The Disposable Syringe with permanently attached needle is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin.

The Safety Syringe with permanently attached needle is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin. The Safety sheath of Syringe is designed to aid in the prevention of needle stick injuries and reduce the potential of syringe reuse.

Device Description

The proposed Syringes include Disposable Syringe with permanently attached needle and Safety Syringe with permanently attached needle. The Disposable Syringe with permanently attached needle have one kind of product configuration (TKSPN01) and the Safety Syringe with permanently attached needle has two kinds of product configurations (TKSSPN01 and TKSSPN02).

The proposed syringes are available in different combination of syringe volumes and/or needle sizes. The syringe is sterilized by Ethylene Oxide Gas to achieve a SAL of 10f . The proposed device has a shelf life of three years.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for medical devices, specifically Disposable Syringes with permanently attached needles and Safety Syringes with permanently attached needles. This document focuses on demonstrating substantial equivalence to predicate devices, not on proving overall safety and effectiveness through clinical trials or the type of performance studies typically associated with AI/ML-driven devices.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device (e.g., ground truth
establishment, adjudication methods, MRMC studies, effect sizes of human reader improvement with AI) are not applicable to this submission.

This document describes the safety and performance testing for a physical medical device (syringes) based on established international and national standards and biocompatibility testing. The "acceptance criteria" here are compliance with these recognized standards and demonstrated equivalence to existing predicate devices.

Here's an attempt to extract the relevant information based on the provided document, addressing the requested points where applicable and noting when information is not present or not relevant to this type of submission:

Device: Disposable Syringe with permanently attached needle; Safety Syringe with permanently attached needle

Regulatory Pathway: 510(k) Premarket Notification (demonstrates substantial equivalence to predicate devices)

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for traditional medical devices like syringes are generally defined by compliance with recognized consensus standards and successful completion of specific performance and safety tests. The document doesn't present a "performance table" in the typical sense of AI/ML device metrics (e.g., sensitivity, specificity). Instead, it lists the standards the devices adhere to and states that testing was performed and found acceptable.

Acceptance Criteria (Standards/Tests)	Reported Device Performance (Compliance/Results)
Biocompatibility Testing (ISO 10993-1:2018 for "Blood path indirect, Limited contact (< 24 hours)")	Evaluated in accordance with ISO 10993-1:2018. The following tests were performed and presumably passed (results implied by successful submission):
- Cytotoxicity (ISO 10993-5: 2009)	Performed
- Skin sensitization (ISO 10993-10: 2010)	Performed
- Hemolysis (ISO 10993-4: 2017)	Performed
- Intracutaneous reactivity (ISO 10993-10: 2010)	Performed
- Acute systemic toxicity (ISO 10993-11: 2017)	Performed
- Pyrogenicity (ISO 10993-11: 2017)	Performed
- Particulate matter (USP <788>)	Performed
Sterilization and Shelf Life Testing
- EO/ECH residue (ISO 10993-7:2008)	Testing performed, validation to ISO 11135, routine control parameters determined.
- Bacterial Endotoxin (USP42-NF37 <85>)	Testing performed, limit adhered to.
- Shelf life (3 years) based on aging test (ASTM F1980-16)	Determined based on stability studies, all packaging deemed acceptable for protection and sterility maintenance after environmental conditioning and simulated transportation.
- Package integrity (ASTM F88/F88M-15, ASTM F 1929-2015, ASTM F 1886/ F 1886M-16)	Testing performed, all packaging deemed acceptable.
Performance Testing (Adherence to relevant ISO standards)
- ISO 7886-1: 2017 (Syringes for manual use)	Testing performed according to the standard.
- ISO 7864: 2016 (Stainless Steel Needle Tubing)	Testing performed according to the standard.
- ISO 9626:2016 (Stainless Steel Needle Tubing)	Testing performed according to the standard.
- ISO 6009:2016 (Hypodermic needles - Colour coding)	Testing performed according to the standard.
- ISO 23908:2011 (Sharps injury protection)	Testing performed according to the standard.
Substantial Equivalence	Demonstrated through comparison to predicate devices, addressing differences, and showing continued safety and effectiveness through non-clinical testing.

