The TSK SELECT™ Needle is designed to provide a means of fluid injection and aspiration to and from the body. It is a single lumen needle intended for use with a luer-tip syringe. The TSK SELECT™ Needle consisting of a stainless-steel tube that is sharpened at one end and at the other end joined to a female luer connector (hub) made of polypropylene, or polycarbonate, depending on the hub type, designed to be connected with a male luer fitting of a syringe. The TSK SELECT™ Needle is intended for manual use by health care professionals for administration of fluids. The TSK SELECT™ Needle is provided sterile, is single use only, non-toxic, non-pyrogenic, and sterilized by gamma irradiation.

AI/ML Overview

There is no indication that the TSK SELECT™ Needle incorporates artificial intelligence (AI) or machine learning (ML). The provided 510(k) clearance letter and summary describe a physical medical device (hypodermic needle) and its non-clinical performance and biocompatibility testing.

Therefore, the specific information requested about AI/ML device acceptance criteria and study details (such as sample size for test/training sets, data provenance, expert ground truthing, adjudication methods, MRMC studies, standalone performance, and effect size with AI assistance) is not applicable to this submission.

The document focuses on demonstrating substantial equivalence to a predicate device through:

Indications for Use Comparison: Showing the new device has the same intended use as the predicate.
Technological Comparison: Highlighting similarities and differences in materials, design, and features, and providing justification (e.g., "does not raise new or different questions of safety and effectiveness") for any differences.
Non-Clinical Testing: Demonstrating compliance with recognized standards for physical performance, sterilization, and biocompatibility.

Since the request is specifically about AI/ML device criteria and studies, and this device is not an AI/ML device, I cannot provide the requested information based on the input. The document does not contain any data relevant to AI/ML performance metrics.

Summary

FDA 510(k) Clearance Letter - TSK SELECT™ Needle

Page 1

July 24, 2025

TSK Laboratory, Japan
℅ Anna Galea
Principal Strategy Consultant
NAMSA
400 Highway 169 South, Suite 500
Minneapolis, Minnesota 55426

Re: K250284
Trade/Device Name: TSK SELECT™ Needle
Regulation Number: 21 CFR 880.5570
Regulation Name: Hypodermic Single Lumen Needle
Regulatory Class: Class II
Product Code: FMI, QNS
Dated: June 22, 2025
Received: June 23, 2025

Dear Anna Galea:

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).

Page 2

K250284 - Anna Galea Page 2

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 (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-reporting-combination-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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).

Page 3

K250284 - Anna Galea Page 3

Sincerely,

Shruti N. Mistry -S

Shruti Mistry
Assistant Director, Injection Devices
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

Page 4

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known): K250284

Device Name: TSK SELECT™ Needle

Indications for Use (Describe):
The TSK SELECT™ Needle is indicated for subcutaneous injections of pharmaceutical products, or for withdrawal of fluids.

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)

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
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"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."

Page 5

510(k) Summary

TSK SELECT™ Needle

K250284 510(k) Summary
TSK SELECT™ Needle

Submitter:
TSK Laboratory, Japan
1510-1, Soja-Machi, Tochigi-Shi Tochigi-Ken 328-0002 Japan
+81-282-25-7575
Ms Yumi Ueda
y.ueda@tsklab.co.jp

Date:
July 24, 2025

Correspondent:
NAMSA
400 Highway 169 South, Suite 500, Minneapolis, MN 55426 United States
+1 339-927-2945
Dr. Anna Galea
agalea@namsa.com

Device Trade Name: TSK SELECT™ Needle
Common Name: Hypodermic single lumen needle, Low dead space needle
Classification Name: Hypodermic single lumen needle
Regulation Number: 880.5570
Product Codes: FMI, QNS
Regulation Class: II
Predicate: K210444: EZ-Injec LDV Sterile Safety Needle, Product Code QNS

Device Description Summary:
The TSK SELECT™ Needle is designed to provide a means of fluid injection and aspiration to and from the body. It is a single lumen needle intended for use with a luer-tip syringe. The TSK SELECT™ Needle consisting of a stainless-steel tube that is sharpened at one end and at the other end joined to a female luer connector (hub) made of polypropylene, or polycarbonate, depending on the hub type, designed to be connected with a male luer fitting of a syringe. The TSK SELECT™ Needle is intended for manual use by health care professionals for administration of fluids. The TSK SELECT™ Needle is provided sterile, is single use only, non-toxic, non-pyrogenic, and sterilized by gamma irradiation.

