The WTF Secura Syringe (with needle) is used for aspiration of fluids from vials and ampoules and a variety of fluid injections below the surface of the skin.

The WTF Secura Syringe (with needle) has a manually attached WTF Secura Retracting Needle. The WTF Secura Syringe (with needle) contains an inner mechanism used to allow the WTF Secura Retracting Needle to be retracted inside the plunger rod of the syringe when operator's thumb force released. After activation the needle is fully contained inside the syringe guarding against accidental needle sticks during normal handling and disposal of the used needle/syringe combination.

Device Description

The WTF Secura Safety Syringe (with needle) is a sterile, single use, hypodermic syringe with a 6% Luer taper tip and an integrated Sharps Injury Prevention Feature. The syringe is provided in the following syringe sizes: 1ml, 2.5ml, 3m1, 5ml, and 10ml. and needle sizes: 21-30G. All sizes will be available with a Luer Lock tip and may be packaged as a syringe only, or syringe and needle combination. The syringe assembly consists of a lubricated polypropylene barrel with a graduated scale, a isoamyl stopper, a polypropylene plunger rod and a polypropylene sharps injury prevention feature. The sharps injury prevention feature consists of needle retracting performance before or after use, allowing for secure encapsulation of the needle point. The polypropylene syringe barrel incorporates a male 6% (Luer) connector, and is connectable to a compatible female 6% (Luer) connector. The needle assembly consists of indicidual lubricated retracting stainless steel needle and individual safety syringe.

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the WTF Secura Safety Syringe (with needle):

Acceptance Criteria and Device Performance:

Property / Item	Acceptance Criteria (from text)	Reported Device Performance (from text)
Biological Properties
Sterile	Implied: No growth	Sterile growth
Pyrogen	Implied: Non-pyrogenic	Non-pyrogen
Hemolysis	Compliance with technical requirements <5%	Hemolysis ratio: 1%
Acute systemic toxicity	No acute systemic toxicity reaction	No acute systemic toxicity reaction
Chemical Properties
Readily oxidizable substance	Potassium permanganate consumption <0.5	0.1- (implies <0.5, "Meet the requirement...")
pH value	pH difference <1.0	0.04- (implies <1.0, "Meet the requirement...")
Heavy metal	Total quantity of lead, zinc, tin, and iron ≤5 µg/ml; cadmium content ≤0.1 µg/ml	0.05- (implies meeting requirement, "Meet the following requirement...")
Residual quantity of ethylene oxid	Equal to or less than 10 µg/g	Not detected- (implies meeting requirement, "Meet the requirement...")
Physical Properties
Controllable core pin	Implied: Functional/Operational	Qualified
Self-destruction performance	Implied: Functional/Operational	Qualified
Body adaptation	Implied: Functional/Operational	Qualified
Volume tolerance	Implied: Within specified limits	Qualified
Piercing force of sword	Implied: Within specified limits	Qualified
Needle Rigidity	Implied: Sufficient stiffness	Qualified
Needle Toughness	Implied: Resistant to breakage	Qualified
Needle Corrosion resistance	Implied: Resistant to corrosion	Qualified
Needle Surface	Implied: Smooth/Appropriate finish	Qualified
Needle Cleanliness inside the tube	Implied: Free from contaminants	Qualified
Retracting needle appearance	Implied: Visually acceptable	Qualified
Retracting needle Dimension	Implied: Within specified limits	Qualified
Retracting needle Upright connection	Implied: Secure and straight connection	Qualified
Retracting needle Smooth pinhole	Implied: Free from obstructions	Qualified
Retracting needle Color	Implied: Correct color	Qualified
Scale printing / Marking	Implied: Clear, accurate (includes appearance, scale length, scale volume line, zero line position, metering number, scale printing, jacket length, jacket hemming, handle interval)	Qualified (for all listed sub-items under "Appearance" and "Scale printing")
Piston	Implied: Functional/Operational	Qualified
Sliding property	Implied: Smooth movement	Qualified
Residual capacity	Implied: Within acceptable limits	Qualified
Cone cover: Separating force of sheath	Implied: Within acceptable limits	Qualified
Single packing mark	Implied: Correct and readable	Qualified
Sharps Injury Prevention Feature	One failure among 1000 devices tested is acceptable for confidence and statistical theory. (Implied acceptance of minimal failure rate)	One failure among 1000 devices tested (0.1% failure rate)

Study Details:

