviated as "NRFit") are ISO 80369-6 compliant caps designed to prevent fluid loss in Neuraxial devices. The NRFit cap is made from medical grade polypropylene with yellow colorant. The NRFit cap is available with either a male neuraxial lock connection or a female neuraxial lock connection. The NRFit cap is made of materials appropriate for a limited exposure duration, externally communicating, tissue/bone/dentin contacting medical device.
The provided document describes the NRFit® Caps, Male and Female Neuraxial Tip Caps, and its substantial equivalence to a predicate device. It specifies performance testing but does not contain information about acceptance criteria and a study that proves the device meets those criteria in the context of AI/ML performance.
The document is purely about the 510(k) premarket notification for a physical medical device (caps for neuraxial devices) and its comparison to a similar predicate device. The performance data presented are for non-clinical, physical tests of the device (e.g., leakage, stress cracking, axial separation), not for AI/ML performance metrics.
Therefore, I cannot provide the requested information regarding AI/ML device performance, as the provided text does not pertain to an AI/ML powered medical device.
If you have a document describing an AI/ML medical device and its performance studies, please provide that.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
December 16, 2020
International Medical Industries, Inc. David Meily Director of Quality & Regulatory Affairs 2981 Gateway Drive Pompano Beach, Florida 33069
Re: K201031
Trade/Device Name: NRFit® Caps, Male and Female Neuraxial Tip Caps Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: QEH Dated: November 18, 2020 Received: November 19, 2020
Dear David Meily:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Rumi Young Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201031
Device Name
NRFit® Caps, Male and Female Neuraxial Tip Caps
Indications for Use (Describe)
The NRFit® cap is a sterile, single-use device intended to provide positive closure to prevent fluid loss and contamination in Neuraxial devices CADD Cassettes or Syringes utilizing NRFit® connections. The NRFit® cap is intended to be used for less than 24 hours on any single application.
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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510(k) Summary NRFit® Caps, Male and Female Neuraxial Tip Caps
K201031
1. Submission Sponsor
International Medical Industries, Inc.
2981 Gateway Drive.
Pompano Beach
FL, 33069
USA
Contact: David Meily
Title: Director of Quality & Regulatory Affairs
2. Submission Correspondent
No applicable
3. Date Prepared
December 16, 2020
4. Device Identification
| Trade/Proprietary Name: | NRFit® Caps, Male and Female Neuraxial Tip Caps |
|---|---|
| Common/Usual Name: | syringe, piston |
| Classification Name: | syringe, piston |
| Regulation Number: | 21 CFR§880.5860 |
| Product Code: | QEH |
| Device Class: | Class II |
| Classification Panel: | General Hospital |
5. Legally Marketed Predicate Device(s)
Predicate Device
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K170900
| Trade/Proprietary Name: | DASH 6® NRFit Syringe Cap |
|---|---|
| Common/Usual Name: | syringe, Piston |
| Classification Name: | syringe, piston |
| Regulation Number: | 21 CFR 880.5860 |
| Product Code: | FMF |
| Device Class: | Class II |
| Classification Panel: | General Hospital |
6. Indication for Use Statement
The NRFit® cap is a sterile, single-use device intended to provide positive closure to prevent fluid loss and contamination in Neuraxial devices CADD Cassettes or Syringes utilizing NRFit® connections.
NRFit® cap is intended to be used for less than 24 hours on any single application.
7. Device Description
The NRFit® Caps (abbreviated as "NRFit") are ISO 80369-6 compliant caps designed to prevent fluid loss in Neuraxial devices. The NRFit cap is made from medical grade polypropylene with yellow colorant. The NRFit cap is available with either a male neuraxial lock connection or a female neuraxial lock connection. The NRFit cap is made of materials appropriate for a limited exposure duration, externally communicating, tissue/bone/dentin contacting medical device.
8. Substantial Equivalence Discussion
Based on the above information and FDA Guidance Document "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications", the proposed NRFit caps is concluded to be substantially equivalent to its predicate, DASH 6 NRFit syringe caps.
