(183 days)
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 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.
The provided text is a 510(k) summary for the PROPEL Device, which is a manual bone drill used in orthodontics and dental operative procedures. The submission is focused on demonstrating substantial equivalence to a predicate device (K150392).
Based on the provided information, the device is a manual bone-cutting instrument, not an AI or imaging device, and therefore the concepts of acceptance criteria for AI performance (like sensitivity, specificity, AUC) and an MRMC study are not applicable in this context. The "study that proves the device meets the acceptance criteria" refers to the non-clinical and bench testing performed to ensure the device's functional integrity and safety.
Here's an analysis of the provided text in relation to your request, with an emphasis on why certain aspects of your prompt are not present or applicable given the nature of this medical device:
1. A table of acceptance criteria and the reported device performance:
The document doesn't present a formal table of "acceptance criteria" with quantitative performance metrics in the way one would for an AI algorithm's diagnostic performance. Instead, it relies on demonstrating that the proposed device is substantially equivalent to its predicate. The "performance" is implicitly tied to meeting the same standards as the predicate and the general expectations for such a device.
Here's how we can extract the implicit acceptance criteria and reported performance:
| Acceptance Criterion (Implicit) | Reported Device Performance (as stated in the document) |
|---|---|
| Functional Equivalence to Predicate | The proposed device has identical intended use, technological features, design, and materials as the predicate device (K150392). The only change is an addition to the indications for use. |
| Biological Safety/Biocompatibility | Biocompatibility data for the predicate PROPEL Device demonstrates compliance with FDA Guidance Document, ISO 10993-1. (Since no changes were made to the device, this data is considered applicable to the proposed device). |
| Sterilization Efficacy & Shelf-Life | Sterilization validation (according to ISO 11137-1, -2, -3 to ensure a SAL of 10-6) and shelf-life validation (according to ASTM F1980-07) were conducted for the predicate device, validating a 2-year shelf-life. (Again, applicable to the proposed device due to no changes). |
| Electrical Safety | Electrical safety testing for the predicate PROPEL Device was conducted in compliance with IEC 60601-1 and IEC 60601-1-2. (Applicable to the proposed device). |
| Mechanical Performance & Reliability | Bench testing for the predicate PROPEL Device demonstrated compliance with product specifications, medical community expectations, and product labeling. Specific tests mentioned: - Bit reliability, including deflection resistance and hole depth repeatability - Various tensile and compression tests of components - Dial and bit depth reliability - LED light reliability (Applicable to the proposed device, as no changes were made apart from the added indication). |
| Ability to Create Micro-osteoperforations (New Indication) | Clinical studies demonstrate that the PROPEL Device (which is the same device as the predicate) can be used as a tool to create micro-osteoperforations (OD 1.6 mm and depth of 0, 3, 5, and 7 mm). This is the key "performance" demonstration for the new specific indication. The document states "performance testing supports the subject device for the proposed indications for use" in the "Substantial Equivalence Conclusion." |
2. Sample sized used for the test set and the data provenance:
- Sample Size: The document does not specify exact sample sizes for the non-clinical tests (e.g., how many bits were tested for reliability, how many devices for electrical safety). It refers to "bench testing" and "clinical studies" but doesn't provide numbers of subjects or devices.
- Data Provenance: Not specified. Given it's a medical device, the studies would typically be conducted under Good Laboratory Practice (GLP) or similar standards. The clinical studies mentioned are stated to "demonstrate that the PROPEL Device (1) can be used to manually drill holes... and (2) can be used as a tool to create micro-osteoperforations." This suggests a prospective design for clinical evaluation, but details like location (country), number of subjects, or how the studies were conducted are not provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This concept is not applicable here. Ground truth in the context of an AI device typically refers to definitive labels or diagnoses from experts or pathology to train/evaluate the AI. For a manual surgical instrument, "ground truth" would be established by the physical and mechanical properties of the device, its manufacturing specifications, and its ability to perform its intended function in a clinical setting (i.e., successfully drilling holes/micro-osteoperforations). The "experts" are the engineers and clinicians who conducted and evaluated the bench and clinical studies, ensuring the device met its functional requirements and safety standards. Their qualifications are implicit in the fact that the studies were conducted within a regulated medical device development framework.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. This is a method used for resolving discrepancies in expert labeling for AI training/evaluation datasets.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. The PROPEL Device is a manual instrument, not an AI or imaging diagnostic tool that assists human "readers." The "clinical studies" mentioned are to show the device's capability, not to compare human performance with and without AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is not an AI algorithm. Its "standalone" performance is its mechanical and electrical function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For this device, "ground truth" would be:
- Engineering Specifications: For dimensions, material properties, electrical function (LED light).
- Standardized Test Methods: Compliance with ISO, ASTM, and IEC standards for biocompatibility, sterilization, electrical safety, and mechanical performance.
- Clinical Observation/Functionality: Evidence from clinical use showing that the device can manually drill holes and create micro-osteoperforations as intended, to the specified depths and diameters.
