(185 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a standard syringe and needle, with no mention of AI or ML capabilities.
No
The device is a syringe used for injecting or withdrawing fluids/gas, not for treating or preventing a disease or condition itself.
No
The device description states its purpose is to inject or withdraw fluid, not to diagnose a medical condition.
No
The device description clearly states it is a physical syringe and needle made of plastic and silicone materials, intended for injecting or withdrawing fluids. It does not mention any software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "inject fluid into or withdraw fluid from body." This describes a direct interaction with the patient's body for therapeutic or diagnostic purposes within the body, not for testing samples outside the body.
- Device Description: The description focuses on the mechanical function of a syringe and needle for fluid transfer to or from the body or a medical device. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such analysis.
Therefore, the Shina Syringe and Shina Safety Syringe are medical devices used for fluid administration and withdrawal, but they do not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Shina Syringe, Shina Safety Syringe is a plastic sterile syringe and hypodermic single lumen needle intended to be used for medical purpose to inject fluid into or withdraw fluid from body.
Product codes (comma separated list FDA assigned to the subject device)
MEG, FMF, FMI
Device Description
A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is (not) included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.
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
Adults and Pediatrics
Intended User / Care Setting
Not Found
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 test were performed. Bench testing included biocompatibility and mechanical testing. The tests demonstrated that the device performs in a substantially equivalent manner to the predicate device. The following bench testing is performed to demonstrate the functionality is substantially equivalent.
Syringe:
- Appearance and Structure: ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
- Graduated capacity: ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
- Scale: ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
- Barrel: ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
- Plunger stopper / Plunger assembly: ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
- Nozzle: ISO 7886-1:2017 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use
- Dead Space: ISO 7886-1:2017 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use
- Freedom from liquid leakage past plunger stopper: ISO 7886-1:2017 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use
- Freedom from air leakage past plunger stopper: ISO 7886-1:2017 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use
- Force to operate the piston: ISO 7886-1:2017 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use
- Fit of plunger stopper / plunger in barrel: ISO 7886-1:2017 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use
- Amount of Silicon Oil: 0.25mg or less per square centimeter of inner area
- EO Gas residuals: ISO 10993-7:2008 Ethylene oxide sterilization residuals
- Sterility test: EO, ECH residuals
Needle:
- Cleanliness: ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods
- Size designation: ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods
- Colour coding: ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods
- Needle hub: ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods
- Needle tube (Tolerances on length): ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods
- Freedom from defects: ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods
- Lubricant: ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods
- Needle point: ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods
- Bond between hub and needle tube: ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods
- Patency of lumen: ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods
- Sharps injury protection: ISO 23908:2011 Sharps injury protection
- Materials: ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices – Requirements and test methods
- Surface finish and visual appearance: ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices – Requirements and test methods
- Cleanliness: ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices – Requirements and test methods
- Limits for acidity and alkalinity: ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices – Requirements and test methods
