(268 days)
No
The device description and performance studies focus on basic power delivery, mechanical, electrical, and software validation for controlling standard dental instruments, with no mention of AI or ML capabilities.
No
The device provides power and serves as a base for other dental devices and instruments, but it does not directly perform a therapeutic function on a patient. It is a support system for therapeutic devices.
No
The device is described as a base that supplies power (air, water, vacuum, low voltage electrical power) to other dental devices and accessories, such as handpieces, instruments, and intra-oral cameras. Its primary function is to enable these other devices, not to diagnose.
No
The device description clearly outlines a physical unit with components for delivering air, water, electrical power, and vacuum, along with various hardware parts like a Doctor's Unit, Assistant's Unit, Cuspidor, mount arms, foot control, and junction box. While it mentions software validation, the core function and description are of a hardware-based dental operative unit.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for supplying power and serving as a base for other dental devices and accessories used by professional dental practitioners in a dental operatory. This describes a device used during a dental procedure, not for testing samples outside the body to diagnose a condition.
- Device Description: The description details how the unit provides air, water, electrical power, and vacuum to handpieces and instruments. This aligns with the function of a dental delivery system used for treatment, not for in vitro testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.
The device is a piece of dental equipment used to facilitate dental procedures, not to perform diagnostic tests on samples.
N/A
Intended Use / Indications for Use
The Spirit Dental Operative Units are intended to supply power to and serve as a base for other dental devices and accessories by providing air. water, vacuum and low voltage electrical power to hand held dental instruments. The Spirit Dental Operative Units are intended for use by professional dental practitioners in providing treatment in a dental operatory.
Product codes (comma separated list FDA assigned to the subject device)
EIA
Device Description
The Spirit Dental Operative Units serves as a base that includes components to deliver air, water, electrical power, and vacuum to dental handpieces, instruments, and accessories. The controls are contained in a Doctor's Unit, an Assistant's Unit, and a Cuspidor. Additional parts include mount arms, foot control, and a junction box that houses a power supply and air/water regulators. Various Handpieces and accessories can be added to the Spirit Dental Operative Unit which Pelton & Crane does not manufacture but does provide a means to connect them into the Sprit Dental Operative Units. These include, but not limited to, pneumatic handpieces, electric motors with handpieces, scalers, intra-oral cameras, curing lights, air/water syringes, SE and HVE vacuum instruments.
The Spirit Dental Operative Units are available in three different series (3000, 2000, and 1000) which are offered in various mounting configurations such as chair mount traditional delivery, chair ellipse delivery, cabinet mount delivery, wall mount delivery, cart delivery, flexible work station delivery, and mobile work station delivery. The differences between the three series and mounting configurations are cosmetic in nature such as size/shape of the delivery head, mount arms, and instrument hangers. All critical components within the Spirit Dental Operative units are common.
The delivery head is mounted to an arm mechanism for support and positioning of the delivery head around the patient. The types of mounting configurations include chair, cabinet, wall, cart, and floor mounts. Depending on mounting configuration, a junction box or utility center provides housing for connections to the facility air, water, vacuum, and power sources, regulators for air and water, and transformers for optional integrated accessories. Regulated air and water, source vacuum, and power tubing and cables are routed through the mounting arms to the delivery head where the utilities are distributed to the individual dental instruments with a handpiece control system contained in the delivery head.
The handpiece control system is a pneumatic control system that distributes utilities to desired instruments that acts as "selected" instrument once removed from the respective instrument holder. The foot control activates the handpiece drive air, coolant air and water. Individual handpiece drive air and water flow adjustments are individually controlled by the operator via the control block and control valves. The delivery head is provided with master on-off switch to control air/water flow.
An optional foot control may be integrated into the system that acts as an intermediate manual user control for air and water activation to a selected instrument.
Suction instruments are not activated with the handpiece control system as the vacuum supply is manually controlled by the user with a flow control valve integrated in the instrument body. Also, air and water syringes are not activated with the handpiece control system as air and water flow is manually opened and closed with button actuated valves integrated into the syringe body.
Some handpieces may be power driven. The delivery head is provided with low voltage power to drive these handpieces. For some single and dual electrically driven motor configurations, the delivery system utilizes components and software from the device manufacturer, Kaltenbach & Voigt GMBH which was approved under 510(k) K103027 (ELECTROtorque TLC) and K080677 (COMFORTronic 4894 and COMFORTdrive 200XDA Handpiece) to control features and functionality of the motor(s). The Spirit dental operative unit provides the means to internally mount and house the electrically driven motor control and handpiece components and the utilities needed for operation (air, water, and low-voltage electricity). For the dual electrically driven motor configuration, an air activated switching board is used to drive the motors from one control board.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional dental practitioners in providing treatment in a dental operatory.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Electrical, mechanical, and performance testing according to standard AAMI ES60601-1, was performed, and EMC testing was conducted in accordance with standard IEC 60601-1-2. The Pelton & Crane Spirit dental operative units passed all tests.
