(175 days)
The Self-destruction Safety Syringes for Single Use are intended to be used for medical purposes to inject fluid into or withdraw fluid from body. Its secondary intended use is to retract inside the safety barrel, contain the contaminated needle and aid in the prevention of accidental needle stick injuries.
The Sterile Hypodermic Syringes for Single Use are intended to be used for medical purpose to inject fluid into or withdraw fluid from body.
The Sterile Hypodermic Needles for Single Use are intended to be used with a luer slip syringe and injection devices for general purpose fluid injection/aspiration.
The Sterile Safety Hypodermic Needles for Single Use are intended to be used with a luer slip or luer slip syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.
The Self-destruction Safety Syringes for Single Use are intended for single use only. The proposed device is available in 1mL, 3mL, 5mL, 10mL volumes with a 25 gauge, 25mm needle. The safety feature will be manually activated to retract the needle immediately after use to minimize risk of accidental needle sticks.
The Sterile Hypodermic Syringes for Single Use are intended for single use only, which consists of barrel, plunger and piston. The proposed device is available in 1mL, 2mL, 5mL, 10mL, 20mL, 30mL and 50mL volumes. The syringe is available in luer lock connector types which are intended to be connected with a hypodermic needle.
The Sterile Safety Hypodermic Needles for Single Use are intended for single use only, which consists of a hypodermic needle with a safety sheath attached to the needle hub. The proposed device is available in 18-27 gauge and 6-50 mm lengths. The safety sheath will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.
The Sterile Hypodermic Needles for Single Use are intended for single use only. The proposed device is available in 14-30 gauge and 6-60 mm lengths.
The provided text is an FDA 510(k) summary for various medical devices, including "Self-destruction Safety Syringes for Single Use" and "Sterile Safety Hypodermic Needles for Single Use," which incorporate safety features to prevent accidental needle stick injuries. The summary describes the non-clinical tests performed to demonstrate substantial equivalence to predicate devices, focusing on physical, mechanical, chemical properties, sterility, shelf-life, and biocompatibility.
However, the provided document does not describe a study involving an AI-powered device or a multi-reader multi-case (MRMC) comparative effectiveness study. Instead, it focuses on the performance and safety of physical medical devices (syringes and needles). Therefore, I cannot extract the requested information related to acceptance criteria and study proving AI device performance, sample sizes for test and training sets, expert ground truth establishment, adjudication methods, or effects of AI assistance on human readers.
The section "Simulated Clinical Use" on page 8 of 13 does mention "pre-established criteria" and a study on 500 device samples for the safety features of the syringes and needles, but these are related to the physical device's function, not an AI or imaging diagnostic performance.
In summary, the provided document does not contain the information required to answer the prompt's specific questions about an AI device's acceptance criteria and performance study.
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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.
August 9, 2018
Berpu Medical Technology Co., Ltd % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai. 200120 CHINA
Re: K180417
Trade/Device Name: Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single Use; Sterile Hypodermic Needles for Single Use; Sterile Safety Hypodermic Needles for Single Use
Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: MEG. FMF. FMI Dated: July 18, 2018 Received: July 30, 2018
Dear Diana Hong:
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.
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-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,
Alan M. Stevens -S
Tina Kiang, Ph.D. for Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K180417
Device Name
Seff-destruction Safety Syringes for Single Hypodermic Syringes for Single Use: Sterile Hypodermic Needles for Single Use; Sterile Safety Hypodermic Needles for Single Use
Indications for Use (Describe)
The Self-destruction Safety Syringes for Single Use are intended to be used for medical purposes to inject fluid into or withdraw fluid from body. Its secondary intended use is to retract inside the safety barrel, contain the contaminated needle and aid in the prevention of accidental needle stick injuries.
The Sterile Hypodermic Syringes for Single Use are intended to be used for medical purpose to inject fluid into or withdraw fluid from body.
The Sterile Hypodermic Needles for Single Use are intended to be used with a luer slip syringe and injection devices for general purpose fluid injection/aspiration.
