(100 days)
The Automatically Retractable Safety Syringes with detachable needle devices are indicated for use where a safe and reliable method for intramuscular and subcutaneous injection of medication in a patient is desired.
The Disposable Automatically Retractable Safety Syringes (with Detachable Needle) devices are piston syringes, intended for medical purpose and consist of a calibrated hollow barrel and a movable plunger. The syringe works like a conventional hypodermic syringe except that the contaminated needle is retracted inside the syringe immediately after patient injection. The needle retracting mechanism is activated by a spring action mechanism after injection is completed. The exposed needle remains safely inside the syringe plunger for disposal. The Disposable Automatically Retractable Safety Syringes (with Detachable Needle) devices are sterile, single use, disposable and non-reusable.
The provided document, a 510(k) Premarket Notification summary for Disposable Automatically Retractable Safety Syringes, does not describe the acceptance criteria and study that proves the device meets the acceptance criteria in the manner typically found for AI/ML-based medical devices. This document specifically pertains to a physical medical device (syringes) and not an AI/ML diagnostic or therapeutic system.
Therefore, the requested information regarding acceptance criteria, performance metrics, sample sizes for test and training sets, expert qualifications, ground truth establishment, MRMC studies, and standalone performance for an AI/ML device is not applicable to this document.
The document discusses the substantial equivalence of a new syringe design to a predicate device based on non-clinical testing of physical and chemical properties and a simulated clinical study for sharps injury prevention.
Here's an interpretation of the closest relevant sections to your request formats, acknowledging the fundamental difference in device type:
1. A table of acceptance criteria and the reported device performance:
The document lists "Non-Clinical Tests performed on the subject device" and references various ISO standards for syringe and needle properties. These standards implicitly define the acceptance criteria, and the statement "The proposed devices were tested per the following standards, to evaluate its performance" implies that the device met these standards. However, the document does not report specific quantitative performance data or explicit acceptance thresholds met by the device for each test. It only lists the tests performed.
| Acceptance Criteria (Implied by Standards) | Reported Device Performance |
|---|---|
| ISO 7886-1:2017 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use | "The proposed devices were tested per the following standards, to evaluate its performance." (Implies compliance, but no specific data provided) |
| - Limits for acidity or alkalinity | - |
| - Limits for extractable metals | - |
| - Lubricant | - |
| - Tolerance on graduated capacity | - |
| - Scale, Numbering of scales, Position of Scale | - |
| - Barrel dimensions, Barrel flanges, Plunger stopper/plunger assembly, Conical fitting, Position of nozzle on end of barrel, Nozzle lumen, Dead space | - |
| - Freedom from air and liquid leakage past plunger stopper | - |
| - Force to operate the piston, Fit of plunger stopper/plunger in barrel | - |
| ISO 7886-4:2006 Sterile hypodermic syringes for single use -- Part 4: Syringes with re-use prevention feature | "The proposed devices were tested per the following standards, to evaluate its performance." (Implies compliance, but no specific data provided) |
| - Self-destructive performance | - |
| ISO 7864:2016 Sterile hypodermic needles for single use | "The proposed devices were tested per the following standards, to evaluate its performance." (Implies compliance, but no specific data provided) |
| - Cleanliness, Limits for acidity and alkalinity, Limits for extractable metals, Size designation, Color coding, Needle tube, Freedom from defects, Lubricant, Needle point, bond between hub and needle tube, Patency of lumen, Fragmentation test for medical needles, Determination of flow rate through the needle | - |
| ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices. | "The proposed devices were tested per the following standards, to evaluate its performance." (Implies compliance, but no specific data provided) |
| - Surface finish and visual appearance testing, Cleanliness, Limits for acidity and alkalinity, Size designation, Dimensions, Stiffness, Resistance to breakage, Resistance to corrosion | - |
| ISO 23908:2011 Sharps Injury Prevention | "The proposed devices were tested per the following standards, to evaluate its performance." (Implies compliance) "It can support a conclusion that 99% reliability of device activation is achievable." (Specific claim for this test, which is a key safety feature.) |
| - Force applied on the plunger to activate the retractable mechanism | - |
| - Testing simulated clinical use | - |
