1ml Luer Slip or Luer Lock Syringe is intended to be connected with the luer slip or luer lock needle and 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 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 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.

Device Description

The proposed Syringes include 1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety Syringe with permanently attached needle.

Each of the 1ml Luer Slip or Luer Lock Syringe, Safety Syringe with permanently attached needle. have one kind of product configuration, and the Syringe with permanently attached needle has two kinds of product configurations (Type A and Type B).

The proposed syringes are available in different combination of syringe volumes and/or needle sizes (refer to Table 1).

The proposed Syringe is sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 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 a 510(k) premarket notification for three types of syringes. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than proving the device meets acceptance criteria through a clinical study or performance evaluation in the typical sense of AI/medical imaging device submissions.

Therefore, many of the requested criteria (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable to this type of regulatory submission, as it's a conventional medical device and not an AI-powered one. The submission relies on non-clinical performance testing against established international standards to show equivalency in safety and efficacy.

Here's a breakdown of the available information based on your request, with an emphasis on what is and isn't present in this specific 510(k) summary:

Acceptance Criteria and Device Performance (Non-Clinical)

The acceptance criteria for these devices are defined by adherence to various international and national standards for medical syringes and needles. The "reported device performance" is a statement that the device complies with these standards, indicating successful non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not present a single "acceptance criteria table" with specific numerical thresholds and corresponding "reported performance values" in the way one might see for an AI algorithm's sensitivity/specificity. Instead, the performance is demonstrated by compliance with the referenced standards.

Acceptance Criteria (Governing Standard/Requirement)	Reported Device Performance (Compliance Statement)
Piston Syringe Performance (General)	Complies with ISO 7886-1:2017
Small-bore Connectors (Intravascular/Hypodermic)	Complies with ISO 80369-7:2016
Common Test Methods for Small-bore Connectors	Complies with ISO 80369-20:2015
Stainless Steel Needle Tubing	Complies with ISO 9626:2016
Sterile Hypodermic Needles (Requirements & Test Methods)	Complies with ISO 7864:2016
Sterilization Residuals (Ethylene Oxide)	Complies with ISO 10993-7:2008
Bacterial Endotoxin Limit	Complies with USP 41-NF36:2018<85> (20 EU per device)
Seal Strength of Flexible Barrier Materials (Sterility)	Complies with ASTM F88/F88M-15
Detecting Seal Leaks in Porous Medical Package	Complies with ASTM F1929-15
Integrity of Seals for Flexible Packaging by Visual Inspection	Complies with ASTM F1886/F1886M-16
Sharps Injury Protection Features	Complies with ISO 23908:2011 & FDA Guidance, demonstrated through internal safety feature performance specs (see below)
Biocompatibility	Conforms to ISO 10993 series standards (via reference device K150758)
Sterility Assurance Level (SAL)	Meets 10⁻⁶ SAL (EO Sterilized)
Labeling	Complies with 21 CFR part 801
Safety Feature Performance Specifications (for Safety Syringe)	The torque to lock: < 10 N·cm The force to destroy forward: ≥ 30 N The force to destroy backward: ≥ 60 N The torque to unscrewing: > 20 N·cm

Study Details (Non-Clinical Performance Testing)

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

Sample Size: Not explicitly stated in the provided text. The document refers to compliance with standards, which typically involve specific sample sizes for their respective tests, but these are not enumerated here.
Data Provenance: The tests were non-clinical performance tests conducted by the manufacturer, Jiangsu Caina Medical Co., Ltd. The country of origin for the data is China, implicitly, as that is the manufacturer's location. The tests are prospective in the sense that they were performed to support this submission.

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 conventional medical device, typically manufactured and tested according to engineering standards. "Ground truth" in the clinical sense (e.g., diagnosis by experts) is not relevant for proving substantial equivalence of a syringe. Compliance with ISO and ASTM standards is the "truth" here.

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

Not Applicable. See point 3.

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 not an AI/imaging device. No MRMC study was conducted.

