(125 days)
The Laminar Flow Phacoemulsification Tips are used to break up (emulsify) the nucleus of a cataractous lens and remove the remaining nuclear fragments.
The Irrigation Sleeve is a device intended to direct irrigation solution across the shaft of a phacoemulsification tip, allowing the solution to enter the eye during ocular surgery.
The Phacoemulsification tip is intended for use in conjunction with the Irrigation Sleeve during ocular surgery.
Phacoemulsification (Phaco) is a technique used during cataract surgery to emulsify and extract a cataractous lens from the eye with an ultrasonic handpiece. The ultrasonic handpiece is connected to, and powered by a phacoemulsification system, which is identified in 21 CFR 886.4670 as "an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract."
The fragmentation needle, also referred to as a phaco tip, vibrates at an ultrasonic frequency and emulsifies the cataract when connected to an ultrasonic phacoemulsification handpiece. The fragmented tissue can then be aspirated and removed through the lumen of the tip. During a surgical procedure, irrigation solution, typically Balanced Salt Solution (BSS), is used to irrigate the eye and this is passed with the help of an Irrigation Sleeve. The Irrigation Sleeve directs the irrigation solution across the shaft of the phacoemulsification tip, allowing it to enter the eye during ocular surgery. This small molded component is placed over the Phacoemulsification tip. The proposed tips and irrigation sleeves are made of fitanium and medical grade silicone respectively.
The subject of this 510(k) premarket notification is the Reusable Phacoemulsification Tips (Phaco Tips) & Irrigation Sleeves (Phaco Sleeves), which will be additions to the family of Disposable Laminar Flow Phacoemulsification Tips & Sleeves. The Phaco tips that are the subject of this 510(k) premarket notification have two different designs, straight and curved tip. The same two designs were the subject of the predicate device and have been cleared by the FDA under K111882 (AMO Laminar Flow Phaco Tips). These tips were cleared by the FDA for single use only and now AMO intends to introduce the reusable version of the same models into the market to offer a broad range of products to our customers. These tips will be compatible with all our currently marketed AMO ultrasonic handpieces, and will be made of the same surgical grade titanium as the predicate device. Moreover, these 21G tips will also be compatible with our 21G Irrigation Sleeves (Phaco Sleeve), which is the other subject device of this 510(k) premarket notification. The 21G Irrigation Sleeve will have a slightly different design as compared to the predicate device, which has been cleared under K103023 (AMO Irrigation Sleeve). The reduced gauge size (21G) is designed for use with the 21G Phaco tips. The proposed Light Blue and Orange sleeve will be made of the same medical grade silicone material as the predicate device (Yellow Sleeve), with a difference in the colorant to distinguish between the various AMO sleeve offerings in the market.
This looks like a 510(k) summary for a medical device (Laminar Flow Phacoemulsification Tip and Irrigation Sleeve) where the primary change from predicate devices is the claim of reusability, a different gauge size for the irrigation sleeve, and a higher flow rate for the irrigation sleeve.
However, the provided text does not contain acceptance criteria for specific performance metrics (like sensitivity, specificity, or accuracy) derived from a study comparing the device's output to a ground truth. Instead, it focuses on demonstrating that the device (the reusable Phaco Tips and Irrigation Sleeves) is substantially equivalent to legally marketed predicate devices, with additional testing performed to support the new features (reusability, different gauge size, higher flow rate).
The document mentions "Functional validation testing has been performed to demonstrate higher flow rate for the proposed irrigation Sleeve," and "Additional testing including Cleaning and Autoclave validation has been performed to demonstrate reusability for both the proposed subject devices." It also lists various standards used in testing.
Given the information provided, I cannot populate the table or answer all the questions as they relate to typical clinical performance studies (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance). The 510(k) summary focuses on demonstrating engineering equivalence and safety for the reusable aspect and functional performance (like flow rate), rather than diagnostic accuracy or effectiveness in terms of human reader improvement.
Here's what I can extract and state based on the provided text, and where I must note missing information:
1. A table of acceptance criteria and the reported device performance
| Feature/Test | Acceptance Criteria (or Reference to Standard) | Reported Device Performance |
|---|---|---|
| Irrigation Sleeve Flow Rate | $\ge 40$ cc/min | Functional validation testing performed to demonstrate higher flow rate; reported to be $\ge 40$ cc/min (this is both the criteria and reported performance, implying it met or exceeded this value). This is specifically compared to the predicate's $\ge 18$ cc/min. |
| Phaco Tips & Irrigation Sleeve Reusability | Demonstrated through Cleaning and Autoclave validation | Cleaning and Autoclave validation performed, results indicated successful demonstration of reusability. |
| Functional Testing | Compliance with applicable safety standards (e.g., ANSI/AAMI/IEC 80601-2-58:2008) | Performed, "considered successful," and "demonstrates that Phaco Tips & Irrigation Sleeve perform equivalently to the predicate devices with respect to safety and effectiveness." |
| Sterilization | ISO 11137-1, -2, -3; ANSI/AAMI ST79; ISO 17664 | Performed, in compliance with applicable safety standards. |
| Shelf Life | Not specified | Performed, in compliance with applicable safety standards. |
| Packaging Integrity | Not specified | Performed, in compliance with applicable safety standards. |
| Biocompatibility | Not specified | Performed, "results have shown the material used in these devices to be biocompatible and safe for use during the cataract surgery." |
| Non-Clinical Animal Studies | Not specified | Performed for Straight and Curved Laminar Flow Phaco Tips along with Irrigation Sleeves. "Both studies demonstrate that Phaco tips and sleeves are safe and effective for human use and that they perform well with our various AMO phacoemulsification systems and handpieces and pose no additional risks." "Demonstrate similar effectiveness and performance profiles with respect to their predicates." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for any of the individual tests. The document refers to "various testing" and "studies" but does not give numerical sample sizes.
- Data Provenance: Not specified. Assumed to be internal testing by Abbott Medical Optics Inc., located in Santa Ana, CA, USA.
- Retrospective/Prospective: Not specified, but functional and validation testing would typically be prospective (conducted specifically for this submission).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable as this is not a diagnostic device involving expert adjudication of ground truth for performance metrics like sensitivity/specificity. The ground truth for functional tests would be based on engineering specifications and standard test methods.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for the types of engineering and safety tests described.
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
- No MRMC study was done. This is not an AI/diagnostic device that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm-only device. The described tests are for the physical device's functional integrity, safety, and reusability.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the tests mentioned (e.g., flow rate, sterilization, biocompatibility, reusability) would be established by:
- Engineering specifications and measurements: For flow rate, dimensional analysis.
- Validated test methods and standards: For sterilization (ISO, AAMI standards), cleaning validation, biocompatibility (ISO 10993 series, though not explicitly listed for biocompatibility, it's the standard practice).
- Animal study observations: For non-clinical animal studies to confirm safety and effectiveness in a biological system.
8. The sample size for the training set
- Not applicable. This is not a machine learning/AI device requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not a machine learning/AI device.
§ 886.4670 Phacofragmentation system.
(a)
Identification. A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.(b)
Classification. Class II.