The Retractable Safety Syringe works like a conventional hypodermic syringe except for its ability to retract the contaminated needle inside of the syringe immediately after patient injection is activated by the syringe user. Because the contaminated needle is automatically withdrawn into the syringe user is protected from accidental needle sticks. These accidental needle sticks would occur between removing the needle from the patient and disposing of the syringe in a sharps disposable container.

For general injection use: The function of Retractable Safety Syringe is to provide a safe and reliable method of injecting fluids into or withdrawing fluids from the body. The Retractable Safety Syringe is designed to aid in the prevention of needle stick injuries and reduce the potential or syringe contains various capacity, such as 1ml, 2.5ml, 3ml, 5ml and 10ml.

For allergy use: The 1ml Retractable Safety Allergy Syringe is intended for the preparation/mixing of allergenic extracts/ prescribed substances, the manual aspiration of fluids, and for the injection of fluids into parts of the body below the surface of the skin. The Retractable Safety Syringe is designed to aid in the prevention of needle stick injuries and reduce the potential or syringe reuse.

For Tuberculin use: The 1ml Retractable Safety Tuberculin Syringe is intended for the delivery of Tuberculin. The Retractable Safety Syringe is designed to aid in the prevention of needle stick injuries and reduce the potential or syringe reuse.

Device Description

The proposed devices are available in various specifications, including 1ml, 2.5ml, 3ml, 5ml and 10ml. The applications of Retractable Safety Syringe include general injection, allergy and Tuberculin. General injection use is for 1ml, 2.5ml, 3ml, 5ml and 10ml, while allergy and Tuberculin uses are only for 1ml. The combinations of syringe and needle are listed in the below table.

The proposed device consists of eleven components: (1) piston, (3) barrel, (4) needle cap, (5) sealing plug, (6) slide bushing, (7) needle tube, (8) spring, (9) plunger lid, (10) barrel barb, (11) hub.

The proposed devices are provided sterile. The product is sterilized by Ethylene Oxide Gas to achieve a SAL of 10 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of five years.

AI/ML Overview

The provided text describes the 510(k) premarket notification for a Retractable Safety Syringe. It does not contain information about a study proving the device meets specific acceptance criteria in the context of AI/ML performance. Instead, it focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing against established international standards for medical devices.

Therefore, many of the requested elements for an AI/ML-focused study acceptance criteria cannot be extracted from this document, such as sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, or ground truth types.

However, I can extract information related to the device's functional and safety performance, which are its acceptance criteria in this context, and the studies performed to demonstrate these.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

For medical devices like syringes, "acceptance criteria" are typically defined by regulatory standards (e.g., ISO, ASTM, USP) that specify performance requirements. The "reported device performance" is then the demonstration that the device meets these standards.

Acceptance Criteria (Standard & Requirement)	Reported Device Performance (Compliance)
Biocompatibility: Device is not adverse to human tissue	Complies with ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2010 (irritation and delayed-type hypersensitivity), ISO 10993-11 (systemic toxicity), ASTM F756-17 (hemolytic properties), ISO 10993-4:2017 (interactions with blood)
Sterilization: Ethylene Oxide Sterilization Residuals	Complies with ISO 10993-7:2008
Pyrogenicity: Absence of pyrogens	Complies with USP <151> Pyrogen Test
Packaging Seal Integrity: Detection of seal leaks	Complies with ASTM F1929-15 (dye penetration)
Packaging Seal Strength: Strength of flexible barrier materials	Complies with ASTM F88/F88M-15
Packaging Visual Integrity: Integrity of seals by visual inspection	Complies with ASTM F1886/F1886M-16
Endotoxins: Absence of bacterial endotoxins	Complies with USP 39-NF34 <85> Bacterial Endotoxins Test
Needle Requirements: Sterile hypodermic needles for single use	Complies with ISO 7864:2016 (requirements and test method)
Needle Tubing: Stainless steel needle tubing requirements	Complies with ISO 9626:2016 (requirements and test method)
Syringe Performance: Sterile hypodermic syringe for manual use	Complies with ISO 7886-1:2017 (Part 1: Syringes for manual use)
Sharps Injury Protection: Requirements and test methods for sharps protection features	Complies with ISO 23908:2011 (sharps protection features)
Particulate Matter: Absence of particulate matter in injection	Complies with USP 39-NF34 <788> Particulate Matter in Injection
Safety Feature Effectiveness: Effect of safety feature in preventing sharps injuries	Complies with requirements demonstrated by a simulated clinical use study per FDA Guidance "Medical Devices with Sharps Injury Prevention Features"

