Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe
Device Facts
| Record ID | K213013 |
|---|---|
| Device Name | Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe |
| Applicant | Jeil Tech Co., Ltd. |
| Product Code | QNQ · General Hospital |
| Decision Date | Sep 19, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5860 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
STERILE SINGLE USE LDV SYRINGE/CHOICARE STERILE SINGLE USE LDV SYRINGE 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.
Device Story
Disposable syringe with permanently attached hypodermic needle; consists of calibrated barrel, plunger, piston, and safety guard. Manual operation by healthcare professionals for fluid aspiration and injection. Low dead volume (LDV) design (< 0.0284ml). Single-use; E.O. gas sterilized. Safety guard mechanism aids in prevention of needle stick injuries. Bench testing confirms performance per ISO standards.
Clinical Evidence
Bench testing only. No clinical data. Testing included biocompatibility (ISO 10993), mechanical performance (ISO 7886-1, ISO 7864, ISO 9626), sterility/EO residuals (ISO 11135, ISO 11737), and sharps injury protection (ISO 23908). All tests passed.
Technological Characteristics
Materials: Barrel/Plunger/Safety guard (PP), Piston (Polyisoprene), Needle (Stainless Steel 304). Manual piston-driven syringe. Low dead volume design. E.O. gas sterilization. Conforms to ISO 7886-1:2017, ISO 9626:2016, ISO 7864:2016, and ISO 23908:2011.
Indications for Use
Indicated for health care professionals for general purpose aspiration of fluid from vials, ampoules, and liquid injection below the skin surface.
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
- Safety Syringe With Permanently Attached Needle (K192551)
Submission Summary (Full Text)
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September 19, 2022
Jeil Tech Co., Ltd. % Peter Chung President Plus Global 300. Atwood Pittsburgh, Pennsylvania 15213
Re: K213013
Trade/Device Name: Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: QNQ, FMI Dated: August 17, 2022 Received: August 17, 2022
Dear Peter Chung:
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,
CAPT Alan M. 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) K213013
Device Name
Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe
#### Indications for Use (Describe)
STERILE SINGLE USE LDV SYRINGE/CHOICARE STERILE SINGLE USE LDV SYRINGE 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.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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# K213013 - 510(k) Summary
[as required by 807.92(c)]
#### 1. Date of Preparation: September 19, 2022
#### 2. Applicant
- 1) Company: Jeil Tech Co., Ltd.
- 2) Address: 190, Maesilro, Sojeongmyeon, Sejong-si, Republic of Korea
- Tel : +82-44-862-2656 3)
- 4) Fax : +82-44-826-2657
- 5) Contact person : Peter Chung, 412-512-8802
- ୧) Contact person address : 300 Atwood Street, Pittsburgh, PA, 15213, USA
- 7) Submission date: Sep. 10, 2021
- 8) Prior related submission : Not applicable
#### 3. Subject Device Information
- Trade name : STERILE SINGLE USE LDV SYRINGE, CHOICARE STERILE SINGLE USE LDV SYRINGE 1)
- Common name : Disposal syringe with needle 2)
- 3) Classification name : Piston syringe/ Needle, Hypodermic, Single Lumen
- Product code : QNQ, FMI 4)
- 5) Regulation number : 880.5860
- 6) Class of device : Class II
- 7) Panel : General hospital
#### 4. Predicate Devices
Trade name: Safety Syringe With Permanently Attached Needle Premarket Notification: K192551 Manufacturer: Jiangsu Caina Medical Co., Ltd.
#### 5. Device description
A Disposable Syringe with Needle 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 hypodermic single lumen needle which is permanently attached. The device is used to inject fluids into, or withdraw fluids from, the body. This is a single-use device. This product is packed by sterile paper and sterilized by E.O gas.
#### 6. Intended Use:
STERILE SINGLE USE LDV SYRINGE/CHOICARE STERILE SINGLE is intended to be used for medical purposes to inject fluids to the body.
#### 7. Indication for Use:
STERILE SINGLE USE LDV SYRINGE/CHOICARE STERILE SINGLE 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.
#### 8. Performance data:
- Bench tests were performed. Bench testing included biocompatibility, mechanical testing, sterility 1) testing including EO residues. The tests demonstrated that the device performs in a substantially equivalent manner to the predicate device. The devices conform to ISO 7886-1:2017, ISO 9626:2016, ISO 7864:2016, and ISO 23908:2011. For example, the following bench testing is performed to demonstrate the functionality is substantially equivalent.
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| Requirement – Test (ISO 7886-1) | Result |
|---------------------------------------------|--------|
| Visual check | Pass |
| Dimension (out diameter of the needle tube) | Pass |
| Length of the needle tube | Pass |
| Nozzle | Pass |
| Tightness | Pass |
| Piston/Plunger Assembly | Pass |
| Requirement – Test (ISO 7864) | Result |
|-------------------------------|--------|
| Elasticity | Pass |
| Flexural strength | Pass |
| Pullout | Pass |
| Requirement – Test (ISO 9626) | |
| Stiffness | Pass |
| Resistance to breakage | Pass |
| Resistance to corrosion | Pass |
#### 2) Dead volume
In accordance with the FDA's requirements, to claim that the aspect "Low Dead Volume" the specification for syringe and needle combined dead volume shall be satisfied with the following criteria. ( < 0.0284ml)
According to the provided testing result, STERILE SINGLE USE LDV SYRINGE, CHOICARE STERILE SINGLE USE LDV SYRINGE conforms this requirement.