Additional testing was conducted to ensure the technological characteristic differences between the Pelton & Crane Spirit Dental Operative Units and the predicate device, the Midmark Elevance Dental Delivery Unit (K120239), did not present any new concerns about substantial equivalence. The Pelton & Crane Spirit Dental Operative Unit passed all tests. Hence, the device demonstrates substantial equivalence.
Substantial equivalence of the Spirit dental operative unit with dual electric motors has been successfully evaluated with passing results via validation and verification testing.
Electrical Safety and EMC testing on the Spirit dental operative unit with dual electric motors was performed to confirm conformance.
Biocompatibility evaluation was conducted on patient contacting parts and found to be in conformance with ISO 10993-1.
Additionally, the Spirit Dental operative unit software was successfully validated to confirm the performance of the device per AMMI ANSI IEC 62304:2006 Medical Device Software. Software for the dual electric motors from the device manufacturer, Kaltenbach & Voiqt GMBH has already been cleared under 510(k) K103027 (ELECTROtorque TLC) and K080677 (COMFORTronic 4894 and COMFORTdrive 200XDA Handpiece). These two 510(k) devices are being integrated into the Spirit Dental Operative units and are listed in the optional accessories (devices) table. The testing also considered FDA Software Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem depicts a stylized human figure in profile, with three overlapping heads suggesting a sense of community or interconnectedness. The figure is rendered in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 18, 2015
Pelton & Crane Mr. Frank Ray Regulatory Affairs Manager 11727 Fruehauf Dr. Charlotte, North Carolina 28273
Re: K143696
Trade/Device Name: Spirit Regulation Number: 21 CFR 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: August 19, 2015 Received: August 21, 2015
Dear Mr. Rav:
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.
1
Page 2 - Mr. Frank Ray
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K143696
Device Name
Spirit
Indications for Use (Describe)
The Spirit Dental Operative Units are intended to supply power to and serve as a base for other dental devices and accessories by providing air. water, vacuum and low voltage electrical power to hand held dental instruments. The Spirit Dental Operative Units are intended for use by professional dental practitioners in providing treatment in a dental operatory.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the text "Pelton & Crane" in a stylized, cursive font. The text is a dark blue color, and the ampersand symbol is used between the two names. The font is elegant and flowing, giving the text a sophisticated appearance. The overall impression is that of a professional logo or brand name.
Section V - 510(k) Summary for Spirit
-
- Submitter Information: Pelton & Crane 11727 Fruehauf Drive Charlotte, NC 28273
| Contact Person: | Frank Ray |
|---|---|
| Telephone Number: | (704) 587-7227 |
| Fax Number: | (704) 587-7250 |
Date Prepared: December 19, 2014
-
- Device Name:
- Proprietary Name: ●
- SPIRIT Common Name: ● Dental Delivery Unit
- Classification Name: Unit, Operative Dental
- CFR Number: ●
- 872.6640 Device Class:
- I ● Product Code: EIA ●
-
- Predicate Device:
- ELEVANCE (K120239) Proprietary Name: ●
I
- . Common Name: Dental Delivery Unit
- Classification Name: Unit, Operative Dental ●
- CFR Number: 872.6640 ●
- Device Class: ●
- EIA . Product Code:
-
- Description of Device:
The Spirit Dental Operative Units serves as a base that includes components to deliver air, water, electrical power, and vacuum to dental handpieces, instruments, and accessories. The controls are contained in a Doctor's Unit, an Assistant's Unit, and a Cuspidor. Additional parts include mount arms, foot control, and a junction box that houses a power supply and air/water regulators. Various Handpieces and accessories can be added to the Spirit Dental Operative Unit which Pelton & Crane does not manufacture but does provide a means to connect them into the Sprit Dental Operative Units. These include, but not limited to, pneumatic handpieces,
4
electric motors with handpieces, scalers, intra-oral cameras, curing lights, air/water syringes, SE and HVE vacuum instruments.
