Disposabel Syringe with permanently attached needle, Safety Syringe with permanently attached needle

K220204 · Anhui Tiankang Medical Technology Co., Ltd. · FMF · Jul 14, 2022 · General Hospital

Device Facts

• Record ID: K220204
• Device Name: Disposabel Syringe with permanently attached needle, Safety Syringe with permanently attached needle
• Applicant: Anhui Tiankang Medical Technology Co., Ltd.
• Product Code: FMF · General Hospital
• Decision Date: Jul 14, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 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 Story

Disposable and safety syringes with permanently attached needles; used by healthcare professionals for fluid aspiration and subcutaneous/intramuscular injection. Safety variant includes a sliding sheath mechanism to cover the needle post-use to prevent needlestick injuries and reuse. Devices are single-use, manual, and sterile. Components include polypropylene barrels/plungers, stainless steel 304 needles, and polyisoprene pistons. Safety models incorporate a polycarbonate connector base. Devices are provided sterile via Ethylene Oxide gas. Clinical benefit includes safe, accurate delivery of injectable medications and protection of clinicians from sharps injuries.

Clinical Evidence

No clinical data. Bench testing only, including biocompatibility (ISO 10993 series), sterility validation (ISO 11135), package integrity (ASTM F88, F1929, F1886), and performance testing per ISO 7886-1, ISO 7864, ISO 9626, ISO 6009, and ISO 23908.

Technological Characteristics

Materials: Polypropylene (barrel, plunger, cap, sleeve), Stainless Steel 304 (needle), Polyisoprene (piston), Polycarbonate (safety connector). Sterilization: Ethylene Oxide (SAL 10^-6). Standards: ISO 7886-1, ISO 7864, ISO 9626, ISO 6009, ISO 23908, ISO 10993, ASTM F1980, ASTM F88, ASTM F1929, ASTM F1886. Manual operation, single-use.

Indications for Use

Indicated for health care professionals for general purpose fluid aspiration from vials/ampoules and liquid injection below the skin surface. Safety syringe variant includes features to prevent needle stick injuries and syringe reuse.

Regulatory Classification

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.

Predicate Devices

• Syringe with permanently attached needle (K192551)
• Safety Syringe with permanently attached needle (K192551)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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 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 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) | |
|---------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| <span> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CER 801 Subpart D) </span> | <span> ☐ Over-The-Counter Use (21 CER 801 Subpart C) </span> |

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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: [phone] Fax: [phone] E-mail: [e-mail]

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 Syringe<br>Syringe with permanently attached needle (used as Predicate Device)<br>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

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.

| Model | Syringe<br>Volume | Needle Length | Needle<br>Gauge | Wall<br>type | Needle<br>Bevel |
|-----------------------------------------------------------------------|-------------------|--------------------------------------------------------------|-----------------|--------------|-----------------|
| Disposable Syringe<br>with permanently<br>attached needle<br>-TKSPN01 | 0.5ml; 1ml | 3/8" (10mm);<br>1/2" (13mm);<br>5/8" (16mm); | 23G | TW | LB |
| | | 3/4" (20mm); | 24G | RW | LB |
| | | 7/8" (22mm);<br>1" (25mm); | 25G | RW | LB |
| | | 3/8" (10mm);<br>1/2" (13mm);<br>5/8" (16mm);<br>3/4" (20mm); | 26G | RW | LB |
| | | 3/8" (10mm);<br>1/2" (13mm);<br>5/8" (16mm); | 27G | RW | LB |
| | | 3/8" (10mm);<br>1/2" (13mm);<br>5/8" (16mm); | 28G | RW | LB |
| | | 3/10" (8mm); | 29G | RW | LB |
| | | 3/8" (10mm);<br>1/2" (13mm); | 30G | RW | LB |
| | | 5/8" (16mm); | 31G | RW | LB |
| Safety Syringe with<br>permanently attached<br>needle -TKSSPN01 | 0.3ml | 3/8" (10mm);<br>1/2" (13mm);<br>5/8" (16mm); | 27G | RW | LB |
| | | 3/8" (10mm);<br>1/2" (13mm);<br>5/8" (16mm); | 28G | RW | LB |
| | | 3/10" (8mm); | 29G | RW | LB |
| | | 3/8" (10mm);<br>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);<br>1/2" (13mm);<br>5/8" (16mm); | 25G | RW | LB |
|----------------------------------------------------------------|------------|--------------------------------------------------------------|-----|----|----|
| | | | 26G | RW | LB |
| | | | 27G | RW | LB |
| | | | 28G | RW | LB |
| | | 3/10" (8mm);<br>3/8" (10mm);<br>1/2" (13mm);<br>5/8" (16mm); | 29G | RW | LB |
| | | | 30G | RW | LB |
| | | | 31G | RW | LB |
| Safety Syringe with<br>permanently attached<br>needle-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

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.