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

Sample Size: Not explicitly stated for each specific test. For medical devices like syringes, testing often involves a defined number of units per batch or per test series to meet statistical requirements of the standards (e.g., 30 samples for a particular mechanical test). The document confirms that various tests were "performed" according to the relevant standards, which implies the use of appropriate sample sizes as defined by those standards.
Data Provenance: The tests are non-clinical (laboratory/bench testing, material analysis, sterility validation). The manufacturer is Anhui Tiankang Medical Technology Co., Ltd. in Tianchang City, Anhui, China. The data would originate from their internal testing or qualified third-party labs, but the specific country of origin for each test data set is not detailed beyond the manufacturer's location. The studies are by nature prospective in the sense that they are conducted specifically to support this regulatory submission, but they are not clinical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. This is a physical medical device. "Ground truth" in the context of expert consensus and adjudication is typically relevant to AI/ML devices where the "truth" for image interpretation or diagnosis needs to be established by human experts. For syringes, the "truth" is determined by objective measurements, chemical analyses, and adherence to physical performance specifications outlined in the referenced ISO/ASTM standards. The "experts" involved would be qualified laboratory technicians, engineers, and quality assurance personnel performing the tests according to the standard operating procedures.

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

Not Applicable. See point 3. This concept is for AI/ML device performance evaluation methods, not for physical medical device testing.

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 device is a manual syringe, not an AI-assisted diagnostic tool. No human reader involvement or AI assistance is mentioned or relevant.

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

Not Applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" for this device's performance is established by objective measurements against defined specifications in international and national consensus standards (e.g., ISO, ASTM, USP). This includes:
- Physical and Mechanical Performance: e.g., plunger force, needle pull-out force, fluid leakage, needle sharpness, volume accuracy based on ISO 7886-1, ISO 7864, ISO 9626.
- Material Properties and Biocompatibility: Chemical analysis, in vitro and in vivo biological tests (Cytotoxicity, Hemolysis, Skin Sensitization, etc.) as per ISO 10993 series for specific material components.
- Sterility Assurance: Sterility testing, bacterial endotoxin testing, and ethylene oxide residue testing according to ISO 11135 and USP standards.
- Shelf-Life Stability: Accelerated aging and real-time stability studies confirming physical properties, sterility, and package integrity over time per ASTM standards.

8. The sample size for the training set

Not Applicable. This is a traditional medical device, not an AI/ML model that requires training data.

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

Not Applicable. See point 8.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

Anhui Tiankang Medical Technology Co., Ltd. Zhang Yong Management No.228,Weiyi Road, Economic Development Zone,Tianchang City, Anhui. China. Tianchang, Anhui 239300 China

Re: K220204

Trade/Device Name: Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF, MEG Dated: June 10, 2022 Received: June 21, 2022

Dear Zhang Yong:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For CAPT Alan Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K220204

Device Name

Disposable Syringe with permanently attached needle; Safety Syringe with permanently attached needle

Indications for Use (Describe)

The Safety Syringe with permanently attached needle is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the skin. The Safety sheath of Syringe is designed to aid in the prevention of needle stick injuries and reduce the potential of syringe reuse.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CER 801 Subpart D)	☐ Over-The-Counter Use (21 CER 801 Subpart C)

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510(k) Summary

K220204

I Submitter

Device submitter: Anhui Tiankang Medical Technology Co., Ltd.

No.228, Weiyi Road, Economic Development Zone, Tianchang City, Anhui, China.

