(30 days)
The Vesco Medical NRFit™ Tip Syringes are intended to inject fluids into or withdraw fluids from the body.
The Vesco Medical NRFit Tip Syringes are sterile, single use devices consisting of rigid polypropylene barrels and plungers with a synthetic rubber gasket. The tips of the syringe barrels are NRFit ISO 80369-6 compliant. The NRFit tip allows for connections of neuraxial specific applications while reducing the likelihood of misconnections to non-neuraxial devices. The syringe barrel is printed with graduated markings indicating, in milliliters, the volume of liquid inside the syringe barrel.
The document provides information on the non-clinical testing conducted for the Vesco Medical NRFit™ Tip Syringes to demonstrate substantial equivalence to predicate devices. Here's a breakdown based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Basic Syringe Functions | BS EN ISO 7886-1:1997 | In compliance. |
| Determination of Dead Space | BS EN ISO 7886-1:1997 | In compliance. |
| Liquid Leakage at Syringe Piston Under Compression | BS EN ISO 7886-1:1997 | In compliance. |
| Air Leakage Past Syringe Piston During Aspiration and for Separation of Piston and Plunger | BS EN ISO 7886-1:1997 | In compliance. |
| Fluid Leakage (Connector) | ISO 80369-20:2015 and ISO 80369-6 (for positive pressure fluid leakage) | Met the standards. The NRFit connector helps reduce the residual risk of misconnections. |
| Stress Cracking (Connector) | ISO 80369-20:2015 and ISO 80369-6 | Met the standards. The NRFit connector helps reduce the residual risk of misconnections. |
| Resistance to separation from axial load (Connector) | ISO 80369-20:2015 and ISO 80369-6 | Met the standards. The NRFit connector helps reduce the residual risk of misconnections. |
| Resistance to separation from unscrewing (Connector) | ISO 80369-20:2015 and ISO 80369-6 | Met the standards. The NRFit connector helps reduce the residual risk of misconnections. |
| Resistance to overriding (Connector) | ISO 80369-20:2015 and ISO 80369-6 | Met the standards. The NRFit connector helps reduce the residual risk of misconnections. |
| Disconnection by unscrewing (Connector) | ISO 80369-20:2015 | (Implied met standards, as it is listed as performed during compliance testing for NRFit™ Tip Syringes) - no specific pass/fail noted, but overall conclusion points to compliance. |
| NRFit Dimensional Verification | ISO 80369-20:2015 and ISO 80369-6 for NRFit dimensional verification | Met the standards. The NRFit connector helps reduce the residual risk of misconnections. |
| Biocompatibility | ISO 10993-1:2009, with FDA modified matrix presented in General Program Memorandum # G95-1 | Same materials, manufacturer, manufacturing materials as primary predicate. (Claimed "Substantially equivalent" based on this). |
2. Sample Size used for the test set and the data provenance
The document does not specify the exact sample sizes (number of units tested) for each non-clinical test. It only states that "Verification and validation Testing was performed with the Vesco Medical NRFit Tip Syringes."
The data provenance is from non-clinical tests performed by Jiangyin Caina Technology Co., Ltd and Vesco Medical. No country of origin is explicitly stated for the testing facilities within this document, though Jiangyin Caina Technology Co., Ltd is likely a Chinese company based on its name. These tests are non-clinical verification and validation studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the study described is a series of non-clinical, laboratory-based performance tests against international standards (ISO). There are no "experts" establishing ground truth in the context of clinical or diagnostic performance; instead, the ground truth is defined by the technical specifications and criteria set forth in the ISO standards themselves.
4. Adjudication method for the test set
This information is not applicable. Adjudication methods are typically employed in studies where human interpretation or subjective assessment of data is involved (e.g., medical image interpretation). For objective physical and mechanical tests against ISO standards, the results are directly measured and compared to predefined pass/fail criteria.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic aid devices, particularly those involving AI in image interpretation. The device in question, Vesco Medical NRFit™ Tip Syringes, is a physical medical device (syringe) and does not involve AI or human "readers" in its function or evaluation in the context of this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm only) performance study was not done. This concept is specific to AI/software as a medical device. The Vesco Medical NRFit™ Tip Syringes is a physical device subject to physical and mechanical testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for these non-clinical tests is based on international standards and specifications (e.g., ISO 80369-6:2016, ISO 80369-20:2016, BS EN ISO 7886-1:1997). The device's performance is measured against the specific requirements and pass/fail criteria outlined in these standards.
