(211 days)
The Elevance is intended for use by professional dental practitioners in providing treatment to dental patients in a dental operatory. The system is designed to deliver air, water, vacuum and low-voltage electricity to hand-held dental instruments.
The Elevance Delivery Unit includes components to deliver air, water, electrical power, and vacuum to dental handpieces and accessories. The controls are contained in a Doctor's Unit, an Assistant's Unit, and a Cuspidor. Additional parts include mount arms, console mount housing, and a junction box that houses a power supply and air/water regulators. Handpiece accessories or instruments can be added to the Unit, Midmark does not manufacture these accessories but, do provide means to connect them into the Unit. These include high and low speed pneumatic handpiece tubing, electric handpiece motors, scalers, intraoral cameras, curing lights, air/water syringe, and SE and HVE vacuum instruments.
Here's an analysis of the provided 510(k) summary regarding the Midmark Elevance dental delivery unit, focusing on acceptance criteria and supporting studies:
This 510(k) document is for a dental delivery unit, not an AI or imaging device. Therefore, the typical "acceptance criteria" and "study" framework involving performance metrics like sensitivity, specificity, F1-score, and ground truth established by experts is not applicable in the same way it would be for an AI-powered diagnostic tool.
Instead, the acceptance criteria for this type of device revolve around demonstrating substantial equivalence to a predicate device, primarily through engineering and regulatory compliance testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from 510(k) context) | Reported Device Performance (from 510(k) summary) |
|---|---|
| Technological Characteristics: | |
| - Indications for Use (consistent) | Found to have similar technological characteristics |
| - Function of Handpiece Accessories (consistent) | Found to have similar technological characteristics |
| - Performance of Handpiece Accessories (consistent) | Found to have similar technological characteristics |
| Safety and Efficacy: | |
| - No adverse impact from minor differences | Minor differences (centrally located controls, touchpad, proportional solenoid valves for air/water adjustment) determined to not have any impact on the safety or efficacy of the Elevance. |
| Non-Clinical Performance: | |
| - Design Verification (Qualification Run evaluation) | Conducted |
| - Electrical Safety (e.g., IEC 60601-1) | EN 60601-1-2:2007 Part 1-2 conducted; IEC 60601-1 Part 1 conducted |
| - Electromagnetic Compatibility (EMC) (e.g., EN 60601-1-2) | EN 60601-1-2:2007 Part 1-2 conducted |
| - Harmonic Current Emissions (e.g., EN 61000-3-2) | EN 61000-3-2:2006 +A1:2009 +A2:2009 Part 3-2 conducted |
| - Dental Equipment General Requirements (ISO 7494-1) | ISO 7494-1:2004 conducted |
| - Dental Equipment Water/Air Supply Requirements (ISO 7494-2) | ISO 7494-2:2003 conducted |
| Conclusion: | The data shows that the Elevance demonstrates substantial equivalence to the predicate as a Dental Delivery Unit. |
For the remainder of the questions, the answers will reflect the nature of device clearance (510(k) for a medical device that is not an AI/imaging diagnostic tool) rather than an AI performance study.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable in the context of an AI/imaging diagnostic test set. The "testing" here refers to engineering and regulatory compliance tests on the physical device itself, not a dataset of patient images or conditions. The number of units tested for electrical safety or functional verification is not specified in the summary but would be determined by internal quality and regulatory standards for device manufacturing.
- Data Provenance: Not applicable in the context of clinical data provenance. The "data" comes from the physical testing of the Elevance device, likely performed in a lab setting by Midmark Corporation or a contracted testing facility.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. "Ground truth" in the AI/imaging sense does not apply here. The "truth" for this device relies on its adherence to engineering specifications and international standards (like ISO and EN).
- Qualifications of Experts: Not applicable. The "experts" would be the engineers and technicians who designed, built, and tested the device, along with regulatory specialists who ensured compliance with standards. Their qualifications would be in engineering, quality assurance, and regulatory affairs, not clinical medical expertise for diagnostic ground truth.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no ambiguous result or expert discrepancy requiring adjudication for this type of device testing. Tests either pass or fail based on predetermined criteria outlined in the relevant standards (e.g., specific voltage limits, pressure ranges, insulation resistance).