Establishment Registration Number 3007590959

Contact person: Name: Zhang Yong Title: Management representative Phone: +86-13705505106 Fax: +86-550-7309158 E-mail: zy@tkmedical.com

Preparation Date: July 13, 2022

II Device

Trade Name of Device: Disposable Syringe with permanently attached needle Safety Syringe with permanently attached needle Common Name: Piston syringe Regulation Number: 21CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: II Product code: FMF, MEG Review Panel: General Hospital

III Predicate Devices

Trade name:	1ml Luer Slip or Luer Lock SyringeSyringe with permanently attached needle (used as Predicate Device)Safety Syringe with permanently attached needle (used as Predicate Device)
Common name:	Piston Syringe and antistick syringe
Classification:	Class II, 21 CFR 880.5860
Product Code:	FMF, MEG

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Premarket Notification: K192551 Manufacturer: Jiangsu Caina Medical Co., Ltd.

IV Device description

Model	SyringeVolume	Needle Length	NeedleGauge	Walltype	NeedleBevel
Disposable Syringewith permanentlyattached needle-TKSPN01	0.5ml; 1ml	3/8" (10mm);1/2" (13mm);5/8" (16mm);	23G	TW	LB
		3/4" (20mm);	24G	RW	LB
		7/8" (22mm);1" (25mm);	25G	RW	LB
		3/8" (10mm);1/2" (13mm);5/8" (16mm);3/4" (20mm);	26G	RW	LB
		3/8" (10mm);1/2" (13mm);5/8" (16mm);	27G	RW	LB
		3/8" (10mm);1/2" (13mm);5/8" (16mm);	28G	RW	LB
		3/10" (8mm);	29G	RW	LB
		3/8" (10mm);1/2" (13mm);	30G	RW	LB
		5/8" (16mm);	31G	RW	LB
Safety Syringe withpermanently attachedneedle -TKSSPN01	0.3ml	3/8" (10mm);1/2" (13mm);5/8" (16mm);	27G	RW	LB
		3/8" (10mm);1/2" (13mm);5/8" (16mm);	28G	RW	LB
		3/10" (8mm);	29G	RW	LB
		3/8" (10mm);1/2" (13mm);	30G	RW	LB
		5/8" (16mm);	31G	RW	LB

Table 1 specification of proposed device

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	0.5ml; 1ml	3/8" (10mm);1/2" (13mm);5/8" (16mm);	25G	RW	LB
			26G	RW	LB
			27G	RW	LB
			28G	RW	LB
		3/10" (8mm);3/8" (10mm);1/2" (13mm);5/8" (16mm);	29G	RW	LB
			30G	RW	LB
			31G	RW	LB
Safety Syringe withpermanently attachedneedle-TKSSPN02	1ml	3/4" (20mm);	21G	TW	LB
		7/8" (22mm);	22G	TW	LB
		1" (25mm);	23G	TW	LB
		1 1/4" (32mm);	24G	RW	LB
		1 1/2" (38mm);	25G	RW	LB
		3/4" (20mm)	26G	RW	LB
		3/4" (20mm)	27G	RW	LB

V Indications for Use

Disposable Syringe with permanently attached needle

Safety Syringe with permanently attached needle

VI Comparison of technological characteristics with the predicate devices

The Disposable Syringe with permanently attached needle and Safety Syringe with permanently attached needle have the same intended use, technology, design and performance specifications are either identical or substantially equivalent to existing legally marketed predicate devices. The main differences between subject devices and predicate devices are the specification of syringe volume, needle gauge and needle length. The differences between the subject device and the predicate do not affect the safety and effectiveness of the subject device because evaluation is conducted using industry consensus standards and based on the performance requirements of the device. Therefore, these differences do not impact its safety and effectiveness.

