Automatically Retractable Safety Syringe (with fixed needle) (5cc/ml 22×1-1/4) is a sterile, single-use, disposable and non-reusable, retractable safety syringe which is intended to provide a safe and reliable method for intramuscular and subcutaneous injection of medication into a patient.

Device Description

The Automatically Retractable Safety Syringe (with fixed needle) 5cc/ml 22×11/4 is a piston syringe. The device is intended for medical purposes and 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 the body. Automatically Retractable Safety Syringe (with fixed needle) (5cc/ml 22×11/4") works like a conventional hypodermic syringe except for its ability to retract the contaminated needle inside of the syringe immediately after patient injection. Needle retraction is activated by the syringe user. The needle retracting mechanism is activated by a spring action mechanism after injection is completed, while the exposed needle remains safety inside the empty syringe barrel for disposal.

AI/ML Overview

The provided document describes a 510(k) premarket notification for an Automatically Retractable Safety Syringe. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria for device performance in the way typically seen for diagnostic algorithms.

Therefore, the requested information elements related to specific performance metrics (e.g., sensitivity, specificity), sample sizes for test/training sets, experts for ground truth, adjudication methods, MRMC studies, and ground truth types are not applicable to this document's content.

However, I can extract the acceptance criteria and a summary of how the device meets them based on the equivalence testing performed to satisfy the 510(k) submission.

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are implied by the comparison to the predicate device and relevant industry standards. The reported device performance is that it meets these criteria, demonstrating equivalence.

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical/Physical Performance:
Delivery Accuracy (per ISO 7886-1:1993/Corrigendum 1:1995)	Conforms to ISO 7886-1:1993/Corrigendum 1:1995
Needle Cover Strength (<15N)	Meets criteria (<15N)
Hub/Needle Bond Strength (40N)	Meets criteria (40N)
Biocompatibility (per ISO 10993-1)	Conforms to ISO 10993-1
Material Composition (Equivalent to Predicate)	Materials are equivalent to predicate (Polypropylene, Isoprene rubber, Stainless steel, Silicon dioxide)
Lubricant Amount/cm² (<0.25mg/cm²)	Meets criteria (<0.25mg/cm²)
Design & Function (Equivalent to Predicate):
Retraction mechanism after injection	Activated by syringe user, contaminated needle retracts inside syringe
Single-Use, Disposable, Non-reusable	Single-use, disposable, non-reusable
Intended Use (IM and SC injection of medication)	Same as predicate in purpose and function
Safety Feature (Active, manually activated)	Active safety feature, manually activated by users
Sterilization Method (Gamma Sterilization)	Gamma Sterilization
Barrel Marking Specs (per ISO 7886-1:1993/Corrigendum 1:1995)	Conforms to ISO 7886-1:1993/Corrigendum 1:1995
Gradation Legibility (0.2ml)	0.2ml
Barrel Transparency (Clear)	Clear

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The submission focuses on demonstrating substantial equivalence through comparison of design, intended use, and similar safety and performance testing to the predicate device. Details about the specific sample sizes or data provenance for these tests are not included.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the document describes a medical device (syringe) rather than a diagnostic algorithm that requires expert-established ground truth. The "ground truth" here is compliance with established standards and performance metrics for the device itself, verified through engineering and biocompatibility testing.

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

This is not applicable for the same reasons as #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

This is not applicable as the device is a syringe, not an AI-assisted diagnostic tool.

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

This is not applicable as the device is a syringe, not a standalone algorithm.

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

The "ground truth" for this device's performance is established by international standards (e.g., ISO 7886-1:1993, ISO 10993-1) and the performance characteristics of the legally marketed predicate device (VanishPoint™ Syringe K970803). The device demonstrates "conformance" to these standards and "similarity" to the predicate.

8. The sample size for the training set

This is not applicable as the document describes a medical device, not a machine learning model requiring a training set.

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

This is not applicable for the same reasons as #8.

