(354 days)
The BD® Syringe NRFit™ Lok and BD® Syringe NRFit™ Slip are intended for neuraxial use by healthcare professionals for aspiration/injection of fluids.
The BD® Syringe NRFit™ Lok and BD® Syringe NRFit™ Slip are sterile, single use syringes with ISO 80369-6 (NRFit™) compliant fittings. They are available in 3mL, 5mL and 10mL, lock and slip configurations and 20mL and 50mL lock configurations. The NRFit™ tips allow for connections of neuraxial specific applications while reducing the likelihood of misconnections to non-neuraxial devices. The syringe assembly consists of a lubricated polypropylene barrel with a graduated scale in milliliters (mL), a lubricated synthetic rubber stopper and a polypropylene plunger rod. The plunger rod is yellow to designate a device intended to only connect to ISO 80369-6 compatible devices such as spinal or epidural needles. The plunger rod is pulled back to aspirate fluids or depressed to inject or expel fluids.
The provided text does not describe an AI/ML powered medical device, but rather a Becton, Dickinson and Company's (BD) Syringe NRFit Lok and BD Syringe NRFit Slip, which are medical devices that are substantially equivalent to a predicate device. Therefore, the specific details regarding acceptance criteria and studies for AI/ML performance (such as sample size for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable or present in this document.
However, based on the provided text, the acceptance criteria and the studies performed to demonstrate equivalence of the BD Syringe NRFit™ Lok and BD Syringe NRFit™ Slip to a predicate device (BD Single Use, Hypodermic Syringe, K980987) are as follows:
1. Table of Acceptance Criteria and Reported Device Performance:
The document details numerous functional, packaging, and biocompatibility tests performed according to specific ISO and ASTM standards. The reported device performance consistently states that the subject device "met all predetermined acceptance criteria for the above-listed performance tests" or comparable phrases indicating successful adherence to the standards. Since the exact numerical criteria and results are not always explicitly stated (e.g., for stress cracking, it doesn't give a specific force value), this table will summarize the type of test and the general outcome.
| Category | Test / Characteristic | Acceptance Criteria (Standard Reference) | Reported Device Performance |
|---|---|---|---|
| Functional Testing | |||
| Connectors | Fluid leakage by Pressure Decay | Per ISO 80369-6:2016 and ISO 80369-20:2015 | Met predetermined acceptance criteria |
| Subatmospheric pressure air leakage | Per ISO 80369-6:2016 and ISO 80369-20:2015 | Met predetermined acceptance criteria | |
| Stress cracking | Per ISO 80369-6:2016 and ISO 80369-20:2015 | Met predetermined acceptance criteria | |
| Resistance to separation from axial load | Per ISO 80369-6:2016 and ISO 80369-20:2015 | Met predetermined acceptance criteria | |
| Resistance to separation from unscrewing | Per ISO 80369-6:2016 and ISO 80369-20:2015 | Met predetermined acceptance criteria | |
| Resistance to overriding | Per ISO 80369-6:2016 and ISO 80369-20:2015 | Met predetermined acceptance criteria | |
| Internal | Needle hub connectivity | Per BD internal requirements | Met predetermined acceptance criteria |
| Tip integrity | Per BD internal requirements | Met predetermined acceptance criteria | |
| Dead space | Per ISO 7886-1:2017 | Met predetermined acceptance criteria | |
| Volumetric accuracy | Per ISO 7886-1:2017 | Met predetermined acceptance criteria | |
| Maximum usable capacity | Per ISO 7886-1:2017 | Met predetermined acceptance criteria | |
