SLIT LAMP BO 900, BQ 900, BP900

K100202 · Haag-Streit AG · HJO · Mar 19, 2010 · Ophthalmic

Device Facts

• Record ID: K100202
• Device Name: SLIT LAMP BO 900, BQ 900, BP900
• Applicant: Haag-Streit AG
• Product Code: HJO · Ophthalmic
• Decision Date: Mar 19, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1850
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

An AC-powered slitlamp biomicroscope is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.

Device Story

AC-powered slitlamp biomicroscope used for clinical eye examinations. Device projects thin, intense beam of light into patient's eye via control diaphragm. Patient positions chin and forehead on headrest; clinician adjusts height and uses control lever to focus slit on cornea. Microscope optics allow observation of anterior eye segment at various magnifications. Clinician manually adjusts slit width, tilt, and illumination angle to visualize structures. Output is visual image of eye segment observed through microscope, aiding diagnosis of disease or trauma. Used in clinical settings by eye care professionals.

Clinical Evidence

Bench testing only. Device performance evaluated against ISO 15004-2:2007 (radiation hazards), ISO 10939:2007 (slit lamps), IEC 60601-1 (electrical safety), and IEC 60601-1-2 (EMC). No clinical data presented.

Technological Characteristics

AC-powered biomicroscope. Components: light source (Tungsten, Halogen, or LED), slit, collimation/imaging optics, IR/UV filters, dielectric mirror. Brightness control via potentiometer, rotating switch, or push-button. Horizontal slit movement ±90°, vertical 0-20°. Conforms to ISO 10939, IEC 60601-1, IEC 60601-1-2.

Indications for Use

Indicated for eye examination of the anterior eye segment (cornea epithelium to posterior capsule) to aid in the diagnosis of diseases or trauma affecting structural properties of the anterior eye segment. For prescription use.

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

• Haag-Streit Slit Lamp BC 900 (K982057)

Submission Summary (Full Text)

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510(k)

Slit Lamps BM 900 / BQ 900 / BQ 900 LED illumination Ll 900

Kl00202

Chapter 5: 510(k) Summary

Page 5-1 of 5-7

# CHAPTER 5: 510(K) SUMMARY

MAR 1 9 2010

# 510(K) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(c).

#### 1. Submitter of this pre-market notification:

Haag-Streit AG Gartenstadtstrasse 10 CH-3098 Koeniz / Switzerland

#### Contact person:

Oscar Banz, Manager Regulatory Affairs Phone: [phone] Fax: [phone] E-Mail: [e-mail]

This summary was prepared.on November 16, 2009

## 2. Trade names of the devices:

- Slit Lamp BM 900 -
- Slit Lamp BQ 900 -
- Slit Lamp BP 900 —

#### 3. Common / usual name:

AC-powered Slitlamp Biomicroscope

# 4. Classification Information:

Classification name: Biomicroscope, Slit-Lamp, AC-Powered 21 CFR 886.1850 CFR title: Product code: HJO Device Class: Class II Classification Panel: Ophthalmic Device Panel

દ્ધ

Haag-Streit AG Gartenstadtstrasse 10 3098 Koeniz/Switzerland November 16, 2009

,

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Image /page/1/Picture/0 description: The image shows the logo for Haag-Streit International. The logo consists of the letters "HS" in a bold, blocky font on the left side of the image. To the right of the letters, the words "HAAG-STREIT INTERNATIONAL" are written in a bold, sans-serif font, with "HAAG-STREIT" on the top line and "INTERNATIONAL" on the bottom line.

510(k)

LED Illumination LI 900

Chapter 5: 510(k) Summary

Page 5-2 of 5-7

### 5. Predicate Device:

We claim substantial equivalence to the following device:

Haag-Streit AG Manufacturer: Slit Lamp BC 900 Device name: 510(k) Premarket Notification no .: K982057 Biomicroscope, Slit-Lamp, AC-Powered Classification name: 21 CFR 886.1850 CFR title: HJO Product code: Device Class: Class II Ophthalmic Device Panel Classification Panel:

## 6. General Device Description:

An AC-powered slitlamp biomicroscope is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.

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.

The slit lamp illumination is composed of the light source, the slit; collimation and imaging optics, and infrared and ultraviolet filters and a dielectric mirror. The slit lamps have the option to combine a background illumination together with the slit illumination.