Summary

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K113587 page 1 of

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FEB 2 4 2012

510(k) Summary

Submitter's References
Shantou Wealy Medical Instrument Co., Ltd.North Jinhuan Road (Near of Qishan Mid-School)Shantou City, Guangdong Province, ChinaZip: 515064FDA Registration Number: 3005202235Owner/Operator Number: 9074040Tel:+86-754-88218123Fax:+86-754-82121654
Official Correspondent
IRC- Mr. Charles Mack77325 Joyce WayEcho, Oregon 97826Ph. 931-625-4938Fax: 541-376-5063Email: charliemack@irc-us.com
Summary Contents
Submitted Device Device Description Statement of Intended Use Substantial Equivalence Safety Effectiveness Conclusions

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K113587 page 2 of 8

1. Submitted Device

Trade Name	Automatically Retractable SafetySyringe (with fixed needle)5cc/ml 22×11/4
Common Name	Syringe, anti-stick
Classification Name	Piston Syringe

1.1. Predicate/Legally Marketed Device

Model	Manufacturer	K Number	Submitted Device
Anti-StickSyringe WithIntegralHypodermicNeedleVanishpointSyringe	RetractableTechnologies,Inc.	K970803	AutomaticallyRetractableSyringe(withneedle)5cc/ml 22×11/4Safety fixed

Proposed Indications 1.2.

The proposed indications for the predicate Anti-stick Vanishpoint and the submitted Automatically Retractable Syringe are the same. The design, intended use and construction are exactly the same.

Both the predicate and the submitted device are single-use, anti-stick piston type syringes. The function of the predicate and the submitted device is to provide a safe and reliable method of injecting medication into a patient. Both devices work like a simple piston syringe except for the syringe's ability to retract the contaminated needle inside of the syringe immediately after patient injection. Needle retraction is activated by the syringe user.

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2. Device Description

2.1 Description :

Automatically Retractable Safety Syringe (with fixed needle) (5cc/ml 22×11/4") works like a conventional hypodermic syringe except for its ability to retract the contaminated needle inside of the syringe immediately after patient injection. Needle retraction is activated by the syringe user. The needle retracting mechanism is activated by a spring action mechanism after injection is completed, while the exposed needle remains safety inside the empty syringe barrel for disposal.

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K113587 page 4 of 8

Image /page/3/Figure/1 description: The image shows a diagram of a syringe and a corresponding table that labels the different parts of the syringe. The diagram labels 18 different parts of the syringe with numbers ranging from 1 to 18. The table lists the name of each part, such as 'Leak-proof ring', 'Zero line', 'Capacity graduation', 'Needle', and 'Needle covers', corresponding to the numbers in the diagram.

The plunger rod, barrel, needle hub, needle protector and slider are made from polypropylene. The spring and cannula are made from Stainless steel. The piston is made from isoprene rubber and the piston O-ring is made from silicon dioxide. The components are glued together with acrylic glue. All of these components have been tested to verify biocompatibility.

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K113587 page 5 of 8

Statement of Intended Use 3.

Substantial Equivalence 4.

The submitted Automatically Retractable Safety Syringe is constructed to perform like the predicate Vanishpoint Syringe. Both devices are simple piston syringes with ability to retract the used needle into the body after use. Both devices are single use devices and constructed in the same manner. The submitted device and predicate have undergone similar safety and performance testing and the submitted device has passed these tests.

5. Differences

Please refer to the tables on the following pages for noted differences.

