The Auto-Disable Sterile Safety Syringe for Single Use ,5ml, is used to inject fluids into, or withdraw fluids from the body. In addition, the retractable needle of the syringe goes into the barrel after use. It is designed to aid in the prevention of needle stick injuries.

Device Description

The Auto-Disable Sterile Safety Syringe for Single Use is used to inject fluids into, or withdraw fluids from the body. In addition, the retractable needle of the syringe goes into the barrel after use. It is designed to aid in the prevention of needle stick injuries. The retractable type of piston syringe is a plastic disposable anti-needle stick syringe made of the below components: Cap, Needle, Needle house, Hub, Barrel, Gasket, Plunger.

AI/ML Overview

This looks like a 510K submission for a medical device. I will break down the information section by section as requested.

Acceptance Criteria and Device Performance Study for Auto-Disable Sterile Safety Syringe For Single Use, 5mL (K121637)

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state numerical acceptance criteria in a table format for a specific "device performance" study that would typically involve sensitivity, specificity, accuracy, etc., for an AI/diagnostic device. Instead, the performance testing focuses on compliance with various ISO and ASTM standards relevant to the physical and biological aspects of a sterile safety syringe.

However, the "Simulated Clinical Use Study" directly addresses the safety and usability of the device's main feature. We will infer the acceptance criteria from the study design and the conclusion of substantial equivalence.

Inferred Acceptance Criteria and Reported Device Performance for Simulated Clinical Use:

Acceptance Criteria Category	Specific Criteria (Inferred from study design and intent)	Reported Device Performance
Safety Feature Reliability	Safety mechanism (retractable needle) functions as intended consistently, preventing needle stick injuries.	Performed comparably to the predicate device, Invirosnap Safety Syringe. The study aimed to assess the "reliability and usability of the safety feature."
Usability	The device can be used effectively and safely by healthcare professionals (nurses). The user experience is comparable to predicate device.	Nurses reported their experience with the device; implicit acceptance if similar to predicate.
Mechanical Integrity	Device does not fail or malfunction during simulated use.	No reported failures or malfunctions that would indicate non-substantial equivalence to the predicate.
General Functionality	Injecting/withdrawing fluids is effective, and the retraction mechanism activates as designed.	No issues reported, implying proper functionality for its intended use.

Other Performance Testing (Compliance with Standards):

The device underwent and passed a series of standard tests for biological evaluation, sterilization, packaging, and general syringe functionality to demonstrate substantial equivalence to the predicate device. These are not performance metrics in the sense of sensitivity/specificity but rather compliance with established safety and quality standards.

No	Standard/Description	Reported Performance
1	ISO10993-1:2009 (Biological evaluation)	Passed
2	ISO10993-5:2009 (In Vitro Cytotoxicity)	Passed
3	ISO 10993-10:2010 (Irritation and Delayed-Type Hypersensitivity)	Passed
4	ISO10993-11:2006 (Systemic toxicity - Acute)	Passed
5	ISO7886-1:1993/Corrigendum 1:1995 (Syringes for manual use)	Passed
6	ISO 7864 Third edition 1993-05-15 (Sterile hypodermic needles)	Passed
7	AAMI/ANSI/ISO 10993-7:2008 (Ethylene Oxide Sterilization Residuals)	Passed
8	AAMI/ANSI/ISO11607-1:2006/(R)2010 (Packaging)	Passed (supports 3 years shelf life)
9	ISO 11737-1:2006 (Microorganism population)	Passed
10	ISO 11737-2: 2009 (Sterility tests)	Passed
11	ISO/AAMI/ANSI11135-1 :2007 (EO Sterilization validation)	Passed (all predetermined parameters met)
12	ASTM F 1980-07 (Accelerated Aging Test)	Passed (supports 3 years shelf life)

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

Sample Size for Simulated Clinical Use:
- Test Device (Auto-Disable Syringe): 500 samples
- Predicate Device (Invirosnap Safety Syringe): 100 samples
Data Provenance: The study was a "simulated clinical use study" conducted by Sunwell Biotech Co., Ltd. The document does not explicitly state the country of origin for the data or if it was retrospective or prospective. However, "simulated clinical use" implies a prospective collection of data in a controlled environment, likely in the country of the submitting company (China) or a contracted facility.