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

Not Applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" for this device is its adherence to established engineering, manufacturing, and performance standards for syringes and needles (e.g., ISO, ASTM). Biocompatibility is confirmed by referencing a previously cleared device with identical patient-contact materials (K150758).

8. The sample size for the training set

Not Applicable. This is a physical device, not an AI model.

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

Not Applicable. This is a physical device, not an AI model.

Summary of Approach:

The provided K192551 document demonstrates substantial equivalence based on:

Direct comparison of the proposed devices' characteristics (e.g., configuration, materials, volume, needle size, performance standards) to legally marketed predicate devices.
Non-clinical performance testing to ensure compliance with relevant international and national consensus standards (ISO, ASTM, USP). The "acceptance criteria" are the thresholds and requirements defined within these standards.
Biocompatibility assessment by referencing a previously cleared device (K150758) that uses identical patient-contact materials.

No clinical studies or expert-driven evaluations of performance (like those for AI/imaging devices) were part of this submission, as stated clearly: "No clinical study is included in this submission."

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 10, 2020

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

Re: K192551

Trade/Device Name: 1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety Syringe with permanently attached needle Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF. MEG Dated: June 24, 2020 Received: July 13, 2020

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.

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

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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 (QS) 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 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) K192551

Device Name

1ml Luer Slip or Luer Lock Syringe Syringe with permanently attached needle Safety Syringe with permanently attached needle

Indications for Use (Describe)

1ml Luer Slip or Luer Lock Syringe

Syringe with permanently attached needle

Safety Syringe with permanently attached needle

as annlicahle)

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 skin. The Safety sheath of Syringe is designed to aid in the prevention of needle stick injuries and reduce the potential or syringe reuse.

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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Exhibit #3 510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number:____K192551

1. Date of Preparation: 08/06/2020
1. Sponsor Identification

Jiangsu Caina Medical Co., Ltd.

No.23, Huanxi Road, Zhutang Town, Jiangyin City, Jiangsu, 214415, China

Establishment Registration Number: 3005670221

Contact Person: Jianwei Pan Position: Management Representative Tel: +86-0510-8686 6666-8027 Fax: +86-0510-8686 6666-8009 Email: jianwei.pan@cainamed.com

Designated Submission Correspondent 3.
Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (Alternative Contact Person)

Mid-Link Consulting Co., Ltd

P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net

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Identification of Proposed Device 4.

Trade Name: 1ml Luer Slip or Luer Lock Syringe Syringe with permanently attached needle Safety Syringe with permanently attached needle Common Name: Piston Syringe and antistick syringe

Regulatory Information: Classification Name: Piston Syringe; Classification: II; Product Code: FMF, MEG; Regulation Number: 21CFR 880.5860 Review Panel: General Hospital;

Indications for Use:

1ml Luer Slip or Luer Lock Syringe

Syringe with permanently attached needle

Safety Syringe with permanently attached needle

Device Description

The proposed Syringes include 1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety Syringe with permanently attached needle.

The proposed syringes are available in different combination of syringe volumes and/or needle sizes

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(refer to Table 1).

