PLPT LDV (Low Dead Volume) LC(Luer-Cone) Sterile Syringe / PLPT LDV (Low Dead Volume) LL(Luer-Lock) Sterile 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 Description

PLPT LDV LC Sterile Syringe / PLPT LDV LL Sterile Syringe is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the skin. The device consists of a calibrated barrel (cylinder) with a plunger, and metal tube that is sharpened at one end and at the other end joined to a female connector (hub). This device is intended for various medical applications and is not dedication administration. The distal end of the barrel has a Luer-Cone or Luer-lock connector for the attachment to a hypodermic needle or an administration set. The attached needle is covered by the protective cap which is intended to provide physical protection to the needle tube. The attached needle may have a safety guard that protects the user after use. This product is packed by sterile paper and sterilized by EO gas, and is a single-use device.

AI/ML Overview

This document is a 510(k) summary for the PLPT LDV (Low Dead Volume) LC (Luer-Cone) Sterile Syringe and PLPT LDV (Low Dead Volume) LL (Luer-Lock) Sterile Syringe. It outlines the performance data and equivalence comparison to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily relies on compliance with established ISO standards and USP requirements rather than defining specific acceptance criteria values with corresponding measured performance values in a single table. Instead, it states that tests were "passed" or "met requirements." This is typical for medical device submissions demonstrating substantial equivalence to a predicate device by adhering to recognized consensus standards.

Here's a summary of the acceptance criteria (standards/test criteria) and reported performance:

Test Item	Test Method / Test Criteria	Reported Device Performance
Biocompatibility		All evaluation acceptance criteria were met.
Cytotoxicity Test	When tested accordingly to ISO 10993-5, tests for in vitro cytotoxicity - Test on extracts method, it should satisfy the requirements.	Pass
Hemolysis Test	When tested accordingly to ISO 10993-4, Selection of tests for interactions with blood - evaluation of hemolytic properties of medical devices and medical device materials, it should satisfy the requirements.	Pass
Intracutaneous Reactivity Test	When tested accordingly to ISO 10993-10, Tests for irritation and skin sensitization - Animal intracutaneous (Intradermal) reactivity test, it should satisfy the requirements.	Pass
Skin Sensitization Test	When tested accordingly to ISO 10993-10, Tests for irritation and skin sensitization - Guinea pig maximization test (GPMT), it should satisfy the requirements.	Pass
Acute Systemic Toxicity Test	When tested accordingly to ISO 10993-11, Tests for systemic toxicity - Acute systemic toxicity, it should satisfy the requirements.	Pass
Pyrogen Test	When tested accordingly to ISO 10993-11, Tests for systemic toxicity - Information on material-mediated pyrogens, it should satisfy the requirements.	Pass
LAL Test	USP39 <85>, Bacterial Endotoxins Test	Pass
Particulate Matter Injection	USP <788>, Particulate Matter for Injections (Method 1 Light Obscuration Particle Count Test). Test result should satisfy the requirements described in the USP <788>.	Pass
Sterility and LAL Test
LAL test	USP39 <85>, Bacterial Endotoxins Test (Unit : EU/Device)	Pass
E.O sterilization validation	According to ISO 11135:2014 E.O 30%, CO2 70% Temperature: 50 $\pm$ 7°C Exposure time: 5 hours	Pass
Sterility test	According to ISO 11737-2	Pass
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
Needle Injury Test
Needle penetration force	ISO 23908: 2011 Sharps injury protection	Pass
Pull-out force	ISO 23908: 2011 Sharps injury protection	Pass
Needle cap removal force	ISO 23908: 2011 Sharps injury protection	Pass
Activation (locking) force	ISO 23908: 2011 Sharps injury protection	Pass
Unlocking force	ISO 23908: 2011 Sharps injury protection	Pass
Mechanical Performance	Complies with ISO 7886-1:2017 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use.	Complies
Needle Performance Requirements	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.	Complies
Safety Feature Performance Specs	ISO 23908:2011 Sharps Injury Protection - Requirements And Test Methods - Sharps Protection Features For Single-Use Hypodermic Needles, Introducers For Catheters And Needles Used For Blood Sampling.	Complies
Dead Space Specification (Syringe)	≤ 0.023mL with 95% confidence/95% reliability	≤ 0.023mL
Dead Space Specification (Needle)	≤ 0.0054ml (No specific confidence/reliability mentioned for needle, but implied to meet this target)	≤ 0.0054ml
Shelf Life	ISO 11607-1:2006 and ISO 11607-2:2006 compliance for 5 years.	Validated for 5 years

