PROPEL device

K150392 · Propel Orthodontics, LLC · DZJ · Sep 18, 2015 · Dental

Device Facts

• Record ID: K150392
• Device Name: PROPEL device
• Applicant: Propel Orthodontics, LLC
• Product Code: DZJ · Dental
• Decision Date: Sep 18, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4120
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PROPEL device is indicated for manually drilling holes in tissue and bone for orthodontic and dental operative procedures including initiation holes for drill bits, implants, screws, plates and other orthodontic appliances.

Device Story

The PROPEL device is a manual bone-cutting instrument used in dental and orthodontic procedures. It features a stainless steel drill tip and a plastic handle with a retractable sleeve that locks to specific depths (3, 5, or 7mm) to prevent over-penetration. The device includes a battery-operated red LED that illuminates when the drill tip reaches the pre-set depth, providing visual feedback to the clinician. It is a single-use, sterile device. It is operated manually by a clinician (dentist/orthodontist) to create initiation holes for orthodontic appliances or implants. The device does not use a motor and cannot be attached to powered drivers. The LED signal assists the clinician in achieving precise depth control, potentially improving procedural accuracy and patient safety during bone-cutting tasks.

Clinical Evidence

Bench testing only. Testing included biocompatibility (ISO 10993-1, ISO 7405), sterilization validation (ISO 11137), shelf-life (ASTM F1980-07), electrical safety/EMC (IEC 60601-1, IEC 60601-1-2), and performance testing (bit reliability, deflection resistance, depth repeatability, LED reliability). Clinical evidence is limited to a cited literature article (Alikhani et al., 2013) documenting the device's ability to create holes through gum tissue into alveolar bone.

Technological Characteristics

Manual bone drill with stainless steel drill bit. Body materials: ABS and polycarbonate. Features a retractable sleeve for depth control (3, 5, 7mm) and a battery-powered LED depth indicator. Single-use, provided sterile. Complies with ISO 10993-1, ISO 7405, ISO 11137, ASTM F1980-07, IEC 60601-1, and IEC 60601-1-2.

Indications for Use

Indicated for patients requiring manual drilling of holes in tissue and bone for orthodontic and dental procedures, including initiation holes for drill bits, implants, screws, plates, and other orthodontic appliances.

Regulatory Classification

Identification

A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.

Predicate Devices

• Synthes 90° Screwdriver (K082649)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 18, 2015

Propel Orthodontics, LLC c/o Mr. Craig J. Coombs Coombs Medical Device Consulting, Inc. 1193 Sherman Street Alameda. California 94501

Re: K150392

Trade/Device Name: PROPEL Device Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: II Product Code: DZJ Dated: August 18, 2015 Received: August 19, 2015

Dear Mr. Coombs:

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.

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Page 2 - Mr. Craig J. Coombs

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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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

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# Indications for Use

510(k) Number (if known) K150392

Device Name PROPEL Device

#### Indications for Use (Describe)

The PROPEL device is indicated for manually drilling holes in tissue and bone for orthodontic and dental operative procedures including initiation holes for drill bits, implants, screws, plates and other orthodontic appliances.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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Image /page/3/Picture/0 description: The image shows the logo for Propel Orthodontics. The word "PROPEL" is written in a large, sans-serif font in blue. Below the word "PROPEL" is the word "ORTHODONTICS" in a smaller, sans-serif font, also in blue. Above the word "PROPEL" is a series of blue arcs that form a semi-circle.

| A. Device Information: | |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Category | Comments |
| Sponsor: | Propel Orthodontics, LLC.<br>384 South Abbott Avenue<br>Milpitas, CA 95035<br>Company Contact: Bryce Way<br>Chief Executive Officer<br>Tel: [phone]<br>Email: [e-mail] |
| Correspondent Contact<br>Information: | Craig Coombs<br>Coombs Medical Device Consulting<br>1193 Sherman Street<br>Alameda, CA 94501<br>Tel: [phone]<br>Fax: [phone] |
| Device Common Name: | Manual Bone Drill |
| Device Classification Number<br>& Name: | 21 CFR 872.4120<br>Bone Cutting Instrument and Accessories |
| Device Classification &<br>Product Code: | Class II,<br>DZJ |
| Device Proprietary Name: | PROPEL Device |

# Section 5: 510(k) Summary

#### Predicate Device Information:

| Predicate Device: | 90° Screwdriver |
|----------------------------------------------------|------------------------------------------------------------|
| Predicate Device Manufacturer: | Synthes |
| Predicate Device Common Name: | Manual Screwdriver & Bone Drill |
| Predicate Device Premarket Notification # | K082649 |
| Predicate Device Classification & Name: | 21 CFR 872.4120<br>Bone Cutting Instrument and Accessories |
| Predicate Device Classification &<br>Product Code: | Class II,<br>DZJ |

#### B. Date Summary Prepared

14 September 2015

#### C. Description of Device

The PROPEL Device is intended for use in dental operative procedures involving the preparation of tissue and bone. The PROPEL Device can be used manually as a bone cutting instrument in accordance with the FDA regulation 21 CFR Sec. 872.4120. It CANNOT be attached to any powered driver.