# Safety Syringe with permanently attached needle

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.

#### 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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| Device<br>feature | Subject Device | Predicate Device K192551 | Comment |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Product | Disposable Syringe with<br>permanently attached<br>needle | Syringe with permanently<br>attached needle | / |
| Syringe type | Piston syringe | Piston syringe | Same |
| Indications<br>for use | The Disposable Syringe<br>with permanently attached<br>needle is intended for use<br>by health care professionals<br>for general purpose<br>aspiration of fluid from vials,<br>ampoules and liquid<br>injection below the surface<br>of the skin. | 1ml Luer Slip or Luer Lock<br>Syringe<br>1ml Luer Slip or Luer Lock<br>Syringe is intended to be<br>connected with the luer slip<br>or luer lock needle and<br>intended for use by health<br>care professionals for<br>general purpose aspiration<br>of fluid from vials, ampoules<br>and liquid injection below<br>the surface of the skin.<br>Syringe with permanently<br>attached needle<br>The Syringe with<br>permanently attached<br>needle is intended for use<br>by health care professionals<br>for general purpose<br>aspiration of fluid from vials,<br>ampoules and liquid<br>injection below the surface<br>of the skin.<br>Safety Syringe with<br>permanently attached<br>needle<br>The Safety Syringe with<br>permanently attached | Similar,<br>Comment 1 |
| Device<br>feature | Subject Device | Predicate Device K192551 | Comment |
| | | needle is intended for use<br>by health care professionals<br>for general purpose<br>aspiration of fluid from vials,<br>ampoules and liquid<br>injection below the surface<br>of the skin. The Safety<br>sheath of Syringe is<br>designed to aid in the<br>prevention of needle stick<br>injuries and reduce the<br>potential or syringe reuse. | |
| Product code | FMF | FMF | Same |
| Regulation<br>number | 21 CFR 880.5860 | 21 CFR 880.5860 | Same |
| Class | II | II | Same |
| Principle of<br>operation | For Manual Use Only, For<br>Single Use Only | For Manual Use Only, For<br>Single Use Only | Same |
| Connector<br>Type | Attached needle | Attached needle | Same |
| Needle<br>gauge | 23G, 24G, 25G, 26G, 27G,<br>28G, 29G, 30G, 31G | 21G, 23G, 25G, 26G, 27G,<br>28G, 29G, 30G, 31G | Different<br>Comment 2 |
| Needle<br>Length | 8mm, 10mm, 13mm, 16mm,<br>20mm, 22mm, 25mm | 8mm, 10mm, 13mm, 16mm,<br>20mm, 25mm | |
| Needle wall<br>type | RW, TW | RW, TW | |
| Needle bevel | 11°±2° | 11°±2°, 15°±2° | |
| Syringe<br>Volume | 0.5ml, 1ml | 0.3ml, 0.5ml, 1ml | |
| Device<br>feature | Subject Device | Predicate Device K192551 | Comment |
| Main<br>structure and<br>materials | (1) Needle cap (PP)<br>(2) Needle (Stainless Steel<br>304)<br>(3) Piston (Polyisoprene)<br>(4) Plunger (PP)<br>(5) Barrel (PP) | Syringe with permanently<br>attached needle-type A<br>(1) needle cap (PP or PE)<br>(2) needle (Stainless Steel<br>304)<br>(3) piston (Polyisoprene)<br>(4) plunger (PP)<br>(5) barrel (PP)<br>(6) end cap (PP or PE)<br>Syringe with permanently<br>attached needle-type B<br>(1) needle cap (PP or PE)<br>(2) needle (Stainless Steel<br>304)<br>(3) piston (Polyisoprene)<br>(4) plunger (PP or ABS)<br>(5) barrel (PP) | Different<br>Comment 3 |
| Single Use | Yes | Yes | Same |
| Sterilization | EO Sterilization | EO Sterilization | Same |
| SAL | 10-6 | 10-6 | Same |
| Biocompatibility | Contact level: blood path,<br>indirect, limited contact (<24<br>hours).<br>Conforms to the<br>requirement of ISO 10993<br>series Standards | Contact level: blood path,<br>indirect, limited contact (<24<br>hours).<br>Conforms to the<br>requirement of ISO 10993<br>series Standards | Same |
