(8 days)
The ANUTRA Feedback Aspiration Syringe is intended for use by healtheare professionals for general purpose fluid aspiration/injection.
The ANUTRA Feedback Aspiration Syringe is a piston syringe (control syringe) consisting of a plastic barrel which contains a printed graduated scale (5mL nominal volume) and 6% male Luer Lock connection, a plunger, and a plastic plunger rod. The internal surface of the ANUTRA Feedback Aspiration Syringe barrel is lubricated with polydimethylsiloxane (silicone). The plunger rod design contains a finger ring to allow for ease of use, and tab features with interface with the barrel to provide audible and tactile feedback to the user.
The ANUTRA Feedback Aspiration Syringe is single-use only, non-pyrogenic, and sterilized by gamma irradiation.
The Anutra Feedback Aspiration Syringe's acceptance criteria and performance data are primarily based on demonstrating substantial equivalence to a predicate device (BD Single Use, Hypodermic Syringe, K110771) through a battery of performance tests conforming to international standards.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a "table of acceptance criteria" with "reported device performance" in a quantitative manner for most tests. Instead, it lists the tests performed on the subject device and implies that the device met the "specified requirements" for these tests, thereby demonstrating substantial equivalence. For some tests, the predicate device also had similar tests performed.
Implied Acceptance Criteria and Performance (based on "Tests Performed on Subject Device")
| Test Category / Standard | Specific Test (if detailed) | Implied Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ISO 7886-1 (Syringes) | Section 5 (Cleanliness) | Device is clean and free from particulate matter. | Met. |
| Section 6 (Limits for Acidity or Alkalinity) | Extracts from the device do not significantly alter pH. | Met. (Performed on both subject and predicate device). | |
| Section 7 (Limits for Extractable Metals) | Extracts from the device do not exceed specified limits for metals. | Met. (Performed on both subject and predicate device). | |
| Section 8 (Lubricant) | Lubricant properties meet specified standards. | Met. | |
| Section 9 (Tolerance on graduated capacity) | Accuracy of graduated volume markings within specified tolerances. | Met. | |
| Section 10 (Graduated Scale) | Graduated scale is clear, accurate, and durable. | Met. | |
| Section 11 (Barrel) | Barrel integrity and dimensions meet specifications. | Met. | |
| Section 12 (Piston/plunger assembly); Annex B | Piston/plunger assembly functions correctly and smoothly. | Met. | |
| Section 13 (Nozzle) | Nozzle dimensions and integrity meet specifications. | Met. | |
| Section 14.1 (Dead Space) | Dead space is minimized and within acceptable limits. | Met. | |
| Section 14.2 (Freedom from air and liquid leakage past piston); Annex B and Annex D | No air or liquid leakage past the piston. | Met. (Specifically, liquid leakage at syringe piston under compression (Annex D) and freedom from air and liquid leakage past piston (Annex B and D) were tested, with the predicate also testing Annex D). | |
| Annex G (Forces to operate the plunger) | Plunger operation forces are within acceptable range (not too high for user comfort/control, not too low for accidental movement). | Met. (Performed on both subject and predicate device). | |
| Section 15 (Packaging) | Packaging meets integrity and labeling requirements. | Met. | |
| Section 16 (Labeling) | Labeling meets specified requirements for content and legibility. | Met. | |
| ISO 594-2 (Luer Connections) | Section 3 (Dimensions and tolerances) | Luer lock dimensions meet standard specifications for compatibility. | Met. |
| Section 4.1 (Gauging) | Luer lock fits standard gauges correctly. | Met. | |
| Section 5.2 (Liquid leakage from fitting assembly under pressure) | No liquid leakage from the Luer lock connection under pressure. | Met. | |
| Section 5.3 (Air leakage into fitting assembly during aspiration) | No air leakage into the Luer lock connection during aspiration. | Met. | |
| Section 5.4 (Separation force of fitting assembly) | Connection remains secure under specified separation forces. | Met. | |
| Section 5.5 (Unscrewing torque of fitting assembly) | Connection can be unscrewed with appropriate torque. | Met. | |
| Section 5.6 (Ease of assembly) | Connection is easy to assemble. | Met. | |
| Section 5.7 (Resistance to overriding) | Connection prevents overriding (e.g., cross-threading). | Met. | |
| Section 5.8 (Stress cracking) | Material maintains integrity under stress. | Met. | |