The patient sits in front of the slit lamp with his chin rest and his forehead against the forehead band. The chin rest is adjusted in height until the eyes of the patient are level with the black mark of the headrest column. The light is switched on and the brightness is controlled with a knob on the power supply and with a 10% grey filter. With the control lever the instrument can be moved back- and forward until the slit appears in focus on the cornea. The image can be observed through the microscope. Various magnifications can be selected on the microscope. For different observations the slit width can be changed, the slit can be tilted horizontally and the angle between the illumination unit and the microscope can also be varied horizontally.

#### 7. Indication for use

An AC-powered slitlamp biomicroscope is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.

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Image /page/2/Picture/0 description: The image shows the logo for Haag-Streit International. The logo consists of two parts: a stylized black square with two white dots, and the text "HAAG-STREIT INTERNATIONAL" in black bold letters. The text is aligned to the right of the square.

510(k)

Slit Lamps BM 900 / BQ 900 / BQ 900

LED Illumination Ll 900

Chapter 5: 510(k) Summary

Page 5-3 of 5-7

## 8. Comparison with predicate device

The slit lamps BM 900, BQ 900 and BP 900 are substantially equivalent to the predicate device BC 900, because they use similar technology and perform similar functions to provide the physician with the necessary information to make a diagnosis.

Major different technological characteristics are as follows:

| | Predicate Device | Haag-Streit Slit Lamps | Description of differences |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Haag-Streit Slit Lamp BC 900 | BM 900 / BQ 900 / BP 900 | and discussion |
| Brightness<br>Controls | With Power Supply LC-SLT and<br>Halogen Bulb:<br>Variable control by potentiometer:<br>Maximum brightness:<br>Position 1: approx. 300'000 Lux | For BM 900 and BQ 900:<br>With Power Supply PS-A and Tungsten Bulb:<br>Rotating switch with 3 steps:<br>Maximum brightness:<br>Position 2: approx. 600'000 Lux<br>With Power Supply PS-A and Halogen Bulb:<br>Rotating switch with 3 steps:<br>Maximum brightness:<br>Position 2: approx. 370'000 Lux<br>With Power Supply PS-AV and Tungsten Bulb:<br>Variable control by potentiometer:<br>Maximum brightness:<br>Position 2: approx. 600'000 Lux<br>With Power Supply PS-AV and Halogen Bulb:<br>Variable control by potentiometer:<br>Maximum brightness:<br>Position 2: approx. 370'000 Lux<br>With Power Supply PS-LED and LED:<br>Variable control by potentiometer:<br>Maximum brightness:<br>Position 10: approx. 450'000 Lux<br>Additional Fill Illumination Fl 01f:<br>Variable control by potentiometer:<br>Maximum brightness:<br>Position 10: approx. 15'000 Lux<br>Additional Fill Illumination FI 01p:<br>Variable control by potentiometer:<br>Maximum brightness:<br>Position 10: approx. 30'000 Lux | The brightness controls<br>are either by a variable,<br>continuous potentiometer,<br>by a rotating switch with<br>fixed positions or by a<br>push button.<br>The maximum brightness<br>of the slit lamps differs.<br>The differences in<br>brightness controls are<br>not significant. They allow<br>the user to select a<br>convenient brightness to<br>achieve optimum results.<br>The maximum brightness<br>is significantly different.<br>The predicate device BC<br>900 has a maximum<br>brightness of approx.<br>300'000 Lux, whereas the<br>slit lamps BM 900, BQ 90<br>and BP 900 can have<br>approx. 600'000 Lux with<br>the tungsten bulb and<br>approx. 370'000 Lux with<br>the halogen bulb.<br>As all slit lamps conform<br>to the relevant standard<br>ISO 10939, there are no<br>new issues of safety and<br>effectiveness. |
| | Predicate Device<br>Haag-Streit Slit Lamp BC 900 | Haag-Streit Slit Lamps<br>BM 900 / BQ 900 / BP 900 | Description of differences<br>and discussion |
| Brightness<br>Controls | | <b>For BP 900:</b><br>With Power Supply PS-B and Tungsten Bulb:<br>Push-button control in 3 steps:<br>Maximum brightness:<br>Level 2:<br>Lux approx. 600'000 | See above |
| | | With Power Supply PS-B and Halogen Bulb:<br>Push-button control in 3 steps:<br>Maximum brightness:<br>Level 2:<br>approx. 370'000<br>Lux | |
| | | With Power Supply PS-LED and LED:<br>Variable control by potentiometer:<br>Maximum brightness:<br>Position 10:<br>approx. 450'000<br>Lux | |
| | | Additional Fill Illumination Fl 01f:<br>Variable control by potentiometer:<br>Maximum brightness:<br>Position 10:<br>approx. 15'000<br>Lux | |
| | | Additional Fill Illumination Fl 01p:<br>Variable control by potentiometer:<br>Maximum brightness:<br>Position 10:<br>approx. 30'000<br>Lux | |
| Slit image<br>width | 0 - 14 mm continuous | 0 - 8 mm continuous | The differences are not significant. The predicate device BC 900 has a larger slit width, because when fitting contact lenses it is necessary to illuminate the whole cornea up to the sclera.<br><br>The slit lamps BM 900, BQ 900 and BP 900 are mainly used to examine the inner parts of the eye. For this a very narrow slit width is needed, usually less than 1 mm. For this reason it is nol necessary for these slit lamps to have a slit width wider than 8 mm.<br><br>There are no new issues of safety and effectiveness. |
| | Predicate Device<br>Haag-Streit Slit Lamp BC 900 | Haag-Streit Slit Lamps<br>BM 900 / BQ 900 / BP 900 | Description of differences<br>and discussion |
| Slit image<br>length | 1 - 14 mm continuous | 1 - 8 mm continuous | The differences are not<br>significant.<br><br>As the illumination field is<br>defined by a circular aperture,<br>the slit length can not be larger<br>than the slit width.<br><br>For slit lamps BM 900, BQ 900<br>and BP 900 a slit length of 8<br>mm is sufficient as the Iris<br>usually has a diameter of<br>maximum 6 mm.<br><br>There are no new issues of<br>safety and effectiveness. |
| Illumination<br>field<br>diameter | 14 mm | Ø 8 / 5 / 3 / 2 / 1 / 0.2mm | The differences are not<br>significant.<br><br>The slit lamp BC 900 has<br>the possibility to<br>continuously adjust the<br>illumination field diameter<br>from 1mm to 14mm, the<br>slit lamps BM 900, BQ<br>900 and BP 900 can<br>adjust from 1mm to 8mm.<br>Additionally the slit lamps<br>BM 900, BQ 900 and BP<br>900 can chose some<br>fixed diameters for user's<br>convenience.<br><br>As described further up<br>the difference in field<br>diameter is due to the<br>intended use.<br><br>There are no new issues<br>of safety and<br>effectiveness. |