| ISO 80369-7:2018 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications | "The proposed devices were tested per the following standards, to evaluate its performance." (Implies compliance, but no specific data provided) |
| - Fluid leakage, Sub-atmospheric Pressure Air Leakage, Stress Cracking, Resistance to Separation from Unscrewing, Resistance to Separation from Axial Load, Resistance to Overriding | - |
| Biocompatibility Tests (ISO 10993 series) | "The proposed devices were tested per the following standards, to evaluate its performance." (Implies compliance, but no specific data provided) |
| - Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Haemocompatibility | - |
| - Accelerated aging testing, Package verification, Simulated transportation testing | - |
| - USP<788> Particulate matter in injection, USP42-NF 37<151> Pyrogen Test, Ethylene Oxide(EO) residue test, Ethylene Oxide(EO) sterilization validation | - |
2. Sample size(s) used for the test set and the data provenance:
- Sample Size for Test Set: Not explicitly stated, but the "Simulated Clinical Study Summary" mentions a study "conducted as recommended in FDA guidance document for Industry and FDA Staff: Medical Devices with Sharps Injury Prevention Features." While the exact number of devices tested is not provided, the claim of "99% reliability of device activation is achievable" implies a statistically significant sample was used to arrive at this figure.
- Data Provenance: Not explicitly stated for specific test data, but the manufacturer is "Shantou Wealy Medical Instrument CO.,Ltd." located in Guangdong, China. The testing was conducted to international ISO standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a physical device; "ground truth" as it applies to AI/ML diagnostic or annotation data is not relevant here. Performance is measured against physical standards and functional requirements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. This is a physical device. Adjudication methods are relevant for subjective interpretations of data, typically in diagnostic imaging or clinical assessments, usually involving multiple human readers. Here, performance is based on objective lab measurements and functional tests.
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 a physical device and involves no human "readers" or AI assistance. The "Simulated Clinical Study" refers to evaluating the sharps injury prevention feature, not an AI-assisted diagnostic task.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical device. There is no algorithm to run in a standalone fashion.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. For this physical device, "ground truth" is established by the specifications of the relevant ISO standards (e.g., a certain force must be applied, there should be no leakage, specific dimensions are met, activation must occur). The "99% reliability of device activation" from the simulated clinical study would be considered a performance outcome, not a "ground truth" in the AI/ML sense.
8. The sample size for the training set:
- Not Applicable. This is a physical device; there is no AI/ML training set.
9. How the ground truth for the training set was established:
- Not Applicable. This is a physical device; there is no AI/ML training set or associated ground truth.
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Shantou Wealy Medical Instrument CO.,Ltd. % Eva Li Consultant Shanghai SUNGO Management Consulting Co. Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai, 200122 China
Re: K222452
Trade/Device Name: Disposable Automatically Retractable Safety Syringes (with detachable needle) Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: MEG, FMF, FMF, FMI Dated: October 24, 2022 Received: October 24, 2022
Dear Eva Li:
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,
Courtney
Digitally signed by Courtney Evans -S Date: 2022.11.23 06:45:27
Evans -S -05'00' 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) K222452
Device Name
Disposable Automatically Retractable Safety Syringes (with detachable needle)
Indications for Use (Describe)
The Automatically Retractable Safety Syringes with detachable needle devices are indicated for use where a safe and reliable method for intramuscular and subcutaneous injection of medication in a patient is desired.
| 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 — K222452
1. Submitter Information
Name: Shantou Wealy Medical Instrument CO.,Ltd. Address: North Jinhuan Road(near of Qishan mid-school), Shantou, 515064, Guangdong, China
2. Correspondent Information
Contact: Eva Li Phone: + 86 (215) 881-7802 Email: eatereva@hotmail.com Address: Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave, Shanghai, 200122 CHN
3. Date Prepared - Nov 22nd, 2022
4. Device Information
| Trade name: | Disposable Automatically Retractable SafetySyringes (with detachable needle) |
|---|---|
| Common name: | Syringe, Antistick Piston Syringe |
| Classification name: | Piston Syringe |
5. Predicate Device Information
Trade Name: AUTOMATICALLY RETRACTABLE SAFETY SYRINGES WITH FIXED NEEDLE 510(K) Number: K141640 Company: SHANTOU WEALY MEDICAL INSTRUMENT CO., LTD.
