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 the surface of the skin. The device consists of a calibrated barrel (cylinder) with 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. At 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. Attached needle has covered by the protective cap which is intended to provide physical protection to the needle tube. Attached needle may have safety guard that protect the user after use. This product is packed by sterile paper and sterilized by EO gas, and single-use device.

AI/ML Overview

This document describes the regulatory approval for a medical device, specifically a Low Dead Volume (LDV) Sterile Syringe (PLPT LDV LC/LL Sterile Syringe). The provided text is an FDA 510(k) Premarket Notification, which focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness or clinical superiority through extensive comparative clinical trials.

Therefore, the information about acceptance criteria and study proving the device meets those criteria will be focused on bench testing and biocompatibility assessments demonstrating equivalence to established standards and predicate devices, rather than complex multi-reader, multi-case studies typically seen for AI/ML devices.

Here's the breakdown based on the provided text:

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

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

Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily based on established international standards for medical devices and comparison to predicate devices. The device's performance is demonstrated through adherence to these standards and the fulfillment of specific regulatory requirements.

Acceptance Criteria Category	Specific Acceptance Criteria (Standard / Test Method / Limit)	Reported Device Performance (Compliance / Result)
Mechanical Performance	ISO 7886-1:2017 Sterile hypodermic syringes for single use (Syringe performance)	Complies with ISO 7886-1:2017
	ISO 7864:2016 Sterile hypodermic needles for single use (Needle performance)	Complies with ISO 7864:2016
	ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices	Complies with ISO 9626:2016
	ISO 80369-7:2021 Small-bore connectors for liquids and gases in healthcare applications (Connector performance)	Complies with ISO 80369-7:2021
Biocompatibility	ISO 10993-1:2018 (Body contact: External communication device – Blood path indirect; Duration: Limited (< 24 hours))	All evaluation acceptance criteria were met.
	Cytotoxicity (ISO 10993-5)	Satisfied requirements
	Hemolysis (ISO 10993-4)	Satisfied requirements
	Intracutaneous Reactivity (ISO 10993-10)	Satisfied requirements
	Skin Sensitization (ISO 10993-10, GPMT)	Satisfied requirements
	Acute Systemic Toxicity (ISO 10993-11)	Satisfied requirements
	Pyrogenicity (ISO 10993-11)	Satisfied requirements
	LAL Test (USP39 <85>, Bacterial Endotoxins Test)	Satisfied requirements
	Particulate Matter Injection (USP <788>)	Satisfied requirements
Sterility	ISO 11135:2014 Ethylene Oxide (EO) Sterilization Validation (Parameters: EO 30%, CO2 70%; Temp: 50 ±7°C; Exposure: 5 hours)	Validated and deemed acceptable.
	Sterility Test (ISO 11737-2)	Complied
	EO Residual Test (ISO 10993-7:2008)	Met test requirements
	Sterility Assurance Level (SAL)	10⁻⁶
	Endotoxin Limit	20 EU per device
Low Dead Volume	Syringe Dead Space: ≤ 0.023 mL	≤ 0.023 mL (Same as predicate)
	Needle Dead Space: < 0.0054 mL	< 0.0054 mL (Same as predicate)
Sharps Injury Protection	ISO 23908:2011 Sharps injury protection	Complies with ISO 23908:2011
Shelf-Life	ISO 11607-1:2006 and ISO 11607-2:2006 (for 3 years)	Validated for 3 years
Labeling	21 CFR part 801	Complied

2. Sample size used for the test set and the data provenance:

The document does not explicitly state the numerical sample sizes for each specific test (e.g., how many syringes were tested for each mechanical property, or how many biological samples were used for biocompatibility tests). However, for medical devices cleared via 510(k), it is expected that sufficient samples were used to meet the statistical requirements of the referenced ISO standards for design verification and validation.

Data Provenance: The studies were bench tests and biocompatibility evaluations. The data would be prospective, generated specifically for this 510(k) submission, likely conducted at the manufacturer's facilities or accredited testing labs. The country of origin for the data generation is not explicitly stated, but the manufacturer is based in Republic of Korea.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This type of information is generally not applicable for a 510(k) submission for a physical medical device like a syringe. The "ground truth" for these tests comes from adherence to established international engineering and biological standards (ISO, USP). There isn't a subjective "ground truth" established by human experts in the way there would be for an AI-based diagnostic tool. The "experts" are the engineers and scientists conducting the tests according to the specified protocols.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing consensus "ground truth" in human-in-the-loop diagnostic studies, typically involving image interpretation. For physical device performance, the results are quantitative measurements against predefined pass/fail criteria established by engineering standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a physical syringe, not an AI-assisted diagnostic tool. No MRMC study was conducted.