| Plunger Retention Force | Per ISO 7886-1:2017 | Met predetermined acceptance criteria | |
| Sticktion | Per ISO 7886-2:1996 | Met predetermined acceptance criteria | |
| Plunger Movement Force | Per ISO 7886-2:2020 | Met predetermined acceptance criteria | |
| Syringe Compliance | Per ISO 7886-2:2020 | Met predetermined acceptance criteria | |
| Break Out Force (3ml, 5ml, 10ml, 20ml, 50ml) | ≤ 4 lb, ≤ 4 lb, ≤ 4.5 lb, ≤ 7.5 lb, ≤ 9.0 lb (Max @ 500mm/min) | Met predetermined acceptance criteria | |
| Sustaining force (3ml, 5ml, 10ml, 20ml, 50ml) | ≤ 1.5 lb, ≤ 2.0 lb, ≤ 2.0 lb, ≤ 2.5 lb, ≤ 5.0 lb (Max @ 500mm/min) | Met predetermined acceptance criteria | |
| Scale Permanency | No Heavy Removal under solvent rub | Met predetermined acceptance criteria | |
| Packaging Testing | |||
| Bubble Leak Testing | Per ASTM F2096:2011 | Met predetermined acceptance criteria | |
| Seal Strength Testing | Per ASTM F88/F88M:2015 | Met predetermined acceptance criteria | |
| Microbial Barrier Testing | Per ASTM F1608:2009 | Met predetermined acceptance criteria | |
| Biocompatibility | |||
| Cytotoxicity | Per ISO 10993-5:2009, Non-cytotoxic | Non-cytotoxic | |
| Hemolysis | Per ISO 10993-4:2017, Non-hemolytic | Non-hemolytic | |
| Acute Systemic Toxicity | Per ISO 10993-11:2006, Non-toxic | Non-toxic | |
| Intracutaneous Reactivity | Per ISO 10993-10:2010, Non-irritant | Non-irritant | |
| Sensitization | Per ISO 10993-10:2010, Non-sensitizer | Non-sensitizer | |
| Material-mediated Pyrogenicity | Per ISO 10993-11:2006 and USP <151>, Non-pyrogenic | Non-pyrogenic | |
| LAL Endotoxin | Per USP <85>, < 2.15 EU/device | Met acceptance criteria (< 2.15 EU/device) | |
| Chemical Characterization | Per ISO 10993-18:2005, acceptable extractables/leachables profile | Acceptable extractables/leachables profile | |
| Subacute/Subchronic | Per ISO 10993-11; No treatment related adverse effects | No treatment related adverse effects | |
| Genotoxicity | Per ISO 10993-3:2014, Non-mutagenic and non-clastogenic | Non-mutagenic and non-clastogenic | |
| Additional Testing | |||
| Acidity/Alkalinity and Extractable Metals | Per ISO 7886-1:2017, Met limits | Met limits | |
| Particulate Matter | Per USP <788>, Met limits | Met limits | |
| Neurotoxicity Assessment | No signs of systemic toxicity or neurological impairment from exposure of leachable compounds from the test article | No signs of systemic toxicity or neurological impairment |
For the following points, as the device is a syringe and not an AI/ML powered device, these sections are generally not applicable and the provided text does not contain this information.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable for this type of medical device assessment. The tests involve physical samples of the syringe rather than data sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth for physical device performance is established through adherence to national and international standards, rather than expert consensus on interpretive tasks.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as the evaluation is based on objective measurements against specified standard limits, not interpretive judgment.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by international and national consensus standards (ISO, ASTM, USP) that define safety and functional attributes for syringes and medical device materials, along with BD internal requirements for specific characteristics not fully covered by external standards.
8. The sample size for the training set
Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device.