| Manufacturer | International Medical Industries,Inc. | INTERVENE Group Limited | |
|---|---|---|---|
| Proprietary DeviceName | NRFit® Caps, Male and FemaleNeuraxial Tip Caps | DASH 6® NRFit™ Syringe Caps | Comparison |
| 510(k) # | K201031 | K170900 | N/A |
| Indications for Use | The NRFit® cap is a sterile, single-use device intended to provide positive closure to prevent fluid loss and contamination in Neuraxial devices CADD Cassettes | DASH 6® NRFit Syringe cap is intended to be used with ISO 80369-6 NRFit neuraxial syringes for sealing the tip of the syringe. | Similar, both are used with neuraxial devices |
| Table 5-A: NRFit Caps and Predicate Device Comparison | |||
|---|---|---|---|
| Manufacturer | International Medical Industries,Inc. | INTERVENE Group Limited | Comparison |
| Proprietary DeviceName | NRFit® Caps, Male and FemaleNeuraxial Tip Caps | DASH 6® NRFit™ Syringe Caps | Comparison |
| Product Code | or Syringes utilizing NRFit®connections. NRFit® cap isintended to be used for less than24 hours on any singleapplication. | FMF | New productcode forneuraxialdevices |
| Regulation No. | 21 CFR 880.5860 | 21 CFR 880.5860 | Same |
| Classification | Class II | Class II | Same |
| Device Description | The NRFit® Caps are ISO 80369-6compliant caps designed toprevent fluid loss in Neuraxialdevices. The NRFit® cap is madefrom medical gradepolypropylene with yellowcolorant. The NRFit® cap isavailable with either a maleneuraxial lock connection or afemale neuraxial lock connection.The NRFit® cap is made ofmaterials appropriate for alimited exposure duration,externally communicating,tissue/bone/dentin contactingmedical device < 24 contactduration | DASH 6® NRFit Syringe Caps areSingle Use, In-Hospital devices. Itincorporates a female ISO 80369-6NRFit connector to be connectedon an ISO 80369-6 compliant maleport. The device will be supplied asindividually packed (sterile) and thebulk packed (non-sterile). Thesterile packed items will besupplied directly to the user andthe bulk packed will be supplied toAnesthetic Conduction Kitmanufacturers to be packaged intokit. The devices packaging willindicate it is a syringe cap and thesterility/sterilization method thedevice has undergone. | Similar.IMI'sdescription isbased onfunction,materialcompositionand patientcontact.INTERVENE'sdescription isof packagingand sterility.Bothcompaniesagree oncompliance toISO 80369-6 |
| Environment | General Hospital | General Hospital | Same |
| User | Hospital/clinical personnel | Hospital/clinical personnel | Same |
| Sterilization Method | Ethylene Oxide | Ethylene Oxide | Same |
| Number of Uses | Single Use | Single Use | Same |
| Cap Material | Polypropylene (PP) | Polypropylene (PP) | Same |
| BiocompatibilityContact and Duration | External communicating, bloodpath (indirect) for a duration of<24 Hrs | External communicating, bloodpath (indirect) for a duration of ≤24Hrs | Same |
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The predicate device is a Syringe Family and Accessories. The NRFit® caps are substantially equivalent to the accessory- DASH 6® NRFit Syringe caps.
Note: Based on the comparison above, there are no new or different questions of safety or effectiveness.
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9. Non-Clinical Performance Data
| Table 5-B: Summary of NRFit® Caps Testing | ||
|---|---|---|
| ------------------------------------------- | -- | -- |
| Test Name | Test Description |
|---|---|
| Falling Drop Liquid Leakage | NRFit® device shall show no signs of leakage sufficient to form afalling drop of water |
| Sub-atmospheric-pressure air leakage | NRFit® Device shall not leak by more than 0.005 Pa (m^3)/sduring aspiration |
| Stress Cracking | NRFit® Device shall show no evidence of stress cracking (i.e.visible cracks in the threads or taper of the connector) orleakage after Stress Crack testing |
| Axial Separation | NRFit® Device shall not separate from a properly installedreference connector while being subjected to at least 35Ndisconnection tensile axial force |
| Resistance to Unscrewing | NRFit® Device shall not separate from a properly installedreference connector |
| Resistance to Overriding | NRFit® device shall not override the threads or lugs of thereference connector |
| Visual | NRFit® device shall be a similar yellow in color to other NRFitproducts available on the open market |
| Visual Inspection | Device must be available in a primary package blisterconfiguration consisting of PETG film with Tyvek Lid. |
| Visual Inspection | Heat seals must meet ASTM F1886:2013 Standard test methodfor determining integrity of seals for flexible packaging by visualinspection |
| Wearing a set of disposable nitrile gloves,run a finger along the outer edge of thepackaging and ensure glove does not catchon any feature such that a hole or tear isformed | Primary packaging must not expose the user to sharps that maycause injury or a breach in aseptic technique |
| Visual Inspection | Product outer packaging must be free from gross cosmeticdefects, particulate, and foreign material |
| Transportation, Shelf Life | Simulated transportation conditions and shelf life followed bydesign verification testing. |
| Product Validation | Human factors and Usability |
| Biocompatibility | Cytotoxicity, Intracutaneous Irritation testing, Sensitizationtesting, Hemolysis testing direct/indirect, Acute systemictoxicity, Pyrogenicity, Chemical Characterization, Extractablesand Leachables, Toxicological Risk assessment. |
| Performance | ISO 80369-6:2016 and ISO 80369-20:2015 |
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10. Clinical Performance Data
There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device.
11. Statement of Substantial Equivalence
The male and female NRFit® caps have the same intended use, function, materials and patient contact as the predicate device. Both devices are compliant to ISO 80369-6. Minor technological differences do not raise new or different questions of safety and effectiveness.
The NRFit® caps, as designed and manufactured, are determined to be substantially equivalent to the referenced predicate device.
§ 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).