TopFine® LDS (Low Dead Space) Syringe is intended for use to inject fluid into or withdraw fluids from the parts of body below the surface of the skin.

Device Description

The TopFine® LDS (Low Dead Space) 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 hypodermic single lumen needle which is a permanently attached. The device is used to inject fluids into, or withdraw fluids from, the body. It is made of plastic and silicone materials that allows for smooth plunger movement, and is manually operated. This is a single-use device. This product is packed by sterile paper and sterilized by Ethylene Oxide gas.

The proposed device has 2 models depending on the diameter of the needle.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device, specifically a syringe. It does not contain information about an Artificial Intelligence/Machine Learning (AI/ML) device. Therefore, it is not possible to describe acceptance criteria or a study related to AI/ML device performance.

The document focuses on demonstrating substantial equivalence of the "TopFine® LDS (Low Dead Space) Syringe" to a predicate syringe through various performance tests and material comparisons.

Here's an analysis based on the information provided, specifically addressing the technical performance of the syringe, not AI/ML:

Acceptance Criteria and Reported Device Performance (Non-AI/ML Syringe)

The document details various performance criteria for the syringe. There isn't a single table explicitly labeled "Acceptance Criteria and Reported Device Performance" with detailed numerical results for each criterion. However, the "Comparison of technological characteristics with the predicate device" section (page 5) and "Performance data" section (page 7) implicitly define the acceptance criteria by stating compliance with recognized standards and providing general results.

Here's an attempt to construct a table based on the provided information, focusing on criteria where reported performance is available, even if only generally stated as "Same" or "Complies."

Acceptance Criteria Category	Specific Criteria / Standard	Acceptance Criteria (Expected/Reference)	Reported Device Performance (TopFine® LDS Syringe)
General Characteristics	Regulation Number	21 CFR 880.5860	Same (21 CFR 880.5860)
	Product Code	QNQ	Same (QNQ)
	Indications for Use	Intended for use to inject fluid into or withdraw fluids from the parts of body below the surface of the skin.	Same
	Type of use	Prescription Use	Same
	Mechanism of action	Plunger can be pulled and pushed along inside the barrel, allowing the syringe to take in and expel fluids through the connector to the patient.	Same
	Number of uses	Single Use Only	Same
	Material (Needle)	SUS 304	Same (SUS 304)
	Material (Cap)	Polypropylene	Same (Polypropylene)
	Material (Barrel)	Polypropylene	Same (Polypropylene)
	Material (Plunger)	Polypropylene	Same (Polypropylene)
	Material (Gasket)	Polyisoprene	Same (Polyisoprene)
	Needle Gauge	23G, 25G	Same (23G, 25G)
	Needle OD (23G)	0.600 ~ 0.673 mm	Same (0.600 ~ 0.673 mm)
	Needle OD (25G)	0.500 ~ 0.530 mm	Same (0.500 ~ 0.530 mm)
	Syringe nozzle type	Permanently attached	Same
	Syringe capacity	1 ml	Same (1 ml)
Performance - Biocompatibility	ISO 10993-1 Classification	Externally Communicating Device, Blood Path Indirect, Limited Contact (<24hours)	Device classified the same.
	Cytotoxicity	Complies with ISO 10993-1	Testing conducted and met criteria (implied by "following testing was conducted").
	Sensitization	Complies with ISO 10993-1	Testing conducted and met criteria.
	Irritation	Complies with ISO 10993-1	Testing conducted and met criteria.
	Acute Systemic Toxicity	Complies with ISO 10993-1	Testing conducted and met criteria.
	Material Mediated Pyrogenicity	Complies with ISO 10993-1	Testing conducted and met criteria.
	Hemolysis	Complies with ISO 10993-1	Testing conducted and met criteria.
	Particulate Matter	USP <788> acceptance criteria	Met USP acceptance criteria.
Performance - Physical	Needle Length (23G, 25G)	Predicate: 25.0 mm, 25.4 mm, 38.1 mm	Proposed: 26.5 mm (+1.5 / -2.5 mm) - Different, but performance verified.
	Hub/needle bond strength (23G)	≥ 34 N (ISO 7864)	Same (≥ 34 N)
	Hub/needle bond strength (25G)	≥ 22 N (ISO 7864)	Same (≥ 22 N)
	Dead space	≤ 0.03 ml	Same (≤ 0.03 ml)
	Performance Needle Standard	ISO 7864:2016	Same (ISO 7864:2016)
	Needle Tubing Standard	ISO 9626:2016	Same (ISO 9626:2016)
	Syringe Standard	ISO 7886-1:2017	Same (ISO 7886-1:2017)
Performance - Sterility	Sterilization Method	EO Gas, SAL=10-6	Same (EO Gas, SAL=10-6)
	EO Residue	Not detected (LOD: 0.001)	EO not detected.
	ECH Residue	Not detected (LOD: 0.02)	ECH not detected.
	Pyrogen Test	Bacterial endotoxin USP <161>, USP <85>	Testing conducted and met criteria.
	Package Integrity (ASTM D4169-22)	Acceptable for protection and sterility maintenance after environmental conditioning and simulated transportation.	All packaging is acceptable.
	Seal Peel Test	Complies with ASTM F88/F88 -15	Performed.
	Dye Migration	Complies with ASTM F1929-15	Performed.
	Shelf Life	3 years (validated using ASTM F1980-21)	3 years validated.
Labeling	Compliance	Complies with 21 CFR part 801	Same (Complies with 21 CFR part 801)