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "non-clinical tests" and a "simulated clinical use study." However, it does not specify the exact sample sizes for these tests. The data provenance (country of origin, retrospective/prospective) is also not stated. These are typically detailed in the full test reports, which are not included in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. This device is a physical medical device (syringe) and its performance is evaluated against engineering and biological standards, not through expert-labeled ground truth for AI/ML performance.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. As above, this pertains to expert review for AI/ML ground truth, which is not relevant here.

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 for AI/ML-assisted diagnostic or interpretative devices.

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

Not applicable. This device is a manual physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance is established by international and national standards (e.g., ISO, ASTM, USP) for physical and biological characteristics of syringes and needles. For the safety feature, it involves demonstration of compliance during a simulated clinical use study as per FDA guidance.

8. The sample size for the training set

Not applicable. This is for AI/ML models.

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

Not applicable. This is for AI/ML models.

Summary of the Study Proving Acceptance Criteria:

The study proving the device meets its acceptance criteria is a comprehensive set of non-clinical performance tests conducted in accordance with recognized international and national standards. These include:

Biocompatibility tests (ISO 10993 series, ASTM F756-17) to ensure the materials are safe for human contact.
Sterilization and packaging integrity tests (ISO 10993-7, USP <151>, ASTM F1929-15, ASTM F88/F88M-15, ASTM F1886/F1886M-16, USP 39-NF34 <85>) to confirm sterility and maintain it until use.
Physical and functional performance tests for needles and syringes (ISO 7864:2016, ISO 9626:2016, ISO 7886-1:2017) to ensure they meet specifications for injection.
Sharps injury prevention tests (ISO 23908:2011) to verify the effectiveness of the retractable safety feature.
Particulate matter tests (USP 39-NF34 <788>) to ensure fluid cleanliness for injection.
A simulated clinical use study to specifically evaluate the effect and effectiveness of the safety feature as per FDA guidance.

The document states that "The test results demonstrated that the proposed device complies with the following standards" for each category, indicating that the device met the acceptance criteria defined by these standards.

Summary

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October 3, 2019

Jiangsu Caina Medical Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120, China

Re: K191490

Trade/Device Name: Retractable Safety Syringe, Retractable Safety Tuberculin Syringe, Retractable Safety Allergy Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: MEG Dated: August 19, 2019 Received: August 28, 2019

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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Page 2

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/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 medical devices and radiation-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.

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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Indications for Use

510(k) Number (if known) K191490

Device Name Retractable Safety Syringe Retractable Safety Tuberculin Syringe Retractable Safety Allergy Syringe

Indications for Use (Describe)

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: K191490

1. Submitter Information

Jiangsu Caine Medical Co., Ltd.

Submitter Name: Xinyan Ruan Submitter Address: No.23, Huanxi Road, Zhutang Town, Jiangsu, 214425, China Position: Quality Engineer Tel: +86-510-86205183 Fax: +86-510-86215183 Email: sherry.ruan@cainamed.com

Mid-Link Consulting Co., Ltd

Contact Person: Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (Alternative Contact Person) Contact Address: P.O. Box 120-119, Shanghai, 200120, China Tel: +86-21-22815850, Fax: 001-3609253199 Email: info@mid-link.net

Date of Preparation: 10/3/2019

1. Identification of Predicate Device
  Predicate Device 1 510(k) Number: K980069 Product Name: Automated Retractable VanishPoint Syringe

Predicate Device 2 510(k) Number: K031594 Product Name: Bak'snap Duopro Safety Syring (Duopross) Safety'tray Allergy Safety Syringe Tray

