(142 days)
Not Found
No
The summary describes a sterile, single-use accessory tip for a surgical system that uses heated irrigating solution. There is no mention of AI, ML, image processing, or any computational analysis of data. The performance studies focus on physical and fluid dynamics characteristics of the tip.
Yes.
It is used to assist in the removal of residual cortical material and lens epithelial cells, which are part of a medical procedure.
No
This device is for surgical removal of materials, not for diagnosing conditions.
No
The device is described as a sterile, single-use physical product (a "Tip") that is an accessory to a handpiece and a vision system. The performance studies focus on physical characteristics like retention strength, flow rates, temperature, and leakage, which are indicative of a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Device Function: The AquaLase® Capsule Wash Tip is used during a surgical procedure (likely cataract surgery, given the mention of capsular surface and lens epithelial cells) to physically remove material from within the eye. It is an accessory to a system that delivers heated irrigating solution directly into the eye.
- Lack of Diagnostic Testing: The description does not mention any form of testing on biological samples to diagnose, monitor, or determine the state of a disease or condition. Its purpose is purely therapeutic/procedural.
Therefore, the AquaLase® Capsule Wash Tip is a surgical accessory used for a therapeutic purpose, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The AquaLase® Capsule Wash Tip is indicated to assist in the removal of residual cortical material and lens epithelial cells.
Product codes
HQC
Device Description
The AquaLase® Capsule Wash Tip is a sterile, single-use product. It is an accessory to the AquaLase® Handpiece (K980292), which produces the heated intraocular irrigating solution (Balanced Salt Solution or equivalent fluid) that washes the capsular surface. The AquaLase® Capsule Wash Tip and the AquaLase® Handpiece are accessories to the INFINITI® Vision System (K021566). The AquaLase® Capsule Wash Tip utilizes existing packaging configurations and has the same shelf life as existing AquaLase® tips.
To use the AquaLase® Capsule Wash Tip as intended, no modification to the existing INFINITI® System is required.
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
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
Non-clinical test and Results: Biocompatibility evaluations of materials coming in contact with the patient fluid path have been performed to the following standards:
- 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
- 10993-7:2008 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
Summary of Performance Testing: The AquaLase® Capsule Wash Tip has been developed and manufactured in compliance with recognized international consensus standards and FDA regulations/ guidance documents. Performance testing demonstrates that the AquaLase® Capsule Wash Tip operates as intended on the INFINITI® Vision System and is substantially equivalent to the predicate device. Salient tip performance characteristics such as fluid output volume and fluid output temperature are analogous to the 1.1mm Liquefaction Tip. The fluid output profile is modified from the 1.1mm Liquefaction Tip; the Capsule Wash Tip's profile is to better serve the intended use.
Performance test results are provided in the following table:
- Nozzle and Tube Retention: Tips passed the minimum retention strength.
- Passive Flow: Tips passed the passive flow requirements.
- Wrench/Tip Detachment: Tips passed the wrench/tip detachment force.
- Fluid Output Profile: Tips passed the fluid output profile requirement of being collimated.
- Handpiece Compatibility: Tips passed the handpiece compatibility requirement.
- Irrigation Free Flow: Tips passed the minimum irrigation free flow rate requirement.
- Injection Fluid Active Flow (Average Pulse Flow Rate): Tips passed the injection fluid active flow.
- Injection Pulse Volume: Tips passed the maximum injection pulse volume requirement.
- Pulse Fluid Exit Temperature: Tips passed the maximum temperature requirement.
- Leakage: Tips passed the requirement to remain leak free during use.
- Particulates: Tips passed the metallic particulate requirements.
- Endurance: Tips passed the endurance requirement for Injection Fluid Active Flow and the endurance requirement for Leakage.
Key Metrics
Not Found
Predicate Device(s)
K980292/K021566, K911808/K910245, K030957
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows the date "MAR - 4 2010" at the top. Below the date is the word "Alcon" in a bold, sans-serif font. The word "Alcon" is the primary focus of the image, with the date appearing as a secondary element.
