(364 days)
STERILE SINGLE USE LDV SYRINGE/CHOICARE STERILE SINGLE USE LDV SYRINGE is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin.
A Disposable Syringe with Needle 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 hypodermic single lumen needle which is permanently attached. The device is used to inject fluids into, or withdraw fluids from, the body. This is a single-use device. This product is packed by sterile paper and sterilized by E.O gas.
This document is an FDA 510(k) Premarket Notification for a medical device (Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe). The provided text describes the device, its intended use, performance data, and a comparison to a predicate device to demonstrate substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
Important Note: The provided document is a 510(k) submission for a syringe, which is a relatively low-risk medical device. The types of acceptance criteria and studies are primarily focused on bench testing and adherence to existing international standards, rather than complex clinical studies or AI/software performance evaluations. Therefore, many of the requested points related to AI, MRMC studies, and expert ground truth establishment for complex image analysis are not applicable or detailed in this document.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily defined by adherence to various ISO standards and specific quantitative thresholds for certain tests. The reported device performance is consistently "Pass" for all tested criteria, indicating the device met the acceptance criteria.
| Requirement – Test (Standard) | Acceptance Criteria (Implicit for "Pass") | Reported Device Performance |
|---|---|---|
| ISO 7886-1:2017 (Syringe Performance) | Conformance to standard requirements for manual use syringes (e.g., proper dimensions, tightness, piston/plunger assembly) | Pass |
| Visual check | N/A (Visual inspection, implied to be defect-free) | Pass |
| Dimension (out diameter of the needle tube) | N/A (Within specified tolerance per standard) | Pass |
| Length of the needle tube | N/A (Within specified tolerance per standard) | Pass |
| Nozzle | N/A (Conforms to design and standard) | Pass |
| Tightness | N/A (No leakage at specified pressures) | Pass |
| Piston/Plunger Assembly | N/A (Smooth movement, no binding) | Pass |
| ISO 7864:2016 (Hypodermic Needle Performance) | Conformance to standard requirements (e.g., elasticity, flexural strength, pullout) | Pass |
| Elasticity | N/A (Meets specified flexibility) | Pass |
| Flexural strength | N/A (Withstands specified bending force) | Pass |
| Pullout | N/A (Withstands specified pullout force) | Pass |
| ISO 9626:2016 (Stainless Steel Needle Tubing) | Conformance to standard requirements (e.g., stiffness, resistance to breakage/corrosion) | Pass |
| Stiffness | N/A (Meets specified rigidity) | Pass |
| Resistance to breakage | N/A (Withstands specified forces without breaking) | Pass |
| Resistance to corrosion | N/A (Shows no significant corrosion after specified tests) | Pass |
| Dead Volume | < 0.0284ml | Conforms (Implied: < 0.0284ml) |
| Biocompatibility (ISO 10993 Series) | Conformance to the requirements for each specific test (e.g., no cytotoxicity, no hemolysis, acceptable reactivity) | Pass (for all listed tests) |
| Cytotoxicity test (ISO 10993-5) | Satisfy the requirements for in vitro cytotoxicity | Pass |
| Hemolysis test (ISO 10993-4) | Satisfy the requirements for hemolytic properties | Pass |
| Intracutaneous reactivity test (ISO 10993-10) | Satisfy the requirements for irritation and skin sensitization | Pass |
| Skin sensitization test (ISO 10993-10) | Satisfy the requirements for irritation and skin sensitization | Pass |
| Acute systemic toxicity test (ISO 10993-11) | Satisfy the requirements for acute systemic toxicity | Pass |
| Pyrogen Test (ISO 10993-11) | Satisfy the requirements for material-mediated pyrogens | Pass |
| LAL Test (USP39 <85>) | Satisfy the requirements for bacterial endotoxins | Pass |
| Particulate Matter Injection (USP <788>) | Satisfy the requirements for particulate matter | Pass |
| Sterility & EO Residuals | Conformance to standard requirements (e.g., SAL of 10^-6, low EO residuals) | Pass (for all listed tests) |
| LAL test (USP39 <85>) | Satisfy the requirements for bacterial endotoxins | Pass |