Sample size used for the test set and the data provenance:
- Test Set Sample Size: 1000 devices.
- Data Provenance: The study was conducted by Beijing WanTeFu Medical Apparatus Co., Ltd. in China ("simulated clinical study" according to "chapter 10 of 'Guidance for Industry and FDA Staff-- Medical Devices with Sharps Injury Prevention Features on Aug.9. 2005'"). The study appears to be prospective in nature, as it describes an evaluation based on testing new devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the number of experts or their qualifications for establishing ground truth for the "simulated clinical study." It simply states the device "had been evaluated by simulated clinical study." The nature of the evaluation (e.g., whether it involved expert assessment of each device or simply functional testing) is not detailed.
Adjudication method for the test set:
- The document does not specify any adjudication method for the test set. Given the simulated nature, it's likely a pass/fail assessment based on device functionality rather than a consensus among multiple observers.
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:
- No, an MRMC comparative effectiveness study was not done. This device is a medical apparatus (syringe), not an AI-powered diagnostic tool, so such a study would not be applicable. The document discusses comparing the device to a predicate device (BD Integra Syringe) based on general performance characteristics and ease of use, but this is not an MRMC study related to AI.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, a standalone algorithm-only performance study was not done. As mentioned, this is a physical medical device (syringe), not an algorithm or AI system. The "simulated clinical study" evaluates the mechanical sharps injury prevention feature.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the "simulated clinical study" was based on the functional success (or failure) of the sharps injury prevention feature. The acceptance criterion for this feature was "one failure among 1000 devices tested," indicating a direct measurement of the device's mechanical performance against a predefined safety standard. Other product performance tests (biological, chemical, physical) likely used laboratory-based measurements and standard testing protocols to determine compliance with specified limits.
The sample size for the training set:
- The document does not mention a training set. This is expected as the device is a physical medical apparatus, not an AI or machine learning model that requires training data.
How the ground truth for the training set was established:
- Not applicable, as there is no mention of a training set for this device.

Summary

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510(K) Summary

Date: 2013-12-11

1. Sponsor

Beijing WanTeFu Medical Apparatus Co., Ltd. Niantou Industrial Park, Machikou, Changping District, 102200, Beijing,China Tel: 8610-60750950 Fax: 8610-60750961

2. Submission Correspondent

Beijing WanTeFu Medical Apparatus Co., Ltd. Niantou Industrial Park, Machikou, Changping District, Beijing,China Tel: 8610-60750950 Fax: 8610-60750961 Email: lightsman@163.com

3. Summary of technological characteristics of proposed Device:

PRODUCT	SPECIFICATIONS	REF
Safety Syringe	1 ml	110101
	2.5 ml	110251
	3 ml	110301
	5 ml	110501
	10 ml	111001
Retracting Needle	25G 1"	212551/222551
	23G 1"	212351
	22G 1"	212251
	21G 1 1/8"	212161
	30G 1"	223051/213051
	21G 1 1/4"	212171
	22G 1 1/4"	212271
Filling Needle (Optional)	18G 1"	311812

DEC 12 2013

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Niantou Industrial Park, Machikou, Changping District, Belilng, China Tel: 8610-60750950 Fax: 8610-60750961

Trade Name: WTF Secura Safety Syringe (with Needle) ●
. Common Name: Safety syringe (with needle)
. Classification Name: Piston Syringe
. Review Panel: General Hospital
Product Code: FMF, FMF, FMI, MEG ●
. Regulation Number: 880.5860
Device Class: II .
Predicate Device Trade name: BD Integra 1ml Syringe K023752 .
Predicate Device manufacturer: BD Medical Surgical 1 Becton Drive MC226 ♥ Franklin Lakes, NJ

4. Intended use:

The WTF Secura Syringe (with needle) is used for aspiration of fluids from vials and ampoules and a variety of fluid injections below the surface of the skin.

5. Product Description:

a. Description of each component:

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Niantou Industrial Park, Machikou, Changping District, Beijing, China Tel: 8610-60750950 Fax: 8610-60750961

needle assembly consists of indicidual lubricated retracting stainless steel needle and individual safety syringe.

PRODUCT	SPECIFICATIONS	REF
Safety Syringe	1 ml	110101
	2.5 ml	110251
	3 ml	110301
	5 ml	110501
	10 ml	111001
Retracting Needle	25G 1"	212551/222551
	23G 1"	212351
	22G 1"	212251
	21G 1 1/8"	212161
	30G 1"	223051/213051
	21G 1 1/4"	212171
	22G 1 1/4"	212271
Filling Needle	18G 1"	311812

b. Main material of WTF Secura Safety Syringe (with needle) are Polypropylene pellets (PP) , Isoamyl rubber piston, retracting needle made of stainless tube, and its main package material are gumming paper and Medical composite membrane.
c. Standards applied: EN ISO 13485:2012/AC 2012, EN ISO 14971:2009, EN ISO 11135-1:2007, EN ISO 11607-1:2009, EN ISO 11607-2:2009, EN ISO 10993-1:2009, EN 556-1, EN1041:2008, EN 980:2008, ISO 9626, ISO 594-1,ISO 594-2, ISO 7886-4:2006, ISO ISO 7886-1:1993. ISO 7864:1993. WTF/JS-H-AZS7-A-01-2010

