FLUID ISOLATION DEVICE

K091915 · Lenstec, Inc. · HQC · Oct 27, 2009 · Ophthalmic

Device Facts

• Record ID: K091915
• Device Name: FLUID ISOLATION DEVICE
• Applicant: Lenstec, Inc.
• Product Code: HQC · Ophthalmic
• Decision Date: Oct 27, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4670
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Lenstec Fluid Isolation Device is intended to hold and seal the lens capsule, to allow irrigation of the capsular bag in an aphakic patient, in order to remove residual cortex and/or epithelial cells

Device Story

The Fluid Isolation Device (FID) is a single-use manual surgical tool used by ophthalmic surgeons following cataract extraction. It consists of a vacuum ring with a circular suction cup connected via medical-grade silicone tubing to a 20 mL Vaclok syringe. The surgeon places the suction cup onto the posterior surface of the anterior capsule and manually draws back the syringe plunger to create a vacuum seal. Once sealed, the surgeon injects irrigating solution through an internal channel into the capsular bag to flush out residual cortex and epithelial cells. This process allows for cleaning the capsular bag without damaging other internal ocular structures. The device is provided sterile via ethylene oxide.

Clinical Evidence

No clinical data. Performance equivalence established via bench testing, including biocompatibility assessments and side-by-side functional suction power comparisons against the predicate device.

Technological Characteristics

Materials: Medical-grade silicone (vacuum ring, tubing). Energy source: Manual (surgeon-operated). Form factor: Vacuum ring with circular suction cup and 20 mL syringe. Sterilization: Ethylene oxide. Connectivity: None. Software: None.

Indications for Use

Indicated for aphakic patients undergoing cataract surgery to hold and seal the lens capsule for irrigation and removal of residual cortex and/or epithelial cells.

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

• Milvella Perfect Capsule (K030957)

Submission Summary (Full Text)

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K679115

192

Image /page/0/Picture/1 description: The image shows a logo for "LENS TEC CO" in a bold, stylized font. The letters are outlined in black, giving them a three-dimensional appearance. To the right of the text, there is a circular graphic, possibly representing a lens. The "TM" symbol is located in the upper right corner of the logo.

OCT 2 7 2009

1765 Commerce Ave. N. · St. Petersburg, FL 33716 · USA Telephone: [phone] · Fax: [phone] · E-mail: [e-mail]

## 510(k) Summary (21 CFR 807.92)

Date Summary Prepared: June 25th, 2009

### Lenstec Inc. 510(k) Premarket Notification Submission Lenstec Fluid Isolation Device (FID) 510(k) Premarket Notification Summary

Trade/Device Name: Fluid Isolation Device (FID) Lenstec Inc Establishment Registration Number: 1063199 Type of 510(k) Submission: Traditional Reason for Submission: New Device Regulation Number: 21 CFR 886. 4670 Regulation Name: Phacofragmentation system Regulatory Class: Class II Product Code: HQC

Confidentiality:

Lenstec requests that the Agency treat the contents of this submission as confidential and proprietary to Lenstec Inc

#### Labeling:

Federal (United States) Law restricts this device to sale by or on the order of a physician

1. Applicant Information:

- a. Name: Lenstec Inc.
- b. Address: 1765 Commerce Ave N St. Petersburg, FL 33716 Telephone Number: [phone] Fax Number: [phone]
- c. Contact Person: Jimmy Chacko, Vice President, Regulatory Affairs (Email: [e-mail])
- 2. Name of Device
- a. Trade Name: Fluid Isolation Device
- b. Common Name: FID
- c. Classification Name: Phacofragmentation system (HQC, 886.4670)
- 3. Substantially Equivalent legally-marketed devices:

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# 691915

- a. Milvella Perfect Capsule (K030957)
### 4. Device Description

The Fluid Isolation Device (FID) is a medical device which is intended to hold and seal the lens capsule, to allow irrigation of the capsular bag in an aphakic patient, in order to remove residual cortex and/or epithelial cells. The system consists of the following components:

- . Vacuum ring suction cup connected to lure lock with silicone tubing
- 20 mL Vaclok Syringe ●

Following cataract extraction, the device's vacuum ring suction cup is placed onto the posterior surface of the anterior capsule, and a seal is created by the user drawing back the handle of the Vaclok Syringe. Once the seal is created, the user irrigates the capsule of residual cortex and/or epithelial cells. The device is provided sterile (ethylene oxide).

#### 5. Use:

The Fluid Isolation Device (FID) is a single use sterile device used to hold and seal the lens capsule, to allow irrigation of the capsular bag in an aphakic patient, in order to remove residual cortex and/or epithelial cells. The device comprises a vacuum ring with circular suction cup whose seal is activated when the user draws back on the attached syringe plunger. Irrigating solution can then be injected into the capsular bag through an internal channel, allowing removal of residual cortex and/or epithelial cells without damaging other internal structures within the eye.

Indications for use:

The Fluid Isolation Device is intended to hold and seal the lens capsule, to allow irrigation of the capsular bag in an aphakic patient, in order to remove residual cortex and/or epithelial cells. This indication for use is substantially equivalent to its predicate device.

- 6. Technological characteristics:
The FID is comprised of a vacuum ring with circular suction cup whose seal is activated when the user draws back on the syringe plunger. The vacuum ring and tubing which connects the vacuum ring to a lure lock (which attaches it to the syringe) is manufactured of medical grade silicone. The syringe is supplied connected to this apparatus and is a commercially available unit. All the technological characteristics are similar to the predicate device, the Milvella Perfect Capsule. The predicate device is also comprised of a vacuum ring which is connected to the identical commercially available syringe using similar silicone tubing. And the source of energy which forms the suction (i.e. the user, an ophthalmic surgeon) is identical.

- 7. Performance data: Non clinical tests

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- All contact materials have been tested for biocompatibility and all results a. were satisfactory (Section 16 of this submission, 'Biocompatibility') and considered equivalent to the predicate device.
- b. Performance equivalence was established using a side by side comparison of functional suction power over time, and all results were satisfactory (Section 19 of this submission, 'Performance Testing- Bench') and considered equivalent to the predicate device.

8. Clinical tests: Not required

#### 9. Conclusions:

The Fluid Isolation Device is substantially equivalent in safety and efficacy to the legally marketed predicate device.

Jimmy Chacko Vice President, Regulatory Affairs Lenstec Inc.

June 25th, 2009

Date

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name, "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA," arranged in a circular pattern around a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with healthcare, with a triple helix design representing the interconnectedness of health, science, and human services. The seal is presented in black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

## OCT 2 7 2009

Lenstec, Inc. c/o Mr. Jimmy Chacko Vice President, Regulatory Affairs 1765 Commerce Avenue N St. Petersburg, FL 33716

Re: K091915

Trade Name: Lenstec Fluid Isolation Device Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation system Regulatory Class: Class II Product Code: HQC Dated: September 23, 2009 Received: September 25, 2009

Dear Mr. Chacko:

We have reviewed vour 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.

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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/cdrh/mdr/ 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Earle. R. Remm Jr

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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K091915

## INDICATION FOR USE STATEMENT

510(k) Number: not yet known

Device Name: Lenstec Fluid Isolation Device

- Indications for Use: The Lenstec Fluid Isolation Device is intended to hold and seal the lens capsule, to allow irrigation of the capsular bag in an aphakic patient, in order to remove residual cortex and/or epithelial cells
Prescription Use X (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daryl L. Kaush
(Division Sign-Off)

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

CO91915

510(k) Number_

11