6. Indications for use
The Automatically Retractable Safety Syringes with detachable needle devices are indicated for use where a safe and reliable method for intramuscular and subcutaneous injection of medication in a patient is desired.
7. General Description of the Device and principle of operation
The Disposable Automatically Retractable Safety Syringes (with Detachable Needle) devices are piston syringes, intended for medical purpose and consist of a calibrated hollow barrel and a movable plunger. The syringe works like a conventional hypodermic syringe except that the contaminated needle is retracted inside the syringe immediately after patient injection. The needle retracting mechanism is activated by a spring action mechanism after injection is completed. The exposed needle remains safely inside the syringe plunger for disposal. The Disposable Automatically Retractable Safety Syringes (with Detachable Needle) devices are sterile, single use, disposable and non-reusable.
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| Needle Size | Lengthmetric system (mm) /British System(in) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| metricsystem | BritishSystem | Color | 61/4 | 85/16 | 131/2 | 165/8 | 193/4 | 204/5 | 251 | 321 1/4 | 381 1/2 |
| 0.30 | 30G | Yellow | |||||||||
| 0.33 | 29G | Red | |||||||||
| 0.36 | 28G | Bluegreen | |||||||||
| 0.40 | 27G | MediumGrey | |||||||||
| 0.45 | 26G | Brown | |||||||||
| 0.50 | 25G | Orange | |||||||||
| 0.55 | 24G | Purple | |||||||||
| 0.60 | 23G | DeepBlue | |||||||||
| 0.70 | 22G | Black | |||||||||
| 0.80 | 21G | DeepGreen | |||||||||
| 0.90 | 20G | Yellow | |||||||||
| 1.20 | 18G | Pink | |||||||||
| 1.60 | 16G | White | |||||||||
| Syringe Sizes0.5ml, 1ml, 3ml, 5ml, 10ml, 20ml |
Disposable Automatically Retractable Safety Syringes (with Detachable Needle)
8. Comparison with predicate device
The table below compares the intended use and technological characteristics of the subject and predicate device
| Device | Proposed Device | Predicate DeviceK141640 | Comparison | |
|---|---|---|---|---|
| Manufacturer | Shantou Wealy MedicalInstrument CO.,Ltd. | Shantou Wealy MedicalInstrument CO.,Ltd. | Same | |
| Indications for use | The AutomaticallyRetractable Safety Syringes | The AutomaticallyRetractable Safety Syringes | Same | |
| with Detachable Needledevices are indicated foruse where a safe andreliable method forintramuscular andsubcutaneous injection ofmedication in a patient isdesired. | with Fixed Needle devicesare indicated for usewhere a safe and reliablemethod for intramuscularand subcutaneousinjection of medication in apatient is desired. | |||
| Add = North Jinhuan Road(near of Qishan mid-school), Shantou, 515064, Guangdong, China | ||||
| Environment of use | Hospital | Hospital | Same | |
| Proprietary/trade name | Disposable AutomaticallyRetractable SafetySyringes (with detachableneedle) | Automatically RetractableSafety Syringes with FixedNeedle | — | |
| Product code | MEG, FMI, FMF | MEG, FMI, FMF | Same | |
| Intended users | Medical professionals | Medical professionals | Same | |
| barrel dimensions | 0.5ml barrel length:83.42mm1ml barrel length:83.42mm3ml barrel length:72.26mm5ml barrel length:73.62mm10ml barrellength:92.36mm20ml barrel length:111.72mm | 0.5ml barrel length:82.10mm1ml barrel length:82.10mm3ml barrel length:72.83mm5ml barrel length:73.62mm10ml barrel length:87.36mm20ml barrel length:106.58mm | Different: Thedifference inspecification doesnot raise differentquestions ofsafety andeffectiveness. | |
| plungerdimensions | 0.5ml plunger length:95.51mm1ml plunger length:95.51mm3ml plunger length:88.23mm5ml plunger length:86.80mm10ml plunger length:104.12mm20ml plunger length:128.62mm | 0.5ml plunger length:94.00mm1ml plunger length:94.00mm3ml plunger length:86.80mm5ml plunger length:86.80mm10ml plunger length:100.02mm20ml plunger length:126.60mm | Different: Thedifference inspecification doesnot raise differentquestions ofsafety andeffectiveness. | |
| needle sheathdimensions | 39~57mm (subject to thelength of the needle tube) | 55mm | Different: Thedifference inspecification doesnot raise differentquestions ofsafety andeffectiveness. | |