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

Number of Experts: 10 nurses.
Qualifications of Experts: They are identified as "nurses," implying healthcare professionals with practical experience in using syringes for injections and withdrawals. Specific years of experience or specialization are not provided.

4. Adjudication Method for the Test Set

The document states that the 10 nurses "reported their experience with each sample." This suggests a direct user feedback or observation method rather than a formal adjudication process where multiple experts collectively establish a single ground truth for each case. Given the nature of a safety syringe (does it retract or not, is it easy to use), direct user experience reports serve as the primary data. There is no mention of a 2+1, 3+1, or similar adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted in the context of an AI/diagnostic device improving human reader performance. This device is a physical medical instrument (syringe), not a diagnostic algorithm. The "simulated clinical use study" involved human users (nurses) testing the device, but it was not designed to measure an effect size of how much human readers improve with AI assistance.

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

No, this question is not applicable. The device is a physical auto-disable safety syringe, not an algorithm or AI system. Therefore, there is no "standalone" algorithm performance to evaluate.

7. The Type of Ground Truth Used

For the simulated clinical use study, the "ground truth" was based on user experience and observation of functional performance by the participating nurses, guided by the objective to assess the "reliability and usability of the safety feature." The success or failure of the needle retraction, ease of use, and overall experience reported by the nurses effectively constitute the ground truth for this type of device performance evaluation.

8. The Sample Size for the Training Set

This device is a physical safety syringe, not an AI/ML algorithm that requires a "training set" of data. Therefore, the concept of a training set sample size is not applicable to this submission.

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

As the concept of a training set is not applicable to this physical device, there is no information on how ground truth for a training set was established.

Summary

{0}------------------------------------------------

K121637

510(k) Summary

OCT 25 2012

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

Date: June 4, 2012

Company and Correspondent making the submission:

Name - Sunwell Biotech Co., Ltd.

Address - No.9,Yongxing Road, Gangzha Economic Development Zone, Nantong City, Jiangsu, China 226002

Telephone - 86-513-85308888

Fax - 86-513-85308899

Contact - Mr. Charlie Mack

Email - charliemack@irc-us.com

Device :

Trade/proprietary name: Auto-Disable Sterile Safety Syringe For Single Use, 5mL

Common Name

: Antistick Syringe

Classification Name : Piston, Syringe

Predicate Device:

Model	Manufacturer	K Number	Submitted Device
InvirosnapSafetySyringe, 1ml2ml 3ml 5ml10ml and20ml	Inviro MedicalDevices, Inc.	K092430	Auto-Disable SterileSafety Syringe forSingle Use, 5mL

Classifications Names & Citations : 21CFR 880.5860, MEG, Anti-Stick Syringe, Class II

{1}------------------------------------------------

Description :

General

The retractable type of piston syringe is a plastic disposable anti-needle stick syringe made of the below components:

Cap - Covers the needle until the syringe is to be used
Needle - The needle penetrates the patient's skin to inject/withdraw fluid from the body
Needle house - a plastic part, as a assembly part with needle to fasten together with epoxy glues
Hub - a plastic part for minimizes the risk of leakage around the needle assembly
Barrel - The barrel has a scale showing the capacity of the syringe , in addition ,the top of the barrel has a airproof ring lock fitting for minimize risk of leakage around the Hub
Gasket - A TPE (Thermoplastic Elastomer) molding part. The gasket is to be assembled with plunger for bring plus/minus pressure within barrel when the plunger to be fully depressed/retracted
Plunger - Once the plunger is fully depressed, it engages the needle assembly, as the plunger is retracted ,the needle assembly is retracted into the barrel, once the plunger is fully retracted and locked in place, the plunger is snapped off leaving the needle in the barrel of the syringe

Indications For Use

{2}------------------------------------------------

Sterilization:

Sunwell Biotech Co., Ltd., has successfully performed the EO validation according to ISO 11135-1:2007 for Auto-Disable Sterile Safety Syringe for Single Use. All predetermined parameters have been met.

