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510(k) Data Aggregation
(140 days)
HORIZON PHACOEMULSIFICATION SYSTEM, MODEL HZN-2030
The Horizon Phacoemulsification System performs phacofragmentation/ phacoemulsification with ultrasonic energy to disrupt and extract cataractous lens material from the eye.
The Horizon Phacoemulsification System utilizes the same technology as the currently marketed predicate devices that employ ultrasonic energy to emulsify a cataractous lens and remove it from the eye. The intended use and performance specifications are also comparable to the predicate devices. The subject of this 510(k) is the Horizon Phacoemulsification System's design configuration of a non-invasive vacuum sensing system that maintains sterile fluids, and the unit's software controlled user interface.
The Horizon Phacoemulsification System utilizes an external tubing cartridge venting to the bottle versus air, to minimize the possibility of introducing contamination into the fluid path. The external tubing cartridge design is advantageous as the fluid path is visible to the user, easily removed/ replaced at the end of the case. The Horizon system uses a software-controlled interface that assists the user in not only system set up but in all modes of operation during surgery. The advanced microprocessors allow the surgeon to program surgical parameters for up to six different users by an LCD touch panel display.
The Horizon Phacoemulsification System has similar operation modes as the predicate devices, i.e. Ultrasonic (U/S), Irrigation, Irrigation/ Aspiration (I/A), Vitrectomy, and Diathermy or Coagulation modes utilized in cataract extraction. The component parts of the Horizon Phacoemulsification System include the U/S handpiece, the tubing cartridge, and the footswitch as these items can only be used with this system. The Cautery, Vitrectomy, and Irrigation/ Aspiration devices are universal-type handpieces that are considered additional accessories to the Horizon system.
The provided text describes a 510(k) submission for the Horizon Phacoemulsification System. It does not include a study proving the device meets acceptance criteria in the traditional sense of a clinical trial or performance study with defined metrics. Instead, the submission relies on demonstrating substantial equivalence to predicate devices.
Here's an analysis based on the information provided, addressing your requested points:
1. Table of Acceptance Criteria and Reported Device Performance
This section is not applicable in the traditional sense of a performance study with specific numerical acceptance criteria. The "acceptance criteria" here are implied by the demonstration of substantial equivalence to predicate devices, meaning the device must perform similarly to those already on the market. The reported performance is the assertion that its characteristics are the same or comparable, without new technological characteristics or performance specifications.
| Characteristic / "Acceptance Criterion" | Reported Device Performance (Horizon Phacoemulsification System) |
|---|---|
| Intended Use (Phacofragmentation/phacoemulsification of cataractous lens material) | Performs phacofragmentation/phacoemulsification with ultrasonic energy to disrupt and extract cataractous lens material from the eye. (Same as predicate devices) |
| Technological Characteristics | Same as Predicate Devices. |
| Console Display | LCD Touch Screen (Predicate P4000 & Ocusystem: Touch Pad; OMS Diplomax: LCD Touch Pad) - Considered equivalent due to similar functionality. |
| Pump Type | Peristaltic, low pulsation (Same as predicate devices). |
| Pump Vacuum Range | 0 to 500 mmHg (Same as predicate devices). |
| Aspiration Rate | 0 to 50 cc/min (Same as P4000 & Ocusystem; OMS Diplomax: 0 to 44 cc/min) - Within comparable range and likely considered equivalent for this type of submission. |
| Fluidics | External Fluid Path (Same as P4000 & Ocusystem; OMS Diplomax: Internal Fluid Path) - A difference, but the submission claims it's an advantage ('external tubing cartridge venting to the bottle versus air, to minimize the possibility of introducing contamination into the fluid path') and still allows for substantial equivalence. |
| System Tubing | Reusable Tubing Cartridge* (Predicate P4000 & Ocusystem: Disposable/Reusable Tube Set; OMS Diplomax: Disposable/Reusable T-Fitting) - A difference in design, but functionality for fluid path is considered equivalent. |
| Vent | Fluid Vent (Predicate P4000 & OMS Diplomax: Air Vent; Ocusystem: Fluid Vent) - Variation among predicates, Horizon is similar to Ocusystem. |
| Modes | U/S Phaco, Irrigation/Aspiration, Vitrectomy, Bipolar Coagulation (Same as predicate devices). |
| Programmable User Parameters | Yes (Same as predicate devices). |
| Handpiece Material | Titanium (Predicate P4000: Titanium; Ocusystem: Plastic/Titanium; OMS Diplomax: Stainless Steel/Titanium) - Comparable materials for the intended function. |
| Handpiece Frequency | 40 kHz, 4 crystals (Predicate P4000: 40 kHz, 4 crystals; Ocusystem: 55 kHz, 4 crystals; OMS Diplomax: 38 kHz, 2 crystals) - Similar to P4000, and within the range of frequencies found in predicate devices. |
| Footswitch Operational Control | 3 mode position, activates reflux (Same as predicate devices). |
| Safety and Effectiveness | Substantially equivalent to predicate devices; no new technological characteristics or performance specifications. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. No "test set" in the context of a clinical performance study was conducted. The assessment is based on a comparison of device characteristics against predicate devices.
- Data Provenance: The data provided is for the device's design and features, compared against existing predicate devices already on the market (K931354, K991852, K946054). This is a retrospective comparison of product specifications, not prospective data from a human trial. The country of origin for the data is implied to be the US, as it's an FDA submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. "Ground truth" in the clinical sense was not established for a test set. This type of submission relies on the regulatory body (FDA) comparing the provided device characteristics with those of already cleared devices to determine substantial equivalence.
- Qualifications of Experts: The FDA reviewers are the "experts" in determining substantial equivalence based on regulatory guidelines and their understanding of medical devices. Their qualifications would involve scientific and regulatory expertise.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No formal adjudication of results from a test set was performed. The FDA's review process itself serves as the adjudication by the regulatory body.
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
- MRMC Study: No. This device is a phacoemulsification system, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: No, not in the sense of an algorithm. This is a medical device (hardware and embedded software) for a surgical procedure. Its performance is inherent in its physical and operational characteristics, not a standalone algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for this submission is implicitly the established safety and effectiveness of the legally marketed predicate devices. The new device is deemed safe and effective because its characteristics and intended use are substantially equivalent to those predicates, which have already gone through the regulatory process to demonstrate their own safety and effectiveness. No new clinical outcomes data or pathology results were submitted as ground truth for this specific device.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is not an AI/ML product developed using a training set in the typical machine learning sense. The "training" for this device would be its engineering design, development, and testing processes to meet its specifications, drawing upon established engineering principles and data from similar devices.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable. As per point 8, there isn't a "training set" in the AI/ML context. The design and manufacturing of the device are based on established engineering and medical principles for phacoemulsification systems, which were validated through the prior regulatory clearance of its predicate devices.
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