2. Sample Size Used for the Test Set and Data Provenance:

The document mentions "Bench tests for the device's performance were conducted." and "Performance testing was conducted for this change". However, it does not specify the sample sizes used for the test sets for any of the performance or biocompatibility evaluations.

The data provenance is not explicitly stated in terms of country of origin, but the manufacturer is "Poonglim Pharmatech Inc." located in "Gunsan, 54001, Republic of Korea." The nature of the tests (bench, biocompatibility, sterility) implies prospective testing on manufactured devices, not retrospective data analysis.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not applicable and not provided in the document. The tests performed are objective, laboratory-based physical, chemical, and biological tests governed by international standards (ISO, USP). They do not require interpretation by a panel of human experts in the way clinical diagnostic or AI-based image analysis studies might.

4. Adjudication Method for the Test Set:

This information is not applicable as the tests are objective, laboratory-based evaluations against predetermined criteria. There is no human subjective assessment that requires adjudication.

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 information is not applicable and not provided. This document pertains to the market clearance of a sterile syringe, which is a physical medical device. It does not involve any artificial intelligence (AI) component or human diagnostic interpretation that would warrant an MRMC study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This information is not applicable and not provided. This device is a physical syringe and does not have an algorithm or AI component.

7. The Type of Ground Truth Used:

The "ground truth" for the performance criteria and biocompatibility assessments is based on established international consensus standards (ISO) and pharmacopeial monographs (USP). For instance, cytotoxicity is evaluated against requirements of ISO 10993-5, sterility against ISO 11737-2, and mechanical properties against ISO 7886-1 and ISO 23908. These standards define the acceptable limits and methodologies, which serve as the "ground truth" for compliance.

8. The Sample Size for the Training Set:

This information is not applicable and not provided. This device is a physical syringe and does not involve machine learning or a training set.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable and not provided as there is no training set for this type of device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 29, 2024

Poonglim Pharmatech Inc. % Peter Chung, President PlusGlobal 300 Atwood Street Pittsburgh, Pennsylvania 15213

Re: K241190

Trade/Device Name: PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: Class II Product Code: QNQ, QNS, FMI Dated: January 19, 2024 Received: April 29, 2024

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.

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).

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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).

Sincerely,

Gang Peng -S

for

Shruti Mistry Assistant Director Division of Drug Delivery and General Hospital Devices, and Human Factors 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) K241190

Device Name

PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe: PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image contains a logo for "PLPT POONGLIM Pharmatech Inc.". The logo has the letters "PLPT" in blue, stacked on top of the company name in Korean and English. The font is sans-serif and the overall design is simple and modern.

510(k) Summary K241190

[as required by 807.92(c)]

Date of Preparation: May 23, 2024 1.

2. Applicant

Company: Poonglim Pharmatech Inc. 1)
1. Address: 21, Jayumuyeok 1-Gil, Gunsan, 54001, Republic of Korea
1. Tel: +82-63-451-8141
1. Fax: +82-63-451-8145
ર) Contact person: Peter Chung, 412-512-8802
Contact person address: 300 Atwood Street, Pittsburgh, PA, 15213, USA 6)
1. Submission date: April 29, 2024

3. Subject Device Information

1. Trade name: PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe
1. Common name: Piston syringe
Classification name: Low Dead Space Piston Syringe 3)
1. Product code: QNQ, QNS, FMI
1. Regulation number: 21 CFR 880.5860
Class of device: Class II 6)
1. Panel: General hospital

4. Predicate Device

1.1 Predicate device
1. Trade name (Predicate Submission Number):

PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe (K221860)

1. Manufacturer: Poonglim Pharmatech Inc.

રા Device description

6. Indications for Use:

7. Performance data:

1. Bench tests for the device's performance were conducted. Bench testing includes the mechanical testing, sterility testing including EO residuals. The tests demonstrated that the device performs in a substantially equivalent manner to the predicate device. Bench testing was done in accordance with the following standards:
- ISO 7886-1:2017 Sterile hypodermic syringes for single use a.
- ISO 7864:2016 Sterile hypodermic needles for single use b.
- ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices Requirements C. and test methods
- ISO 80369-7:2021- Small-bore connectors for liquids and gases in healthcare applications Part 7: d.

