The Sterile Hypodermic Syringe is a sterile, single-use, polypropylene syringe that consists of the barrel, plunger, and stopper and is assembled with a hypodermic needle.

The Sterile Hypodermic Needle is a single lumen needle made of austenitic steel, consisting of a protective cap, a needle seat and a needle tube connection.

AI/ML Overview

This document describes the FDA 510(k) premarket notification for a Sterile Syringe for Single Use (with Needle) and a Sterile Hypodermic Needle for Single Use by Jiangsu Zhiyu Medical Instrument Co., Ltd. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device (K201284).

However, the provided text does not contain details about a study conducted to prove the device meets acceptance criteria in the context of an AI/human reader performance study. The document is a regulatory submission for a physical medical device (syringes and needles) and focuses on demonstrating substantial equivalence through bench testing (per ISO standards) and biocompatibility testing.

Therefore, I cannot provide the information requested in your prompt regarding:

A table of acceptance criteria and reported device performance related to AI/human reader studies. The acceptance criteria discussed pertain to physical properties and safety of the syringe/needle, not diagnostic performance.
Sample size and data provenance for an AI test set.
Number of experts and qualifications for ground truth establishment for an AI study.
Adjudication method for an AI test set.
MRMC comparative effectiveness study results (AI vs. without AI assistance).
Standalone (algorithm only) performance.
Type of ground truth used (expert consensus, pathology, outcomes data) for an AI study.
Sample size for the training set (for an AI model).
How ground truth for the training set was established (for an AI model).

The document explicitly states: "No clinical study is included in this submission." This further confirms that no studies involving human reader performance comparisons or algorithm-only performance for diagnostic purposes (the typical context for MRMC or standalone AI studies) were conducted or submitted.

What the document DOES provide regarding acceptance criteria and performance:

The acceptance criteria for these devices are based on adherence to recognized international and US standards for medical devices, primarily ISO standards and USP. The "study" proving the device meets these criteria refers to bench testing, biocompatibility testing, and sterilization validation.

Here's a summary of the actual acceptance criteria and performance demonstrated (not a diagnostic AI study):

1. Table of Acceptance Criteria and Reported Device Performance (as per the document):

Acceptance Criteria Category	Specific Standard/Requirement	Reported Device Performance/Compliance
Material Properties	ISO 9626:2016 (Stainless steel needle tubing)	Complied with. (Ensures the physical integrity and performance of the needle tubing)
Syringe Performance	ISO 7886-1:2017 (Sterile hypodermic syringes for single use)	Complied with. (Covers various aspects of syringe performance like accuracy of dose, resistance to leakage, plunger movement, barrel integrity. Explicitly stated: "The requirements of the standard are met" for the 2ml syringe volume difference.)
Needle Performance	ISO 7864:2016 (Sterile hypodermic needles for single use)	Complied with. (Covers aspects like needle rigidity, resistance to breakage, patency, cannula-hub attachment strength. Explicitly stated: "The needles meet the requirements of the ISO 9626 and ISO 7864 standards" for needle length differences.)
Biocompatibility	ISO 10993-4:2017 (Interactions with Blood)	Complied with. (Hemocompatibility tests conducted for patient-contact components).
	ISO 10993-5:2009 (In Vitro Cytotoxicity)	Complied with. (Cytotoxicity tests conducted for patient-contact components).
	ISO 10993-10:2010 (Irritation and Skin Sensitization)	Complied with. (Irritation and sensitization tests conducted for patient-contact components).
	ISO 10993-11:2017 (Systemic Toxicity)	Complied with. (Acute systemic toxicity tests conducted for patient-contact components).
Sterilization	ISO 10993-7:2008 (Ethylene oxide sterilization residuals)	Complied with.
	ISO 11135:2014 (Ethylene oxide sterilization validation)	Complied with. (Requirements for development, validation, and routine control of sterilization process).
Sterility Assurance Level	SAL	10^-6 (This is a target SAL, indicating less than 1 in 1 million chance of a non-sterile unit after sterilization). The document implies this is achieved through validated processes per ISO 11135.
Endotoxin Limit	Specified Limit	20 EU per device. (Implied compliance, as this is listed as a characteristic similar to the predicate device). Pyrogen test (USP 43-NF38 <151>) was carried out.
Particulate Matter	USP 788 (Particulate Matter in Injections)	Complied with. (Microscopic particle count test (USP 43-NF38 <788>) was carried out).
Packaging	ISO 11607-2:2019 (Validation of packaging for terminally sterilized medical devices)	Complied with.

