(395 days)
Not Found
No
The description focuses on mechanical components and materials for implanting an IOL, with no mention of AI or ML capabilities.
No.
The device is used for the implantation of intraocular lenses, not for treating a disease or condition itself.
No
Explanation: The device is an injection system for implanting intraocular lenses. Its purpose is to deliver an IOL into the capsular bag, not to diagnose a condition or disease.
No
The device description explicitly lists hardware components (cartridge, silicone cushion, injector, lens loader) made of materials like titanium, plastic, polypropylene, and silicone. It describes these components as reusable or single-use and mentions sterilization methods, indicating a physical device, not software only.
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 intraocular lenses (IOLs) into the capsular bag following surgery. This is a surgical procedure performed on the patient, not a test performed on a sample taken from the patient.
- Device Description: The components are an injector, lens loader, and cartridges/silicone cushion. These are tools used for a surgical procedure.
- No mention of testing biological samples: There is no indication that this device is used to analyze blood, urine, tissue, or any other biological sample to diagnose a condition or provide information about a patient's health status.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly operates in vivo (within the body) during a surgical procedure.
N/A
Intended Use / 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.
Product codes
MSS
Device Description
The system consists of the following components:
| Cartridge with
silicone cushion | IOL | Injector | Tip Diameter
(mm) | Lenstec IOL Power
range (D) |
|------------------------------------|---------------------------------------|----------|----------------------|--------------------------------|
| LC 16 | Softec HD
Softec I
Softec HD PS | I-9011S | 1.6 | 5.0 - 26.0 |
| LC 1620 | Softec HD
Softec I
Softec HD PS | I-9011S | 1.6 | 5.0 - 26.0 |
| LC 2420 | Softec HD
Softec I
Softec 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.
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
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, 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.
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 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
-
- 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
-
- 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):
13
OCT 1 8 2013
1
4. Device Description
The system consists of the following components:
| Cartridge with
silicone cushion | IOL | Injector | Tip Diameter
(mm) | Lenstec IOL Power
range (D) |
|------------------------------------|---------------------------------------|----------|----------------------|--------------------------------|
| LC 16 | Softec HD
Softec I
Softec HD PS | I-9011S | 1.6 | 5.0 - 26.0 |
| LC 1620 | Softec HD
Softec I
Softec HD PS | I-9011S | 1.6 | 5.0 - 26.0 |
| LC 2420 | Softec HD
Softec I
Softec 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:
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.
Section 5: pg 2 of 3 510(k) Number (if known):
2
- 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
-
- 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.
-
- 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):
14
3
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
4
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
5
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):