Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on a mechanical needle retraction mechanism and does not mention any AI or ML components.

Therapeutic

No
The device is described as an "anti-stick syringe" intended for the "injection of medical fluids into the body," specifically to reduce the risk of sharps injuries and prevent reuse. Its function is to safely administer medication, not to treat or diagnose a medical condition itself.

Diagnostic

No

The device is described as an anti-stick, single-use, disposable, and retractable safety syringe intended for the injection of medical fluids into the body. Its primary purpose is to deliver substances, not to diagnose conditions.

SaMD (Software as a Medical Device)

No

The device description clearly describes a physical syringe with a needle retraction mechanism, indicating it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, the MySafety Syringe is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use is for the "injection of medical fluids into the body." This is an in-vivo (within the living body) application, not an in-vitro (outside the living body) diagnostic test.
Device Description: The description details a syringe for injecting medication into a patient, focusing on safety features related to needle-stick injuries and reuse prevention. This aligns with an in-vivo medical device.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside the body to provide diagnostic information.

Therefore, the MySafety Syringe is a medical device intended for therapeutic or preventative purposes within the body, not for in-vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

MEG

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."

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Not Found

Key Metrics

Not Found

Predicate Device(s)

K051800

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

0

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

1

Device Description : 10.4.

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

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."

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.

2

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.

3

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 Numeric
ID | Standard Title of
Methods | | Deviations | t N/A | | * 3rd Party
Test Lab | |
|----|-------------------- | | | 1 | ISO 6009 : 1992 coding for identification | 2 | ISO 7864 : 1993 | 3 | ISO 7886-1 : 1993 | 4 | ISO 9626 : 1991 manufacture of medical devices | 5 | ISO 10993-1 : 2009 Part 1 : Evaluation and testing | 6 | ISO 10993-4 : 2002 Part 4 : Selection with blood | 7 | ISO 10993-5 : 2009 Part 5 : Tests for | 8 | ISO 10993-7 : 2008 Part 7 : Ethylene oxide sterilization | 9 | ISO 10993-10 : 2010 Part 10 : Tests for sensitization | 10 | ISO 10993-11 : 2006 Part 11 : Tests for systemic toxicity | 11 | ISO 11135-1 : 2007 Ethylene oxide -- development, validation of a sterilization | 12 | ISO 11607-1 : 2006 devices -- Part 1: materials, sterile barrier systems and | 13 | ISO 14971 : 2007 management to medical devices | 14 | ISO 15223-1 : 2007 medical device labels, information to be supplied | 15 | USP 33 : 2010 | | Adaptation | | Selection
| Requiremen
----|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|------------|----|----------------------------|----|------------|----|---------------------|----|-------------------------|----|
| | | Yes | No | Yes | No | Yes | No | Yes | No | Yes | No |
| Hypodermic needles for single use -- Color
| | V | | V | | V | | V | | V | |
| Sterile hypodermic needles for single use | | V | | V | | V | | V | | V | |
| Sterile hypodermic syringes for single use | | V | | V | | V | | V | | V | |
| Stainless steel needle tubing for
| | V | | V | | V | | V | | V | |
| Biological evaluation of medical devices--
| | V | | V | | V | | V | | V | |
| Biological evaluation of medical devices--
of tests for interaction
| | V | | V | | V | | V | | V | |
| Biological evaluation of medical devices--
cytotoxicity; in vitro | | V | | V | | V | | V | | V | |
| Biological evaluation of medical devices--
| | V | | V | | V | | V | | V | |
| Biological evaluation of medical devices--
irritation and skin
| | V | | V | | V | | V | | V | |
| Biological evaluation of medical devices--
| | V | | V | | V | | V | | V | |
| Sterilization of health care products --
Part 1: Requirements for
and routine control
process for medical | | V | | V | | V | | V | | V | |
| Packaging for terminally sterilized medical
Requirements for
| | V | | V | | V | | V | | V | |
| Medical devices--Application of risk
| | V | | V | | V | | V | | V | |
| Medical devices--Symbols to be used with
labeling and
| | V | | V | | V | | V | | V | |
| 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.

4

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 |

5

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.

6

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

7

Statement of Indications for Use 6.

510(K) Number ( if known ):

Device Name : MySafety Syringe

Indications For Use:

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.

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: _______________________________________________________________________________________________________________________________________________________________