(90 days)
The Chongqing Sunkingdom Slit Lamp LS-1A, LS-1B are AC --- powered slit lamp Biomicroscopes 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 affects the structural properties of the anterior eye segment.
Sunkingdom slit lamp LS-1A, LS-1B are an AC-powered slit lamp 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 affects the structural properties of the anterior eye segment. An AC-powered Slit lamp Bio-microscope 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. Components: The optical body, movement mechanism, illumination system, portable handle, power supply.
The given text is a 510(k) Pre-market Notification for the Sunkingdom Slit Lamp LS-1A, LS-1B. It details the device's technical characteristics and performance testing conducted to demonstrate substantial equivalence to a predicate device.
Acceptance Criteria and Device Performance:
The document primarily relies on demonstrating compliance with relevant industry standards and showing that the proposed device's performance characteristics are comparable to or better than the predicate device. The acceptance criteria are implicitly defined by these standards and the comparison table.
| Acceptance Criteria (Implied by Standards and Predicate Comparison) | Reported Device Performance (Sunkingdom Slit Lamp LS-1A, LS-1B) |
|---|---|
| Biocompatibility: | |
| - No potential toxicity to L-929 cells (for patient contact materials) | Chinrest pat and Forehead band extract did not show potential toxicity to L-929 cells. |
| - No skin irritation (for patient contact materials) | Extract of applied sample Chinrest pat and Forehead band did not induce skin irritation in rabbitskin. |
| - No skin sensitization (for patient contact materials) | Chinrest pat and Forehead band extract showed no significant evidence of causing skin sensitization in the guinea pig. |
| Electrical Safety and Electromagnetic Compatibility (EMC): | |
| - Compliance with "ANSI AAMI IEC60601-1-2:2007/(R)2012" (EMC) | System complies with "ANSI AAMI IEC60601-1-2:2007/(R)2012". |
| - Compliance with "ANSI AAMIES60601-1:2005/(R)2012AndA1:2012" (Safety) | System complies with "ANSI AAMIES60601-1:2005/(R)2012AndA1:2012". |
| Performance Testing: | |
| - Compliance with "Standard ISO 10939: Ophthalmic instruments-Slit-Lamp microscopes" | System complies with Standard ISO 10939. |
| Light Hazard Protection: | |
| - Compliance with "ISO 15004-2:2007 Ophthalmic instruments -- Fundamental requirements and test methods -- Part 2: Light hazard protection" | System complies with ISO 15004-2:2007. |
| - Classification for light hazard | Classified into Group 2 instruments. Exposure at maximum intensity will exceed safety guidelines after 83 seconds (caution indicated on label). |
| Operational Characteristics (Comparison to Predicate): | |
| - Flammability of materials near light source | None (Same as predicate) |
| - Maximum temperature of parts (operator/patient accessible) | Operator: Eyepiece, Grip, Slit width control ring all 35 °C. Patient: Forehead rest 35 °C. (Same as predicate) |
| - Brightness controls (Maximal Illumination) | ≥250000 Lux (Predicate: ≥30000 Lux. Proposed device is significantly different but justified by light hazard test.) |
| - Slit Width | 0.1mm, 0.2mm, 0.8mm, 1mm, 5mm, 12mm (Predicate: 0 to 12mm continuously adjustable. Differences deemed not significant.) |
| - Slit Length | 1mm, 5mm, 8mm, 12mm (Predicate: 0.2mm, 1mm, 2mm, 12mm. Differences deemed not significant.) |
| - Radial movement of slit light illumination relative to microscope axis | Horizontal ±60° (Predicate: Horizontal ±30°. Proposed device is better.) |
| - Stereo angle | 13° (Same as predicate) |
| - Light sources | LED (Same as predicate; deemed safe with IR/UV filter) |
| - Pupil-distance | 49-75mm (Predicate: 50-75mm. Differences deemed not significant.) |
| - Eyepiece | 12.5X (Predicate: 10X, 16X. Differences deemed not significant.) |
| - Objective | 1X (Same as predicate) |