Biocompatibility:

The biocompatibility study has been conducted for Auto-Disable Sterile Safety Syringe for Single Use 5ml according to the below applicable standards:

In Vitro Cytotoxicity (ISO 10993-5:2009) Delayed Contact Sensitization Study in the Guinea Pig (ISO10993-10:2010) Intracutaneous Test (ISO10993-10:2010) Systemic Toxicity (Acute) (ISO10993-11:2006) Hemolysis Test (ISO 10993-4-2002/Amd. 1:2006) Complement Activity Test (ISO 10993-4-2002/Amd. 1:2006) Thrombosis Test (ISO 10993-4-2002/Amd. 1:2006)

Package and Shelf Life:

Testing was performed to demonstrate package and shelf life verification. The study shows that the subject sterilization package complies with the applicable standards and support the 3 years shelf life claim. The tests noted below were performed:

Accelerated Aging of Sterile Barrier Systems (ASTM F1980-07) Sterilization of medical devices - Microbiological methods (AAMI/ANSI/ISO 11737-2:2009 - Part 2)

Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission (ASTM D3078-02)

Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration (ASTM F1929-98)

Test Method for Seal Strength of Flexible Barrier Materials (ASTM F88/F88M-09) for terminally sterilized medical devices - Part 1: (AAMI/ANSI/ISO 11607-1:2006/) Sterile hypodermic syringes for single use - Part 1: (ISO 7886-1:1993) Sterile hypodermic needles for single use (ISO 7864 Third edition 1993-05-15) Stainless steel needle tubing for the manufacture of medical devices (ISO 9626 First edition 1991-09-01, AMENDMENT 1 2001-06-01)

{3}------------------------------------------------

Simulated Clinical Use Study

Sunwell Biotech Co., Ltd conducted simulated clinical use study of Auto-Disable Sterile Safety Syringe for Single Use, 5ml, in accordance with the FDA Guidance for industry and FDA Staff, Medical Devices with Sharps Injury Prevention Features, August 9, 2005. The objective was to assess the reliability and usability of the safety feature of that device. Based on the simulated clinical use test recommended in that document, 10 nurses were recruited. They tested a total of 500 Auto-Disable Sterile Safety Syringe for Single Use and 100 samples of a similar products, the Invirosnap Safety Syringe( Which is already marketed in the United States with K092430), and reported their experience with each sample. The safety mechanisms and the user actions of the two devices are similar. Samples of the both syringes were provided by Sunwell Biotech Co., Ltd.

Product Picture

Image /page/3/Picture/3 description: The image shows a syringe with a needle. The syringe is made of clear plastic and has a black plunger. The syringe is marked with measurements from 1 to 5 ml. The brand name "Dr. Needl" is printed on the side of the syringe.

