(185 days)
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.
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.
This document describes the acceptance criteria and study proving the device meets those criteria for the Shina Syringe and Shina Safety Syringe.
The listed information primarily focuses on bench testing for mechanical, physical, and biocompatibility properties, rather than effectiveness studies involving human subjects or AI-assisted diagnoses. Therefore, several requested sections, particularly those related to clinical studies, human readers, ground truth establishment for training sets, and effect sizes of AI assistance, are not applicable based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
The device performance is demonstrated by compliance with various ISO standards and USP <788>. The document does not explicitly present specific numerical results for each test item but states that the tests demonstrated that the device performs in a substantially equivalent manner to the predicate device and meets the requirements.
Syringe
| Test Item | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Appearance and Structure | ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use | Demonstrated substantial equivalence |
| Graduated capacity | ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use | Demonstrated substantial equivalence |
| Scale | ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use | Demonstrated substantial equivalence |
| Barrel | ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use | Demonstrated substantial equivalence |
| Plunger stopper / Plunger assembly | ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use | Demonstrated substantial equivalence |
| Nozzle | ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use | Demonstrated substantial equivalence |
| Dead Space | ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use | Meets ISO 7886-1 standard |
| Freedom from liquid leakage past plunger stopper | ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use | Demonstrated substantial equivalence |
| Freedom from air leakage past plunger stopper | ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use | Demonstrated substantial equivalence |
| Force to operate the piston | ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use | Demonstrated substantial equivalence |
| Fit of plunger stopper / plunger in barrel | ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use | Demonstrated substantial equivalence |
| Amount of Silicon Oil | 0.25mg or less per square centimeter of inner area | Demonstrated substantial equivalence |
| EO Gas residuals | ISO 10993-7:2008 Ethylene oxide sterilization residuals | Reported Compliance |
| Sterility test | EO, ECH residuals | Reported Compliance |
Needle
| Test Item | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Cleanliness | ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods | Demonstrated substantial equivalence |
| Size designation | ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods | Demonstrated substantial equivalence |
| Colour coding | ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods | Demonstrated substantial equivalence |
| Needle hub | ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods | Demonstrated substantial equivalence |
| Needle tube (Tolerances on length) | ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods | Demonstrated substantial equivalence |
| Freedom from defects | ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods | Demonstrated substantial equivalence |
| Lubricant | ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods | Demonstrated substantial equivalence |
| Needle point | ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods | Demonstrated substantial equivalence |
| Bond between hub and needle tube | ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods | Demonstrated substantial equivalence |
| Patency of lumen | ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods | Demonstrated substantial equivalence |
| Sharps injury protection | ISO 23908:2011 Sharps injury protection | Reported Compliance |
| Materials | ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices – Requirements and test methods | Demonstrated substantial equivalence |
| Surface finish and visual appearance | ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices – Requirements and test methods | Demonstrated substantial equivalence |
| Cleanliness | ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices – Requirements and test methods | Demonstrated substantial equivalence |
| Limits for acidity and alkalinity | ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices – Requirements and test methods | Demonstrated substantial equivalence |
