(385 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard optical measurement techniques.
No
The device is described as a biometer used for obtaining ocular measurements and performing calculations to assist in the determination of appropriate IOL power and type. It does not exert any direct therapeutic effect on the patient.
Yes
The device is described as "used for obtaining ocular measurements and performing calculations to assist in the determination of the appropriate power and type of IOL". Obtaining measurements and assisting in determination falls under the umbrella of diagnostic activities, as these measurements help in understanding the condition of the eye and planning treatment.
No
The device description explicitly states it is a "non-invasive, non-contact system" and measures physical parameters of the eye using "Optical Low Coherence Reflectometry (OLCR)". This indicates the presence of hardware components for data acquisition, not just software for processing.
Based on the provided information, the LENSTAR LS 900 is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The description clearly states the LENSTAR LS 900 is a "non-invasive, non-contact" device used for obtaining measurements directly from the human eye. It does not involve the collection or analysis of biological samples.
- The intended use is for obtaining ocular measurements and performing calculations. While these measurements are used to assist in determining IOL power, the device itself is measuring physical characteristics of the eye, not analyzing biological markers or substances.
Therefore, the LENSTAR LS 900 falls under the category of a medical device used for diagnostic purposes (obtaining measurements to aid in diagnosis and treatment planning), but it does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The LENSTAR LS 900 is a non-invasive, non-contact OLCR (Optical Low Coherence Reflectometry) Biometer used for obtaining ocular measurements and performing calculations to assist in the determination of the appropriate power and type of IOL (intraocular lens) for implantation after removal of the natural crystalline lens following cataract removal. The LENSTAR LS 900 measures:
- Axial eye length
- Corneal thickness
- Anterior chamber depth
- Aqueous depth
- Lens thickness
- Radii of curvature of flat and steep meridian
- Axis of the flat meridian
- White to white distance
- Pupil diameter
Product codes
MXK
Device Description
The LENSTAR LS 900 is a non-invasive, non-contact system for measuring the parameters of the human eye required to determine the appropriate IOL for implantation and to calculate the optimal power of the IOL. The LENSTAR LS 900 measures: axial eye length, corneal thickness, anterior chamber depth, lens thickness, radii of curvature of flat and steep meridian, axis of flat or step meridian, white to white distance and pupil diameter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical Low Coherence Reflectometry (OLCR)
Anatomical Site
Human eye
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Two prospective, non-randomized, single site comparison studies were performed to substantiate equivalence of the LENSTAR LS 900 to the stated predicate FDA approved medical devices including the IOL-Master (Carl Zeiss Meditec AG), the OLCR (Haag-Streit AG), the Accusonic A-Scan (Accutome) and Keratron (Alliance Medical Marketing). The studies were approved by an ethics committee. The studies were conducted in Berne, Switzerland.
Data includes measurements of axial length, central corneal pachymetry, anterior chamber depth, central lens thickness, average corneal radius, flat corneal axis, white-to-white distance and pupillometry.
Analysis of clinical data substantiates equivalence between the measurement data of the LENSTAR LS 900 with the all predicates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K993357, K030393, K032956, K944616
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.1850 AC-powered slitlamp biomicroscope.