Predicate Device 3 510(k) Number: K132681 Product Name: Sol-Guard Insulin and Tuberculin Safety Syringes

1. Identification of Subject Device
  Trade Name: Retractable Safety Syringe Retractable Safety Tuberculin Syringe

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Retractable Safety Allergy Syringe

Models: 1ml, 2.5ml, 3ml, 5ml and 10ml (for Retractable Safety Syringe) 1ml (for Retractable Safety Tuberculin Syringe and Retractable Safety Allergy Syringe)

Regulatory Information Regulation Name: Piston syringe Regulation Number: 21 CFR 880.5860 Classification: II Product Code: MEG Common Name: Syringe, Antistick

Device Description 4.

Syringe	Syringe volume	Matched needle
		Needle gauge	Needle length	Needle wall	Bevel
RetractableSafety Syringe	1ml	31G	8mm/10mm/13mm	Regular Wall	11±2°
		30G	8mm/10mm/13mm/16mm	Regular Wall	11±2°
		29G	8mm/10mm/13mm/16mm	Regular Wall	11±2°
		28G	8mm/10mm/13mm/16mm	Regular Wall	11±2°
		27G	10mm/13mm/16mm/20mm	Regular Wall	11±2°
		26G	13mm/16mm/20mm/25mm	Regular Wall	11±2°
		25G	13mm/16mm/20mm/25mm	Regular Wall	11±2°
		24G	16mm/20mm/25mm	Regular Wall	11±2°
	2.5ml/3ml	27G	10mm/13mm/16mm/20mm	Regular Wall	11±2°
		26G	13mm/16mm/20mm/25mm	Regular Wall	11±2°
		25G	13mm/16mm/20mm/25mm	Regular Wall	11±2°
		24G	16mm/20mm/25mm	Regular Wall	11±2°
		23G	20mm/25mm/32mm	Thin Wall	11±2°
		22G	20mm/25mm/32mm	Thin Wall	11±2°
	5ml/10ml	25G	13mm/16mm/20mm/25mm	Regular Wall	11±2°
		24G	16mm/20mm/25mm	Regular Wall	11±2°
		23G	20mm/25mm/32mm	Thin Wall	11±2°
		22G	20mm/25mm/32mm	Thin Wall	11±2°

Table 1 Combination of syringe and needle

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		21G	20mm/25mm/32mm	Thin Wall	11 $\pm$ 2°
		20G	20mm/25mm/32mm	Thin Wall	11 $\pm$ 2°
RetractableSafetyTuberculinSyringe/RetractableSafety AllergySyringe	1ml	31G	8mm/10mm/13mm	Regular Wall	11 $\pm$ 2°
		30G	8mm/10mm/13mm/16mm	Regular Wall	11 $\pm$ 2°
		29G	8mm/10mm/13mm/16mm	Regular Wall	11 $\pm$ 2°
		28G	8mm/10mm/13mm/16mm	Regular Wall	11 $\pm$ 2°
		27G	10mm/13mm/16mm/20mm	Regular Wall	11 $\pm$ 2°
		26G	13mm/16mm/20mm/25mm	Regular Wall	11 $\pm$ 2°
		25G	13mm/16mm/20mm/25mm	Regular Wall	11 $\pm$ 2°
		24G	16mm/20mm/25mm	Regular Wall	11 $\pm$ 2°

The proposed devices are provided sterile. The product is sterilized by Ethylene Oxide Gas to achieve a SAL of 10 · and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of five years.

