The Lenstec LC Injection System is intended for use in the implantation of the Softec HD, Softec I and Softec HD PS model Lenstec IOLs, as well as any IOL which has indicated for its use in its approved labeling, into the capsular bag following extracapsular extraction.

Device Description

The system consists of the following components: Cartridge with silicone cushion, IOL, Injector. One type of injector is provided: it is syringe based and is reusable and autoclavable. One type of lens loader is provided, which is reusable and autoclavable. The cartridges/silicone cushion is single-use and provided sterile. The system has three major components: a reusable injector, a reusable lens loader and one of three disposable cartridges (LC 16, LC 1620, LC 2420) with a silicone cushion (SIC-01-02). a. the injector is manufactured of titanium and can be autoclaved. b. the lens loader is manufactured from plastic and can be autoclaved. c. the cartridge is manufactured of medical grade polypropylene and is for single use. d. the silicone tip is manufactured of medical grade silicone and is for single use.

AI/ML Overview

The provided text describes the Lenstec LC Injection System, an intraocular lens injection system. However, it does not contain specific acceptance criteria or a study that quantitatively proves the device meets such criteria with detailed metrics like sensitivity, specificity, or accuracy.

The document generally outlines the device's design, intended use, and substantial equivalence to a predicate device. It mentions "non clinical tests" for biocompatibility and satisfactory testing with specific IOL models, but it does not provide details on the acceptance criteria for "satisfactory" or the performance results.

Therefore, many of the requested items cannot be extracted from the provided text.

Here's what can be extracted based on the given text:

Table of acceptance criteria and reported device performance:

Acceptance Criteria	Reported Device Performance
Biocompatibility	Satisfactory results
Compatibility with Softec HD IOL	Satisfactory results
Compatibility with Softec I IOL	Satisfactory results
Compatibility with Softec HD PS IOL	Satisfactory results

Note: The document uses "satisfactory results" without defining specific quantitative acceptance criteria or performance metrics.

Sample size used for the test set and the data provenance: Not specified in the document. The text only mentions "All contact materials have been tested for biocompatibility" and "the system was tested with each of the following Lenstec intraocular lens models."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not specified. The testing described appears to be technical performance and biocompatibility testing, not expert-adjudicated clinical data.
Adjudication method for the test set: Not applicable/not specified.
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 device is an IOL injection system, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an algorithm.
The type of ground truth used: For biocompatibility, it would typically be established by standardized laboratory tests (e.g., ISO 10993 series). For IOL compatibility, it would likely be successful injection and proper IOL handling without damage or complications during the process. The document does not specify further details.
The sample size for the training set: Not applicable. This is a physical medical device, not a machine learning model requiring a training set.
How the ground truth for the training set was established: Not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows a logo that says "LENS-TECO" in a stylized, blocky font. The letters are outlined in black, with a white fill and a textured, slightly distressed appearance. The "TM" symbol is present in the upper right corner of the logo. The letters are stacked on top of each other, with "LENS" on the top line and "TECO" on the bottom line.

1765 Commerce Ave. N. · St. Petersburg, FL 33716 · U. Telephone: (727) 571-2272 · Fax: (727) 571-1792 · E-mail: lenstec@lenstec.com

Section 5: 510(k) Summary

Date Summary Prepared: May 25, 2012

Lenstec Inc 510(k) Summary for Premarket Notification Submission for Lenstec LC Injection System

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 Avenue North St. Petersburg, FL 33716
- ・ Telephone Number: (727) 571-2272 Fax Number: (727) 571-1792
- c. Contact Person: Jimmy Chacko, Vice President, Regulatory Affairs Email: JChacko@Lenstec.com

2. Name of Device

Trade name: Lenstec LC Injection System a.
b. Common name: Intraocular lens injection system
Regulation name: Intraocular lens guide c.
Regulatory class: Class I, reserve ರ್.
e. Product code: MSS
Regulation number: 21 CFR 886.4300 ﺕ
1. Substantially Equivalent legally-marketed device:
- a. Lenstec Injection System for STAAR Collamer Plate Intraocular Lens (K063802)

Section 5: pg 1 of 3 510(k) Number (if known):

OCT 1 8 2013

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4. Device Description

The system consists of the following components:

