(119 days)
The ACE Cannula is intended to inject fluids intradermally.
The ACE Cannula is provided as a single-use, sterile device. It is comprised of needles, hub and cap. This device comes in a variety of needle gauges and lengths. This device offers AN type and B type within the package. The AN type is a hypodermic single lumen needle intended to prepare the site for injection. The tip of this pilot needle is sharpened at one end, while the other end is joined to a hub. The B type has a metal tube with the tip, which is closed and blunt, while the cannula has an opening laterally at a lower point under the tip. On the other end, the device is joined to a female connector(hub) designed to mate with a male connector(nozzle) of a piston syringe or secondary medication sets to prepare and administer fluids/medications/drugs to a patient.
The provided document is a 510(k) summary for a medical device called the "ACE Cannula." It details the device's characteristics and compares it to a predicate device to demonstrate substantial equivalence, rather than providing the results of a clinical study or performance data based on human-in-the-loop or standalone AI performance.
Therefore, most of the requested information regarding acceptance criteria, study design (sample size, data provenance, expert adjudication, MRMC study, standalone performance), and ground truth establishment (for training and test sets) is not applicable to this type of submission. This document outlines bench testing for physical characteristics, material safety (biocompatibility), and sterility, all of which are laboratory-based and do not involve patient data or expert reader studies in the way you've described for AI/CADe devices.
Here's an analysis based on the information that is present in the document:
Device: ACE Cannula
Purpose: Intended to inject fluids intradermally.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the ACE Cannula are based on compliance with international standards for medical devices, specifically hypodermic needles and cannulas, and biocompatibility. The "reported device performance" is the manufacturer's assertion that the device "Pass"ed all these tests.
| Requirements - Test (Standard) | Acceptance Criteria (Implied by standard) | Reported Device Performance |
|---|---|---|
| Mechanical Performance (ISO 7864) | ||
| Appearance | Meet visual specifications | Pass |
| Color coding (Section 4.7) | Correct color coding | Pass |
| Color of hub (Section 4.8.2) | Correct color of hub | Pass |
| Needle tube Tolerance on length (Section 4.10.2) | Within specified tolerance | Pass |
| Needle tube Freedom from defects (Section 4.10.3) | Free from defects | Pass |
| Needle point (Section 4.11) | Meet point specifications | Pass |
| Bond between hub and needle tube (Section 4.12) | Secure bond | Pass |
| Patency of lumen (Section 4.13) | Lumen unobstructed | Pass |
| Mechanical Performance (ISO 9626) | ||
| Dimension (Section 5.6) | Within specified dimensions | Pass |
| Stiffness (Section 5.8) | Meet stiffness requirements | Pass |
| Resistance to breakage (Section 5.9) | Does not break under specified conditions | Pass |
| Resistance to corrosion (Section 5.10) | Resists corrosion | Pass |
| Luer Connector Performance (ISO 80369-7, ISO 80369-20) | ||
| Leakage by pressure decay (6.1.2/Annex B) | No leakage beyond acceptable limits | Pass |
| Positive Pressure Liquid Leakage (6.1.3/Annex C) | No leakage under positive liquid pressure | Pass |
| Sub-atmospheric Pressure Air Leakage (6.2/Annex D) | No air leakage under sub-atmospheric pressure | Pass |
| Stress Cracking (6.3/Annex E) | No cracking under stress | Pass |
| Resistance to separation from axial load (6.4/Annex F) | Resists separation under axial load | Pass |
| Resistance to separation from unscrewing (6.5/Annex G) | Resists separation when unscrewed | Pass |
| Resistance to overriding (6.6/Annex H) | Luer connection does not override | Pass |
| Disconnection by unscrewing (Annex I) | Allows disconnection by unscrewing | Pass |
| Chemical Properties (ISO 7864) | ||
| Extraction: pH | Difference of pH shall be ≤ 1.0 | Pass |
| Extraction: Potassium permanganate reducing substances | Difference of the consumption shall be ≤ 2.0 mL | Pass |
| Extraction: Residue on evaporation | Amount of residue shall be ≤ 1.0 mg | Pass |
| Extraction: Pb, Fe, Sn, Zn (Heavy metals) | Total content of heavy metals shall be ≤ 5.0 mg/L | Pass |
| Extraction: Cd | Content of Cd shall be ≤ 0.1 mg/L | Pass |
| Biocompatibility (ISO 10993-1, -4, -5, -7, -10, -11) | ||
| Cytotoxicity test | Should satisfy requirements (e.g., no toxic leachate) | Pass |
| Hemolysis test | Should satisfy requirements (e.g., no significant hemolysis) | Pass |
| Intracutaneous reactivity test | Should satisfy requirements (e.g., no significant irritation) | Pass |
| Skin sensitization test | Should satisfy requirements (e.g., no sensitization) | Pass |
| Acute systemic toxicity test | Should satisfy requirements (e.g., no systemic toxic effects) | Pass |
| Pyrogen Test | Should satisfy requirements (e.g., no pyrogenic response) | Pass |
| Particulate Matter Injection (USP ) | Meet USP requirements for particulate matter | Pass |
| Sterility & EO Residuals (ISO 11135, ISO 11737-2, ISO 10993-7) | ||
| LAL test (Bacterial Endotoxins) | Meet USP39 requirements (Unit : EU/Device) | Pass |
| E.O sterilization validation | Meet ISO 11135:2014 requirements for sterilization | Pass |
| Sterility test | Meet ISO 11737-2 requirements (e.g., sterile to SAL 10^-6^) | Pass |
| E.O Residual test | Meet ISO 10993-7:2008 requirements for EO residuals | Pass |
2. Sample size used for the test set and the data provenance:
- This is a 510(k) submission for a conventional medical device (a cannula), not an AI/CADe device. The "test set" here refers to samples of the device undergoing laboratory bench testing according to various ISO standards.
- The document does not specify the exact sample size for each individual bench test (e.g., how many cannulas were tested for bond strength). However, it implies that sufficient samples were tested to demonstrate compliance with the relevant standards.
- Data Provenance: The tests were conducted by Ace Medical Industry Co., Ltd. (Korea, as per company address in the 510(k) summary) or a qualified third-party lab under their direction. These are prospective tests performed on newly manufactured devices to demonstrate compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device's performance is evaluated through physical, chemical, and biological laboratory tests against pre-defined, objective engineering and safety standards (e.g., ASTM, ISO standards). It does not involve subjective human interpretation of data (like medical images), so no human experts are needed to establish "ground truth" for a test set in the clinical sense.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. As above, the testing is objective and based on engineering/scientific measurements, not subjective human assessments requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This relates to AI/CADe devices assisting human clinicians. The ACE Cannula is a physical, sterile, single-use device for fluid injection, not an AI or imaging device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This relates to the performance of an AI algorithm. The ACE Cannula does not have an "algorithm" in this context. Its "performance" is its mechanical, material, and biological properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the tests performed, the "ground truth" is defined by the objective pass/fail criteria established within the referenced international standards (e.g., ISO, USP, ASTM). For example, "pass" for patency of lumen means the lumen was unobstructed as per the standard's definition; "pass" for cytotoxicity means the extracts did not cause a cytotoxic effect beyond the acceptable limits defined in ISO 10993-5. It is based on objective, measurable criteria rather than expert consensus or clinical outcomes data relevant to AI/CADx devices.
8. The sample size for the training set:
- Not applicable. There is no "training set" for this type of device. The device is manufactured and then tested for compliance with established standards. There is no machine learning model being trained.
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set for an AI model, there is no ground truth established for it. The product's design and manufacturing rely on engineering principles, material science, and established quality control practices.
§ 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).