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Element of comparison	Company	Subject Device	Claimed SE Device
	DA510(K) Number	Shantou Wealy Medical Instrument Co.,Ltd.	Retractable Technologies, Inc.
		N/A	K970803
Device Name		Automatically Retractable Safety Syringe with Fixed Needle	VanishPoint™ Syringe
Volume		5ml	5 ml and 10ml
Needle length		1-1/4 Inch	1-1/2 Inch
Available needle gauge sizes		22G	20/21/22/25G
Intended Use		Automatically Retractable Safety Syringe (with fixed needle) (5ml/CC 22G×1 1/4") is a sterile, single-use, disposable and non-reusable, retractable safety syringe which is intended to provide a safe and reliable method for intramuscular and subcutaneous injection of medication into a patient.	The function of the VanishPoint™ Syringe is to provide a safe and reliable method of injecting medication into a patient or withdrawing blood from a patient. The VanishPoint™ Syringe works like a conventional hypodermic syringe except for its ability to retract the contaminated needle inside of the syringe immediately after patient injection. Needle retraction is activated by the syringe user. Because the contaminated needle is automatically withdrawn into the syringe barrel, The syringe user is protected from accidental needle sticks. These accidental needle sticks would occur between removing the needle from the patient and disposing of the syringe in a sharps disposable container.
Principle of operation		The needle is automatically retracted from the patient into the barrel of the syringe when the plunger is fully depressed. Automatically Retractable Safety Syringe reduces the risk of healthcare worker exposure to hazardous drugs during reconstitution, preparation, transport, and disposal.	The needle is automatically retracted from the patient into the barrel of the syringe when the plunger is fully depressed. VanishPoint™ Syringe reduces the risk of healthcare worker exposure to hazardous drugs during reconstitution, preparation, transport, and disposal.
Syringe type		Plunger, anti-stick with hypodermic needle	Plunger, anti-stick with hypodermic needle
Sites of use		Hospitals, clinics, laboratories	Hospitals, clinics, laboratories
Safety Features		Active safety feature, manually activated by users	Active safety feature, manually activated by users
Element ofcomparison	Subject Device	Claimed SE Device
Specific drug use	Conventional drugs	Conventional drugs
Needle tip configuration	Tri-Beveled Tip	Tri-Beveled Tip
Nozzle type	Needle and hub are integral to the syringe, not separable.	Needle and hub are integral to the syringe, not separable.
Barrel marking specs	Scale :conforms to ISO 7886-1:1993/ Corrigendum 1:1995	Scale :conforms to ISO 7886-1:1993/ Corrigendum 1:1995
Gradations legibility	0.2ml	0.2ml
Needle cover color	colorless	colorless
Lubricant composition	Polydimethylsiloxane (PDMS)	Polydimethylsiloxane (PDMS)
Lubricant amount/cm²	<0.25mg/cm²	<0.25mg/cm²
Barrel transparency	Clear	Clear
Delivery accuracy	conforms to ISO 7886-1:1993/ Corrigendum 1:1995	conforms to ISO 7886-1:1993/ Corrigendum 1:1995
Needle cover strength	<15N	<15N
Hub/needle bondstrength	40N	40N
Biocompatibility	Conform to ISO 10993-1	Conform to ISO 10993-1
omparisorElement of	Subject Device	Claimed SE Device
Materials	Plastic parts : PolypropylenePiston : Isoprene rubberNeedle : Stainless steel)-ring: Silicon dioxide	Plastic parts : PolypropylenePiston : Isoprene rubberNeedle : Stainless steelO-ring: Silicon dioxide
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Syringe type	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Antistick syringe------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	Antistick syringe------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Reuse	lon-reusable	Non-reusable
Sterilization	______________________________________________________________________________________________________________________________________________________________________________	Gamma Sterilizatio

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page 7 of 8

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A Production Production Comments of Comments of Comments of Comments of Comments of Comments of Comments of Comments of Comments of Comments of Comments of Comments of Commen

END

K113587 page 8 of 8

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Image /page/8/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in bold, black font. The text is horizontally oriented and appears to be a title or heading. The words are capitalized and evenly spaced.

Image /page/8/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's emblem in the center. The emblem is a stylized representation of a human figure, with three profiles overlapping each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

Public Health Service

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

Shantou Wealy Medical Instrument Company, Limited C/O Mr. Charlie Mack Principal Engineer IRC 77325 Joyce Way Echo, Oregon 97826

FEB 2 4 2012

Re: K113587

Trade/Device Name: Automatically Retractable Safety Syringe (with Fixed Needle) 5ml/CC 22G*1 1/4"

Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: November 27, 2011 Received: December 7, 2011

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.

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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, 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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Indications for Use

510(k) Number (if known):

Device Name: Automatically Retractable Safety Syringe (with Fixed Needle) 5ml/CC 22G×1 1/4"

Indications For Use:

AND/OR Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

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

IPLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of _

$\frac{l_{i} \mathbb{N}}{(\mathbb{D}i: \mathbb{C}i} for REC Feb 22, 2012

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

510(k) Number: K11358 +

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).