(57 days)
The LUSTRE ClearSkin Renew Pro Facewear Mask is an over-the-counter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris of the face. The LUSTRE ClearSkin Renew Pro Facewear Mask is an over-the-counter device intended to emit energy in the red and Near Infra-red spectrum and is intended for the use in the treatment of full-face wrinkles.
LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001) is an over-the-counter light emitting diode (LED) device that emits energy for use in dermatology for the treatment of acne and wrinkles. The device has anti-wrinkle mode and anti-acne, the former is to emit red light (630nm) and infrared light (830nm) to treat wrinkles, the latter is to emit red light (630nm) and blue light (415nm) to treat mild to moderate acne. There is only one button on the outside of the mask, which have the functions of controlling startup, shutdown, and switching modes. The treatment lasts for 10 minutes by default, and after the treatment, the device will automatically shut down if it is not operated within five minutes. The product contents include an LED mask, Adjustable Velcro Straps, Removable Eye Protection, USB-C cable, cloth bag and user manual, the function of the Removable Eye Protection is to protect the eyes from the harm of led light.
The provided text is a 510(k) Summary for the LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001). It outlines the device's characteristics and compares it to a predicate device (Shani Darden LED light therapy mask, K214103) to establish substantial equivalence.
Based on the provided document, here's an analysis regarding acceptance criteria and study information:
Key Takeaway from the Document:
The submission explicitly states: "No clinical study is included in this submission." This means that no clinical performance data for the device's effectiveness in treating acne or wrinkles has been provided or evaluated as part of this 510(k) clearance process. Substantial equivalence for this device is primarily based on its technical specifications, intended use, and comparison to a predicate device, along with non-clinical (electrical safety, EMC, biocompatibility) testing.
Therefore, the following points address what can be extracted from the document and what cannot.
1. A table of acceptance criteria and the reported device performance:
Since no clinical study was performed for this 510(k) submission, there are no "acceptance criteria" for clinical performance data or "reported device performance" in terms of efficacy on patients. The acceptance criteria here would primarily relate to the non-clinical tests demonstrating safety and technical equivalence to the predicate device.
| Acceptance Criteria (related to technical equivalence/safety) | Reported Device Performance (based on non-clinical testing and comparison) |
|---|---|
| Equivalence in Design Principle, Intended Use, Indications for Use, Functions, Material, and Applicable Standards to Predicate Device (K214103) - Wavelengths: Red (630±5nm), Blue (415±5nm), NIR (830±5nm) - Intensity (e.g., Blue, Red, NIR mW/cm²) - Total Intensity (e.g., Blue/Red, Red/NIR mW/cm²) - Dose (J/cm²) - Treatment time (10 minutes) - Treatment protocol (Acne: 4x weekly, 6 weeks; Wrinkles: 5x weekly, 6 weeks) - Software Control (timer for treatment duration) - Intended Location of Use (Face) - Energy Type (LEDs) | Substantial Equivalence Demonstrated to Predicate Device (K214103) - Design Principle, Intended Use, Indications for Use, Functions, Material, and Applicable Standards: "The subject device is very similar in design principle, intended use, indications for use, functions, material and the applicable standards." - Wavelengths: Matches predicate (Red: 630±5nm, Blue: 415±5nm, NIF: 830±5nm vs. Predicate Red: 630nm±10nm, Blue: 415nm±10nm, NIF: 830nm±10nm). - Intensity: Blue: 26 mw/cm² (Predicate: 28 mw/cm²); Red: 16 mw/cm² (Predicate: 16 mw/cm²); Red (for wrinkles): 18 mw/cm² (Predicate: 18 mw/cm²); NIR: 12 mw/cm² (Predicate: 11 mw/cm²). - Total Intensity: Blue/Red: 42 mw/cm² (Predicate: 44 mw/cm²); Red/NIR: 30 mw/cm² (Predicate: 29 mw/cm²). - Dose: Blue: 15.6J/cm² (Predicate: 16.8J/cm²); Red: 9.6J/cm² (Predicate: 9.6J/cm²); Red (for wrinkles): 10.8J/cm² (Predicate: 11J/cm²); NIR: 7.2J/cm² (Predicate: 7J/cm²). - Treatment Time: Same (10 minutes). - Treatment Protocol: Same (Acne: 4x weekly, 6 weeks; Wrinkles: 5x weekly, 6 weeks). - Software Control: Same (device uses a timer and software to control treatment duration). - Intended Location of Use: Same (Face). - Energy Type: Same (Light emitting diodes). - Minor Differences Justification: Despite slight differences in intensity and dose, "the treatment parameters of the subject device are very close to the predicate device and both of them meet the requirements of the IEC 60601-2-57. So, the minor difference... will not raise any safety or effectiveness issues." |
| Electrical Safety Standards Compliance: - ANSI AAMI ES60601-1 - IEC 60601-1-11 - IEC 60601-1-2 - IEC 60601-2-57 - IEC 62133-2 - IEC 62471 | Compliance Demonstrated: "LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001) has been evaluated the safety and performance by lab bench testing as following: [Lists all standards]... and the test results are compliance with safety standards' requirements." |
| Biocompatibility Standards Compliance: - ISO 10993-5 (Cytotoxicity) - ISO 10993-10 (Sensitization) - ISO 10993-23 (Irritation) | Compliance Demonstrated: "The component materials for Adjustable Velcro Straps, Removable Eye Protection, shell (Inner surface), and shell (Outer surface) of the subject device are identical to the corresponding component materials of the K2217752. So, the subject device can comply with the biocompatibility requirements..." |
Since the submission states "No clinical study is included in this submission," the following points cannot be answered from the provided text:
2. Sample sized used for the test set and the data provenance: Not applicable, no clinical test set for performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, no clinical test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, no clinical test set.