- Size designation: ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices – Requirements and test methods
- Dimension: ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices – Requirements and test methods
- Stiffness: ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices – Requirements and test methods
- Resistance to breakage: ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices – Requirements and test methods
- Resistance to corrosion: ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices – Requirements and test methods
Syringe with needle (Model : WNLS0125):
- Extraction : pH: Difference of pH ≤ 1.0
- Extraction : Potassium permanganate reducing substances: Difference of the consumption ≤ 2.0 mL
- Extraction: Residue on evaporation: Amount of residue ≤ 1.0 mg
- Extraction: Pb, Fe, Sn, Zn: Total content of heavy metals ≤ 5.0 mg/L
- Extraction: Cd: Content of Cd ≤ 0.1 mg/L
Syringe with needle (Model : WNLG0123, WNLS0123, WNSG0125, WNLS0125); (Model : WNLG0323, WNLS0323, WNSG0325, WNLS0325); (Model : WNLG0523, WNLS0523, WNSG0525, WNLS0525); (Model : WNLG1023, WNLS1023, WNSG1025, WNLS1025):
- Particulate test report: USP Method 1. Light obscuration method
Safety test with ISO 23908:
- Simulated Clinical Use: ISO 23908:2011 Sharps injury protection
Biocompatibility for 25G Model (Model : SSN2501), 23G Model (Model : SSN2301), and Syringe (Model : SSN2301):
- Cytotoxicity: ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- Acute systemic toxicity test: ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
- Pyrogen test: ISO 10993-11:2017 Test for systemic toxicity, pyrogen test USP
- Sensitization test: ISO 10993-10:2010 Biological evaluation of medical devices - Part 10 Tests for irritation and skin sensitization
- Hemolytic test: ISO 10993-4:2017, ASTM F756-17
- Intracutaneous reactivity test: ISO 10993-23 :2021 Biological evaluation of medical devices - Part 23 Tests for irritation
The performance tests demonstrated that the subject device performs in a substantially equivalent manner to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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 contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 27, 2023
Shina Med Corporation % Peter Chung President Plus Global 300, Atwood street Pittsburgh, Pennsylvania 15213
Re: K231165
Trade/Device Name: Shina Syringe; Shina Safety Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: MEG. FMF. FMI Dated: September 22, 2023 Received: September 22, 2023
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
Sincerelv.
Juliane C. Lessard -S
Juliane C. Lessard, Ph.D. Director DHT3C: Division of Drug Delivery and General Hospital Devices,
2
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
3
Indications for Use
510(k) Number (if known)
Device Name
Shina Syringe, Shina Safety Syringe
Indications for Use (Describe)
Shina Syringe, Shina Safety Syringe is a plastic sterile syringe and hypodermic single lumen needle intended to be used for medical purpose to inject fluid into or withdraw fluid from body.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
4
510(k) Summary
1. Applicant
- Company : Shina Med Corporation 1)
-
- Address : 455-30. Bogaewonsam-ro, Anseong-si, Gyeonggi-do, Republic of Korea
-
- Tel : 82-31-8057-2125
-
- Fax :
- Prepared date : 10/16/2023 5)
-
- Contact person : Peter Chung, 412-512-8802
-
- Contact person address : 300, Atwood Street, Pittsburgh, PA, 15213, USA
-
- Submission date : Apr. 25, 2023
2. Device Information
- Trade name : Shina Syringe, Shina Safety Syringe 1)
-
- Common name : Piston syringe
- Regulation name : Syringe, Antistick 2)
- Product code : MEG / FMF, FMI 3)
-
- Regulation number : 21 CFR 880.5860
- 21 CFR 880.5570
-
- Class of device : Class II
-
- Panel : General Hospital
3. The legally marketed device to which we are claiming equivalence
K210443, Poonglim Pharmatech Inc. / PLPT LDV (Low Dead Volume) Sterile Syringe K210444, Poonglim Pharmatech Inc. / EZ-Injec LDV Sterile safety Needle
4. Device description
A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is (not) included. lt is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.
5. Intended Use
Shina Syringe, Shina Safety Syringe is a plastic sterile syringe and hypodermic single lumen needle intended to be used for medical purpose to inject fluid into or withdraw fluid from body.
6. Performance data:
- Bench test were performed. Bench testing included biocompatibility and mechanical testing. The tests 1) demonstrated that the device performs in a substantially equivalent manner to the predicate device. The following bench testing is performed to demonstrate the functionality is substantially equivalent.
