← Product Code [HQC](/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC) · K093210
# AQUALASE CAPSULE WASH TIP (K093210)
_Alcon Manufacturing, Ltd. · HQC · Mar 4, 2010 · Ophthalmic · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC/K093210
## Device Facts
- **Applicant:** Alcon Manufacturing, Ltd.
- **Product Code:** [HQC](/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC.md)
- **Decision Date:** Mar 4, 2010
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.4670
- **Device Class:** Class 2
- **Review Panel:** Ophthalmic
- **Attributes:** Therapeutic
## Intended Use
The AquaLase® Capsule Wash Tip is intended for prescription use only. The AquaLase® Capsule Wash Tip is indicated to assist in the removal of residual cortical material and lens epithelial cells.
## Device Story
AquaLase® Capsule Wash Tip is a sterile, single-use accessory for the INFINITI® Vision System and AquaLase® Handpiece. It functions by delivering a heated intraocular irrigating solution (Balanced Salt Solution) to wash the capsular surface. The device is operated by a physician in a clinical setting. It transforms fluid input from the handpiece into a collimated output stream to assist in removing residual cortical material and lens epithelial cells. The device is used during cataract surgery to improve capsular cleaning, potentially benefiting the patient by reducing residual material. No modifications to the existing INFINITI® System are required for use.
## Clinical Evidence
Bench testing only. Performance testing demonstrated compliance with functional requirements including nozzle/tube retention, passive flow, wrench/tip detachment, fluid output profile (collimated), handpiece compatibility, irrigation free flow, injection pulse volume, pulse fluid exit temperature, leakage, and particulate requirements.
## Technological Characteristics
Sterile, single-use accessory. Materials evaluated per ISO 10993-1, -5, -7, -10, -11, -12. Employs fluid irrigation principle using heated Balanced Salt Solution. Compatible with INFINITI® Vision System. Ethylene Oxide sterilized per ISO 11135-1:2007. Manufactured per 21 CFR 820 and ISO 14971:2003.
## Regulatory 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
- AquaLase® 1.1 mm Liquefaction Tip ([K980292](/device/K980292.md)/[K021566](/device/K021566.md))
- ALCON® Silicone I/A Tip ([K911808](/device/K911808.md)/[K910245](/device/K910245.md))
- Milvella Perfect capsule ([K030957](/device/K030957.md))
## Submission Summary (Full Text)
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# 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 |
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### 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 |
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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.
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| 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).
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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.
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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
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#### 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
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