(140 days)
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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JUL 9 2002
| 510(k) Summary of Safety and Effectiveness | |
|---|---|
| Contact | American Optisurgical Inc.25501 Arctic OceanLake Forest, CA 92630949 580 1266Nanette CanepaDirector, Regulatory AffairsJuly 3, 2002510(k): K020527 |
| Name of Device, Common Name and Classification | Name of Device: Horizon Phacoemulsification SystemCommon Name: Phacofragmentation or Phacoemulsification SystemClassification Name: As per 21 CFR 886.4670, the product nomenclature is Phacofragmentation System. |
| Predicate Devices | P4000 Phacoemulsifier System (K931354)Ocusystem Art Advantage (K991852)OMS Diplomax Phacoemulsifier (K946054) |
| Intended Use | The Horizon Phacoemulsification System performs phacofragmentation/ phacoemulsification with ultrasonic energy to disrupt and extract cataractous lens material from the eye. |
| Technological characteristics | The technological characteristics of the Subject Device are the same as the Predicate Devices. |
| Performance data | Performance data was not required as the Subject Device does not utilize any new technological characteristics or performance specifications than the currently marketed Predicate Devices. |
Continued on next page
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| Device description | 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. | |
| Conclusion | Based on the 510(k) summaries and the 510(k) statements (21 CFR §807) and the information provided herein, we conclude that the Subject Device is substantially equivalent to the Predicate Devices under the Federal Food, Drug and Cosmetic Act. |
| Continued on next page |
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Comparison of device characteristics
The table below lists the characteristics of the Subject Device and Predicate Devices as a comparison of essential components.
| DeviceCharacteristics | Subject DeviceHorizonPhacoemul-sificationSystem | Predicate DeviceP4000Phacoemulsifier | Predicate DeviceOcusystem ArtAdvantagePhacoemulsifier | Predicate DeviceOMS DiplomaxPhacoemulsifier |
|---|---|---|---|---|
| Console | ||||
| Display | LCD TouchScreen | Touch Pad | Touch Pad | LCD Touch Pad |
| Pump | Peristaltic, lowpulsation | Same | Same | Same |
| Pump VacuumRange | 0 to 500 mmHg | 0 to 500 mmHg | 0 to 500 mmHg | 0 to 500 mmHg |
| Aspiration Rate | 0 to 50 cc/min | 0 to 50 cc/min | 0 to 50 cc/min | 0 to 44 cc/min |
| Fluidics | External FluidPath | External FluidPath | External FluidPath | Internal FluidPath |
| System Tubing | Reusable TubingCartridge* | Disposable/Reusable Tube Set | Disposable/Reusable TubingSet | Disposable/Reusable T-Fitting |
| Vent | Fluid Vent | Air Vent | Fluid Vent | Air Vent |
| Modes | U/S Phaco,Irrigation/Aspiration,Vitrectomy,BipolarCoagulation | Same | Same | Same |
| ProgrammableUser Parameters | Yes | Yes | Yes | Yes |
| Handpieces | ||||
| Material | Titanium | Titanium | Plastic/ Titanium | Stainless Steel/Titanium |
| Frequency | 40 kHz,4 crystals | 40 kHz,4 crystals | 55 kHz,4 crystals | 38 kHz,2 crystals |
| Footswitch | ||||
| Operationalcontrol | 3 mode position,activates reflux | Same | Same | Same |
- Disposable tubing is not yet available.
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 9 2002
American Optisurgical, Inc. c/o Nanette Canepa 25501 Arctic Ocean Lake Forest, CA 92630
Re: K020527
Trade/Device Name: Horizon Phacoemulsification System Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation System Regulatory Class: Class II Product Code: HQC Dated: February 15, 2002 Received: February 19, 2002
Dear Ms. Canepa:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the 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, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Nanette Canepa
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address . http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k) Number: K_O20527 ______________________________________________________________________________________________________________________________________________________
Device Name: Horizon Phacoemulsification System
Indications for Use: The Horizon Phacoemulsification System performs phacofragmentation/ phacoemulsification with ultrasonic energy to disrupt and extract cataractous lens material from the eye.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off)Division of Ophthalmic Ear,Nose and Throat Devises | |
|---|---|
| Prescription Use(Per 21 CFR 801.109) | 510(k) Number K020527 |
(Optional Format 3-10-98)
§ 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.