(162 days)
Not Found
No
The description focuses on mechanical and software changes related to increased cut rate and RFID recognition, with no mention of AI or ML algorithms for analysis, decision-making, or image processing.
Yes
The device is used to remove vitreous and dissect tissues in the eye, which are therapeutic interventions.
No
The device is described as a vitrectomy probe used to remove vitreous and dissect tissues in the eye, which are therapeutic actions, not diagnostic.
No
The device description clearly states it is a "modified vitrectomy probe," which is a physical surgical instrument, not software. While it includes software changes for RFID recognition, the core device is hardware.
Based on the provided information, the ALCON® Enhanced UltraVit® Probe is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "remove vitreous and dissect tissues in the eye." This describes a surgical procedure performed directly on a living patient, not a test performed on a sample taken from the body.
- Device Description: The description details a surgical probe used with a surgical system (CONSTELLATION® System). It focuses on mechanical and software modifications for surgical performance.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The ALCON® Enhanced UltraVit® Probe is a surgical instrument used for therapeutic purposes within the eye.
N/A
Intended Use / Indications for Use
The ALCON® Enhanced UltraVit® Probe is intended to be used to remove vitreous and dissect tissue in the eve.
Product codes (comma separated list FDA assigned to the subject device)
MLZ
Device Description
The ALCON Enhanced UltraVit® Probe is a modified vitrectomy probe that will be added to the existing Alcon UltraVit® probe family. The ALCON Enhanced UltraVit® Probe is the same size and shape as existing Alcon vitrectomy probes and is made with the same material as the Alcon UltraVit® probes used on the CONSTELLATION® System (Alcon Vision System, K063583). The ALCON Enhanced UltraVit® Probe will utilize existing packaging configurations and have the same shelf life as existing vitrectomy probes. It will be used with the CONSTELLATION® System. The differences between the enhanced and predicate versions are:
- Increased maximum cut rate. .
- . Software look-up table changes to accommodate RFID recognition of new probe.
- Parylene N Coating on "O" ring seals. .
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)
Brief Summary of Non-clinical test and Results
Biocompatibility evaluations of materials coming in contact with the patient or 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 |
| 10993-7:1995 AAMI/ANSI/ISO | Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals |
| 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 |
The ALCON® Enhanced UltraVit Probe is provided sterile and intended for single use only. This product is Ethylene Oxide sterilized and the process has been validated to a SAL of 10to per FDA Recognized Consensus Standard - "EN ISO 11135-1:2007, Sterilization of health care products - Ethylene oxide - Part 1: Requirements for 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® Enhanced UltraVit® Probe 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.
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
§ 886.4150 Vitreous aspiration and cutting instrument.
(a)
Identification. A vitreous aspiration and cutting instrument is an electrically powered device, which may use ultrasound, intended to remove vitreous matter from the vitreous cavity or remove a crystalline lens.(b)
Classification. Class II (special controls). The device, when it is phacofragmentation unit replacement tubing, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
0
510 (k): K093305
APR - 2 2010
Image /page/0/Picture/2 description: The image shows the logo for Alcon Research, LTD. The logo is in black and white and features the word "Alcon" in large, outlined letters. Below the word "Alcon" is the phrase "RESEARCH, LTD." in smaller, outlined letters. The logo has a simple and clean design.
ALCON RESEARCH, LTD.
15800 ALTON PARKWAY
IRVINE, CA 92816
(949) 753-1393
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):
| Trade Name: | Enhanced UltraVit Probe |
|---|---|
| Common Name: | Vitrectomy Probe |
| Classification Name: | Vitreous aspiration and cutting instrument |
| (886.4150) |
Product Code: MLZ
Predicate Devices
The legally marketed devices(s) to which we are claiming equivalence to are:
| 510(k) Number | Device |
|---|---|
| K063583 | ALCON® Vision System (CONSTELLATION®) UltraVit |
| Probes |
1
Device Description
The ALCON Enhanced UltraVit® Probe is a modified vitrectomy probe that will be added to the existing Alcon UltraVit® probe family. The ALCON Enhanced UltraVit® Probe is the same size and shape as existing Alcon vitrectomy probes and is made with the same material as the Alcon UltraVit® probes used on the CONSTELLATION® System (Alcon Vision System, K063583). The ALCON Enhanced UltraVit® Probe will utilize existing packaging configurations and have the same shelf life as existing vitrectomy probes. It will be used with the CONSTELLATION® System. The differences between the enhanced and predicate versions are:
- Increased maximum cut rate. .
- . Software look-up table changes to accommodate RFID recognition of new probe.
- Parylene N Coating on "O" ring seals. .
Indications for Use
The ALCON® Enhanced UltraVit® Probe is intended to be used to remove vitreous and dissect tissue in the eve.
Brief Summary of Non-clinical test and Results
Biocompatibility evaluations of materials coming in contact with the patient or 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 | |
| 10993-7:1995 AAMI/ANSI/ISO | Biological evaluation of medical devices - Part |
| 7: Ethylene oxide sterilization residuals | |
| 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® Enhanced UltraVit Probe is provided sterile and intended for single use only. This product is Ethylene Oxide sterilized and the process has been validated to a SAL of 10to per FDA Recognized Consensus Standard - "EN ISO 11135-1:2007, Sterilization of health care products - Ethylene oxide - Part 1: Requirements for 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® Enhanced UltraVit® Probe 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.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three overlapping lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the bird symbol. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
APR - 2 2010
Alcon Research, Ltd. c/o Mr. Martin A. Kaufman Director, Regulatory Affairs 15800 Alcon Parkway Irvine, CA 92816
Re: K093305
Trade/Device Name: Enhanced UltraVit Probe Regulation Number: 21 CFR 886.4150 Regulation Name: Vitreous Aspiration and Cutting Instrument Regulatory Class: II Product Code: MLZ Dated: February 5, 2010 Received: February 5, 2010
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
4
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.
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/CDRH/CDRHOffices/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.
Sincerely yours.
Kesia Alexander
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
Indications for Use Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: ALCON® Enhanced UltraVit® Probe Indications for Use:
The ALCON® Enhanced UltraVit® Probe is indicated to be used to remove vitreous and dissect tissues in the eye.
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)
a
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K013305