| - Total magnifications | LS-1A: 10X; LS-1B: 10X, 16X (Predicate: 10X, 16X (Optional). Differences deemed not significant.) |
| - Filter | Neutral density, Red-free, Cobalt blue (Predicate: Cobalt blue, Red-free, Color Temperature Compensation. Differences deemed not significant.) |
| - Working distance | 100mm (10X), 80mm (16X) (Predicate: 60mm. Differences deemed not significant.) |
| - Power | 7.4V/680mAh, AA Battery (Predicate: 7.4V 2200mA Li Battery, Rechargeable. Differences deemed not significant as both conform to ISO 10939.) |
| - Working time | 4 hours (Predicate: 2.5 hours. Proposed device is better.) |
| - Net Weight | 890g (with battery) (Predicate: 900g. Differences deemed not significant.) |
Study Information:
-
Sample size used for the test set and the data provenance:
- The document does not explicitly state a "test set" in the context of clinical data for performance evaluation. The performance data provided is primarily from bench testing and compliance with standardized tests (Biocompatibility, Electrical safety, EMC, Performance testing according to ISO 10939, Light Hazard Protection according to ISO 15004-2).
- For biocompatibility, the tests were conducted with specific samples (e.g., "Chinrest pat and Forehead band extract," "rabbitskin," "guinea pig," "L-929 cells").
- The data provenance is not specified beyond the tests being conducted on the "Sunkingdom Slit Lamp LS-1A, LS-1B" and under recognized FDA standards and Good Laboratory Practice (21 CFR 58). This suggests the tests were carried out by the manufacturer or a contracted lab. There's no indication of retrospective or prospective human clinical data.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as the study did not involve human expert interpretation of clinical cases to establish ground truth. The "ground truth" for the performance claims were objective measurements and adherence to technical specifications and international standards.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable, as no human adjudication of clinical cases was performed.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study was done. This device is a traditional medical instrument (slit lamp biomicroscope), not an AI-powered diagnostic tool.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable, as this is a medical device for direct human use in eye examination, not an algorithm.
-
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- The ground truth is established by objective measurements against engineering specifications and compliance with international standards for medical device safety and performance (e.g., ISO 10993 for biocompatibility, IEC 60601 series for electrical safety/EMC, ISO 10939 for slit lamps, ISO 15004-2 for light hazard).
-
The sample size for the training set:
- Not applicable. This device does not use an AI component requiring a training set.
-
How the ground truth for the training set was established:
- Not applicable. This device does not use an AI component or a training set.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 22, 2018
Chongqing Sunkingdom Medical Instrument Co Ltd Joy Tse Sales Director 1012, Block A of China Resource Center No.55 of XieJiaWan,JiuLongPo Chongqing, 400050 Cn
Re: K182306
Trade/Device Name: Sunkingdom Slit Lamp Regulation Number: 21 CFR 886.1850 Regulation Name: AC-Powered Slitlamp Biomicroscope Regulatory Class: Class II Product Code: HJO Dated: August 24, 2018 Received: August 24, 2018
Dear Joy Tse:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely yours.
Bradley S. Cunningham -A
for Malvina B. Evdelman, M.D. Director Division of Ophthalmic and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K182306
Device Name Sunkingdom Slit Lamp LS-1A,LS-1B
Indications for Use (Describe)
The Chongqing Sunkingdom Slit Lamp LS-1A, LS-1B are AC --- powered slit lamp Biomicroscopes 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 affects the structural properties of the anterior eye segment.
| Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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510(k) Summary
This summary of 510k safety and effectiveness is being submitted in according with 21CFR part 807.92
| Submitter(510K Owner): | Chongqing Sunkingdom Medical Instrument Co.,Ltd35-2,YingTian GuangDian GongGu,CaiJiaGangIndustry Zone,BeiBei District,ChongQing,ChinaContact Person: Joy TsePhone: +86 23 68643990Fax: +86 23 68102793E-Mail: joy.t@cqsunkingdom.comRegistration # 3010610157 |
|---|---|
| Official correspondent: | Amado DiazJr6095 N.W. 167 Street,Unit D-9,Hialeah, FL 33015Phone: 305-542-7556Fax:(305)863-0122 |
| Dateof Preparation: | August 24,2018 |
| Proprietary Name: | Sunkingdom Slit LampLS-1A,LS-1B |
| Common or usualname: | AC- Powered Slit-Lamp Biomicroscope |
| ClassificationName: | Biomicroscope, Slit-Lamp,AC-Powered21 C.F.R. 886.1850Class II |
| Productcode: | HJO |
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Predicate Devices:
| Predicate devices | Suzhou 66 Vision Tech YZ Slit Lamp YZ3 |
|---|---|
| Manufacturer | Suzhou 66 Vision-Tech Co.,Ltd |
| K# | K131711 |
Device Description:
Sunkingdom slit lamp LS-1A, LS-1B are an AC-powered slit lamp 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 affects the structural properties of the anterior eye segment.
An AC-powered Slit lamp Bio-microscope 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.
Components: The optical body, movement mechanism, illumination system, portable handle, power supply.
Intended Use/ Indication for use
The AC-powered slit lamp bio-microscope 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 affects the structural properties of the anterior eye segment.
Substantial Equivalence
The Portable slitlamp LS-1A,LS-1B is substantially equivalent to the predicate device Suzhou 66VisionTech YZ Slit LampYZ3 as they have the exactly same indication for use, which is to examine the anterior eye segment for diagnostic purposes. Also Sunkingdom slit lamp use similar technology and perform similar functions to provide the physician with the necessary information to make a diagnosis, the slit lamp project a beam of light into the patient's eve through a control diaphragm.
The Slit Lamp LS-1A,LS-1B has the same intended use and indications for use, technological characteristics, and principles of operation as the previously cleared predicates.
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Comparation Table
| Descriptiveinformation | Proposed Device | Predicate Device | Description of differencesand discussion |
|---|---|---|---|
| Manufacturer | ChongqingSunkingdomMedical InstrumentCo.,Ltd | 66 Vision TechCo.,Ltd. | |
| 510(k)Number | K131711 | ||
| Proprietary orModel Name | LS-1A,LS-1BPortable Slit Lampmicroscope | YZ3 Portable SlitLamp microscope | |
| Indications forUse | The SunkingdomPortable Slit lamp isan AC-powerslitlamp biomicroscopeintended for use ineye examination ofthe anterior eyesegment, from thecornea epithelium tothe posteriorcapsule. It is used toaid in the diagnosisof diseases ortrauma whichaffects the structuralproperties of theanterior eyesegment. | Same | |
| Flammabilityof materialsnear the lightsource | None | None | |
| Descriprtiveinformation | Proposed Device | Predicate Device | Description of differencesand discussion |
| Maximumtemperature ofparts of thedevice held bythe operator oraccessible tothe patient | Maximumtemperature of partsof the device heldby the operator:-Eyepiece:35 °-Grip:35 °-Slit width controlring:35 °Maximumtemperature of partsof the deviceaccessible to thepatient:Forehead rest 35 ° | Same | |
