Who is the manufacturer of HORIZON PHACOEMULSIFICATION SYSTEM, MODEL HZN-2030?

American Optisurgical, Inc. filed the 510(k) submission for HORIZON PHACOEMULSIFICATION SYSTEM, MODEL HZN-2030 (K020527).

What is the FDA product code for HORIZON PHACOEMULSIFICATION SYSTEM, MODEL HZN-2030?

HQC. It is classified under 21 CFR 886.4670 as a Class 2 device in the Ophthalmic panel.

What is the regulatory pathway for HORIZON PHACOEMULSIFICATION SYSTEM, MODEL HZN-2030?

510(k) clearance (submission type: Traditional).

What are the predicate devices for HORIZON PHACOEMULSIFICATION SYSTEM, MODEL HZN-2030?

P4000 Phacoemulsifier System (K931354); Ocusystem Art Advantage (K991852); OMS Diplomax Phacoemulsifier (K946054).

Who can help prepare an FDA 510(k) submission like HORIZON PHACOEMULSIFICATION SYSTEM, MODEL HZN-2030?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

HORIZON PHACOEMULSIFICATION SYSTEM, MODEL HZN-2030

K020527 · American Optisurgical, Inc. · HQC · Jul 9, 2002 · Ophthalmic

Device Facts

Record ID	K020527
Device Name	HORIZON PHACOEMULSIFICATION SYSTEM, MODEL HZN-2030
Applicant	American Optisurgical, Inc.
Product Code	HQC · Ophthalmic
Decision Date	Jul 9, 2002
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 886.4670
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Horizon Phacoemulsification System performs phacofragmentation/ phacoemulsification with ultrasonic energy to disrupt and extract cataractous lens material from the eye.

Device Story

Horizon Phacoemulsification System uses ultrasonic energy to emulsify and remove cataractous lens material. System inputs include surgeon-programmed parameters via LCD touch panel; outputs include controlled ultrasonic energy, irrigation, and aspiration. Device features non-invasive vacuum sensing and external tubing cartridge venting to minimize contamination. Operated by surgeons in clinical settings; system assists in setup and surgical modes (U/S, I/A, Vitrectomy, Diathermy). Microprocessor-based control allows customization for up to six users. Benefits include improved fluid path visibility and reduced contamination risk via external venting. Clinical decision-making is supported by real-time system feedback and programmable surgical parameters.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is based on comparison of technological characteristics and performance specifications to legally marketed predicate devices.

Technological Characteristics

Console with LCD touch screen; peristaltic pump (0-500 mmHg vacuum, 0-50 cc/min aspiration); external fluid path with reusable tubing cartridge; fluid vent. Titanium ultrasonic handpiece (40 kHz, 4 crystals). Modes: U/S Phaco, I/A, Vitrectomy, Bipolar Coagulation. Software-controlled interface for system setup and operation. Programmable user parameters.

Indications for Use

Indicated for patients requiring cataract surgery to disrupt and extract cataractous lens material from the eye using ultrasonic energy.

Regulatory Classification

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.

Predicate Devices

P4000 Phacoemulsifier System (K931354)
Ocusystem Art Advantage (K991852)
OMS Diplomax Phacoemulsifier (K946054)

Related Devices

K111446 — SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEM · Abbott Medical Optics, Inc. · Dec 21, 2011
K151636 — AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance Linear (Four-Button) Foot Pedal, WHITESTAR Signature Pro (Wireless) Remote Control · Abbott Medical Optics, Inc. · Oct 19, 2015
K981116 — SOVEREIGN CATARACT EXTRACTION SYSTEM · Allergan, Inc. · May 19, 1998
K230858 — QUATERA 700 · Carl Zeiss Meditec, AG · Jul 31, 2023
K133115 — COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACK · Abbott Medical Optics, Inc. · Feb 27, 2014

Submission Summary (Full Text)

{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 | , . ﻳ : . ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ ﻬ . ット {2}------------------------------------------------ ## 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)