2. Sample size used for the test set and data provenance:

For physical and performance testing, the sample sizes would be based on the specific ISO standards and industry best practices for device testing, typically involving a statistically significant number of units to ensure consistency and reliability. The exact numbers are not provided in this summary document.
Data provenance: This is a submission from Jiangsu Zhiyu Medical Instrument Co., Ltd. in China. The tests are internal company tests conducted to demonstrate compliance with standards.

3. Number of experts used to establish the ground truth and their qualifications:

Not applicable in the context of this document. Ground truth for this type of device is established by adherence to engineering specifications and performance standards through laboratory testing, not expert clinical interpretation of images or patient data.

4. Adjudication method for the test set:

Not applicable. Adjudication is relevant for subjective assessments, typically in clinical readings or AI ground truth labeling. Bench testing results are objective measurements against defined criteria.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:

No. The document explicitly states: "No clinical study is included in this submission."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No. This is not an AI device.

7. The type of ground truth used:

The "ground truth" for this device's performance is defined by the specifications and acceptable limits set forth in the referenced ISO and USP standards. This includes, for example, specific force required to move a plunger, volume accuracy, needle sharpness, and biocompatibility limits. It is established through physical measurements and laboratory assays.

8. The sample size for the training set:

Not applicable. This device does not use a training set as it is not an AI/ML device.

9. How the ground truth for the training set was established:

Not applicable.

In summary, the provided document is for a conventional medical device (syringes and needles) seeking 510(k) clearance based on substantial equivalence to a predicate device, demonstrated through rigorous bench testing and adherence to recognized performance and safety standards, not through AI performance studies.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Jiangsu Zhiyu Medical Instrument Co, Ltd. Ellen Guan Official Correspondent No 88, Nanyuan Road, Industrial Park Taixing, Jiangsu 225400 China

Re: K212857

Trade/Device Name: Sterile Syringe for Single Use (with Needle). Sterile Hypodermic Needle for Single Use Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF, FMF, FMI Dated: April 12, 2023 Received: April 12, 2023

Dear Ellen Guan:

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 Evans -S

Digitally signed by Courtnev Evans -S Date: 2023.05.09 14:10:13 -04'00'

For 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K212857

Device Name

Sterile Syringe for Single Use (with Needle) Sterile Hypodermic Needle for Single Use

Indications for Use (Describe)

The Sterile Syringe for Single Use (with Needle) is intended to be used for medical purposes to inject fluid into or withdraw fluid from body.

The Sterile Hypodermic Needle for Single Use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.

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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K212857 510(K) Summary

[As required by section 807.92(c)]

I. SUBMITTER (OWNER)

Name: Jiangsu Zhiyu Medical Instrument Co., Ltd. Address: No.88, Nanyuan Road, Industrial Park, West Taixing City, 225400, Jiangsu Province, China Phone: +86-0523-82565715, +86-0523-82565758 Contact person: Ellen Guan Contact email: gxyellen1004@aliyun.com Date of preparation: May 4, 2023

II. DEVICE IDENTIFICATION

2.1 Trade name: Sterile Syringe for Single Use (with Needle) Common name: Hypodermic Syringe Classification name: Piston Syringe Classification regulation: 21 CFR 880.5860 Product code: FMF Classification: II 2.2 Trade name: Sterile Hypodermic Needle for Single Use Common name: Hypodermic Needle Classification name: Hypodermic Single Lumen Needle Classification regulation: 21 CFR 880.5570 Product code: FMI Classification: II