| Size designation | ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices – Requirements and test methods | Demonstrated substantial equivalence |
| Dimension | ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices – Requirements and test methods | Demonstrated substantial equivalence |
| Stiffness | ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices – Requirements and test methods | Demonstrated substantial equivalence |
| Resistance to breakage | ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices – Requirements and test methods | Demonstrated substantial equivalence |
| Resistance to corrosion | ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices – Requirements and test methods | Demonstrated substantial equivalence |
Syringe with needle (Model : WNLS0125)
| Test Item | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Extraction : pH | Difference of pH $\leq$ 1.0 | Reported Compliance |
| Extraction : Potassium permanganate reducing substances | Difference of the consumption $\leq$ 2.0 mL | Reported Compliance |
| Extraction: Residue on evaporation | Amount of residue $\leq$ 1.0 mg | Reported Compliance |
| Extraction: Pb, Fe, Sn, Zn | Total content of heavy metals $\leq$ 5.0 mg/L | Reported Compliance |
| Extraction: Cd | Content of Cd $\leq$ 0.1 mg/L | Reported Compliance |
Syringe with needle (Particulate test for various models including WNLG0123, WNLS0123, WNSG0125, WNLS0125, WNLG0323, WNLS0323, WNSG0325, WNLS0325, WNLG0523, WNLS0523, WNSG0525, WNLS0525, WNLG1023, WNLS1023, WNSG1025, WNLS1025)
| Test Item | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Particulate test report | USP <788> Method 1. Light obscuration method | Reported Compliance |
Safety test
| Test Item | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Simulated Clinical Use | ISO 23908:2011 Sharps injury protection | Reported Compliance |
Biocompatibility (for 25G Model, 23G Model, and Syringe Model SSN2301)
| Test Item | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Cytotoxicity | ISO 10993-5:2009 Biological evaluation of medical devices - Part 5 | Reported Compliance |
| Acute systemic toxicity test | ISO 10993-11:2017 Biological evaluation of medical devices - Part 11 | Reported Compliance |
| Pyrogen test | ISO 10993-11:2017 Test for systemic toxicity, pyrogen test USP <151> | Reported Compliance |
| Sensitization test | ISO 10993-10:2010 Biological evaluation of medical devices - Part 10 | Reported Compliance |
| Hemolytic test | ISO 10993-4:2017, ASTM F756-17 | Reported Compliance |
| Intracutaneous reactivity test | ISO 10993-23:2021 Biological evaluation of medical devices - Part 23 | Reported Compliance |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size for each bench test conducted. The provenance of the data is that these are bench tests conducted by the manufacturer, Shina Med Corporation, in the Republic of Korea. The studies are by nature retrospective in the context of device development, where the device is manufactured and then tested to established standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable. The ground truth for these types of mechanical, physical, and biocompatibility tests is established by published international standards (ISO, USP, ASTM), not by expert consensus in diagnostic interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. Adjudication methods are typically used in clinical studies involving interpretation of medical data by multiple experts. The reported studies are bench tests against defined international standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This section is not applicable. No MRMC comparative effectiveness study was performed or discussed, as the device is a syringe and needle, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is a physical medical device (syringe and needle) and does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for these tests are established international and national standards for medical devices, specifically:
- ISO 7886-1: Sterile hypodermic syringes for single use
- ISO 7864: Sterile hypodermic needles for single use
- ISO 9626: Stainless steel needle tubing
- USP <788>: Particulate Matter in Injections
- ISO 23908: Sharps injury protection
- ISO 10993 series for Biological evaluation of medical devices (Parts 4, 5, 7, 10, 11, 23)
- ASTM F756-17: Standard Practice for Assessment of Hemolytic Properties of Materials
8. The sample size for the training set
This section is not applicable. As this is a physical medical device submission focusing on bench testing, there is no AI model or "training set" in the context of machine learning.
9. How the ground truth for the training set was established
This section is not applicable for the same reasons as section 8.