K241190

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Image /page/4/Picture/0 description: The image contains the logo for Poonglim Pharmatech Inc. The logo consists of the letters "pLpT" in blue, stacked on top of the company name in Korean and English. The English version of the name, "POONGLIM Pharmatech Inc.", is in a smaller font size and is located below the Korean version.

Connectors for intravascular or hypodermic applications

2) Biocompatibility

Biocompatibility of the PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile 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; Pyrogenicity. All evaluation acceptance criteria were met.

Test item	Test method / Test criteria	Test result
Cytotoxicitytest	When it was tested accordingly to ISO 10993-5, tests for in vitro cytotoxicity-Test on extracts method, it should satisfy the requirements.	Pass
Hemolysis test	When it was tested accordingly to ISO 10993-4, Selection off tests forinteractions with blood-evaluation of hemolytic properties of medical devicesand medical device materials, it should satisfy the requirements.	Pass
Intracutaneousreactivity test	When it was tested accordingly to ISO 10993-10, Tests for irritation and skinsensitization-Animal intracutaneous (Intradermal) reactivity test, it shouldsatisfy the requirements.	Pass
Skinsensitizationtest	when it was tested accordingly to ISO 10993-10, Tests for irritation and skinsensitization-Guinea pig maximization test (GPMT), it should satisfy therequirements.	Pass
Acute systemictoxicity test	When it was tested accordingly to ISO 10993-11, Tests for systemic toxicity-Acute systemic toxicity, it should satisfy the requirements.	Pass
Pyrogen Test	When it was tested accordingly to ISO 10993-11, Tests for systemic toxicity-Information on material-mediated pyrogens, it should satisfy the requirements.	Pass
LAL Test	USP39 <85>, Bacterial Endotoxins Test	Pass
ParticulateMatter Injection	USP <788>, Particulate Matter for Injections (Method 1 Light ObscurationParticle Count Test). Test result should satisfy the requirements described in theUSP <788>.	Pass

3) Sterility and LAL test

The sterilization method has been validated to ISO 11135, which has thereby determined the routine control and monitoring parameters. The testing is performed according to the following standards:

#	Test item	Test standard	Test result
1	LAL test	USP39 <85>, Bacterial Endotoxins Test (Unit : EU/Device)	Pass
2	E.O sterilizationvalidation	According to ISO 11135:2014E.O 30%, CO2 70%Temperature: 50 $\pm$ 7°CExposure 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 sterilizationresiduals, the test articles should meet the test requirements.	Pass

4) Needle injury test

#	Test item	Test standard	Test result
1	Needlepenetration force	ISO 23908: 2011 Sharps injury protection	Pass
2	Pull-out force	ISO 23908: 2011 Sharps injury protection	Pass
3	Needle capremoval 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

8. Substantially Equivalent (SE) Comparison

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Image /page/5/Picture/0 description: The image contains a logo for Poonglim Pharmatech Inc. The logo consists of the letters "pLpT" in blue, stacked above the Korean text "풍림파마텍" which is also in blue. Below the Korean text is the English translation "POONGLIM Pharmatech Inc." in a smaller font size, also in blue.

Syringe 8.1.