(a)
Identification. An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.(b)
Classification. Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
0
510(K) SUMMARY
Date Prepared
October 16, 2009
SPONSOR/510(K) OWNER/ MANUFACTURER
Haag-Streit AG Gartenstadtstrasse 10 Koeniz, Berne, Switzerland CH-3098 011-41319780209 Telephone: 011-41319780286 Facsimile: rudolf.waelti@haag-streit.ch Email: Establishment Registration Number: 1000176188
OCT 20 2009
OFFICIAL CONTACT PERSON
Lena Sattler Orasi Consulting, LLC. 1667 Ridgewood Rd. Wadsworth, OH 44281 (440) 554-3706 Telephone: Facsimile: (866) 904-4315 E-mail: lena@orasiconsulting.com
COMMON/USUAL NAME
Device, Analysis, Anterior Segment
PROPRIETARY NAMES
LENSTAR LS 900 Allegro Biograph
CLASSIFICATION INFORMATION
Classification Name: Medical Specialty: Device Class: Classification Panel: Product Codes:
Device, Analysis, Anterior Segment Ophthalmic II Ophthalmic Device Panel MXK - Device, Analysis, Anterior Segment
PRODUCT CODE: CLASSIFICATION / CFR TITLE
MXK:
Class II § 21 CFR 886.1850
1
1
LEGALLY MARKETED PREDICATE DEVICES
Trade/Device Name: Applicant: 510(k) Premarket Notification number: Classification: FDA Product Code:
Establishment Registration number:
Trade/Device Name:
Applicant: 510(k) Premarket Notification number: Classification: FDA Product Code: Establishment Registration number:
Trade/Device Name:
Applicant: 510(k) Premarket Notification number: Classification: FDA Product Code: Establishment Registration number:
Trade/Device Name: Applicant: 510[k] Premarket Notification number: Classification: FDA Product Code: Establishment Registration number:
IOLMaster Carl Zeiss Inc. K993357 Class II HJO - Biomicroscope, Slit Lamp, AC Powered 9615030
Optical Low Coherence Reflectometry Pachymeter (OLCR) Haag-Streit AG K030393 Class II MXK - Device, Analysis, Anterior Segment 1000176188
Accusonic A-Scan Model 24-4000 Accutome K032956 Class II IYO - System, Imaging, Pulsed echo 2521877
Keratron Alliance Medical Marketing K944616 Class I HLQ-Keratoscope 1058327
2
GENERAL DEVICE DESCRIPTION
The LENSTAR LS 900 is a non-invasive, non-contact system for measuring the parameters of the human eye required to determine the appropriate IOL for implantation and to calculate the optimal power of the IOL. The LENSTAR LS 900 measures: axial eye length, corneal thickness, anterior chamber depth, lens thickness, radii of curvature of flat and steep meridian, axis of flat or step meridian, white to white distance and pupil diameter.
INDICATIONS FOR USE
The LENSTAR LS 900 is a non-invasive, non-contact OLCR (Optical Low Coherence Reflectometry) Biometer used for obtaining ocular measurements and performing calculations to assist in the determination of the appropriate power and type of IOL (intraocular lens) for implantation after removal of the natural crystalline lens following cataract removal. The LENSTAR LS 900 measures:
- Axial eye length b
- ë Corneal thickness
- Anterior chamber depth も
- � Aqueous depth
- Lens thickness .
- Radii of curvature of flat and steep meridian �
- � Axis of the flat meridian
- White to white distance .
- Pupil diameter .
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
The LENSTAR LS 900 and the predicate devices are substantially equivalent because they use similar technology and perform similar functions to provide the ocular measurements and to perform calculations needed to allow a physician to choose the appropriate power and type of IOL for a patient eye.
3
CLINICAL SUMMARY
Two prospective, non-randomized, single site comparison studies were performed to substantiate equivalence of the LENSTAR LS 900 to the stated predicate FDA approved medical devices including the IOL-Master (Carl Zeiss Meditec AG), the OLCR (Haag-Streit AG), the Accusonic A-Scan (Accutome) and Keratron (Alliance Medical Marketing). The studies were approved by an ethics committee. The studies were conducted in Berne, Switzerland.
Data includes measurements of axial length, central corneal pachymetry, anterior chamber depth, central lens thickness, average corneal radius, flat corneal axis, white-towhite distance and pupillometry.
Analysis of clinical data substantiates equivalence between the measurement data of the LENSTAR LS 900 with the all predicates.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Haag-Streit AG c/o Ms. Lena Sattler Official Correspondent Orasi Consulting, LLC 1667 Ridgewood Road Wadsworth, OH 44281
OCT 2 0 2009
Re: K082891
Trade/Device Name: Haag-Streit LENSTAR LS 900 Regulation Number: 21 CFR 886.1850 Regulation Name: AC-powered Slitlamp Biomicroscope Regulatory Class: II Product Code: HJO Dated: October 16, 2009 Received: October 19, 2009
Dear Ms. Sattler:
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 Foend, Or re 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.
5
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Kessa 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
6
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): _K082891
Device Name: LENSTAR LS 900
Indications for Use:
The LENSTAR LS 900 is a non-invasive, non-contact OLCR (Optical Low Coherence Reflectometry) Biometer used for obtaining ocular measurements and performing calculations to assist in the determination of the appropriate power and type of IOL (intraocular lens) for implantation after removal of the natural crystalline lens following cataract removal. The LENSTAR LS 900 measures:
- Axial eye length .
- . Corneal thickness
- . Anterior chamber depth
- . Aqueous depth
- . Lens thickness
- Radii of curvature of flat and steep meridian .
- Axis of the flat meridian .
- White to white distance
- . Pupil diameter
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 IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
$
\frac{}{\text{Signature of}}
$
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K 042891