| E.O sterilization validation (ISO 11135:2014) | Process validated to achieve sterility | Pass |
| Sterility test (ISO 11737-2) | No microbial growth | Pass |
| E.O Residual test (ISO 10993-7:2008) | Meets test requirements for ethylene oxide sterilization residuals | Pass |
| Needle Injury Test (ISO 23908:2011 Sharps Injury Protection) | Conformance to standard requirements for sharps injury protection (e.g., acceptable penetration, pull-out, cap removal, activation/locking, unlocking forces) | Pass (for all listed tests) |
| Needle penetration force | N/A (Within specified range) | Pass |
| Pull-out force | N/A (Within specified range) | Pass |
| Needle cap removal force | N/A (Within specified range) | Pass |
| Activation (locking) force (for safety feature) | N/A (Within specified range) | Pass |
| Unlocking force (for safety feature) | N/A (Within specified range) | Pass |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the numerical sample sizes for each bench test conducted. However, for a 510(k) submission, testing is typically performed on a statistically relevant number of units as required by the referenced ISO standards.
- Data Provenance: The document indicates that the tests were performed by Jeil Tech Co., Ltd. (Republic of Korea). The studies are "bench tests," which are laboratory tests, not clinical studies involving human patients. The nature is prospective in the sense that the tests were performed specifically for this submission to verify the device's adherence to standards and safety.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of device and study. Bench testing for a syringe relies on objective measurements against engineering specifications and international standards (e.g., ISO, USP). There isn't "ground truth" to be established by human experts in the context of diagnostic interpretation or clinical outcomes. The "experts" involved would be qualified lab technicians and engineers performing and verifying the tests.
4. Adjudication Method for the Test Set
This is not applicable. Since the tests are objective bench measurements against quantitative or qualitative (Pass/Fail based on standard adherence) criteria, there is no need for an adjudication method. The results are either within specification or not.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
This is not applicable. This submission is for a physical medical device (syringe), not an AI-powered diagnostic or assistive tool. Therefore, no MRMC comparative effectiveness study was performed or required.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This is not applicable. As stated above, this is not an AI/algorithm device.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is the adherence to established international standards (ISO 7886-1, ISO 7864, ISO 9626, ISO 23908, ISO 10993 series, ISO 11135, ISO 11737-2) and specific quantitative requirements (e.g., dead volume, endotoxin limits). This is an engineering specification and regulatory standard conformance type of ground truth.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" as this is not an AI or machine learning device. The device is manufactured based on design specifications, and tested to ensure it meets those specifications and relevant standards.
9. How the Ground Truth for the Training Set was Established
This is not applicable as there is no training set for this device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
September 19, 2022
Jeil Tech Co., Ltd. % Peter Chung President Plus Global 300. Atwood Pittsburgh, Pennsylvania 15213
Re: K213013
Trade/Device Name: Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: QNQ, FMI Dated: August 17, 2022 Received: August 17, 2022
Dear Peter Chung:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
CAPT Alan M. 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) K213013
Device Name
Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe
Indications for Use (Describe)
STERILE SINGLE USE LDV SYRINGE/CHOICARE STERILE SINGLE USE LDV SYRINGE is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin.
| 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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K213013 - 510(k) Summary
[as required by 807.92(c)]
1. Date of Preparation: September 19, 2022
2. Applicant
-
- Company: Jeil Tech Co., Ltd.
