(168 days)
Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe is used to inject fluids into, or withdraw fluids from, the body.
Profoject™ Low Dead Space Syringe with Needle/ Profoject™ Tuberculin Syringe with Needle is used to inject fluids into, or withdraw fluids from, the body.
Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle is intended for use to inject fluid into or withdraw fluids from the parts of body below the surface of the skin.
Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety Syringe is intended for use to inject fluid into or withdraw fluids from the parts of body below the surface of the skin. The Sharps Injury Prevention Feature (SIPF) is designed to aid in the prevention of needle stick injuries and syringe reuse.
Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe: Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe consists of a barrel with a Luer Slip or Luer Lock connector which comply with ISO 80369-7, a plunger, and a plunger stopper. The device is available in 0.5 mL and 1 mL capacities. It is sterile, single-use, and non-toxic device that operates on the principle of a piston syringe.
Profoject™ Low Dead Space Syringe with Needle/ Profoject™ Tuberculin Syringe with Needle: Profoject™ Low Dead Space Syringe with Needle/ Profoject™ Tuberculin Syringe with Needle is sterile, single-use device. Each consists of either a Luer slip or Luer lock syringe assembly integrated with a pre-attached needle, and the syringe is available in two capacities (0.5mL and 1mL). For each capacity variant, the pre-attached needle is available in the following gauge specifications: 16G, 18G, 19G, 21G, 22G, 23G, 25G, 27G and 30G.
Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle: Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle is sterile, single-use, non-toxic devices that work on the principle of a piston syringe, and the syringes are available in three capacities: 0.3mL, 0.5mL, and 1mL. Each capacity variant is equipped with a permanently attached needle, available in the following gauge specifications: 21G, 23G, 25G, 26G, 27G, 28G, 29G, 30G and 31G.
Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety Syringe: Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety Syringe is sterile, single-use, non-toxic devices that work on the principle of a piston syringe, and the syringes are available in three capacities: 0.3mL, 0.5mL, and 1mL. Each capacity variant is equipped with a permanently attached needle, available in the following gauge specifications: 21G, 23G, 25G, 26G, 27G, 28G, 29G, 30G and 31G.
N/A
FDA 510(k) Clearance Letter - K252814
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.03
February 19, 2026
CMT Health Pte. Ltd.
Monica Ma
150 Beach Road, #28-05, Gateway West
Singapore, 189720, Singapore
Re: K252814
Trade/Device Name: Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe; Profoject™ Low Dead Space Syringe with Needle /Profoject™ Tuberculin Syringe with Needle; Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle; Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety Syringe
Regulation Number: 21 CFR 880.5860
Regulation Name: Piston Syringe
Regulatory Class: Class II
Product Code: QNQ, MEG
Dated: September 2, 2025
Received: January 20, 2026
Dear Monica Ma:
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"
Page 2
(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).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13484 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 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 Management System Regulation (QMSR) (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
Sincerely,
Shruti N. Mistry -S
Shruti Mistry
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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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): K252814
Device Name: Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe; Profoject™ Low Dead Space Syringe with Needle /Profoject™ Tuberculin Syringe with Needle; Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle; Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety Syringe
Indications for Use (Describe)
Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe is used to inject fluids into, or withdraw fluids from, the body.
Profoject™ Low Dead Space Syringe with Needle/ Profoject™ Tuberculin Syringe with Needle is used to inject fluids into, or withdraw fluids from, the body.
Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle is intended for use to inject fluid into or withdraw fluids from the parts of body below the surface of the skin.
Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety Syringe is intended for use to inject fluid into or withdraw fluids from the parts of body below the surface of the skin. The Sharps Injury Prevention Feature (SIPF) is designed to aid in the prevention of needle stick injuries and syringe reuse.
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.