The Sterile Safety Hypodermic Needles for Single Use are intended to be used with a luer slip or luer slip syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.
| 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
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K180417
-
- Date of Preparation: 08/08/2018
-
- Sponsor Identification
BERPU MEDICAL TECHNOLOGY CO., LTD NO.14 Xingji Road, Yongxing Street, Longwan District, 325000, Wenzhou, Zhejiang Province
Establishment Registration Number: 3004496829
Contact Person: Jundong Tan Position: Management Representative Tel: +86-577-86651999 Fax: +86-577-86630389 Email: BERPU@BERPU.COM
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net
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4. Identification of Proposed Device
Trade Name: Self-destruction Safety Syringes for Single Use Sterile Hypodermic Syringes for Single Use Sterile Hypodermic Needles for Single Use Sterile Safety Hypodermic Needles for Single Use
Regulatory Information
Classification Name: Piston Syringe Classification: II Product Code: MEG (antistick syringe) Regulation Number: 21 CFR 880.5860 Review Panel: General Hospital
Classification Name: Piston Syringe Classification: II Product Code: FMF Regulation Number: 21 CFR 880.5860 Review Panel: General Hospital
Classification Name: Hypodermic single lumen needle Classification: II Product Code: FMI Regulation Number: 21 CFR 880.5570 Review Panel: General Hospital
Intended Use Statement:
The Self-destruction Safety Syringes for Single Use are intended to be used for medical purposes to inject fluid into or withdraw fluid from body. Its secondary intended use is to retract inside the safety barrel, contain the contaminated needle and aid in the prevention of accidental needle stick injuries.
The Sterile Hypodernic Syringes for Single Use are intended to be used for medical purpose to inject fluid into or withdraw fluid from body.
The Sterile Hypodermic Needles for Single Use are intended to be used with a luer slip or luer slip syringe and injection devices for general purpose fluid injection/aspiration.
The Sterile Safety Hypodermic Needles for Single Use are intended to be used with a luer slip or luer
{5}------------------------------------------------
slip syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.
Device Description
The Self-destruction Safety Syringes for Single Use are intended for single use only. The proposed device is available in 1mL, 3mL, 5mL, 10mL volumes with a 25 gauge, 25mm needle. The safety feature will be manually activated to retract the needle immediately after use to minimize risk of accidental needle sticks.
The Sterile Hypodermic Syringes for Single Use are intended for single use only, which consists of barrel, plunger and piston. The proposed device is available in 1mL, 2mL, 5mL, 10mL, 20mL, 30mL and 50mL volumes. The syringe is available in luer lock connector types which are intended to be connected with a hypodermic needle.
The Sterile Safety Hypodermic Needles for Single Use are intended for single use only, which consists of a hypodermic needle with a safety sheath attached to the needle hub. The proposed device is available in 18-27 gauge and 6-50 mm lengths. The safety sheath will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.
The Sterile Hypodermic Needles for Single Use are intended for single use only. The proposed device is available in 14-30 gauge and 6-60 mm lengths.
న్. Identification of Predicate and Reference Devices
Predicate Device 1 510(k) Number: K072739 Product Name: Retractable Auto-Disable Syringe for Single Use, with/without Needle Sterile Hypodermic Needle for Single Use Sterile Hypodermic Syringe for Single Use with/without Needle
Predicate Device 2 510(k) Number: K113422 Product Name: TERUMO® SurGuard® 3 Safety Needle
Reference Device 510(k) Number: K162180 Product Name: Disposable Insulin Syringe
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6. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications and is Substantially Equivalent (SE) to the predicate device. The test results demonstrate conformance with the related standard requirements and include the following:
Physical, Mechanical, Chemical testing were performed on all syringe volumes of Self-destruction Safety Syringes for Single Use and Sterile Hypodermic Syringes for Single Use, the test items include:
| Cleanliness | Clause 5 of ISO 7886-1:1993 |
|---|---|
| Limits for acidity or alkalinity | Clause 6 of ISO 7886-1:1993 |
| Limits for extractable metals | Clause 7 of ISO 7886-1:1993 |
| Lubricant | Clause 8 of ISO 7886-1:1993 |
| Tolerance on graduated capacity | Clause 9 of ISO 7886-1:1993 |
| Graduated scale | Clause 10 of ISO 7886-1:1993 |
| Barrel | Clause 11 of ISO 7886-1:1993 |
