PROPEL Device

K172164 · Propel Orthodontics, LLC · DZJ · Jan 17, 2018 · Dental

Device Facts

• Record ID: K172164
• Device Name: PROPEL Device
• Applicant: Propel Orthodontics, LLC
• Product Code: DZJ · Dental
• Decision Date: Jan 17, 2018
• 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: (1) initiation holes for drill bits, implants, screws, plates, and other orthodontic appliances; and (2) for use as a tool to create micro-osteoperforations.

Device Story

Manual, single-use, hand-held bone drill; stainless steel (17-4) drill tip (1.6 mm OD); plastic (ABS/polycarbonate) handle with retractable tube for depth control (0, 3, 5, 7 mm). Device lacks motor; battery-powered red LED signals when target depth is reached. Used by oral surgeons/orthodontists in operating room/clinical settings for alveolar osteotomies without prior tissue retraction. Provides precise depth control to prevent over-penetration; benefits patient via minimally invasive access for orthodontic/dental procedures.

Clinical Evidence

Clinical studies demonstrate the device can be used to manually drill holes in tissue and bone for orthodontic and dental procedures and as a tool to create micro-osteoperforations (1.6 mm OD; 0, 3, 5, 7 mm depths).

Technological Characteristics

Manual drill; 17-4 stainless steel bit; ABS/polycarbonate body. Depth control via retractable tube. Battery-powered LED depth indicator. Single-use; provided sterile. Complies with ISO 10993-1 (biocompatibility), ISO 11137-1/2/3 (sterilization), ASTM F1980-07 (shelf-life), IEC 60601-1 (electrical safety), and IEC 60601-1-2 (EMC).

Indications for Use

Indicated for patients requiring manual drilling of tissue and bone for orthodontic and dental procedures, including initiation holes for appliances/implants and creation of micro-osteoperforations.

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

• PROPEL Device (K150392)

Submission Summary (Full 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Propel Orthodontics LLC c/o Jeffrey K. Shapiro Director Hyman, Phelps & McNamara, P.C. 700 13th Street NW, Suite 1200 Washington, DC 20005

January 17, 2018

Re: K172164

Trade/Device Name: PROPEL Device Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: Class II Product Code: DZJ Dated: December 6, 2017 Received: December 7, 2017

Dear Jeffrey K. Shapiro:

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.

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

## Mary S. Runner -S

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) K172164

Device Name

PROPEL Device

Indications for Use (Describe)

The PROPEL Device is indicated for manually drilling holes in tissue and bone for orthodoutic and dental operative procedures including: (1) initiation holes for drill bits, implants, screws, plates, and other orthodontic appliances; and (2) for use as a tool to create micro-osteoperforations.

| Type of Use (Select one or both, as applicable) | <span> [X] Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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| FORM FDA 3881 (7/17) | Page 1 of 1 | PSC Publishing Services [phone] | EP |
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## 510(k) Summary PROPEL Device

| Submitter Name: | Propel Orthodontics LLC |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address: | 394 South Abbott Ave<br>Milpitas, CA 95035 |
| Contact Person: | Bryce Way |
| Phone Number: | 408-394-5851 |
| Fax Number: | 914-560-2056 |
| Date Prepared: | January 9, 2018 |
| Device Trade Name: | PROPEL Device |
| Classification Name: | Bone Cutting Instrument and Accessories |
| Device Common Name: | Manual Bone Drill |
| Product Code: | DZJ |
| Classification: | Class II pursuant to 21 C.F.R. § 872.4120 |
| Predicate Device: | PROPEL Device (K150392) |
| Indications for Use: | The PROPEL Device is indicated for manually drilling holes in<br>tissue and bone for orthodontic and dental operative procedures<br>including: (1) initiation holes for drill bits, implants, screws,<br>plates, and other orthodontic appliances; and (2) for use as a tool to<br>create micro-osteoperforations. |
| Device Description: | The PROPEL Device has a stainless steel drill tip with an outer<br>diameter (drill bit OD) of 1.6 mm that can be manually adjusted to<br>the length needed for treatment or cutting depth. The plastic<br>handle incorporates a retractable plastic tube over the cutting drill<br>instrument. This enables the drill tip to be locked into a specific<br>depth (0, 3, 5, or 7 mm), thus preventing the drill tip from<br>penetrating the bone beyond the targeted depth when used for<br>osteotomies during dental operative procedures. The handle<br>contains the red LED operated by batteries. The LED is<br>illuminated when the tip of the drill tip reaches the set depth.<br>There is no motor in the device. The batteries are only for<br>signaling when the prescribed depth has been achieved. |

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Performance data: The nonclinical testing cleared as part of the predicate device's 510(k) submission supports substantial equivalence of the proposed device because the intended use, technological features, design, and materials of the proposed device are similar to the predicate device. Because no changes have been made to the PROPEL Device, aside from the addition of a specific indication for use as a tool to create micro-osteoperforations (diameter and range of depth dimensions noted above), no additional nonclinical testing was conducted for purposes of this submission.

> Biocompatibility data for the predicate PROPEL Device demonstrates that the PROPEL Device is in compliance with the FDA Guidance Document, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process."