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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:
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Page 5
K252814 510(k) Summary
[As required by 21 CFR 807.92]
1. Submission Information
| Field | Value |
|---|---|
| 510(k) Number: | K252814 |
| Date: | February 12, 2026 |
| Type of 510(k) Submission: | Traditional |
| Submitter: | CMT HEALTH PTE. LTD.150 BEACH ROAD, #28-05, GATEWAY WEST, SINGAPORE, 189720 |
| Contact Person: | Monica Ma |
| E-mail: | ra@cmthealth.com |
| Tel: | +65 6846 1379 |
2. Device Description
| Field | Value |
|---|---|
| Proprietary Name | Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe,Profoject™ Low Dead Space Syringe with Needle /Profoject™ Tuberculin Syringe with Needle,Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle,Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety Syringe |
| Common Name | Low Dead Space Piston, Syringe, Antistick |
| Regulation Name | Piston syringe |
| Product Code | QNQ, MEG |
| Device Class | II |
| Regulation Number | 21 CFR 880.5860 |
| Review Panel | General Hospital |
Indications for use
| Device | Indication |
|---|---|
| Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe | Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe is used to inject fluids into, or withdraw fluids from, the body. |
| Profoject™ Low Dead Space Syringe with Needle/ Profoject™ Tuberculin Syringe with Needle | Profoject™ Low Dead Space Syringe with Needle/ Profoject™ Tuberculin Syringe with Needle is used to inject fluids into, or withdraw fluids from, the body. |
| Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle | Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle 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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| Device | Indication |
|---|---|
| Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety Syringe | Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety Syringe is intended for use to inject fluid into or withdraw fluids from the parts of body below the surface of the skin.The Sharps Injury Prevention Feature (SIPF) is designed to aid in the prevention of needle stick injuries and syringe reuse. |
Device Description
| Device | Description |
|---|---|
| Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe | Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe consists of a barrel with a Luer Slip or Luer Lock connector which comply with ISO 80369-7, a plunger, and a plunger stopper. The device is available in 0.5 mL and 1 mL capacities. It is sterile, single-use, and non-toxic device that operates on the principle of a piston syringe. |
| Profoject™ Low Dead Space Syringe with Needle/ Profoject™ Tuberculin Syringe with Needle | Profoject™ Low Dead Space Syringe with Needle/ Profoject™ Tuberculin Syringe with Needle is sterile, single-use device. Each consists of either a Luer slip or Luer lock syringe assembly integrated with a pre-attached needle, and the syringe is available in two capacities (0.5mL and 1mL). For each capacity variant, the pre-attached needle is available in the following gauge specifications: 16G, 18G, 19G, 21G, 22G, 23G, 25G, 27G and 30G. |
| Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle | Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle is sterile, single-use, non-toxic devices that work on the principle of a piston syringe, and the syringes are available in three capacities: 0.3mL, 0.5mL, and 1mL. Each capacity variant is equipped with a permanently attached needle, available in the following gauge specifications: 21G, 23G, 25G, 26G, 27G, 28G, 29G, 30G and 31G. |
| Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety Syringe | Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety Syringe is sterile, single-use, non-toxic devices that work on the principle of a piston syringe, and the syringes are available in three capacities: 0.3mL, 0.5mL, and 1mL. Each capacity variant is equipped with a permanently attached needle, available in the following gauge specifications: 21G, 23G, 25G, 26G, 27G, 28G, 29G, 30G and 31G. |
3. Predicate Device Identification
| Proposed Device | Predicate Device |
|---|---|
| Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe,Profoject™ Low Dead Space Syringe with Needle/ Profoject™ Tuberculin Syringe with Needle | K242291 - SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle, SOL-M Luer Lock Syringe (Low Dead Space) w/Exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle, SOLM Slip Tip Syringe (Low Dead Space) w/Exchangeable Needle |
| Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle | K231856 - TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TSLDS2534)) |
| Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety Syringe | K231856 - TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TSLDS2534))Reference Device: K220204 - Safety Syringe with permanently attached needle. |
4. Non-Clinical Test Conclusion
Non-clinical verification of the Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe,
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Profoject™ Low Dead Space Syringe with Needle/ Profoject™ Tuberculin Syringe with Needle, Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle, Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety Syringe have been conducted to evaluate their safety, performance, and functionality.