| Brightnesscontrols | MaximalIllumination≥250000Lx | MaximalIllumination≥30000Lx | The brightness controls are by avariable continuouspotentiometer. It allow the userto select a convenientbrightness to achieve optimumresults.The maximum brightness issignificantly different.The predicate device YZ3 hasa maximumbrightness≥30000LUX, the LS-1Aand LS-1B has a maximumbrightness of 250000LUX.For light hazard, test accordingto ISO 15004-2 is proceed, LS-1A and LS-1B are classifiedinto Group 2 intruments.Exposure to light from thisinstrument when operated atmaximum intensity will exceedthe safety guideline after 83seconds. Manufacturer willindicate this caution on label toremind the practice.LS-1A and LS-1B are conformto the relevant electronic andoptical safety standard of ANSIAAMI IEC60601-1-2,AAMIES60601-1:2005, ISO15004-2, and ISO10939.It's approved to be safe, and noissues of safety andeffectiveness. |
| Descriptiveinformation | Proposed Device | Predicate Device | Description of differencesand discussion |
| Slit Width | 0.1mm,0.2mm,0.8mm, 1mm, 5mm,12mm | 0 to 12mmcontinuouslyadjustable | LS-1A & LS-1B from SKhave 6 step of the slitwidth, the maximum slitwidth is 12mm which issame like predict device of66 vision, all other stepwhich is in the width areaof 66 vision.The differences are notsignificant, There are nonew issues of safety andeffectiveness. |
| Slit Length | 1mm,5mm,8mm,12mm | 0.2mm,1mm,2mm,12mm | The differences are notsignificant. As theillumination field is definedby a circular aperture, theslit length cannot be largerthan the slit width. Themaximum slit length of SKMED is also the same aspredict device which is12mm.There are no new issues ofsafety and effectiveness. |
| Radialmovement ofthe slit lightilluminationrelative to themicroscopeaxis | Horizontal±60 ° | Horizontal ±30 ° | The predicate device hashorizontal±30 °Whereas,the LS-1A,LS-1B slit lamphas horizontal±60.When examing the conea,the proposed device havelarger angle to ensure theclear view of coneaformed.SK MED's parameter isbetter than the predicatedevice.There are no new issues ofsafety and effectiveness. |
| Stereo angle | 13 ° | Same | The differences are notsignificantThere are no new issues ofsafety and effectiveness. |
| Descriprtiveinformation | Proposed Device | Predicate Device | Description of differencesand discussion |
| Light sources | LED | LED | LED is a safety lightsource, it already filter theIR and UV light which isharmful to eye.Image: Spectral Power Distribution CharacteristicsBoth SK MED andpredicate device are usingLED light source.The differences are notsignificant , There are nonew issues of safety andeffectiveness. |
| Pupil-distance | 49-75mm | 50 to 75mm | The differences are notsignificant, There are nonew issues of safety andeffectiveness. |
| Eye piece | 12.5X | 10X,16X | The differences are notsignificant, There are nonew issues of safety andeffectiveness. |
| Objective | 1X | Same | There are no new issues ofsafety and effectiveness. |
| Totalmagnifications | LS-1A:10XLS-1B:10X,16X | 10X,16X(Optional) | The differences are notsignificant.There are nonew issues of safety andeffectiveness. |
| Filter | Neutral density,red-free, cobalt blue | Cobalt blue, Red-free,Color TemperatureCompensation | The differences are notsignificant. There are nonew issues of safety andeffectiveness. |
| Descriprtiveinformation | Proposed Device | Predicate Device | Description of differencesand discussion |
| OpticalRadiationEmissions | Conform to ISO15004-2 | Conform to ISO15004-2 | The predict device andLS-1A & LS-1B are allconform toISO15004-2.The differences are notsignificant.There are no new issues ofsafety and effectiveness. |
| Workingdistance | 100mm(10X),80mm(16X) | 60mm | The differences are notsignificant. There are nonew issues of safety andeffectiveness. |
| Power | 7.4V/680mAh,AABattery | 7.4V 2200mA LiBattery, Rechargeable | The differences are notsignificant.Predicate device has 7.4V2200mA Li Battery,whereas the slit lampLS-1A,LS-1B has7.4V/680mAh,AA Battery.As all slit lamps conform tothe relevant standard ISO10939. There are no newissues of safety andeffectiveness. |
