(25 days)
The ProfojectTM Disposable Syringe and the ProfojectTM Disposable Syringe with Needle are intended to be used for medical purposes to inject fluid into or withdraw fluid from body.
The ProfojectTM Disposable Syringe is available in a sterile state. It is a single-use device comprising a polypropylene barrel with a Luer slip or Luer lock nozzle, a polypropylene plunger, and a polyisoprene rubber plunger stopper. Syringes are available in various volume specifications, ranging from 1mL to 60mL. The syringe barrel is printed with a legible graduated scale in milliliters. The syringe is compatible with U.S. legally marketed devices featuring Luer slip or Luer lock connectors that comply with ISO 80369-7. The syringe is intended for manual use only. The plunger of the syringe is pulled back to aspirate fluids or depressed to inject or expel fluids.
The ProfojectTM Disposable Syringe with Needle is supplied in a sterile state. It is a single-use device comprising a Luer slip or Luer lock syringe and a hypodermic needle. The hypodermic needle consists of a stainless steel needle tube, a polypropylene needle hub, and a polypropylene needle cap. The hypodermic needle is available in variety of combinations of needle gauge (18G, 20G, 21G, 22G, 23G, 25G, 26G, 27G) and needle length (15mm, 20mm, 25mm, 30mm, 38mm). Needle hubs are color-coded to identify the gauge of the needle tube. The Disposable Syringe with Needle is available in various combinations of syringe volume and needle size. It is intended for manual use only. The plunger of the syringe is pulled back to aspirate fluids or depressed to inject or expel fluids.
The provided FDA 510(k) clearance letter and summary for the Profoject™ Disposable Syringe and Profoject™ Disposable Syringe with Needle focuses on establishing substantial equivalence to a predicate device (K211211) through non-clinical testing. It does not describe a study involving an AI component, human readers, or a ground truth established in the way typical for AI/ML medical devices.
Therefore, the requested information regarding acceptance criteria, device performance, sample size for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable as this is a traditional medical device submission without an AI/ML component.
Instead, the submission relies on a comparison of technological characteristics and performance testing against recognized international standards for syringes and needles to demonstrate substantial equivalence.
Here's a summary based on the provided document, addressing the relevant points and noting where information is not applicable due to the nature of the device:
Acceptance Criteria and Study Details for Profoject™ Disposable Syringe
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are based on compliance with a comprehensive set of international standards rather than specific performance metrics directly stated in a table for each criterion. The "reported device performance" is indicated by the statement that the tests met the requirements of these standards.
| Acceptance Criterion (Compliance with Standard) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| ISO 10993-1:2018 (Cytotoxicity, Skin sensitization, Intracutaneous reactivity, Acute systemic toxicity, Pyrogen test, Hemocompatibility) | Met the requirements in the standards. |
| USP Particulate Matter in Injections | Met the USP acceptance criteria. |
| Performance Testing: | |
| ISO 7886-1:2017 (Sterile hypodermic syringes for single use - Part 1: Syringes for manual use) | Complied with the standard. |
| ISO 7864:2016 (Sterile hypodermic needles for single use - Requirements and test methods) | Complied with the standard. |
| ISO 9626:2016 (Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods) | Complied with the standard. |
| ISO 80369-7:2021 (Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications) | Complied with the standard. |
| ISO 6009:2016 (Hypodermic needles for single use — Colour coding for identification) | Complied with the standard. |
| Sterilization, Package, and Shelf Life Testing: | |
| ISO 11135:2014 (Ethylene Oxide Sterilization Validation) | Validated, establishing routine control and monitoring parameters. |
| ISO 11737-1:2018+AMD1:2021 (Bioburden test) | Test results demonstrated compliance. |
| ISO 11737-2:2019 (Sterility test) | Test results demonstrated compliance. |
| ISO 10993-7:2008+AMD1:2019 (EO and ECH residue test) | Test results demonstrated compliance. |
| USP (Bacterial Endotoxins Test) | Test results demonstrated compliance. |
| ISTA 3A:2018 (Simulated distribution testing for packaging) | Test results demonstrated compliance. |
| ASTM F88/F88M-23 (Seal strength) | Packaging found acceptable. |
| ASTM F1929-23 (Dye penetration) | Packaging found acceptable. |
| ASTM F1886/F1886M-16 (Visual inspection) | Packaging found acceptable. |
| ASTM F1140/F1140M-13 (Reapproved 2020)e1 (Internal pressurization) | Packaging found acceptable. |
| USP (Sterility test for packaging) | Packaging found acceptable. |
| ASTM F1980-21 (Accelerated aging for shelf life) | Device shelf-life determined to be 5 years. |
| Labeling Compliance | Met the requirements of 21 CFR Part 801. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each test. It states that "the following tests have been performed" and that "the testing results demonstrate that the proposed device complies with the applicable standards requirements." For biocompatibility, performance, sterilization, package, and shelf-life testing, samples of the device were used as required by the specific standards.
- Sample Size: Not explicitly stated as a single number for a "test set." Samples were drawn and tested according to the requirements of each individual standard (e.g., ISO, ASTM, USP).
- Data Provenance: The tests were conducted by the manufacturer (CMT Health Pte. Ltd., based in Singapore) or their designated testing facilities to demonstrate compliance with international standards. This is prospective testing performed on manufactured devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
N/A. This device is a traditional medical device (syringes) and not an AI/ML device requiring expert-established ground truth for a diagnostic test. The "ground truth" here is compliance with established engineering and biological safety standards.
4. Adjudication Method for the Test Set
N/A. Not applicable to engineering performance and biocompatibility testing of a physical device. Test results are compared directly against the quantitative or qualitative pass/fail criteria defined within the referenced international standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
N/A. This is a traditional medical device (syringe), not an AI-assisted diagnostic or interpretative device. Therefore, MRMC studies are not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This device does not involve an AI algorithm. Its performance is evaluated through bench testing against established standards.
7. The Type of Ground Truth Used
The "ground truth" for this device's acceptance is defined by the objective, measurable requirements and pass/fail criteria specified within the referenced international and national standards (ISO, ASTM, USP) for its physical, chemical, and biological properties. This includes:
- Engineering specifications (e.g., dimensions, force required for operation, leak integrity).
- Material safety (biocompatibility, leachable substances).
- Sterility assurance.
- Packaging integrity.
- Shelf-life stability.
8. The Sample Size for the Training Set
N/A. This is a traditional medical device and does not involve machine learning algorithms requiring a training set.
9. How the Ground Truth for the Training Set Was Established
N/A. No training set is applicable for this device.
§ 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).