(15 days)
This device is to be used to expand the tooth socket to facilitate tooth extraction, and/or to prepare the site for placement of endosseous dental implants or abutments.
The Powertome periotome is designed as an aid to dental professionals in the extraction of a tooth, or multiple teeth, from their socket. It is designed to minimize alveolar bone loss, thus providing an initial step in the preparation prior to placing dental implants, whose success rate is highly dependent on minimal (or no) bone loss. It functions by severing the periodontal ligaments that attach the cementum of the tooth to the alveolar bone, by use of different sized and shaped tips that provide the leverage and effect desired. These ligaments are one of two methods by which teeth stay in the jaw. The second function is to push the alveolar bone away from the tooth, thus disengaging the mechanical leverage the alveolar bone uses on the imequiarity of the tooth to also help hold the tooth in place. Once the ligaments are cut, and the alveolar bone pushed away, the tooth extracts trivially. Our method is the same as using a manual periotome and mallet, except that instead of an assistant tapping on the end of the periotome with a mallet, we use a small solenoid in the handpiece, which delivers a small but consistent force on the periotome tip, controlled in duration by the professional by use of a foot switch (for on/off control). The total delivered power for each stroke is controlled, and can be set by the professional.
This submission is about a medical device (Powertome Periotome) and not an AI/ML device, therefore, the information requested in the prompt regarding AI/ML device evaluation is not available in the provided text.
The Powertome Periotome is a dental tool designed to aid in tooth extraction by severing periodontal ligaments and minimizing alveolar bone loss, especially in preparation for dental implants. It uses a small solenoid to deliver controlled force to the periotome tip, simulating the action of a mallet but with greater control for the dental professional.
Here's an analysis of the provided text based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state "acceptance criteria" in a quantitative sense as might be found for an AI/ML device. Instead, it compares the technological characteristics and functional success of the Powertome Periotome to predicate (manual) periotomes. The "acceptance criteria" can be inferred from the stated claims of improvement and equivalence.
| Characteristic | Predicate Device (Mallet-assisted manual periotome) | Powertome Periotome (Proposed Device) | Acceptance Criteria (Implied) | Performance Met? |
|---|---|---|---|---|
| Maximum amount of force/stroke | 122 lb | 90 lb | Sufficient force to sever ligaments and expand socket | Yes (lower but still effective, and controlled) |
| Minimum amount of force/stroke | 16 lb | 21 lb | Sufficient force to sever ligaments and expand socket | Yes (higher minimum indicates more reliable impact) |
| Standard deviation force/stroke | 27 lb | 15 lb | Reduced variability in force delivery | Yes (lower SD indicates better control) |
| Mean force/stroke | 79 lb | 52 lb | Sufficient average force, potentially leading to less trauma | Yes (lower mean force, likely due to controlled strokes) |
| Frequency | 200 milliseconds/stroke | 50 milliseconds/stroke | Faster, more precise strokes | Yes (significantly faster) |
| Duration of impact | 420 ms | 70 ms | Shorter, more controlled impact | Yes (significantly shorter) |
| Force controlled by professional | No | Yes | Professional control over force | Yes |
| Max/Min length of power/stroke | 1/3 - 10" | .01" max., .01" min. | Precise and consistent stroke length | Yes (highly precise) |
| Success in cutting periodontal ligament | Yes, with verbal control | Yes, with electronic control | Equivalent or improved success in cutting ligaments | Yes (claims success with electronic control) |
| Success in expanding tooth socket by movement of alveolar bone | Yes, with verbal control | Yes, with electronic control | Equivalent or improved success in expanding socket | Yes (claims success with electronic control) |
| Repeatability | Low | High | Improved repeatability of action | Yes |
| Safety: Force controlled by professional | No | Yes | Improved safety through professional control | Yes |
Conclusion from the document: The Powertome Periotome is claimed to be "as safe and as effective as the predicate device in performing its indicated use," and offers "significantly increased control over the outcome."
2. Sample Size Used for the Test Set and the Data Provenance:
- Sample Size for Test Set: Not applicable in the context of clinical trials or AI/ML model performance evaluation. The "test" in this context refers to engineering characterization of the device's physical properties compared to manual methods.
- Data Provenance: The force and frequency data for both the predicate device (mallet-assisted) and the Powertome periotome were generated through bench testing and characterization. For the predicate device, typical numbers were also "characterized ... by interviewing professionals." This suggests an internal, controlled environment for the Powertome and a combination of observation/interview for the manual method.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- Number of Experts: Not applicable for establishing ground truth in a clinical or diagnostic sense. The comparison here is based on physical characteristics (force, frequency, duration, etc.) and anecdotal feedback.
- Qualifications of Experts: For the anecdotal data, "Two dental professionals have been using prototype versions of the product." Their specific qualifications (e.g., years of experience) are not provided beyond being "dental professionals." For the "characterization of typical numbers by interviewing professionals" no exact number or qualification is provided.
4. Adjudication Method for the Test Set:
- Not applicable. This was not a study involving human interpretation of medical data requiring adjudication. The comparison was based on physical device performance measurements.