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III. PREDICATE DEVICE IDENTIFICATION

3.1 510(k) number: K201284
3.2 Trade name: Sterile Hypodermic Syringe for Single use, with/without needle; luer/luer-lock

Sterile Hypodermic needle for Single use

3.3 Common name: Hypodermic Syringe
Hypodermic Needle
3.4 Classification regulation: 21 CFR 880.5860, 21 CRF 880.5570
3.5 Product code: FMF, FMI
3.6 Classification: II

IV. DEVICE DESCRIPTION

4.1 Overview

The Sterile Hypodermic Syringe is a sterile, single-use, polypropylene syringe that consists of the barrel, plunger, and stopper and is assembled with a hypodermic needle.

The Sterile Hypodermic Needle is a single lumen needle made of austenitic steel, consisting of a protective cap, a needle seat and a needle tube connection.

4.2 Models

Syringe: 1mL, 2mL, 5mL, 10mL, 20mL, 50mL

Needle Gauge	Outer Diameter of Stylet
	Normal wall	Thin wall	Ultra-thin wall
30G x 1/2"	X	X	-
29G x 1/2"	X	X	-
28G x 1/2"	X	X	-
27G x 1/2"	X	X	-
27G x 5/8"	X	X	-
26G x 1/2"	X	X	-
26G x 5/8"	X	X	-
25G x 5/8"	X	X	-
25G x 3/4"	X	X	-

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25G x 1"	X	X	-
24G x 3/4"	X	X	-
24G x 1"	X	X	-
23G x 1"	X	X	X
23G x 5/4"	X	X	X
23G x 3/2"	X	X	X
22G x 1"	X	X	X
22G x 5/4"	X	X	X
22G x 3/2"	X	X	X
21G x 5/4"	X	X	X
21G x 3/2"	X	X	X
20G x 5/4"	X	X	X
20G x 3/2"	X	X	X
19G x 5/4"	X	X	X
19G x 3/2"	X	X	X
18G x 5/4"	X	X	X
18G x 3/2"	X	X	X

1ml, 2ml and 5ml syringe can use the needles:

30G x 1/2″, 29G x 1/2″, 28G x 1/2″, 27G x 1/2″, 27G x 5/8″, 26G x 1/2″, 26G x 5/8″, 25G x 5/8″, 25G x 3/4″, 25G x 1″, 24G x 3/4″, 24G x 1″, 23G x 5/4″, 23G x 3/2″, 22G x 1″, 22G x 5/4″, 22G x 3/2″, 21G x 5/4″, 21G x 3/2″;

10ml syringe can use the needles:

25G x 5/8″, 25G x 3/4″, 25G x 1″, 24G x 3/4″, 24G x 1″, 23G x 5/4″, 23G x 3/2″, 22G x 1", 22G x 5/4", 22G x 3/2", 21G x 5/4", 21G x 3/2", 20G x 3/2″, 19G x 5/4", 19G x 3/2″, 18G x 5/4″, 18G x 3/2″;

20ml and 50ml syringe can use the needles:

21G x 5/4″, 21G x 3/2″, 20G x 5/4″, 20G x 3/2″, 19G x 3/2″, 18G x 5/4″, 18G x 3/2".

4.3 Device Characteristics

The device is EO sterilized and for single use only.

4.4 Environment of Use
General hospital
4.5 Operation Principle

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The plunger of syringe can be pulled and pushed along inside the barrel, allowing the syringe to take in and expel the fluids through the connector to the patient. For Manual Use Only.

4.6 Materials of Use
Medical polypropylene, Natural rubber or Synthetic rubber, austenitic stainless steel (SUS304)

Contact type: Tissue/bone/dentin

Duration: Limited exposure (less than 24h)

V. INDICATIONS FOR USE

The Sterile Syringe for Single Use (with Needle) is intended to be used for medical purposes to inject fluid into or withdraw fluid from body.