8. The sample size for the training set
This information is not applicable. There is no "training set" in the context of non-clinical performance testing for a physical medical device like a syringe. Training sets are relevant for machine learning algorithms.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for this type of device and study.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 24, 2017
Vesco Medical, LLC % Mark Job Official Correspondent Regulatory Technology Services. LLC 1394 25th Street, NW Buffalo, Minnesota 55313
Re: K170218
Trade/Device Name: Vesco Medical NRFit Tip Syringes Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: January 23, 2017 Received: January 25, 2017
Dear Mark Job:
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.
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
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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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/ResourcesforYou/Industry/default.htm. 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.
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.
Michael J. Ryan -S
for 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
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Indications for Use
510(k) Number (if known)
Device Name
Vesco Medical NRFit™ Tip Syringes
Indications for Use (Describe) The Vesco Medical NRFit™ Tip Syringes are intended to inject fluids into or withdraw fluids from the body.
| 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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TAB 6 510(k) Summary
Submitter I.
| Official Contact | Name: Chris O'KeefeTitle: VP Product Development and InnovationEmail: cokeefe@vescomedical.com |
|---|---|
| Vesco MedicalAddress: 692 N. High Street, Suite 205efColumbus, Ohio 43215 | |
| Phone: 614-914-5991Fax: 614-902-3275 | |
| Date of Preparation | November 04, 2016 |
II. Device
| Name of Device: | Vesco Medical NRFitTM Tip Syringes |
|---|---|
| Common/Usual Name: | Syringe, Piston |
| Device Classification: | Class II |
| Classification Name/Product Code: | General Hospital and Personal Use Devices (21 CFR 880.5860) / FMF |
Legally Marketed Predicate Devices III.
- Jiangyin Caina Technology Co., Ltd (Caina) Syringes With or Without Needles (Luer Slip/Lock) were cleared under notification K113091.
- Shanghai Kindly Enterprises Sterile Hypodermic Syringe for Single Use, With or WithoutNeedle (Luer Slip/Lock) were cleared under notification K112057.
Device Description IV.
The Vesco Medical NRFit Tip Syringes are sterile, single use devices consisting of rigid polypropylene barrels and plungers with a synthetic rubber gasket. The tips of the syringe barrels are NRFit ISO 80369-6 compliant. The NRFit tip allows for connections of neuraxial specific applications while reducing the likelihood of misconnections to non-neuraxial devices. The syringe barrel is printed with graduated markings indicating, in milliliters, the volume of liquid inside the syringe barrel. The proposed models are listed in Table 6.1.
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| Vesco Medical NRFit Tip Syringes | |
|---|---|
| Model # | Volume |
| VND-603EO | 3 mL |
| VND-610EO | 10 mL |
| VND-620EO | 20 mL |
Table 6.1: Proposed models of Vesco Medical NRFit Tip Syringes
Intended Use V.
The Vesco Medical NRFit™ Tip Syringes are intended to inject fluids into or withdraw fluids from the body.
VI. Comparison of Technological Characteristics with the Predicate
Device
The proposed Vesco Medical NRFit Tip Syringes and the predicate devices are all intended to injectfluids into or withdraw fluids from the body. These products have similar intended uses, technological characteristics, manufacturing methods, and operating principles. There are no significant differences that would affect the performance of the Vesco Medical NRFit Tip Syringes as compared to the predicate devices. Table 6.2 lists the comparisons of the proposed device to the predicate devices.
