(21 days)
The Phaco Needles are intended for use with a Bausch & Lomb Millennium, Protegé or Premiere Microsurgical System for the emulsification of an opacified crystalline lens.
The phacoemulsification (phaco) needle is the cylindrical, metal tip which is connected to the distal end of a phaco handpiece. The needle is the component of a phaco system which, as driven by the ultrasonic handpiece, contacts and fragments the cataractous crystalline lens. Irrigation fliud flows around the external surface of the needle into the eye. The emulsified lens material and irrigant are aspirated from the eye through the phaco needle lumen. The proposed Phaco Chop Needle has the same external and internal tip design as Bausch & Lomb's currently marketed MicroFlow and MicroFlow Plus Needles. However, the internal restriction is deeper within the needle bore
This document describes a 510(k) submission for a new medical device, the Phaco Chop Needle, which is a variation of existing phacoemulsification needles used in cataract surgery. The submission claims substantial equivalence to previously marketed Bausch & Lomb Phaco Needles.
Analysis of Acceptance Criteria and Study Details:
Based on the provided information, this submission focuses on demonstrating substantial equivalence to existing, legally marketed devices rather than establishing novel performance criteria through a standalone clinical study with acceptance criteria.
The core of the submission is a comparison matrix that highlights the design similarities between the proposed Phaco Chop Needle and the predicate devices (Standard Phaco Needle, MicroFlow Needle, MicroFlow+ Needle). The key difference noted for the proposed device is that "the internal restriction is deeper within the needle bore" compared to its external and internal tip design, which is the same as the MicroFlow and MicroFlow Plus Needles.
Therefore, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the traditional sense of a clinical trial with pre-defined performance thresholds does not directly apply to this 510(k) summary. Instead, the "acceptance criteria" here are implied to be that the device operates safely and effectively for its intended use, performing comparably to the predicate devices.
Here's how to interpret your request in the context of this 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (as demonstrated by comparison) |
|---|---|
| Intended Use Equivalence: Phaco needles are used for anterior segment surgery with Bausch and Lomb Microsurgical Systems for emulsification of an opacified crystalline lens. | Met: Proposed Phaco Chop Needle shares the identical "Indications for Use" statement with predicate devices: "The Phaco Needles are intended for use with a Bausch & Lomb Millennium, Protegé or Premiere Microsurgical System for the emulsification of an opacified crystalline lens." |
| Design Feature Equivalence (External & Internal Tip): External and internal tip design should be similar to predicate devices to ensure comparable interaction with the crystalline lens. | Met: "The proposed Phaco Chop Needle has the same external and internal tip design as Bausch & Lomb's currently marketed MicroFlow and MicroFlow Plus Needles." |
| Material/Size Equivalence (Key Dimensions): Needle Tip OD and ID are critical for surgical performance and compatibility. | Met: |
- Needle Tip OD (in.): 0.042 (same as Standard and MicroFlow, MicroFlow+ is 0.046)
- Needle Tip ID (in.): 0.036 (same as all predicates) |
| Operational Equivalence (Sterility/Reusability): Deviations from predicate in these areas need to be justified for safety. | Met (with specific differences acknowledged): - Sterile/Non-Sterile: Proposed is "Non-Sterile only" (Predicates are "Sterile & Non-Sterile"). This implies the device is intended for sterilization by the user.
- Single Use/Reusable: Proposed is "Reusable only" (Predicates are "Single Use & Reusable"). This is a notable difference but likely addressed by demonstrating cleaning/sterilization protocols. |
| Tip Angle Options: Range of tip angles offered. | Met (with specific differences acknowledged): Proposed offers 30 & 45 degrees (Predicates offer wider ranges, e.g., 0, 15, 30, & 45). The offered angles are a subset of the predicate's range. |
| Safety and Effectiveness (overall implicit criteria): The device should not raise new questions of safety or effectiveness and be as safe and effective as the predicate devices. | Met (by FDA determination): The FDA's 510(k) clearance letter states, "We have determined in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that this device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976." This is the ultimate "proof" in a 510(k) context. |
2. Sample Size for the Test Set and Data Provenance:
- Sample Size for Test Set: Not applicable in the context of a clinical performance study with a dedicated "test set" and a 510(k) for a device with a similar design and intended use to existing devices. The "test" here is largely the design comparison and potentially benchtop testing (which is not detailed in this summary). There is no mention of human subject testing (clinical trial) for this specific 510(k) submission.
- Data Provenance: Not applicable. The "data" primarily consists of design specifications and a comparison table, rather than clinical data from a "test set."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. There is no mention of specific experts establishing ground truth for a clinical test set in this 510(k) summary. The "ground truth" for substantial equivalence is based on existing regulatory clearances of the predicate devices and internal engineering assessments by the manufacturer.
4. Adjudication Method for the Test Set:
- Not applicable. There is no clinical test set requiring an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done, as this is a device design submission, not an AI or diagnostic imaging product requiring human reader evaluation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- No, a standalone (algorithm only) performance study was not done. This device is a physical medical instrument, not an algorithm or AI.
7. The Type of Ground Truth Used:
- The "ground truth" in this 510(k) submission is the established safety and effectiveness of the legally marketed predicate devices (Bausch & Lomb Standard Phaco Needle, MicroFlow Phaco Needle, MicroFlow+ Phaco Needle). The submission aims to demonstrate that the new device is sufficiently similar to these predicates that it shares their safety and effectiveness profile, as determined by the FDA. This is essentially regulatory precedent and engineering design comparison.
8. The Sample Size for the Training Set:
- Not applicable. This is a physical medical device, not a machine learning model, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set for a physical medical 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.