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Devicefeature	Subject Device	Predicate Device K192551	Comment
Product	Disposable Syringe withpermanently attachedneedle	Syringe with permanentlyattached needle	/
Syringe type	Piston syringe	Piston syringe	Same
Indicationsfor use	The Disposable Syringewith permanently attachedneedle is intended for useby health care professionalsfor general purposeaspiration of fluid from vials,ampoules and liquidinjection below the surfaceof the skin.	1ml Luer Slip or Luer LockSyringe1ml Luer Slip or Luer LockSyringe is intended to beconnected with the luer slipor luer lock needle andintended for use by healthcare professionals forgeneral purpose aspirationof fluid from vials, ampoulesand liquid injection belowthe surface of the skin.Syringe with permanentlyattached needleThe Syringe withpermanently attachedneedle is intended for useby health care professionalsfor general purposeaspiration of fluid from vials,ampoules and liquidinjection below the surfaceof the skin.Safety Syringe withpermanently attachedneedleThe Safety Syringe withpermanently attached	Similar,Comment 1
Devicefeature	Subject Device	Predicate Device K192551	Comment
		needle is intended for useby health care professionalsfor general purposeaspiration of fluid from vials,ampoules and liquidinjection below the surfaceof the skin. The Safetysheath of Syringe isdesigned to aid in theprevention of needle stickinjuries and reduce thepotential or syringe reuse.
Product code	FMF	FMF	Same
Regulationnumber	21 CFR 880.5860	21 CFR 880.5860	Same
Class	II	II	Same
Principle ofoperation	For Manual Use Only, ForSingle Use Only	For Manual Use Only, ForSingle Use Only	Same
ConnectorType	Attached needle	Attached needle	Same
Needlegauge	23G, 24G, 25G, 26G, 27G,28G, 29G, 30G, 31G	21G, 23G, 25G, 26G, 27G,28G, 29G, 30G, 31G	DifferentComment 2
NeedleLength	8mm, 10mm, 13mm, 16mm,20mm, 22mm, 25mm	8mm, 10mm, 13mm, 16mm,20mm, 25mm
Needle walltype	RW, TW	RW, TW
Needle bevel	11°±2°	11°±2°, 15°±2°
SyringeVolume	0.5ml, 1ml	0.3ml, 0.5ml, 1ml
Devicefeature	Subject Device	Predicate Device K192551	Comment
Mainstructure andmaterials	(1) Needle cap (PP)(2) Needle (Stainless Steel304)(3) Piston (Polyisoprene)(4) Plunger (PP)(5) Barrel (PP)	Syringe with permanentlyattached needle-type A(1) needle cap (PP or PE)(2) needle (Stainless Steel304)(3) piston (Polyisoprene)(4) plunger (PP)(5) barrel (PP)(6) end cap (PP or PE)Syringe with permanentlyattached needle-type B(1) needle cap (PP or PE)(2) needle (Stainless Steel304)(3) piston (Polyisoprene)(4) plunger (PP or ABS)(5) barrel (PP)	DifferentComment 3
Single Use	Yes	Yes	Same
Sterilization	EO Sterilization	EO Sterilization	Same
SAL	10-6	10-6	Same
Biocompatibility	Contact level: blood path,indirect, limited contact (<24hours).Conforms to therequirement of ISO 10993series Standards	Contact level: blood path,indirect, limited contact (<24hours).Conforms to therequirement of ISO 10993series Standards	Same
Labeling	Complied with 21 CFR part801	Complied with 21 CFR part801	Same
Devicefeature	Subject DeviceK220204	Predicate DeviceK192551	Comment