Table 6.2: Comparison of Vesco Medical NRFit Tip Syringes to predicate devices regarding substantial equivalence રાજ્યના વાંતિત
| Design Features/ Function | Syringes With orWithout NeedlesK113091(Primary Predicate) | Sterile HypodermicSyringe for SingleUse, With or WithoutNeedle K112057(SecondaryPredicate) | Vesco MedicalNRFit™ TipSyringes(Proposed) | SubstantialEquivalence |
|---|---|---|---|---|
| Indications forUse | Syringes with orwithout needle areintended to injectfluids into or withdrawfluids from the body. | The SterileHypodermic Syringefor Single Use with /without needle isintended to be used formedical purposes toinject fluid into orwithdraw fluid frombody. | The Vesco MedicalNRFit™ TipSyringes areintended to injectfluids into orwithdraw fluids fromthe body. | Substantiallyequivalent. |
| Intended Use | Syringes with orwithout needle areintended to injectfluids into or withdrawfluids from the body. | The SterileHypodermic Syringefor Single Use with /without needle isintended to be used formedical purposes toinject fluid into orwithdraw fluid frombody. | The Vesco MedicalNRFit™ TipSyringes areintended to injectfluids into orwithdraw fluids fromthe body. | Substantiallyequivalent. |
| Environment ofUse | Unspecified, hospitaluse implied | Unspecified, hospitaluse implied | Hospital | Similar to both. |
| Traditional 510(k) Vesco Medical NRFitTM Tip Syringes | ||||
| Design Features / Function | Syringes With or Without Needles K113091 (Primary Predicate) | Sterile Hypodermic Syringe for Single Use, With or Without Needle K112057 (Secondary Predicate) | Vesco Medical NRFitTM Tip Syringes (Proposed) | Substantial Equivalence |
| Intended Users | Trained Clinicians (implied) | Trained Clinicians (implied) | Medical Professionals and trained care givers | Similar to both. There are no differences in intended users that would impact equivalence. |
| Patient Population | RX only | RX only | RX only, patients over 1 year | Similar to both. There are no differences in patient population that would impact equivalence. |
| Single Use | Yes | Yes | Yes | Substantially equivalent. |
| Sterility Condition | Sterile (EtO) and non-pyrogenic | Sterile (method unspecified) | Sterile (EtO) and non-pyrogenic | Substantially equivalent. |
| Type of placement | Used with catheter or needle | Used with catheter or needle | Used with catheter or needle with Neuraxial compliant connector | The NRFit connector does not change the intended use or function of the proposed device. From the Risk Analysis and DFMEA, it was found that the NRFit connector helps reduce the residual risk of misconnections. |
| NRFit Connector | No; Luer Slip/Lock connector. | No; Luer Slip/Lock connector. | Yes; compliant with ISO 80369-6. | The NRFit connector does not change the intended use or function of the proposed device. From the Risk Analysis and DFMEA, it was found that the NRFit connector helps reduce the residual risk of misconnections. |
| Syringe Barrel and Plunger Material | Polypropylene | Polypropylene | Polypropylene | Substantially equivalent. |
| Syringe Piston Material | Synthetic Rubber | Synthetic Rubber | Synthetic Rubber | Substantially equivalent. |
| Syringe Piston Lube Coating | Polydimethylsiloxane, Silanol Terminated | Medical Grade Silicone | Polydimethylsiloxane Silanol Terminated | Substantially equivalent. |
| Traditional 510(k)Design Features / Function | Syringes With or Without Needles K113091 (Primary Predicate) | Sterile Hypodermic Syringe for Single Use, With or Without Needle K112057 (Secondary Predicate) | Vesco Medical NRFit™ Tip Syringes (Proposed) | Substantial Equivalence |
| Markings on Syringe for Measuring Liquid Volume | TAMPAPUR TPU | Black Medical Grade | TAMPAPUR TPU | Substantially equivalent. |
| Volumes | Various volume sizes based upon customer request | 1 mL, 2 mL, 3 mL, 5 mL, 10 mL, 20 mL, 30 mL, 35 mL, 50 mL | 3 mL, 10 mL, 20 mL | Similar to both. 3, 10 and 20 mL are a subset of sizes cleared under both. |
| Biocompatibility | Biocompatibility testing has demonstrated that this device meets guidelines presented in ISO 10993-1:2009, with the FDA modified matrix presented in General Program Memorandum # G95-1 | Biocompatibility testing has demonstrated that this device meets guidelines presented in ISO 10993-1:2009, with the FDA modified matrix presented in General Program Memorandum # G95-1 | Same materials, manufacturer, manufacturing materials as primary predicate | Substantially equivalent. |