#### 3) Biocompatibility
Biocompatibility of the STERILE SINGLE USE LDV SYRINGE, CHOICARE STERILE SINGLE USE LDV SYRINGE was 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; Skin sensitization; Hemolysis; Intracutaneous reactivity; Acute systemic toxicity;
| Test item | Test method / Test criteria | Test result |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Cytotoxicity<br>test | When it was tested accordingly to ISO 10993-5, tests for in vitro cytotoxicity-Test<br>on extracts method, it should satisfy the requirements. | Pass |
| Hemolysis<br>test | When it was tested accordingly to ISO 10993-4, Selection off tests for interactions<br>with blood-evaluation of hemolytic properties of medical devices and medical<br>device materials, it should satisfy the requirements. | Pass |
| Intracutaneous reactivity<br>test | When it was tested accordingly to ISO 10993-10, Tests for irritation and skin<br>sensitization-Animal intracutaneous (Intradermal) reactivity test, it should satisfy<br>the requirements. | Pass |
| Skin<br>sensitization<br>test | when it was tested accordingly to ISO 10993-10, Tests for irritation and skin<br>sensitization-Guinea pig maximization test (GPMT), it should satisfy the<br>requirements. | Pass |
| Acute<br>systemic<br>toxicity test | When it was tested accordingly to ISO 10993-11, Tests for systemic toxicity-<br>Acute systemic toxicity, it should satisfy the requirements. | Pass |
| Pyrogen Test | When it was tested accordingly to ISO 10993-11, Tests for systemic toxicity-<br>Information on material-mediated pyrogens, it should satisfy the requirements. | Pass |
| LAL Test | USP39 <85>, Bacterial Endotoxins Test | Pass |
| Particulate<br>Matter<br>Injection | USP <788>, Particulate Matter for Injections (Method 1 Light Obscuration<br>Particle Count Test). Test result should satisfy the requirements described in the<br>USP <788>. | Pass |
#### Sterility and LAL test 4)
The sterilization method has been validated to ISO11135, which has thereby determined the routine control and monitoring parameters. The testing is performed according to the following standards:
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| # | Test item | Test standard | Test result |
|---|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| 1 | LAL test | USP39 <85>, Bacterial Endotoxins Test (Unit : EU/Device) | Pass |
| 2 | E.O sterilization<br>validation | According to ISO 11135:2014<br>E.O 30%, CO2 70%<br>Temperature: 50 ±7°C<br>Exposure time: 5 hours | Pass |
| 3 | Sterility test | According to ISO 11737-2 | Pass |
| 4 | E.O Residual test | Under the conditions of ISO 10993-7:2008, Ethylene oxide sterilization<br>residuals, the test articles should meet the test requirements. | Pass |
#### 5) Needle injury test
| # | Test item | Test standard | Test result |
|---|--------------------------------|------------------------------------------|-------------|
| 1 | Needle<br>penetration<br>force | ISO 23908: 2011 Sharps injury protection | Pass |
| 2 | Pull-out force | ISO 23908: 2011 Sharps injury protection | Pass |
| 3 | Needle cap<br>removal force | ISO 23908: 2011 Sharps injury protection | Pass |
| 4 | Activation<br>(locking) force | ISO 23908: 2011 Sharps injury protection | Pass |
| 5 | Unlocking force | ISO 23908: 2011 Sharps injury protection | Pass |
# 6) Substantially Equivalent (SE) Comparison
# Table 1. Comparison table
| Manufacturer | Item | Jeil Tech Co., Ltd.<br>Proposed device | Jiangsu Caina Medical Co., Ltd.<br>Predicate device | Remark |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| 510(K) No. | K192551 | | N/A | |
| Indication for use | STERILE SINGLE USE LDV SYRINGE/ CHOICARE<br>STERILE SINGLE USE LDV SYRINGE is intended<br>for use by health care professionals for<br>general purpose aspiration of fluid from vials,<br>ampoules, and liquid injection below the<br>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 or syringe reuse. | Same |
| Components | Barrel, Plunger, Piston, Safety cap | Barrel, Plunger, Piston, Safety sheath | | Same |
| Materials | Needle cap | PE | PP or PE | Same |
| | Needle | Stainless Steel 304 | Stainless Steel 304 | |
| | Safety guard | PP | Safety mechanism<br>PP | |
| | Piston | Polyisoprene | Piston<br>Polyisoprene | |
| | Plunger<br>Barrel | PP<br>PP | Plunger<br>Barrel<br>PP | |
| Capacity<br>(Syringe volume) | 0.5 1ml | | 0.3, 0.5, 1ml | Different #1 |
| Nozzle type | Permanently attached | | Permanently attached | Same |
| Needle Gauge | 23, 25G | | 25, 26, 27, 28, 29, 30, 31G | Different #2 |
| Needle Length | 25mm | | 8, 10, 13, 16mm | |
| Needle wall type | TW | | RW, TW | |
| Needle bevel | 11°±2° | | 11°±2°, 15°±2° | |
| Needle Hub | Polypropylene (PP) | | Polypropylene (PP) | Same |
| Principle of operation | For Manual Use Only<br>For Single Use Only | | For Manual Use Only<br>For Single Use Only | Same |
