(240 days)
Not Found
No
The document describes a simple mechanical cap for neuraxial devices and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No
The device is a cap intended to provide closure to prevent fluid loss and contamination in neuraxial devices. It does not treat or diagnose any disease or condition.
No
Explanation: The device description states its purpose is to prevent fluid loss and contamination in neuraxial devices and provides positive closure. It does not mention any function related to diagnosing a condition or disease.
No
The device description clearly states it is a physical cap made from medical grade polypropylene, intended for physical closure of neuraxial devices. It undergoes non-clinical performance studies related to physical properties and biocompatibility, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide positive closure to prevent fluid loss and contamination in Neuraxial devices. This is a mechanical function related to containing fluids within a medical device, not for examining specimens from the human body to provide diagnostic information.
- Device Description: The description focuses on the physical characteristics and materials of a cap designed for connection to other medical devices. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD-related information: The document does not mention any of the typical elements associated with IVDs, such as:
- Analysis of biological specimens (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Diagnostic purposes (identifying diseases, conditions, etc.)
- Reagents or assays
The device is a sterile, single-use accessory for Neuraxial devices, focused on preventing contamination and fluid loss. This falls under the category of a general medical device, not an in vitro diagnostic device.
N/A
Intended Use / 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 or Syringes utilizing NRFit® connections. The NRFit® cap is intended to be used for less than 24 hours on any single application.
Product codes (comma separated list FDA assigned to the subject device)
QEH
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.
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
Hospital/clinical personnel / General Hospital
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)
Non-Clinical Performance Data:
Test Name: Falling Drop Liquid Leakage, Sub-atmospheric-pressure air leakage, Stress Cracking, Axial Separation, Resistance to Unscrewing, Resistance to Overriding, Visual, Visual Inspection (packaging and heat seals), Visual Inspection (product outer packaging), Transportation, Shelf Life, Product Validation, Biocompatibility, Performance
Key results: NRFit® device shall show no signs of leakage sufficient to form a falling drop of water; NRFit® Device shall not leak by more than 0.005 Pa (m^3)/s during aspiration; NRFit® Device shall show no evidence of stress cracking (i.e. visible cracks in the threads or taper of the connector) or leakage after Stress Crack testing; NRFit® Device shall not separate from a properly installed reference connector while being subjected to at least 35N disconnection tensile axial force; NRFit® Device shall not separate from a properly installed reference connector; NRFit® device shall not override the threads or lugs of the reference connector; NRFit® device shall be a similar yellow in color to other NRFit products available on the open market; Device must be available in a primary package blister configuration consisting of PETG film with Tyvek Lid.; Heat seals must meet ASTM F1886:2013 Standard test method for determining integrity of seals for flexible packaging by visual inspection; Primary packaging must not expose the user to sharps that may cause injury or a breach in aseptic technique; Product outer packaging must be free from gross cosmetic defects, particulate, and foreign material; Simulated transportation conditions and shelf life followed by design verification testing.; Human factors and Usability; Cytotoxicity, Intracutaneous Irritation testing, Sensitization testing, Hemolysis testing direct/indirect, Acute systemic toxicity, Pyrogenicity, Chemical Characterization, Extractables and Leachables, Toxicological Risk assessment.; ISO 80369-6:2016 and ISO 80369-20:2015.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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
1
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
2
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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3
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
4
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 Device
Name | NRFit® Caps, Male and Female
Neuraxial 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 Device | |||
| Name | NRFit® Caps, Male and Female | ||
| Neuraxial Tip Caps | DASH 6® NRFit™ Syringe Caps | Comparison | |
| Product Code | or Syringes utilizing NRFit® | ||
| connections. NRFit® cap is | |||
| intended to be used for less than | |||
| 24 hours on any single | |||
| application. | FMF | New product | |
| code for | |||
| neuraxial | |||
| devices | |||
| Regulation No. | 21 CFR 880.5860 | 21 CFR 880.5860 | Same |
| Classification | Class II | Class II | Same |
| Device Description | The NRFit® Caps are ISO 80369-6 | ||
| 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 |