-
- Address: 190, Maesilro, Sojeongmyeon, Sejong-si, Republic of Korea
- Tel : +82-44-862-2656 3)
-
- Fax : +82-44-826-2657
-
- Contact person : Peter Chung, 412-512-8802
- ୧) Contact person address : 300 Atwood Street, Pittsburgh, PA, 15213, USA
-
- Submission date: Sep. 10, 2021
-
- Prior related submission : Not applicable
3. Subject Device Information
- Trade name : STERILE SINGLE USE LDV SYRINGE, CHOICARE STERILE SINGLE USE LDV SYRINGE 1)
- Common name : Disposal syringe with needle 2)
-
- Classification name : Piston syringe/ Needle, Hypodermic, Single Lumen
- Product code : QNQ, FMI 4)
-
- Regulation number : 880.5860
-
- Class of device : Class II
-
- Panel : General hospital
4. Predicate Devices
Trade name: Safety Syringe With Permanently Attached Needle Premarket Notification: K192551 Manufacturer: Jiangsu Caina Medical Co., Ltd.
5. Device description
A Disposable Syringe with Needle 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 hypodermic single lumen needle which is permanently attached. The device is used to inject fluids into, or withdraw fluids from, the body. This is a single-use device. This product is packed by sterile paper and sterilized by E.O gas.
6. Intended Use:
STERILE SINGLE USE LDV SYRINGE/CHOICARE STERILE SINGLE is intended to be used for medical purposes to inject fluids to the body.
7. Indication for Use:
STERILE SINGLE USE LDV SYRINGE/CHOICARE STERILE SINGLE is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin.
8. Performance data:
- Bench tests were performed. Bench testing included biocompatibility, mechanical testing, sterility 1) testing including EO residues. The tests demonstrated that the device performs in a substantially equivalent manner to the predicate device. The devices conform to ISO 7886-1:2017, ISO 9626:2016, ISO 7864:2016, and ISO 23908:2011. For example, the following bench testing is performed to demonstrate the functionality is substantially equivalent.
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| Requirement – Test (ISO 7886-1) | Result |
|---|---|
| Visual check | Pass |
| Dimension (out diameter of the needle tube) | Pass |
| Length of the needle tube | Pass |
| Nozzle | Pass |
| Tightness | Pass |
| Piston/Plunger Assembly | Pass |
| Requirement – Test (ISO 7864) | Result |
|---|---|
| Elasticity | Pass |
| Flexural strength | Pass |
| Pullout | Pass |
| Requirement – Test (ISO 9626) | |
| Stiffness | Pass |
| Resistance to breakage | Pass |
| Resistance to corrosion | Pass |
2) Dead volume
In accordance with the FDA's requirements, to claim that the aspect "Low Dead Volume" the specification for syringe and needle combined dead volume shall be satisfied with the following criteria. ( < 0.0284ml)
According to the provided testing result, STERILE SINGLE USE LDV SYRINGE, CHOICARE STERILE SINGLE USE LDV SYRINGE conforms this requirement.
3) Biocompatibility
Biocompatibility of the STERILE SINGLE USE LDV SYRINGE, CHOICARE STERILE SINGLE USE LDV SYRINGE was evaluated in accordance with ISO 10993-1:2018 for the body contact category of "External communication device – Blood path indirect" with a contact duration of "Limited (< 24 hours)". The following tests were performed, as recommended: Cytotoxicity; Skin sensitization; Hemolysis; Intracutaneous reactivity; Acute systemic toxicity;
| Test item | Test method / Test criteria | Test result |
|---|---|---|
| Cytotoxicitytest | When it was tested accordingly to ISO 10993-5, tests for in vitro cytotoxicity-Teston extracts method, it should satisfy the requirements. | Pass |
| Hemolysistest | When it was tested accordingly to ISO 10993-4, Selection off tests for interactionswith blood-evaluation of hemolytic properties of medical devices and medicaldevice materials, it should satisfy the requirements. | Pass |
| Intracutaneous reactivitytest | When it was tested accordingly to ISO 10993-10, Tests for irritation and skinsensitization-Animal intracutaneous (Intradermal) reactivity test, it should satisfythe requirements. | Pass |
| Skinsensitizationtest | when it was tested accordingly to ISO 10993-10, Tests for irritation and skinsensitization-Guinea pig maximization test (GPMT), it should satisfy therequirements. | Pass |
