PLPT LDV (Low Dead Volume) Sterile Syringe

K210443 · Poonglim Pharmatech, Inc. · QNQ · Feb 16, 2021 · General Hospital

Device Facts

• Record ID: K210443
• Device Name: PLPT LDV (Low Dead Volume) Sterile Syringe
• Applicant: Poonglim Pharmatech, Inc.
• Product Code: QNQ · General Hospital
• Decision Date: Feb 16, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

PLPT LDV (Low Dead Volume) Sterile Syringe is intended to be used for medical purpose to inject fluid into or withdraw fluid from body.

Device Story

Sterile, single-use, 1ml piston syringe; consists of calibrated polypropylene barrel and plunger with rubber seal; features Luer-lock connector for attachment to hypodermic needles or administration sets. Designed with specific plunger geometry to minimize dead space and reduce fluid waste. Operated manually by clinicians or healthcare providers in clinical settings for fluid injection or withdrawal. Device does not include a needle. Performance validated through bench testing for dead space reduction, biocompatibility, and sterility.

Clinical Evidence

Bench testing only. Conformance demonstrated with ISO 7886-1 (syringes), ISO 10993 series (biocompatibility), ISO 80369-7 (connectors), ASTM F756-17 (hemolysis), and USP standards for sterility, endotoxins, and particulate matter. Low dead space capability verified via bench testing.

Technological Characteristics

1ml piston syringe; materials: polypropylene (barrel/plunger rod), rubber (plunger). Luer-lock connection. Dead space ≤ 0.023mL. Sterilization: Ethylene Oxide (EO) gas. Standards: ISO 7886-1, ISO 10993-1/4/5/7/10/11, ISO 80369-7, ASTM F756-17, USP <71>, USP <85>, USP <788>.

Indications for Use

Indicated for medical use to inject or withdraw fluids from the body. No specific patient population, age, or gender restrictions stated.

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

• 1ml Luer Slip or Luer Lock Syringe (K192551)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Poonglim Pharmatech Inc. % Peter Chung President Plus Global 300, Atwood Pittsburgh, Pennsylvania 15213

Re: K210443

Trade/Device Name: PLPT LDV (Low Dead Volume) Sterile Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: QNQ Dated: February 11, 2021 Received: February 16, 2021

Dear Peter Chung:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Rumi Young Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K210443

Device Name PLPT LDV (Low Dead Volume) Sterile Syringe

Indications for Use (Describe)

PLPT LDV (Low Dead Volume) Sterile Syringe is 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) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(K) SUMMARY

| Preparation Date: | February 10, 2021 |
|--------------------|------------------------------------------------------|
| Submitter Name: | POONGLIM Pharmatech Inc. |
| | 21, Jayumuyeok 1-gil, Gunsan-si, Jeollabuk-do, Korea |
| Contact Person: | Peter Chung |
| | President, Plus Global |
| Telephone Number: | 412-512-8802 |
| E-mail Address: | [e-mail] |
| Trade Name: | PLPT LDV (Low Dead Volume) Sterile Syringe |
| Regulation Name: | Piston Syringe |
| Regulation Number: | 21 CFR 880.5860 |
| Product Code: | QNQ |
| Device Class: | Class II |
| Predicate Device: | K192551, 1ml Luer Slip or Luer Lock Syringe |

# Device Description

A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is not included. It is intended for various medical applications and is not dedication administration. At the distal end of the barrel is a Luer-lock connector for the attachment to a hypodermic needle or an administration set. This is a single-use device.

The PLPT LDV (Low Dead Volume) Sterile Syringe is designed to reduce the fluid waste because of its plunger design.

## Indications for Use

PLPT LDV (Low Dead Volume) Sterile Syringe

PLPT LDV (Low Dead Volume) Sterile Syringe is intended to be used for medical purpose to inject fluid into or withdraw fluid from body.

#### Discussions of differences in Indications for Use statement

The indications for use statement for the subject device is similar to the predicate device.