8. The sample size for the training set:
Not applicable. This device does not use an AI algorithm that requires a "training set."
9. How the ground truth for the training set was established:
Not applicable. No AI training set is involved.
Summary of Key Takeaways from the document relevant to your request:
The fundamental premise of this 510(k) submission is that the proposed device is substantially equivalent to a previously cleared predicate device. This means that:
- The non-clinical testing already performed for the predicate device (biocompatibility, sterilization, electrical safety, bench testing for mechanical reliability) supports the proposed device because there are no changes to its core design, materials, or underlying technology.
- The only new element is the explicit addition of "micro-osteoperforations" to the indications for use. For this specific addition, the document states that "performance testing supports the subject device for the proposed indications for use," and "Clinical studies demonstrate that the PROPEL Device... can be used as a tool to create micro-osteoperforations." This implies that the clinical studies provided sufficient evidence for this expanded indication without needing a full de novo clearance or a different type of study, given the device's existing clearance for drilling holes in bone.
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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 (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
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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) | [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 AveMilpitas, 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 intissue and bone for orthodontic and dental operative proceduresincluding: (1) initiation holes for drill bits, implants, screws,plates, and other orthodontic appliances; and (2) for use as a tool tocreate micro-osteoperforations. |
| Device Description: | The PROPEL Device has a stainless steel drill tip with an outerdiameter (drill bit OD) of 1.6 mm that can be manually adjusted tothe length needed for treatment or cutting depth. The plastichandle incorporates a retractable plastic tube over the cutting drillinstrument. This enables the drill tip to be locked into a specificdepth (0, 3, 5, or 7 mm), thus preventing the drill tip frompenetrating the bone beyond the targeted depth when used forosteotomies during dental operative procedures. The handlecontains the red LED operated by batteries. The LED isilluminated when the tip of the drill tip reaches the set depth.There is no motor in the device. The batteries are only forsignaling 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 | PROPOSEDPROPEL Device | PREDICATEPROPEL Device(K150392) | Similarities andDifferences |
|---|---|---|---|
| Intended Use | Intended formanually drillingholes in tissue andbone for orthodonticand dental operativeprocedures. | Intended formanually drillingholes in tissue andbone for orthodonticand dental operativeprocedures. | Identical |
| Indications forUse | The PROPEL Deviceis indicated formanually drillingholes in tissue andbone for orthodonticand dental operativeprocedures including:(1) initiation holes fordrill bits, implants,screws, plates, andother orthodonticappliances; and (2)for use as a tool tocreate micro-osteoperforations. | The PROPEL Deviceis indicated formanually drillingholes in tissue andbone for orthodonticand dental operativeprocedures includinginitiation holes fordrill bits, implants,screws, plates andother orthodonticappliances. | Similar. Addition inbold italics . |
| FDA ProductCode | DZJ | DZJ | Identical |
| OperatingPrinciple(Technology) | Hand-held manualdrill | Hand-held manualdrill | Identical |
| Drill Angle | Drills holes at a 0°angle(i.e., inline) with thehandle | DesignDrills holes at a 0°angle(i.e., inline) with thehandle | Identical |
| Powered orManual | Manually operateddrill | Manually operateddrill | Identical |
| Direct Drive orGeared | Direct drive, device isturned by rotatingproximal end | Direct drive, device isturned by rotatingproximal end | Identical |
| Method forCreating Holes | Stainless Steel DrillBit | Stainless Steel DrillBit | Identical |
| InterchangeableDrill Bits | No. Drill bit built-in. | No. Drill bit built-in. | Identical |
| Drill Bit OuterDiameter (OD) | 1.6 mm | 1.6 mm | Identical |
| Specification | PROPOSEDPROPEL Device | PREDICATEPROPEL Device(K150392) | Similarities andDifferences |
| Drill BitWorkingLength (depth) | 0, 3, 5, and 7 mm | 0, 3, 5, and 7 mm | Identical |
| Depth Stops | Yes, by adjusting thedepth stop on thedrill. | Yes, by adjusting thedepth stop on thedrill. | Identical |
| Types ofScrewdriverBits | None. Device cannotbe converted into ascrewdriver | None. Device cannotbe converted into ascrewdriver | Identical |
| Indicator ofAchievement ofProper Depth | LED light comes onto preventunwarranted pressureon tissue | LED light comes onto preventunwarranted pressureon tissue | Identical |
| Materials: DrillBits | Stainless Steel (17-4) | Stainless Steel (17-4) | Identical |
| Materials:Device Body | ABS andpolycarbonate | ABS andpolycarbonate | Identical |
| PrincipalOperator | Oralsurgeon/orthodontist | Oralsurgeon/orthodontist | Identical |
| Can Be Used AsMinimallyInvasive? | Yes. Can be used foralveolar osteotomieswithout prior tissueretraction. | Yes. Can be used foralveolar osteotomieswithout prior tissueretraction. | 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.
§ 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.