The PROPEL Device has a stainless steel drill tip that can be manually adjusted to the length needed for treatment or cutting depth. The plastic handle incorporates a retractable plastic tube

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Image /page/4/Picture/0 description: The image shows the logo for Propel Orthodontics. The word "PROPEL" is written in a large, sans-serif font in blue. Below it, the word "ORTHODONTICS" is written in a smaller, sans-serif font, also in blue. Above the word "PROPEL" is a semi-circular design made of several curved lines that get progressively shorter from left to right.

over the cutting drill instrument. This enables the drill tip to be locked into a specific depth at 3. 5. or 7mm, thus preventing the drill tip from penetrating the bone bevond the targeted depth when used during orthodontic and dental operative procedures. The handle contains a red LED. operated by batteries. The LED is illuminated when the tip of the drill tip reaches the set depth. There is no motor in the device. The batteries are only for signaling when the prescribed depth has been achieved.

The device is provided sterile and is for single use only.

### D. Indications for Use

The PROPEL device is indicated for manually drilling holes in tissue and bone for orthodontic and dental operative procedures including initiation holes for drill bits, implants, screws, plates and other orthodontic appliances.

### E. Comparison to Predicate Device

The PROPEL device is substantially equivalent in intended use, technology, design, materials, and physician use as that found in the predicate Synthes 90° Screwdriver (K082649).

#### Product Code Equivalence

Both the subject PROPEL device and the predicate Synthes 90° Screwdriver have identical product codes: DZJ.

#### Indications for Use Equivalence

The subject device is indicated "for manually drilling holes in tissue and bone for orthodontic and dental operative procedures including initiation holes for drill bits, implants, screws, plates and other orthodontic appliances."

The predicate device is indicated "for the manual and powered pre-drilling and insertion of bone fixation screws in oral/maxillofacial surgery."

Both devices are bone-cutting devices for initiation holes for screws and other devices. The PROPEL device is a manual drill, whereas the predicate device is a powered drill. The subject device does not have a screwdriver function like the predicate. As a result, the subject device is indicated for a subset of performance features of the predicate device.

Because subject device features are a subset of the predicates, they do not raise new questions of safety or efficacy; they allow the conclusion of substantial equivalence between the Indications for Use.

#### Technological Equivalence

Both devices use rotating steel drill bits to cut holes in the bone of the upper or lower jaw. They differ in that the predicate device is a pneumatically powered drill, and the subject device is a manually powered drill.

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Image /page/5/Picture/0 description: The image shows the logo for Propel Orthodontics. The word "PROPEL" is written in a sans-serif font in blue. Below the word "PROPEL" is the word "ORTHODONTICS" in a smaller, gray sans-serif font. Above the word "PROPEL" is a series of blue lines that form an arc.

