The MySafety Syringe is designed as an anti-stick syringe to reduce the risk of sharps injuries and the potential for syringe re-use and is a single use, disposable and retractable safety syringe which is intended for injection of medical fluids into the body.

Device Description

The submitted device MySafety Syringe is a 1cc / ml size, sterile, single-use, disposable, non-reusable, needle-retractable, piston syringe, provided with an attached needle , which is intended for the injection of medication into a patient, while minimizing the potential for accidental injury as a result of needle-stick ( sharps injury) and preventing syringe reuse. The submitted device MySafety® Syringe works like a conventional hypodermic syringe except for its ability to retract the used needle inside the syringe barrel at the end of injection. The needle retraction mechanism is activated as the following. "After injection is completed, remove the syringe from patient's body, add pressure to the plunger by pushing the plunger further ahead with one hand till you hear a clear audible "click" sound and you see the needle fully retracted into the syringe barrel."

AI/ML Overview

The provided text describes a 510(k) summary for the "MySafety® Syringe" and demonstrates its substantial equivalence to a predicate device, rather than outlining a study with specific acceptance criteria and detailed device performance metrics in the way a clinical trial for a novel AI device might.

Based on the provided information, here's an analysis of the acceptance criteria and how the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by conformance to established standards and demonstrated "substantial equivalence" to a predicate device. The performance is not reported in quantitative metrics against specific acceptance thresholds but rather by stating that the device conforms to these standards and shares technological characteristics with the predicate.

Acceptance Criteria	Reported Device Performance
Physical Specification Standards: ISO 6009:1992, ISO 7864:1993, ISO 7886-1:1993, ISO 9626:1991	The submitted device "conforms to applicable standards" as described in a "Conformance of Standards Summary Report." This implies the device was tested and met the requirements outlined in these standards for hypodermic needles, syringes, and stainless steel tubing.
Chemical Specification Standards: Not explicitly detailed, but implied by biological and material standards.	The submitted device "conforms to applicable standards." Materials are stated to be the same as the predicate device.
Biological Specification Standards: ISO 10993-1:2009, ISO 10993-4:2002, ISO 10993-5:2009, ISO 10993-7:2008, ISO 10993-10:2010, ISO 10993-11:2006, USP 33:2010<151> (Pyrogen Test)	The submitted device "conforms to applicable standards." This indicates the device passed tests for biocompatibility, cytotoxicity, irritation, sensitization, systemic toxicity, interaction with blood, and pyrogenicity.
Packaging & Sterilization Specification Standards: ISO 11135-1:2007, ISO 11607-1:2006	The submitted device "conforms to applicable standards." This verifies that the device's sterilization process (Ethylene Oxide) and packaging ensure sterility and maintain the sterile barrier.
Risk Management Standard: ISO 14971:2007	The submitted device "conforms to applicable standards." This indicates that a risk management process was applied during the development of the device.
Labeling Standard: ISO 15223-1:2007	The submitted device "conforms to applicable standards." This confirms that the labeling uses appropriate symbols.
Intended Use Equivalence: Same as predicate device (K051800 - "IN6 SAFETY SYRINGE MODEL 3ML")	The MySafety Syringe is designed to reduce the risk of sharps injuries and syringe re-use, and is intended for injection of medical fluids, which is consistent with the predicate. The document states "The submitted device MySafety Syringe has the same intended use... as the originally cleared 510(k) Number: K051800."
Technological Characteristics Equivalence: Same as predicate device	The device shares the same spring-based retracting mechanism, one-hand activation, full needle retraction, mode of operation, and materials/components as the predicate. The document states "The submitted device MySafety Syringe has the same... technological characteristics... as the originally cleared 510(k) Number: K051800."
Safety and Effectiveness Equivalence: No new questions of safety or effectiveness compared to predicate.	The conclusion explicitly states: "The submitted device MySafety Syringe does not raise any new questions of safety or effectiveness. Thus, the submitted device MySafety Syringe is substantially equivalent to the originally cleared as K051800."

2. Sample Size Used for the Test Set and Data Provenance

This is not applicable in the context of this 510(k) summary. The submission is for a medical device (a syringe), not an AI algorithm. The performance evaluation relies on conformance to engineering and biological standards, and demonstration of substantial equivalence to a previously cleared device, rather than a clinical "test set" in the way an AI study would use. The testing described would typically involve laboratory tests on batches of devices, not clinical data from patients.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This information is relevant for AI image analysis or diagnostic studies where expert consensus establishes clinical ground truth. For a physical medical device like a syringe, "ground truth" is established through adherence to technical standards and physical/material property testing.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used in studies involving human interpretation, often clinical AI studies, to resolve discrepancies in expert opinions. This is not relevant for the type of device and submission described.