| Labeling | Complied with 21 CFR part<br>801 | Complied with 21 CFR part<br>801 | Same |
| Device<br>feature | Subject Device<br>K220204 | Predicate Device<br>K192551 | Comment |
| Product | Safety Syringe with<br>permanently attached<br>needle | Safety Syringe with<br>permanently attached<br>needle | / |
| Syringe type | Piston syringe | Piston syringe | Same |
| Indications<br>for use | The Safety Syringe with<br>permanently attached<br>needle is intended for use<br>by health care professionals<br>for general purpose<br>aspiration of fluid from vials,<br>ampoules and liquid<br>injection below the surface<br>of the skin. The Safety<br>sheath of Syringe is<br>designed to aid in the | 1ml Luer Slip or Luer Lock<br>Syringe<br>1ml Luer Slip or Luer Lock<br>Syringe is intended to be<br>connected with the luer slip<br>or luer lock needle and<br>intended for use by health<br>care professionals for<br>general purpose aspiration<br>of fluid from vials, ampoules<br>and liquid injection below | Similar,<br>Comment 1 |
| Device<br>feature | Subject Device<br>K220204 | Predicate Device<br>K192551 | Comment |
| | prevention of needle stick<br>injuries and reduce the<br>potential or syringe reuse. | the surface of the skin.<br>Syringe with permanently<br>attached needle<br>The Syringe with<br>permanently attached<br>needle is intended for use<br>by health care professionals<br>for general purpose<br>aspiration of fluid from vials,<br>ampoules and liquid<br>injection below the surface<br>of the skin.<br>Safety Syringe with<br>permanently attached<br>needle<br>The Safety Syringe with<br>permanently attached<br>needle is intended for use<br>by health care professionals<br>for general purpose<br>aspiration of fluid from vials,<br>ampoules and liquid<br>injection below the surface<br>of the skin. The Safety<br>sheath of Syringe is<br>designed to aid in the<br>prevention of needle stick<br>injuries and reduce the<br>potential or syringe reuse. | |
| Product code | MEG | MEG | Same |
| Regulation<br>number | 21 CFR 880.5860 | 21 CFR 880.5860 | Same |
| Class | II | II | Same |
| Principle<br>of | For Manual Use Only, For | For Manual Use Only, For | Same |
| Device<br>feature | Subject Device<br>K220204 | Predicate Device<br>K192551 | Comment |
| operation | Single Use Only | Single Use Only | |
| Connector<br>Type | Attached needle | Attached needle | Same |
| Needle<br>gauge | 21G, 22G, 23G, 24G, 25G,<br>26G, 27G, 28G, 29G, 30G,<br>31G | 21G, 23G, 25G, 26G, 27G,<br>28G, 29G, 30G, 31G | Different<br>Comment 4 |
| Needle<br>Length | 8mm, 10mm, 13mm, 16mm,<br>20mm, 22mm, 25mm,<br>32mm, 38mm | 8mm, 10mm, 13mm, 16mm,<br>20mm, 25mm | |
| Needle wall<br>type | RW, TW | RW, TW | |
| Needle bevel | $11°±2°$ | $11°±2°, 15°±2°$ | |
| Syringe<br>Volume | 0.3ml, 0.5ml, 1ml | 0.3ml, 0.5ml, 1ml | Same |
| Main<br>structure and<br>materials | (1) Protective cap (PP)<br>(2) Needle (Stainless Steel<br>304)<br>(3) Safety mechanism-<br>Connector base (PC)<br>(4) Piston (Polyisoprene)<br>(5) Safety mechanism-<br>Sliding sleeve (PP)<br>(6) Plunger (PP)<br>(7) Barrel (PP) | (1) needle cap (PP or PE)<br>(2) needle (Stainless Steel<br>304)<br>(3) safety mechanism (PC)<br>(4) piston (Polyisoprene)<br>(5) safety mechanism (PP)<br>(6) plunger (PP)<br>(7) barrel (PP) | Same |
| Performance<br>specifications | Complies with ISO 7886-1;<br>ISO 9626 and ISO 7864 | Complies with ISO 7886-1;<br>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,<br>indirect, limited contact (<24<br>hours). | Contact level: blood path,<br>indirect, limited contact (<24<br>hours). | Same |
| | Conforms to the<br>requirement of ISO 10993<br>series Standards | Conforms to the<br>requirement of ISO 10993<br>series Standards | |
| Labeling | Complied with 21 CFR part<br>801 | Complied with 21 CFR part<br>801 | 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.