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

Not applicable. This device is a physical syringe, not an algorithm.

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

The "ground truth" for this device's performance is based on objective measurements and results from standardized bench tests and validated biological assays as defined by:

International Organization for Standardization (ISO) standards (e.g., ISO 7886-1, ISO 80369-7, ISO 10993 series, ISO 11135, ISO 11607, ISO 23908).
United States Pharmacopeia (USP) guidelines (e.g., USP <85>, USP <788>).

These standards define the acceptable performance characteristics for syringes and needles.

8. The sample size for the training set:

Not applicable. This device is a physical product and does not involve AI/ML requiring a "training set" in the computational sense.

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

Not applicable for the same reason as above.

Summary

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September 15, 2023

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

Re: K221860

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 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: QNG, QNG, FMI Dated: September 1, 2023 Received: September 5, 2023

Dear Peter Chung:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (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.

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542 of the Act); 21 CFR 1000-1050.

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 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 (QS) 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-

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.

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Digitally signed by Courtney Evans -S Date: 2023.09.15 22:15:47 -04'00'

For CAPT Alan Stevens 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) K221860

Device Name

PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe; PLPT LDV(Low Dead Volume) LC(Luer-Cone) 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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510(k) Summary K221860

[as required by 807.92(c)]

1. Date of Preparation: September 12, 2023

2. Applicant

1. Company: Poonglim Pharmatech Inc.
Address: 21, Jayumuyeok 1-Gil, Gunsan, 54001, Republic of Korea 2)
Tel : +82-63-451-8141 3)
Fax : +82-63-451-8145 4)
Contact person : Peter Chung, 412-512-8802 ર)
Contact person address : 300 Atwood Street, Pittsburgh, PA, 15213, USA 6)
Submission date: September 12, 2023 7)

Subject Device Information 3.

Trade name : PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) 1) LL(Luer-Lock) Sterile Syringe
1. Common name : Disposal syringe
1. Classification name : Low Dead Space Piston Syringe
Product code : ONQ 4)
1. Regulation number : 21 CFR 880.5860
Class of device : Class II 6)
Panel : General hospital 7)

Predicate/Reference Device 4.

4.1 Predicate device

1. Trade name (Predicate Submission Number):
- (1) PLPT LDV (Low Dead Volume) Sterile Syringe (K210443)
- (2) EZ-Injec LDV Sterile Safety Needle (K210444)

Manufacturer: Poonglim Pharmatech Inc.

4.2 Reference device
1. Trade name
(1) EZ-Injec Single Use Needle (K192222)
1. Manufacturer: Poonglim Pharmatech Inc.

న్. Device description

6. Indications for Use:

7. Performance data:

Bench tests for the device's performance were conducted. Bench testing includes the mechanical testing, sterility 1) testing including EO residues. The tests demonstrated that the device performs in a substantially equivalent mamer to the predicate device. The following bench testing is performed to demonstrate the functionality is substantially equivalent.

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Test Standard
ISO 7886-1:2017 Sterile hypodermic syringes for single use
ISO 7864:2016 Sterile hypodermic needles for single use
ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices
ISO 80369-7:2021 Small-bore connectors for liquids and gases in healthcare applications

2)

Biocompatibility of the STERILE SINGLE USE LDV SYRINGE, CHOICARE STERILE SINGLE USE LDV 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
Cytotoxicitytest	When it was tested accordingly to ISO 10993-5, tests for in vitro cytotoxicity-Teston extracts method, it should satisfy the requirements.
Hemolysis test	When it was tested accordingly to ISO 10993-4, Selection off tests for interactionswith blood-evaluation of hemolytic properties of medical devices and medicaldevice materials, it should satisfy the requirements.
Intracutaneousreactivity test	When it was tested accordingly to ISO 10993-10, Tests for irritation and skinsensitization-Animal intracutaneous (Intradermal) reactivity test, it should satisfythe requirements.
Skinsensitizationtest	when it was tested accordingly to ISO 10993-10, Tests for irritation and skinsensitization-Guinea pig maximization test (GPMT), it should satisfy therequirements.
Acutesystemictoxicity test	When it was tested accordingly to ISO 10993-11, Tests for systemic toxicity-Acute systemic toxicity, it should satisfy the requirements.
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.
LAL Test	USP39 <85>, Bacterial Endotoxins Test
ParticulateMatterInjection	USP <788>, Particulate Matter for Injections (Method 1 Light ObscurationParticle Count Test). Test result should satisfy the requirements described in theUSP <788>.