	Proposed device	Approved device	Remark
Manufacturer	POONGLIM Pharmatech Inc.	POONGLIM Pharmatech Inc.	Same
510(K) No.	K241190	K221860	N/A
Indication for use	PLPT LDV (Low Dead Volume) LC(Luer-Cone) Sterile Syringe / PLPT LDV (LowDead Volume) LL(Luer-Lock) Sterile Syringeis intended for use by health care professionalsfor general purpose aspiration of fluid fromvials, ampoules and liquid injection below thesurface of the skin.	PLPT LDV (Low Dead Volume) LC(Luer-Cone) Sterile Syringe / PLPT LDV (LowDead Volume) LL(Luer-Lock) Sterile Syringeis intended for use by health care professionalsfor general purpose aspiration of fluid fromvials, ampoules and liquid injection below thesurface of the skin.	Same
Classification name	Syringe, Piston	Syringe, Piston	Same
Components	Barrel, Plunger, Plunger rod	Barrel, Plunger, Plunger rod	Same
Dead spacespecification	≤ 0.023mL with 95% confidence/95%reliability	≤ 0.023mL with 95% confidence/95%reliability	Same
Connection type	Luer-lock, Luer-cone	Luer-lock, Luer-cone	Same
	Raw Materials
Plunger rod	PP	PP	Same
Plunger	Rubber	Rubber	Same
Barrel	PP	PP	Same
Capacity (Syringevolume)	0.5, 1, 3, 5, 10 mL	0.5, 1 mL	Difference#1
Sterilization method	E.O Gas Sterilization	E.O Gas Sterilization	Same
SAL	10-6	10-6	Same
Performances	Complies with ISO 7886-1 : 2017 Sterilehypodermic syringes for single use - Part 1 :Syringes for manual use	Complies with ISO 7886-1 : 2017 Sterilehypodermic syringes for single use - Part 1 :Syringes for manual use	Same
Biocompatibility	Conforms to therequirements of ISO 10993series standards.CytotoxicityHemolysis testPyrogen testIntracutaneous reactivity testSkin sensitization testAcute systemic toxicity testLAL test (Endotoxin)Sterility testE.O. Gas Residual	Conforms to therequirements of ISO 10993series standards.CytotoxicityHemolysis testPyrogen testIntracutaneous reactivity testSkin sensitization testAcute systemic toxicity testLAL test (Endotoxin)Sterility testE.O. Gas Residual	Same
Principle ofOperation	The plunger of syringe can be pulled andpushed along inside the barrel, allowing thesyringe to take in and expel the fluids throughthe connector to the patient. For Manual UseOnly,For Single Use Only	The plunger of syringe can be pulled andpushed along inside the barrel, allowing thesyringe to take in and expel the fluids throughthe connector to the patient. For Manual UseOnly,For Single Use Only	Same

Equivalence discussion

Difference 1 - Capacity (Syringe Volume)

Although the configuration of PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe is similar to the configuration of the predicate device, the capacity (syringe volume) of the proposed device is different from the predicate device. However, this change is just in dimension. This difference does not alter the risks or raise potential risks per its intended use. Other aspects (e.g., Biocompatibility) are the same with the predicate device. Performance testing was conducted for this change, and it was confirmed that the differences on configuration do not raise new or different questions of safety and effectiveness when compared to the predicate device.

8.2. Needle

	Proposed device	Approved device	Remark
Manufacturer	POONGLIM Pharmatech Inc.	POONGLIM Pharmatech Inc.	Same
510(K) No.	K241190	K221860	N/A
Indication for use	PLPT LDV (Low Dead Volume) LC(Luer-Cone) Sterile Syringe / PLPT LDV (Low	PLPT LDV (Low Dead Volume) LC(Luer-Cone) Sterile Syringe / PLPT LDV (Low	Same

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Image /page/6/Picture/0 description: The image contains a logo for POONGLIM Pharmatech Inc. The logo consists of the letters "pLpT" in blue, stacked on top of each other. Below the letters, there is Korean text, followed by the English text "POONGLIM Pharmatech Inc."