The Sterile Hypodermic Needle for Single Use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.

VI. COMPARISON WITH THE PREDICATE DEVICE

5.1 Technical Characteristics

Table 1: Hypodermic Syringe

Item	proposed device	Predicate Device	Comparison
Product name	Sterile Syringe forSingle Use (withNeedle)	Sterile HypodermicSyringe for Singleuse, with/withoutneedle; luer/luer-lock	/
Product code	FMF	FMF	similar
Regulation No.	21 CFR 880.5860	21 CFR 880.5860	similar
Class	II	II	similar
Indication foruse	The SterileHypodermic Syringefor Single Usewith/without needleis intended to beused for medicalpurposes to inject	The SterileHypodermic Syringefor Single Usewith/without needle isintended to be usedfor medical purposesto inject fluid into or	similar
	fluid into or withdrawfluid from body.	withdraw fluidfrom body.
Configuration	PistonPlungerBarrel	PistonPlungerBarrel	similar
Volume	1mL, 2mL, 5mL,10mL, 20mL, 50mL	1ml, 3ml, 5ml, 6ml,10ml, 20ml, 30ml,35ml, 50ml, 60 ml	Difference 1
Needle size	18G, 19G, 20G,21G, 22G, 23G,24G, 25G, 26G,27G, 28G, 29G,30G	18G, 19G, 20G, 21G,22G, 23G, 24G, 25G,26G, 27G, 28G, 29G,30G	similar
Needle length	13mm-38mm	4–38 mm	Difference 2
Intended user	Medicalprofessionals andtrained care givers	Medical professionalsandtrained care givers	similar
Environment ofuse	Hospital	Hospital	similar
Single use	Yes	Yes	similar
	For Manual UseOnly.	For Manual Use Only.
Operation mode	The plunger ofsyringe can bepulled and pushedalong inside thebarrel, allowingthe syringe to takein and expel the	The plunger of syringecan be pulled andpushed along insidethe barrel, allowingthe syringe to take inand expel the fluidsthrough the connector	similar
	fluids through theconnector to the	to the patient.
	patient.
Label/labeling	Complied with 21CFR part 801	Complied with 21CFR part 801	similar
Performance	Complied withISO 7886-1ISO 7864ISO 9626	Complied withISO 7886-1ISO 7864ISO 9626	similar
	Biocompatibility	Complied with ISO10993-4/5/10/11	Complied with ISO10993-4/5/10/11	similar
	Patient contact component and material
Piston	Isoprene Rubber	Isoprene Rubber	similar
Barrel	PP	PP	similar
Plunger	PP	PP	similar
Needle	PP, SUS304	PP, SUS304	similar
Sterilization
Sterilitycondition	EO sterilized	EO sterilized	similar
SAL	10-6	10-6	similar
Endotoxin Limit	20 EU per device	20 EU per device	similar

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Table 2: Hypodermic Needle

Item	proposed device	Predicate Device	Comparison
Product Name	Sterile HypodermicNeedle for Single Use	Sterile Hypodermicneedle for Singleuse	similar
Product code	FMI	FMI	similar
Regulation No.	21 CFR 880.5570	21 CFR 880.5570	similar
Class	II	II	similar
Indication foruse	The SterileHypodermic Needlefor Single Use isintended for use with	The SterileHypodermic Needlefor single use isintended for use with	similar

	syringes and injectiondevices for generalpurpose fluidinjection/aspiration.	syringes andinjection devices forgeneral purposefluidinjection/aspiration.
Configuration	Protective capNeedleAdhesivesNeedle hub	Protective capNeedleAdhesivesNeedle hub	similar



Intended user	Medical professionalsandtrained care givers	Medicalprofessionals andtrained care givers	similar