#### Technological Characteristics

The table below includes a comparison of the technological characteristics between the new device and those of the predicate device:

| Technological<br>Characteristic | Subject Device<br>PLPT LDV Sterile Syringe (Poonglim<br>Pharmatech Inc.)<br>K210443 | Predicate Device<br>1ml Luer Slip or Luer Lock Syringe<br>(Jiangsu Caina Medical Co., Ltd)<br>K192551 | Comments |
|---------------------------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|----------|
|---------------------------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|----------|

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| Syringe size | 1 ml | 1 ml | Same | |
|------------------------------|--------------------------------------------------|--------------------------------------------------|------------|------|
| Connection Type | Luer-lock type | Luer-lock or Luer-slip type | Same | |
| Dead space specification | $≤$ 0.023mL with 95% confidence/95% reliability | ISO 7886-1 compliant | Comment #1 | |
| Materials of<br>Construction | Barrel: PP<br>Plunger rod: PP<br>Plunger: Rubber | Barrel: PP<br>Plunger rod: PP<br>Plunger: Rubber | Comment #2 | |
| | Sterilization Method | EO gas | EO gas | Same |

## Discussions of differences in technological characteristics

## Comment #1

PLPT LDV (Low Dead Volume) Sterile Syringe is design reduce dead space of the piston syringe. Dead space testing per ISO 7886-1 and analysis of drug delivery capability was provided to verify and validate this change.

#### Comment #2

PLPT LDV (Low Dead Volume) Sterile Syringe materials of construction are similar to the materials of the predicate. Differences were addressed through biocompatibility testing per ISO 10993-1.

# Performance Testing

The device, PLPT LDV Sterile Syringe, described in this summary was tested and demonstrated to be in conformance with the following FDA recognized standards:

- ISO 7886-1 Second edition: Sterile hypodermic syringes for single use - Part 1: Syringes for manual use
- ISO 10993-1:2018 Biological evaluation of medical devices-Part 1: Evaluation and testing ●
- ISO 10993-4:2017 Biological evaluation of medical devices-part 4: Selection of tests for interactions with blood
- ISO 10993-5:2009 Biological evaluation of medical devices-Part 5: Test for in vitro cytotoxicity ●
- ISO 10993-7:2008 Ethylene Oxide sterilization residuals ●
- ISO 10993-10:2010 Biological evaluation of medical devices-Part 10: Tests for irritation and skin ● sensitization
- ISO 10993-11:2017 Biological evaluation of medical devices-Part 11: Test for systemic toxicity ●
- ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications-Part 7: ● Connectors for intravascular or hypodermic applications
- ASTM F756-17 Standard practice for assessment of hemolytic properties of materials
- USP 39, <71> Sterility Test ●
- USP 39, <85> Bacterial Endotoxins Test

Additionally, bench testing demonstrating the low dead space capability of the syringe was conducted.

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#### Biocompatibility

In accordance with ISO 10993-1, the syringe is classified as: Externally Communicating Device, Blood Path Indirect, Limited Contact (<24 hours). The following testing results were conformed:

- Cytotoxicity .
- Sensitization .
- Irritation ●
- Acute Systemic Toxicity
- Material-Mediated Pyrogenicity ●
- Hemocompatibility ●

Particulate matter testing was conducted in accordance with USP <788> Particulate Matter in Injections and met the USP acceptance criteria.

#### Sterility, Shipping and Shelf-Life

- Sterilization validation was performed in accordance with ISO11135:2014 to prove that the EO Gas ● sterilization process has been suitable for the continuous production. Through validation, sterilization process was deemed acceptable.
- Shelf life of 3 years is validated in accordance with ISO11607-1:2006 and ISO11607-2:2006 ●

# Conclusions

The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The PLPT LDV Sterile Syringe (Poonglim Pharmatech Inc.) is substantially equivalent to the 1ml Luer Slip or Luer Lock Syringe (Jiangsu Caina Medical Co., Ltd) with respect to the indications for use, target populations, treatment method, and technological characteristics.