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
- This is not applicable as the Elevance is a dental delivery unit, not an AI or imaging device that would involve human readers interpreting cases.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable as the Elevance is a dental delivery unit, not an algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not applicable in the AI/imaging diagnostic sense. The "ground truth" for this device is its adherence to established engineering specifications, safety standards (e.g., electrical, EMC), and functional performance criteria as defined by international standards (ISO, EN, IEC). It's about meeting an objective, defined physical state or performance level, rather than correlating with a clinical diagnosis or outcome.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. The Elevance is a physical medical device, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth Was Established: Not applicable. As there is no AI model or training set, there is no "ground truth" to establish for a training set.
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510(k) Special Midmark Corporation Elevance
| 6. 510(k) Summary or 510(k) Statement | |
|---|---|
| 510(k) SUMMARY | |
| AUG 2 4 2012 | |
| 510(k) Owner | Midmark Corporation60 Vista DriveVersailles, Ohio 45380-0286TEL: 937-526-8249 |
| Contact person | Robyn ScopisRegulatory Consultant to Midmark Corp.Regulatory Specialists, Inc.3722 Ave. SausalitoIrvine, CA 92606TEL: 949.422.3853FAX: 949.552.2821EMAIL: robyn@regulatoryspecialists.com |
| Date summary was prepared | August 22, 2012 |
| Name of device | Elevance |
| Common Name | Dental Delivery Unit |
| Classification Name | Unit, Operative Dental |
| Regulation | 872.6640 |
| Product Code | EIA |
| Unmodified Device | Midmark Procenter Instrument Delivery SystemK003090 |
| Description |
Description
The Elevance Delivery Unit includes components to deliver air, water, electrical power, and vacuum to dental handpieces and accessories. The controls are contained in a Doctor's Unit, an Assistant's Unit, and a Cuspidor. Additional parts include mount arms, console mount housing, and a junction box that houses a power supply and air/water regulators. Handpiece accessories or instruments can be added to the Unit, Midmark does not manufacture these accessories but, do provide means to connect them into the Unit. These include high and low speed pneumatic handpiece tubing, electric handpiece motors, scalers, intraoral cameras, curing lights, air/water syringe, and SE and HVE vacuum instruments.
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510(k) Special Midmark Corporation Elevance
Intended Use
The Midmark Elevance Instrument Delivery System is intended for use by professional dental practitioners in providing treatment to dental patients in a dental operatory. The system is designed to deliver air, water, vacuum and lowvoltage electricity to hand-held dental instruments.
Technological Characteristics
The Unmodified Device and the Elevance were compared in the following areas and found to have similar technological characteristics and to be · equivalent:
・ Indications for Use
Function of Handpiece Accessories Performance of Handpiece Accessories
The Unmodified Device and the Elevance were compared in the following areas and found to have minor different technological characteristics. The following differences have been determined to not have any impact on the safety or efficacy of the Elevance:
Centrally located controls for instruments Touch Pad on the Control Settings Air and Water Adjustment made via proportional solenoid valves
The following non-clinical performance tests were conducted:
Qualification Run evaluation to verify design EN 60601-1-2:2007 Part 1-2 EN 61000-3-2:2006 +A1:2009 +A2:2009 Part 3-2 EN 60601-1-2:2007 Part 1-2 IEC 60601-1 Part 1 ISO 7494-1:2004 ISO 7494-2:2003
Conclusions from non-clinical performance data
After performing non-clinical performance studies, the data shows that the Elevance demonstrates substantial equivalence to the predicate as a Dental Delivery Unit.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Midmark Corporation C/O Ms. Robyn Scopis Regulatory Consultant Regulatory Specialists, Incorporated 1801 Edgecliff Drive Fullerton, California 92831
Re: K120239
Trade/Device Name: Elevance Regulation Number: 21 CFR 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: August 15, 2012 Received: August 21, 2012
Dear Ms. Scopis:
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.
AUG 2 4 2012
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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); 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/ucm1115809.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.
Susan Runner
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Special Midmark Corporation Elevance
K12.02.32
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ TBD
Device Name: Elevance
Indications for Use:
The Elevance is intended for use by professional dental practitioners in providing treatment to dental patients in a dental operatory. The system is designed to deliver air, water, vacuum and low-voltage electricity to hand-held dental instruments.
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runne
Division Sign-Off) . livision of Anesthesiology, General Hospital nfection Control, Dental Devices
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10(k) Number: K120039
1 of 1 | Regulatory Specialists, Inc.
§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.