## Comparison of Technological Aspects of the Predicate and Application Devices

| Characteristic | Predicate Device:<br>Synthes 90° Screwdriver<br>K082649 | Subject Device:<br>Propel Orthodontics, LLC<br>PROPEL Device | How do differences, if any,<br>pertain to justification of<br>substantial equivalence? |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Operating<br>Principle | Hand-held powered drill or<br>hand-held manual<br>screwdriver | Hand-held manual drill | Difference in power mode<br>and lack of screwdriver<br>function in application device<br>does not raise new questions<br>of safety or efficacy. |
| Drill Angle | Drills holes or inserts screws<br>at a 90° angle from the handle | Drills holes an a 0° angle<br>(i.e. inline) with the handle | Difference in angle does not<br>does not raise new questions<br>of safety or efficacy for what<br>the application device is<br>indicated for |
| Powered or<br>Manual | Screwdriver intended to<br>operate manually:<br>Drill intended to operate<br>connected to a mechanical<br>power source compatible<br>with a Intra coupling<br>according to ISO 3964/EN 23<br>964 | Manually operated drill | Difference in power mode and<br>lack of screwdriver function<br>in application device does not<br>raise new questions of safety<br>or efficacy. |
| Direct drive or<br>geared? | 2:1 gearing ratio when<br>turning proximal end | No gearing, device is turned<br>by rotating proximal end | No clinical difference |
| Method for<br>creating holes | Stainless Steel Drill Bit | Stainless Steel Drill Bit | Clinically Identical |
| Interchangeable<br>drill bits | Yes | No. Drill bit built-in | Identical result as far as<br>creating holes |
| Characteristic | Predicate:<br>Synthes 90° Screwdriver<br>(K082649) | Subject Device:<br>Propel Orthodontics, LLC<br>PROPEL Device | How do differences, if any,<br>pertain to justification of<br>substantial equivalence? |
| Drill Bit OD | 1.0 - 2.4mm | 1.6mm | Size available in application<br>device is a subset of those<br>available in the predicate<br>device |
| Drill Bit Working<br>Length | 4 – 18mm | 3, 5, or 7 mm | The smaller length available<br>in the application device are<br>to serve the techniques<br>described in the Indication for<br>Use. Does not raise new<br>questions of safety or efficacy |
| Depth Stops | Yes, buy selecting the<br>appropriate length bit | Yes, by adjusting the depth<br>stop on the drill. | Clinically Identical |
| Types of<br>Screwdriver bits | Screwholder bits for screw<br>OD's of 1.5, 2.0 and 2.4mm | None. Device cannot be<br>converted into a screwdriver | Raises no questions of safety<br>or efficacy |
| Indicator of<br>Achievement of<br>Proper Depth | Head of drill in contact with<br>tissue | LED light comes on to<br>prevent unwarranted pressure<br>on tissue | Clinically Identical |
| Materials: Drill<br>Bits | Stainless Steel | Stainless Steel | Clinically Identical |
| Materials: device<br>body | Metallic | ABS and polycarbonate | Clinically Identical |
| Single Use? | Reusable | Single Use Only | Clinically Identical |
| Sterilization | Provided non-sterile, can be<br>resterilized | Provided sterile | Clinically Identical after<br>sterilization of predicate |

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Image /page/6/Picture/0 description: The image shows the logo for Propel Orthodontics. The word "PROPEL" is in a large, sans-serif font and is colored in a light blue. Above the word, there is a series of curved lines that are also light blue, creating an arc shape. Below the word "PROPEL", the word "ORTHODONTICS" is in a smaller, sans-serif font and is colored in gray.

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Image /page/7/Picture/0 description: The image shows the logo for Propel Orthodontics. The word "PROPEL" is in a large, blue, sans-serif font. Below it, the word "ORTHODONTICS" is in a smaller, gray, sans-serif font. Above the word "PROPEL" is a curved, dashed line that resembles an arch.

The subject and predicate devices use steel drill bits to cut holes in the bone of upper or lower jaw. The diameter of the holes created by the PROPEL device are a subset of those available from the predicate device. Both devices allow the user to control the depth of the hole. The predicate uses different length bits to achieve the intended depth. The subject device has a retractable sleeve around its drill bit that allows the physician to preselect the hole depth up to7mm. The predicate device drills holes at a 90° angle to the axis of the handle, whereas the subject device drills holes in-line with the axis of the handle.

Propel Orthodontics, LLC, concludes that the subject PROPEL device and the predicate Synthes 90° Screwdriver are substantially equivalent.

## F. Summary of Supporting Data

Biocompatibility data demonstrates that the PROPEL device is in compliance with ISO 10993-1: Biological evaluation of medical devices as described in ISO 7405: Dentistry — Evaluation of biocompatibility of medical devices used in dentistry.

Sterilization validation according to ISO 11137-1, -2, and -3 to ensure a SAL of 10th and shelf-life validation according to ASTM F1980-07 were conducted to validate the 2 year shelf-life of the PROPEL device.

Electrical safety testing demonstrates that the PROPEL device is in compliance with IEC 60601-1: Medical electrical equipment - Part 1: General reauirements for basic safety and essential performance and IEC 60601-1-2: Medical electrical equipment – Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests.

Bench testing has demonstrated that the PROPEL is in compliance with its product specifications, the expectations of the medical community and the product labeling. The following bench tests were conducted to demonstrate the Propel device's performance.

Bit reliability, including deflection resistance and hole depth repeatability Various tensile and compression tests of components Dial and bit depth reliability LED light reliability

A clinical literature article has documented that the PROPEL device can create holes through the gum tissue into alveolar bone in humans.

## G. 510(k) Summary Conclusion

In accordance with 21CFR807.92(b)(3), it can be concluded from the nonclinical testing and the clinical literature that the PROPEL device is as safe and as effective as the predicate device in the context of its Indications for Use and technological characteristics.

It can be concluded that the PROPEL device is substantially equivalent to the predicate Synthes 90° Screwdriver.

¹ Alikhani M, Rapis M, Soldan B, et al. Effect of micro-osteoperforations on the rate of tooth movement. Am J Orthod Dentofacial Orthop. 144:639-48; 2013.