| Piston/ plunger assembly | Clause 12 of ISO 7886-1:1993 |
| Nozzle | Clause 13 of ISO 7886-1:1993 |
| Performance | Clause 14 of ISO 7886-1:1993 |
| For Safety syringe: | |
| Safety Feature | ISO 23908 |
Physical, Mechanical, Chemical testing were performed on all needle gauges and lengths of Sterile Hypodermic Needles for and Single Use Sterile Safety Hypodermic Needles for Single Use, the test items include:
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| Cleanliness | Clause 4.3 of ISO 7864:2016 |
|---|---|
| Limits for acidity or alkalinity | Clause 4.4 of ISO 7864:2016 |
| Limits for extractable metals | Clause 4.5 of ISO 7864:2016 |
| Size designation | Clause 4.6 of ISO 7864:2016 |
| Colour coding | Clause 4.7 of ISO 7864:2016and ISO 6009 |
| Needle hub | Clause 4.8 of ISO 7864:2016 |
| Needle Cap | Clause 4.9 of ISO 7864:2016 |
| Needle tube | Clause 4.10 of ISO 7864:2016 |
| Needle point | Clause 4.11 of ISO 7864:2016 |
| Bond between hub and needle tube | Clause 4.12 of ISO 7864:2016 |
| Patency of lumen | Clause 4.13 of ISO 7864:2016 |
| Surface finish | Clause 5.2 of ISO 9626:2016 |
| Cleanliness | Clause 5.3 of ISO 9626:2016 |
| Limits for acidity and alkalinity | Clause 5.4 of ISO 9626:2016 |
| Size designation | Clause 5.5 of ISO 9626:2016 |
| Dimensions | Clause 5.6 of ISO 9626:2016 |
| Stiffness | Clause 5.8 of ISO 9626:2016 |
| Resistance to breakage | Clause 5.9 of ISO 9626:2016 |
| Resistance to corrosion | Clause 5.10 of ISO 9626:2016 |
For Safety needle: Safety Feature
ISO 23908
Sterile Barrier Packaging Testing performed on the proposed device:
| Seal strength | ASTM F88/F88-15 |
|---|---|
| Dye penetration | ASTM F1929-15 |
Sterilization and Shelf Life Testing performed on the proposed device:
| EO residue | ISO 10993-7:2008 |
|---|---|
| ECH residue | ISO 10993-7:2008 |
| Bacteria Endotoxin Limit | USP 38-NF 33 <85> |
| Shelf Life Evaluation | Physical, Mechanical, Chemical, Package Tests were performed on aging samples to verify the claimed shelf life of the device |
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1ml Self-destruction Safety Syringes for Single Use, 1ml Sterile Hypodermic Syringes for Single Use, 27G×20mm Sterile Safety Hypodermic Needles for Single Use and 30G×12mm Sterile Hypodermic Needles for Single Use are used for sterilization validation test.
The shelf life validation test was performed on syringe from 1ml to 50ml and needle gauge from 14G30G with 660mm length
Biocompatibility Testing:
The devices meet biocompatibility endpoints for cytotoxicity, irritation, systemic toxicity, hemolysis and material-mediated pyrogens. The data was supplied in the reference device submission, K162180, and the manufacturer certified that the devices, in their final finished form, are identical to the K162180 reference device (cleared 12/29/2016) in formulation, processing, sterilization, and geometry and no other chemicals have been added (e.g., plasticizers, fillers, cleaning agents, mold release agents).
Simulated Clinical Use
A simulated clinical use study was performed on 500 device samples each for the safety syringe and safety needles according to FDA Guidance, Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature, issued on August 9, 2005 and ISO 23908 to evaluate the safety mechanism of the proposed device. The results demonstrated that the proposed device met the pre-established criteria.
7. Clinical Test Conclusion
No clinical study is included in this submission.
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8. Substantially Equivalent (SE) Comparison
| ITEM | Proposed Device | Predicate Device 1 | ||
|---|---|---|---|---|
| Product Code | MEG | K072739 | ||
| Regulation No. | 21 CFR 880.5860 | Same | ||
| Class | CLASS II | Same | ||
| Intended Use | The Self-destruction Safety Syringes for Single Use are intended to be used for medical purposes to inject fluid into or withdraw fluid from body. Its secondary intended use is to retract inside the safety barrel, contain the contaminated needle and aid in the prevention of accidental needle stick injuries. | The Retractable Auto-Disable Syringe for single use with/without needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body. Its secondary intended use is to retract inside the safety barrel, contain the contaminated needle and aid in the prevention of accidental needle stick injuries. | ||
| Configurationand material | Barrel | Polypropylene (PP) | Barrel | |
| Plunger | Polypropylene (PP) | Plunger | ||
| Piston | Polyisoprene | Piston | PP, Stainless Steel | |
| Needle hub | Polypropylene (PP) | Needle hub | ||
| Needle tube | Stainless Steel | Needle tube | ||
| Operation Mode | For manual use only | Same | ||
| Safety Feature | Retracted | Same | ||
| Label/Labeling | Comply with 21 CFR part 801 | Same | ||