Comparison with predicate device :- Please see the next page

{4}------------------------------------------------

SE Table

Element of comparison	Subject Device	Claimed SE Device
Company	Sunwell Biotech Co., Ltd.	Inviro Medical Devices, Inc.
FDA510(K) Number	N/A	K092430
Device Name	Auto-Disable Sterile Safety Syringe for Single Use	Invirosnap Safety Syringe
Model Number	5ml	1ml 2ml 3ml 5ml 10ml and 20ml
Intended Use	The Auto-Disable Sterile Safety Syringe for Single Useis used to inject fluids into, or withdraw fluids from thebody. In addition, the retractable needle of the syringegoes into the barrel after use. It is designed toaid in the prevention of needle stick injuries	The InviroSnap Safety Syringe is used to inject fluids into, orwithdraw fluids from, the body. In addition, the InviroSnapSafety Syringe is designed to aid in the prevention of needlestick injuries.
Principle of operation	Identical	After use, the health care professional fully depresses theplunger to engage the luer assembly. Once the luerassembly is engaged, pulling back the plunger causes theAdapter and the attached needle to be withdrawn into thesafety of the barrel. In this position against the flange, lateralpressure on the plunger results in a controlled fracture ofthe plunger. Both the syringe and plunger are discarded in asharps container.
Safety feature	Identical	Manually retractable safety syringe with permanent disable
Specific drug use	Identical	Conventional drugs
Sterilization	Identical	Sterilized by ethylene oxide gas
Needle length	Identical	1 1/4 Inch
Needle gauge	22G	21/22/23G
Needle tip configuration	Identical	Tri-Beveled Tip
Wall type	Identical	Regular wall
Nozzle type	Identical	Needle and hub are integral to the syringe, not separable.
Barrel marking specs	identical	conforms to ISO 7886-1:1993/ Corrigendum 1:1995
Gradations legibility	identical	0.2ml
Needle cover color	identical	clarity
Lubricant composition	identical	Polydimethylsiloxane oil (PDMS)
Lubricant amount/cm²	Identical	<0.25mg/cm²
Barrel transparency	Identical	transparency
Delivery accuracy	Identical	conforms to ISO 7886-1-1993/Corrigendum 1:1995

২

21 - 21 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 21 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 -

. .

{5}------------------------------------------------

{6}------------------------------------------------

Performance Testing:

Biological, sterility and performance testing have been ac complished according to the table below to demonstrate this product is substantially equivalent to the predicate device. The submitted device passed all of these tests.

No	Serial Number/version	Standard and description
1	ISO10993-1:2009	Biological evaluation of medical devices
2	ISO10993-5:2009	Biological Evaluation of Medical Devices- Part 5 Tests for In Vitro Cytotoxicity.
3	ISO 10993-10:2010	Biological Evaluation of Medical Devices- Part 10: Tests for Irritation andDelayed-Type Hypersensitivity
4	ISO10993-11:2006	Test for systemic toxicity (Acute)
5	ISO7886-1:1993/Corrigendum 1:1995	Sterile hypodermic syringes for singleuse - Part 1: Syringes for manual use
6	ISO 7864 Third edition 1993-05-15	Sterile hypodermic needles for singleuse.
7	AAMI/ANSI/ISO 10993-7:2008	Biological Evaluation of Medical Devices -Part 7: Ethylene Oxide SterilizationResiduals
8	AAMI/ANSI/ISO11607-1:2006/(R)2010	Packaging for terminally sterilized medicaldevices - Part 1: Requirements formaterials, sterile barrier systems andpackaging systems
9	ISO 11737-1:2006	Sterilization of medical devices-Microbiological methods-Part 1:Determination of the population ofmicroorganisms on
10	ISO 11737-2: 2009	Sterilization of medical devicesMicrobiological methods -Part 2: Tests ofsterility performed in the definition,validation
11	ISO/AAMI/ANSI11135-1 :2007	Sterilization of health care products -Ethylene Oxide - Part 1: Requirementsfor development, validation and routinecontrolof a sterilization process for medicaldevices
12	ASTM F 1980-07	Accelerated Aging Test

{7}------------------------------------------------

Conclusions:

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification The Sunwell Biotech Co., Ltd. Auto-Disable Sterile Safety Syringe for Single Use, 5mL is substantially equivalent to the predicate device as described herein.

END

{8}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol.

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

Sunwell Biotech Company, Limited
C/O IRC
Mr. Charlie Mack
Principal Engineer
77325 Joyce Way
Echo, Oregon 97826

Re: K121637

Trade/Device Name: Auto-Disable Sterile Safety Syringe For Single Use, 5ml Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: October 15, 2012 Received: October 19, 2012

Dear Mr. Mack:

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.

OCT 25 2012

{9}------------------------------------------------

Page 2- Mr. Mack

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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.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. Watson

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

{10}------------------------------------------------

Indications for Use

510(k) Number (if known):

Device Name: Auto-Disable Sterile Safety Syringe For Single Use, 5ml

Indications for Use:

Prescription Use _ × 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 PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

hijd Mhi for RZC at 22,2012

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

510(k) Number: K12)637

Page 1 of

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).