Sterilization validation according to ISO 11137-1, -2, and -3 to ensure a SAL of 106 and shelf-life validation according to ASTM F1980-07 were conducted to validate the 2-year shelf-life of the predicate PROPEL Device.

Electrical safety testing for the predicate PROPEL Device was conducted in compliance with IEC 60601-1: Medical electrical equipment – Part 1: General requirements 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 for the predicate PROPEL Device has demonstrated that the PROPEL Device 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

Clinical studies demonstrate that the PROPEL Device (1) can be used to manually drill holes in tissue and bone for orthodontic and dental operative procedures and (2) can be used as a tool to create micro-osteoperforations (OD 1.6 mm and depth of 0, 3, 5, and 7 mm).

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## Substantial Equivalence: The intended use and technological characteristics of the proposed PROPEL Device are similar to the predicate PROPEL Device. There is a change in the indications for use statement between the predicate and proposed devices for use as a tool to create microosteoperforations. A comparison of the proposed and predicate devices is shown in Table VI.1, below.

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Table VI.1: Comparison to Predicate

| Specification | PROPOSED<br>PROPEL Device | PREDICATE<br>PROPEL Device<br>(K150392) | Similarities and<br>Differences |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| Intended Use | Intended for<br>manually drilling<br>holes in tissue and<br>bone for orthodontic<br>and dental operative<br>procedures. | Intended for<br>manually drilling<br>holes in tissue and<br>bone for orthodontic<br>and dental operative<br>procedures. | Identical |
| Indications for<br>Use | The PROPEL Device<br>is indicated for<br>manually drilling<br>holes in tissue and<br>bone for orthodontic<br>and dental operative<br>procedures including:<br>(1) initiation holes for<br>drill bits, implants,<br>screws, plates, and<br>other orthodontic<br>appliances; and (2)<br>for use as a tool to<br>create micro-<br>osteoperforations. | The PROPEL Device<br>is indicated for<br>manually drilling<br>holes in tissue and<br>bone for orthodontic<br>and dental operative<br>procedures including<br>initiation holes for<br>drill bits, implants,<br>screws, plates and<br>other orthodontic<br>appliances. | Similar. Addition in<br><b>bold italics</b> . |
| FDA Product<br>Code | DZJ | DZJ | Identical |
| Operating<br>Principle<br>(Technology) | Hand-held manual<br>drill | Hand-held manual<br>drill | Identical |
| Drill Angle | Drills holes at a 0°<br>angle<br>(i.e., inline) with the<br>handle | <b>Design</b><br>Drills holes at a 0°<br>angle<br>(i.e., inline) with the<br>handle | Identical |
| Powered or<br>Manual | Manually operated<br>drill | Manually operated<br>drill | Identical |
| Direct Drive or<br>Geared | Direct drive, device is<br>turned by rotating<br>proximal end | Direct drive, device is<br>turned by rotating<br>proximal end | Identical |
| Method for<br>Creating Holes | Stainless Steel Drill<br>Bit | Stainless Steel Drill<br>Bit | Identical |
| Interchangeable<br>Drill Bits | No. Drill bit built-in. | No. Drill bit built-in. | Identical |
| Drill Bit Outer<br>Diameter (OD) | 1.6 mm | 1.6 mm | Identical |
| Specification | PROPOSED<br>PROPEL Device | PREDICATE<br>PROPEL Device<br>(K150392) | Similarities and<br>Differences |
| Drill Bit<br>Working<br>Length (depth) | 0, 3, 5, and 7 mm | 0, 3, 5, and 7 mm | Identical |
| Depth Stops | Yes, by adjusting the<br>depth stop on the<br>drill. | Yes, by adjusting the<br>depth stop on the<br>drill. | Identical |
| Types of<br>Screwdriver<br>Bits | None. Device cannot<br>be converted into a<br>screwdriver | None. Device cannot<br>be converted into a<br>screwdriver | Identical |
| Indicator of<br>Achievement of<br>Proper Depth | LED light comes on<br>to prevent<br>unwarranted pressure<br>on tissue | LED light comes on<br>to prevent<br>unwarranted pressure<br>on tissue | Identical |
| Materials: Drill<br>Bits | Stainless Steel (17-4) | Stainless Steel (17-4) | Identical |
| Materials:<br>Device Body | ABS and<br>polycarbonate | ABS and<br>polycarbonate | Identical |
| Principal<br>Operator | Oral<br>surgeon/orthodontist | Oral<br>surgeon/orthodontist | Identical |
| Can Be Used As<br>Minimally<br>Invasive? | Yes. Can be used for<br>alveolar osteotomies<br>without prior tissue<br>retraction. | Yes. Can be used for<br>alveolar osteotomies<br>without prior tissue<br>retraction. | Identical |
| Use Location | Operating room | Operating room | Identical |
| Single Use? | Single-use only | Single-use only | Identical |
| Sterilization | Provided sterile | Provided sterile | Identical |

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## Substantial Equivalence Conclusion:

The intended use and technological characteristics for the subject PROPEL Device are identical to those of the predicate PROPEL Device. The addition of an indication as a tool to create micro-osteoperforations is a specific bone cutting indication and performance testing supports the subject device for the proposed indications for use. Therefore, the information in this submission demonstrates that the subject PROPEL Device is substantially equivalent to the predicate device.