Since this is concerning a non-AI/ML medical device, the following points are not applicable or cannot be answered from the provided text:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not specify exact sample sizes for each physical or biological test. It only mentions that tests were "conducted."
- Data provenance (country of origin, retrospective/prospective) is not mentioned for the testing data.
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 as this is not an AI/ML device requiring expert ground truth for image/data interpretation. This refers to standard performance testing.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically for clinical studies involving human interpretation or AI/ML output.
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 is not an AI/ML device. "Clinical studies were not required to support substantial equivalence."
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the syringe, "ground truth" would be established by direct physical measurements, chemical analyses, and biological assays according to the specified international and national standards (e.g., ISO, USP, ASTM). For example, the "dead space" measurement itself would be the ground truth for that specific characteristic, and the acceptance criterion is a predefined maximum value (≤ 0.03 ml).
The sample size for the training set
- Not applicable. This is not an AI/ML device with a training set.
How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device.

In summary, the document addresses a traditional medical device (syringe) and demonstrates its substantial equivalence to a predicate device through adherence to manufacturing standards, material comparisons, and performance testing against established physical, chemical, and biological criteria, rather than through AI/ML performance metrics.

Summary

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March 15, 2024

MedExel Co., Ltd. % Peter Chung, President PlusGlobal 300 Atwood Street Pittsburgh, Pennsylvania 15213

Re: K231856

Trade/Device Name: TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534)) Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: QNQ Dated: February 14, 2024 Received: February 14, 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 820.70) 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, Shruti N. Mistry -S

Shruti Mistry Assistant Director, Injection Team 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

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Indications for Use

510(k) Number (if known) K231856

Device Name

TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534))

Indications for Use (Describe)

TopFine® LDS (Low Dead Space) Syringe is intended for use to inject fluid into or withdraw fluids from the parts of body below the surface of the skin.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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K231856- 510(K) Summary

I. Submitter
510(k) Submitter: MedExel Co., Ltd.252, Geumgwangosan-ro, Geumgwang-myeonAnseong Korea, SouthPhone: +82-10-9992-9912
Primary Contact: Peter ChungUS Agentcontact@plusglobal.net
Secondary Contact: Juntaek SeoRA managerjtseo@medexel.co.kr
Date prepared: 15 March, 2024

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II. Device Name

Device Trade Name	TopFine® LDS (Low Dead Space)Syringe(2 models (TS-LDS2334, TS-LDS2534))
Common Name	Piston syringe
Classification Name	Low Dead Space Piston Syringe
Regulation Number	21 CFR 880.5860
Product Code	QNQ

III. Legally Marketed Predicate Device

Predicate #	K213010
Predicate Trade Name	FEELject LDV (Low dead volume) syringe

Device Description IV.

The proposed device has 2 models depending on the diameter of the needle.

No.	Model name	Diameter of needle	Length of needle
1	TS-LDS2334	23G (0.600 ~ 0.673 mm)	26.5 mm (+1.5 / -2.5 mm)
2	TS-LDS2534	25G (0.500~ 0.530 mm)	26.5 mm (+1.5 / -2.5 mm)

The difference between the above 2 models is only the needle diameter.

V. Indications for Use

TopFine® LDS (Low Dead Space) Syringe is intended for use to inject fluid into or withdraw fluids from the parts of body below the surface of the skin.