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
1	LAL test	USP39 <85>, Bacterial Endotoxins Test (Unit : EU/Device)
2	E.O sterilizationvalidation	According to ISO 11135:2014E.O 30%, CO2 70%Temperature: 50 ±7°CExposure time: 5 hours
3	Sterility test	According to ISO 11737-2
4	E.O Residual test	Under the conditions of ISO 10993-7:2008, Ethylene oxide sterilizationresiduals, the test articles should meet the test requirements.

4) Needle injury test

Test standard
ISO 23908:2011 Sharps injury protection

8. Substantially Equivalent (SE) Comparison

8.1. Syringe

	subject device	Predicate device #1
Manufacturer	Poonglim Pharmatech Inc.	Poonglim Pharmatech Inc.	Remark

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510(k) Summary

Item	Subject device	Predicate device
510(K) No.	K221860	K210443
Indication for use	PLPT LDV (Low Dead Volume) LC(Luer-Cone) Sterile Syringe / PLPT LDV (Low Dead Volume) LL(Luer-Lock) SterileSyringe 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) Sterile Syringe is intended to be used for medical purpose to inject fluid into or withdraw fluid from body.	Different #1
Components	Barrel, Plunger, Needle (Cannula), Needle hub, Piston, Needle cap, Safety guard	Barrel, Plunger, Piston	Same
Materials	PistonPlungerBarrel	RubberPPPP	Same
Nozzle type	Luer-lock	Luer-lock, Luer-slip	Different #2
Capacity(Syringe volume)	0.5, 1 mL	1 mL	Different #3
Dead spacespecification	≤ 0.023mL	≤ 0.023mL	Same
Principle ofoperation	For Manual Use OnlyFor Single Use Only	For Manual Use OnlyFor Single Use Only	Same
SyringePerformanceRequirements	Complies withISO 7886-1 : 2017 Sterile hypodermic syringes for single use - Part 1 : Syringes for manual useISO 80369-7 : 2016 Small-bore connector for liquids and gases in healthcare applications - Part 7 : Connectors for intravascular or hypodermic applications	Complies withISO 7886-1 : 2017 Sterile hypodermic syringes for single use - Part 1 : Syringes for manual useISO 80369-7 : 2016 Small-bore connector for liquids and gases in healthcare applications - Part 7 : Connectors for intravascular or hypodermic applications	Same
Biocompatibility	Conforms to therequirements of ISO 10993series standards.CytotoxicityAcute systemic toxicityPyrogenicitySensitizationIrritationHemolysisIntracutaneous reactivityBacterial EndotoxinsParticulate Matter Injection	Conforms to therequirements of ISO 10993series standards.CytotoxicityAcute systemic toxicityPyrogenicitySensitizationIrritationHemolysisIntracutaneous reactivityBacterial EndotoxinsParticulate Matter Injection	Same
Sterilization	E.O Gas Sterilized	E.O Gas Sterilized	Same
SAL	10-6	10-6	Same
Endotoxin Limit	20 EU per device	20 EU per device	Same
Principle ofoperation	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.	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.	Same
Label/Labeling	Complied with 21 CFR part 801	Complied with 21 CFR part 801	Same
	Subject device	Predicate device #2	Remark
Manufacturer	POONGLIM Pharmatech Inc.	POONGLIM Pharmatech Inc.	Same
510(K) No.	K221860	K210444	N/A
Indication foruse	PLPT LDV (Low Dead Volume)LC(Luer-Cone) Sterile Syringe / PLPTLDV (Low Dead Volume) LL(Luer-Lock)Sterile Syringe is intended for use byhealth care professionals for generalpurpose aspiration of fluid from vials,ampoules, and liquid injection below thesurface of the skin.	This device is intended for use to injectfluids into or withdraw from parts of thebody below the surface of the skin	Different #4
	Raw Material
Hub of needle	Polypropylene (PP)	Polypropylene (PP)	Same
Protect cap	Polypropylene (PP)	Polypropylene (PP)
Cannula	SUS304	SUS304
Adhesive	Epoxy	Epoxy
Length	4, 6, 8, 13, 16, 25, 30, 40mm	25 mm
Gauge	21, 22, 23, 25, 26, 27, 29, 30, 31, 32, 33,34G	25G	Different #5
Dead spacespecification	<0.0054ml	<0.0054ml	Same
Tipconfiguration	Bevel	Bevel	Same
Wall type	TW	TW	Same
NeedlePerformanceRequirements	ISO 7864 : 2016 Sterile hypodermic needlesfor single use - Requirementsand test methodsISO 9626 : 2016 Stainless steel needletubing for the manufacture of medicaldevices - Requirements and test methods	ISO 7864 : 2016 Sterile hypodermic needlesfor single use - Requirements and testmethodsISO 9626 : 2016 Stainless steel needletubing for the manufacture of medicaldevices - Requirements and test methods	Same
Safety featureperformanceRequirements	ISO 23908 : 2011 Sharps InjuryProtection - Requirements And TestMethods - Sharps Protection Features ForSingle-Use Hypodermic Needles,Introducers For Catheters And NeedlesUsed For Blood Sampling	ISO 23908 : 2011 Sharps Injury Protection -Requirements And Test Methods - SharpsProtection Features For Single-UseHypodermic Needles, Introducers ForCatheters And Needles Used For BloodSampling	Different #6
Biocompatibility	Conforms to therequirements of ISO 10993series standards.CytotoxicityCytotoxicity (Hub)Hemolysis testPyrogen test	Conforms to therequirements of ISO 10993series standards.CytotoxicityCytotoxicity (Hub)Hemolysis testPyrogen test	Same

