(125 days)
Not Found
No
The description focuses on a physical tip and explicitly states no software modification is required for existing systems. There is no mention of AI/ML terms or data processing.
Yes
The device is used to separate a cataractous lens, which is a medical treatment.
No
The device is described as forming part of a system used to physically separate a cataractous lens into smaller pieces, which is a therapeutic intervention, not a diagnostic one.
No
The device is a physical tip made of Titanium 6AL-4V alloy, designed to be attached to existing ultrasonic handpieces. It is a hardware component, not software.
Based on the provided information, the ALCON® UltraChopper is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "separate a cataractous lens into smaller pieces" during surgery. This is a surgical tool used directly on a patient's tissue in vivo (within the living body).
- Device Description: The description details a surgical tip used with a phacofragmentation handpiece. This is consistent with a surgical instrument.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the living body) to provide information for diagnosis, monitoring, or screening. The ALCON® UltraChopper does not perform any such analysis on specimens.
Therefore, the ALCON® UltraChopper is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The ALCON® UltraChopper is indicated to be used with an Ultrasonic Phacofragmentation Handpiece to separate a cataractous lens into smaller pieces.
Product codes (comma separated list FDA assigned to the subject device)
HOC
Device Description
The ALCON® UltraChopper tip is a modified ultrasonic tip that will be added to the existing ALCON® Phaco tip family. The ALCON® UltraChopper tip is of a similar size and shape as existing Alcon phaco tips and is made with the same material (Titanium 6AL-4V alloy) as the Alcon phaco tips currently used on the INFINITI® System and CONSTELLATION® System. The ALCON® UltraChopper tip will utilize existing packaging configurations and have the same shelf life as existing phaco tips. It can be used with the same ultrasonic handpieces (INFINITI®, INFINITI® NeoSonix® or INFINITI® OZil) currently used on the Alcon systems such as the INFINITI® System and CONSTELLATION® System. To use the ALCON® UltraChopper as intended, no modification to the existing INFINITI® System and CONSTELLATION® System software is required. The ALCON® UltraChopper tip is provided sterile and intended for single use only. This product is Gamma sterilized and the process has been validated to a SAL of 10° per FDA Recognized Consensus Standard - "EN ISO 11137-1:2006, Sterilization of health care products – Radiation – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices".
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Non-clinical testing has demonstrated that the functional requirements have been met and that the device is equivalent to the 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.
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OCT 2 0 2009
Image /page/0/Picture/1 description: The image shows the word "Alcon" in a bold, sans-serif font. The letters are all capitalized, and the word is black. There is a registered trademark symbol to the right of the "n" in "Alcon". The background is white.
K091777 Sick :
PREMARKET NOTIFICATION 510(k) SUMMARY
This summary document is being prepared in accordance with section 21 CFR. 807.92(c).
The submitter of the 510(k) is:
Martin A. Kaufman Director, Regulatory Affairs Alcon Research, Ltd. 15800 Alton Parkway Irvine, CA 92618 Phone: (949) 753-6250 Fax: (949) 753-6237
Device Subject to this 510(k):
ALCON® UltraChopper Trade Name: Common Name: Phacofragmentation tip Classification Name: Phacofragmentation tip (per 21 CFR 886.4670)
1. Predicate Devices
The legally marketed devices(s) to which we are claiming equivalence to are:
| 510(k) Number | Device |
|---|---|
| K041998 | Bausch & Lomb Phaco Chop Needle |
| K021566 | INFINITI® Cataract Extraction System |
| K063583 | ALCON® Vision System (CONSTELLATION®) |
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2. Device Description
The ALCON® UltraChopper tip is a modified ultrasonic tip that will be added to the existing ALCON® Phaco tip family. The ALCON® UltraChopper tip is of a similar size and shape as existing Alcon phaco tips and is made with the same material (Titanium 6AL-4V alloy) as the Alcon phaco tips currently used on the INFINITI® System and CONSTELLATION® System. The ALCON® UltraChopper tip will utilize existing packaging configurations and have the same shelf life as existing phaco tips. It can be used with the same ultrasonic handpieces (INFINITI®, INFINITI® NeoSonix® or INFINITI® OZil) currently used on the Alcon systems such as the INFINITI® System and CONSTELLATION® System.
To use the ALCON® UltraChopper as intended, no modification to the existing INFINITI® System and CONSTELLATION® System software is required.
3. Indications for Use
The ALCON® UltraChopper is indicated to be used with an Ultrasonic Phacofragmentation Handpiece to separate a cataractous lens into smaller pieces.
Brief Summary of Non-clinical test and Results 4.
Biocompatibility evaluations of materials coming in contact with the patient fluid path have been performed to the following standards:
| Standard # | Title |
|---|---|
| 10993-1: 2003 AAMI/ANSI/ISO | Biological Evaluation of Medical Devices -- |
| Part 1: Evaluation and testing | |
| 10993-5: 1999 AAMI/ANSI/ISO | Biological Evaluation of medical devices -- |
| Part 5: Tests for In Vitro cytotoxicity | |
| 10993-10:2002/A1:2006 AAMI/ | |
| ANSI/ISO | Biological Evaluation of Medical Devices -- |
| Part 10: Tests for irritation and delayed-type | |
| hypersensitivity – Including A1:2006 | |
| 10993-11:2006 AAMI/ANSI/ISO | Biological Evaluation of Medical Devices -- |
| Part 11: Tests for systemic toxicity | |
| 10993-12:2007 AAMI/ANSI/ISO | Biological Evaluation of Medical Devices -- |
| Part 12: Sample Preparation and Reference | |
| Materials |
2
The ALCON® UltraChopper tip is provided sterile and intended for single use only. This product is Gamma sterilized and the process has been validated to a SAL of 10° per FDA Recognized Consensus Standard - "EN ISO 11137-1:2006, Sterilization of health care products – Radiation – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices".
Technological characteristics affecting clinical performance are similar to those of predicate devices previously listed. The ALCON® UltraChopper tip has been developed and will be manufactured in compliance with section 21 CFR 820 and ISO 14971:2003. Non-clinical testing has demonstrated that the functional requirements have been met and that the device is equivalent to the predicate devices.
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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 features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. Martin Kaufman Director, Regulatory Affairs Alcon Research, Ltd. 15800 Alton Parkway Irvine CA 92618
OCT 2 0 2009
Re: K091777
Trade/Device Name: Alcon UltraChopper Regulation Number: 21 CFR 886.4670 Regulation Name: Phacoemulsification Tip Regulatory Class: II Product Code: HOC Dated: September 25, 2009 Received: September 29, 2009
Dear Mr. Kaufman:
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Kessà Alexander for
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Alcon Research, Ltd. Traditional 510(k) Premarket Notification ALCON® UltraChopper
June 15, 2009
Indications for Use Statement 4.
The Indications for Use statement is provided here and is also included in Attachment A. The ALCON® UltraChopper is intended for prescription use only.
510(k) Number (if known): _kua) 777 Device Name: ALCON® UltraChopper Indications for Use:
The ALCON® UltraChopper is indicated to be used with an Ultrasonic Phacofragmentation Handpiece to separate a cataractous lens into smaller pieces.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(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, Neurological and Ear,
Nose and Throat Devices
510(k) Number K091777