Model	Needle length (mm)	Needle gauge	Needle wall type	Needle bevel	Syringe size/volume
1ml Luer Slip or Luer Lock Syring	NA	NA	NA	NA	1ml
Syringe with permanently attached needle-type B	20, 25	21G	RW, TW	11°±2°, 15°±2°	1ml
	20, 25	23G	RW, TW	11°±2°, 15°±2°
Syringe with permanently attached needle-type A	8,10,13,16	29G	RW, TW	11°±2°, 15°±2°	0.3ml
	8,10,13,16	30G	RW, TW	11°±2°, 15°±2°
	8,10,13,16	31G	RW, TW	11°±2°, 15°±2°
	10, 13, 16	25G	RW, TW	11°±2°, 15°±2°	0.5ml
	10, 13, 16	26G	RW, TW	11°±2°, 15°±2°
	10, 13, 16	27G	RW, TW	11°±2°, 15°±2°
	10, 13, 16	28G	RW, TW	11°±2°, 15°±2°
	8, 10, 13, 16	29G	RW, TW	11°±2°, 15°±2°
	8, 10, 13, 16	30G	RW, TW	11°±2°, 15°±2°
	8, 10, 13, 16	31G	RW, TW	11°±2°, 15°±2°
	10, 13, 16	25G	RW, TW	11°±2°, 15°±2°	1ml
	10, 13, 16	26G	RW, TW	11°±2°, 15°±2°
	10, 13, 16	27G	RW, TW	11°±2°, 15°±2°
	10, 13, 16	28G	RW, TW	11°±2°, 15°±2°
	8, 10, 13, 16	29G	RW, TW	11°±2°, 15°±2°
	8, 10, 13, 16	30G	RW, TW	11°±2°, 15°±2°
	8, 10, 13, 16	31G	RW, TW	11°±2°, 15°±2°
Safety Syringe with permanently attached needle	8,10,13,16	29G	RW, TW	11°±2°, 15°±2°	0.3ml
	8,10,13,16	30G	RW, TW	11°±2°, 15°±2°
	8,10,13,16	31G	RW, TW	11°±2°, 15°±2°
	10, 13, 16	25G	RW, TW	11°±2°, 15°±2°	0.5ml
	10, 13, 16	26G	RW, TW	11°±2°, 15°±2°
	10, 13, 16	27G	RW, TW	11°±2°, 15°±2°
	10, 13, 16	28G	RW, TW	11°±2°, 15°±2°
	8, 10, 13, 16	29G	RW, TW	11°±2°, 15°±2°
	8, 10, 13, 16	30G	RW, TW	11°±2°, 15°±2°
	8, 10, 13, 16	31G	RW, TW	11°±2°, 15°±2°
10, 13, 16	25G	RW, TW	11°±2°, 15°±2°	1ml
10, 13, 16	26G	RW, TW	11°±2°, 15°±2°
10, 13, 16	27G	RW, TW	11°±2°, 15°±2°
10, 13, 16	28G	RW, TW	11°±2°, 15°±2°
8, 10, 13, 16	29G	RW, TW	11°±2°, 15°±2°
8, 10, 13, 16	30G	RW, TW	11°±2°, 15°±2°
8, 10, 13, 16	31G	RW, TW	11°±2°, 15°±2°

Table 1 specification of proposed device

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The proposed Syringe 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.

ડ. Identification of Predicate Devices

5.1 Predicate device 1
510(k) Number: K170651 Product Name: Sterile Disposable Syringe with Safety Needle Sterile Disposable Syringe with Needle Sterile Disposable Syringe (used as predicate device) Sterile Disposable Safety Needle Sterile Disposable Needle Manufacturer: Yangzhou Medline Industry Co., Ltd.
5.2 Predicate device 2
510(k) Number: K132681 Product Name: Sol-Guard Insulin Safety Syringe and Tuberculin Safety Syringe Manufacturer: Sol-Millennium Medical, Inc.

Identification of Reference Devices 6.

510(k) Number: K150758 Product Name: Safelock Disposable Insulin Syringe Manufacturer: Jiangsu Caina Medical Co., Ltd.

Indication for Use:

Safelock disposable insulin syringe is intended to inject U-100 insulin into the human body and aid in the prevention of accidental needle stick injuries.

The safety shield of the proposed syringes is the same as that of the legally marketed device, Safety Insulin Syringe (Safelock Disposable Insulin Syringe), as cleared in K150758, which is also

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manufactured by Jiangsu Caina Medical Co., Ltd

7. Non-Clinical Test Conclusion

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:

A ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications.
A ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications — Part 20: Common test methods.
ISO 7886-1:2017 Sterile hypodermic syringes for single use- Part 1: Syringes for manual use.
ISO 9626:2016, Stainless Steel Needle Tubing for the Manufacture of Medical Devices.
ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods
ISO 10993-7:2008 Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals.
USP 41-NF36:2018<85> Bacterial Endotoxin Limit
ASTM F88/F88M-15, Standard Test Method for Seal Strength of Flexible Barrier Materials. (Sterility)
ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration
ASTM F1886/F1886M-16, Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
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.
Medical Devices with Sharps Injury Prevention Features - Guidance for Industry and FDA Staff

