(281 days)
No
The description focuses on precise laser delivery and pre-programmed patterns, with no mention of AI/ML terms or functionalities.
Yes
The device is used for anterior capsulotomy during cataract surgery, which is a therapeutic surgical procedure.
No
The device is described as a surgical laser system used for performing anterior capsulotomy during cataract surgery, which is a therapeutic procedure involving tissue modification, not a diagnostic one.
No
The device description clearly outlines hardware components such as a laser beam, scanning optic system, and a sterile (disposable) Patient Interface consisting of a contact lens and suction clip. The performance studies also involve bench testing on physical eyes and phantoms, further indicating a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for performing anterior capsulotomy during cataract surgery. This is a surgical procedure performed on a living patient, not a test performed on a sample taken from a patient.
- Device Description: The description details a surgical laser system that physically interacts with and modifies tissue within the eye. This is characteristic of a surgical device, not a diagnostic device that analyzes samples.
- Anatomical Site: The target is the anterior capsule, which is part of the eye in situ.
- Performance Studies: The studies described evaluate the surgical outcome (accuracy, predictability, smoothness of incision, lack of tears, IOL centering) of the procedure performed by the device, not the accuracy of a diagnostic test result.
- Predicate Devices: The predicate devices listed are also surgical laser systems used in ophthalmic procedures.
IVD devices are designed to examine specimens (like blood, urine, tissue samples) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis on a specimen.
N/A
Intended Use / Indications for Use
The Femtec Laser System for Capsulotomy is indicated for anterior capsulotomy during cataract surgery.
Product codes
OOE
Device Description
The Femtec Laser System for Capsulotomy is a precision ophthalmic surgical laser indicated for use in patients undergoing anterior capsulotomy during cataract surgery. Capsular dissection is achieved through precise individual micro-photodisruption of tissue, measuring a few microns in diameter, created by tightly focusing ultrashort laser pulses into the targeted capsular tissue. Surgical effects are produced by scanning thousands of individual pulses, producing a continuous incision. The location of the tissue photodisruption is controlled by a fixed laser beam focused through a scanning optic system to the desired location. Pre-programmed patterns produce capsular resections of predetermined diameter and height.
Laser pulses are delivered through a sterile (disposable) Patient Interface, consisting of a contact lens and suction clip to provide suction. The contact lens and suction clip assembly creates a reference surface for depth control and fix the eye relative to the delivery of the laser beam.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior capsulotomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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
Pre-clinical and clinical testing has included bench testing and a prospective clinical trial.
Performance Data: Testing and analyses included accuracy and reproducibility of capsulotomy incisions in porcine eyes, as well as in plastic and agar gel optical phantoms. The data demonstrated that the Femtec Laser System produces anterior capsulotomies that are accurate and predictable in size, shape, and centration over a range of depths. The capsular edge created by the Femtec Laser system is also at least as smooth as that created during anterior capsulotomy.
Clinical Trial: A clinical trial of the Femter Laser System was conducted to evaluate the performance of the laser system in the creation of anterior capsulotomy during cataract surgery. Anterior capsulotomy was successfully performed in all eyes using the Femtec Laser System; i.e., the capsulotomy was complete in all eyes, with no radial tears observed intraoperatively or postoperatively, and with an intraocular lens placed in each capsular bag. Postoperatively, the course of follow-up in the study population was unremarkable. The intraocular lens was centered in all study eyes, and no posterior capsule tears were observed. All capsulotomies were judged to be well-centered by the surgeon using visual inspection in the operating microscope. While shown to be equally safe as manual capsulorhexis, the Femtec Laser System anterior capsulotomy procedure produced significantly more circular capsulorhexis than the manual technique, and significantly more pupil-centered capsulorhexis compared to manual capsulotomy.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.4390 Ophthalmic laser.
(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.
0
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| APPLICANT: | Technolas Perfect Vision GmbH
Messerschmittstr. 1 +3
80992 Munich, Germany
Tel: 49 174 3494062 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Betty M. Johnson
Sr. Manager, Regulatory Affairs
Technolas Perfect Vision GmbH
PO Box 17190
Anaheim, CA 92817
Ph: 714-273-8254
Fax: 714-855-2794
Email: b.johnson@technolaspv.com |
| TRADE NAME: | Femtec Laser System for Capsulotomy |
| COMMON NAME: | Ophthalmic Laser |
| CLASSIFICATION
NAME: | Ophthalmic Femtosecond Laser |
| DEVICE
CLASSIFICATION: | Class II |
| PRODUCT CODE | OOE (Ophthalmic Femtosecond Laser) |
| PREDICATE
DEVICES: | LenSx 550 Laser System, LensAR Laser System for Anterior
Capsulotomy |
PREDICATE DEVICES:
| 510(K) NUMBER | PRODUCT TRADE NAME | MANUFACTURER |
|---|---|---|
| K082947 | LenSx 550 Laser System | LenSx Lasers / Alcon |
| K090633 | LensAR Laser System for | |
| Anterior Capsulotomy | LensAR, Inc. | |
| K060372 | IntraLase FS Laser | Abbott Medical Optics |
| K040204 | Zyoptix XP Microkeratome | Technolas Perfect Vision GmbH |
| K022560 | Moria 2 Microkeratome | Moria |
1
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
Description of the Device Subject to Premarket Notification:
The Femtec Laser System for Capsulotomy is a precision ophthalmic surgical laser indicated for use in patients undergoing anterior capsulotomy during cataract surgery. Capsular dissection is achieved through precise individual micro-photodisruption of tissue, measuring a few microns in diameter, created by tightly focusing ultrashort laser pulses into the targeted capsular tissue. Surgical effects are produced by scanning thousands of individual pulses, producing a continuous incision. The location of the tissue photodisruption is controlled by a fixed laser beam focused through a scanning optic system to the desired location. Pre-programmed patterns produce capsular resections of predetermined diameter and height.
