(316 days)
GEX, 878.4810
No
The description mentions a "computer-controlled scanning system" but does not provide any indication of AI or ML being used for decision-making, image analysis, or adaptive control beyond basic programmed patterns. The performance studies also do not mention any AI/ML-specific metrics or evaluation methods.
Yes
The device is described as an ophthalmic surgical laser used to perform an anterior capsulotomy during cataract surgery, which directly treats the patient by altering tissue.
No
The device description clearly states it is an "ophthalmic surgical laser intended for use in patients requiring an anterior capsulotomy." This describes a therapeutic, intervention-based function, not a diagnostic one.
No
The device description explicitly states it is a "LenSx 550 Laser System" and describes physical components like a laser beam, scanning system, and a disposable contact lens, indicating it is a hardware device with integrated software control.
Based on the provided information, the LenSx 550 Laser System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is "anterior capsulotomy during cataract surgery." This is a surgical procedure performed directly on a patient's eye.
- Device Description: The description details a surgical laser that focuses light pulses to create an incision in the anterior lens. This is a therapeutic/surgical device, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), providing diagnostic information, or being used in a laboratory setting.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The LenSx 550 Laser System performs a surgical action on the patient's body.
N/A
Intended Use / Indications for Use
The LenSx 550 Laser System is indicated for anterior capsulotómy during cataract surgery.
Product codes
OOE
Device Description
The LenSx 550 Laser is an ophthalmic surgical laser intended for use in patients requiring an anterior capsulotomy. The LenSx 550 Laser focuses a beam of low energy pulses of infrared light into the anterior lens. Consistent with commercially available femtosecond lasers used for lamellar resection of the cornea (GEX, 878.4810), the cutting effect is produced by scanning individual pulses to produce a continuous incision. The location of the tissue photodisruption is controlled by moving the focus of the laser beam to the desired location. A computer-controlled scanning system directs the laser beam throughout a three-dimensional pattern to produce an incision. Finally, the laser pulses are delivered through an off-the-shelf disposable contact lens that contacts the cornea and fixes the eye with respect to the delivery system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior lens, cornea
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
Pre-clinical and clinical testing has included bench testing and a prospective, single-center clinical trial.
Summary of Pre-Clinical Testing: Testing and analyses performed included accuracy and reproducibility of capsulotomy size and depth in porcine eyes and plastic substrates, as well as scanning electron microscopy. The data demonstrated the LenSx 550 produces anterior capsulotomies that are uniform, accurate and predictable in size over a wide range of depths. The capsular edge created by the LenSx 550 is also at least as smooth as that created during manual anterior capsulotomy.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Testing: A clinical trial of the LenSx 550 Laser was conducted to evaluate the performance of this laser system in the creation of anterior capsulotomy during cataract/IOL surgery. Anterior capsulotomy was successfully performed in all eyes using the LenSx 550 Laser. i.e., the capsulotomy was complete in all eyes, with no radial tears observed intraoperatively or postoperatively, and with an intraocular lens placed in the capsular bag. Postoperatively, the course of follow-up in the study population was unremarkable, The intraocular lens was centered in all study cyes, 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K001498, K040005, K052806, K021548, K033354, K993153, K001211, K002890, K013941, K031960, K041893, K060372, K063682, K073404
Reference Device(s)
Not Found
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
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(a).
SUBMITTER'S NAME, ADDRESS, TELEPHONE NUMBER, CONTACT PERSON, AND DATE SUMMARY PREPARED
| a. | Applicant: | LenSx Lasers, Inc.
33 Journey, Suite 175
Aliso Viejo, CA 92656
Tel: (949) 360-6010
Fax: (949) 612-1843 |
|----|-----------------|--------------------------------------------------------------------------------------------------------------------|
| b. | Contact Person: | Judy Gordon, D.V.M.
ClinReg Consulting Services, |
Inc. 733 Bolsana Drive Laguna Beach, CA 92651 judy@clinregconsulting.com Tel: (949) 715-0609 Fax: (949) 715-0610
NAME OF DEVICE, INCLUDING TRADE NAME AND CLASSIFICATION NAME
| a. | Trade/Proprietary Name: | LenSx 550 Laser System |
|---|---|---|
| b. | Common/Usual Name: | LenSx 550 Laser System |
| c. | Device Classification: | Ophthalmic Femtosecond Laser, Class II, |
| 21 CFR 886.4390 | ||
| d. | Product Code: | OOE |
ರ. Product Code:
K082947- SUMMARY OF SAFETY AND EFFECTIVENESS
..
