(136 days)
The Lenstec LC Injection System is intended for use in the implantation of STAAR Collamer Intraocular Lens model CC4204BF into the capsular bag following extracapsular extraction.
The system consists of the following components: Cartridge (LC-16 w/ Silicone Cushion (SIC-01-02) or LC-24 w/ Silicone Cushion (SIC-01-02)) and Injector (I-9011). One type of injector is provided: it is syringe based and is reusable and autoclavable. The cartridges/silicone cushion is single-use and provided sterile.
The provided document, K063802, does not include detailed acceptance criteria or a study proving the device meets specific performance metrics in the way that would typically be described for software or AI/ML-based medical devices.
This device, the Lenstec LC Injection System, is an intraocular lens (IOL) guide and injector system. The submission focuses on demonstrating substantial equivalence to existing predicate devices, a common pathway for Class I and II medical devices that do not involve complex software or AI.
Here's an analysis based on the document, addressing the prompt's questions where applicable, and noting where information is not present due to the nature of the device and submission:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity, or error rates for an AI system). Instead, its "performance data" section is very brief and focuses on:
- Biocompatibility: "All contact materials have been tested for biocompatibility." This implies meeting regulatory standards for material safety.
- System Functionality: "The system was tested with STAAR Collamer Intraocular Lens model CC4204BF." This broadly suggests it was confirmed to function with its intended IOL, likely encompassing aspects like smooth delivery and lack of damage to the IOL.
Given the device type (an injector system), acceptance criteria would likely revolve around mechanical integrity, successful IOL delivery without damage, and material biocompatibility. These are implicitly assumed to be met for substantial equivalence, but explicit metrics are not provided.
| Acceptance Criteria (Inferred from device type) | Reported Device Performance |
|---|---|
| Materials are biocompatible. | All contact materials have been tested for biocompatibility. |
| System functions with intended IOL (STAAR Collamer Intraocular Lens model CC4204BF). | The system was tested with STAAR Collamer Intraocular Lens model CC4204BF. |
| IOL is successfully implanted without damage. | (Implicitly assumed through testing with IOL) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The document only states "The system was tested with STAAR Collamer Intraocular Lens model CC4204BF." There is no mention of a specific number of tests or samples.
- Data Provenance: Not specified. Given the lack of clinical trials, the testing would likely have been bench testing or preclinical, presumably conducted by the manufacturer, Lenstec Inc., based in St. Petersburg, FL, USA.
- Retrospective or Prospective: Not applicable. The testing described is non-clinical/bench testing, not clinical data collection.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. This device is an injector system, not a diagnostic or AI device that requires expert-established ground truth for its performance evaluation (e.g., image interpretation). Performance would be assessed through objective measurements during bench testing (e.g., successful ejection, force required, IOL integrity).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. There is no expert adjudication process described or required for this type of device's performance evaluation.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/ML device or a diagnostic device that involves human readers or interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a mechanical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "testing" mentioned, the ground truth would likely be objective physical criteria (e.g., visual inspection of IOL for damage, measurement of injection force, successful deployment, material analysis for biocompatibility). These are fundamental engineering and biocompatibility benchmarks, not clinical ground truth in the sense of disease diagnosis or prognosis.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device that requires a training set.
Summary regarding the device and approval:
The K063802 submission for the Lenstec LC Injection System is a 510(k) premarket notification. The core of this submission is to demonstrate substantial equivalence to legally marketed predicate devices, specifically:
- Lenstec Injection System for Tetraflex Intraocular lenses (K050638)
- Lenstec Injection System for Softec Injection System (K060533)
The "study that proves the device meets the acceptance criteria" is implicitly the set of non-clinical tests mentioned (biocompatibility, system testing with the specific IOL). For this class and type of device, substantial equivalence often relies on demonstrating that the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness compared to the predicate. The FDA concluded that clinical tests were "Not required" for this submission, indicating that the non-clinical data and comparison to predicates were deemed sufficient to establish substantial equivalence.
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Image /page/0/Picture/1 description: The image shows a logo for a company called "LENS TEC". The logo is in a bold, sans-serif font, with the letters outlined in black. To the right of the text is a circle, which is also outlined in black. The letters are stacked on top of each other, with "LENS" on top and "TEC" on the bottom.