The results of these tests have demonstrated the overall performance of the proposed device in accordance with relevant test methods and support a substantial equivalence determination. Particularly, the following was conducted to adequately demonstrate the performance of the proposed device in accordance with relevant test methods cited below:
Performance Testing
- ISO 7864 Fourth edition 2016-08-01 Sterile hypodermic needles for single use - Requirements and test methods
- ISO 9626 Second edition 2016-08-01 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
- ISO 7886-1 Second edition 2017-05 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use
- ISO 23908: 2011 Sharps Injury Protection – Requirements and Test Methods – Sharps Protection Features for Single Use Hypodermic Needles, Introducers for Catheters and Needles Uses for Blood Sampling
- ISO 80369-7 Second edition 2021-05 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
- ASTM F1886/F1886M-16 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
- ASTM F1140/F1140M-13 (2020) Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages
- ASTM F88/F88M-23 Standard Test Method for Seal Strength of Flexible Barrier Materials
- ASTM F1929-23 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- USP - NF <71> Sterility Tests
- ISO 10993-7 Second edition 2008-10-15 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals[Including: Amendment 1 (2019)]
- ISTA 3A: 2018 Packaged-Products for Parcel Delivery System Shipment 70 kg (150 lb) or Less
- ISO 11135 Second edition 2014-07-15 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2018)]
- USP - NF <788> Particulate Matter in Injections
- USP - NF <85> Bacterial Endotoxin Testing
- ISO 11607-1 Second edition 2019-02 [Including AMD1:2023] Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems [Including Amendment 1 (2023)]
Usability Testing
FDA guidance document Medical Devices with Sharps Injury Prevention Features.
Biocompatibility Testing
The biocompatibility evaluation for Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe, Profoject™ Low Dead Space Syringe with Needle/ Profoject™ Tuberculin Syringe with Needle,
Page 8
Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle, Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety Syringe were conducted in accordance with ISO 10993-1:2018 Biological Evaluation of Medical Devices - Part 1. Evaluation and Testing within a Risk Management Process, as recognized by FDA. The proposed devices classified as an externally communicating with limited, blood path indirect contact.
- ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10 Fourth edition 2021-11 Biological evaluation of medical devices - Part 10: Tests for skin sensitization
- ISO 10993-23 First edition 2021-01 Biological evaluation of medical devices - Part 23: Tests for irritation
- USP <151> Rabbit Pyrogen Study
- ISO 10993-11 Third edition 2017-09 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
- ISO 10993-4 Third edition 2017-04 Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood
- ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials
5. Substantial Equivalent Based on Assessment of Clinical Performance Data
Clinical data was not including in this submission
6. Substantially Equivalent Comparison Conclusion
Table 1 Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe, Profoject™ Low Dead Space Syringe with Needle /Profoject™ Tuberculin Syringe with Needle
| Parameters | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| 1 | 510(k) Number | K252814 | K242291 |
| 2 | 510(k) Holder | CMT HEALTH PTE. LTD. | Sol-Millennium Medical Inc. |
| 3 | Device name | Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe, Profoject™ Low Dead Space Syringe with Needle/ Profoject™ Tuberculin Syringe with Needle | SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle, SOL-M Luer Lock Syringe (Low Dead Space) w/Exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle, SOLM Slip Tip Syringe (Low Dead Space) w/Exchangeable Needle |
| 4 | Common Name | Low Dead Space Piston Syringe | Low Dead Space Piston Syringe |