Per the Guidance for Industry and FDA Staff; Bundling Multiple Devices or Multiple Indications in a Single Submission, dated June 22, 2007, Pelton & Crane is bundling the Spirit dental operative unit models listed in Table 5.1 below as the models do not differ significantly in purpose, design, materials, energy source, function or any other feature related to substantial equivalence. The device description and intended use are identical for all configuration models listed in Table 5.1 below. The differences between the three series and mounting configurations are cosmetic in nature such as size/shape of the delivery head, mount arms, and instrument hangers. All critical components within the Spirit Dental Operative units are common.
The Spirit Dental Operative Units are available in three different series (3000, 2000, and 1000) which are offered in various mounting configurations such as chair mount traditional delivery, chair ellipse delivery, cabinet mount delivery, wall mount delivery, cart delivery, flexible work station delivery, and mobile work station delivery. The various mounting configurations for the Spirit dental operative units are illustrated within the Use and Care manuals. The differences between the Spirit 3000, 2000, and 1000 series are the Spirit 3000 series are the premier level dental operative units, the Spirit 2000 series are the mid-level dental operative units, and the Spirit 1000 series are the economy level dental operative units.
| Series | Model | Description | Integrated Dual Electric Motors (previously cleared under K103027 and K080677) |
|---|---|---|---|
| 3000 | SDW 30 | Spirit 3000 Wall Delivery | Optional |
| 3000 | SDC 30 | Spirit 3000 Cabinet Delivery | Optional |
| 3000 | SCT30 | Spirit 3000 OTP w/Traditional Delivery | Optional |
| 3000 | SET30 | Spirit 3000 OTP Ellipse w/Traditional Delivery | Optional |
| 3000 | FWS30 | Spirit 3000 Flexible Work Station (Renaissance) | Optional |
| 2000 | SCT20 | Spirit 2000 OTP w/Traditional Delivery | N/A |
| 2000 | SET20 | Spirit 2000 OTP Ellipse w/Traditional Delivery | N/A |
| 2000 | SDW-D | Spirit 2000 Wall Delivery | N/A |
| 2000 | SDC-D | Spirit 2000 Cabinet Delivery | N/A |
| 2000 | MWS-C | Spirit 2500 Mobile Work Station | N/A |
| 2000 | FWS-C | Spirit 2000 Flexible Work Station (Centennial) | N/A |
| 2000 | FCT-C | Spirit 2000 Flexible Cart | N/A |
| 1000 | SCT15 | Spirit 1500 OTP w/Traditional Delivery | N/A |
| 1000 | SET15 | Spirit 1500 OTP Ellipse w/Traditional Delivery | N/A |
| 1000 | SCE15 | Spirit 1500 OTP w/Euro Delivery | N/A |
| 1000 | SEE15 | Spirit 1500 OTP Ellipse w/Euro Delivery | N/A |
| 1000 | CRT15 | Spirit 1500 Cart | N/A |
| 1000 | SDWD15 | Spirit 1500 Wall Delivery | N/A |
| 1000 | SDCD15 | Spirit 1500 Cabinet Delivery | N/A |
| 1000 | CD15 | Spirit 1500 Cabinet Delivery | N/A |
| 1000 | SCT17 | Spirit 1700 OTP w/Traditional Delivery | N/A |
| 1000 | SET17 | Spirit 1700 OTP Ellipse w/Traditional Delivery | N/A |
| 1000 | RE15 | Spirit Cuspidor/PMU/Assistant's Unit | N/A |
Table 5.1
5
| 2000 | N/A | ||
|---|---|---|---|
| 1000 | AV | Spirit Cabinet Mount Assistant's Unit | |
| 3000 | N/A | ||
| 2000 | |||
| 1000 | RM | Spirit Rear Chair Mount Assistant's Unit | |
| 1000 | EX 15 | Spirit Executive Dental Unit | N/A |
The Pelton & Crane Spirit dental operative units can also be equipped with available and already marketed Pelton & Crane products. These products include:
- Tip-A-Dilly Tip ●
- Tip-A-Dilly ●
- Tip - A
- Tip - D
- Tip E ●
- Tip F ● .
- Tip C
Optional accessories (devices) from other manufacturers that are integrated/attached to the Spirit dental operative units have already been cleared by the FDA.
Principle of Operation:
The delivery head is mounted to an arm mechanism for support and positioning of the delivery head around the patient. The types of mounting configurations include chair, cabinet, wall, cart, and floor mounts as illustrated within the Use and Care manuals. Depending on mounting configuration, a junction box or utility center provides housing for connections to the facility air, water, vacuum, and power sources, regulators for air and water, and transformers for optional integrated accessories. Regulated air and water, source vacuum, and power tubing and cables are routed through the mounting arms to the delivery head where the utilities are distributed to the individual dental instruments with a handpiece control system contained in the delivery head.