Product	Safety Syringe withpermanently attachedneedle	Safety Syringe withpermanently attachedneedle	/
Syringe type	Piston syringe	Piston syringe	Same
Indicationsfor use	The Safety Syringe withpermanently attachedneedle is intended for useby health care professionalsfor general purposeaspiration of fluid from vials,ampoules and liquidinjection below the surfaceof the skin. The Safetysheath of Syringe isdesigned to aid in the	1ml Luer Slip or Luer LockSyringe1ml Luer Slip or Luer LockSyringe is intended to beconnected with the luer slipor luer lock needle andintended for use by healthcare professionals forgeneral purpose aspirationof fluid from vials, ampoulesand liquid injection below	Similar,Comment 1
Devicefeature	Subject DeviceK220204	Predicate DeviceK192551	Comment
	prevention of needle stickinjuries and reduce thepotential or syringe reuse.	the surface of the skin.Syringe with permanentlyattached needleThe Syringe withpermanently attachedneedle is intended for useby health care professionalsfor general purposeaspiration of fluid from vials,ampoules and liquidinjection below the surfaceof the skin.Safety Syringe withpermanently attachedneedleThe Safety Syringe withpermanently attachedneedle is intended for useby health care professionalsfor general purposeaspiration of fluid from vials,ampoules and liquidinjection below the surfaceof the skin. The Safetysheath of Syringe isdesigned to aid in theprevention of needle stickinjuries and reduce thepotential or syringe reuse.
Product code	MEG	MEG	Same
Regulationnumber	21 CFR 880.5860	21 CFR 880.5860	Same
Class	II	II	Same
Principleof	For Manual Use Only, For	For Manual Use Only, For	Same
Devicefeature	Subject DeviceK220204	Predicate DeviceK192551	Comment
operation	Single Use Only	Single Use Only
ConnectorType	Attached needle	Attached needle	Same
Needlegauge	21G, 22G, 23G, 24G, 25G,26G, 27G, 28G, 29G, 30G,31G	21G, 23G, 25G, 26G, 27G,28G, 29G, 30G, 31G	DifferentComment 4
NeedleLength	8mm, 10mm, 13mm, 16mm,20mm, 22mm, 25mm,32mm, 38mm	8mm, 10mm, 13mm, 16mm,20mm, 25mm
Needle walltype	RW, TW	RW, TW
Needle bevel	$11°±2°$	$11°±2°, 15°±2°$
SyringeVolume	0.3ml, 0.5ml, 1ml	0.3ml, 0.5ml, 1ml	Same
Mainstructure andmaterials	(1) Protective cap (PP)(2) Needle (Stainless Steel304)(3) Safety mechanism-Connector base (PC)(4) Piston (Polyisoprene)(5) Safety mechanism-Sliding sleeve (PP)(6) Plunger (PP)(7) Barrel (PP)	(1) needle cap (PP or PE)(2) needle (Stainless Steel304)(3) safety mechanism (PC)(4) piston (Polyisoprene)(5) safety mechanism (PP)(6) plunger (PP)(7) barrel (PP)	Same
Performancespecifications	Complies with ISO 7886-1;ISO 9626 and ISO 7864	Complies with ISO 7886-1;ISO 9626 and ISO 7864	Same
Single Use	Yes	Yes	Same
Sterilization	EO Sterilization	EO Sterilization	Same
SAL	10-6	10-6	Same
Biocompatibility	Contact level: blood path,indirect, limited contact (<24hours).	Contact level: blood path,indirect, limited contact (<24hours).	Same
	Conforms to therequirement of ISO 10993series Standards	Conforms to therequirement of ISO 10993series Standards
Labeling	Complied with 21 CFR part801	Complied with 21 CFR part801	Same