Biocompatibility testing

The contact level of the proposed device is blood path, indirect, and the contact duration is limited contact (<24 hours). The patient-contact components and materials of the 1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety Syringe with permanently attached needle, are identical to the patient-materials of product components of Safety Insulin Syringe (Safelock Disposable Insulin Syringe), as cleared in K150758, which is also manufactured by Jiangsu Caina Medical Co., Ltd. Therefore, the proposed syringes' biocompatibility can be demonstrated by the reference device (K150758).

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Clinical Test Conclusion 8.

No clinical study is included in this submission.

Substantially Equivalent (SE) Comparison 9.

Table 2 Comparison of differences for 1ml Luer Slip or Luer Lock Syringe

ITEM	Proposed Device	Predicate Device 1K170651	Reference deviceK150758	Remark
Product	1ml Luer Slip or LuerLock Syringe	Sterile DisposableSyringe	Safeflock DisposableInsulin Syringe	/
Product code	FMF	FMF	FMFMEG	Same
RegulationNo.	21CFR 880.5860	21CFR 880.5860	21CFR 880.5860	Same
Class	II	II	II	Same
Indicationsfor Use	1ml Luer Slip or LuerLock Syringe is intendedto be connected with theluer slip or luer lockneedle and intended foruse by health careprofessionals for generalpurpose aspiration offluid from vials,ampoules and liquidinjection below thesurface of the skin.	The Sterile DisposableSyringe is a sterile luerlock or luer slip syringewhich is intended to beused with a hypodermicneedle for the aspirationand injection of fluidsfor medical purpose.	Safeflock disposableinsulin syringe isintended to inject U-100insulin into the humanbody and aid in theprevention of accidentalneedle stick injuries.	Difference1
Configurationand material	(1) barrel (PP)(2) plunger (PP)(3) piston (Polysoprene)	(1) barrel (PP)(2) plunger (PP)(3) piston (Polysoprene)	(1) Protective end cap(PE)(2) Plunger (PP)(3) Piston (Polysoprene)(4) barrel (PP)(5) needle cap (PE)(6) needle (Stainlesssteel 304)(7) Protective shield(PE)	Same
SyringeVolume	1ml	1ml, 2ml, 2.5ml, 3ml,5ml, 10ml, 20ml, 30ml,50ml, 60ml	0.3ml, 0.5ml, 1ml	Difference2

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ConnectorType	Luer Lock/ Luer slip	Luer Lock/ Luer slip	NA	Same
Syringeperformance	ISO 7886-1	ISO 7886-1	ISO 7886-1	Same
Biocompatibility	Conforms to therequirements of ISO10993 series standards.	Conforms to therequirements of ISO10993 series standards.	Conforms to therequirements of ISO10993 series standards.	Same
Method	EO Sterilized	EO Sterilized	EO Sterilized	Same
SAL	10-6	10-6	10-6	Same
EndotoxinLimit	20 EU per device	20 EU per device	20 EU per device	Same
OperationPrinciple	For Manual Use Only,For Single Use Only	For Manual Use Only,For Single Use Only	For Manual Use Only,For Single Use Only	Same
Label/Labeling	Complied with 21 CFRpart 801	Complied with 21 CFRpart 801	Complied with 21 CFRpart 801	Same

Difference 1- Indication for use

The proposed devices have the same operation principle as that of the predicate device. The description of the indication for use of the proposed device and the predicate devices and reference device are different, but they are all used by health care professionals for fluid aspiration and injection. The essential use of the syringe is the same. Therefore, this item is considered substantially equivalent.