The handpiece control system is a pneumatic control system that distributes utilities to desired instruments that acts as "selected" instrument once removed from the respective instrument holder. The foot control activates the handpiece drive air, coolant air and water. Individual handpiece drive air and water flow adjustments are individually controlled by the operator via the control block and control valves. The delivery head is provided with master on-off switch to control air/water flow.
An optional foot control may be integrated into the system that acts as an intermediate manual user control for air and water activation to a selected instrument.
Suction instruments are not activated with the handpiece control system as the vacuum supply is manually controlled by the user with a flow control valve integrated in the instrument body. Also, air and water syringes are not activated with the handpiece control system as air and water flow is manually opened and closed with button actuated valves integrated into the syringe body.
6
Some handpieces may be power driven. The delivery head is provided with low voltage power to drive these handpieces. For some single and dual electrically driven motor configurations, the delivery system utilizes components and software from the device manufacturer, Kaltenbach & Voigt GMBH which was approved under 510(k) K103027 (ELECTROtorque TLC) and K080677 (COMFORTronic 4894 and COMFORTdrive 200XDA Handpiece) to control features and functionality of the motor(s). The Spirit dental operative unit provides the means to internally mount and house the electrically driven motor control and handpiece components and the utilities needed for operation (air, water, and low-voltage electricity). For the dual electrically driven motor configuration, an air activated switching board is used to drive the motors from one control board.
-
- Indications for Use:
The Spirit dental operative units are intended to supply power to and serve as a base for other dental devices and accessories by providing air, water, vacuum and low voltage electrical power to hand held dental instruments. The Spirit dental operative units are intended for use by professional dental practitioners in providing treatment to dental patients in a dental operatory.
- Indications for Use:
6. Description of Substantial Equivalence: Technological Characteristics:
The Spirit Dental Operative Units, manufactured by Pelton & Crane, is being modified to have the ability to control two (2) electric motors. The Spirit Dental Operative Units has the same intended use as previously cleared Elevance Dental Operative Unit (K120239), manufactured by Midmark Corporation, but does have different technological characteristics. However, these different technological characteristics do not raise new concerns of substantial equivalence. The performance data and testing of the Pelton & Crane Spirit Dental Operative Units demonstrates substantial equivalence to the Midmark Elevance Dental Delivery Unit. Hence, the device is substantially equivalent.
Table 5.2
| Feature | Midmark Elevance Dental
Delivery Unit (K120239) | Pelton & Crane Spirit Dental
Operative Unit |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Midmark instrument delivery
systems are intended to
provide dental professionals
with air, water, and suction
along with low-voltage
electricity to operate dental
handpieces, syringes, and
accessories during dental
examinations and treatments. | The Spirit Dental Operative Units
are intended to supply power to
and serve as a base for other
dental devices and accessories by
providing air, water, vacuum and
low voltage electrical power to
hand held dental instruments. The
Spirit Dental Operative Units are
intended for use by professional
dental practitioners in providing
treatment to dental patients in a
dental operatory. |
| Regulation Number | 21 CFR 872.6640 | Same |
| Requlation Title | Dental operative unit and
accessories | Same |
7
| Feature | Midmark Elevance Dental
Delivery Unit (K120239) | Pelton & Crane Spirit Dental
Operative Unit | | |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------|------------------------------------------------|--|--|
| Regulation Class | I | Same | | |
| Product Code | EIA | Same | | |
| Device Classifications
(Electrical) | Class I, Type B applied part,
IPX0, continuous operation | Same | | |
| | Utilities and Standards | | | |
| Transportation /
Storage temperature | 23°F to 100°F | -68°F to 122°F | | |
| Relative humidity
range | 10% to 90% | Same | | |
| Operating temperature
range | 59°F to 95°F | 68°F to 76°F | | |
| Air supply pressure
range | 80-100 psi | 80-105 psi | | |
| Air/oil separator | Gauze | Same | | |
| Water supply pressure
range | 30-50 psi | 40-80 psi | | |
| Isolated water bottle
system | Optional | Same | | |
| Standards | EN 60601-1-2:2007 Part 1-2 | EN 60601-1-2:2007 Part 1-2 | | |
| | EN 61000-3-:2006+A1:2009
+A2:2009 Part 3-2 | EN 61000-3-2:2006+A1:2009
+A2:2009 Part 3-2 | | |
| | IEC 60601-1 Part 1 | ES 60601 -1 Part 1 | | |
| | ISO 7494-1:2004 | ISO 7494-1:20041 | | |
| | ISO 7494-2:2003 | ISO 7494-2:20031 | | |
