(81 days)
The Lenstec IOL Injection System if intended for use in implantation of the Lenstec Tetraflex™ Accommodating Posterior Chamber Intraocular Lens into the capsular bag following extracapsular extraction.
The system consists of the following components: Cartridge, Injector. Two types of injectors are provided: both injectors are syringe based and are reusable and autoclavable. The cartridges/silicone cushion are single-use and provided sterile.
The Lenstec Injector System for Tetraflex™ Intraocular Lenses (K050638) is a Class I medical device, and as such, clinical tests were not required for its premarket notification. The device's approval was based on demonstrating substantial equivalence to legally marketed predicate devices through non-clinical testing and shared technological characteristics.
Therefore, the following information, typically found in a clinical study report proving device performance against acceptance criteria, is not available or applicable for this submission:
- A table of acceptance criteria and the reported device performance
- Sample sizes used for the test set and data provenance
- Number of experts used to establish ground truth and their qualifications
- Adjudication method for the test set
- Multi-reader multi-case (MRMC) comparative effectiveness study results
- Standalone (algorithm only) performance study results
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Sample size for the training set
- How the ground truth for the training set was established
Instead, the submission focused on non-clinical aspects and established substantial equivalence based on:
- Technological Characteristics: The device consists of a reusable titanium injector and single-use polypropylene cartridges. The submission details the nominal incision sizes and power ranges of the Tetraflex™ intraocular lenses used with the system.
- Biocompatibility: All contact materials were tested for biocompatibility.
- System Testing: The Lenstec Injector System was tested with Tetraflex™ intraocular lenses to ensure compatibility and functionality.
- Comparison to Predicate Devices: The Lenstec Injector System was deemed substantially equivalent to the Medicel MultiJect Injector for IOLs and MicroGlide Cartridge (K040837) and the STAAR Surgical Foam Tip™ Injector System (K980696) in terms of safety and efficacy.
In summary, for K050638:
- Acceptance Criteria & Device Performance: Not explicitly detailed as clinical performance metrics. The implicit acceptance criteria were that the device performs its intended function (inserting IOLs) safely and effectively, as demonstrated through non-clinical testing and comparison to predicate devices.
- Study Type: Non-clinical tests, primarily biocompatibility and functional testing with the intended IOLs.
- Clinical Studies: "Not required" as explicitly stated in the submission.
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2870 Scherer Drive · Suite 300 · St. Petersburg, FL 33716 · USA Telephone: (727) 571-2272 · Fax: (727) 571-1792 · E-mail: lenstec @lenstec.com
510(K) Summary
Date Summary Prepared: March 8, 2005
Lenstec. Inc. 510(k) Premarket Notification Submission Lenstec Injector System for Tetraflex™ Intraocular Lenses 510(K) Premarket Notification Summary
Trade/Device Name: Lenstec Injector System for Tetraflex™ Intraocular Lenses Regulation Number: 21 CFR 886.1850 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I Product Code: MSS
Labeling:
Federal (United States) Law restricts this device to sale by or on the order of a physician.
-
- Applicant Information:
- a. Name: Lenstec, Inc.
- b. Address: 2870 Scherer Drive, Suite 300 St. Petersburg, FL 33716 Telephone Number: 727 571-2272 Fax: 727 571-1792
- c. Contact Person: Luis A. Ruiz, Vice President, Quality Assurance
- d. Address: 2870 Scherer Drive, Suite 300 St. Petersburg, FL 33716 Telephone Number: 727 571-2272 Fax: 727 571-1792 Email: Iruiz@lenstec.com
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- Name of Device:
- a. Trade Name: Lenstec Injector System for Tetraflex™ Intraocular Lenses
- b. Common Name: Intraocular lens guide.
- Classification Name: Folders and injectors, intraocular lens (IOL) (MSS, c. 886.4300)
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- Substantially Equivalent legally-marketed devices:
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- Device Description:
The system consists of the following components:
| Cartridge | Injector | NominalIncision Size (mm) | Used with Tetraflex™Intraocular LensesPower Range (D) |
|---|---|---|---|
| LC604220 | I 9000 | 2.8 | 5.0 - 36.0 |
| LC604240 | I 9007 | 2.2 | 5.0 - 26.0 |
| W/LS604500 |
Two types of injectors are provided: both injectors are syringe based and are reusable and autoclavable. The cartridges/silicone cushion are single-use and provided sterile.
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- Use:
The Lenstec Injector System is to be used solely to insert the foldable Tetraflex™ intraocular lenses manufactured by Lenstec and is used in conjunction with the Medicel cartridges, MicroGlide LC604220 and ViscoGlide LC604240 (w/Silicone Cushion LS604500).
- Use:
-
- Indications for use:
The Lenstec IOL Injection system is intended for use in implantation of the Lenstec Tetraflex™ Accommodating Posterior Chamber Intraocular Lens into the capsular bag following extracapsular extraction.
- Indications for use:
7. Technological characteristics:
The primary system has two major components: a reusable injector and a disposable cartridge LC604240. A secondary system also has three major components: a reusable injector and a disposable cartridge LC604220 and includes the use of a Silicone Cushion supplied with the LC604220 cartridge.
- The injector is manufactured of titanium and can be autoclaved. a.
- b. The cartridge is manufactured of lubricated polypropylene and is Single Use.
- c. The silicone tip is manufactured of medical grade polypropylene body and a silicone tip and also is Single Use.
-
- Performance data:
- a. Non-clinical tests
All contact materials have been tested for biocompatibility. The system was tested with Tetraflex™ intraocular lenses.
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- Clinical tests:
Not required
- Clinical tests:
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10. Conclusions
The Lenstec Injector System with MicroGlide cartridges are substantially equivalent in safety and efficacy to the legally marketed predicate device.
Luis A. Ruiz
Vice President, Quality Assurance
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 3 1 2005
Lenstec Inc. c/o Mr. Luis A. Ruiz Vice President, Quality Assurance 2870 Scherer Drive, suite 300 St. Petersburg, FL 33716
Re: K050638
Trade/Device Name: Lenstec Intraocular Lens (IOL) Injection System Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I Product Code: MSS Dated: May 12, 2005 Received: May 13, 2005
Dear Mr. Ruiz:
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 such 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); 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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Page 2 - Mr. Luis A. Ruiz
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 827-8910. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
David M. Whipple
Acting Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 3 - Mr. Luis A. Ruiz
Indications for Use
510(k) Number: K050638
Device Name: Lenstec Intraocular (IOL) Lens Injection System
Indications For Use: The Lenstec IOL Injection System if intended for use in implantation of the Lenstec Tetraflex™ Accommodating Posterior Chamber Intraocular Lens into the capsular bag following extracapsular extraction.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jivision Sign-Off Division of Ophthatinic Ear, Nose and Throat Devises
510(k) Number_LOS
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§ 886.4300 Intraocular lens guide.
(a)
Identification. An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.(b)
Classification. Class I (general controls). Except when used as folders or injectors for soft or foldable intraocular lenses, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.