	Dead Volume) LL(Luer-Lock) Sterile	Dead Volume) LL(Luer-Lock) Sterile
	Syringe is intended for use by health care	Syringe is intended for use by health care
	professionals for general purpose aspiration	professionals for general purpose aspiration
	of fluid from vials, ampoules and liquid	of fluid from vials, ampoules and liquid
	injection below the surface of the skin.	injection below the surface of the skin.
Raw Material
Hub of needle	Polypropylene (PP)	Polypropylene (PP)
Protect cap	Polypropylene (PP)	Polypropylene (PP)	Same
Cannula	SUS304	SUS304
Adhesive	Epoxy	Epoxy
Length	4, 6, 8, 13, 16, 25, 30, 40mm	4, 6, 8, 13, 16, 25, 30, 40mm
Gauge	18, 21, 22, 23, 25, 26, 27, 29, 30, 31, 32,	21, 22, 23, 25, 26, 27, 29, 30, 31, 32, 33,	Difference#2
	33, 34G	34G
Dead space
specification	≤0.0054ml	≤0.0054ml	Same
Tip configuration	Bevel	Bevel	Same
Wall type	TW	TW	Same
	ISO 7864: 2016 Sterile hypodermic needles	ISO 7864: 2016 Sterile hypodermic needles
	for single use - Requirements and test	for single use - Requirements and test
Needle	methods	methods
Performance			Same
Requirements	ISO 9626: 2016 Stainless steel needle	ISO 9626: 2016 Stainless steel needle
	tubing for the manufacture of medical	tubing for the manufacture of medical
	devices - Requirements and test methods	devices - Requirements and test methods
Safety featureperformancespecification	ISO 23908: 2011 Sharps Injury Protection -	ISO 23908: 2011 Sharps Injury Protection -	Same
	Requirements And Test Methods - Sharps	Requirements And Test Methods - Sharps
	Protection Features For Single-Use	Protection Features For Single-Use
	Hypodermic Needles, Introducers For	Hypodermic Needles, Introducers For
	Catheters And Needles Used For Blood	Catheters And Needles Used For Blood
	Sampling	Sampling
	Conforms to the	Conforms to the	Same
	requirements of ISO 10993	requirements of ISO 10993
	series standards.	series standards.

	Cytotoxicity	Cytotoxicity
	Cytotoxicity (Hub)	Cytotoxicity (Hub)
	Hemolysis test	Hemolysis test
Biocompatibility	Pyrogen test	Pyrogen test
	Intracutaneous reactivity test	Intracutaneous reactivity test
	Skin sensitization test	Skin sensitization test
	Acute systemic toxicity test	Acute systemic toxicity test
	LAL test (Endotoxin)	LAL test (Endotoxin)
	Sterility test	Sterility test
	E.O. Gas Residual	E.O. Gas Residual
Sterilization method	E.O Gas Sterilization	E.O Gas Sterilization	Same
SAL	10-6	10-6	Same
Label/Labeling	Complied with 21 CFR part 801	Complied with 21 CFR part 801	Same

Equivalence discussion

Difference #2 – Needle gauge

The overall configuration of PLPT LDV LL/LC Sterile Syringe's needle component is similar as the configuration of the predicate device; the difference is that the subject device has more variable needle configurations. However, the needle configuration is widely used clinically. Performance testing for the needle component was conducted in accordance to internationally recognized standard (ISO 7864, and the testing shows that the needle configuration of the subject device conforms with the relevant standards. Therefore, the differences in the configuration do not raise new or different questions of safety and/or effectiveness when compared to the predicate device.

9. Sterility, Shipping and Shelf-Life

Sterilization validation was performed in accordance with ISO 11135:2014 to show that the E.O Gas sterilization process has been suitable for the continuous production, sterilization process was deemed acceptable.

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Image /page/7/Picture/0 description: The image contains a logo for a company called "POONGLIM Pharmatech Inc." The logo consists of the letters "pLpT" in blue, stacked on top of each other. Below the letters, the company name is written in Korean and English. The Korean text is larger and bolder than the English text.

Also, the device's Shelf life of 5 years is validated in accordance with ISO 11607-1:2006 and ISO 11607-2:2006.

10. Substantially Equivalent (SE) Conclusion

The differences between the subject and predicate devices do not raise any new or different questions of safety and effectiveness when compared to the predicate device. A comparison to the predicate device has been conducted and demonstrated that the specifications and performance of the device are substantially equivalent as the legally marketed predicate device.

Regulation Number and Section

§ 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).