| effectiveness. | ||||
| needle length | 6-38mm | 6-38mm | Same | |
| hub/needle bond strength (N) | 11, 22, 34, 40, 44, 54, 69, 69 | 11, 22, 34, 40, 44, 54, 69, 69 | Same | |
| color | Barrel color: transparentPlunger color: whiteNeedle sheath color:transparent Needle hub color see below. | Barrel color: transparentPlunger color: whiteNeedle sheath color:transparent Needle hub color see below. | Same | |
| shelf life | 3 years | 3 years | Same | |
| Principle of Operation | It has a detachable needle with a dedicated fitting.The syringe works like a conventional hypodermic syringe except that the contaminated needle is retracted inside the syringe immediately after patient injection. The needle retracting mechanism is activated by a spring action mechanism after injection is completed. The exposed needle remains safely inside the empty syringe barrel for disposal. | It is an integrated needle and piston syringe. The syringe works like a conventional hypodermic syringe except that the contaminated needle is retracted inside the syringe immediately after patient injection. The needle retracting mechanism is activated by a spring action mechanism after injection is completed. The exposed needle remains safely inside the empty syringe barrel for disposal. | Similar: The proposed device and predicate device has the similar Principle of Operation. Difference is proposed device has detachable needle, and the predicate device has fixed needle. The device meet the requirement of ISO80369-7:2018. It do not raise questions of safety and effectiveness. | |
| syringe type | Plunger, anti-stick with hypodermic needle | Plunger, anti-stick with hypodermic needle | Same | |
| Safety Features | Active safety feature, automatically activated when injection is finished | Active safety feature, automatically activated when injection is finished | Same | |
| tip type | Tri-Beveled Tip | Tri-Beveled Tip | Same | |
| volume | 0.5ml, 1ml, 3ml, 5ml, 10ml, 20ml | 1, 3, 10 ml | Different: The difference in specification does not raise different questions of safety and effectiveness. | |
| needle length | Tolerances on length comply to ISO 7864 | Tolerances on length comply to ISO 7864 | Same | |
| needle gauge | 30G, 29G, 28G, 27G, 26G, 25G, 24G, 23G, 22G, 21G, | 30G, 29G, 27G, 26G, 25G, 24G, 23G, 22G, 21G, 20G | Different: The difference in | |
| 20G, 18G, 16G | specification doesnot raise differentquestions ofsafety andeffectiveness. | |||
| needle tipconfiguration | $11°+- 2° /17°+- 2°$ | $11°+- 2°$ | Different: Thedifference inspecification doesnot raise differentquestions ofsafety andeffectiveness. | |
| nozzle type | Needle hub Luerconnector;Needle & syringeseparable | Needle & syringe notseparable | Different: Thedifference meetthe requirementof ISO80369-7:2018. It do notraise questions ofsafety andeffectiveness. | |
| material | Barrel | PP | PP | Same |
| Plunger | PP | PP | ||
| Piston | Isoprene rubber | Isoprene rubber | ||
| NeedleHub | PP | PP | ||
| Needle | Stainless Steel | Stainless Steel | ||
| NeedleSheath | PE | PE | ||
| O-ring | Silicone | Silicone | ||
| Biocompatibility | CytotoxicitySensitizationIrritationSystemic ToxicityHaemocompatibility | CytotoxicitySensitizationIrritationSystemic ToxicityHaemocompatibility | Same | |
| Sterilization leveland method | SAL 10-6 EO sterilizationaccording to ISO 11135 | SAL 10-6 EO sterilizationaccording to ISO 11135 | Same |
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Shantou Wealy Medical Instrument CO.,Ltd. Add z North Jinhuan Road(near of Qishan mid-school), Shantou, 515064, Guangdong, China
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Shantou Wealy Medical Instrument CO.,Ltd. Add = North Jinhuan Road(near of Qishan mid-school), Shantou, 515064, Guangdong, China
Comparison Summary:
The indication for use of the proposed device and predicate device is same. The proposed and predicate device have different technological features as noted in the table above. These technological differences do not raise different questions of safety or effectiveness.
