(364 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML.
No.
The device description and intended use indicate it is for general purpose aspiration of fluid and liquid injection, not for treating a specific disease or condition.
No
The device description indicates its use for "injecting fluids into, or withdrawing fluids from, the body," and its intended use is for "general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin." These functions are therapeutic or procedural, not diagnostic.
No
The device description clearly describes a physical syringe with a needle, which is a hardware component. There is no mention of software as the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin." This describes a procedure performed on the body (injection/aspiration from the body or containers for administration to the body), not a test performed on a sample outside the body to diagnose a condition.
- Device Description: The description details a syringe and needle used for injecting or withdrawing fluids from the body. This aligns with a medical device used for direct patient care, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (like blood, urine, tissue, etc.) to provide diagnostic information. The device is a tool for administering or collecting substances, not for performing a diagnostic test.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This syringe does not fit that description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
QNQ, FMI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench tests were performed. Bench testing included biocompatibility, mechanical testing, sterility 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.
Key Results:
- 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
- Elasticity: Pass
- Flexural strength: Pass
- Pullout: Pass
- Stiffness: Pass
- Resistance to breakage: Pass
- Resistance to corrosion: Pass
- Dead volume: Conforms to
§ 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).
0
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 and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
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
1
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
2
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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3
K213013 - 510(k) Summary
[as required by 807.92(c)]
1. Date of Preparation: September 19, 2022
2. Applicant
-
- Company: Jeil Tech Co., Ltd.
-
- Address: 190, Maesilro, Sojeongmyeon, Sejong-si, Republic of Korea
- Tel : +82-44-862-2656 3)
-
- Fax : +82-44-826-2657
-
- Contact person : Peter Chung, 412-512-8802
- ୧) Contact person address : 300 Atwood Street, Pittsburgh, PA, 15213, USA
-
- Submission date: Sep. 10, 2021
-
- 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)
-
- Classification name : Piston syringe/ Needle, Hypodermic, Single Lumen
- Product code : QNQ, FMI 4)
-
- Regulation number : 880.5860
-
- Class of device : Class II
-
- 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.
4
| 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. ( , Bacterial Endotoxins Test | Pass |
| Particulate
Matter
Injection | USP , Particulate Matter for Injections (Method 1 Light Obscuration
Particle Count Test). Test result should satisfy the requirements described in the
USP . | 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:
5
| # | Test item | Test standard | Test result |
|---|---|---|---|
| 1 | LAL test | USP39 , Bacterial Endotoxins Test (Unit : EU/Device) | Pass |
| 2 | E.O sterilization | ||
| validation | According to ISO 11135:2014 | ||
| E.O 30%, CO2 70% | |||
| Temperature: 50 ±7°C | |||
| 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 | |
| residuals, the test articles should meet the test requirements. | Pass |
5) Needle injury test
| # | Test item | Test standard | Test result |
|---|---|---|---|
| 1 | Needle | ||
| penetration | |||
| force | ISO 23908: 2011 Sharps injury protection | Pass | |
| 2 | Pull-out force | ISO 23908: 2011 Sharps injury protection | Pass |
| 3 | Needle cap | ||
| removal force | ISO 23908: 2011 Sharps injury protection | Pass | |
| 4 | Activation | ||
| (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.
Proposed device | Jiangsu Caina Medical Co., Ltd.
Predicate device | Remark |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| 510(K) No. | K192551 | | N/A | |
| Indication 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. | | 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
PP | |
| | Piston | Polyisoprene | Piston
Polyisoprene | |
| | Plunger
Barrel | PP
PP | Plunger
Barrel
PP | |
| Capacity
(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
For Single Use Only | | For Manual Use Only
For Single Use Only | Same |
6
| Syringe
Performances | Complies with ISO 7886-1 : 2017 Sterile
hypodermic syringes for single use - Part 1 :
Syringes for manual use | Complies with ISO 7886-1 : 2017 Sterile
hypodermic syringes for single use - Part
1 : Syringes for manual use | Same |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Needle
Performances | ISO 7864 : 2016 Sterile hypodermic needles
for single use - Requirements and test
methods
ISO 9626 : 2016 Stainless steel needle tubing
for the manufacture of medical devices -
Requirements and test methods | ISO 7864 : 2016 Sterile hypodermic
needles for single use - Requirements
and test methods
ISO 9626 : 2016 Stainless steel needle
tubing for the manufacture of medical
devices - Requirements and test methods | Same |
| Safety feature
performance
specification | 1) Safety guard clamping force shall
be less than 15 N
2) Needle should not be separated
from safety guard until pushed
vertically by 25mm. | i. The torque to lock shall be less than
10N·cm
ii. The force to destroy forward shall not
be less than 30N
iii. The force to destroy backward shall
not be less than 60N
iv. The torque to unscrewing shall be
greater than 20N·cm | Different #3 |
| Biocompatibility | Conforms to the
requirements of ISO 10993
series standards.
Cytotoxicity
Acute systemic toxicity
Pyrogenicity
Sensitization
Irritation
Hemolysis
Intracutaneous reactivity
Bacterial Endotoxins
Particulate Matter Injection | Conforms to the
requirements of ISO 10993
series standards.
Cytotoxicity
Acute systemic toxicity
Pyrogenicity
Sensitization
Irritation
Hemolysis
Intracutaneous reactivity
Bacterial Endotoxins
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
operation | The plunger of syringe can be pulled and
pushed along inside the barrel, allowing
the syringe to take in and expel the fluids
through the connector to the patient. | The plunger of syringe can be pulled
and pushed along inside the barrel,
allowing the syringe to take in and
expel the fluids through the connector
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
7
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.