રું. Indications for Use Statement

	Subject Device	Predicate Device	Predicate Device	Predicate Device
Characteristic	Device Name	Device Name	Device Name	Device Name
	K191490	K980069	K031594	K132681
Indications for Use	The Retractable SafetySyringe works like aconventionalhypodermic syringeexcept for its ability toretract thecontaminated needleinside of the syringeimmediately afterpatient injection.Needle retraction isactivated by thesyringe user. Becausethe contaminatedneedle is automaticallywithdrawn into thesyringe plunge, the	The function ofthe VanshPointSyringe is toprovide a safe andreliable method ofinjectingmedication into apatient orwithdrawingblood from apatient. TheVanishPointSyringe workslike aconventionalhypodermicsyringe except for	The 1 mL Bak'SnapDuoProTM SafetySyringe(DuoProSSTM) is asterile, single use,disposable and non-reusable, manual,retractable safetysyringe which isintended forinjection of fluidsinto the body, whilereducing the risk ofsharps injuries andthe potential forsyringe reuse.	The Sol-GuardTuberculin (TB)Safety Syringe isintended for thedelivery ofTuberculin.The Sol-GuardTB SafetySyringe SafetySleeve covers theneedle whenactivated. In theactivatedposition, theSafety Shieldguards againstaccidental needle

Table 2 Indications for Use Statement List
--------------------------------------------	--	--	--	--

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syringe user is	its ability to	stick.
protected from	retract the
accidental needle	contaminated
sticks. These	needle inside of
accidental needle	the syringe
sticks would occur	immediately after
between removing the	patient injection.
needle from the patient	Needle retraction
and disposing of the	is activated by the
syringe in a sharps	syringe user.
disposable container.	Because the
For general injection	contaminated
use: The function of	needle is
Retractable Safety	automatically
Syringe is to provide a	withdrawn into
safe and reliable	the syringe
method of injecting	plunge, the
fluids into or	syringe user is
withdrawing fluids	protected from
from the body. The	accidental needle
Retractable Safety	sticks. These
Syringe is designed to	accidental needle
aid in the prevention	sticks would
of needle stick injuries	occur between
and reduce the	removing the
potential or syringe	needle from the
reuse. The syringe	patient and
contains various	disposing of the
capacity, such as 1ml,	syringe in a
2.5ml, 3ml, 5ml and	sharps disposable
10ml.	container.
For allergy use: The

1ml Retractable Safety
Allergy Syringe is
intended for the
preparation/mixing of
allergenic
extracts/prescribed
substances, the manual
aspiration of fluids,
and for the injection of

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	fluids into parts of the
	body below the
	surface of the skin.
	The Retractable Safety
	Syringe is designed to
	aid in the prevention
	of needle stick injuries
	and reduce the
	potential or syringe
	reuse.
	For Tuberculin use:
	The 1ml Retractable
	Safety Tuberculin
	Syringe is intended for
	the delivery of
	Tuberculin. The
	Retractable Safety
	Syringe is designed to
	aid in the prevention
	of needle stick injuries
	and reduce the
	potential or syringe
	reuse.
Prescription Only or
Over the Counter	Prescription	Prescription	Prescription	Prescription

Discussion of differences in Indications for use statement

The differences in Indications for use statement for general injection use:

The indications for use of subject device (Retractable Safety Syringe) are substantially equivalent to that of the predicate device (K980069). Both work like a conventional hypodermic syringe and have the safety feature to aid in the prevention of needle stick injuries and reduce the potential or syringe reuse. The indications for use of the subject device include the syringe volumes and the predicate device doesn't include this information. But this difference will not affect the subject device's safety and effectiveness.

The differences in Indications for use statement for allergy use:

Although the indications for use of the predicate device (K031594) doesn't state the predicate device is an allergy syringe, its 510(k) Summary shows it is for allergy use. Additionally, the subject device and the predicate device have the safety feature to aid in the prevention of needle stick injuries and reduce the potential or syringe reuse.

The differences in Indications for use statement for tuberculin use:

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Both the subject device and predicate device (K132681) are for tuberculin use, and they the safety feature to aid in the prevention of needle stick injuries and reduce the potential or syringe reuse. The indications for use of the subject device include the syringe volumes and the predicate device doesn't include this information. But this difference will not affect the subject device's safety and effectiveness.

Summary of technological characteristics 6.