| Sterile Barrier Packaging Testing | ASTM F2096-11 (Detecting Gross Leaks) | No gross leaks in packaging. | Met. |
| ASTM F88-09 (Seal Strength) | Packaging seals exhibit required strength. | Met. | |
| ASTM F1886/F1886M-09(2013) (Integrity by Visual Inspection) | Packaging seals are visually intact and show no defects. | Met. | |
| General Performance | Syringe package shall be easy to open with gloved hands | Packaging can be easily opened by a user wearing gloves. | Met. |
| Syringe shall be able to aspirate and deliver using one hand | Device can be comfortably and effectively operated with one hand. | Met. | |
| Tactile feedback | The tactile feedback feature functions as intended during aspiration/injection. | Met. | |
| Finger reach | The finger ring and plunger are ergonomically designed for ease of use. | Met. | |
| Biocompatibility Testing (ISO 10993) | Cytotoxicity by Elution Test (Cytotoxicity) | No cytotoxic effects. | Met. (Summary provided in Section 15 of full submission, not provided here). |
| Intracutaneous Reactivity (Irritation or Intracutaneous Reactivity) | No significant irritation or intracutaneous reactivity. | Met. (Summary provided in Section 15 of full submission, not provided here). | |
| Maximization Test for Delayed Hypersensitivity (Sensitization) | No significant sensitization potential. | Met. (Summary provided in Section 15 of full submission, not provided here). | |
| Acute Systemic Toxicity (Systemic Toxicity (Acute)) | No acute systemic toxicity. | Met. (Summary provided in Section 15 of full submission, not provided here). | |
| Evaluation of Hemocompatibility: Interaction with Blood (Hemocompatibility/Hemolysis) | Does not cause significant hemolysis or adverse blood interaction. | Met. (Summary provided in Section 15 of full submission, not provided here). |
The "Reported Device Performance" for all listed tests is implicitly "Met" or "Demonstrated to meet the specified requirements" as stated in Section 5.8: "Test results demonstrated that the ANUTRA Feedback Aspiration Syringe is as safe, as effective and performs as well as or better than the legally marketed predicate device (BD Single Use, Hypodermic Syringe)."
2. Sample Size for the Test Set and Data Provenance
The document does not specify the sample sizes used for each individual performance test (e.g., number of syringes tested for leakage, force, etc.).
The data provenance is from performance testing of the manufactured device (Anutra Feedback Aspiration Syringe) and a comparison to a predicate device. It is a prospective evaluation of the new device's performance against established standards. The country of origin of the data is not explicitly stated but would presumably be the testing labs contracted by Anutra Medical, Inc., or Gilero, LLC (based in the US).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This device is a medical device (syringe), not an AI/diagnostic software. Therefore, the concept of "ground truth" established by experts in a diagnostic sense, or based on a "test set" of cases/images with expert interpretations, is not applicable here. The performance evaluation relies on meeting engineering and biocompatibility standards through physical and chemical testing.
4. Adjudication Method for the Test Set
As this is not a diagnostic device or an AI application with human interpretation, an "adjudication method" (like 2+1, 3+1) is not applicable. The test results are objective measurements against specified standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No. This is a hardware medical device (syringe), not an AI system or diagnostic tool where MRMC studies involving human readers are performed.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device, not an algorithm. Its standalone performance is assessed through the physical and chemical tests mentioned.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance evaluation is based on:
- International Standards: ISO 7886-1 for sterile hypodermic syringes, ISO 594-2 for Luer taper fittings, and ISO 10993 for biocompatibility.
- ASTM Standards: For packaging integrity (ASTM F2096, F88, F1886M).
- Predicate Device Characteristics: Comparison of technical and performance characteristics to a legally marketed predicate device to establish substantial equivalence.
These standards define the acceptable performance parameters (e.g., limits for acidity, leakage thresholds, force ranges, biocompatibility responses).
8. The Sample Size for the Training Set
Not applicable. This is a hardware medical device, not an AI/machine learning system that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set 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).