Page 6

The model numbers associated with the TSK SELECT™ Needle are presented in the table below. Some model numbers have two variations based on wall thickness:

TSN-xxxxxx: Thin Wall (TW)
TSN-xxxxxxE: Extra Thin Wall (ETW)
TSN-xxxxxxR: Regular Wall (RW)

Note: All needles are Model TSN

Product Code	Nominal outer diameter (mm)	Gauge size (G)	Needle Length (mm)	Color Code	Hub	Wall Thickness	Device Description
TSN050013	0.50	25	13	Orange	Natural	TW	TSK SELECT Needle 25G(0.40mm) x 13mm TW
TSN050025R	0.50	25	25	Orange	Natural	RW	TSK SELECT Needle25G(0.50mm) x 25mm RW
TSN040013	0.40	27	13	Medium grey	Natural	TW	TSK SELECT Needle27G(0.50mm) x 13mm RW
TSN040019R	0.40	27	19	Medium grey	Natural	RW	TSK SELECT Needle 27G(0.40mm) x 19mm TW
TSN030004	0.30	30	4	Yellow	Natural	TW	TSK SELECT Needle 30G(0.30mm) x 4mm TW
TSN030009	0.30	30	9	Yellow	Natural	TW	TSK SELECT Needle 30G(0.30mm) x 9mm TW
TSN030013	0.30	30	13	Yellow	Natural	TW	TSK SELECT Needle 30G(0.30mm) x 13mm TW
TSN030013E	0.30	30	13	Yellow	Natural	ETW	TSK SELECT Needle 30G(0.30mm) x 13mm ETW
TSN025004	0.25	31	4	White	Natural	TW	TSK SELECT Needle 31G(0.25mm) x 4mm TW
TSN025009	0.25	31	9	White	Natural	TW	TSK SELECT Needle 31G(0.25mm) x 9mm TW
TSN025013	0.25	31	13	White	Natural	TW	TSK SELECT Needle 31G(0.25mm) x 13mm TW
TSN023004	0.23	32	4	Deep green	Natural	TW	TSK SELECT Needle 32G(0.23mm) x 4mm TW
TSN023009	0.23	32	9	Deep green	Natural	TW	TSK SELECT Needle 32G(0.23mm) x 9mm TW
TSN023013	0.23	32	13	Deep green	Natural	TW	TSK SELECT Needle 32G(0.23mm) x 13mm TW
TSN020004	0.20	33	4	Black	Natural	TW	TSK SELECT Needle 33G(0.20mm) x 4mm TW
TSN020004R	0.20	33	4	Black	Natural	RW	TSK SELECT Needle 33G(0.20mm) x 4mm RW
TSN020009	0.20	33	9	Black	Natural	TW	TSK SELECT Needle 33G(0.20mm) x 9mm TW
TSN020009R	0.20	33	9	Black	Natural	RW	TSK SELECT Needle 33G(0.20mm) x 9mm RW
TSN018004	0.18	34	4	Orange	Natural	TW	TSK SELECT Needle 34G(0.18mm) x 4mm TW

Page 7

| TSN018009 | 0.18 | 34 | 9 | Orange | Natural | TW | TSK SELECT Needle 34G(0.18mm) x 9mm TW |

Indications for Use:
The TSK SELECT™ Needle is indicated for subcutaneous injections of pharmaceutical products, or for withdrawal of fluids.

Indications for Use Comparison:
The indication for use is the equivalent to that of the predicate. Please refer to the Table below in Technological Comparison.