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 device. The submission describes a safety syringe.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an AI device.

7. The Type of Ground Truth Used

The "ground truth" for this medical device is established by:

Conformance to International and National Standards: These standards (e.g., ISO for biological evaluation, sterile hypodermic syringes, packaging, risk management, etc., and USP for pyrogen testing) define acceptable limits and performance characteristics.
Demonstrated Equivalence to a Predicate Device: The predicate device (K051800 - "IN6 SAFETY SYRINGE MODEL 3ML") has already been determined by the FDA to be safe and effective. The new device is shown to have the same intended use, technological characteristics, and performance, thereby leveraging the predicate's established "ground truth" of safety and effectiveness.

8. The Sample Size for the Training Set

Not applicable. This is not an AI device.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is not an AI device.

Summary of the Study Proving Acceptance Criteria:

The "study" proving the device meets its acceptance criteria is a Substantial Equivalence demonstration to a legally marketed predicate device (K051800) combined with conformance testing to relevant international and national standards.

Rationale: The manufacturer, MedicalChain International Corp., is seeking 510(k) clearance for the MySafety® Syringe by demonstrating its "substantial equivalence" to its own previously cleared device, the "IN6 SAFETY SYRINGE MODEL 3ML" (K051800).
Methodology:
- Comparison of Characteristics: The submission highlights that the MySafety® Syringe has the same intended use, technological characteristics, materials, and fundamental scientific technology as the predicate device. The only stated difference is the capacity of volume (1cc/ml vs. 3cc/ml).
- Conformance to Standards: The device underwent testing to ensure compliance with a comprehensive list of standards covering physical specifications (e.g., ISO 6009, 7864, 7886-1, 9626), biological evaluation (e.g., ISO 10993 series, USP Pyrogen Test), packaging, sterilization (e.g., ISO 11135-1, 11607-1), risk management (ISO 14971), and labeling (ISO 15223-1). These tests were conducted by a 3rd party test laboratory, TüV SüD PSB Pte Ltd.

In essence, the "study" is a regulatory submission process that demonstrates through comparative analysis and standard conformance testing that the new device is as safe and effective as a device already on the market, rather than a novel clinical trial for a new technology or AI algorithm.

Summary

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SEP - 6 2011

10. 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 8807.92

10.1.	Submitter's Name :	MedicalChain International Corp.
	Address :	No. 413, Ming-Hsouie Rd., Taipei, Taiwan
	Tel :	886-2-25322825
	Fax :	886-2-25636489
	Contact Person :	Ms. Lin Lee, Lee / President
	510 (k) Owner :	MedicalChain International Corp.

Summary Prepared Date : June 15, 2011

MySafety® 10.2. Device Name : Syringe MySafety® Syringe Trade Name : (Proprietary Name) Common Name : Safety Syringe (with attached needle )

Classification Name : Piston Syringe / Anti-Stick Syringe Classification : Class II Regulatory Number : 21 CFR 880.5860 Product Code : MEG

Predicate Device : 10.3.

" IN6 SAFETY SYRINGE MODEL 3ML ", 510(k) Number : K051800 marketed by MedicalChain International corp.

(B) MySafety Syringe

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Device Description : 10.4.

The device description of the submitted device .MySafety Syringe is as follows.

The submitted device MySafety® Syringe works like a conventional hypodermic syringe except for its ability to retract the used needle inside the syringe barrel at the end of injection. The needle retraction mechanism is activated as the following.

"After injection is completed, remove the syringe from patient's body, add pressure to the plunger by pushing the plunger further ahead with one hand till you hear a clear audible "click" sound and you see the needle fully retracted into the syringe barrel."

The submitted device MySafety Syringe is a smaller version of is MuSafety Syringe 3cc / ml which was originally cleared as " IN6 SAFETY SYRINGE MODEL 3ML ", 510(k) Number : K051800. The submitted device MySafety Syringe is comparable to the MySafety Syringe 3cc / ml; there is no significant change with regards to the intended use, the fundamental scientific technology, and the materials. Only the specification, such as capacity of volume, differs.

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10.5. Intended Use :

The submitted device MySafety Syringe is designed as an anti-stick syringe to reduce the risk of sharps injuries and the potential for syringe re-use and is a single use, disposable and retractable safety syringe which is intended for iniection of medical fluids into the body.

Technological Characteristics 10.6.

The submitted device MySafety Syringe has the same technological characteristics as the predicate device 510(k) Number : K051800 , as below.

