(136 days)
Not Found
No
The device description and intended use focus on a mechanical injection system for intraocular lenses, with no mention of AI, ML, image processing, or data-driven performance metrics.
No.
The document describes an injection system for implanting intraocular lenses, which is a surgical tool rather than a device designed to treat a disease or condition itself.
No
Explanation: The device is an "Injection System" designed for the "implantation of STAAR Collamer Intraocular Lens". Its purpose is to deliver an intraocular lens, not to diagnose a condition or disease.
No
The device description explicitly lists hardware components (Cartridge and Injector) and describes their physical characteristics and use.
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 extracapsular extraction. This is a surgical procedure performed directly on a patient's body.
- Device Description: The device is an injection system for delivering a physical object (an intraocular lens) into the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health. This device does not interact with or analyze biological specimens.
Therefore, the Lenstec LC Injection System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Lenstec LC Injection System is intended for use in the 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).
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.
Product codes
MSS
Device Description
The system consists of the following components:
Cartridge: LC-16 w/ Silicone Cushion (SIC-01-02), LC-24 w/ Silicone Cushion (SIC-01-02)
Injector: I-9011
Tip Diameter (mm): 1.6, 2.4
STAAR IOL Power range (D): 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.
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)
- a. the injector is manufactured of titanium and can be autoclaved
- b. the cartridge is manufactured of lubricated medical grade polypropylene and is single use
- c. the silicone tip is manufactured of medical grade polypropylene and 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
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)
Non clinical tests: All contact materials have been tested for biocompatibility. The system was tested with STAAR Collamer Intraocular Lens model CC4204BF
Clinical tests: Not required
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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
-
- 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
-
- 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)
1
-
- Substantially Equivalent legally-marketed devices:
-
- Device Description
The system consists of the following components:
| Cartridge | Injector | Tip Diameter
(mm) | STAAR IOL
Power range (D) |
|---------------------------------------------|----------|----------------------|------------------------------|
| LC-16
w/ Silicone Cushion
(SIC-01-02) | I-9011 | 1.6 | 10.5 - 34.0 |
| LC-24
w/ 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.
-
- 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:
-
- 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:
-
- 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:
-
a. the injector is manufactured of titanium and can be autoclaved
-
b. the cartridge is manufactured of lubricated medical grade polypropylene and is single use
-
the silicone tip is manufactured of medical grade polypropylene and is C. single use
-
- 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
-
- Clinical tests: Not required
2
- 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
3
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.
4
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
5
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