Environment ofuse	Hospital	Hospital	similar
Single use	Yes	Yes	similar
Operation mode	For Manual Use OnlyFor Single Use only	For Manual Use OnlyFor Single Use only	similar
Label/labeling	Complied with 21CFR part 801	Complied with 21CFR part 801	similar
Performance	Complied with:ISO 7864ISO 9626	Complied with:ISO 7864ISO 9626	similar


Biocompatibility	Complied with ISO10993-4/5/10/11	Complied with ISO10993-4/5/10/11	similar

Needle size	18G, 19G, 20G, 21G,22G, 23G, 24G, 25G,26G, 27G, 28G, 29G,30G	18G, 19G, 20G,21G, 22G, 23G,24G, 25G, 26G,27G, 28G, 29G, 30G	similar



Needle length	13mm-38mm	4mm-38mm	Difference 1
Patient contact component and material
Protective cap	PP	PP	similar
Adhesive	Epoxy resin	Epoxy resin	similar
Needle Hub	PP	PP	similar
Needle	SUS304	SUS304	similar
Sterilization
Sterility condition	EO sterilized	EO sterilized	similar
SAL	10-6	10-6	similar
Endotoxin Limit	20 EU per device	20 EU per device	similar

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Substantial Equivalence Discussion

Hypodermic Syringe discussion: There are 2 differences between the proposed device and the predicated device related to the volume and needle length.

Difference 1: The proposed device includes 2ml volume syringes which the predicate device doesn't have. But this difference have no adverse effect on clinical safety and performance as the size is within the range of 1mL to 10mL syringes cleared under the predicate. Additionally, the proposed device has been tested according to the standard ISO 7886-1. The requirements of the standard are met.

Difference 2: The needle lengths of the proposed device range from 13mm to 38mm, which is covered by the predicated device's (4mm - 38mm). The needles meet the requirements of the ISO 9626 and ISO 7864 standards.

Hypodermic Needle discussion: There is one difference between the proposed device and the predicated device related to the needle length. The needle lengths of the proposed device range from 13mm to 38mm, which is covered by the predicated device's (4mm - 38mm). The needle meets the requirements of ISO 9626 and ISO 7864 standards.

5.2 Performance Testing

The Hypodermic Syringe and Hypodermic Needle described in this summary were tested and demonstrated to be in conformance with the following FDA recognized standards:

ISO 9626:2016: Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods

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ISO 7886-1:2017 Sterile hypodermic syringes for single use Part 1: Syringes for manual use
ISO 7864:2016 Fourth Edition: Sterile hypodermic needles for single use -Requirements and test methods
ISO 10993-4:2017 Biological Evaluation Of Medical Devices Part 4: Selection Of Tests For Interactions With Blood
ISO 10993-5:2009 Biological Evaluation Of Medical Devices Part 5: Tests For In Vitro Cytotoxicity
ISO 10993-10:2010 Biological Evaluation Of Medical Devices Part 10: Tests For Irritation And Skin Sensitization
ISO 10993-11:2017 Biological Evaluation Of Medical Devices Part 11: Tests For Systemic Toxicity
USP 788 Particulate Matter in Injections
ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
ISO 11135:2014 Sterilization of health-care products Ethylene oxide -Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 11607-2:2019 Packaging for terminally sterilized medical devices -- Part 2: Validation

The device is considered in the category of "External Communicating Devices" and are accepted to be in contact for a period less than 24 hours with "Tissue/Bone". Thus, cytotoxicity (ISO 10993-5:2009), irritation and sensitization (ISO 10993-10:2010), acute systemic toxicity (ISO 10993-11:2017), hemocompatibility (ISO 10993-4:2017) , pyrogen test (USP 43-NF38 <151>) and microscopic particle count test (USP 43-NF38 <788>) were carried out for the device in question.

5.3 Clinical Test

No clinical study is included in this submission.

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VIII. CONCLUSIONS

The intended use, technological characteristics and method of operation are similar in the subject device and predicate device. Through performance testing, the subject device has demonstrated substantial equivalence to the predicate device.

Regulation Number and Section

§ 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).