| Test item | Requirements |
|---|---|
| Appearance and Structure | ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use |
| Graduated capacity | ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use |
| Scale | ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use |
| Barrel | ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use |
| Plunger stopper / Plunger assembly | ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use |
Svringe
5
| Nozzle | ISO 7886-1:2017 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use |
|---|---|
| Dead Space | ISO 7886-1:2017 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use |
| Freedom from liquid leakage past plunger stopper | ISO 7886-1:2017 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use |
| Freedom from air leakage past plunger stopper | ISO 7886-1:2017 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use |
| Force to operate the piston | ISO 7886-1:2017 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use |
| Fit of plunger stopper / plunger in barrel | ISO 7886-1:2017 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use |
| Amount of Silicon Oil | 0.25mg or less per square centimeter of inner area |
| EO Gas residuals | ISO 10993-7:2008 Ethylene oxide sterilization residuals |
| Sterility test | EO, ECH residuals |
Needle
| Test item | Requirements |
|---|---|
| Cleanliness | ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods |
| Size designation | ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods |
| Colour coding | ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods |
| Needle hub | ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods |
| Needle tube (Tolerances on | |
| length) | ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods |
| Freedom from defects | ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods |
| Lubricant | ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods |
| Needle point | ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods |
| Bond between hub and needle | |
| tube | ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods |
| Patency of lumen | ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods |
| Sharps injury protection | ISO 23908:2011 Sharps injury protection |
| Materials | ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical |
| devices – Requirements and test methods | |
| Surface finish and visual appearance | ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical |
| devices – Requirements and test methods | |
| Cleanliness | ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical |
| devices – Requirements and test methods | |
| Limits for acidity and alkalinity | ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical |
| devices – Requirements and test methods | |
| Size designation | ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical |
| devices – Requirements and test methods | |
| Dimension | ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical |
| devices – Requirements and test methods | |
| Stiffness | ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical |
| devices – Requirements and test methods | |
| Resistance to breakage | ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical |
| devices – Requirements and test methods | |
| Resistance to corrosion | ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical |
| devices – Requirements and test methods |
Syringe with needle (Model : WNLS0125)
| Test item | Requirements |
|---|---|
| Extraction : pH | Difference of pH $\leq$ 1.0 |
| Extraction : Potassium permanganate reducing | Difference of the consumption $\leq$ 2.0 mL |
6
| substances | |
|---|---|
| Extraction: Residue on evaporation | Amount of residue ≤ 1.0 mg |
| Extraction: Pb, Fe, Sn, Zn | Total content of heavy metals ≤ 5.0 mg/L |
| Extraction: Cd | Content of Cd ≤ 0.1 mg/L |
Syringe with needle (Model : WNLG0123, WNLS0123, WNSG0125, WNLS0125)
| Test item | Requirements |
|---|---|
| Particulate test report | USP Method 1. Light obscuration method |
Syringe with needle (Model : WNLG0323, WNLS0323, WNSG0325, WNLS0325)
| Test item | Requirements |
|---|---|
| Particulate test report | USP Method 1. Light obscuration method |
Syringe with needle (Model : WNLG0523, WNLS0523, WNSG0525, WNLS0525)
| Test item | Requirements |
|---|---|