Cartridge withsilicone cushion	IOL	Injector	Tip Diameter(mm)	Lenstec IOL Powerrange (D)
LC 16	Softec HDSoftec ISoftec HD PS	I-9011S	1.6	5.0 - 26.0
LC 1620	Softec HDSoftec ISoftec HD PS	I-9011S	1.6	5.0 - 26.0
LC 2420	Softec HDSoftec ISoftec HD PS	I-9011S	2.4	5.0 - 36.0

One type of injector is provided: it is syringe based and is reusable and autoclavable. One type of lens loader is provided, which is reusable and autoclavable. The cartridges/silicone cushion is single-use and provided sterile.

S. Use:
The Lenstec LC Injection System is intended for use in the implantation of the Softec HD, Softec I and Softec HD PS model Lenstec IOLs, as well as any IOL which has indicated for its use in its approved labeling, into the capsular bag following extracapsular extraction. The predicate device was comprised of the nearly identical components.

Lenstec has added a pair of cartridges to the LC Injection system (LC 1620 and LC 2420}. These two additional cartridges only differ from the originals in that their tips are angulated to 20°, as opposed to the LC 16, which has a 45° tip.

This submission also removes the LC24 model cartridge.

The only changes in this injection system are

a) the modified indication for inclusion for use of the Lenstec model IOLs identified above, and removal of STAAR Collamer Plate IOL previously indicated for use with
b) Change in the models of cartridge validated for use
c) the replacement of the lens fork loader with the lens loader (this is discussed in greater detail elsewhere in this submission)

6. Indications for use:

Section 5: pg 2 of 3 510(k) Number (if known):

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Technological characteristics:

The system has three major components: a reusable injector, a reusable lens loader and one of three disposable cartridges (LC 16, LC 1620, LC 2420) with a silicone cushion (SIC-01-02)

a. the injector is manufactured of titanium and can be autoclaved

b. the lens loader is manufactured from plastic and can be autoclaved
the cartridge is manufactured of medical grade polypropylene and is for C. single use
d. the silicone tip is manufactured of medical grade silicone and is for single use
1. Performance data:
- a. Non clinical tests
  - All contact materials have been tested for biocompatibility, with satisfactory results. Also, the system was tested with each of the following Lenstec intraocular lens models with satisfactory results: Softee HD, Softec I and Softec HD PS.
1. Clinical tests: Not required

Conclusions:

The Lenstec LC Injection System is substantially equivalent to the legally marketed predicate device, and the included testing validates the expanded indication for use.

Jimmy Chacko Vice President, Regulatory Affairs Lenstec Inc.

25 MAY 12

Date

Section 5: pg 3 of 3 510(k) Number (if known):

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Image /page/3/Picture/0 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of a caduceus, a symbol often associated with healthcare. The caduceus is depicted with a staff entwined by two snakes and topped with wings.

DEPARTMENT OF HEALTH & HUMAN SERVICES

October 18, 2013

・・・

Public Health Service

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

Lenstec, Inc. % Mr. Hans-Gerd Evering . Lead Technical Reviewer British Standards Institute (BSI) Kitemark Court, Davy Avenue Knowlhill, Milton Keynes MK5 8PP, UK

Re: K122848

Trade/Device Name: Lenstec LC Injection System Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular lens guide Regulatory Class: Class I (reserve) Product Code: MSS Dated: October 2, 2013 Received: October 4, 2013

Dear Mr. Evering:

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.

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

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Page 2 - Mr. Hans-Gerd Evering

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 yours,

Kesia Y. Alexander -S

for 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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Section 4: Indications for Use Statement

510(k) Number (if known): not yet known

Device Name: Lenstec LC Injection System

Indications for Use: The Lenstec LC Injection System is intended for use in the implantation of the Softec HD, Softec I and Softec HD PS model Lenstec IOLs, as well as any IOL which has indicated for its use in its approved labeling, into the capsular bag following extracapsular extraction
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)

Image /page/5/Picture/9 description: The image shows the text "Tieuv H. Nguyen" on the top line. The second line of text shows the date and time as "2013.10.17 15:40:20.04'00'". The text is surrounded by a decorative border.

Section 4: pg 1 of 1 510(k) Number (if known):

Regulation Number and Section

§ 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.