1
PREDICATE DEVICES
| 510(k) # | TRADE NAME | MANUFACTURER |
|---|---|---|
| K001498 | The Fugo Blade | Medisurg Research and |
| Management Corp. | ||
| K040005 | Profile 3000 laser System and | |
| Delivery Devices and | ||
| Accessories | Sciton, Inc. | |
| K052806 | Burane Laser System | WaveLight Laser Technologie, |
| AG | ||
| K021548 | Fotona Dualis | |
| Nd:YAG/Er:YAG Laser System | Fontona D.D. | |
| K033354 | FEMTEC Laser Microkeratome | 20/10 Perfect Vision Optische |
| Gerate GMBH | ||
| K993153, K001211, | ||
| K002890, K013941, | ||
| K031960, K041893, | ||
| K060372, K063682, and | ||
| K073404 | IntraLase FS Lasers | IntraLase Corp. |
DEVICE DESCRIPTION
The LenSx 550 Laser is an ophthalmic surgical laser intended for use in patients requiring an anterior capsulotomy. The LenSx 550 Laser focuses a beam of low energy pulses of infrared light into the anterior lens. Consistent with commercially available femtosecond lasers used for lamellar resection of the cornea (GEX, 878.4810), the cutting effect is produced by scanning individual pulses to produce a continuous incision. The location of the tissue photodisruption is controlled by moving the focus of the laser beam to the desired location. A computer-controlled scanning system directs the laser beam throughout a three-dimensional pattern to produce an incision. Finally, the laser pulses are delivered through an off-the-shelf disposable contact lens that contacts the cornea and fixes the eye with respect to the delivery system.
STATEMENT OF INTENDED USE
The LenSx 550 Laser System is indicated for anterior capsulotomy during cataract surgery.
2
TECHNOLOGICAL CHARACTERISTICS COMPARISON
The LenSx 550 laser shares a similar intended use, and indication for use as the Fugo Blade by Medisurg Research and Management Corp., the Profile 3000 Laser System (K040005), the Burane Laser System (K052806) and the Fontona Dualis Nd:YAG/Er:YAG Laser System (K021548). The LenSx 550 mode of operation and the technology utilized to create the cutting action are similar to the 20/10 Perfect Vision FemTec Laser Microkeratome, and the IntraLase FS Lasers and is therefore substantially equivalent to these legally marketed predicate devices.
BRIEF SUMMARY OF NONCLINICAL TESTS AND RESULTS
LenSx has developed the LenSx 550 for use in anterior capsulotomy, employing the precision and control of femtosecond lasers for this procedure. Pre-clinical and clinical testing has included bench testing and a prospective, single-center clinical trial.
Summary of Pre-Clinical Testing
Testing and analyses performed included accuracy and reproducibility of capsulotomy size and depth in porcine eyes and plastic substrates, as well as scanning electron microscopy. The data demonstrated the LenSx 550 produces anterior capsulotomies that are uniform, accurate and predictable in size over a wide range of depths. The capsular edge created by the LenSx 550 is also at least as smooth as that created during manual anterior capsulotomy.
Summary of Clinical Testing
A clinical trial of the LenSx 550 Laser was conducted to evaluate the performance of this laser system in the creation of anterior capsulotomy during cataract/IOL surgery. Anterior capsulotomy was successfully performed in all eyes using the LenSx 550 Laser. i.e., the capsulotomy was complete in all eyes, with no radial tears observed intraoperatively or postoperatively, and with an intraocular lens placed in the capsular bag. Postoperatively, the course of follow-up in the study population was unremarkable, The intraocular lens was centered in all study cyes, 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.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
LenSx Lasers, Inc. c/o Judy Gordon, D.V.M. Regulatory Consultant to LenSx Lasers, Inc. ClingReg Consulting Services, Inc. 733 Bolsana Drive Laguna Beach, CA 92651
AUG 1 4 2009
Re: K082947
Trade/Device Name: LenSx 550 Laser System Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: II Product Code: OOE Dated: July 8, 2009 Received: July 9, 2009
Dear Dr. Gordon:
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 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 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.
4
Page 2 - Judy Gordon, D.V.M.
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/cdrh/mdr/ 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/cdrh/industry/support/index.html.
Sincerely yours,
Kesia Alexander for
Malvina 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): K082947
LenSx 550 Laser System Device Name(s):
Indications for Use:
The LenSx 550 Laser System is indicated for anterior capsulotómy during cataract surgery.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page __ 1__ of __ 1
Bruce Drum
(Division Sign-Off) Division of Ophthalmie, Neurological and Ear, Nose and Throat Devices
510(k) Number K082947