(140 days)
Not Found
No
The summary describes a phacoemulsification system with a software-controlled user interface and programmable parameters, but there is no mention of AI or ML capabilities for tasks like image analysis, automated parameter adjustment based on real-time feedback, or predictive modeling. The performance studies section also states that performance data was not required as the device does not utilize new technological characteristics compared to predicate devices, which would likely be the case if AI/ML were incorporated.
Yes
The device performs "phacofragmentation/ phacoemulsification with ultrasonic energy to disrupt and extract cataractous lens material from the eye," which is a therapeutic intervention.
No
This device is a surgical system used for phacoemulsification, a procedure to remove cataractous lens material. It does not perform diagnostic functions.
No
The device description clearly outlines hardware components such as a U/S handpiece, tubing cartridge, footswitch, and an LCD touch panel display, in addition to the software-controlled user interface.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "perform phacofragmentation/ phacoemulsification with ultrasonic energy to disrupt and extract cataractous lens material from the eye." This is a surgical procedure performed directly on the patient's eye.
- Device Description: The description focuses on the mechanical and software aspects of a surgical system used for cataract removal. It describes the handpiece, tubing, footswitch, and different surgical modes.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, or other bodily fluids) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) during surgery.
N/A
Intended Use / Indications for Use
The Horizon Phacoemulsification System performs phacofragmentation/ phacoemulsification with ultrasonic energy to disrupt and extract cataractous lens material from the eye.
Product codes (comma separated list FDA assigned to the subject device)
HQC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
JUL 9 2002
| 510(k) Summary of Safety and Effectiveness | |
|---|---|
| Contact | American Optisurgical Inc. |
| 25501 Arctic Ocean | |
| Lake Forest, CA 92630 | |
| 949 580 1266 |
Nanette Canepa
Director, Regulatory Affairs
July 3, 2002
510(k): K020527 |
| Name of Device, Common Name and Classification | Name of Device: Horizon Phacoemulsification System
Common Name: Phacofragmentation or Phacoemulsification System
Classification 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
1
| 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.
| Device
Characteristics | Subject Device
Horizon
Phacoemul-
sification
System | Predicate Device
P4000
Phacoemulsifier | Predicate Device
Ocusystem Art
Advantage
Phacoemulsifier | Predicate Device
OMS Diplomax
Phacoemulsifier |
|---------------------------------|-----------------------------------------------------------------------------------|----------------------------------------------|-------------------------------------------------------------------|-----------------------------------------------------|
| Console | | | | |
| Display | LCD Touch
Screen | Touch Pad | Touch Pad | LCD Touch Pad |
| Pump | Peristaltic, low
pulsation | Same | Same | Same |
| Pump Vacuum
Range | 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 Fluid
Path | External Fluid
Path | External Fluid
Path | Internal Fluid
Path |
| System Tubing | Reusable Tubing
Cartridge* | Disposable/
Reusable Tube Set | Disposable/
Reusable Tubing
Set | Disposable/
Reusable T-
Fitting |
| Vent | Fluid Vent | Air Vent | Fluid Vent | Air Vent |
| Modes | U/S Phaco,
Irrigation/
Aspiration,
Vitrectomy,
Bipolar
Coagulation | Same | Same | Same |
| Programmable
User 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 | | | | |
| Operational
control | 3 mode position,
activates reflux | Same | Same | Same |
- Disposable tubing is not yet available.
3
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.
4
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
5
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)