| Acutesystemictoxicity test | When it was tested accordingly to ISO 10993-11, Tests for systemic toxicity-Acute systemic toxicity, it should satisfy the requirements. | Pass |
| Pyrogen Test | When it was tested accordingly to ISO 10993-11, Tests for systemic toxicity-Information on material-mediated pyrogens, it should satisfy the requirements. | Pass |
| LAL Test | USP39 <85>, Bacterial Endotoxins Test | Pass |
| ParticulateMatterInjection | USP <788>, Particulate Matter for Injections (Method 1 Light ObscurationParticle Count Test). Test result should satisfy the requirements described in theUSP <788>. | Pass |
Sterility and LAL test 4)
The sterilization method has been validated to ISO11135, which has thereby determined the routine control and monitoring parameters. The testing is performed according to the following standards:
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| # | Test item | Test standard | Test result |
|---|---|---|---|
| 1 | LAL test | USP39 <85>, Bacterial Endotoxins Test (Unit : EU/Device) | Pass |
| 2 | E.O sterilizationvalidation | According to ISO 11135:2014E.O 30%, CO2 70%Temperature: 50 ±7°CExposure time: 5 hours | Pass |
| 3 | Sterility test | According to ISO 11737-2 | Pass |
| 4 | E.O Residual test | Under the conditions of ISO 10993-7:2008, Ethylene oxide sterilizationresiduals, the test articles should meet the test requirements. | Pass |
5) Needle injury test
| # | Test item | Test standard | Test result |
|---|---|---|---|
| 1 | Needlepenetrationforce | ISO 23908: 2011 Sharps injury protection | Pass |
| 2 | Pull-out force | ISO 23908: 2011 Sharps injury protection | Pass |
| 3 | Needle capremoval force | ISO 23908: 2011 Sharps injury protection | Pass |
| 4 | Activation(locking) force | ISO 23908: 2011 Sharps injury protection | Pass |
| 5 | Unlocking force | ISO 23908: 2011 Sharps injury protection | Pass |
6) Substantially Equivalent (SE) Comparison
Table 1. Comparison table
| Manufacturer | Item | Jeil Tech Co., Ltd.Proposed device | Jiangsu Caina Medical Co., Ltd.Predicate device | Remark |
|---|---|---|---|---|
| 510(K) No. | K192551 | N/A | ||
| Indication for use | STERILE SINGLE USE LDV SYRINGE/ CHOICARESTERILE SINGLE USE LDV SYRINGE is intendedfor use by health care professionals forgeneral purpose aspiration of fluid from vials,ampoules, and liquid injection below thesurface of the skin. | The Safety Syringe with permanently attached needle is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin. The Safety sheath of Syringe is designed to aid in the prevention of needle stick injuries and reduce the potential or syringe reuse. | Same | |
| Components | Barrel, Plunger, Piston, Safety cap | Barrel, Plunger, Piston, Safety sheath | Same | |
| Materials | Needle cap | PE | PP or PE | Same |
| Needle | Stainless Steel 304 | Stainless Steel 304 | ||
| Safety guard | PP | Safety mechanismPP | ||
| Piston | Polyisoprene | PistonPolyisoprene | ||
| PlungerBarrel | PPPP | PlungerBarrelPP | ||
| Capacity(Syringe volume) | 0.5 1ml | 0.3, 0.5, 1ml | Different #1 | |
| Nozzle type | Permanently attached | Permanently attached | Same | |
| Needle Gauge | 23, 25G | 25, 26, 27, 28, 29, 30, 31G | Different #2 | |
| Needle Length | 25mm | 8, 10, 13, 16mm | ||
| Needle wall type | TW | RW, TW | ||
| Needle bevel | 11°±2° | 11°±2°, 15°±2° | ||
| Needle Hub | Polypropylene (PP) | Polypropylene (PP) | Same | |
| Principle of operation | For Manual Use OnlyFor Single Use Only | For Manual Use OnlyFor Single Use Only | Same |
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| SyringePerformances | Complies with ISO 7886-1 : 2017 Sterilehypodermic syringes for single use - Part 1 :Syringes for manual use | Complies with ISO 7886-1 : 2017 Sterilehypodermic syringes for single use - Part1 : Syringes for manual use | Same |
|---|---|---|---|
