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.

AI/ML Overview

The provided FDA 510(k) summary for the PLPT LDV (Low Dead Volume) Sterile Syringe describes its performance testing but does not contain information typically associated with studies for AI/algorithm-driven medical devices.

This document describes a traditional medical device (a syringe) and focuses on engineering, material, and biological compatibility testing, not on algorithm performance, human reader studies, or ground truth establishment for AI.

Therefore, many of the requested sections (2, 3, 4, 5, 6, 7, 8, 9) are not applicable or cannot be answered from the provided text.

Here's a breakdown of the relevant and irrelevant information based on your request:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Standard)	Reported Device Performance
Dead space specification (ISO 7886-1 compliant)	≤ 0.023mL with 95% confidence/95% reliability
Cytotoxicity (ISO 10993-5)	Conformed (Met acceptance criteria)
Sensitization (ISO 10993-10)	Conformed (Met acceptance criteria)
Irritation (ISO 10993-10)	Conformed (Met acceptance criteria)
Acute Systemic Toxicity (ISO 10993-11)	Conformed (Met acceptance criteria)
Material-Mediated Pyrogenicity (ISO 10993-11 for systemic toxicity)	Conformed (Met acceptance criteria)
Hemocompatibility (ISO 10993-4, ASTM F756-17)	Conformed (Met acceptance criteria)
Particulate Matter (USP <788>)	Met USP acceptance criteria
Sterility (USP 39, <71>, ISO 11135:2014)	Sterilization process deemed acceptable (validated)
Bacterial Endotoxins (USP 39, <85>)	(Implied met, as part of ISO 10993-4/11 or general biocompatibility)
Shelf-life (3 years) (ISO 11607-1:2006 and ISO 11607-2:2006)	Validated
Small-bore connectors (ISO 80369-7:2016)	(Implied met, as listed as conformed standard)
General requirements for sterile hypodermic syringes (ISO 7886-1)	(Implied met, as listed as conformed standard)
Biological evaluation of medical devices (ISO 10993-1:2018)	Conformed (Relevant parts tested and met criteria)
Ethylene Oxide sterilization residuals (ISO 10993-7:2008)	(Implied met, as part of overall sterilization validation)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable / Not provided. This information is for AI/algorithm studies. The document describes bench testing for a physical device. While specific sample sizes for tests like dead space measurement, biocompatibility, or sterility validation would have been used, they are not detailed in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable / Not provided. This information is for AI/algorithm studies. The "ground truth" for a physical device is typically established through direct measurement against established standards or validated laboratory methods, not expert consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable / Not provided. This information is for AI/algorithm studies involving human readers or interpretation.

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

No. This is not an AI-assisted device. The device is a physical syringe.

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

Not applicable / No. This is not an algorithm-only device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the performance testing of this physical device relied on established international and national standards, laboratory methods, and physical measurements. For example:
- Dead space: Measured directly against the specified quantitative limit.
- Biocompatibility: Evaluated through laboratory tests like cytotoxicity, sensitization, and irritation following ISO standards.
- Sterility: Determined through microbiological testing according to USP and ISO standards.
- Particulate Matter: Measured using methods described in USP <788>.

8. The sample size for the training set

Not applicable / Not provided. This information is for AI/algorithm studies. This document describes a physical medical device.

9. How the ground truth for the training set was established

Not applicable / Not provided. This information is for AI/algorithm studies.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
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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:	peterchung210@gmail.com
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

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:

TechnologicalCharacteristic	Subject DevicePLPT LDV Sterile Syringe (PoonglimPharmatech Inc.)K210443	Predicate Device1ml Luer Slip or Luer Lock Syringe(Jiangsu Caina Medical Co., Ltd)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 ofConstruction	Barrel: PPPlunger rod: PPPlunger: Rubber	Barrel: PPPlunger rod: PPPlunger: 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.

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).