| 5 | Regulation Name | Piston Syringe | Piston Syringe |
| 6 | Product Code | QNQ | QNQ |
| 7 | Regulation Number | 21 CFR 880.5860 | 21 CFR 880.5860 |
Page 9
| Parameters | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| 8 | Review Panel | General Hospital | General Hospital |
| 9 | Device Class | II | II |
| 10 | Indications for use | The Profoject™ Low Dead Space Syringe/ Profoject™ Tuberculin Syringe is used to inject fluids into, or withdraw fluids from, the body.The Profoject™ Low Dead Space Syringe with Needle/ Profoject™ Tuberculin Syringe with Needle is used to inject fluids into, or withdraw fluids from, the body. | The Luer Lock/Slip Tip Syringe (Low Dead Space) is to inject fluids into, or withdraw fluids from, the body.The Luer Lock/Slip Tip Syringe (Low Dead Space) with exchangeable needle is used to inject fluids into, or withdraw fluids from, the body. |
| 11 | Type of use | Prescription use | Prescription use |
| 12 | Syringe configuration and material | 1) Plunger stopper (IR rubber)2) Plunger (PP)3) Barrel (PP)4) Lubricant (polydimethylsiloxane) | 1) Plunger stopper (IR rubber)2) Plunger (PP)3) Barrel (PP)4) Lubricant (Silicone) |
| 13 | Needle material (for Profoject™ Low Dead Space Syringe with Needle/ Profoject™ Tuberculin Syringe with Needle) | SUS 304 | SUS 304 |
| 14 | Luer lock | Luer lock or Luer slip (Slip Tip) | Luer lock or Luer slip (Slip Tip) |
| 15 | Syringe volume | 0.5mL, 1 mL | 1 mL |
| 16 | Luer compliance | ISO 80369-7 | ISO 80369-7 |
| 17 | Needle gauge and length | 16G,18G,19G,20G,21G,22G,23G,25G, 26G,27G,30G3/8'', 1/2'', 5/8'', 3/4'', 7/8'', 1'', 1 1/4'', 1 1/2'', 2'' | 23G, 25G, 27G, 30G1/2'', 5/8'', 1'', 1 1/2'' |
| 18 | Needle performance | Conforming with ISO 9626 and ISO 7864 | Conforming with ISO 9626 and ISO 7864 |
| 19 | Syringe performance | Conforming with ISO 7886-1 | Conforming with ISO 7886-1 |
| 20 | Dead space specification | Syringe: Low Dead Space Max: 0.035mL | Syringe: Low Dead Space Max: 0.02mL |
| 21 | Biocompatibility | Conforms with ISO 10993-1 | Conforms with ISO 10993-1 |
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| Parameters | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| 22 | Sterility | Sterile | Sterile |
| 23 | Sterilization method | EO Sterilization | EO Sterilization |
| 24 | Shelf Life | 5 years | 5 years |
Discussion
# 1 - Syringe configuration and material:
The materials of lubricant are different between the proposed device and predicate device. This difference does not raise any new questions of safety and effectiveness. The biocompatibility test of the proposed device was conducted to demonstrate that the proposed device met the biocompatibility requirements.
# 2 - Syringe volume, Needle gauge and length:
The syringe volume and needle gauge of the proposed device are different from those of the predicate device. However, this difference is just in dimension. Different syringe or needle specifications will be selected by physicians based on patients' conditions, and the differences does not raise new questions of safety and effectiveness. In addition, bench performance testing was conducted on the proposed device according to ISO 7886-1, ISO 7864, ISO 9626, and ISO 80369-7, and the results met the requirements of these standards. Therefore, the difference in syringe volume, needle gauge, and needle length does not raise different questions of safety and effectiveness when compared to the predicate device.
# 3 - Dead space specification:
While the Low Dead Space maximum limits differ between the proposed device and predicate device, both are significantly below the ISO 7886-1 requirement of 0.07 mL for syringes ≤2 mL. This difference does not affect the substantial equivalence of the proposed device's Low Dead Space syringe compared to the predicate device.
Conclusion
Based on the comparison of indications for use, type of use, performance test, dead space specification, etc. the device is as safe, as effective, and performs as well as the legally marketed device identified in the submission. Thus, the proposed device is substantially equivalent to the predicate device.