9. Non-Clinical Tests performed on the subject device
The proposed devices were tested per the following standards, to evaluate its performance.
• ISO7886-1:2017 Sterile hypodermic syringes for single use - Part 1: Syringes for manual
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use
- ▶ Limits for acidity or alkalinity
-
Limits for extractable metals
- ▶ Lubricant
- ▶ Tolerance on graduated capacity
- レ Scale
- V Numbering of scales
- レ Position of Scale
-
Barrel dimensions
- レ Barrel flanges
- ▶ Plunger stopper/plunger assembly
- レ Conical fitting
- レ Position of nozzle on end of barrel
- レ Nozzle lumen
- レ Dead space
- D Freedom from air and liquid leakage past plunger stopper
- ▶ Force to operate the piston
- D Fit of plunger stopper/plunger in barrel
• ISO 7886-4:2006 Sterile hypodermic syringes for single use -- Part 4: Syringes with re-use prevention feature
-
Self-destructive performance
- · ISO7864:2016 Sterile hypodermic needles for single use
- D Cleanliness
- Limits for acidity and alkalinity D
-
Limits for extractable metals
- V Size designation
- レ Color coding
- レ Needle tube
- V Freedom from defects
- レ Lubricant
- ♪ Needle point
-
bond between hub and needle tube
-
Patency of lumen
- D Fragmentation test for medical needles
-
Determination of flow rate through the needle
- ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices.
- ► Surface finish and visual appearance testing
- ► Cleanliness
- ► Limits for acidity and alkalinity
- ► Size designation
- ► Dimensions
- ► Stiffness
- ► Resistance to breakage
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- ► Resistance to corrosion
- ISO 23908:2011 Sharps Injury Prevention
- D Force applied on the plunger to activate the retractable mechanism
-
Testing simulated clinical use
• ISO80369-7:2018 Small-bore connectors for liquids and gases in healthcare applications-
Part 7: Connectors for intravascular or hypodermic applications
-
Fluid leakage
- Sub-atmospheric Pressure Air Leakage >
- ▶ Stress Cracking
- レ Resistance to Separation from Unscrewing
-
Resistance to Separation from Axial Load
- ▶ Resistance to Overriding
- Accelerated aging testing
- Package verification
- · Simulated transportation testing
10. Biocompatibility
| Test | Standards |
|---|---|
| Cytotoxicity | ISO 10993-4: 2017 Biological evaluation of medical devices –Part 4: Selection of tests for interactions with blood |
| Sensitization | |
| Irritation | ISO 10993-5:2009 Biological evaluation of medical devices –Part 5: Tests for in vitro cytotoxicity |
| Systemic Toxicity | ISO 10993-11:2006 Biological evaluation of medical devices –Part 11: Tests for systemic toxicity |
| Haemocompatibility | ISO 10993-10:2002/Amd1:2006 Biological evaluation of medicaldevices — Part 10: Tests for irritation and skin sensitization |
- USP<788> Particulate matter in injection
- USP42-NF 37<151> Pyrogen Test ●
- . Ethylene Oxide(EO) residue test
- . Ethylene Oxide(EO) sterilization validation
11. The Simulated Clinical Study Summary
Simulated clinical testing on the sharps injury prevention features was conducted as recommended in FDA guidance document for Industry and FDA Staff: Medical Devices with Sharps Injury Prevention Features. It can support a conclusion that 99% reliability of device activation is achievable.
12. Conclusion:
Based on the Indications for use, technology characteristics, and performance testing, the subject device and the predicate devices are substantially equivalent.
§ 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).