Difference 2- Syringe volume

The Syringe volume for proposed devices are different from the predicate devices 1. However, this difference is just in dimension. Different volume devices will be selected by physician per patient's condition. This difference does not affect intended use. In addition, differences in syringe volume between the predicate and subject device were addressed through ISO 7886-1:2017 performance testing. Therefore, this difference does not affect substantially equivalence on safety and effectiveness.

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ITEM	Proposed Device	Predicate Device 2	Reference device	Remark
		K132681	K150758
Product	Syringe with permanentlyattached needle	Sol-Guard Insulin SafetySyringe and TuberculinSafety Syringe	Safelock DisposableInsulin Syringe	/
Productcode	FMF	MEG	FMFMEG	Difference3
RegulationNo.	21CFR 880.5860	21CFR 880.5860	21CFR 880.5860	Same
Class	II	II	II	Same
Indicationsfor Use	The Syringe withpermanently attachedneedle is intended for useby health care professionalsfor general purposeaspiration of fluid fromvials, ampoules and liquidinjection below the surfaceof the skin.	For TB UseThe Sol-GuardTuberculin (TB) SafetySyringe is intended forthe delivery ofTuberculin.The Sol-Guard TBSafety Syringe SafetySleeve covers the needlewhen activated. In theactivated position, theSafety Shield guardsagainst accidental needlestick.For Insulin UseThe Sol-Guard InsulinSafety Syringe isintended for the deliveryof U-1 00 insulin.The Sal-Guard InsulinSafety Syringe SafetySleeve covens the needlewhen activated. In theactivated position, theSafety Shield guardsagainst accidental needlestick.	Safelock disposableinsulin syringe isintended to inject U-100insulin into the humanbody and aid in theprevention of accidentalneedle stick injuries.	Difference4
Configuratio	Syringe with permanently	(1) needle cap	1) Protective end cap	Difference
nandmaterial	attached needle-type A
	(1) needle cap (PP or PE)	(2) needle	(PE)	5
	(2) needle (Stainless Steel304)	(3) piston	(2) Plunger (PP)
	(3) piston (Polysoprene)	(4) plunger	(3) Piston (Polysoprene)
	(4) plunger (PP)	(5) barrel	(4) barrel (PP)
	(5) barrel (PP)	(6) end cap	(5) needle cap (PE)
	(6) end cap (PP or PE)	(7) safety mechanism	(6) needle (Stainlesssteel 304)
	Syringe with permanentlyattached needle-type B	The material of predicatedevice is not exposuredin the predicate device's510(k) summary, so thematerials of predicatedevice is unknown	(7) Protective shield(PE)
	(1) needle cap (PP or PE)
	(2) needle (Stainless Steel304)
	(3) piston (Polysoprene)
	(4) plunger (PP or ABS)
	(5) barrel (PP)
SyringeVolume	0.3ml, 0.5ml, 1ml	0.3ml, 0.5ml, 1ml	0.3ml, 0.5ml, 1ml	Same
NeedleGauge	21G, 23G, 25G, 26G, 27G,28G, 29G, 30G, 31G	25G, 27G, 28G, 29G,30G, 31G	28G, 29G, 30G	Difference6
NeedleLength	8mm, 10mm, 13mm, 16mm,20mm, 25mm	8mm, 13mm, 16mm,25mm	8mm, 10mm, 13mm,16mm
Needle walltype	RW, TW	Unknown	RW
Needlebevel	11°±2°, 15°±2°	15 degree regular point	12°±2°
Needleperformance	ISO 9626ISO 7864	ISO 9626ISO 7864	ISO 9626ISO 7864	Same
Syringeperformance	ISO 7886-1	ISO 7886-1	ISO 7886-1	Same
Biocompatibility	Conforms to therequirements of ISO 10993series standards.	Conforms to therequirements of ISO10993 series standards.	Conforms to therequirements of ISO10993 series standards.	Same
Method	EO Sterilized	EO Sterilized	EO Sterilized	Same
SAL	10-6	10-6	10-6	Same
EndotoxinLimit	20 EU per device	20 EU per device	20 EU per device	Same
Operation	For Manual Use Only, For	For Manual Use Only,	For Manual Use Only,	Same
Label/Labeling	Complied with 21 CFR part 801	Complied with 21 CFR part 801	Complied with 21 CFR part 801	Same
ng