Technological Comparison:
The device has the same technological characteristics and materials as the predicate. Testing on the subject device is the same as that on the predicate.

Comparison of Subject Device to Predicate Device	Subject Device TSK Select Needle	Predicate Device EZ-Injec LDV Sterile Safety Needle (K210444)	Discussion
Manufacturer	TSK Laboratory-Japan	POONGLIM PHARMATECH INC.
Regulation	21 CFR 880.5570	21 CFR 880.5570
Product Code	FMI, QNS	QNS
Class	Class II	Class II
Classification Name	Hypodermic single lumen needle	Low Dead Space Needle, Single Lumen, Hypodermic
Indications for Use	The TSK SELECT™ Needle is indicated for subcutaneous injections of pharmaceutical products, or for withdrawal of fluids.	This product is intended for use to inject fluid into or withdraw fluids from parts of the body below the surface of the skin.	Same
Intended Use	The TSK SELECT™ Needle is intended for use with a syringe, for injection of a pharmaceutical product or draining of a fluid.	To inject fluid into or withdraw fluids from parts of the body below the surface of the skin.	Same
Intended User and Environment	Clinicians in a clinical setting	N/A	Different: This does not raise new or different questions of safety and effectiveness as this just specifies the intended user for the subject device.
Device Components	Needle, Needle Hub, Needle Cap. Designed to fit standard luer fittings	Needle, Needle Hub and protector	Different: This does not raise new or different questions of safety and effectiveness as the device design has been adequately supported by verification and validation data.
Materials-Needle	Stainless Steel	Stainless Steel	Same

Page 8

| Needle Hub | Polycarbonate | Polypropylene | Different: The subject device has been verified in accordance with the FDA recognized standards and therefore it does not raise new question of safety and effectiveness for the subject device when compared to the predicate device. |
| Lubricant | Silicone | N/A | Different: The subject device has been verified in accordance with the FDA recognized standards and therefore it does not raise new question of safety and effectiveness for the subject device when compared to the predicate device. |
| Adhesive | Epoxy | Epoxy | Same |
| Needle Cap | Polyethylene | Polypropylene | Different: The subject device has been verified in accordance with the FDA recognized standards and therefore it does not raise new question of safety and effectiveness for the subject device when compared to the predicate device. |
| Needle Gauge | 25G – 34G | 25G | Different: The subject device has been verified in accordance with the FDA recognized standards and therefore it does not raise new question of safety and effectiveness for the subject device when compared to the predicate device. |
| Needle Length (exposed) | 4mm, 9mm, 13mm, 19mm, 25mm | 25mm | Different: The subject device has been verified in accordance with the FDA recognized standards and therefore it does not raise new question of safety and effectiveness for the subject device when compared to the predicate device. |
| Needle Tip | Regular Bevel | "Bevel" | Different: The subject device has been verified in accordance with the FDA recognized standards and therefore it does not raise new question of safety and effectiveness for the subject device when compared to the predicate device. |
| Dead Volume | ≤0.0054ml | ≤0.0054ml | Same |
| Safety Feature | No safety feature | Yes- safety feature | Different: The subject device does not have a safety feature. This does not raise new or different questions of safety and effectiveness. |
| Syringe Compatibility | Luer-lock, Luer Slip ISO 80369-7 compliant | Luer Lock, Luer Slip ISO 80369-7 compliant | Same |
| Needle Color Coding | Conforms to ISO 6009 | N/A | Different: The subject device is compliant to ISO 6009 for the needle color coding, therefore, this does not raise a new or |

