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

Q: Who is the manufacturer of PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe?

Poonglim Pharmatech, Inc. filed the 510(k) submission for PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe (K241190).

Q: What is the FDA product code for PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe?

QNQ. It is classified under 21 CFR 880.5860 as a Class 2 device in the General Hospital panel.

Q: What is the regulatory pathway for PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe?

510(k) clearance (submission type: Special).

Q: Who can help prepare an FDA 510(k) submission like PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K241190 · Poonglim Pharmatech, Inc. · QNQ · May 29, 2024 · General Hospital

Device Facts

Record ID	K241190
Device Name	PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe
Applicant	Poonglim Pharmatech, Inc.
Product Code	QNQ · General Hospital
Decision Date	May 29, 2024
Decision	SESE
Submission Type	Special
Regulation	21 CFR 880.5860
Device Class	Class 2
Attributes	Therapeutic

Intended Use

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 Story

Device consists of calibrated barrel, plunger, and sharpened metal needle with hub; distal end features Luer-Cone or Luer-Lock connector for attachment to needle or administration set. Used by healthcare professionals for fluid aspiration and injection below skin surface. Manual operation: user pulls/pushes plunger within barrel to intake/expel fluids. Needle includes protective cap; some versions include safety guard. Single-use, EO-sterilized device. Benefits include low dead volume, reducing medication waste.

Clinical Evidence

Bench testing only. Testing included mechanical performance, sterility, EO residuals, and biocompatibility (ISO 10993). Performance met requirements for ISO 7886-1 (syringes), ISO 7864 (needles), ISO 9626 (tubing), ISO 80369-7 (connectors), and ISO 23908 (sharps injury protection).

Technological Characteristics

Materials: PP (barrel, plunger rod, hub, cap), Rubber (plunger), SUS304 (cannula), Epoxy (adhesive). Principle: Manual piston syringe. Connectivity: None. Sterilization: EO gas (ISO 11135). Dimensions: Syringe 0.5-10 mL; Needle 4-40 mm length, 18-34G. Connectors: Luer-Cone/Luer-Lock (ISO 80369-7).

Indications for Use

Indicated for use by healthcare professionals for general purpose aspiration of fluid from vials, ampoules, and liquid injection below the skin surface.

Regulatory Classification

Identification

A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.

Predicate Devices

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

Related Devices

K221860 — PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe · Poonglim Pharmatech, Inc. · Sep 15, 2023
K133493 — SINGLE USE STERILE SYRINGE WITH NEEDLE · Jiangxi Kelun Medical Devices Manufacturing Co.,Lt · Mar 27, 2014
K022159 — PISTON SYRINGE & HYPODERMIC NEEDLE · International Medsurg Connection · Nov 7, 2002
K130230 — STERILE PISTON HYPODERMIC SYRINGES (WITH/WITHOUT NEEDLE), HYPODERMIC NEEDLES · Wuxi Yushou Medical Applicances Co., Ltd. · Nov 20, 2013
K231729 — Sterile syringes for single use with/without needle · Wepon Medical Technology Co., Ltd. · Sep 8, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ 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). {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) 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. Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) <input checked="true" type="checkbox"/> | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Over-The-Counter Use (21 CFR 801 Subpart C) <input type="checkbox"/> | ### 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." {3}------------------------------------------------ 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) - 2) Address: 21, Jayumuyeok 1-Gil, Gunsan, 54001, Republic of Korea - 3) Tel: +82-63-451-8141 - 4) Fax: +82-63-451-8145 - ર) Contact person: Peter Chung, 412-512-8802 - Contact person address: 300 Atwood Street, Pittsburgh, PA, 15213, USA 6) - 7) 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 - 2) Common name: Piston syringe - Classification name: Low Dead Space Piston Syringe 3) - 4) Product code: QNQ, QNS, FMI - 5) Regulation number: 21 CFR 880.5860 - Class of device: Class II 6) - 7) 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) - 2) Manufacturer: Poonglim Pharmatech Inc. ### રા 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. #### 6. Indications for Use: 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. #### 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 {4}------------------------------------------------ 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 | |-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------| | Cytotoxicity test | 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 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 it was 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 it was 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 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 | | 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 | ### 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 sterilization validation | According to ISO 11135:2014 E.O 30%, CO2 70% Temperature: 50 $\pm$ 7°C Exposure time: 5 hours | Pass | | 3 | Sterility test | According to ISO 11737-2 | Pass | | 4 | E.O Residual test | Under the conditions of ISO 10993-7:2008, Ethylene oxide sterilization residuals, the test articles should meet the test requirements. | Pass | ### 4) Needle injury test | # | Test item | Test standard | Test result | |---|-------------------------------|------------------------------------------|-------------| | 1 | Needle penetration force | ISO 23908: 2011 Sharps injury protection | Pass | | 2 | Pull-out force | ISO 23908: 2011 Sharps injury protection | Pass | | 3 | Needle cap removal force | ISO 23908: 2011 Sharps injury protection | Pass | | 4 | Activation (locking) force | ISO 23908: 2011 Sharps injury protection | Pass | | 5 | Unlocking force | ISO 23908: 2011 Sharps injury protection | Pass | ### 8. Substantially Equivalent (SE) Comparison {5}------------------------------------------------ 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 (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. | 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. | Same | | Classification name | Syringe, Piston | Syringe, Piston | Same | | Components | Barrel, Plunger, Plunger rod | Barrel, Plunger, Plunger rod | Same | | Dead space specification | ≤ 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 (Syringe volume) | 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 Sterile hypodermic syringes for single use - Part 1 : Syringes for manual use | Complies with ISO 7886-1 : 2017 Sterile hypodermic syringes for single use - Part 1 : Syringes for manual use | Same | | Biocompatibility | Conforms to the requirements of ISO 10993 series standards. Cytotoxicity Hemolysis test Pyrogen test Intracutaneous reactivity test Skin sensitization test Acute systemic toxicity test LAL test (Endotoxin) Sterility test E.O. Gas Residual | Conforms to the requirements of ISO 10993 series standards. Cytotoxicity Hemolysis test Pyrogen test Intracutaneous reactivity test Skin sensitization test Acute systemic toxicity test LAL test (Endotoxin) Sterility test E.O. Gas Residual | Same | | Principle of Operation | The plunger of syringe can be pulled and pushed along inside the barrel, allowing the syringe to take in and expel the fluids through the connector to the patient. For Manual Use Only, For Single Use Only | The plunger of syringe can be pulled and pushed along inside the barrel, allowing the syringe to take in and expel the fluids through the connector to the patient. For Manual Use Only, 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 | {6}------------------------------------------------ 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 feature performance specification | 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. {7}------------------------------------------------ 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.

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

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Predicate Devices

Related Devices

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

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

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