Parts	Material of thepart	Size	Standards	Component
	polypropylene	K4818K4912	1. The requirements for polyethylenespecial material for medical use inYY/T0242-2007 shall be met.2. The material meeting YY/T0242-2008standard cannot be found due toprocurement cause, and it shall bereplaced by other similar materials.Furthermore, the biological performanceof the used material shall be evaluatedaccording to the requirements of GB/T16886.1 (BS EN ISO 10993-1), so as toensure that the requirements for safety ofproduct material are met (the biologicalassessment and type inspection havebeen performed for the fabricated smallbatch of samples).	Sleeve,Outer core bar,Limit sheath,Inner core bar,Needle baseconnectorcover,Needle base,Needle baseconnector,Protectivecover,Protection cap,Luer adapters,Filling needlebase
injectionmoulding	TPEthermoplasticelastomer	A805-60R62E2000-45R92	Shore hardness: 65Elongation rate: 270Biological detection shall be performedfor the first batch of supplied material (orentrust the third party to perform thebiological detection). The haemolyticactivity shall not exceed 5%; it shall haveno acute systemic toxicity; in vitrocytotoxic response level shall be nolarger than level 1, and there shall be nosensitization response.	Stop dog
	Colorconcentrate	Green,orange,blue,black	tinctorial strength 95-105%:Chromatic aberration≤0.3	Thedifferentcolorscorrespond todifferentspecificationsneedle baseand needlebase connector

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Beijing WanTeFu Medical Apparatus Co., Ltd.
Niantou Industrial Park, Machikou, Changping District, Beijing, China
Tel: 8610-60750950 Fax: 8610-60750961

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Niantou Industrial Park, Machikou, Changping District, Beijing, China Tel: 8610-60750950 Fax: 8610-60750961

Needletube	Filling needle( bareneedle )	0.4(27G),0.5(25G),0.6(23G),0.7(22G),0.8(21G),0.9(20G)	Meet standards of ISO 8764 SterileHypodermic Needle for Single Use andISO 9626 Stainless steel needle tubingfor the manufacture of medical devices	Integratedneedle、Fillingneedle、Fillingneedle tube
spring	Stainless tube	$¢$ 0.1, $¢$0.3	tensile strength≥110kg/mm
O ring	Ø5.0×1.05Ø3.9×1.05		silicon rubberHardness 55~60

silica gel or Isoprene rubber	2.5ml;3m1; 5ml;10ml		1、Meet YY/T0243-2003 Plunger ofsterile controllable safety syringe forsingle use (with detachable needle)2、Meet WTF/JS-A-AZS3-2-06-2005	Plunger

6. Product Performance Test Summary

I. Product test report information

Property	ltem	Conclusion
	Sterile	sterile growth
	Pyrogen	Non-pyrogen
Biologicalproperty	Hemolysis	Hemolysis ratio: 1%Compliance with technicalrequirements <5%
	Acute systemictoxicity	No acute systemic toxicityreaction
Chemicalproperty	Readily oxidizablesubstance ml	0.1-Meet the requirement ofpotassium permanganateconsumption <0.5
	pH value	0.04-Meet the requirement of pHdifference <1.0
	Heavy metal u g/ml	0.05-Meet the following requirement:namely total quantity of lead, zinc, tinand iron is ≤5, cadmium content is≤0.1

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Niantou Industrial Park, Machikou, Changping District, Beijing, China Tel: 8610-60750950 Fax: 8610-60750961

		Residual quantity ofethylene oxide μ g/g	Not detected-Meet the requirement thatresidual quantity of ethylene oxide isequal to or less than 10
	Controllable core pin		Qualified
	Self-destructionperformance		Qualified
	Body adaptation		Qualified
	Volume tolerance		Qualified
	Piercing force ofsword		Qualified
		Rigidity	Qualified
	Needle	Toughness	Qualified
Physicalproperty		Corrosion resistance	Qualified
		Surface	Qualified
		Cleanliness insidethe tube	Qualified
		Appearance
		Scale length
		Scale volume line
		Zero line position
	Metering number		Qualified
	Scale printing		Qualified
	Jacket length		Qualified
	Jacket hemming		Qualified
	Handle interval		Qualified
	Piston		Qualified
	Sliding property		Qualified
	Residual capacity		Qualified
		retractingneedle	Appearance
	Dimension		Qualified
	Uprightconnection		Qualified
	Smoothpinhole		Qualified
	Color		Qualified
Conecover	Separating force ofsheath		Qualified

	Single packing mark		Qualified

III. Conclusion

Based on the test report analysis, main indexes of products meet the product standard requirements.