Page 9

| | | | different question of safety and effectiveness. |
| Sterilization and Shelf Life | Provided Sterile, Single-Use 100 individual needles packaged in a hardcase and then packaged into a shelf carton. Sterilization Method: Gamma Irradiation SAL: 10-6 Shelf-life: 5 years | Sterilization Method: EO gas SAL: 10-6 Shelf-life: 5 years | Different: The subject device has been validated in accordance with the FDA recognized standards and therefore it does not raise new question of safety and effectiveness for the subject device when compared to the predicate device. |
| Biocompatibility | ISO 10993-1 (Biological Evaluation) | ISO 10993-1 (Biological Evaluation) | Same |
| | ISO 10993-4 (Hemocompatibility) | N/A | Different: The subject device has been validated in accordance with the FDA recognized standards and therefore it does not raise new question of safety and effectiveness for the subject device when compared to the predicate device. |
| | ISO 10993-5 (Cytotoxicity) | Cytotoxicity | Same |
| | ISO 10993-10 (Sensitization) | Sensitization | Same |
| | ISO 10993-23 (Irritation: intracutaneous reactivity) | Irritation | Same |
| | ISO 10993-11 (Acute Systemic Toxicity) | Acute Systemic Toxicity | Same |
| | ISO 10993-11 (Pyrogen) | Material-Mediated Pyrogenicity | Same |
| | USP <788> Particulate Matter in Injections | USP <788> Particulate Matter in Injections | Same |
| Performance Data | Meets ISO 7864 Meets ISO 9626 Meets ISO 80369-7 Meets USP <788> | Meets ISO 7864 Meets ISO 9626 Meets ISO 23908 Meets ISO 80369-7 Meets USP <788> | Different: The subject device has done additional testing to support the verification of the device. This does not raise new or different questions of safety and effectiveness. |

Subject device packaging and sterilization method is not the same as the predicate. However, the subject device has been validated in accordance with the FDA recognized standards and therefore it does not raise new question of safety and effectiveness for the subject device when compared to the predicate device.

Biocompatibility testing was performed to demonstrate that device material differences between the subject device and predicate do not raise new questions of safety and effectiveness.

Performance testing was conducted in accordance with ISO 7864, ISO 9626, ISO 80369-7, and USP <788> to demonstrate that subject device performance does not raise new questions of safety or effectiveness.

Page 10

Non-Clinical Tests Summary and Conclusions:

The TSK SELECT™ Needle underwent bench testing in accordance with the following standards:

ISO 7864:2016_Sterile hypodermic needles for single use
ISO 9626:2016_Stainless steel needle tubing for the manufacture of medical devices
ISO 80369-1:2018_Small-bore connectors for liquids and gases in healthcare applications -- Part 1: General requirements
ISO 80369-7:2021_Small-bore connectors for liquids and gases in healthcare applications —Part 7:Connectors for intravascular or hypodermic applications
USP<788> Particulate matter in injections

The TSK SELECT™ Needle was sterilized in accordance with the following standards:

ISO 11137-1:2006/Amd2:2018_Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices Amendment 2
ISO 11737-2:2013/A1:2022_Sterilization of medical devices – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ISO 11137-4_Sterilization of health care products - Radiation - Part 4: Guidance on process control
ISO 11737-1:2018/A1:2021_Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products
ISO 11737-2:2019_Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ISO 11607-1:2019_Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 11607-2_Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes

The TSK SELECT™ Needle also passed biocompatibility tests in the following categories:

Biological Evaluation
Hemocompatibility
Cytotoxicity
Sensitization
Irritation: intracutaneous reactivity
Acute Systemic Toxicity
Material Mediated Pyrogenicity
Particulate Matter in Injection

The biocompatibility tests were performed in accordance with the following standards:

ISO 10993-1:2018/Cor1:2018_Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

Page 11

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: Tests for in vitro cytotoxicity
ISO 10993-10:2021_Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity
ISO 10993-11:2017_ Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
ISO 10993-12:2021_Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
ISO 10993-18:2020/A1:2022_Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process AMENDMENT 1
ISO 10993-23:2021_Biological evaluation of medical devices - Part 23: Tests for irritation

Conclusion

The results of non-clinical testing demonstrate that the subject device is substantially equivalent to, and is as safe and effective as the predicate device for its intended use.

Regulation Number and Section

§ 880.5570 Hypodermic single lumen needle.

(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).