(193 days)
It is intended for use by health care professionals for puncture, drainage and fluid collection of the anterior chamber of the eye. Its operation is manual. The Disposable Aqueous Humor Collector is single use only. The Disposable Aqueous Humor Collector is suitable for ophthalmic use.
Disposable aqueous humor collector is composed of a liquid collecting needle sheath, a liquid collecting needle, a needle seat, a liquid collecting needle rubber sheath, a rubber plug, a liquid collecting tube, a cylinder body, a rubber ring, push rod and buckle structure.
Models: SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27
Volume: 50μL, 100μL
Needle Gauge: 25G, 27G
The provided FDA 510(k) clearance letter and summary for the "Disposable Aqueous Humor Collector" does not contain acceptance criteria or a detailed study description of device performance, beyond general statements about compliance with ISO standards and a brief mention of an OUS study.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (StaClear Syringe) by comparing specifications and stating that differences do not raise new safety or effectiveness concerns, supported by various non-clinical tests (biocompatibility, sterility, bench functional performance).
Therefore, I cannot fulfill the request to provide the acceptance criteria and the study that proves the device meets them based solely on the provided text. The document refers to testing being performed, but does not present the specific acceptance criteria or the detailed results of those tests.
However, I can extract the information that is present and highlight what is missing based on your request:
Missing Information: The provided document states that "required testing was conducted to validate the cumulative modifications made to the subject devices" and that "Substantial Equivalence is being supported with full performance testing," including bench functional performance tests. It also mentions "An outside of the United States (OUS) study was performed demonstrating the effectiveness of the subject device to collect 50 uL of liquid with the 50 uL model." However, it does not detail the specific acceptance criteria for these tests, nor does it provide a full study report with reported device performance against those criteria.
Here is what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Bench Functional Performance: | |
| ISO 7886-1:2017: Sterile hypodermic syringes for single use. Part 1: Syringes for manual use | "Complied" |
| ISO 9626:2016: Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods | "Complied" |
| ISO 7864:2016: Sterile hypodermic needles for single use — Requirements and test methods | "Complied" |
| Needle point penetration force: $\le$ 0.70N | (Not explicitly reported, but implied to be met for compliance with ISO 9626) |
| Liquid production volume and precision: 50 µL ± 20%, 100 µL ± 20% | "Effectiveness... to collect 50 uL of liquid with the 50 uL model" (from OUS study, specific performance values not given) |
| Resistance to corrosion of the liquid collecting needle: (Specific criteria not provided) | (Not explicitly reported, but implied to be met for compliance with ISO 9626) |
| Total content of heavy metals: not exceed 5 µg/mL | (Not explicitly reported) |
| Biocompatibility: Compliant with ISO 10993 series | "Differences do not raise new or different questions of safety and effectiveness" |
| Irritation, Ocular: Not considered irritants to the ocular tissue | "Not considered irritants to the ocular tissue" |
| Irritation; Intracameral Injection: Not considered inflammatory to intraocular tissues | "Not considered inflammatory to intraocular tissues" |
| Sterility: SAL 10^-6 | "SAL: 10^-6" (achieved via Irradiation sterilization) |
| Shelf Life: 2 years | "Confirms the 2 year shelf life" |
| USP Particulate Matter in Injection: (Specific criteria not provided) | (Not explicitly reported, but implied compliance) |
| USP Particulate Matter in ophthalmic solutions: (Specific criteria not provided) | (Not explicitly reported, but implied compliance) |
| Bacterial Endotoxins (ANSI AAMI ST72:2019, USP ): (Specific criteria not provided) | (Not explicitly reported, but implied compliance) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified for any of the tests.
- Data Provenance: The document mentions "An outside of the United States (OUS) study." This indicates a prospective clinical study conducted outside the US. No further details on the country of origin are provided. Bench and biocompatibility testing locations are not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not Applicable. This device is a medical instrument (collector/syringe) for fluid collection, not an AI/diagnostic device that typically requires expert-established ground truth for its performance evaluation (e.g., image interpretation). Its performance is evaluated through physical and chemical property testing (e.g., volume accuracy, needle strength, sterility).
4. Adjudication Method for the Test Set
- Not Applicable. As noted above, this type of device does not involve expert adjudication for ground truth establishment.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study is typically for evaluating the performance of diagnostic devices, especially those involving human interpretation of data (e.g., radiology images) with and without AI assistance. This device is a manual fluid collector, so such a study is not relevant.
6. If a Standalone Performance Study Was Done
- Yes, implicitly. The bench functional performance tests (ISO 7886-1, ISO 9626, ISO 7864), biocompatibility tests, sterility tests, and the OUS study (which demonstrated effectiveness to collect 50 µL) all represent standalone performance evaluations of the device itself, without human interpretation as a variable.
7. The Type of Ground Truth Used
- Metrological and Biological Standards: The ground truth for this device's performance is established by reference to international standards (e.g., ISO for syringes and needles), specific quantitative measurements (e.g., needle force, volume, heavy metal limits, SAL for sterility), and established biocompatibility principles (ISO 10993 series). In the case of the OUS study, the "ground truth" for liquid collection would be the actual measured volume collected by the device.
8. The Sample Size for the Training Set
- Not Applicable. This is a hardware medical device, not an AI/software device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As it's not an AI/software device, a training set and its associated ground truth are not relevant.
§ 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).