| Particulate test report | USP Method 1. Light obscuration method |
Syringe with needle (Model : WNLG1023, WNLS1023, WNSG1025, WNLS1025)
| Test item | Requirements |
|---|---|
| Particulate test report | USP Method 1. Light obscuration method |
Safety test with ISO 23908
| Test item | Requirements |
|---|---|
| Simulated Clinical Use | ISO 23908:2011 Sharps injury protection |
2) Biocompatibility
25G Model (Model : SSN2501)
| # | Test item | Test method / Test criteria |
|---|---|---|
| 1 | Cytotoxicity | ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests |
| for in vitro cytotoxicity | ||
| 2 | Acute systemic toxicity | |
| test | ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: | |
| Tests for systemic toxicity | ||
| 3 | Pyrogen test | ISO 10993-11:2017 Test for systemic toxicity, pyrogen test |
| USP | ||
| 4 | Sensitization test | ISO 10993-10:2010 Biological evaluation of medical devices - Part 10 |
| Tests for irritation and skin sensitization | ||
| 5 | Hemolytic test | ISO 10993-4:2017, ASTM F756-17 |
| 6 | Intracutaneous reactivity | |
| test | ISO 10993-23 :2021 Biological evaluation of medical devices - Part 23 | |
| Tests for irritation |
23G Model (Model : SSN2301)
| # | Test item | Test method / Test criteria |
|---|---|---|
| 1 | Cytotoxicity | ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests |
| for in vitro cytotoxicity | ||
| 2 | Acute systemic toxicity | |
| test | ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: | |
| Tests for systemic toxicity | ||
| 3 | Pyrogen test | ISO 10993-11:2017 Test for systemic toxicity, pyrogen test |
| USP | ||
| 4 | Sensitization test | ISO 10993-10:2010 Biological evaluation of medical devices – Part 10 |
| Tests for irritation and skin sensitization | ||
| 5 | Hemolytic test | ISO 10993-4:2017, ASTM F756-17 |
| 6 | Intracutaneous reactivity | |
| test | ISO 10993-23:2021 Biological evaluation of medical devices – Part 23 | |
| Tests for irritation |
7
Syringe (Model : SSN2301)
| # | Test item | Test method / Test criteria |
|---|---|---|
| 1 | Cytotoxicity | ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests |
| for in vitro cytotoxicity | ||
| 2 | Acute systemic toxicity | |
| test | ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: | |
| Tests for systemic toxicity | ||
| 3 | Pyrogen test | ISO 10993-11:2017 Test for systemic toxicity, pyrogen test |
| USP | ||
| 4 | Sensitization test | ISO 10993-10:2010 Biological evaluation of medical devices – Part 10 |
| Tests for irritation and skin sensitization | ||
| 5 | Hemolytic test | ISO 10993-4:2017, ASTM F756-17 |
| 6 | Intracutaneous reactivity | |
| test | ISO 10993-23 :2021 Biological evaluation of medical devices – Part 23 | |
| Tests for irritation |
The performance tests demonstrated that the subject device performs in a substantially equivalent manner to the predicate device.
7. Predicate device comparison table
| Manufacturer | Shina Med Corporation | Poonglim Pharmatech Inc. | Poonglim Pharmatech Inc. | Remark |
|---|---|---|---|---|
| 510(k) No. | K210443 | K210444 | N/A | |
| Indication for | ||||
| use | Shina Syringe, Shina Safety | |||
| Syringe is a plastic sterile | ||||
| syringe and hypodermic | ||||
| single lumen needle | ||||
| intended to be used for | ||||
| medical purpose to inject | ||||
| fluid into or withdraw fluid | ||||
| from body. | PLPT LDV (Low Dead Volume) | |||
| Sterile Syringe is intended to | ||||
| be used for medical purpose | ||||
| to inject fluid into or withdraw | ||||
| fluid from body. | This produce is intended for | |||
| use to inject fluid into or | ||||
| withdraw fluids from parts of | ||||
| the body below the surface of | ||||
| the skin. | Identical | |||
| Classification | ||||
| name | Syringe, Antistick | Low Dead Space Piston | ||
| Syringe | Low Dead Space Needle, | |||
| Single Lumen, Hypodermic | Different | |||
| Trade name | Shina Syringe, Shina Safety | |||
| Syringe | PLPT LDV (Low Dead Volume) | |||
| Sterile Syringe | EZ-Injec LDV Sterile Safety | |||
| Needle | N/A | |||
| Model/type | 40 Models including WOS01 | - | - | N/A |
| Components | Needle, Hub, Safety cover, | |||
| Barrel, Gasket, Plunger | Barrel, Gasket, Plunger | Needle, Hub, Safety cover | Identical | |
| Nozzle type | Lock and Slip type | Lock type | Lock and Slip type | Identical |