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| Syringe<br>Performances | Complies with ISO 7886-1 : 2017 Sterile<br>hypodermic syringes for single use - Part 1 :<br>Syringes for manual use | Complies with ISO 7886-1 : 2017 Sterile<br>hypodermic syringes for single use - Part<br>1 : Syringes for manual use | Same |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Needle<br>Performances | ISO 7864 : 2016 Sterile hypodermic needles<br>for single use - Requirements and test<br>methods<br>ISO 9626 : 2016 Stainless steel needle tubing<br>for the manufacture of medical devices -<br>Requirements and test methods | ISO 7864 : 2016 Sterile hypodermic<br>needles for single use - Requirements<br>and test methods<br>ISO 9626 : 2016 Stainless steel needle<br>tubing for the manufacture of medical<br>devices - Requirements and test methods | Same |
| Safety feature<br>performance<br>specification | 1) Safety guard clamping force shall<br>be less than 15 N<br>2) Needle should not be separated<br>from safety guard until pushed<br>vertically by 25mm. | i. The torque to lock shall be less than<br>10N·cm<br>ii. The force to destroy forward shall not<br>be less than 30N<br>iii. The force to destroy backward shall<br>not be less than 60N<br>iv. The torque to unscrewing shall be<br>greater than 20N·cm | Different #3 |
| Biocompatibility | Conforms to the<br>requirements of ISO 10993<br>series standards.<br>Cytotoxicity<br>Acute systemic toxicity<br>Pyrogenicity<br>Sensitization<br>Irritation<br>Hemolysis<br>Intracutaneous reactivity<br>Bacterial Endotoxins<br>Particulate Matter Injection | Conforms to the<br>requirements of ISO 10993<br>series standards.<br>Cytotoxicity<br>Acute systemic toxicity<br>Pyrogenicity<br>Sensitization<br>Irritation<br>Hemolysis<br>Intracutaneous reactivity<br>Bacterial Endotoxins<br>Particulate Matter Injection | Same |
| Sterilization | E.O Sterilized | E.O Sterilized | Same |
| SAL | 10-6 | 10-6 | Same |
| Endotoxin Limit | 20 EU per device | 20 EU per device | Same |
| Principle of<br>operation | The plunger of syringe can be pulled and<br>pushed along inside the barrel, allowing<br>the syringe to take in and expel the fluids<br>through the connector to the patient. | The plunger of syringe can be pulled<br>and pushed along inside the barrel,<br>allowing the syringe to take in and<br>expel the fluids through the connector<br>to the patient. | Same |
| Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same |
# 2. Equivalence discussion
### Different 1 - Capacity (Syringe volume)
The Syringe volume for proposed devices is different from the predicate devices 1.
This difference does not affect intended use and does not raise new questions of safety and effectiveness. Differences in syringe volume between the predicate and subject device were addressed through ISO 7886-1:2017 performance testing.
### Different 2 - Needle gauge, length, wall type and bevel
The needle gauge and length for proposed devices is different from the predicate devices. This difference does not affect intended use and does not raise new questions of safety and effectiveness in needle length and gauge between the predicate and proposed device were addressed through ISO 7864:2016 and ISO 9626:2016 performance testing.
The needle wall type for predicate device is differ from proposed device. However, the performance test for proposed device has been conducted and the test result conform with requirements of ISO 7864:2016 and ISO 9626:2016 standards. Also proposed device's needle wall type is included in range of predicate device's needle
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wall type. According to 510(k) summary of predicate device, it has Regular(RW) type. Subject device only has a thin wall type needle, which does not affect its intended use, and does not raise any new questions of safety and effectiveness.
The needle bevel for proposed devices is different from the predicate device. This difference does not affect intended use. In addition, subject device is conforming to recommendation by the relevant standard(ISO 7864:2016, section 4.11 Needle point). The differences in needle bevel between the predicate and subject device were addressed through ISO 9626:2016 performance testing.
# Different 3 - Safety feature performance specification
The Safety feature performance specifications for predicate device is different from the predicate device. However, the safety feature performance test for proposed device has been evaluated and the test result conforms to requirements of ISO 23908:2011 standards. Therefore, the differences on configuration and materials does not affect substantially equivalence.
# 3. Substantially Equivalent (SE) Conclusion
The STERILE SINGLE USE LDV SYRINGE of Jeil Tech Co., Ltd. is substantially equivalent to the legally marketed predicate device.