Table 1 General Comparison with K980069 – for General Injection Use
ITEM	Subject Device	Predicate Device	Comments
Product code	K191490MEG	K980069MEG	Same
Regulation No.	21 CFR 880.5860	21 CFR 880.5860	Same
Class	II	II	Same
Configuration	PistonPlungerBarrel (graduated)Safety feature	PistonPlungerBarrel (graduated)Safety feature	Same
Sterility condition	EO Sterilized	EO Sterilized	Same
Environment of use	Hospital	Hospital	Same
Safety feature principle	Spring retraction	Spring retraction	Same
Volume	1ml, 2.5ml, 3ml, 5ml and 10ml.	1ml, 3ml, 5ml and 10ml	See Comment #1
Needle gauge	20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G and 31G	20-25G	See Comment #2
Needle length	8mm, 10mm, 13mm, 16mm, 20mm, 25mm and 32mm	32mm~16mm	See Comment #2
Needle Wall	Regular WallThin Wall	Unknown	See Comment #2
Bevel	$11\pm2^\circ$	Unknown	See Comment #2
Single use	Yes	Yes	Same
Operation mode	For Manual Use Only, For Single Use only	For Manual Use Only, For Single Use only	Same
Label/labeling	Complied with 21 CFR part 801	Complied with 21 CFR part 801	Same
Materials	Plunger/Barrel/Needle cap/Plunger lid/Barrel barb: PPPiston: Polyisoprene,Sealing plug: TPE+PP	Unknown	See Comment #3

משמעות משמעות המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המו

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Needle tube/Spring: Stainless Steel,
Hub: MABS
Lubricant: Polydimethysiloxane

Discussion of Technological Characteristics

The following differences do not raise different questions of safety and effectiveness.

Comment 1

Differences in syringe volume between the predicate and subject device were addressed through ISO 7886-1 syringe performance testing.

Comment 2

Differences in needle gauge, length, wall and between the predicate and subject device were addressed through ISO 7864 and ISO 9626 needle performance testing.

Comment 3

Differences in materials between the predicate and subject device were addressed through ISO 10993 Biocompatibility testing.

ITEM	Subject Device	Predicate Device	Comment
	K191490	K031594
Product code	MEG	MEG	Same
Regulation No.	21 CFR 880.5860	21 CFR 880.5860	Same
Class	II	II	Same
Configuration	PistonPlungerBarrel (graduated)Safety feature	PistonPlungerBarrel (graduated)Safety feature	Same
Sterilitycondition	EO Sterilized	EO Sterilized	Same
Environment ofuse	Hospital	Hospital	Same
Safety featureprinciple	Spring retraction	Spring retraction	Same
Volume	1ml	1ml	Same
Needle gauge	24G, 25G, 26G, 27G, 28G, 29G, 30Gand 31G	Unknown	See Comment 4
Needle length	8mm, 10mm, 13mm, 16mm, 20mm,25mm	Unknown	See Comment 5

Table 2 SE Comparison with K031594 - for allergy use

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Needle wall	Regular Wall	Unknown	See Comment 5
Bevel	$11\pm2^\circ$	Unknown	See Comment 5
Single use	Yes	Yes	Same
Operation mode	For Manual Use Only, For Single Use	For Manual Use Only,For Single Use only	Same
	only
Label/labeling	Complied with 21 CFR part 801	Complied with 21 CFR part 801	Same

Materials	Plunger/Barrel/Needle cap/Plunger lid/Barrel barb: PPPiston: Polyisoprene,Sealing plug: TPE+PP,Needle tube/Spring: Stainless Steel,Hub: MABSLubricant: Polydimethysiloxane	Unknown	See Comment 6

Discussion of Technological Characteristics

The following differences do not raise different questions of safety and effectiveness.

Comment 4

Differences in syringe volume between the predicate and subject device were addressed through ISO 7886-1 syringe performance testing.

Comment 5

Differences in needle gauge, length, wall and between the predicate and subject device were addressed through ISO 7864 and ISO 9626 needle performance testing.

Comment 6

Differences in materials between the predicate and subject device were addressed through ISO 10993 Biocompatibility testing.

