FLUID ISOLATION DEVICE

• K Number: K091915
• Device Name: FLUID ISOLATION DEVICE
• Manufacturer: LENSTEC, INC.
• Date Cleared: 2009-10-27 ( 119 days)
• Product Code: HQC
• Regulation Number: 886.4670
• Type: Traditional
• Panel: Ophthalmic
• Reference & Predicate Devices: K030957
• Predicate For: N/A

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 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).

AI/ML Overview

Here's an analysis of the provided text regarding the Lenstec Fluid Isolation Device (FID) and its acceptance criteria, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Biocompatibility	All contact materials tested; all results satisfactory and considered equivalent to the predicate device.
Functional Suction Power over Time	Performance equivalence established using a side-by-side comparison; all results satisfactory and considered equivalent to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a specific "test set" sample size in the context of clinical or in-vivo testing. The performance data presented are from non-clinical bench testing for functional suction power and biocompatibility.

Data Provenance: The studies were non-clinical (bench tests) and were performed by Lenstec Inc. No country of origin for a clinical test set is relevant here, nor is it retrospective or prospective in the clinical sense.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. The performance testing was non-clinical (biocompatibility and functional suction power). "Ground truth" in the sense of expert clinical diagnosis or interpretation is not relevant for these types of tests.

4. Adjudication Method for the Test Set

Not applicable, as the tests were non-clinical bench tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document explicitly states: "Clinical tests: Not required." Therefore, no MRMC study comparing human readers with or without AI assistance was conducted.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. The Fluid Isolation Device (FID) is a medical device, not an AI algorithm. Its performance is directly dependent on user interaction (ophthalmic surgeon drawing back the syringe plunger to create suction).

7. The Type of Ground Truth Used

For the non-clinical tests:

• Biocompatibility: Likely based on standardized assays and comparison to established biological safety limits for medical device materials.
• Functional Suction Power over Time: Likely based on objective measurements of pressure/vacuum and seal integrity, with "ground truth" being the measurements themselves and the comparison to the predicate device's measured performance.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as this device is not an AI algorithm.

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Summary of the Study Proving Device Meets Acceptance Criteria:

The Lenstec Fluid Isolation Device (FID) was determined to be substantially equivalent to its predicate device, the Milvella Perfect Capsule (K030957), based on non-clinical performance data.

The studies conducted were:

• Biocompatibility Testing: All contact materials were tested, and the results were deemed "satisfactory" and "equivalent to the predicate device" (Section 16 of the submission). This addresses the biological safety of the materials used in the device.
• Functional Suction Power over Time Testing (Bench Test): A "side-by-side comparison" of the FID's functional suction power over time was performed against the predicate device. All results were found to be "satisfactory" and "equivalent to the predicate device" (Section 19 of the submission). This test aimed to demonstrate that the FID could achieve and maintain the necessary seal and suction performance comparable to the legally marketed predicate.

No clinical studies were required or performed for this 510(k) submission, as the device's technological characteristics and intended use were considered substantially equivalent to a predicate device already on the market. The equivalence was established through material testing and bench performance comparisons.

Summary

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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

Regulation Number and Section

§ 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.