Table 6-1 Substantial equivalence discussion for Disposable Syringe with permanently attached needle

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Comment 1

The Indications for use of predicated device include the full indication for Use of three products. The 1ml Luer Slip or Luer Lock Syringe does not apply to the proposed device. Compared between Disposable Syringe with permanently attached needle and predicate device (Syringe with permanently attached needle), the IFU is same. And compared between Safety Syringe with permanently attached needle and predicate device (Safety Syringe with permanently attached needle), the IFU is also same. It does not change the intended use.

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Comment 2

The needle bevel of subject device (11°±2°) is smaller than the predicate device's bevel range of 11°±2° and 15°±2°. The subject device's 0.5ml and 1ml syringe volume is smaller than the predicated device's syringe volume range of 0.3ml and 1ml. And the needle gauge and length of subject devices are similar to the predicate device, the difference is just in dimension. Different specification will be selected by physician per patient's condition. This difference does not affect its intended use. In addition, differences were addressed through ISO 7886-1, ISO 7864 and ISO 9626. Therefore, the differences on syringe volume, needle bevel, needle gauge and length do not raise different question of safety and effectiveness.

Comment 3

The configuration of subject device is same as type B of predicate device, and compared with type A, the difference is that the subject device does not have an end cap, however, it has a needle protective cap that protects the needle. This difference does not raise new questions about safety and effectiveness.

The materials of subject device are similar to the predicated device. Biocompatibility testing is performed with the proposed device. Therefore, the differences on configuration and materials do not raise new questions of safety and effectiveness.

Table 6-2 Substantial equivalence discussion for Safety Syringe with permanently attached needle

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Comment 4

The needle bevel of subject device (11°±2°) is smaller than the predicate device's bevel range of 11°±2° and 15°±2°. And the needle gauge and length of subject devices are similar to the predicate device, the difference is just in dimension. Different specification will be selected by physician per patient's condition. This difference does not affect intended use. In addition, differences were addressed through ISO 7864 and ISO 9626. Therefore, the differences on syringe volume, needle bevel, needle gauge and length do not raise different question of safety and effectiveness.

VII Performance data

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility testing

Biocompatibility of the Disposable Syringe with permanently attached needle and Safety Syringe with permanently attached needle were evaluated in accordance with ISO 10993-1:2018 for the body contact category of "External communication device – Blood path indirect" with a contact duration of "Limited (< 24 hours)". The following tests were performed, as recommended:

Cytotoxicity	ISO 10993-5: 2009
Skin sensitization	ISO 10993-10: 2010
Hemolysis	ISO 10993-4: 2017
Intracutaneous reactivity	ISO 10993-10: 2010
Acute systemic toxicity	ISO 10993-11: 2017
Pyrogenicity	ISO 10993-11: 2017
Particulate matter	USP <788>

Sterilization and shelf life testing

The sterilization method has been validated to ISO11135, which has thereby determined the routine control and monitoring parameters. Bacteria Endotoxin Limit is carried out according to USP42-NF37 <85> Bacterial Endotoxins Test.

The testing is performed according to the following standards:

EO/ECH residue	ISO 10993-7:2008
----------------	------------------

Bacteria Endotoxin	USP42-NF37 <85>
--------------------	-----------------

The shelf life of 3 year is determined based on stability studies which include aqeing test according to FDA recognized standard ASTM F1980-16.

Package integrity testing was conducted on the final, packaged, and sterile devices after environmental conditioning and simulated transportation. All packaging deemed acceptable for protection of product and sterility maintenance.

The testing is performed according to the following standards:

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Seal strength	ASTM F88/F88M-15
Blue Dye Penetration	ASTM F 1929-2015
Seal Integrity (Visual Inspection)	ASTM F 1886/ F 1886M-16

Performance testing

Performance testing is performed according to the following standards:

ISO 7886-1: 2017, Sterile hypodermic syringes for single use- Part 1: Syringes for manual use.
A ISO 7864: 2016, ISO 9626:2016, Stainless Steel Needle Tubing For The Manufacture of Medical Devices.
ISO 9626:2016, Stainless Steel Needle Tubing for The Manufacture of Medical Devices.
ISO 6009:2016, Hypodermic needles for single use – Colour coding identification
ISO 23908:2011 Sharps injury protection - Requirements and test methods -Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling.

VIII Clinical Test Conclusion

No clinical study is included in this submission.

IX Conclusion

The Disposable Syringe with permanently attached needle and Safety Syringe with permanently attached needle are substantially equivalent to its predicate devices. The non-clinical testing demonstrates that the device is as safe, effective and performs as well as the legally marketed device.

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).