| | User / Service Interface | | | |
| Number of user
accounts | Three | One2 | | |
| Setting display | LED screen | LCD screen2 | | |
| Screen navigation | Navigation arrows | Same | | |
| Software updates | Via external USB port | Via internal 10-pin port2 | | |
| Error tracking | Offered | Same | | |
| Built-in diagnostics | Offered | Same | | |
| Hand Held Devices | | | | |
| Optional accessories | Air/water syringe
Saliva ejector
HVE
Up to 2 micro motors
Scaler
Camera
Curing light | Same | | |
8
| Feature | Midmark Elevance Dental
Delivery Unit (K120239) | Pelton & Crane Spirit Dental
Operative Unit |
|------------------------------------------------------|----------------------------------------------------|------------------------------------------------|
| Accessory connection | Pneumatic motor | |
| Accessory connection | Integrated | Same |
| Number of hand piece
locations | 4-6 | Same |
| Hand piece control
system | Kink Valve | Valve block |
| Syringe water flow
control | Adjustable | Same |
| Syringe air flow
control | Adjustable | Same |
| Coolant air flow
control | Adjustable | Same |
| Hand piece air and
water bypass | Offered | Not applicable3 |
| Number of hand piece
presets | Five | Six2 |
| Remote hand piece
activation with water
toggle | Via foot control | Same |
| Positioning | | |
| Delivery unit head
positioning | Flex arm | Same |
| Flex arm brake release | Integrated | Same |
| Maximum load on flex
arm mounted units | 10 lbs. | Same4 |
| Additional Features | | |
| Endodontic capability | Offered | Same |
| Hand piece flush | Standard feature | Same |
| Air/Water quick
connect ports | Offered | Same |
| Light control | Offered | Same |
| Tray options | Three | One2 |
| Unit configurations for
dominant hand | Left/Right | Same |
1 The Spirit Dental Operative Unit meets all requirements found in ISO 7494-1 and ISO 7494-2
² These differences do not affect substantial equivalence as they are only differences in marketing features between the proposed device and the predicate device
3 Hand piece air and water by pass is not necessary for the Spirit Dental Operative Unit as both air and water are pneumatically controlled rather than electronically controlled.
4 In the Spirit Dental Operative Unit manuals, it states: "The maximum weight capacity for the control head is 3 lbs." However, this only notes the limit of additional weight that can be placed on the control head. When considering the load of the control head itself and included accessories, the maximum load on the flex arm is 10 lbs.
9
Performance Data:
Electrical, mechanical, and performance testing according to standard AAMI ES60601-1, was performed, and EMC testing was conducted in accordance with standard IEC 60601-1-2. The Pelton & Crane Spirit dental operative units passed all tests. In addition to testing governed by requlatory standards, additional testing was conducted to ensure the technological characteristic differences between the Pelton & Crane Spirit Dental Operative Units and the predicate device, the Midmark Elevance Dental Delivery Unit (K120239), did not present any new concerns about substantial equivalence. The Pelton & Crane Spirit Dental Operative Unit passed all tests. Hence, the device demonstrates substantial equivalence.
Substantial equivalence of the Spirit dental operative unit with dual electric motors has been successfully evaluated with passing results via validation and verification testing.
Electrical Safety and EMC testing on the Spirit dental operative unit with dual electric motors was performed to confirm conformance.
Biocompatibility evaluation was conducted on patient contacting parts and found to be in conformance with ISO 10993-1.
Additionally, the Spirit Dental operative unit software was successfully validated to confirm the performance of the device per AMMI ANSI IEC 62304:2006 Medical Device Software. Software for the dual electric motors from the device manufacturer, Kaltenbach & Voiqt GMBH has already been cleared under 510(k) K103027 (ELECTROtorque TLC) and K080677 (COMFORTronic 4894 and COMFORTdrive 200XDA Handpiece). These two 510(k) devices are being integrated into the Spirit Dental Operative units and are listed in the optional accessories (devices) table. The testing also considered FDA Software Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
Clinical Performance Data:
Clinical data is not needed to characterize performance and establish substantial equivalence. The non-clinical test data characterize all performance aspects of the device based on well-established scientific and engineering principles. Clinical testing has not been conducted on this product.
Conclusion as to Substantial Equivalence:
Based on the comparison of intended use, technological characteristics, and performance data, the minor differences between the Spirit dental operative units with dual electric motors, and the predicate device, ELEVANCE Delivery Unit (K120239), do not raise new concerns regarding substantial equivalence for the proposed indications of use. Pelton & Crane concludes that the Spirit dental operative units are substantially equivalent to the predicate device.