Search Results

The 3DOSE 1ml Syringe is intended for use by health care professionals for general purpose fluid aspiration/ injection.

The 3DOSE 1ml Syringe is a sterile, single-use, disposable and non-reusable manual syringe which is intended for injection of fluids into the body. The syringe can be used for pulling up any mixture, and after operating the locking handle for accurate dosing according to the ml/unit scale on the plunger.

The 3DOSE 1ml Syringe is used like a classic syringe, but includes a feature that provides tactile and audible feedback to the user during dosing.

Models: 3DOSE 1ml Syringe (125 GREEN)
3DOSE 1ml Syringe (100 ORANGE)

The provided FDA 510(k) clearance letter for the 3DOSE 1ml Syringe does not detail any study involving human readers, AI, or diagnostic performance metrics typically associated with AI/ML-based medical devices. This clearance is for a piston syringe, a physical medical device, not an AI/ML software as a medical device (SaMD).

Therefore, I cannot provide information for the following points as they are not applicable to this device and its clearance documentation:

• A table of acceptance criteria and the reported device performance (in terms of diagnostic metrics like sensitivity, specificity, AUC)
• Sample sizes used for the test set and data provenance (for diagnostic performance of an algorithm)
• Number of experts used to establish the ground truth for the test set and their qualifications
• Adjudication method for the test set
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done
• If a standalone (algorithm only) performance study was done
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
• The sample size for the training set
• How the ground truth for the training set was established

However, I can extract information related to the device's technical specifications, performance standards, and the non-clinical testing performed to establish its safety and effectiveness relative to a predicate device.

Here's the summary of acceptance criteria and the study that proves the device meets them, based on the provided document, specifically for a physical medical device (syringe):

1. Acceptance Criteria and Reported Device Performance (Non-Diagnostic)

For a physical device like a syringe, acceptance criteria relate to its physical properties, functionality, and compliance with recognized standards. The "performance" reported is its compliance with these standards, indicating mechanical functionality, material safety, and sterility.

• ISO 80369-7:2016: Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
• ISO 80369-20:2015: Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods | - Complies with ISO 7886-1:2017
• Complies with ISO 80369-7:2016
• Complies with ISO 80369-20:2015
  (Demonstrated through "Functional Performance Testing") |
  | Sterility | - ISO 11135: Sterilization of health-care products - Ethylene oxide
• ISO 11607-1: 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
• ISO 10993-7: Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals | - Device is sterile, single-use, disposable.
• Sterilized using Ethylene Oxide.
• Validated shelf-life of 5 years.
  (Demonstrated through "Sterility" testing per listed ISO standards) |
  | Biocompatibility | - ISO 10993-1: Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process (including Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Hemocompatibility)
• ISO 10993-4: Tests for interactions with blood
• ISO 10993-5: Tests for in vitro cytotoxicity
• ISO 10993-10: Tests for irritation and skin sensitization
• ISO 10993-11: Tests for systemic toxicity
• USP Particulate Matter In Injections | - Biocompatibility evaluation conducted in accordance with ISO 10993-1 and FDA recognized standards.
• Syringe of testing included Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Hemocompatibility.
• All a-forementioned tests passed, demonstrating the device is biocompatible. (Demonstrated through "Biocompatibility Testing") |
  | Chemical Properties | - ISO 7886-1 (Section for chemical properties: Limits for acidity or alkalinity, Limits for extractable metals) | - Chemical performances inspection based on ISO 7886-1.
• Results conform to ISO 7886-1 for limits for acidity or alkalinity and extractable metals. (Demonstrated through "Chemical properties" testing) |
  | Material/Design Integrity | - Functionality of the "audible/tactile feature" (ratcheting dose mechanism)
• No negative effect on overall device performance due to new features (locking arm, plastic part, audible/tactile feedback) | - In-process quality control tests performed to confirm the audio notification mechanism works correctly and does not have a negative effect on overall performance.
• Performance testing conducted for the ratcheting lock mechanism (locking arm, plastic part) to ensure it does not raise new questions of safety or effectiveness. (Demonstrated through implicit in-house testing/QC) |

2. Sample Sizes used for the Test Set and Data Provenance

The document does not specify exact sample sizes for each non-clinical test (e.g., how many syringes were tested for extractable metals or sterility). It generally states "The collective results of the nonclinical testing demonstrate..." This implies a sufficient number of samples were tested to meet the statistical requirements of the respective ISO standards.

• Data Provenance: The tests would have been performed in a laboratory setting, likely in Turkey (Bimed Teknik Aletler Sanayi & Ticaret A.S. is based in Istanbul, Turkey) or by accredited labs contracted by them. These are prospective tests performed specifically for this 510(k) submission.

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

This concept is not applicable here as there is no "ground truth" in the clinical diagnostic sense. The "truth" for device functionality, sterility, and biocompatibility is established by compliance with internationally recognized consensus standards (ISO, USP) and physical/chemical measurements by qualified laboratory personnel.

4. Adjudication method for the test set

Not applicable. This is not a study assessing human or AI diagnostic performance.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done

No. This type of study is for evaluating observer performance, typically in medical imaging or diagnostics, and is not relevant to a physical medical device like a syringe.

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

No. This device is not an algorithm or software. It is a manually operated piston syringe.

7. The type of ground truth used

For this device, the "ground truth" is defined by the specifications and limits set by the referenced international standards (e.g., ISO 7886-1, ISO 10993 series). For example:

• Dimensional accuracy of volume: defined by ISO 7886-1 tolerances.
• Sterility: defined by ISO 11135 and ISO 11607 series (e.g., SAL of 10^-6).
• Biocompatibility: Defined by the absence of adverse biological reactions as per ISO 10993 series tests.
• Chemical properties: Defined by limits for acidity/alkalinity and extractable metals in ISO 7886-1.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/ML model that requires training data.

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

Not applicable.

Ask a specific question about this device