| Piston/Plunger Assembly Testing | Tested and met standards of ISO 7886-1:1993 Sterile Hypodermic Syringes for Single Use - Part 1: Syringes for Manual Use | Tested and met standards of ISO 7886-1:1993 Sterile Hypodermic Syringes for Single Use - Part 1: Syringes for Manual Use | Tested and met standards of ISO 7886-1:1997 Sterile Hypodermic Syringes for Single Use – Part 1: Syringes for Manual Use | Substantially equivalent. |
| Dead Space Testing | Tested and met standards of ISO 7886-1:1993 Sterile Hypodermic Syringes for Single Use - Part 1: Syringes for Manual Use | Tested and met standards of ISO 7886-1:1993 Sterile Hypodermic Syringes for Single Use - Part 1: Syringes for Manual Use | Tested and met standards of ISO 7886-1:1997 Sterile Hypodermic Syringes for Single Use - Part 1: Syringes for Manual Use | Substantially equivalent. |
| Air Leakage Past Syringe Piston During Aspiration Testing | Tested and met standards of ISO 7886-1:1993 Sterile Hypodermic Syringes for Single Use - Part 1: Syringes for Manual Use | Tested and met standards of ISO 7886-1:1993 Sterile Hypodermic Syringes for Single Use - Part 1: Syringes for Manual Use | Tested and met standards of ISO 7886-1:1997 Sterile Hypodermic Syringes for Single Use - Part 1: Syringes for Manual Use | Substantially equivalent. |
| Liquid Leakage Past Syringe Piston Under Compression Testing | Tested and met standards of ISO 7886-1:1993 Sterile Hypodermic Syringes for Single Use - Part 1: Syringes for Manual Use | Tested and met standards of ISO 7886-1:1993 Sterile Hypodermic Syringes for Single Use - Part 1: Syringes for Manual Use | Tested and met standards of ISO 7886-1:1997 Sterile Hypodermic Syringes for Single Use - Part 1: Syringes for Manual Use | Substantially equivalent. |
| Traditional 510(k)Vesco Medical NRFit TM Tip Syringes | ||||
| Design Features/ Function | Syringes With orWithout NeedlesK113091(Primary Predicate) | Sterile HypodermicSyringe for SingleUse, With or WithoutNeedle K112057(SecondaryPredicate) | Vesco MedicalNRFit™ TipSyringes(Proposed) | SubstantialEquivalence |
| Fluid Leakage:Connector | Not Applicable; noNRFit Connector | Not Applicable; noNRFit Connector | Tested per ISO80369-20 and metthe standards of ISO80369-6 for positivepressure fluidleakage. | The NRFitconnector doesnot change theintended use orfunction of theproposed device.From the RiskAnalysis andDFMEA, it wasfound that theNRFit connectorhelps reduce theresidual risk ofmisconnections. |
| Air Leakage:Connector | Not Applicable; noNRFit Connector | Not Applicable; noNRFit Connector | Tested per ISO80369-20 and metthe standards of ISO80369-6 for subatmosphericpressure air leakage. | The NRFitconnector doesnot change theintended use orfunction of theproposed device.From the RiskAnalysis andDFMEA, it wasfound that theNRFit connectorhelps reduce theresidual risk ofmisconnections. |
| Stress Cracking:Connector | Not Applicable; noNRFit Connector | Not Applicable; noNRFit Connector | Tested per ISO80369-20 and metthe standards of ISO80369-6 for stresscracking. | The NRFitconnector doesnot change theintended use orfunction of theproposed device.From the RiskAnalysis andDFMEA, it wasfound that theNRFit connectorhelps reduce theresidual risk ofmisconnections. |
| Traditional 510(k)Vesco Medical NRFit TM Tip Syringes | ||||
| Design Features / Function | Syringes With or Without Needles K113091 (Primary Predicate) | Sterile Hypodermic Syringe for Single Use, With or Without Needle K112057 (Secondary Predicate) | Vesco Medical NRFit™ Tip Syringes (Proposed) | Substantial Equivalence |
| Resistance to separation from axial load: connector | Not Applicable; no NRFit Connector | Not Applicable; no NRFit Connector | Tested per ISO 80369-20 and met the standards of ISO 80369-6 Resistance to separation from axial load. | The NRFit connector does not change the intended use or function of the proposed device. From the Risk Analysis and DFMEA, it was found that the NRFit connector helps reduce the residual risk of misconnections. |
