(183 days)
PROPEL Device (K150392)
Not Found
No
The device description details a purely mechanical and electrical device with no mention of AI or ML capabilities. The LED is a simple indicator based on a physical depth setting.
Yes
The device is used to mechanically create micro-osteoperforations in tissue and bone, which is a direct physical intervention for therapeutic purposes in orthodontic and dental procedures.
No
The device is described as a tool for manually drilling holes and creating micro-osteoperforations, which are surgical interventions, not diagnostic procedures. Its function is to perform a physical action on tissue and bone, not to detect, monitor, or assess a medical condition.
No
The device description clearly outlines physical components including a stainless steel drill tip, plastic handle, retractable plastic tube, and an LED light powered by batteries. This indicates a hardware device, not a software-only device.
Based on the provided information, the PROPEL Device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The PROPEL Device is used to manually drill holes directly into tissue and bone within the patient's body during surgical procedures. It does not analyze samples taken from the body.
- The intended use describes a surgical tool. The description clearly states its purpose is for "manually drilling holes in tissue and bone" and "to create micro-osteoperforations." These are direct surgical interventions, not diagnostic tests performed on samples.
- The device description focuses on mechanical function and depth control. The components described (drill tip, handle, retractable tube, LED) are all related to the physical act of drilling and controlling the depth of penetration. There are no components or functions related to analyzing biological samples.
Therefore, the PROPEL Device is a surgical instrument, not an In Vitro Diagnostic device.
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: (1) initiation holes for drill bits, implants, screws, plates, and other orthodontic appliances; and (2) for use as a tool to create micro-osteoperforations.
Product codes (comma separated list FDA assigned to the subject device)
DZJ
Device Description
The PROPEL Device has a stainless steel drill tip with an outer diameter (drill bit OD) of 1.6 mm 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 (0, 3, 5, or 7 mm), thus preventing the drill tip from penetrating the bone beyond the targeted depth when used for osteotomies during dental operative procedures. The handle contains the 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tissue and bone for orthodontic and dental operative procedures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Oral surgeon/orthodontist; Operating room
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)
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 10-6 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).
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.
PROPEL Device (K150392)
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/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);
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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) | [X] Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
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| FORM FDA 3881 (7/17) | Page 1 of 1 | PSC Publishing Services (301) 443-6740 | EP |
|---|---|---|---|
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510(k) Summary PROPEL Device
| Submitter Name: | Propel Orthodontics LLC |
|---|---|
| Submitter Address: | 394 South Abbott Ave |
| 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 |
| 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 Description: | The PROPEL Device has a stainless steel drill tip with an outer |
| diameter (drill bit OD) of 1.6 mm 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 (0, 3, 5, or 7 mm), thus preventing the drill tip from | |
| penetrating the bone beyond the targeted depth when used for | |
| osteotomies during dental operative procedures. The handle | |
| contains the 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. |
4
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).
5
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
PROPEL Device | PREDICATE
PROPEL Device
(K150392) | Similarities and
Differences |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| Intended Use | Intended for
manually drilling
holes in tissue and
bone for orthodontic
and dental operative
procedures. | Intended for
manually drilling
holes in tissue and
bone for orthodontic
and dental operative
procedures. | Identical |
| Indications for
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. | 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. | Similar. Addition in
bold italics . |
| FDA Product
Code | DZJ | DZJ | Identical |
| Operating
Principle
(Technology) | Hand-held manual
drill | Hand-held manual
drill | Identical |
| Drill Angle | Drills holes at a 0°
angle
(i.e., inline) with the
handle | Design
Drills holes at a 0°
angle
(i.e., inline) with the
handle | Identical |
| Powered or
Manual | Manually operated
drill | Manually operated
drill | Identical |
| Direct Drive or
Geared | Direct drive, device is
turned by rotating
proximal end | Direct drive, device is
turned by rotating
proximal end | Identical |
| Method for
Creating Holes | Stainless Steel Drill
Bit | Stainless Steel Drill
Bit | Identical |
| Interchangeable
Drill Bits | No. Drill bit built-in. | No. Drill bit built-in. | Identical |
| Drill Bit Outer
Diameter (OD) | 1.6 mm | 1.6 mm | Identical |
| Specification | PROPOSED
PROPEL Device | PREDICATE
PROPEL Device
(K150392) | Similarities and
Differences |
| Drill Bit
Working
Length (depth) | 0, 3, 5, and 7 mm | 0, 3, 5, and 7 mm | Identical |
| Depth Stops | Yes, by adjusting the
depth stop on the
drill. | Yes, by adjusting the
depth stop on the
drill. | Identical |
| Types of
Screwdriver
Bits | None. Device cannot
be converted into a
screwdriver | None. Device cannot
be converted into a
screwdriver | Identical |
| Indicator of
Achievement of
Proper Depth | LED light comes on
to prevent
unwarranted pressure
on tissue | LED light comes on
to prevent
unwarranted pressure
on tissue | Identical |
| Materials: Drill
Bits | Stainless Steel (17-4) | Stainless Steel (17-4) | Identical |
| Materials:
Device Body | ABS and
polycarbonate | ABS and
polycarbonate | Identical |
| Principal
Operator | Oral
surgeon/orthodontist | Oral
surgeon/orthodontist | Identical |
| Can Be Used As
Minimally
Invasive? | Yes. Can be used for
alveolar osteotomies
without prior tissue
retraction. | Yes. Can be used for
alveolar osteotomies
without prior tissue
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.