Table 3 Comparison of differences for Syringe with permanently attached needle

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Difference 3- Product code

The proposed devices are a syringe with permanently attached needle, so the corresponding product codes is FMF. The predicate devices 2 are a safety syringe with needle and its product code is MEG. Both proposed device and predicate device are all used by health care professionals for fluid aspiration and injection. The syringe without safety feature is widely used in the clinical. Therefore, the difference on product code and regulation number will not raise new questions on safety and effectiveness of the proposed device.

Difference 4-Indication for use

The proposed devices have the same operation principle as that of the predicate device 2. The description of the indication for use of the proposed device and the predicate devices and reference device are different, but they are all used by health care professionals for fluid aspiration and injection. The syringe without safety feature is widely used in the clinical. Therefore, this item is considered substantially equivalent.

Difference 5- Configuration and materials

The configurations of Syringe with permanently attached needle is similar as the configuration of predicate device 2, the difference is that Syringe with permanently attached has no safety mechanism, but the syringe without safety feature is widely used in the clinical. Whether there is a safety mechanism or not will not affect the indication for use of the equipment itself. This difference does not raise new questions about safety and effectiveness.

Although the materials of predicate devices 2 are unknown. The proposed syringes' biocompatibility can be demonstrated by the reference device (K150758). Therefore, the differences on configuration and materials do not raise new questions about safety and effectiveness.

Difference 6- Needle gauge, length, wall type and bevel

The needle gauge and length for proposed devices is different from the predicate devices 2. However, this difference is just in dimension. Different size and length device will be selected by physician per patient's condition. This difference does not affect intended use, differences in needle length and gauge between the predicate and subject device were addressed through ISO 7864:2016 and ISO 9626:2016 performance testing.

The needle wall type for predicate device is unknown. 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.

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the predicate and subject device were addressed through ISO 7864:2016 and ISO 9626:2016 performance testing. Therefore, the differences on needle length, gauge, wall type and bevel does not affect substantially equivalence on safety and effectiveness.