7 The Simulated Clinical Study Summary

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Beijing WanTeFu Medical Apparatus Co., Ltd. Niantou Industrial Park, Machikou, Changping District, Beijing, China Tel: 8610-60750950 Fax: 8610-60750961

According to the chapter 10 of "Guidance for Industry and FDA Staff-- Medical Devices with Sharps Injury Prevention Features on Aug.9. 2005". The WTF Secura Safety Syringe (with needle) had been evaluated by simulated clinical study. For this simulated test, there was only one failure among 1000 devices tested. This result is acceptable for confidence and statistical theory.

Generally, the WTF Secura Safety Syringe (with needle) which is designed and manufactured by Beijing WanTeFu Medical Apparatus Co., Ltd is easily to be handled and safe for clinical uses.

8. Indications for use:

The WTF Secura Syringe (with needle) is used for aspiration of fluids from vials and ampoules and a variety of fluid injections below the surface of the skin.

9. Substantial Equivalence Discussion Summary:

The WTF Secura Syringe (with needle) was compared to the predicate devices (BD Integra Syringe) using the followingcriteria: syringe type, intended use(s), principle of operation, specific drug use, Length, Diameter, tip type, Volume, needle length, needle gauge, needle tip configuration, nozzle type, barrel marking specs, gradations legibility, needle cover dimensions, needle cover color, lubricant composition, lubricant amount/cm2, barrel transparency, delivery accuracy, reuse durability, needle cover strength, hub/needle bond strength, Biocompatibility, Materials, Labeling, Re-use prevention feature. Performance after shipping. The testing to applied standards provides additional evidence that the WTF Secura

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Beijing WanTeFu Medical Apparatus Co., Ltd. Niantou Industrial Park, Machikou. Changping District. Beijing, China Tel: 8610-60750950 Fax: 8610-60750961

Syringe (with needle) is substantially equivalent to the predicate devices in terms of safety, efficacy and performance.

The WTF Secura Syringe (with needle) performed in a similar manner to the predicate devices(BD Integra Syringe). The WTF Secura Syringe (with needle) performed equivalently to the BD Integra Syringe with respect to the following characteristics: Overall performance:

Ease of maintaining standard injection technique .
Ability to maintain aseptic technique ●
Ability to aspirate medication from a vial 방
Ability to read the syringe scale on the barrel #
Ability to passively re-shield and transport r
Ability to easily and safely dispose of the used device in a sharps container s
Perceived safety of the device r

The differences between the WTF Secura Syringe (with needle) and the predicate devices do not raise new issues of safety or effectiveness.

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Image /page/8/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font. The text is centered horizontally in the image. The background of the image is white.

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

December 12, 2013

Beijing WanTeFu Medical Apparatus Company, Limited Mr. Raymond Sun Niantou Industrial Park, Machikou Changping District Beijing, China 102200

Re: K132120

Trade/Device Name: WTF Secura Safety Syringe (with Needle) Regulation Number: 21 CFR 880.5860 Regulation Name: Safety Syringe (with Needle) Regulatory Class: II Product Code: FMF, FMF, FMI & MEG Dated: September 5, 2013 Received: September 16, 2013

Dear Mr. Sun:

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. Sun

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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/ResourcesforYou/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/ReportalProblem/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.

Te
Cli
DA

Sincerely vours.

Tejashri Purchit-Sheth, M.D. Clinical Deputy Director DAGRID

FOR

Erin I. Keith, M.S. Acting 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K132120

.. . . . . . . .

Device Name

WTF Secura Safety Syringe (with needle)

Indications for Use (Describe)

The WTF Secura Syringe (with need for aspiration of fluids from vials and a variety of fluid injections below the surface of the skin.

The WTF Secure Syringe (with needle) has a manually attacting Needle. The WTF Secure Syringe (with needle) contains an inner mechanism used to allow the WTF Secure Retracting Needle to be plunger rod of the syringe when operator's thumb force released. After activation the needle is fully contained inside the syringe guarding against accidental needle sticks during normal handling and disposal of the used needle/syringe combination.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

	FOR FDA USE ONLY
--	------------------

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
------------------------------------------------------------------------------	--	--

	Digitally signed by Richard C.
	ChapmanDate: 2013.12.12 10:02:46 -05'00'

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

FORM FDA 3881 (8/13)

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).