(293 days)
LS OIL is a lubricant and is intended for use to lubricate dental handpieces.
LS OIL is a lubricant intended for use with dental handpieces. It is comprised of the same paraffin oil and oiliness improver (fatty acid ester) as the previouslycleared LS SPRAY reference device. LS OIL is used after clinical use of dental handpieces before sterilization. It is directly added to the devices from its nozzle by dropping into inside of the handpieces. The LS OIL goes through the hollow of the devices and lubricates their components (gears, bearing, and rotating parts).
I am sorry, but the provided text does not contain the information needed to answer your request about acceptance criteria and a study proving device performance as it relates to an AI/ML device.
The document is a 510(k) Premarket Notification for a dental handpiece lubricant called "LS OIL." It discusses:
- Device Name: LS OIL
- Intended Use: Lubricating dental handpieces
- Comparison to a Predicate Device and Reference Device: PANA-SPRAY and LS SPRAY, respectively.
- Technological Characteristics: Paraffin oil and fatty acid ester composition.
- Non-clinical Testing: Viscosity, solubility, density, color, performance testing (sound/vibration after simulated use), shelf life, and biocompatibility (cytotoxicity, irritation, sensitization).
- No Clinical Testing.
There is no mention of:
- AI or machine learning algorithms.
- Acceptance criteria for an AI/ML device's performance (e.g., sensitivity, specificity, AUC).
- A test set, training set, or data provenance for an AI/ML model.
- Experts establishing ground truth for AI/ML performance.
- Adjudication methods.
- Multi-reader multi-case (MRMC) studies.
- Standalone AI performance.
- Effect size of human reader improvement with AI assistance.
- Ground truth types in the context of diagnostic AI.
Therefore, I cannot extract the requested information as it is not present in the provided text.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.
J. Mortia USA, Inc. % Keith Barritt Official Correspondent Fish & Richardson P.C. 1000 Maine Avenue S.W., Suite 1000 Washington, District of Columbia 20024
October 15, 2018
Re: K173920
Trade/Device Name: LS OIL Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: Class I Product Code: EKX Dated: September 11, 2018 Received: September 12, 2018
Dear Keith Barritt:
This letter corrects our substantially equivalent letter of October 11, 2018.
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/cfpmp/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.
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
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 mediation-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.
Mary S. Runner -S3
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental 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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
| 510(k) Number ( if known ) | |
|---|---|
| ----------------------------------- | -- |
Device Name
LS OIL
Indications for Use (Describe)
LS OIL is a lubricant and is intended for use to lubricate dental handpieces.
| 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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K173920 510(k) SUMMARY J. Morita USA, Inc. LS OIL Dental Handpiece Lubricant
The following information is provided pursuant to 21 CFR 807.92.
21 CFR 807.92(a)(1): Submitter's Name and Address
(i) 510(k) Submitter
J. Morita USA, Inc. 9 Mason Irvine, CA 92618
(ii) 510(k) Submitter Contact
Keith A. Barritt Fish & Richardson P.C. 1000 Maine Avenue S.W., Suite 1000 Washington, DC 20024 Phone: (202) 783-5070 Facsimile: (202) 783-2331 Email: barritt@fr.com
(iii) Preparation Date
October 9, 2018
21 CFR 807.92(a)(2): Name of Device
Trade or Proprietary Name: LS OIL Common Name: dental handpiece lubricant Classification Name: dental handpiece and accessories Product Code: EKX Regulation: 21 C.F.R. 872.4200
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21 CFR 807.92(a)(3): Predicate Device
LS OIL is substantially equivalent to NSK America Corp.'s PANA-SPRAY dental device lubricant (K#052700). J. Morita's own LS SPRAY lubricant, cleared most recently as part of the Tri Auto ZX2 device under K#170275, is a reference device.
The LS SPRAY reference device contains only LS OIL plus liquid petroleum gas as a propellant. The liquid petroleum gas volatilizes immediately after spraying and has no effect on the efficacy of the LS OIL in the LS SPRAY.
The chart below provides a comparison of LS OIL, the predicate device PANA-SPRAY, and the reference device LS SPRAY.