A Equivalence discussion

Different #1 – Indication for Use

The Indications for Use statement for the subject device is not identical to the predicate device; however, the differences do not alter the intended use of the device, nor do they affect the safety and effectiveness of the device relative to the predicate. Both the subject and predicate devices have the same intended use for the aspiration of fluid from vials, ampoules and liquid injection. Therefore, this difference does not affect substantially equivalence on safety and effectiveness.

Different #2 - Nozzle Configuration

The configuration of PLPT LDV LC Sterile Syringe is similar as the configuration of predicate device, the

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difference is that propose device has luer-cone nozzle type. However, the syringe with luer-cone type is widely used in the clinical. Whether the nozzle type is a luer-cone or luer-lock type, this will not affect the indication for use of the equipment itself. To validate this claim, performance testing was conducted. In accordance to internationally recognized standard(ISO 7886-1). it is proved that nozzle configuration of subject device conforms with relevant standard. Also, requirements per ISO 80369-7 was validated with subject device. Therefore, the differences on configuration do not raise new questions about its safety and/or effectiveness.

Different #3 - Capacity (Syringe Volume)

Although the configuration of PLPT LDV LC/LL Sterile Syringe is similar to the configuration of predicate devices, the capacity of the subject device is different per predicates. However, this change is just in dimension. This difference does not alter the any rise potential risks per its intended use. Other aspects (e.g., Biocompatibility) are same with the predicates. Performance testing was conducted for this change, and it was confirmed that the differences on configuration do not raise new questions about its safety and effectiveness.

8.2. Needle

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	Intracutaneous reactivity testSkin sensitization testAcute systemic toxicity testLAL test (Endotoxin)Sterility testE.O. Gas Residual	Intracutaneous reactivity testSkin sensitization testAcute systemic toxicity testLAL test (Endotoxin)Sterility testE.O. Gas Residual
Sterilizationmethod	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

A Equivalence discussion

Different #4 - Indication for Use

The Indications for Use statement for the subject device is not identical to the predicate device; however, the differences do not alter the intended use of the device, nor do they affect the safety and effectiveness of the device relative to the predicate. Both the subject and predicate devices have the same intended use for the injecting fluids into or withdraw from parts of the body below the surface of the skin. Therefore, this difference does not affect substantially equivalence on safety and effectiveness.

Different #5 - Needle gauge and length

The overall configuration of PLPT LDV LL/LC Sterile Syringe's needle component is similar as the configuration of predicate device; the difference is that propose device has more variable needle configurations. However, the needle configuration is widely used in the clinical. Whether the different needle configurations are present, this will not affect the indication for use of the equipment itself. To validate this claim, performance testing for the needle component was conducted. In accordance to internationally recognized standard (ISO 7864, it is proved that needle configuration of proposed device conforms with the relevant standard. Therefore, the differences on configuration do not raise new questions about its safety and/or effectiveness.

Different #6 – Safety features

The safety features for each device are identical with each other. Although the configuration of the needle size (cannula's length, gauge) is more variable compared to the predicate device (K210444), See Different #5), the safety guard's mechanism is not affected by its configurations. The design of the safety feature shows that the safety feature performance is dominated by the linkage between the holding component. For this reason, if the structure of the holding component is identical each device will show exact same performance. Referring to the attached product design, this component's structure is identical, and predicate device's safety feature was tested with ISO 23908 and confirmed that it complies with the standards. Therefore, the subject and predicate device's safety features have performance, which is concluded that the difference per the configuration of the needle dimensions does not affect its substantial equivalence on safety and effectiveness.

9. Sterility, Shipping and Shelf-Life

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

Also, the device's Shelf life of 3 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. As this device is comprised of two predicates, each comparison has been conducted and demonstrated that the specifications and performance of the device are substantially equivalent as the legally marketed predicate devices.

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).