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ITEM	Proposed Device	Predicate Device 2K132681	Reference deviceK150758	Remark
Product	Safety Syringe withpermanently attachedneedle	Sol-Guard InsulinSafety Syringe andTuberculin SafetySyringe	Safelock DisposableInsulin Syringe	/
Product code	MEG	MEG	FMFMEG	Same
Regulation No.	21CFR 880.5860	21CFR 880.5860	21CFR 880.5860	Same
Class	II	II	II	Same
Indications for Use	The Safety Syringewith permanentlyattached needle isintended for use byhealth careprofessionals forgeneral purposeaspiration of fluidfrom vials, ampoulesand liquid injectionbelow the surface ofthe skin. The Safetysheath of Syringe isdesigned to aid in theprevention of needlestick injuries andreduce the potential orsyringe reuse.	For TB UseThe Sol-GuardTuberculin (TB)Safety Syringe isintended for thedelivery of Tuberculin.The Sol-Guard TBSafety Syringe SafetySleeve covers theneedle when activated.In the activatedposition, the SafetyShield guards againstaccidental needle stick.For Insulin UseThe Sol-Guard InsulinSafety Syringe isintended for thedelivery of U-100insulin.The Sal-Guard InsulinSafety Syringe SafetySleeve covens theneedle when activated.In the activatedposition, the SafetyShield guards againstaccidental needle stick.	Safelock disposableinsulin syringe isintended to injectU-100 insulin into thehuman body and aid inthe prevention ofaccidental needle stickinjuries.	Difference 7
Configuration andmaterial	(1) needle cap (PP orPE)(2) needle (StainlessSteel 304)(3) safety mechanism(PC)(4) piston(Polysoprene)(5) safety mechanism(PP)(6) plunger (PP)(7) barrel (PP)	(1) needle cap(2) needle(3) piston(4) plunger(5) barrel(6) end cap(7) safety mechanismThe material ofpredicate device is notexposured in thepredicate device's510(k) summary, sothe materials ofpredicate device isunknown	(1) Protective end cap(PE)(2) Plunger (PP)(3) Piston(Polysoprene)(4) barrel (PP)(5) needle cap (PE)(6) needle (Stainlesssteel 304)(7) Protective shield(PE)	Difference 8
Syringe Volume	0.3ml, 0.5ml, 1ml	0.3ml, 0.5ml, 1ml	0.3ml, 0.5ml, 1ml	Same
Needle Gauge	21G, 23G, 25G, 26G,27G, 28G, 29G, 30G,31G	25G, 27G, 28G, 29G,30G 31G	28G, 29G, 30G	Difference 9
Needle Length	8mm, 10mm, 13mm,16mm, 20mm, 25mm	8mm, 13mm, 16mm,25mm	8mm, 10mm, 13mm,16mm
Needle wall type	RW, TW	Unknown	RW
Needle bevel	11° $\pm$ 2°, 15° $\pm$ 2°	15 degree regular point	12° $\pm$ 2°
Needleperformance	ISO 9626ISO 7864	ISO 9626ISO 7864	ISO 9626ISO 7864	Same
Syringeperformance	ISO 7886-1	ISO 7886-1	ISO 7886-1	Same
Safety featureperformancespecifications	i. The torque to lockshall be less than10N·cmii. The force to destroyforward shall notbe less than 30Niii. The force todestroy backwardshall not be lessthan 60Niv. The torque tounscrewing shall	Unknown	Unknown	Difference10
	be greater than20N·cm
Biocompatibility	Conforms to therequirements of ISO10993 series standards.	Conforms to therequirements of ISO10993 series standards.	Conforms to therequirements of ISO10993 series standards.	Same
Method	EO Sterilized	EO Sterilized	EO Sterilized	Same
SAL	10-6	10-6	10-6	Same
Endotoxin Limit	20 EU per device	20 EU per device	20 EU per device	Same
Operation	For Manual Use Only,	For Manual Use Only,	For Manual Use Only,	Same
Principle	For Single Use Only	For Single Use Only	For Single Use Only	Same
Label/Labeling	Complied with 21CFR part 801	Complied with 21CFR part 801	Complied with 21CFR part 801	Same

Table 4 Comparison of differences for Safety Syringe with permanently attached needle

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Difference 7-Indication for use

The proposed devices have the same operation principle as that of the predicate device 2. The description of the indication for use of the proposed device and the predicate devices and reference device are different, but they are all used by health care professionals for fluid aspiration and injection. The essential use of the syringe is the same. Therefore, this item is considered substantially equivalent.

Difference 8- Configuration and materials

The configurations of Syringe with permanently attached needle is similar as the combinations of the configuration of predicate device 2, the difference is that Safety Syringe with permanently attached needle has no end cap, but there are many products on the market without end cap. This difference does not raise new questions about safety and effectiveness. Whether there is an end cap or not will not affect the indication for use of the equipment itself. This difference does not raise new questions about safety and effectiveness.

The predicate devices 2 material of configurations are unknown. Although the materials of predicate devices 2 are unknown. The proposed syringes' biocompatibility can be demonstrated by the reference device (K150758). Therefore, the differences on configuration and materials do not raise new questions about safety and effectiveness.

Difference 9- Needle gauge, length, wall type and bevel

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The needle bevel for proposed devices are different from the predicate device 2. However, this difference is just in dimension. Different needle bevel will be selected by physician per patient's condition. This difference does not affect intended use. In addition, differences in needle bevel between the predicate and subject device were addressed through ISO 7864:2016 and ISO 9626:2016 performance testing. Therefore, the differences on needle length, gauge, wall type and bevel does not affect substantially equivalence on safety and effectiveness.

Difference 10- Safety feature performance specifications

The Safety feature performance specifications for predicate device is unknown. 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.

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10. Substantially Equivalent (SE) Conclusion

Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.

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).