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September 4, 2020
Becton, Dickinson and Company Murtaza Rana Staff Regulatory Affairs Specialist 1 Becton Drive Franklin Lakes, New Jersey 07417
Re: K192538
Trade/Device Name: BD Syringe NRFit Lok and BD Syringe NRFit Slip Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: QEH Dated: August 6, 2020 Received: August 7, 2020
Dear Murtaza Rana:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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 (QS) 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,
For CAPT Alan Stevens 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) K192538
Device Name
BD® Syringe NRFit™ Lok and BD® Syringe NRFit™ Slip
Indications for Use (Describe)
The BD® Syringe NRFit™ Lok and BD® Syringe NRFit™ Slip are intended for neuraxial use by healthcare professionals for aspiration/injection of fluids.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary (21 CFR §807.92)
BD® Syringe NRFit™ Lok and BD® Syringe NRFit™ Slip
| SubmitterInformation | Submitter Name:Submitter Address:Contact Person:Email Address:Phone Number:Fax Number:Date of Preparation: | Becton, Dickinson and Company1 Becton DriveFranklin Lakes, NJ 07417Murtaza RanaStaff Regulatory Affairs SpecialistMurtaza.rana@bd.com(201) 847-6980(201) 847-5307August 6, 2020 |
|---|---|---|
| Subject Device | Trade Name:Common Name:Regulation Number:Regulation Name:Regulatory Class:Product Code:Classification Panel: | BD® Syringe NRFit™ Lok and BD®Syringe NRFit™ SlipPiston Syringe21 CFR §880.5860Piston SyringeClass II deviceQEH (Piston Syringe With NeuraxialConnector - Epidural, Peripheral and/orindirect CSF contact)General Hospital |
| Predicate Device | Trade Name:510(k) Reference:Common Name:Regulation Number:Regulation Name:Regulatory Class:Product Code:Classification Panel: | BD Single Use, Hypodermic SyringeK980987Piston Syringe21 CFR §880.5860Piston SyringeClass II deviceFMF (Syringe, Piston)General Hospital |
| Reason forSubmission | The purpose of this submission is to modify the tip of thecurrent BD Single Use, Hypodermic Syringe (previously clearedunder K980987) from the current Luer connections per ISO594-1 and ISO 594-2 to the new ISO 80369-6 connectorsreferred to as NRFit™. The new BD syringes with NRFit™connectors will be referred to as BD® Syringe NRFit™ Lok andBD® Syringe NRFit™ Slip. BD will continue to market thecurrent BD Single Use, Hypodermic Syringes with Luerconnections for general purpose use, while the new BD®Syringe NRFit™ Lok and BD® Syringe NRFit™ Slip will be forneuraxial use per ISO 80369-6. | |
| Device Description | The BD® Syringe NRFit™ Lok and BD® Syringe NRFit™ Slipare sterile, single use syringes with ISO 80369-6 (NRFit™) | |
| compliant fittings. They are available in 3mL, 5mL and 10mL, lock and slip configurations and 20mL and 50mL lock configurations. The NRFit™ tips allow for connections of neuraxial specific applications while reducing the likelihood of misconnections to non-neuraxial devices. The syringe assembly consists of a lubricated polypropylene barrel with a graduated scale in milliliters (mL), a lubricated synthetic rubber stopper and a polypropylene plunger rod. The plunger rod is yellow to designate a device intended to only connect to ISO 80369-6 compatible devices such as spinal or epidural needles. The plunger rod is pulled back to aspirate fluids or depressed to inject or expel fluids. | ||
| Indications for Use | The BD® Syringe NRFit™ Lok and BD® Syringe NRFit™ Slip are intended for neuraxial use by healthcare professionals for aspiration/injection of fluids. | |
| Technological Characteristics | The subject BD® Syringe NRFit™ Lok and BD® Syringe NRFit™ Slip are equivalent to that of the predicate BD Single Use, Hypodermic Syringe in intended use, materials and performance characteristics. |
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| Element ofComparison | Subject Device | Predicate Device | |