K093210
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: | AquaLase® Capsule Wash Tip |
|---|---|
| Common Name: | Accessory to a Phacoemulsification Device |
| Classification Name: | Accessory to a Phacofragmentation Device (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 |
|---|---|
| K980292/K021566 | AquaLase ® 1.1 mm Liquefaction Tip |
| K911808/K910245 | ALCON® Silicone I/A Tip |
| K030957 | Milvella Perfect capsule |
1
2. Device Description
ﻣﺮ ﻣﺮ ﻣﺮﺍﺟﻊ
The AquaLase® Capsule Wash Tip is a sterile, single-use product. It is an accessory to the AquaLase® Handpiece (K980292), which produces the heated intraocular irrigating solution (Balanced Salt Solution or equivalent fluid) that washes the capsular surface. The AquaLase® Capsule Wash Tip and the AquaLase® Handpiece are accessories to the INFINITI® Vision System (K021566). The AquaLase® Capsule Wash Tip utilizes existing packaging configurations and has the same shelf life as existing AquaLase® tips.
To use the AquaLase® Capsule Wash Tip as intended, no modification to the existing INFINITI® System is required.
3. Indications for Use
The AquaLase® Capsule Wash Tip is indicated to assist in the removal of residual cortical material and lens epithelial cells.
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 | |
| 10993-7:2008 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 AquaLase® Capsule Wash tip 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 10t per FDA Recognized Consensus Standard - ""ISO 11135-1:2007, Sterilization of health care products — Ethylene oxide — 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 AquaLase® Capsule Wash 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.
Summary of Performance Testing 5.
The AquaLase® Capsule Wash Tip has been developed and manufactured in compliance with recognized international consensus standards and FDA requlations/ guidance documents. Performance testing demonstrates that the AquaLase® Capsule Wash Tip operates as intended on the INFINITI® Vision System and is substantially equivalent to the predicate device. Salient tip performance characteristics such as fluid output volume and fluid output temperature are analogous to the 1.1mm Liquefaction Tip. The fluid output profile is modified from the 1.1mm Liquefaction Tip; the Capsule Wash Tip's profile is to better serve the intended use.
Performance test results are provided in the following table.
3
| Description | Results |
|---|---|
| Nozzle and Tube Retention | Tips passed the minimum retention |
| strength. | |
| Passive Flow | Tips passed the passive flow |
| requirements. | |
| Wrench/Tip Detachment | Tips passed the wrench/tip detachment |
| force. | |
| Fluid Output Profile | Tips passed the fluid output profile |
| requirement of being collimated. | |
| Handpiece Compatibility | Tips passed the handpiece compatibility |
| requirement. | |
| Irrigation Free Flow | Tips passed the minimum irrigation free |
| flow rate requirement. | |
| Injection Fluid Active Flow (Average | |
| Pulse Flow Rate) | Tips passed the injection fluid active flow. |
| Injection Pulse Volume | Tips passed the maximum injection pulse |
| volume requirement. | |
| Pulse Fluid Exit Temperature | Tips passed the maximum temperature |
| requirement. | |
| Leakage | Tips passed the requirement to remain |
| leak free during use. | |
| Particulates | Tips passed the metallic particulate |
| requirements. | |
| Endurance | Tips passed the endurance requirement |
| for Injection Fluid Active Flow and the | |
| endurance requirement for Leakage |
Results Summary for AquaLase® Capsule Wash Tip (CW Tip)
For this table, the predicate device is the 1.1mm AquaLase® Liquefaction Tip (K980292/ K021566).
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three overlapping, curved lines forming 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
MAR - 4 2010
Alcon Research, Ltd. c/o Mr. Martin A. Kaufman, RAC Director, Regulatory Affairs 15800 Alton Parkway Irvine, CA 92816-3818
Re: K093210
Trade/Device Name:AquaLase® Capsule Wash Tip Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation System (Accessory) Regulatory Class: Class II Product Code: HQC Dated: January 28, 2010 Received: January 29, 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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
5
Page 2 - Mr. Martin A. Kaufman, RAC
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.
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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Kesia 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
6
4. Indications for Use Statement
The Indications for Use statement is provided here and is also included in Attachment A. The AquaLase® Capsule Wash Tip is intended for prescription use only.
510(k) Number (if known): K 0932/0 Device Name: AquaLase® Capsule Wash Tip Indications for Use:
The AquaLase® Capsule Wash Tip is indicated to assist in the removal of residual cortical material and lens epithelial cells.
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)
Callaway
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K093210
Page 8 of 51