(45 days)
Not Found
No
The device description and intended use are purely mechanical, and there is no mention of AI, ML, or any related concepts.
No
The device is an IOL injection system, which is a surgical tool used to implant a lens. It does not exert a therapeutic effect itself.
No
The device is an injection system for implanting intraocular lenses, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly lists physical components (cartridges, injectors) and describes them as hardware (syringe-based, reusable, autoclavable, single-use, sterile). There is no mention of software as a component or the primary function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the implantation of an intraocular lens into the capsular bag following surgery. This is a surgical procedure performed directly on a patient's body.
- Device Description: The device is an injection system for delivering an intraocular lens. This is a physical device used in a surgical setting.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests outside of the body on samples taken from the body. This device is used inside the body during surgery.
N/A
Intended Use / Indications for Use
The Lenstec IOL Injection System is intended for use in implantation of the Lenstec Softec Posterior Chamber Intraocular Lens into the capsular bag following extracapsular extraction.
Product codes (comma separated list FDA assigned to the subject device)
MSS
Device Description
The system consists of the following components:
| Cartridge | Injector | Nominal Incision Size (mm) | Used with Softec Intraocular Lenses Power Range (D) |
|---|---|---|---|
| LC604220 | I 9000 | 2.8 | 26.5D to 42.0D |
| LC604240 | I 9007 | 2.2 | -5.0D to 26.0D |
| 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.
The primary system has two major components: a reusable injector and a disposable cartridge LC604220. A secondary system also has three major components: a reusable injector and a disposable cartridge LC604240 and includes the use of a Silicone Cushion (LS604500) supplied with the LC604240 cartridge.
a. The injector is manufactured of titanium and can be autoclaved.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
capsular bag
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
a. Non-clinical tests: All contact materials have been tested for biocompatibility. The system was tested with Softec intraocular lenses.
Clinical tests: Not required
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Ko60533
Image /page/0/Picture/1 description: The image shows the logo for "LENS-TEC". The logo is in a bold, blocky font with a black outline and a white fill. The letters are arranged in two rows, with "LENS" on the top row and "TEC" on the bottom row. To the right of the word "TEC" is a circle with a white outline and a black fill. The letters are slightly distorted, giving the logo a unique and modern look.
APR 1 4 2006
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: February 12, 2006
Lenstec, Inc. 510(k) Premarket Notification Submission Lenstec Injector System for Softec Intraocular Lenses 510(K) Premarket Notification Summary
Trade/Device Name: Lenstec Injector System for Softec 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
- Name of Device:
- a. Trade Name: Lenstec Injector System for Softec Intraocular Lenses
- b. Common Name: Intraocular lens guide.
- c. Classification Name: Folders and injectors, intraocular Iens (IOL) (MSS, 886.4300)
000018
1
-
- Substantially Equivalent legally-marketed devices:
-
- Device Description:
The system consists of the following components:
| Cartridge | Injector | Nominal
Incision Size (mm) | Used with Softec
Intraocular Lenses
Power Range (D) |
|------------|----------|-------------------------------|-----------------------------------------------------------|
| LC604220 | I 9000 | 2.8 | 26.5D to 42.0D |
| LC604240 | I 9007 | 2.2 | -5.0D to 26.0D |
| 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.
-
- Use:
The Lenstec Injector System is to be used solely to insert the foldable Softec intraocular lenses manufactured by Lenstec and is used in conjunction vitte the Medicel cartridges, MicroGlide LC604220 and ViscoGlide LC604240 (w/ilicone Cushion LS604500.
- Use:
-
- Indications for use:
The Lenstec IOL Injection system is intended for use in implantation of the Lenstec Softec 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 LC604220. A secondary system also has three major components: a reusable injector and a disposable cartridge LC604240 and includes the use of a Silicone Cushion (LS604500) supplied with the LC604240 cartridge.
- The injector is manufactured of titanium and can be autoclaved. a.
- The cartridge is manufactured of lubricated polypropylene and is Single Use. b.
- The silicone tip is manufactured of medical grade polypropylene body and a c. 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 Softec intraocular lenses.
2
-
- Clinical tests: Not required
-
- Conclusions
The Lenstec Injector System with Medicel cartridges are substantially equivalent in safety and efficacy to the legally marketed predicate device.
Luis A. Ruiz
Vice President, Quality Assurance
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Lenstec, Inc. Mr. Luis Ruiz Vice President, Quality Assurance 2870 Scherer Dr. Suite 300 St. Petersburg, FL 33716
APR 1 4 2006
Re: K060533
Trade/Device Name: Lenstec Intraocular Lens (IOL) Injection System Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guides Regulatory Class: Class I Product Code: MSS Dated: February 12, 2006 Reccived: February 28, 2006
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. Drue, 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.
4
Page 2 - Mr. Luis 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,
M.B. Eychus - M.D.
Malvina B. Eydelman, M.D Division Director Division of Ophthalmic and Far, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name: Lenstec Intraocular Lens Injection System
Indications For Use: The Lenstec IOL Injection System is intended for use in implantation of the Lenstec Softec 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 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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rivision of Ophthalmic Ear Jose and Throat Devises
510(k) Number ________________________________________________________________________________________________________________________________________________________________
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