The intended use for injecting medication into patient's body, while (1). helping to reduce the risk of sharps injuries and syringe reuse.
The spring-based retracting mechanism. (2).
The safety mechanism is activated by one hand. (3).
The used needle is fully retracted into the syringe. (4).
The mode of operation (5).
The materials of the syringe and needle. (6).
The components of the syringe including syringe barrel, plunger, piston, (7). needle, needle hub, needle protector, spring and O-Ring.

Substantial Equivalence : 10.7.

MedicalChain International Corp. makes a Substantial Equivalence claim of the submitted device .MySafety Syringe to the original cleared 510(k) Number : K051800 based on similarities in intended use, design, technological, functional and performance characteristics.

A side-by-side Substantial Equivalence Comparison Table of the submitted device MySafety Syringe with the original cleared 510(k) Number : K051800 is provided in Section 8.1.

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10.8. Conformance of Standards Summary Report :

In terms of Physical Specification, Chemical Specification, Biological Specification, Packaging & Sterilization Specification, the submitted device conforms to applicable standards as describing in a Conformance of Standards Summary Report which includes information on all standards utilized during the development of the submitted device as follows.

	Standard NumericID	Standard Title	Adaptation		SelectionofMethods		Deviations		Requirement N/A		* 3rd PartyTest Lab
			Yes	No	Yes	No	Yes	No	Yes	No	Yes	No
1	ISO 6009 : 1992	Hypodermic needles for single use -- Colorcoding for identification	V		V		V		V		V
2	ISO 7864 : 1993	Sterile hypodermic needles for single use	V		V		V		V		V
3	ISO 7886-1 : 1993	Sterile hypodermic syringes for single use	V		V		V		V		V
4	ISO 9626 : 1991	Stainless steel needle tubing formanufacture of medical devices	V		V		V		V		V
5	ISO 10993-1 : 2009	Biological evaluation of medical devices--Part 1 : Evaluation and testing	V		V		V		V		V
6	ISO 10993-4 : 2002	Biological evaluation of medical devices--Part 4 : Selection of tests for interactionwith blood	V		V		V		V		V
7	ISO 10993-5 : 2009	Biological evaluation of medical devices--Part 5 : Tests for cytotoxicity; in vitro	V		V		V		V		V
8	ISO 10993-7 : 2008	Biological evaluation of medical devices--Part 7 : Ethylene oxide sterilization	V		V		V		V		V
9	ISO 10993-10 : 2010	Biological evaluation of medical devices--Part 10 : Tests for irritation and skinsensitization	V		V		V		V		V
10	ISO 10993-11 : 2006	Biological evaluation of medical devices--Part 11 : Tests for systemic toxicity	V		V		V		V		V
11	ISO 11135-1 : 2007	Sterilization of health care products --Ethylene oxide -- Part 1: Requirements fordevelopment, validation and routine controlof a sterilization process for medical	V		V		V		V		V
12	ISO 11607-1 : 2006	Packaging for terminally sterilized medicaldevices -- Part 1: Requirements formaterials, sterile barrier systems and	V		V		V		V		V
13	ISO 14971 : 2007	Medical devices--Application of riskmanagement to medical devices	V		V		V		V		V
14	ISO 15223-1 : 2007	Medical devices--Symbols to be used withmedical device labels, labeling andinformation to be supplied	V		V		V		V		V
15	USP 33 : 2010<151>	Pyrogen Test (USP Rabbit Test)	V		V		V		V	V

Conformance of Standards Summary Report

The 30 party test laboratory used by MCI is TüV SüD PSB Pte Ltd, 1 Science Park Drive, Singapore 118221.

A Declaration of Conformity with Design Controls is provided in Attachment 5.

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10.9. Conclusion :

The submitted device MySafety Syringe has the same intended use, technological characteristics, materials, performance and indications as the originally cleared 510(k) Number : K051800 . The submitted device MySafety Syringe does not raise any new questions of safety or effectiveness. Thus, the submitted device MySafety Syringe is substantially equivalent to the originally cleared as K051800.

ا MySafety Syringe |

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The bird is positioned above the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the bird. The text is in all capital letters.

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

MedicalChain International Corporation C/O Mr. Robin Hwang Consultant ICP Consulting Corporation 1808 Seabrecze Court Thousand Oaks, California 91320

6 2011

Re: K111734

Trade/Device Name: MySafety® Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: August 8. 2011 Received: August 10, 2011

Dear Mr. Hwang:

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 vou, 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 - Mr. Hwang

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 hmited 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm] 15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Anthony D. Mura

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology. General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Statement of Indications for Use 6.

510(K) Number ( if known ):

Device Name : MySafety Syringe

Indications For Use:

Prescription Use X ___________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801 Subpart D)

AND / OR

Over-The-Counter Use (Per 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ald C. Ch 9/6/11

Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

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).