The 3S Safety Insulin Syringe a sterile, single-use, disposable and non-reusable, manual retractable safety insulin syringe intended for injection of insulin into the body, while reducing the risk of sharps injuries and the potential for insulin syringe reuse.

Device Description

The 3S Safety Insulin Syringe is an integrated needle and piston syringe with an innovative antineedle-stick mechanism. The design incorporates the ideal features desired in a safety syringe. No special techniques are required to use the safety mechanism. The mechanism allows clear visualization of the injection site at all times. The mechanism clearly shows the needle is contained within the syringe barrel. After standard techniques for injection, the plunger is withdrawn, snapped off and used syringe is discarded into a sharps container per regulatory provision.

The 3S safety syringe with/without Needle will be available in numerous sizes and combinations between the smallest (0.3cc/ml + 31G) and the largest (1cc/ml + 27G )

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "3S Safety Insulin Syringe." The document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study with acceptance criteria and performance data for a novel device or AI algorithm.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" cannot be fully provided in the format requested. The document does not describe a performance study with specific acceptance criteria, sample sizes, expert ground truth, adjudication methods, or AI comparative effectiveness.

However, I can extract the information related to the device's characteristics and the basis for its substantial equivalence, as presented in the document.

Here's a breakdown of what can be inferred or directly stated from the provided text, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a table of acceptance criteria for a performance study. Instead, it presents a Safety Syringe Comparison Table showing the characteristics of the submitted device against a predicate device to demonstrate substantial equivalence. The "performance" aspect is generally referred to as "Conforms to ISO7864 ISO8537" and "Conforms to ISO10993" for biocompatibility. These are general standards, not specific acceptance criteria for a performance study in the context of device function or efficacy.

Element of Comparison	Submission Device (3S Safety Insulin Syringe)	Predicate Device (InsoSAFE BakSNAP Retractable Insulin Safety Syringe)
Intended Use	A sterile, single-use, disposable and non-reusable, manual retractable safety insulin syringe intended for injection of insulin into the body, while reducing the risk of sharps injuries and the potential for insulin syringe reuse.	A sterile, single-use, disposable and non-reusable, manual retractable safety insulin syringe intended for injection of insulin into the body, while reducing the risk of sharps injuries and the potential for insulin syringe reuse.
Principle of Operation	Normal	Normal
Syringe Capacity	Various Sizes	Various Sizes
Nozzle Type	N.A	N.A
Lubricant for Barrel	Silicone Oil	Silicone Oil
Barrel Transparency	Transparent and Clear	Transparent and Clear
Gradations Legibility	Legible	Legible
Barrel Material	PP	PP
Plunger Material	PP	PP
Piston Material	TPE	TPE
Needle Hub Material	PP	PP
Needle Material	Stainless Steel	Stainless Steel
Needle Sheath Material	PP	PP
Needle Gauge and Length	Various Sizes	Various Sizes
Lubricant for Needle	Silicone Oil	Silicone Oil
Sharps Injury Prevention Method	Manual Retractable	Manual Retractable
Performances Status	Conforms to ISO7864 ISO8537	Conforms to ISO7864 ISO8537
Biocompatibility Status	Conforms to ISO10993	Conforms to ISO10993
Labeling Status	Meet the requirements of 21 CFR Part 801	Meet the requirements of 21 CFR Part 801

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

Sample Size: Not specified in the document.
Data Provenance: Not specified in the document. The document refers to a comparison to a predicate device and conformance to ISO standards, but no details of original test data are provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Not specified. This document pertains to a medical device (syringe), not an AI/imaging diagnostic device requiring expert interpretation for ground truth.

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

Not applicable/Not specified.

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 diagnostic device.

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

Not applicable. This is not an AI/algorithm.

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

Not applicable/Not specified. The assessment relies on conformity to established international standards (ISO7864, ISO8537 for performance; ISO10993 for biocompatibility) and comparison of physical/material characteristics with a predicate device.

8. The sample size for the training set:

Not applicable. This is not an AI/algorithm-based device.

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

Not applicable.

Summary of the Study/Basis for Acceptance (as per the document):

The "study" in this context is a substantial equivalence determination based on a comparison between the 3S Safety Insulin Syringe and a legally marketed predicate device (InsoSAFE BakSNAP Retractable Insulin Safety Syringe, K050131).

The core of the "proof" is the "Safety Syringe Comparison Table" in Section 6, which argues that the "materials, performance, and operational features of both the submitted device and the predicate device are substantially equivalent."

The performance aspects are addressed by stating that the device "Conforms to ISO7864 ISO8537" (likely for sterile hypodermic syringes and needles) and "Conforms to ISO10993" (for biological evaluation of medical devices). This implies that standard tests dictated by these ISO norms were conducted and passed, but the specifics of those tests, their acceptance criteria, and specific data are not detailed in this 510(k) summary.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, layered on top of each other, creating a sense of depth and unity.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 19, 2015

Sincere Medical Device Co., Ltd. Mr. Garfield Wang RA Manager Rm. 218, 2F., No. 183, Zhouzi St. Taipei City, Taipei City 114 TAIWAN (R.O.C.)