|---|---|---|---|
| Indications for Use | The BD® Syringe NRFit™ Lokand BD® Syringe NRFit™ Slipare intended for neuraxial useby healthcare professionalsfor aspiration/injection offluids. | The BD Single Use,Hypodermic Syringe isintended for use by healthcare professionals for generalpurpose fluidaspiration/injection. | |
| Syringe materials | Barrel | Polypropylene | Polypropylene |
| BarrelLubricant | Silicone | Silicone | |
| Plunger Rod | Polypropylene with yellowcolorant | Polypropylene | |
| Stopper | Polyisoprene Rubber | Polyisoprene Rubber | |
| StopperLubricant | Silicone | Silicone | |
| Tip type | NRFit™ lock or slip per ISO80369-6:2016 | Luer-Lok™ or Luer Slip perISO 594-1: 1986 and ISO594-2: 1998 | |
| Sterilization Method | Gamma Irradiation/E-beam Irradiation | Gamma Irradiation/E-beam Irradiation | |
| SAL | 10-6 | 10-6 | |
| Shelf Life | 5 Years | 5 Years | |
| Functional Testing: | |||
| Fluid leakage byPressure Decay | Per ISO 80369-6:2016 andISO 80369-20:2015 | Per ISO 594-1:1986 andISO 594-2:1998 | |
| Subatmosphericpressure air leakage | Per ISO 80369-6:2016 andISO 80369-20:2015 | Per ISO 594-1:1986 andISO 594-2:1998 | |
| Stress cracking | Per ISO 80369-6:2016 andISO 80369-20:2015 | Per ISO 594-1:1986 andISO 594-2:1998 | |
| Resistance toseparation from axialload | Per ISO 80369-6:2016 andISO 80369-20:2015 | Per ISO 594-1:1986 andISO 594-2:1998 | |
| Resistance toseparation fromunscrewing | Per ISO 80369-6:2016 andISO 80369-20:2015 | Per ISO 594-2:1998 | |
| Resistance tooverriding | Per ISO 80369-6:2016 andISO 80369-20:2015 | Per ISO 594-2:1998 | |
| Needle hubconnectivity | Per BD internal requirements | Per BD internal requirements | |
| Tip integrity | Per BD internal requirements | Per BD internal requirements | |
| Dead space | Per ISO 7886-1:2017 | Per ISO 7886-1:1993 | |
| Volumetric accuracy | Per ISO 7886-1:2017 | Per ISO 7886-1:1993 | |
| Maximum usablecapacity | Per ISO 7886-1:2017 | Per ISO 7886-1:1993 | |
| Plunger RetentionForce * | Per ISO 7886-1:2017 | Per ISO 7886-1:2017 | |
| Sticktion* | Per ISO 7886-2:1996 | Per ISO 7886-2:1996 | |
| Plunger MovementForce | Per ISO 7886-2:2020 | N/A. Not required previouslyfor predicate device. | |
| Syringe Compliance | Per ISO 7886-2:2020 | N/A. Not required previouslyfor predicate device. | |
| Break Out Force | Size3ml5ml10ml20ml50ml | Max (lb) @ 500mm/min≤ 4≤ 4≤ 4.5≤ 7.5≤ 9.0 | |
| Sustaining force | Size3ml5ml10ml20ml50ml | Max (lb) @ 500mm/min≤ 1.5≤ 2.0≤ 2.0≤ 2.5≤ 5.0 | |
| Scale Permanency | No Heavy Removal undersolvent rub | No Heavy Removal undersolvent rub | |
| Packaging Testing | |||
| Bubble LeakTesting* | Per ASTM F2096:2011 | Per ASTM F2096:2011 | |
| Seal Strength | Per ASTM F88/F88M:2015 | Per ASTM F88/F88M:2015 | |
| Testing* | |||
| Microbial BarrierTesting* | Per ASTM F1608: 2009 | Per ASTM F1608: 2009 | |
| Biocompatibility Testing: | |||
| Testing per ISO 10993-1:2018: | |||
| Cytotoxicity | Per ISO 10993-5:2009, Non-cytotoxic | Per ISO 10993-5:2009, Non-cytotoxic | |
| Hemolysis | Per ISO 10993-4:2017, Non-hemolytic | Per ISO 10993-4:2002/A1:2006, Non-hemolytic | |
| Acute SystemicToxicity | Per ISO 10993-11:2006, Non-toxic | Per ISO 10993-11:2006, Non-toxic | |
| IntracutaneousReactivity | Per ISO 10993-10:2010, Non-irritant | Per ISO 10993-10:2010, Non-irritant | |
| Sensitization | Per ISO 10993-10:2010, Non-sensitizer | Per ISO 10993-10:2010, Non-sensitizer | |
| Material-mediatedPyrogenicity | Per ISO 10993-11:2006 andUSP<151>, Non-pyrogenic | Per ISO 10993-11:2006 andUSP 151, Non-pyrogenic | |
| LAL Endotoxin | Per USP<85>,2.15 EU/device | Per USP<85>,< 0.2 EU/device | |
| ChemicalCharacterization | Per ISO 10993-18:2005,acceptableextractables/leachablesprofile | Per ISO 10993-18:2005,acceptableextractables/leachablesprofile | |
| Subacute/Subchronic | Per ISO 10993-11; Notreatment related adverseeffects | N/A. Not Required previouslyfor predicate device | |