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| Comparison between the LS OIL and Predicate and Reference Device | |||||
|---|---|---|---|---|---|
| -- | -- | -- | -- | ------------------------------------------------------------------ | -- |
| Product name | LS OIL | Primary predicatePANA SPRAY | Reference deviceLS SPRAY | Similarities/Differences |
|---|---|---|---|---|
| Manufacturer | J. MORITA MFG.CORP. | NSK America Corp. | J. MORITA MFG.CORP. | |
| 510(k) Number | pending | K052700 | K170275 | - |
| Intended use | Lubricant for dentalhandpieces | Lubricant fordentalhandpieces | Lubricant fordentalhandpieces | Intended use for theLS OIL is same asthe primarypredicate, PANASPRAY. |
| Indications for use | LS OIL is a lubricantand is intended foruse to lubricatedental handpieces. | PANA SPRAY is alubricant and isintended for use tolubricate the dentalhandpieces andmedical surgicalhandpieces. | As the LS SPRAYwas included as anaccessory to the TriAuto ZX2 underK170275, there is noseparate indicationsfor use statement forit; however, it is forlubricating dentalhandpieces, exactlythe same as for LSOIL. | The Indications for Usefor the LS OIL arenearly identical to andwithin the indicationsfor the primarypredicate device, butwithout reference to"medical surgicalhandpieces." |
| Patient population | All patients indentistry | Unknown | All patients indentistry | Patient population forthe LS OIL is same asthe reference device. |
| Anatomical sites | Limited durationcontact with intactmucosal tissue | Unknown | Limited durationcontact with intactmucosal tissue | Anatomical sites forthe LS OIL are same asthe reference device. |
| Use environment | Dental clinic,Universityhospital and otherclinical settings | Unknown | Dental clinic,University hospitaland other clinicalsettings | Use environment forthe LS OIL are same asthe reference device. |
| Energy used and/ordelivered | None | None | None | - |
| Product name | LS OIL | Primary predicatePANA SPRAY | Reference deviceLS SPRAY | Similarities/Differences |
| Design/Materials | Oil and oilinessimprover (fatty acidester) for use as alubricant. | Ester lubricant,additive, plus lightpetroleum gas as apropellant. | Oil and oilinessimprover (fatty acidester) for use as alubricant, plus lightpetroleum gas as apropellant. | Conclusion:The LS OIL is thenearly identical to theprimary predicate,PANA SPRAY.Comparison betweenPANA SPRAY and LSSPRAY:The primary predicate,PANA SPRAY,contains ester lubricantplus light petroleumgas as a propellant,which is identical to LSSPRAY.Comparison betweenLS OIL and LSSPRAY:The difference betweenthe LS OIL andreference device, LSSPRAY, is that the LSOIL does not containlight petroleum gas. |
| Performance | No abnormalitiesobserved in gearrotation or contraangle | Unknown | No abnormalitiesobserved in gearrotation or contraangle | Performance isfunctionally identicalto LS SPRAY asdemonstrated byperformance testing. |
| Sterility | LS OIL does notcome sterilized andis not intended to besterilized separatelyprior to use. | PANA SPRAY doesnot come sterilizedand is not intended tobe sterilizedseparately prior touse. | LS SPRAY does notcome sterilized and isnot intended to besterilized separatelyprior to use. | |
| For use with | High & Low speedhandpieces. | Unknown | High & Low speedhandpieces. |
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21 CFR 807.92(a)(4): Device Description
LS OIL is a lubricant intended for use with dental handpieces. It is comprised of the same paraffin oil and oiliness improver (fatty acid ester) as the previouslycleared LS SPRAY reference device.
The device is depicted below:
Image /page/7/Figure/3 description: The image shows a diagram of a bottle with a nozzle and cap. The bottle has a volume of 60ml. The diagram includes measurements, with the total length of the bottle and nozzle being 135±10 units and the diameter of the bottle being φ35±5 units.
LS OIL is used after clinical use of dental handpieces before sterilization. It is directly added to the devices from its nozzle by dropping into inside of the handpieces. The LS OIL goes through the hollow of the devices and lubricates their components (gears, bearing, and rotating parts).
21 CFR 807.92(a)(5): Indications for Use
LS OIL is a lubricant and is intended for use to lubricate the dental handpieces.
21 CFR 807.92(a)(6): Technological Characteristics
LS OIL has the same basic technological characteristics in terms of design, material, and chemical composition as LS SPRAY, except LS OIL does not have a light petroleum gas propellant as does LS SPRAY and thus the concentration of the oil in LS OIL is greater than the pre-application concentration of the oil in LS SPRAY, though the propellant in LS SPRAY dissipates upon application. LS OIL does not have an energy source.
21 CFR 807.92(b)(1): Non-clinical Testing
Testing was conducted which shows that LS OIL has the same physical properties as LS SPRAY as follows:
Viscosity: 12 mm2/s at 15°C Solubility in Water: insoluble Density: 0.86 g/cm3 at 40°C Color: colorless
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Performance testing was conducted to compare LS OIL to LS SPRAY by applying the equivalent of six years of operation and autoclaving of contra angles with the two devices, which demonstrated no abnormalities in sound or vibration.
Shelf life was demonstrated pursuant to ISO 14457 and a comparison to the predicate device and a comparison of a stored and new sample of LS OIL regarding appearance, density, viscosity, water solubility, and infrared absorption.
Substantial biocompatibility testing was also conducted in accordance with ISO 10993 as follows:
Cytotoxicity (ISO 10993-5:2009(E), irritation (ISO 10993-10:2010(E), and sensitization (ISO 10993-10:2010(E)) studies of both the LS OIL and the reference device LS SPRAY.
Risk management principles of ISO 14971 were also followed in the development of LS OIL.
21 CFR 807.92(b)(2): Clinical Testing
There were no clinical tests performed for LS OIL.
21 CFR 807.92(b)(3): Conclusions from Testing
Based on the non-clinical testing conducted of the physical properties and the biocompatibility testing of LS OIL as described above, J. Morita USA, Inc. concludes that LS OIL is substantially equivalent to the PANA SPRAY predicate device identified above.
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.