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Image /page/3/Picture/0 description: The image shows the logo for HAAG-STREIT INTERNATIONAL. The logo consists of the letters 'HS' in a bold, blocky font on the left side. To the right of the letters is the text 'HAAG-STREIT INTERNATIONAL' in a bold, sans-serif font, stacked in two lines.

210(K)

# Slit Lamps BM 900 / BQ 900 / BQ 900

LED Illumination LI 900

Chapter 5: 510(k) Summary

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Image /page/4/Picture/0 description: The image shows the logo for HAAG-STREIT INTERNATIONAL. The logo consists of the letters 'HS' in a bold, blocky font on the left side. To the right of the letters, the words 'HAAG-STREIT' are printed in a bold, sans-serif font, with the word 'INTERNATIONAL' printed below it in a similar font. The entire logo is black and white.

# Slit Lamps BM 900 / BQ 900 / BQ 900

LED Illumination LI 900

#### Chapter 5: 510(k) Summary

## Page 5-5 of 5-7

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510(k)

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Image /page/5/Picture/0 description: The image shows the logo for HAAG-STREIT INTERNATIONAL. The logo consists of two parts: a stylized, solid black square with a white line running through it, and the text "HAAG-STREIT INTERNATIONAL" in bold, black letters. The text is stacked, with "HAAG-STREIT" on top and "INTERNATIONAL" below.