MAY - 7 2007
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: December 20th, 2006
Lenstec Inc.
510(k) Premarket Notification Submission Lenstec LC Injection System for STAAR Collamer Plate Intraocular Lenses 510(k) Premarket Notification Summary
Trade/Device Name: Lenstec LC Injection System for STAAR Collamer Intraocular Lens Model CC4204BF 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
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- Applicant Information:
- a. Name: Lenstec Inc.
- b. Address: 2870 Scherer Drive, suite 300 St. Petersburg, FL 33716 Telephone Number: (727) 571-2272 Fax Number: (727) 571-1792
- Contact Person: Jimmy Chacko, Vice President, Regulatory Affairs C.
- d. Address: 2870 Scherer Drive, suite 300 St. Petersburg, FL 33716 Telephone Number: (727) 571-2272 Fax Number: (727) 571-1792 Email: JChacko@Lenstec.com
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- Name of Device
- Trade Name: Lenstec LC Injection System for STAAR Collamer ಡ.. Intraocular Lens Model CC4204BF
- Common Name: Intraocular Lens guide b.
- 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 | Tip Diameter(mm) | STAAR IOLPower range (D) |
|---|---|---|---|
| LC-16w/ Silicone Cushion(SIC-01-02) | I-9011 | 1.6 | 10.5 - 34.0 |
| LC-24w/ Silicone Cushion(SIC-01-02) | I-9011 | 2.4 | 10.5 - 34.0 |
One type of injector is provided: it is syringe based and is reusable and autoclavable. The cartridges/silicone cushion is single-use and provided sterile.
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- Use:
The Lenstec LC Injection System is intended for use in implantation of STAAR Collamer posterior chamber intraocular lens model CC4204BF, and is used in conjunction with Lenstec LC 16 cartridge (with silicone cushion) or LC 24 cartridge (with silicone cushion).
- Use:
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- Indications for use:
The Lenstec LC Injection System is intended for use in the implantation of STAAR Collamer Intraocular Lens model CC4204BF into the capsular bag following extracapsular extraction.
- Indications for use:
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- Technological characteristics:
The system has two major components: a reusable injector and one of two disposable cartridges (LC 16, LC 24) with a silicone cushion (SIC-01-02)
- Technological characteristics:
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a. the injector is manufactured of titanium and can be autoclaved
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b. the cartridge is manufactured of lubricated medical grade polypropylene and is single use
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the silicone tip is manufactured of medical grade polypropylene and is C. single use
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- Performance data:
- a. Non clinical tests
All contact materials have been tested for biocompatibility. The system was tested with STAAR Collamer Intraocular Lens model CC4204BF
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- Clinical tests: Not required
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- Conclusions:
The Lenstec LC Injection System is substantially equivalent in safety and efficacy to the legally marketed predicate device.
Jimmy Chacko
Jimmy Chackoff
Vide President, Regulatory Affairs
Lenstec Inc.
DECEMBER 20th, 2006
Date
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Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is centered in the image. The font is a serif font and the text is black.
Image /page/3/Picture/13 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping bodies, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 7 2007
Lenstec, Inc. c/o Mr. Jimmy Chacko Vice President, Regulatory Affairs 2870 Scherer Drive, suite 300 St. Petersburg, FL 33716
Re: K063802
Trade/Device Name: Lenstec LC Injection System for STAAR Collamer Intraocular Lens Model CC4204BF
Regulation Number: 21 CFR 886.1850 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I Product Code: MSS Dated: April 5, 2007 Received: April 9, 2007
Dear Mr. Chacko:
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 (OS) 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. Jimmy Chacko
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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
M.B. Eickelmin S.W.D
Malvina B Eydelman, M.D. 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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INDICATION FOR USE
The Lenstec LC Injection System is intended for use in the implantation of STAAR The Lenster Intraocular Lens model CC4204BF into the capsular bag following extracapsular extraction.
K
Jimmy Chacko Vice President, Regulatory Affairs Venstec Inc.
DECEMBER 21, 2006
Date
11 (Division Sign-Off)
Division of Ophthalmic Ear, Nose and Throat Devises
510(k) Number K063802
§ 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.