(212 days)
Not Found
No
The device is a manually operated drill with a depth stop and an LED indicator. There is no mention of any computational processing, learning, or data analysis.
No
The device description states that the PROPEL Device is intended for use in dental operative procedures involving the preparation of tissue and bone, and can be used manually as a bone cutting instrument. It is essentially a manual drill for creating holes, not for treating a disease or condition. Its function is to facilitate a procedure (drilling holes) rather than provide therapy.
No
The device is described as a tool for drilling holes in tissue and bone during dental procedures, specifically as a bone cutting instrument. Its purpose is to prepare tissue and bone for other orthodontic appliances, not to diagnose a condition or disease.
No
The device description clearly states it is a physical instrument with a stainless steel drill tip, plastic handle, and an LED light powered by batteries. It is not software.
Based on the provided information, the PROPEL device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for manually drilling holes in tissue and bone for orthodontic and dental operative procedures. This is a surgical/operative procedure performed directly on the patient's body.
- Device Description: The device is described as a bone cutting instrument used in dental operative procedures. It physically interacts with the patient's tissue and bone.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. The PROPEL device does not perform any such tests on samples.
The PROPEL device is a surgical instrument used for a physical procedure, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DZJ
Device Description
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 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.
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
Not Found
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)
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.
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.
Not Found
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
§ 872.4120 Bone cutting instrument and accessories.
(a)
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.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.
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.
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Image /page/1/Picture/7 description: The image contains a signature and the name "Tina Kiang" in a simple, sans-serif font. The signature is complex and illegible, consisting of loops and lines. The name is positioned to the right of the signature.
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
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) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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. |
| 384 South Abbott Avenue | |
| Milpitas, CA 95035 | |
| Company Contact: Bryce Way | |
| Chief Executive Officer | |
| Tel: 408-394-5851 | |
| Email: BW@PropelOrtho.com | |
| Correspondent Contact | |
| Information: | Craig Coombs |
| Coombs Medical Device Consulting | |
| 1193 Sherman Street | |
| Alameda, CA 94501 | |
| Tel: 510-337-0140 | |
| Fax: 510-337-0416 | |
| Device Common Name: | Manual Bone Drill |
| Device Classification Number | |
| & Name: | 21 CFR 872.4120 |
| Bone Cutting Instrument and Accessories | |
| Device Classification & | |
| Product Code: | Class II, |
| 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 |
| Bone Cutting Instrument and Accessories | |
| Predicate Device Classification & | |
| Product Code: | Class II, |
| 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:
Synthes 90° Screwdriver
K082649 | Subject Device:
Propel Orthodontics, LLC
PROPEL Device | How do differences, if any,
pertain to justification of
substantial equivalence? |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Operating
Principle | Hand-held powered drill or
hand-held manual
screwdriver | Hand-held manual drill | Difference in power mode
and lack of screwdriver
function in application device
does not raise new questions
of safety or efficacy. |
| Drill Angle | Drills holes or inserts screws
at a 90° angle from the handle | Drills holes an a 0° angle
(i.e. inline) with the handle | Difference in angle does not
does not raise new questions
of safety or efficacy for what
the application device is
indicated for |
| Powered or
Manual | Screwdriver intended to
operate manually:
Drill intended to operate
connected to a mechanical
power source compatible
with a Intra coupling
according to ISO 3964/EN 23
964 | Manually operated drill | Difference in power mode and
lack of screwdriver function
in application device does not
raise new questions of safety
or efficacy. |
| Direct drive or
geared? | 2:1 gearing ratio when
turning proximal end | No gearing, device is turned
by rotating proximal end | No clinical difference |
| Method for
creating holes | Stainless Steel Drill Bit | Stainless Steel Drill Bit | Clinically Identical |
| Interchangeable
drill bits | Yes | No. Drill bit built-in | Identical result as far as
creating holes |
| Characteristic | Predicate:
Synthes 90° Screwdriver
(K082649) | Subject Device:
Propel Orthodontics, LLC
PROPEL Device | How do differences, if any,
pertain to justification of
substantial equivalence? |
| Drill Bit OD | 1.0 - 2.4mm | 1.6mm | Size available in application
device is a subset of those
available in the predicate
device |
| Drill Bit Working
Length | 4 – 18mm | 3, 5, or 7 mm | The smaller length available
in the application device are
to serve the techniques
described in the Indication for
Use. Does not raise new
questions of safety or efficacy |
| Depth Stops | Yes, buy selecting the
appropriate length bit | Yes, by adjusting the depth
stop on the drill. | Clinically Identical |
| Types of
Screwdriver bits | Screwholder bits for screw
OD's of 1.5, 2.0 and 2.4mm | None. Device cannot be
converted into a screwdriver | Raises no questions of safety
or efficacy |
| Indicator of
Achievement of
Proper Depth | Head of drill in contact with
tissue | LED light comes on to
prevent unwarranted pressure
on tissue | Clinically Identical |
| Materials: Drill
Bits | Stainless Steel | Stainless Steel | Clinically Identical |
| Materials: device
body | Metallic | ABS and polycarbonate | Clinically Identical |
| Single Use? | Reusable | Single Use Only | Clinically Identical |
| Sterilization | Provided non-sterile, can be
resterilized | Provided sterile | Clinically Identical after
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.