Chapter 5: 510(k) Summary

#### 510(k)

# Slit Lamps BM 900 / BQ 900 / BQ 900

LED Illumination LI 900

#### Page 5-6 of 5-7

| | Predicate Device<br>Haag-Streit Slit Lamp BC 900 | Haag-Streit Slit Lamps<br>BM 900 / BQ 900 / BP 900 | Description of differences<br>and discussion |
|--------------------------------------------------------------------------------------------------------|--------------------------------------------------|-------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Radial<br>movement<br>of the slit<br>light<br>illumination<br>relative to<br>the<br>microscope<br>axis | horizontal ± 90° | horizontal ± 90° , vertical 0 - 20° | This difference is not<br>significant.<br><br>When examining the<br>inner parts of the eye<br>sometimes it may be<br>advantageous to use a<br>horizontal slit for a clear<br>view. In order to have a<br>view to this examination<br>plane it is necessary to<br>be able to move the slit<br>light illumination also in a<br>vertical axis, which is<br>possible with the slit<br>lamps BM 900, BQ 900<br>and BP 900.<br><br>This feature is not<br>needed for the slit lamp<br>BC 900.<br><br>There are no new issues<br>of safety and<br>effectiveness. |
| Light<br>sources | 1. Halogen Bulb 12V / 2.5A | 1. Tungsten Bulb 6V / 4.5A<br>2. Halogen Bulb 7.5V / 38W<br>3. LED Illumination LI 900 | The difference in light<br>source is significant.<br>Predicate device BC 900<br>has a 12V 2.5A halogen<br>bulb, whereas the slit<br>lamps BM 900, BQ 900<br>and BP 900 can have a<br>7.5V 38W halogen bulb, a<br>6V 4.5A tungsten bulb or<br>the 24VDC 1A LED.<br><br>As all slit lamps conform<br>to the relevant standard<br>ISO 10939, there are no<br>new issues of safety and<br>effectiveness. |

#### 9. Performance, Safety and EMC Data

The slit lamps BM 900 and BP 900 illumination units and electrical systems are identical to the BQ 900 illumination unit and electrical system. Therefore all measurements and tests were done with the BQ 900 and have not been repeated for the BM 900 and BP 900.

The slit lamp BQ 900 was tested according to ISO 15004-2;2007 and ISO 10939:2007 for radiation hazards, to IEC 60601-1 for electrical safety and to IEC 60601-1-2 for electromagnetic compatibility. In all tests the slit lamp was in compliance with these FDArecognized standards.

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Image /page/6/Picture/0 description: The image contains a logo for HAAG-STREIT INTERNATIONAL. The logo consists of two parts: a stylized graphic on the left and the text "HAAG-STREIT INTERNATIONAL" on the right. The graphic is a bold, geometric shape, while the text is in a sans-serif font, with "HAAG-STREIT" stacked above "INTERNATIONAL".

Slit Lamps BM 900 / BQ 900 / BQ 900 LED Illumination LI 900

ਜਾਂ

Chapter 5: 510(k) Summary

Page 5-7 of 5-7

#### 10. Conclusions

In accordance to 21 CFR 807.92(d) and based on the technical characteristics and the results of the performance tests we conclude that the slit lamps BM 900, BQ 900 and BP 900 are substantially equivalent and as safe and effective as the predicate device slit lamp BC 900.

210(k)

3098 Koeniz/Switzerland

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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

MAR 1 9 2010

HAAG-STREIT AG c/o Mr. Stefan Preiss TUV SUD America Inc. 1775 Old Highway 8 NW New Brighton, MN 55112

Re: K100202

Trade Name: Slit Lamp BM 900, BQ 900, BP 900 Regulation Number: 21 CFR 886.1850 Regulation Name: AC-powered slitlamp biomicroscope Regulatory Class: Class II Product Code: HJO Dated: March 2, 2010 Received: March 4, 2010

Dear Mr. Preiss:

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.

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

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Page 2 - Mr. Stefan Preiss

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Q. A. Thon

Malvina B. Eydelman, M.I 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 Form

510(k) Number (if known): K100202

Device Name: Slit Lamp BM 900 / Slit Lamp BQ 900 / Slit Lamp BP 900

Indications for Use:

An AC-powered slitlamp biomicroscope is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.

AND/OR Over-The-Counter Use
AND/OR X Prescription Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

(Division Sign-Off)

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number

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