| NeedlePerformances | ISO 7864 : 2016 Sterile hypodermic needlesfor single use - Requirements and testmethodsISO 9626 : 2016 Stainless steel needle tubingfor the manufacture of medical devices -Requirements and test methods | ISO 7864 : 2016 Sterile hypodermicneedles for single use - Requirementsand test methodsISO 9626 : 2016 Stainless steel needletubing for the manufacture of medicaldevices - Requirements and test methods | Same |
| Safety featureperformancespecification | 1) Safety guard clamping force shallbe less than 15 N2) Needle should not be separatedfrom safety guard until pushedvertically by 25mm. | i. The torque to lock shall be less than10N·cmii. The force to destroy forward shall notbe less than 30Niii. The force to destroy backward shallnot be less than 60Niv. The torque to unscrewing shall begreater than 20N·cm | Different #3 |
| Biocompatibility | Conforms to therequirements of ISO 10993series standards.CytotoxicityAcute systemic toxicityPyrogenicitySensitizationIrritationHemolysisIntracutaneous reactivityBacterial EndotoxinsParticulate Matter Injection | Conforms to therequirements of ISO 10993series standards.CytotoxicityAcute systemic toxicityPyrogenicitySensitizationIrritationHemolysisIntracutaneous reactivityBacterial EndotoxinsParticulate Matter Injection | Same |
| Sterilization | E.O Sterilized | E.O Sterilized | Same |
| SAL | 10-6 | 10-6 | Same |
| Endotoxin Limit | 20 EU per device | 20 EU per device | Same |
| Principle ofoperation | The plunger of syringe can be pulled andpushed along inside the barrel, allowingthe syringe to take in and expel the fluidsthrough the connector to the patient. | The plunger of syringe can be pulledand pushed along inside the barrel,allowing the syringe to take in andexpel the fluids through the connectorto the patient. | Same |
| Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same |
2. Equivalence discussion
Different 1 - Capacity (Syringe volume)
The Syringe volume for proposed devices is different from the predicate devices 1.
This difference does not affect intended use and does not raise new questions of safety and effectiveness. Differences in syringe volume between the predicate and subject device were addressed through ISO 7886-1:2017 performance testing.
Different 2 - Needle gauge, length, wall type and bevel
The needle gauge and length for proposed devices is different from the predicate devices. This difference does not affect intended use and does not raise new questions of safety and effectiveness in needle length and gauge between the predicate and proposed device were addressed through ISO 7864:2016 and ISO 9626:2016 performance testing.
The needle wall type for predicate device is differ from proposed device. However, the performance test for proposed device has been conducted and the test result conform with requirements of ISO 7864:2016 and ISO 9626:2016 standards. Also proposed device's needle wall type is included in range of predicate device's needle
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wall type. According to 510(k) summary of predicate device, it has Regular(RW) type. Subject device only has a thin wall type needle, which does not affect its intended use, and does not raise any new questions of safety and effectiveness.
The needle bevel for proposed devices is different from the predicate device. This difference does not affect intended use. In addition, subject device is conforming to recommendation by the relevant standard(ISO 7864:2016, section 4.11 Needle point). The differences in needle bevel between the predicate and subject device were addressed through ISO 9626:2016 performance testing.
Different 3 - Safety feature performance specification
The Safety feature performance specifications for predicate device is different from the predicate device. However, the safety feature performance test for proposed device has been evaluated and the test result conforms to requirements of ISO 23908:2011 standards. Therefore, the differences on configuration and materials does not affect substantially equivalence.
3. Substantially Equivalent (SE) Conclusion
The STERILE SINGLE USE LDV SYRINGE of Jeil Tech Co., Ltd. is substantially equivalent to the legally marketed predicate device.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).