Re: K142436

Trade/Device Name: 3S Safety Insulin Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: August 15, 2014 Received: January 23, 2015

Dear Mr. Wang:

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. 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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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office

of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina
Kiang -S

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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[3S Safety Insulin Syringe]

Rev 0.00 15/08/14

Section 004 Indications for Use

K142436

510(k) Number (if known):

Device Name: 3S SAFETY INSULIN SYRINGE

Indications for Use

Prescription Use V AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Image /page/3/Picture/0 description: The image shows the logo for Sincere Medical Device Co., Ltd. The logo consists of a green circular design with the letter 'S' in the center. The company name, 'Sincere Medical Device Co., Ltd.,' is written in gray text to the right of the logo.

Rev 0.02

05/02/15

[3S Safety Insulin Syringe]

Section_005 510(K) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92

Date Prepared: 15. 01.2015

1. Submitter Name and Address:

Owner Name:	Sincere Medical Device Co., Ltd.
Address:	Rm. 218, 2F., No. 183, Zhouzi St., Neihu Dist., Taipei City 114.Taiwan(R.O.C)
Contactor Name:	Garfield Wang, Vivian Lu
TEL:	+86-13564751751
E-mail:	Wangxuebo_11@hotmail.com
Web:	http://sincere-med.com
Fax:	+886-2-2659-8698

US Agent:

US Agent:	Benjamin Lee.
Address:	8692 9th Street, unit 42, Rancho Cucamonga, ca 91730
TEL:	1909-985-0648

2. Submission Devices Information:

Trade/Proprietary Name: 3S Safety Insulin Syringe Common Name: Syringe, Antistick Piston Syringe Classification name: Piston Syringe.. Class: 2. Panel: 80. Product codes: MEG Submission Type: 510(k) Requlation Number: 880.5860

3. Predicate Devices Information:

Trade Name:	InsoSAFE BakSNAP Retractable Insulin Safety Syringe
510(K) Number:	K050131
Company:	M.K. Meditech Co., Ltd

4. Devices Description:

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Image /page/4/Picture/0 description: The image shows the logo for Sincere Medical Device Co., Ltd. The logo consists of a green circular graphic on the left, with the company name written in gray text to the right of the graphic. The graphic appears to be a stylized representation of a medical symbol, possibly incorporating the letter 'S'.

[3S Safety Insulin Syringe]

Rev 0.02 05/02/15

The 3S safety syringe with/without Needle will be available in numerous sizes and combinations between the smallest (0.3cc/ml + 31G) and the largest (1cc/ml + 27G )

5. Intended Use:

6. Technological Characteristics:

Through comparisons between the submitted devices with the predicate devices as follows tables. We believe the applicant devices are substantially equivalent with the predicate devices.

Safety Syringe Comparison Table

Element of Comparison	Submission Device	Predicate DeviceK040545
Intended Use	The 3S Safety Insulin Syringea sterile, single-use,disposable and non-reusable,manual retractable safetyinsulin syringe intended forinjection of insulin into thebody, while reducing the risk ofsharps injuries and the potentialfor insulin syringe reuse.	The InsoSAFE BakSNAPRetractable Insulin SafetySyringe a sterile, single-use,disposable and non-reusable,manual retractable safetyinsulin syringe intended forinjection of insulin into thebody, while reducing the riskof sharps injuries and thepotential for insulin syringereuse.
Principle of Operation	Normal	Normal
Syringe Capacity	Various Sizes	Various Sizes
Nozzle Type	N.A	N.A
Lubricant for Barrel	Silicone Oil	Silicone Oil
Barrel Transparency	Transparent and Clear	Transparent and Clear
Gradations Legibility	Legible	Legible
Materials
Barrel	PP	PP
Plunger	PP	PP
Piston	TPE	TPE
Needle Hub	PP	PP
Needle	Stainless Steel	Stainless Steel
Needle Sheath	PP	PP
Needle Gauge and Length	Various Sizes	Various Sizes
Lubricant for Needle	Silicone Oil	Silicone Oil
Sharps Injury Prevention	Manual Retractable	Manual Retractable
Features
Performances	Conforms to ISO7864 ISO8537	Conforms to ISO7864 ISO8537
Biocompatibility	Conforms to ISO10993	Conforms to ISO10993
Labeling	Meet the requirements of 21 CFR	Meet the requirements of 21

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Image /page/5/Picture/0 description: The image shows the logo for Sincere Medical Device Co., Ltd. The logo consists of a green circular emblem with the letter 'S' inside, along with the words 'SINCERE MEDICAL' arranged around the circle. To the right of the emblem, the company name 'Sincere Medical Device Co., Ltd.' is written in a clear, sans-serif font.

[3S Safety Insulin Syringe]			Rev 0.02	05/02/15
	Part 801	CFR Part 801

7. Conclusion:

The materials, performance, and operational features of both the submitted device and the predicate device are substantially equivalent.

END

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).