| Genotoxicity | Per ISO 10993-3:2014, Non-mutagentic and non-clastogenic | N/A. Not required previouslyfor predicate device. | |
| Additional Testing : | |||
| Acidity/Alkalinity andExtractable Metals | Per ISO 7886-1:2017, Metlimits | Per ISO 7886-1:1993, Metlimits | |
| Particulate Matter | Per USP <788>, Met limits | N/A. Not required previouslyfor predicate device. | |
| NeurotoxicityAssessment | No signs of systemic toxicityor neurological impairmentfrom exposure of leachablecompounds from the testarticle | N/A. Not required previouslyfor predicate device. |
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The intended uses of the subject and predicate devices are the same in that both are intended for use by healthcare professionals for aspiration/injection of fluids. However, due to the ISO 80369-6 connector, the BD® Syringe NRFit™ Lok and BD® Syringe NRFit™ Slip are limited to neuraxial applications. As such, the neuraxial indication, is a subset of the predicate indications for use, which is for general purpose. Therefore, the above difference in indications for use is not critical to the intended use as the intended
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use remains the same: for use by healthcare professionals for aspiration/injection of fluids. It further does not affect the safety and effectiveness of the device when used as labeled as demonstrated through functional testing. Biocompatibility testing per ISO 10993 and ISO 80369 testing were conducted to address the changes in indications for neuraxial use and tip design, respectively.
BD has performed the following non-clinical/design verification Performance Tests testing/analysis and the results of these tests/analysis demonstrate that the BD® Syringe NRFit™ Lok and BD® Syringe NRFit™ Slip performed in an equivalent manner to the predicate device. Per ISO 80369-6 and ISO 80369-20: . Fluid leakage by Pressure Decay Subatmospheric pressure air leakage . Stress cracking . ● Resistance to separation from axial load ● Resistance to separation from unscrewing Resistance to overriding . Per BD internal requirements: Needle hub connectivity . . Tip integrity Per ISO 7886-1: Dead space . . Volumetric accuracy Maximum usable capacity . Per ISO 7886-2:2020: . Plunger Movement Force Svringe Compliance ● A biocompatibility evaluation was conducted on the subject device per ISO 10993-1:2018. The contact classification is external communicating, indirect contact with blood and tissue with a prolonged use. Based on the evaluation, the following biological tests were conducted: . Cytotoxicity . Hemolysis Acute Systemic Toxicity ● Intracutaneous Reactivity ● . Sensitization . Subacute/Subchronic
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- Genotoxicity .
- Material-mediated Pyrogenicity .
- LAL Endotoxin
- . Chemical Characterization
Additionally, the following tests were performed:
- Acidity/Alkalinity and Extractable Metals per ISO 7886-. 1:2017
- Particulate Matter per USP <788> .
- . Neurotoxicity Assessment
| Functional:Per ISO 7886-1:2017:• Plunger Retention ForcePer ISO 7886-2:1996:• SticktionPer BD internal requirements:• Break Out Force• Sustaining force• Scale Permanency | |
|---|---|
| Packaging:Per ASTM F2096: 2011• Bubble Leak TestingPer ASTM F88/F88M: 2015• Seal Strength TestingPer ASTM F1608:2009• Microbial Barrier Testing | |
| The subject device met all predetermined acceptance criteriafor the above-listed performance tests, demonstratingsubstantial equivalence to the predicate device. | |
| Clinical Testing | Clinical testing was not required for this submission |
| Summary ofSubstantialEquivalence | The BD® Syringe NRFit™ Lok and BD® Syringe NRFit™ Slipare substantially equivalent to the predicate device in intendeduse, principles of operation, technology, design, materials andperformance. |
§ 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).