ITEM	Subject Device	Predicate Device	Comment
Product code	MEG	MEG	Same
Regulation No.	21 CFR 880.5860	21 CFR 880.5860	Same
Class	II	II	Same
Configuration	Piston	Piston	Same
	Plunger	Plunger	Same
	Barrel (graduated)	Barrel (graduated)	Same
	Safety feature	Safety feature	Same
Sterility	EO Sterilized	EO Sterilized	Same
K191490	K132681

Table 3 SE Comparison with K132681 - for tuberculin use

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condition
Environment ofuse	Hospital	Hospital	Same
Safety featureprinciple	Spring retraction	Spring retraction	Same
Volume	1ml	1ml	Same
Needle gauge	24G, 25G, 26G, 27G, 28G, 29G, 30Gand 31G	Unknown	See Comment 7
Needle length	8mm, 10mm, 13mm, 16mm, 20mm,25mm	Unknown	See Comment 8
Needle wall	Regular Wall	Unknown	See Comment 8
Bevel	11±2°	Unknown	See Comment 8
Single use	Yes	Yes	Same
Operation mode	For Manual Use Only, For Single Useonly	For Manual Use Only,For Single Use only	Same
Label/labeling	Complied with 21 CFR part 801	Complied with 21 CFRpart 801	Same
Materials	Plunger/Barrel/Needle cap/Plunger lid/Barrel barb: PPPiston: Polyisoprene,Sealing plug: TPE+PP,Needle tube/Spring: Stainless Steel,Hub: MABSLubricant: Polydimethysiloxane	Unknown	See Comment 9

Discussion of Technological Characteristics

The following differences do not raise different questions of safety and effectiveness.

Comment 7

Differences in syringe volume between the predicate and subject device were addressed through ISO 7886-1 syringe performance testing.

Comment 8

Differences in needle gauge, length, wall and between the predicate and subject device were addressed through ISO 7864 and ISO 9626 needle performance testing.

Comment 9

Differences in materials between the predicate and subject device were addressed through ISO 10993 Biocompatibility testing.

1. Non-Clinical Performance Testing

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Biocompatibility

The proposed device is external communicating device, blood path indirect, contact duration is prolonged (<24hrs to 30 days). The biocompatibility tests were conducted to verify that the proposed devices are not adverse to human tissue based on the following standards,

ISO 10993-5:2009 Biological evaluation of medical devices- Part 5: Test for in vitro cytotoxicity
A ISO 10993-10:20101Biological evaluation of medical devices- Part 10: Test for irritation and delayed-type hypersensitivity
ISO 10993-11 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity
A ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials
A ISO 10993-4:2017 Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood

Other non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

ISO 10993-7:2008 Biological evaluation of medical devices- Part 7: Ethylene Oxide Sterilization Residuals
A USP <151> Pyrogen Test
ASTM F1929-15 Standard test method for detecting seal leaks in porous medical packaging by dye penetration.
ASTM F88/F88M-15 standard method for seal strength of flexible barrier materials
A ASTM F1886 / F1886M-16, Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
USP 39-NF34 <85> Bacterial Endotoxins Test
ISO 7864:2016 Sterile hypodermic needles for single use-requirements and test method.
A ISO 9626:2016 Stainless steel needle tubing for the manufacture of the medical devices-requirements and test method
A ISO 7886-1:2017 Sterile hypodermic syringe for single use- Part 1: Syringes for manual use
ISO 23908:2011 Sharps injury protection -- Requirements and test methods -- Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
A USP 39-NF34<788> Particulate Matter in Injection.

In addition, a simulated clinical use study was conducted on the subject device (Retractable Safety Syringe for general use) to evaluate the effect of safety feature per FDA Guidance "Medical Devices with Sharps Injury Prevention Features" issued on August 9, 2005. The test results demonstrated that the subject device complies with the requirements.

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Clinical Test Conclusion 8.
No clinical study is included in this submission.
Substantially Equivalent (SE) Conclusion 9.
Based on the comparison with predicate device, the proposed device is determined to be Substantially Equivalent (SE) in safety and effectiveness to the legally marketed 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).