| Syringe Volume | 1ml, 3ml, 5ml, 10ml | 3ml, 5ml, 10ml | ||
| Connector Type | Luer Lock | Same | ||
| Needle Gauge | 25G | Unknown | ||
| Biocompatibility | Comply with ISO 10993 | Same | ||
| Sterilization | EO Sterilization | Same | ||
| SAL | 10-6 | Same | ||
| Single Use | Yes | Same | ||
| Label/Labeling | Complied with 21 CFR part 801 | Same |
Table 1 Comparison of Technology Characteristics of Self-destruction Safety Syringes for Single Use
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| ITEM | Proposed Device | Predicate Device 1K072739 |
|---|---|---|
| Product Code | FMF | Same |
| Regulation No. | 21 CFR 880.5860 | Same |
| Class | CLASS II | Same |
| Intended Use | The Sterile Hypodermic Syringes for Single Use are intended to be used for medical purpose to inject fluid into or withdraw fluid from body. | The Sterile Hypodermic Syringe for Single Use with/without needle is intended to be used for medical purpose to inject fluid into or withdraw fluid from body |
| Configurationand material | Barrel | Barrel |
| Plunger | Polypropylene (PP) | |
| Piston | Polyisoprene | |
| Operation Mode | For manual use only | Same |
| Label/Labeling | Complied with 21 CFR part 801 | Same |
| Syringe Volume | 1ml, 2ml, 3ml, 5ml, 10ml, 20ml, 30ml, 50ml | 1ml, 2ml, 3ml, 5ml, 10ml, 20ml, 30ml, 50ml, 100ml |
| Connector Type | Luer Lock/ Luer slip | Same |
| Biocompatibility | Comply with ISO 10993 | Same |
| Sterilization | EO Sterilization | Same |
| SAL | 10-6 | Same |
| Single Use | Yes | Same |
| Label/Labeling | Comply with 21 CFR part 801 | Same |
Table 2 Comparison of Technology Characteristics of Sterile Hypodermic Syringes for Single Use
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| ITEM | Proposed Device | Predicate Device 1 |
|---|---|---|
| K072739 | ||
| Product Code | FMI | Same |
| Regulation No. | 21 CFR 880.5570 | Same |
| Class | CLASS II | Same |
| Intended Use | The Sterile Hypodermic Needles for Single Use are intended to be used with a luer slip or luer slip syringe and injection devices for general purpose fluid injection/aspiration. | The Sterile Hypodermic Needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration. |
| Needle hub Polypropylene (PP) | Needle hub | |
| Protective cap Polypropylene (PP) | Protective cap PP, Stainless Steel | |
| Needle Stainless Steel | Needle tube | |
| Operation Mode | For manual use only | Same |
| Label/Labeling | Complied with 21 CFR part 801 | Same |
| Needle Gauge | Available in14G, 15G, 16G, 17G, 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 29G, 30G | Available in 16G, 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 29G |
| Biocompatibility | Comply with ISO 10993 | Same |
| Sterilization | EO Sterilization | Same |
| SAL | 10-6 | Same |
| Single Use | Yes | Same |
| Label/Labeling | Comply with 21 CFR part 801 | Same |
| Table 3 Comparison of Technology Characteristics of Sterile Hypodermic Needles for Single Use | |||||
|---|---|---|---|---|---|
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| ITEM | Proposed Device | Predicate Device 1K113422 |
|---|---|---|
| Product Code | FMI | Same |
| Regulation No. | 21 CFR 880.5570 | Same |
| Class | CLASS II | Same |
| Intended Use | The Sterile Safety Hypodermic Needlesfor Single Use are intended to be usedwith a luer slip or luer slip syringe foraspiration and injection of fluids formedical purpose. After withdrawal of theneedle from the body, the attachedneedle safety shield can be manuallyactivated to cover the needleimmediately after use to minimize riskof accidental needlestick. | The TERUMO® SurGuard® 3 SafetyNeedle is intended for use in the aspirationand injection of fluids for medicalpurposes. The TERUMO® SurGuard® 3Safety Needle is compatible for use withstandard luer slip and luer lock syringes. |
| Needle hub | Polypropylene (PP) | Needle hub |
| Protective cap | Polypropylene (PP) | Protective cap |
| Needle | Stainless Steel | Needle tube |
| Safety sheath | Polypropylene (PP) | Safety sheath |
| Operation Mode | For manual use only | Same |
| Safety Feature | Slide over the needle to prevent fromneedle sticks | Same |
| Label/Labeling | Comply with 21 CFR part 801 | Same |
| Needle Gauge | Available in 18G, 19G, 20G, 21G, 22G,23G, 24G, 25G, 26G, 27G | 18G~25G |
| Biocompatibility | Comply with ISO 10993 | Same |
| Sterilization | EO Sterilization | Irradiation Sterilization |
| SAL | 10-6 | Same |
| Single Use | Yes | Same |
| Label/Labeling | Complied with 21 CFR part 801 | Same |
| Table 4 Comparison of Technology Characteristics of Sterile Safety Hypodermic Needles for Single Use | ||||
|---|---|---|---|---|
Substantially Equivalent (SE) Conclusion 9.
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.
§ 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).