Laser pulses are delivered through a sterile (disposable) Patient Interface, consisting of a contact lens and suction clip to provide suction. The contact lens and suction clip assembly creates a reference surface for depth control and fix the eye relative to the delivery of the laser beam.
Indication for Use:
The Femtec Laser System for Capsulotomy is indicated for anterior capsulotomy during cataract surgery. The proposed indication for use is identical to the previously cleared LenSx 550 Laser (K082947) and LensAR Laser System for Anterior Capsulotomy (K090633).
Technical Characteristics Comparison:
The Femtec Laser System for Capsulotomy mode of operation and technology are very similar to the previously cleared LenSx 550 Laser (K082947) and LensAR Laser System for Anterior Capsulotomy (K090633). The Femtec Laser System for Capsulotomy utilizes ultrashort, high frequency laser pulses to create photodisruption in the anterior capsule, as do the predicate devices. The Femtec Laser system utilizes a curved patient interface as does the LenSx 550 laser predicate, while the LenAR Laser System utilizes a fluid-fluid interface. However, both patient interface configurations have the same function, which to provide a reference surface through which the laser pulses are delivered to the anterior capsule and are therefore substantially equivalent.
Brief Summary of Preclinical and Clinical Performance Test Results:
Technolas Perfect Vision developed the Femtec Laser system for use in anterior capsulotomy. Pre-clinical and clinical testing has included bench testing and a prospective clinical trial.
Performance Data:
Testing and analyses included accuracy and reproducibility of capsulotomy incisions in porcine eyes, as well as in plastic and agar gel optical phantoms. The data demonstrated that the Femtec Laser System produces anterior capsulotomies that are accurate and predictable in size, shape, and centration over a range of depths. The capsular edge created by the Femtec Laser system is also at least as smooth as that created during anterior capsulotomy.
2
Clinical Trial:
A clinical trial of the Femter Laser System was conducted to evaluate the performance of the laser system in the creation of anterior capsulotomy during cataract surgery. Anterior capsulotomy was successfully performed in all eyes using the Femtec Laser System; i.e., the capsulotomy was complete in all eyes, with no radial tears observed intraoperatively or postoperatively, and with an intraocular lens placed in each capsular bag. Postoperatively, the course of follow-up in the study population was unremarkable. The intraocular lens was centered in all study eyes, and no posterior capsule tears were observed. All capsulotomies were judged to be well-centered by the surgeon using visual inspection in the operating microscope. While shown to be equally safe as manual capsulorhexis, the Femtec Laser System anterior capsulotomy procedure produced significantly more circular capsulorhexis than the manual technique, and significantly more pupil-centered capsulorhexis compared to manual capsulotomy.
Basis for Determination of Substantial Equivalence:
The technological and performance characteristics of the Femtec Laser System for Capsulotomy are substantially equivalent to the technological and performance characteristics of the LenSx 550 Laser System and the LensAR Femtosecond Laser, cleared under K082947 and K090633, respectively, for anterior capsulotomy during cataract surgery.
3
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Technolas Perfect Vision GMBH c/o Ms. Betty M. Johnson Sr. Manager, Regulatory Affairs, Americas PO box 17190 Anaheim, CA 92817
NOV 2 2 2 2011
Re: K110427
Trade/Device Name: Femtec Laser System for Capsulotomy Regulation Number: 21 CFR 886.4390 Regulation Name: Opthalmic Laser Regulatory Class: Class II Product Code: OOE Dated: November 7, 2011 Received: November 8, 2011
Dear Ms. Johnson:
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. 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.
4
Page 2 -- Ms. Betty M. Johnson
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Kevin Alexander
for
Mälvina B. Eydelman, M.D. Director Division of Ophthalmic. Neurological. and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known): _ & 1 / 0 4 L 7
- **
Device Name(s): Femtec Laser System for Capsulotomy
Indications for Use:
The Fentec Laser System for Capsulotomy is indicated for anterior capsulotomy during cataract surgery.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (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)
signature
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
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