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Item	Proposed Device	Predicate Device	Remark
510(k) No.	K231856	K213010	-
Regulation No.	21 CFR 880.5860	21 CFR 880.5860	Same
Product Code	QNQ	QNQ, FMI	Same
Indications for Use	TopFine® LDS (Low Dead Space) Syringe is intended for use to inject fluid into or withdraw fluids from the parts of body below the surface of the skin.	FEELject LDV (Low dead volume) Syringe is intended for use to inject fluid into or withdraw fluids from the parts of body below the surface of the skin.	Same
Type of use	Prescription Use	Prescription Use	Same
Mechanism of action	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
Number of uses	Single Use Only	Single Use Only	Same
Configuration and materials	Needle- Needle: SUS 304- Cap: Polypropylene- Barrel: Polypropylene- Plunger: Polypropylene- Gasket: Polyisoprene	Needle- Needle: SUS 304- Cap: Polypropylene- Barrel: Polypropylene- Plunger: Polypropylene- Gasket: Polyisoprene	Same
	Needle Gauge	23G, 25G	23G, 25G	Same
	Needle dimension – OD	23G: 0.600 ~ 0.673 mm25G: 0.500 ~ 0.530 mm	23G: 0.600 ~ 0.673 mm25G: 0.500 ~ 0.530 mm	Same
	Needle dimension – needle length	26.5 mm(+1.5 / -2.5 mm)	25.0 mm25.4 mm38.1 mm	DifferentSee note 1
	Syringe nozzle type	Permanently attached	Permanently attached	Same
	Syringe capacity	1 ml	1 ml	Same
Dead space	Low dead volume ≤ 0.03 ml	Low dead volume ≤ 0.03 ml	Same
Biocompatibility	According to ISO 10993-1	According to ISO 10993-1	Same
Performance Needle	ISO 7864:2016 Sterile hypodermic needles for single use – Requirements and test methods	ISO 7864:2016 Sterile hypodermic needles for single use – Requirements and test methods	Same
		ISO 9626:2016 Stainlesssteel needle tubing for themanufacture of medicaldevices - Requirementsand test methods	ISO 9626:2016 Stainlesssteel needle tubing for themanufacture of medicaldevices – Requirementsand test methods
	Syringe	ISO 7886-1:2017 Sterilehypodermic syringes forsingle use - Part 1:Syringes for manual use	ISO 7886-1:2017 Sterilehypodermic syringes forsingle use - Part 1:Syringes for manual use	Same
	Sterility	Sterilized by EO GasSAL=10-6	Sterilized by EO GasSAL=10-6	Same
	Endotoxin limit	20 EU/Device	20 EU/Device	Same
	Labeling	Complies with 21 CFRpart 801	Complies with 21 CFRpart 801	Same
	Physicalspecification	Tip type: Slip TipImage: Syringe tip	Tip type: Slip TipImage: Syringe tip	Same
	Mechanicalspecification	Hub/needle bond strength(ISO 7864)1) 23 Gauge: ≥ 34 N2) 25 Gauge: ≥ 22 N	Hub/needle bond strength(ISO 7864)1) 23 Gauge: ≥ 34 N2) 25 Gauge: ≥ 22 N	Same

VI. Comparison of technological characteristics with the predicate device

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Note 1: Needle length

The needle length of proposed device is different from the needle of predicate device. In order to confirm the performance between the different needle specifications, the proposed device was verified by measuring the needle length at each time point of accelerated aging test. The proposed device was found to be substantially equivalent to the predicate device.

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VII. Performance data

1. Biocompatibility Testing

In accordance with ISO 10993-1 the subject device is classified as: Externally Communicating Device, Blood Path Indirect, Limited Contact (<24hours). The following testing was conducted.

1. Cytotoxicity
1. Sensitization
1. Irritation
1. Acute Systemic Toxicity
1. Material Mediated Pyrogenicity
1. Hemolysis

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

2. Physical Performance Testing

(1) ISO 7864:2016-Sterile hypodermic needles for single use requirements and test methods
(2) ISO 7886-1:2017-Sterile hypodermic syringes for single use Part 1: Syringes for manual use
(3) ISO 9626:2016-Stainless steel needle tubing for the manufacture of medical devices

3. Sterility, Shipping and Shelf-Life

The sterilization method is Ethylene Oxide. EO not detected (Limit of Detection: 0001), ECH- Not detected. (Limit of Detection: 0.02), validation method: Overkill Approach (e.g., Half-Cycle method), pyrogen test: Bacterial endotoxin USP <161>Medical devices -Bacterial Endotoxin and pyrogen test, USP <85> Bacterial endotoxins test.

Package integrity testing, after environmental conditioning and simulated transportation using ASTM D4169-22, was conducted on final packaged, and sterile devices. All packaging is acceptable for protection of final finished product and sterility maintenance.
Sterile Barrier Packaging Testing performed on the proposed device:
- Seal peel test ASTM F88/F88 -15 O
- Dye migration- ASTM F1929-15 o
Shelf life of 3 years is validated using the FDA recognized standard ASTM F1980-21 Standard Guide for Accelerated Aging of Sterile Barrier System for Medical Devices.

4. Clinical Studies

Clinical testing was not required to support substantial equivalence.

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VIII. Conclusion

The differences between the predicate device and the subject device do not raise any new or different questions of safety or effectiveness. The TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534) is substantially equivalent to the FEELject LDV (low dead volume) syringe 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).