Table 2 Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle
| Parameters | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| 1 | 510(k) Number | K252814 | K231856 |
| 2 | 510(k) Holder | CMT HEALTH PTE. LTD. | MedExel Co., Ltd. |
| 3 | Trade Name | Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle | TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TSLDS2534)) |
| 4 | Common name | Low Dead Space Piston Syringe | Low Dead Space Piston Syringe |
| 5 | Regulation Name | Piston syringe | Piston syringe |
| 6 | Product Code | QNQ | QNQ |
| 7 | Regulation Number | 21 CFR 880.5860 | 21 CFR 880.5860 |
| 8 | Review Panel | General Hospital | General Hospital |
| 9 | Device Class | II | II |
| 10 | Type of use | Prescription Use | Prescription Use |
| 11 | Indications for use | Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle is intended for use to inject fluid into or withdraw fluids from the parts of body below the surface of the skin. | 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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| Parameters | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| 12 | 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. |
| 13 | Number of uses | Single Use Only | Single Use Only |
| 14 | Configuration and material | 1) Barrel: Polypropylene2) Plunger: Polypropylene3) Plunder Stopper: Polyisoprene rubber4) Needle: SUS 3045) Needle Cap: High Density Polyethylene6) Needle Hub: Polypropylene | 1) Barrel: Polypropylene2) Plunger: Polypropylene3) Gasket: Polyisoprene rubber4) Needle: SUS 3045) Needle Cap: Polypropylene |
| 15 | Needle gauge | 21G, 23G, 25G, 26G, 27G, 28G, 29G, 30G, 31G | 23G, 25G |
| 16 | Needle dimension – OD | 1) 21Gauge:0.800-0.8302) 23Gauge:0.600-0.6733) 25Gauge:0.500-0.5304) 26Gauge:0.440-0.4705) 27 Gauge:0.400-0.4206) 28 Gauge:0.349-0.3707) 29 Gauge:0.324-0.3518) 30 Gauge:0.298-0.3209) 31 Gauge:0.254-0.267 | 23G: 0.600 ~ 0.673 mm25G: 0.500 ~ 0.530 mm |
| 17 | Needle dimension – needle length | 13 mm(+1 / -2 mm)10 mm(+1 / -2 mm)8 mm(+1 / -2 mm) | 26.5 mm (+1.5 / -2.5 mm) |
| 18 | Mechanical specification | Hub/needle bond strength (ISO 7864)1) 21Gauge:44 N2) 23Gauge:34 N3) 25Gauge:22 N4) 26Gauge:22 N5) 27 Gauge:22 N6) 28 Gauge:22N7) 29 Gauge:22 N8) 30 Gauge:11 N9) 31 Gauge:11 N | Hub/needle bond strength (ISO 7864)1) 23 Gauge: 34 N2) 25 Gauge: 22 N |
| 19 | Syringe capacity | 0.3mL, 0.5mL, 1mL | 1mL |
| 20 | Syringe nozzle type | Permanently attached | Permanently attached |
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| Parameters | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| 21 | Dead space | Low dead volume ≤ 0.035 ml | Low dead volume ≤ 0.03 ml |
| 22 | Needle Performance | ISO 7864:2016 Sterile hypodermic needles for single use – Requirements and test methods ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices – Requirements and test methods | ISO 7864:2016 Sterile hypodermic needles for single use – Requirements and test methods ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices – Requirements and test methods |
| 23 | Syringe Performance | ISO 7886-1:2017 Sterile hypodermic syringes for single use – Part 1: Syringes for manual use | ISO 7886-1:2017 Sterile hypodermic syringes for single use – Part 1: Syringes for manual use |
| 24 | Sterility | Sterilized by EO Gas SAL=10-6 | Sterilized by EO Gas SAL=10-6 |
| 25 | Endotoxin limit | 20 EU/Device | 20 EU/Device |
| 26 | Labeling | Complies with 21 CFR part 801 | Complies with 21 CFR part 801 |
| 27 | Biocompatibility | According to ISO 10993-1 | According to ISO 10993-1 |
Discussion
# 1 - Configuration and material:
Compared to the predicate device, the proposed device incorporates an additional needle hub, and performance testing has demonstrated that proposed device compliant with ISO 7864 and ISO 7886-1 requirements. Through the biocompatibility test, the results confirmed that the materials of the proposed device will not cause any safety issues and effectiveness issues.
# 2 - Syringe capacity, Needle specification and Mechanical specification:
The syringe capacity, needle gauge and needle length of the proposed device are different from those of the predicate device. However, this difference is limited to dimensional variations. Different syringe or needle specifications will be selected based on different clinical usages. In addition, bench performance testing was conducted on the proposed device according to ISO 7886-1, ISO 7864, ISO 9626 and ISO 80369-7, the results met the requirements of these standards.
The hub/needle bond strength of proposed device are different from those of the predicate device, and bench performance testing was conducted on the proposed device according to ISO 7864, and the results met the requirements of these standards. Therefore, the difference in proposed device does not raise different questions of safety and effectiveness.
# 3 - Dead space:
While the Low Dead Space maximum limits differ between the proposed device and predicate device, both are significantly below the ISO 7886-1 requirement of 0.07 mL for syringes ≤2 mL. This difference does not affect the substantial equivalence of the proposed device's Low Dead Space syringe compared to the predicate device.