{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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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 onlength) | 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 needletube | 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 medicaldevices – Requirements and test methods |
| Surface finish and visual appearance | ISO 9626:2016 Stainless steel needle tubing for the manufacture of medicaldevices – Requirements and test methods |
| Cleanliness | ISO 9626:2016 Stainless steel needle tubing for the manufacture of medicaldevices – Requirements and test methods |
| Limits for acidity and alkalinity | ISO 9626:2016 Stainless steel needle tubing for the manufacture of medicaldevices – Requirements and test methods |
| Size designation | ISO 9626:2016 Stainless steel needle tubing for the manufacture of medicaldevices – Requirements and test methods |
| Dimension | ISO 9626:2016 Stainless steel needle tubing for the manufacture of medicaldevices – Requirements and test methods |
| Stiffness | ISO 9626:2016 Stainless steel needle tubing for the manufacture of medicaldevices – Requirements and test methods |
| Resistance to breakage | ISO 9626:2016 Stainless steel needle tubing for the manufacture of medicaldevices – Requirements and test methods |
| Resistance to corrosion | ISO 9626:2016 Stainless steel needle tubing for the manufacture of medicaldevices – 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 <788> Method 1. Light obscuration method |
Syringe with needle (Model : WNLG0323, WNLS0323, WNSG0325, WNLS0325)
| Test item | Requirements |
|---|---|
| Particulate test report | USP <788> Method 1. Light obscuration method |
Syringe with needle (Model : WNLG0523, WNLS0523, WNSG0525, WNLS0525)
| Test item | Requirements |
|---|---|
| Particulate test report | USP <788> Method 1. Light obscuration method |
Syringe with needle (Model : WNLG1023, WNLS1023, WNSG1025, WNLS1025)
| Test item | Requirements |
|---|---|
| Particulate test report | USP <788> 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: Testsfor in vitro cytotoxicity |
| 2 | Acute systemic toxicitytest | 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 testUSP <151> |
| 4 | Sensitization test | ISO 10993-10:2010 Biological evaluation of medical devices - Part 10Tests for irritation and skin sensitization |
| 5 | Hemolytic test | ISO 10993-4:2017, ASTM F756-17 |
| 6 | Intracutaneous reactivitytest | ISO 10993-23 :2021 Biological evaluation of medical devices - Part 23Tests 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: Testsfor in vitro cytotoxicity |
| 2 | Acute systemic toxicitytest | 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 testUSP <151> |
| 4 | Sensitization test | ISO 10993-10:2010 Biological evaluation of medical devices – Part 10Tests for irritation and skin sensitization |
| 5 | Hemolytic test | ISO 10993-4:2017, ASTM F756-17 |
| 6 | Intracutaneous reactivitytest | ISO 10993-23:2021 Biological evaluation of medical devices – Part 23Tests 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: Testsfor in vitro cytotoxicity |
| 2 | Acute systemic toxicitytest | 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 testUSP <151> |
| 4 | Sensitization test | ISO 10993-10:2010 Biological evaluation of medical devices – Part 10Tests for irritation and skin sensitization |
| 5 | Hemolytic test | ISO 10993-4:2017, ASTM F756-17 |
| 6 | Intracutaneous reactivitytest | ISO 10993-23 :2021 Biological evaluation of medical devices – Part 23Tests 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 foruse | Shina Syringe, Shina SafetySyringe is a plastic sterilesyringe and hypodermicsingle lumen needleintended to be used formedical purpose to injectfluid into or withdraw fluidfrom body. | PLPT LDV (Low Dead Volume)Sterile Syringe is intended tobe used for medical purposeto inject fluid into or withdrawfluid from body. | This produce is intended foruse to inject fluid into orwithdraw fluids from parts ofthe body below the surface ofthe skin. | Identical |
| Classificationname | Syringe, Antistick | Low Dead Space PistonSyringe | Low Dead Space Needle,Single Lumen, Hypodermic | Different |
| Trade name | Shina Syringe, Shina SafetySyringe | PLPT LDV (Low Dead Volume)Sterile Syringe | EZ-Injec LDV Sterile SafetyNeedle | 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 |
| MaterialsNeedleHubSafety coverBarrelGasketPlunger | Stainless SteelPPPPPPHydrogenated styreneisoprene butadiene blockcopolymerPP | PPRubberPP | Stainless SteelPPPP | 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 ofoperation | Manual | Manual | Manual | Identical |
| Performances | ISO 7886ISO 7864ISO 9626USP <788>ISO 23908 | ISO 7886 | ISO 7864ISO 9626ISO 23908USP <788> | 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 | ||
| SterilizationMethod | 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 |
-
- 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
-
- 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
-
- 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
-
- 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
-
- 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
-
- 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.
§ 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).