| Materials | ||||
| Needle | ||||
| Hub | ||||
| Safety cover | ||||
| Barrel | ||||
| Gasket | ||||
| Plunger | Stainless Steel | |||
| PP | ||||
| PP | ||||
| PP | ||||
| Hydrogenated styrene | ||||
| isoprene butadiene block | ||||
| copolymer | ||||
| PP | PP | |||
| Rubber | ||||
| PP | Stainless Steel | |||
| PP | ||||
| PP | Different | |||
| Capacity | 1mL, 3mL, 5mL, 10mL | 1mL | - | Different |
| Needle Gauge | 23G, 25G | - | 25G | Different |
| Needle Length | 25.4mm | - | 25mm | Different |
| Sharps Function | Safety Guard | - | Safety Guard | Identical |
| Principle of | ||||
| operation | Manual | Manual | Manual | Identical |
| Performances | ISO 7886 | |||
| ISO 7864 | ||||
| ISO 9626 | ||||
| USP | ||||
| ISO 23908 | ISO 7886 | ISO 7864 | ||
| ISO 9626 | ||||
| ISO 23908 | ||||
| USP | Identical |
8
| Manufacturer | Shina Med Corporation | Poonglim Pharmatech Inc. | Poonglim Pharmatech Inc. | Remark |
|---|---|---|---|---|
| Biocompatibility | Cytotoxicity | Cytotoxicity | Cytotoxicity | Identical |
| Acute systemic toxicity | Acute systemic toxicity | Acute systemic toxicity | ||
| Pyrogenicity | Pyrogenicity | Pyrogenicity | ||
| Sensitization | Sensitization | Sensitization | ||
| Hemolysis | Irritation | Irritation | ||
| Intracutaneous test | Hemocompatibility | Hemocompatibility | ||
| Sterilization | ||||
| Method | EO gas | EO gas | EO gas | Identical |
| Populations | Adults and Pediatrics | Adults and Pediatrics | Adults and Pediatrics | Identical |
| Dead space | Meets ISO 7886-1 standard | Less than 0.0023mL with 95% | ||
| confidence and 95% reliability | Less than 0.0054mL with 95% | |||
| confidence and 95% reliability | Different |
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- Different classification name
We set K210443 and K210444 as predicate devices. The product code is set differently to MEG for subject device and QNQ for predicate device respectively. However, K210443 and K210444 were set as predicate devices because of the similarity in appearance and purpose of use of needles and syringes with safety features.
- Different classification name
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- Different syringe capacity
The volume of the syringe is 1mL for the predicate device and 1ml, 3mL and 10mL for the subject device. Syringes with a volume larger than 1 mL are not included in the range, but tests were performed that included each syringe under ISO 7886 standard.
- Different syringe capacity
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- Different needle gauge
The gauge of the needle is 25G for the predicate device and 23G for the subject device. 23G needles are not included in the range, but both the 23G and 25G have been tested for performance under ISO 7864 and ISO 9626 standards.
- Different needle gauge
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- Different needle length
The needle of the subject device is 25.4mm while the needle length of the predicate device is 25mm. Through testing of ISO 7864 and ISO 9626, the needle length of the subject device has been evaluated for substantial equivalence.
- Different needle length
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- Different materials
All materials are not identical. Only gasket material is different. Subject device had been performed the biocompatibility tests according to ISO 10993 series to meet the toxicity endpoints.
- Different materials
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- Different dead space
The subject device was tested to meet the dead space requirements of ISO 7886-1. The predicate device is a low dead volume syringe and needle while the subject device is not a low dead volume device. Although the subject device does not meet a lower dead space specification, it still meets the ISO 7886-1 recommendations to perform its intended use.
- Different dead space
8. Conclusion
The device is investigated for function to compare the operation of function between Shina Syringe, Shina Safety Syringe and predicate devices.
Comparison results demonstrate that the specifications and performance of the device are substantially equivalent to the legally marketed predicate device.
Therefore, it is concluded that Shina Syringe, Shina Safety Syringe are substantially equivalent to the legally marketed predicate devices.