LENSTAR, MODEL LS900

K082891 · Haag-Streit AG · HJO · Oct 20, 2009 · Ophthalmic

Device Facts

• Record ID: K082891
• Device Name: LENSTAR, MODEL LS900
• Applicant: Haag-Streit AG
• Product Code: HJO · Ophthalmic
• Decision Date: Oct 20, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1850
• Device Class: Class 2

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

Device Story

LENSTAR LS 900 is non-invasive, non-contact Optical Low Coherence Reflectometry (OLCR) biometer; used in clinical settings by eye care professionals. Device captures ocular measurements including axial length, corneal thickness, anterior chamber depth, aqueous depth, lens thickness, corneal curvature radii, flat meridian axis, white-to-white distance, and pupil diameter. System processes these inputs to perform calculations assisting physicians in determining appropriate IOL power and type for post-cataract surgery implantation. Output provided to clinician to guide surgical planning and IOL selection; facilitates accurate lens power determination, potentially improving patient visual outcomes post-cataract removal.

Clinical Evidence

Two prospective, non-randomized, single-site comparison studies conducted in Berne, Switzerland. Evaluated axial length, central corneal pachymetry, anterior chamber depth, central lens thickness, average corneal radius, flat corneal axis, white-to-white distance, and pupillometry. Study results substantiated equivalence between LENSTAR LS 900 measurement data and predicate devices (IOL-Master, OLCR, Accusonic A-Scan, and Keratron).

Technological Characteristics

Non-invasive, non-contact OLCR biometer. Measures ocular parameters via optical low coherence reflectometry. Standalone system for clinical use. No specific materials or software architecture details provided.

Indications for Use

Indicated for patients undergoing cataract surgery requiring ocular measurements and IOL power/type calculations for intraocular lens implantation.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• IOLMaster (K993357)
• Optical Low Coherence Reflectometry Pachymeter (OLCR) (K030393)
• Accusonic A-Scan Model 24-4000 (K032956)
• Keratron (K944616)

Submission Summary (Full Text)

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K082891

# 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: [phone] Facsimile: [e-mail] Email: Establishment Registration Number: 1000176188

OCT 20 2009

### OFFICIAL CONTACT PERSON

Lena Sattler Orasi Consulting, LLC. 1667 Ridgewood Rd. Wadsworth, OH 44281 [phone] Telephone: Facsimile: [phone] E-mail: [e-mail]

#### 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

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## 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

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### 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.

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# 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.

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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.

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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 [phone] or [phone] 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

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## 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)

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(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K 042891