(53 days)
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.
This 510(k) summary describes a traditional medical device (Slit Lamps BM 900 / BQ 900 / BP 900) and not an AI/ML powered device. As such, the input document does not contain the information required to answer the requested questions about acceptance criteria and a study proving device conformance for an AI/ML device. The document primarily focuses on demonstrating substantial equivalence to a predicate device (Slit Lamp BC 900) based on similar technology and function, and compliance with general safety and performance standards.
Therefore, I cannot provide a response for the following:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The sample size for the training set
- How the ground truth for the training set was established
The document only details the comparison of technological characteristics between the new devices and the predicate device, and the general safety and EMC data derived from testing one of the new models (BQ 900) against recognized standards (ISO 15004-2, ISO 10939, IEC 60601-1, IEC 60601-1-2). It concludes that the new devices are substantially equivalent to the predicate device and meet safety and effectiveness standards, but does not provide performance metrics or studies in the format requested for an AI/ML product.
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Image /page/0/Picture/0 description: The image shows the logo for HAAG-STREIT INTERNATIONAL. The logo consists of two parts: a bold, black, geometric shape on the left, and the company name in bold, black letters on the right. The text is stacked in two lines, with "HAAG-STREIT" on the top line and "INTERNATIONAL" on the bottom line.
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: +41 31 978 01 48 Fax: +41 31 978 02 82 E-Mail: oscar.banz@haag-streit.com
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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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 | |
| BrightnessControls | With Power Supply LC-SLT andHalogen Bulb:Variable control by potentiometer:Maximum brightness:Position 1: approx. 300'000 Lux | For BM 900 and BQ 900:With Power Supply PS-A and Tungsten Bulb:Rotating switch with 3 steps:Maximum brightness:Position 2: approx. 600'000 LuxWith Power Supply PS-A and Halogen Bulb:Rotating switch with 3 steps:Maximum brightness:Position 2: approx. 370'000 LuxWith Power Supply PS-AV and Tungsten Bulb:Variable control by potentiometer:Maximum brightness:Position 2: approx. 600'000 LuxWith Power Supply PS-AV and Halogen Bulb:Variable control by potentiometer:Maximum brightness:Position 2: approx. 370'000 LuxWith Power Supply PS-LED and LED:Variable control by potentiometer:Maximum brightness:Position 10: approx. 450'000 LuxAdditional Fill Illumination Fl 01f:Variable control by potentiometer:Maximum brightness:Position 10: approx. 15'000 LuxAdditional Fill Illumination FI 01p:Variable control by potentiometer:Maximum brightness:Position 10: approx. 30'000 Lux | The brightness controlsare either by a variable,continuous potentiometer,by a rotating switch withfixed positions or by apush button.The maximum brightnessof the slit lamps differs.The differences inbrightness controls arenot significant. They allowthe user to select aconvenient brightness toachieve optimum results.The maximum brightnessis significantly different.The predicate device BC900 has a maximumbrightness of approx.300'000 Lux, whereas theslit lamps BM 900, BQ 90and BP 900 can haveapprox. 600'000 Lux withthe tungsten bulb andapprox. 370'000 Lux withthe halogen bulb.As all slit lamps conformto the relevant standardISO 10939, there are nonew issues of safety andeffectiveness. |
| Predicate DeviceHaag-Streit Slit Lamp BC 900 | Haag-Streit Slit LampsBM 900 / BQ 900 / BP 900 | Description of differencesand discussion | |
| BrightnessControls | For BP 900:With Power Supply PS-B and Tungsten Bulb:Push-button control in 3 steps:Maximum brightness:Level 2:Lux approx. 600'000 | See above | |
| With Power Supply PS-B and Halogen Bulb:Push-button control in 3 steps:Maximum brightness:Level 2:approx. 370'000Lux | |||
| With Power Supply PS-LED and LED:Variable control by potentiometer:Maximum brightness:Position 10:approx. 450'000Lux | |||
| Additional Fill Illumination Fl 01f:Variable control by potentiometer:Maximum brightness:Position 10:approx. 15'000Lux | |||
| Additional Fill Illumination Fl 01p:Variable control by potentiometer:Maximum brightness:Position 10:approx. 30'000Lux | |||
| Slit imagewidth | 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.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.There are no new issues of safety and effectiveness. |
| Predicate DeviceHaag-Streit Slit Lamp BC 900 | Haag-Streit Slit LampsBM 900 / BQ 900 / BP 900 | Description of differencesand discussion | |
| Slit imagelength | 1 - 14 mm continuous | 1 - 8 mm continuous | The differences are notsignificant.As the illumination field isdefined by a circular aperture,the slit length can not be largerthan the slit width.For slit lamps BM 900, BQ 900and BP 900 a slit length of 8mm is sufficient as the Irisusually has a diameter ofmaximum 6 mm.There are no new issues ofsafety and effectiveness. |
| Illuminationfielddiameter | 14 mm | Ø 8 / 5 / 3 / 2 / 1 / 0.2mm | The differences are notsignificant.The slit lamp BC 900 hasthe possibility tocontinuously adjust theillumination field diameterfrom 1mm to 14mm, theslit lamps BM 900, BQ900 and BP 900 canadjust from 1mm to 8mm.Additionally the slit lampsBM 900, BQ 900 and BP900 can chose somefixed diameters for user'sconvenience.As described further upthe difference in fielddiameter is due to theintended use.There are no new issuesof safety andeffectiveness. |
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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
Page 5-4 of 5-7
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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
・・
510(k)
:
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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 DeviceHaag-Streit Slit Lamp BC 900 | Haag-Streit Slit LampsBM 900 / BQ 900 / BP 900 | Description of differencesand discussion | |
|---|---|---|---|
| Radialmovementof the slitlightilluminationrelative tothemicroscopeaxis | horizontal ± 90° | horizontal ± 90° , vertical 0 - 20° | This difference is notsignificant.When examining theinner parts of the eyesometimes it may beadvantageous to use ahorizontal slit for a clearview. In order to have aview to this examinationplane it is necessary tobe able to move the slitlight illumination also in avertical axis, which ispossible with the slitlamps BM 900, BQ 900and BP 900.This feature is notneeded for the slit lampBC 900.There are no new issuesof safety andeffectiveness. |
| Lightsources | 1. Halogen Bulb 12V / 2.5A | 1. Tungsten Bulb 6V / 4.5A2. Halogen Bulb 7.5V / 38W3. LED Illumination LI 900 | The difference in lightsource is significant.Predicate device BC 900has a 12V 2.5A halogenbulb, whereas the slitlamps BM 900, BQ 900and BP 900 can have a7.5V 38W halogen bulb, a6V 4.5A tungsten bulb orthe 24VDC 1A LED.As all slit lamps conformto the relevant standardISO 10939, there are nonew issues of safety andeffectiveness. |
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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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 (800) 638-2041 or (301) 796-7100 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
Page 1 of 1
§ 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.