| Working time | 4 hours | 2.5 hours | The proposed deviceworking longer thanpredicate device which is abetter performance. Thedifferences are notsignificant.There are no new issues ofsafety and effectiveness. |
| Net Weight | 890g(with battery) | 900g | There are no new issues ofsafety and effectiveness. |
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| Model | LS-1B | LS-1A | |
|---|---|---|---|
| Microsc opeType | Type | Binocular Convergence Biomicroscope | |
| Eyepiece | 13° | ||
| Magnification | 10X, 16X | 10X | |
| Work distance | 16X:80mm,10X:100mm | 10X:100mm | |
| Pupil distance | 49mm~75mm | ||
| Diopter | -7D~+7D | ||
| Slit width | 0.1mm,0.2mm,0.8mm,1mm,5mm,12mm | ||
| Slit length | 1mm,5mm,8mm,12mm | ||
| Illumina tionSystem | Slit angle | Horizontal ±60° | |
| Filters | Neutral density,Redfree(green),Cobalt blue | ||
| Light source | LED | ||
| Brightness | ≥250000Lux | ||
| PowerSupply | LEDwork voltage | DC7.4V,680mAh | |
| Battery | 7.4V/680mAh,AA Battery | ||
| Slit lamp LS-1A,LS-1B are equivalent to each other, the devices all have the same indications | |||
| for use and the devices are equivalent to the predicate devices. |
Difference between each model
Performance Data
The following perfomance data were provided in support of the substantial quivalencedetermination.
Biocompatibilitytesting
The biocompatibility evaluation for the Sunkingdom Slit Lamp LS-1A,LS-1B wasconductedinaccordancewiththe21CFR58GoodLaboratoryPracticefor Nonclinical Laboratory Studies,ISO 10993-10:2010 "Biological Evaluation of Medical Devices-Part 10:Tests For Irritation And Skin Sensitization",Jul,26,2016,and Standard ISO 10993-5:2009 "Biological Evaluation of Medical Devices-Part 5:Tests For In Vitro Cytotoxicity", Dec,23,2016,as recognized by FDA.The portable slit lamp of testing included the followingtests:
- . VitroCytotoxicity
- . SkinIrritation
- SkinSensitization
The test article Chinrest pat and Forhead band extract did not show potential toxicitytoL-929cells.TheextractofappliedsampleChinrestpatandForehead banddidnotinduceskinirritationinrabbitskin.ChinrestpatandForheadband extract showed no significant evidence of causing skin sensitization in the guineapig.
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The material of forhead rest bracket of Portable Slit Lamp LS-1A/LS-1B which is in contact with patient is the same material as the material of test report.
Electrical safety and electromagnetic compatibility(EMC)
Electrical safety and EMC testing were conducted on the Sunkingdom Slit Lamp LS-1A, LS-1B. The system complies with the "ANSI AAMI IEC60601-1-2:2007/(R)2012,Jun,27,2016, standard for EMC and the ANSI AAMIES60601-1:2005/(R)2012AndA1:2012,Jul,09,2014,standardforsafety.
Performance testing
The performance testing was conducted on the Sunkingdom Slit Lamp LS-1A.LS-1B. consisting of the optical body, movement mechanism, illumination system and portable handle. The system complies with Standard ISO 10939 "Ophthalmic instruments-Slit-Lamp microscopes",Dec,19,2017, in accordance with Slit lamp guidance - VI References.
Light Hazard Protection
The light hazard protection for Ophthalmic Instruments was conducted on the Sunkingdom Slit Lamp LS-1A, LS-1B. The system complies with the ISO 15004-2:2007 Ophthalmic instruments -- Fundamental requirements and test methods --Part 2: Light hazard protection .
It is classified into Group 2 instruments according to the requirement of ISO 15004-2, The light emitted from this instrument is potentially hazardous. The longer the duration of exposure, the greater the risk of ocular damage. Exposure to light from this instrument when operated at maximum intensity will exceed the safety guideline after 83 seconds.
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 Portable slit lamp LS-1A,LS-1B are substantially equivalent and as safe and effective as the predicate device 66 Vision Tech Co.,Ltd YZ3 Portable Slit Lamp.
§ 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.