5. 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: Not applicable. This device is a light therapy mask, not an AI diagnostic/imaging device that would involve human readers or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable, as no clinical study was conducted using patients for efficacy. Ground truth for the safety aspects would be the testing protocols of the listed electrical and biocompatibility standards.
8. The sample size for the training set: Not applicable, as this is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established: Not applicable.
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March 15, 2023
Light Tree Ventures Europe B.V. Alain Dijkstra CEO Laan van Ypenburg 108, 2497 GC, The Hague, The Netherlands Hague, Netherlands 2500 Netherlands
Re: K230124
Trade/Device Name: LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001) Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: OHS, OLP Dated: January 12, 2023 Received: January 17, 2023
Dear Alain Dijkstra:
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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Image /page/1/Picture/5 description: The image shows the name "Jianting Wang -S" in a large, sans-serif font. The text is black and appears to be centered on a white background. The letters are clear and easy to read, with consistent spacing between the words and characters.
Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K230124
Device Name
LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001)
Indications for Use (Describe)
The LUSTRE ClearSkin Renew Pro Facewear Mask is an over-the-counter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris of the face. The LUSTRE ClearSkin Renew Pro Facewear Mask is an over-the-counter device intended to emit energy in the red and Near Infra-red spectrum and is intended for the use in the treatment of full-face wrinkles.
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) | X |
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510(k) Summary of K230124
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
Date of the summary prepared: Feb. 9, 2023 1.
Submitter's Information 2.
Company Name: Light Tree Ventures Europe B.V. Establishment Registration Number: 3017422691 Address: Laan van Ypenburg 108, 2497 GC, The Hague, The Netherlands Phone: +86-135-10378748 Fax No: 0755-25024651 Contact Person (including title): Alain Dijkstra (Manager) Email: regulation@kaiyanmedical.com
Manufacturer
Company Name: Shenzhen Kaiyan Medical Equipment Co., Ltd Establishment Registration Number: 3011644607 Address: Building#3 and Building#5, 40th of Fuxin Street, Huaide Community Fuyong Town, Baoan District, Shenzhen, Guangdong 518103, China Phone: 0755-82129361 Fax No: 0755-25024651 Contact Person (including title): Alain Dijkstra (CEO) Email: alaindijkstra@kaiyanmedical.com
Distributor
Distributor Name: Lusre Skin Ltd Address: Alba Innovation Centre, Alba Campus, Livingston Scotland, UK, Eh547GA
Application Correspondent:
Contact Person: Mr. Alain Dijkstra Company Name: Light Tree Ventures Europe B.V. Address: Laan van Ypenburg 108, 2497 GC, The Haque, The Netherlands Tel: +86 755 82129361 Email: regulation@kaiyanmedical.com
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Subject Device Information 3.
Type of 510(k): Traditional Classification Name: Over-The-Counter Powered Light Based Laser For Acne (OLP), Light Based Over-The Counter Wrinkle Reduction (OHS) Trade Name: LUSTRE ClearSkin Renew Pro Facewear Mask Model Name: PR4001 Review Panel: General & Plastic Surgery Product Code: OHS, OLP Regulation Number: 21 CFR 878.4810 Regulatory Class: II
4. Predicate Device Information
Sponsor: Harpar Grace International Trade Name: Shani Darden LED light therapy mask Classification Name: Over-The-Counter Powered Light Based Laser For Acne (OLP), Light Based Over-The Counter Wrinkle Reduction (OHS) 510(k) Number: K214103 Review Panel: General & Plastic Surgery Product Code: OHS, OLP Regulation Number: 21 CFR 878.4810 Regulation Class: II
Device Description 5.
LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001) is an over-the-counter light emitting diode (LED) device that emits energy for use in dermatology for the treatment of acne and wrinkles. The device has anti-wrinkle mode and anti-acne, the former is to emit red light (630nm) and infrared light (830nm) to treat wrinkles, the latter is to emit red light (630nm) and blue light (415nm) to treat mild to moderate acne. There is only one button on the outside of the mask, which have the functions of controlling startup, shutdown, and switching modes. The treatment lasts for 10 minutes by default, and after the treatment, the device will automatically shut down if it is not operated within five minutes. The product contents include an LED mask, Adjustable Velcro Straps, Removable Eye Protection, USB-C cable, cloth bag and user manual, the function of the Removable Eye Protection is to protect the eyes from the harm of led light.
6. Intended Use / Indications for Use
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The LUSTRE ClearSkin Renew Pro Facewear Mask is an over-the-counter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris of the face.
The LUSTRE ClearSkin Renew Pro Facewear Mask is an over-the-counter device intended to emit energy in the red and Near Infra-red spectrum and is intended for the use in the treatment of full-face wrinkles.
7. Comparison to predicate device
Compare with predicate device, the subject device is very similar in design principle, intended use, indications for use, functions, material and the applicable standards. The differences between subject device and predicate device do not raise and new questions of safety or effectiveness.
| Elements ofComparison | Subject Device | Predicate Device | Remark |
|---|---|---|---|
| Company | LIGHT TREE VENTURESEUROPE B.V. | Harpar GraceInternational | -- |
| Trade Name | LUSTRE ClearSkin RenewPro Facewear Mask | Shani Darden LED lighttherapy mask | -- |
| 510(k) Number | K230124 | K214103 | -- |
| Product Code | OHS, OLP | OHS, OLP | Same |
| RegulationNumber | 878.4810Laser surgical instrument foruse in general andplastic surgery and indermatology | 878.4810Laser surgicalinstrument for use ingeneral andplastic surgery and indermatology | Same |
| FDA DeviceClassification | Class II | Class II | Same |
| Use | Over the Counter | Over the Counter | Same |
| Intended useandIndications | The LUSTRE ClearSkinRenew Pro Facewear Mask isan over-the-counter deviceintended to emit energy in thered and blue region of the lightspectrum, specificallyindicated to treat mild tomoderate acne vulgaris of the | The Shani Darden LEDlight therapy mask is anover-the-counter deviceintended to emit energyin the red and blueregion of the lightspectrum, specificallyindicated to treat mild to | Same |
| face. The LUSTRE ClearSkinRenew Pro Facewear Mask isan over-the-counter deviceintended to emit energy in thered and Near Infra-redspectrum and is intended forthe use in the treatment of full-face wrinkles. | moderate acne vulgarisof the face. The ShaniDarden LED lighttherapy mask is anover-the-counter deviceintended to emit energyin the red and NearInfra-red spectrum andis intended for the usein the treatment of full-face wrinkles. | ||
| IntendedLocation of Use | Face | Face | Same |
| Energy Type | Light emitting diodes | Light emitting diodes | Same |
| Wavelengths | Red: 630±5nmBlue: 415±5nmNIF: 830±5nm | Red: 630nm±10nmBlue: 415nm±10nmNIF: 830nm±10nm | Same |
| Intensity(mW/cm²) | Blue: 26 mw/cm²Red: 16 mw/cm²Red: 18 mw/cm²NIR: 12 mw/cm² | Blue: 28 mw/cm²Red: 16 mw/cm²Red: 18 mw/cm²NIR: 11 mw/cm² | SimilarNote 1 |
| Total Intensity(mW/cm²) | Blue/Red 42 mw/cm²Red/NIR 30 mw/cm² | Blue/Red 44 mw/cm²Red/NIR 29 mw/cm² | SimilarNote 1 |
| Dose | Blue 15.6J/cm²Red 9.6J/cm²Red 10.8J/cm²NIR 7.2J/cm² | Blue 16.8J/cm²Red 9.6J/cm²Red 11J/cm²NIR 7J/cm² | SimilarNote 1 |
| Total Numberof LEDs | 80pcs | No publicly available | DifferentNote 3 |
| LEDDistribution | 630nm+415nm (Double wick):30pcs630nm+830nm (Double wick):50pcs | No publicly available | DifferentNote 3 |
| Treatment time | 10 minutes | 10 minutes | Same |
| Treatment | Acne: 4 x weekly, 6 weeks | Acne: 4 x weekly, 6 | Same |
| protocol | weeks | ||
| Treatmentprotocol | Wrinkles: 5 x weekly, 6 weeks | Wrinkles: 5 x weekly, 6 weeks | Same |
| SoftwareControlled | Device uses a timer andsoftware to control treatmentduration | Device uses a timerand software to controltreatment duration | Same |
| Power supply | Lithium battery: 3.7V,1500mAh 5.55WhAdapter Input: 100-240Va.c.,50/60HzAdapter Output: 5Vd.c, 1A | Electrical Input to poweradaptor: 100v-240v.50/60Hz. Rated at 0.7A.Electrical Output frompower adaptor: 12V, 1A | DifferentNote 2 |
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Comparison in Detail(s):
Note 1: Though the "Intensity (mW/cm²)", "Total Intensity (mW/cm²)" and "Dose" of the subject device are slightly different from the predicate device, the treatment parameters of the subject device are very close to the predicate device and both of them meet the requirements of the IEC 60601-2-57. So, the minor difference between the subject device and the predicate device will not raise any safety or effectiveness issues.