| Resistance to separation from unscrewing: connector | Not Applicable; no NRFit Connector | Not Applicable; no NRFit Connector | Tested per ISO 80369-20 and met the standards of ISO 80369-6 for Resistance to separation from unscrewing. | The NRFit connector does not change the intended use or function of the proposed device. From the Risk Analysis and DFMEA, it was found that the NRFit connector helps reduce the residual risk of misconnections. |
| Resistance to overriding: connector | Not Applicable; no NRFit Connector | Not Applicable; no NRFit Connector | Tested per ISO 80369-20 and met the standards of ISO 80369-6 for Resistance to overriding. | The NRFit connector does not change the intended use or function of the proposed device. From the Risk Analysis and DFMEA, it was found that the NRFit connector helps reduce the residual risk of misconnections. |
| Design Features/ Function | Syringes With orWithout NeedlesK113091(Primary Predicate) | Sterile HypodermicSyringe for SingleUse, With or WithoutNeedle K112057(SecondaryPredicate) | Vesco MedicalNRFit™ TipSyringes(Proposed) | SubstantialEquivalence |
| NRFitDimensionalVerification | Not Applicable; noNRFit Connector | Not Applicable; noNRFit Connector | Evaluated per ISO80369-20 and metthe standards of ISO80369-6 for NRFitdimensionalverification. | The NRFitconnector doesnot change theintended use orfunction of theproposed device.From the RiskAnalysis andDFMEA, it wasfound that theNRFit connectorhelps reduce theresidual risk ofmisconnections |
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VII. Performance Data:
Non-Clinical Tests
Verification and validation Testing was performed with the Vesco Medical NRFit Tip Syringes. It was found that Vesco Medical NRFit Tip Svringes 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," ISO 80369-20:2016 "Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common Test Methods, "and BS EN ISO 7886-1:1997 "Sterile Hypodermic Syringes For Single Use – Part 1: Syringes For Manual Use." A risk analysis and a Design FMEA were conducted on the Vesco Medical NRFit™ Tip Syringes; both yielded acceptable results.
The following testing was conducted on the Vesco Medical NRFit Tip Syringes:
- Basic Syringe Functions per BS EN ISO 7886-1:1997 performed by Jiangyin CainaTechnology 1. Co., Ltd and Vesco Medical
- Determination of Dead Space per BS EN ISO 7886-1:1997 performed by Jiangyin Caina 2. Technology Co., Ltd and Vesco Medical
-
- Liquid Leakage at Syringe Piston Under Compression per BS EN ISO 7886-1:1997 performed by Jiangyin Caina Technology Co., Ltd and Vesco Medical
-
- Air Leakage Past Syringe Piston During Aspiration and for Separation of Piston and Plunger per BS EN ISO 7886-1:1997 performed by Jiangyin Caina Technology Co., Ltd and VescoMedical
- Fluid Leakage per ISO 80369-20:2015, performed by Jiangyin Caina Technology Co., Ltd 5.
- Stress Cracking per ISO 80369-20:2015, performed by Jiangyin Caina Technology Co., Ltd 6.
- Resistance to separation from axial load per ISO 80369-20:2015, performed by Jiangyin Caina 7. Technology Co., Ltd
-
- Resistance to separation from unscrewing per ISO 80369-20:2015, performed by Jiangyin Caina Technology Co., Ltd
-
- Resistance to overriding per ISO 80369-20:2015, performed by Jiangyin Caina TechnologyCo., Ltd Disconnection by unscrewing per ISO 80369-20:2015, performed by Jiangyin Caina Technology Co., Ltd
-
- NRFit dimensional verification per ISO 80369-6:2016, performed by Jiangyin Caina Technology Co., Ltd
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Clinical Tests
Clinical tests were not required to demonstrate performance of Vesco Medical NRFitTM Tip Syringes. Product functionality has been adequately assessed by non-clinical tests.
Animal Tests
Animal tests were not required to demonstrate the performance of Vesco Medical NRFit Tip Syringes. Product functionality has been adequately assessed by non-animal tests.
VIII. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the Vesco Medical NRFit Tip Syringes are as safe, as effective, and perform as well as or better than the legally marketed devices identified in part III, "Legally Marketed Predicate Devices" of this section.
{End of tab}
§ 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).