Conclusion
Based on the comparison of indications for use, type of use, performance test, dead space specification, etc. the device is as safe, as effective, and performs as well as the legally marketed device identified in the submission. Thus, the proposed device is substantially equivalent to the predicate device.
Table 3 Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety Syringe
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| Parameters | Proposed Device | Predicate Device | Reference Device | Remark |
|---|---|---|---|---|
| 1 | 510(k) Number | K252814 | K231856 | K220204 |
| 2 | 510(k) Holder | CMT HEALTH PTE. LTD. | MedExel Co., Ltd. | Anhui Tiankang Medical Technology Co., Ltd. |
| 3 | Trade Name | Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety Syringe | TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TSLDS2534)) | Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle |
| 4 | Regulation Name | Piston syringe | Piston syringe | Piston syringe |
| 5 | Product Code | QNQ, MEG | QNQ | MEG |
| 6 | Regulation Number | 21 CFR 880.5860 | 21 CFR 880.5860 | 21 CFR 880.5860 |
| 7 | Review Panel | General Hospital | General Hospital | General Hospital |
| 8 | Device Class | II | II | II |
| 9 | Type of use | Prescription Use | Prescription Use | Prescription Use |
| 10 | Indications for use | Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety Syringe is intended for use to inject fluid into or withdraw fluids from the parts of body below the surface of the skin.The Sharps Injury Prevention Feature (SIPF) is designed to aid in the prevention of needle stick injuries and syringe reuse. | 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. | The Safety Syringe with permanently attached needle 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. The Safety sheath of Syringe is designed to aid in the prevention of needle stick injuries and reduce the potential or syringe reuse. |
| 11 | 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. | Unpublished |
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| Parameters | Proposed Device | Predicate Device | Reference Device | Remark |
|---|---|---|---|---|
| 12 | Number of uses | Single Use Only | Single Use Only | Single Use Only |
| 13 | Configuration and material | 1) Barrel: Polypropylene2) Plunger: Polypropylene3) Plunder stopper: Polyisoprene rubber4) Needle: SUS 3045) Needle Cap: High Density Polyethylene6) Collar: Polycarbonate7) Protective shield: Polypropylene | 1) Barrel: Polypropylene2) Plunger: Polypropylene3) Gasket: Polyisoprene rubber4) Needle: SUS 3045) Needle Cap: Polypropylene | 1) Barrel (PP)2) Plunger (PP)3) Piston (Polyisoprene)4) Needle: Stainless Steel 304)5) Protective cap (PP)6) Safety mechanism Connector base (PC)7) Safety mechanism Sliding sleeve (PP) |
| 14 | Needle gauge | 21G, 23G, 25G, 26G, 27G, 28G, 29G, 30G, 31G | 23G, 25G | 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G, 31G |
| 15 | Needle dimension – OD | 1) 21Gauge:0.800-0.8302) 23Gauge:0.600-0.6733) 25Gauge:0.500-0.5304) 26Gauge:0.440-0.4705) 27 Gauge:0.400-0.4206) 28 Gauge:0.349-0.3707) 29 Gauge:0.324-0.3518) 30 Gauge:0.298-0.3209) 31 Gauge:0.254-0.267 | 23G: 0.600 ~ 0.673 mm25G: 0.500 ~ 0.530 mm | Unpublished |
| 16 | Needle dimension – needle length | 25 mm(+1.5 / -2.5 mm)20 mm(+1 / -2 mm)15 mm(+1 / -2 mm)13 mm(+1 / -2 mm)10 mm(+1 / -2 mm)8 mm(+1 / -2 mm) | 26.5 mm (+1.5 / -2.5 mm) | 8mm, 10mm, 13mm, 16mm, 20mm, 22mm, 25mm, 32mm, 38mm |
| 17 | Mechanical specification | Hub/needle bond strength (ISO 7864)1) 21Gauge:44 N2) 23Gauge:34 N3) 25Gauge:22 N4) 26Gauge:22 N5) 27 Gauge:22 N6) 28 Gauge:22N7) 29 Gauge:22 N8) 30 Gauge:11 N9) 31 Gauge:11 N | Hub/needle bond strength (ISO 7864)1) 23 Gauge: 34 N2) 25 Gauge: 22 N | Unpublished |
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Sharps Injury Prevention Feature is manually activated by the user by a finger-tip or thumb operation.