Note 2: The "Power supply" of the subject device is using a Lithium-lon battery and the predicate device is using a power adaptor, both the subject device and the predicate conduct the safety test according to the IEC 60601 series standards, and the test results are compliance with safety standards' requirements. So, the difference between the subject device and the predicate device will not raise any safety or effectiveness issues.
Note 3: Although there is no publicly available of the "Total Number of LEDs" and the "LED Distribution" for the predicate device, the subject device has the same / similar treatment parameters in "Intensity", "Total Intensity", "Dose" and "Treatment Time" with the predicate device. So, the difference between the subject device and the predicate device will not raise any safety or effectiveness issues.
8. Non-clinical test Summary
8.1 Summary of Electrical safety and EMC
LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001) has been evaluated the safety and performance by lab bench testing as following:
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| StandardNo. | Standards Title | Version | Date |
|---|---|---|---|
| ANSI AAMIES60601-1 | Medical electrical equipment - Part 1: Generalrequirements for basic safety and essentialperformance (IEC 60601-1:2005, MOD) | 2005/(R)2012 & A1:2012,C1:2009/(R)2012 &A2:2010/(R)2012 (Cons.Text) [Incl. AMD2:2021] | 05/30/2022 |
| IEC 60601-1-11 | Medical Electrical Equipment - Part 1-11:General requirements for basic safety andessential performance -- Collateral Standard:Requirements for medical electrical equipmentand medical electrical equipment and medicalelectrical systems used in the home healthcareenvironment (IEC 60601-1-11:2015 MOD) | Edition 2.1 2020-07CONSOLIDATEDVERSION | 12/21/2020 |
| IEC 60601-1-2 | Medical electrical equipment - Part 1-2: Generalrequirements for basic safety and essentialperformance - Collateral Standard:Electromagnetic disturbances - Requirementsand tests | Edition 4.1 2020-09CONSOLIDATEDVERSION | 12/21/2020 |
| IEC 60601-2-57 | Medical Electrical Equipment - Part 2-57:Particular requirements for the basic safety andessential performance of non-laser light sourceequipment intended for therapeutic, diagnostic,monitoring and cosmetic/aesthetic use | Edition 1.0 2011-01 | 03/16/2012 |
| IEC 62133-2 | Secondary cells and batteries containing alkalineor other non-acid electrolytes - Safetyrequirements for portable sealed secondarycells, and for batteries made from them, for usein portable applications - Part 2: Lithium systems | Edition 1.0 2017-02 | 12/23/2019 |
| IEC 62471 | Photobiological safety of lamps and lampsystems | First edition 2006-07 | 08/20/2012 |
8.2 Summary of Biocompatibility
The component materials for Adjustable Velcro Straps, Removable Eye Protection, shell (Inner surface), and shell (Outer surface) of the subject device are identical to the corresponding component materials of the K2217752. So, the subject device can comply with the biocompatibility requirements of ISO 10993-5(Cytotoxicity), ISO 10993-10(Sensitization), and ISO 10993-23(Irritation).
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9. Clinical test Summary
No clinical study is included in this submission.
Final Conclusion:
The subject device is as safe, as effective, and performs as well as or better than the legally marketed predicated devices K214103.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.