| Parameters | Proposed Device | Predicate Device | Reference Device | Remark |
|---|---|---|---|---|
| 18 | Syringe capacity | 0.3mL, 0.5mL, 1mL | 0.3mL, 0.5mL, 1mL | 0.3ml, 0.5ml, 1ml |
| 19 | Syringe nozzle type | Permanently attached | Permanently attached | Unpublished |
| 20 | Dead space | Low dead volume ≤ 0.035 ml | Low dead volume ≤ 0.03 ml | Unpublished |
| 21 | Needle Performance | ISO 7864:2016 Sterile hypodermic needles for single use – Requirements and test methodsISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices – Requirements and test methods | ISO 7864:2016 Sterile hypodermic needles for single use – Requirements and test methodsISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices – Requirements and test methods | Conforms with the requirements of ISO 7864, ISO 9626 |
| 22 | Syringe Performance | ISO 7886-1:2017 Sterile hypodermic syringes for single use – Part 1: Syringes for manual use | ISO 7886-1:2017 Sterile hypodermic syringes for single use – Part 1: Syringes for manual use | Conforms with the requirements of ISO 7886-1 |
| 23 | Sterility | Sterilized by EO Gas SAL=10-6 | Sterilized by EO Gas SAL=10-6 | Sterilized by EO Gas SAL=10-6 |
| 24 | Endotoxin limit | 20 EU/Device | 20 EU/Device | Unpublished |
| 25 | Labeling | Complies with 21 CFR part 801 | Complies with 21 CFR part 801 | Complied with 21 CFR part 801 |
| 26 | Biocompatibility | According to ISO 10993-1 | According to ISO 10993-1 | Contact level: blood path, indirect, limited contact (<24 hours). Conforms to the requirement of ISO 10993 series Standards |
Discussion
# 1 - Product Code
The proposed device is a low dead space syringe with a sharps injury prevention feature, therefore the corresponding product codes are QNQ and MEG. Proposed device, predicate device and reference device are all used by health care professionals for fluid aspiration and injection. Therefore, the difference on product code will not raise new questions of safety and effectiveness of the proposed device.
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# 2 - Mechanism of action
The proposed device incorporates sharps injury prevention feature. The safety feature performance test has been evaluated, and the test result conforms to requirements of ISO 23908 standards. Therefore, the differences with predicate devices do not affect substantial equivalence.
# 3 - Configuration and material:
The configuration and material for proposed device are different from predicate device, through the biocompatibility and performance test, the results confirmed that the configuration and materials of the proposed device do not raise any new questions of safety and effectiveness.
# 4 - Needle specification and Mechanical specification:
The syringe volume, needle gauge and needle length of the proposed device are different from those of the predicate device. However, this difference is limited to dimensional variations. Different syringe or needle specifications will be selected based on different clinical usages. In addition, bench performance testing was conducted on the proposed device according to ISO 7886-1, ISO 7864, ISO 9626, and ISO 80369-7, and the results met the requirements of these standards.
The hub/needle bond strength of proposed device are different from those of the predicate device. However, bench performance testing was conducted on the proposed device according to ISO 7864, and the results met the requirements of these standards. Therefore, the difference in proposed device does not raise different questions of safety and effectiveness.
# 5 - Dead Space:
While the Low Dead Space maximum limits differ between the proposed device and predicate device, both are significantly below the ISO 7886-1 requirement of 0.07 mL for syringes ≤2 mL. This difference does not affect the substantial equivalence of the proposed device's Low Dead Space syringe compared to the predicate device.
Conclusion
Based on the comparison of indications for use, type of use, performance test, etc. the device is as safe, as effective, and performs as well as the legally marketed device identified in the submission. Thus, the proposed device is substantially equivalent to the predicate device and reference device.
The Conclusions:
The conclusions drawn from the non-clinical tests demonstrate that the devices are as safe, as effective, and performs as well as the legally marketed devices identified in the submission. Thus, the subject devices are substantially equivalent to the predicate devices.
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§ 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).