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:
- No, an MRMC comparative effectiveness study was not done. This is not an AI/ML device, and the submission explicitly states: "We have not used clinical data to support our claim of substantial equivalence." The comparison is based on the device's mechanical characteristics and anecdotal feedback.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- No. This is a medical device, not an algorithm. The device is designed to be used with a human professional, providing them with enhanced control over the process.
7. The Type of Ground Truth Used:
- For the physical characteristics (force, frequency, duration), the ground truth was established through direct measurement and engineering characterization of the devices.
- For the effectiveness claims (cutting ligaments, expanding socket, repeatability, safety), the ground truth is based on comparison of mechanical properties and anecdotal feedback from dental professionals, rather than a formal, clinical ground truth (e.g., pathology, outcomes data).
8. The Sample Size for the Training Set:
- Not applicable. This is a hardware medical device, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As above, no training set was used.
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510(k) Summary
Westport Medical, Inc. 6603 Rippling Brook Drive SE Salem, OR 97319 (p)503-510-7560 (f) 866-457-9667
OCT 1 7 2006
Contact information: Ralph Wells 14372 Fishback Rd. Monmouth, OR 97361 (p) 503-623-5880 (f) 503-831-5376
This 510(k) summary was prepared June/July, 2006, and finished 15 July, 2006.
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Trade Name - PowertomeTM Periotome S100
Common name - periotome
Classification name - probe, periodontic (21CFR872.4565, Product Code ElX) We are claiming substantial equivalence to a device made by B.T.I. BIOTECHNOLOGY INSTITUTE. S.L., Osseous Technologies of America, Karl Schumacher, and others, called a periotome.
Device description: The Powertome periotome is designed as an aid to dental professionals in the extraction of a tooth, or multiple teeth, from their socket. It is designed to minimize alveolar bone loss, thus providing an initial step in the preparation prior to placing dental implants, whose success rate is highly dependent on minimal (or no) bone loss. It functions by severing the periodontal ligaments that attach the cementum of the tooth to the alveolar bone, by use of different sized and shaped tips that provide the leverage and effect desired. These ligaments are one of two methods by which teeth stay in the jaw. The second function is to push the alveolar bone away from the tooth, thus disengaging the mechanical leverage the alveolar bone uses on the imequiarity of the tooth to also help hold the tooth in place. Once the ligaments are cut, and the alveolar bone pushed away, the tooth extracts trivially.
Typical methods of extraction of a tooth are:
-
- Use of forceps. The forceps grab the tooth, and the professional then twists the tooth in place, tearing the periodontal ligaments, and also expanding the alveolar bone. Once there is sufficient clearance, and the periodontal ligaments are detached, the tooth can be removed. This results in significant bone loss, and can be painful for the patient.
-
- Use of a manual periotome: The periotome is inserted between the tooth and gum, and pushed between the tooth and bone until it meets resistance. The device can then be pushed toward the root of the tooth by moving the periotome back and forth, tangentially to the tooth surface,
-
- Use of a manual periotome and mallet: The periotome is inserted between the tooth and gum. and pushed between the tooth and bone until it meets resistance. The device can then be tapped on the end with a mallet, driving it through the periodontal ligaments the root of the tooth. Often the use of the mallet is done with an assistant, who taps the end of the periotome with the mallet equal to the number of times the professional says "tap tap" (in this example, 3 taps with the mallet).
-
- Our method is the same as #3, above, except that instead of an assistant tapping on the end of the periotome with a mallet, we use a small solenoid in the handpiece, which delivers a small but consistent force on the periotome tip, controlled in duration by the professional by use of a foot switch (for on/off control). The total delivered power for each stroke is controlled, and can be set by the professional.
This product was designed to simulate the action that is provided by the mallet, but to give greater control over the process, both from a safety (totally controlled by the professional) and effectiveness (controlled stroke allows the professional to easily determine when the tooth has been sufficiently loosened in it's socket). The materials used that come in contact with the patient are the same as used in the manual periotomes - wrought stainless steel. The tips employed are of the same general length, width, and depth as those currently used by manual periotomes.
Intended use: The intended use of this device is as an aid in the removal of teeth, due to caries(decay), trauma, orthodontic reasons, periodontal bone loss or malformation of the tooth. It is also intended to be used to remove teeth as part of the preparation for dental implants, where minimizing bone loss is critical.
All types of devices typically used in extractions, including forceps, periotomes, dental elevators, and even chisels, are Class I, exempt from 510(k). The specific indications for use have been taken from advertising done by various dental distribution or manufacturers, and, although not verbatim on our intended use, have very similar wording. Differences do not impact the safety, not the effectiveness of this device when used as labeled.
Technological characteristics: Our device does have different technological characteristics from the predicate device. The power source to cut through the periodontal ligaments and expand the bone are done either by manually forcing the tip through the ligaments, or with an external power source consisting of an assistant and a hammer (mallet), used to supply additional force to out through the periodontal ligaments and expand the socket. To determine the amount of force, and do a comparison with our device, we tested the amount of force delivered by utilization of our device, and with a hammer, and also characterized typical numbers by interviewing professionals:
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| Characteristic | Predicate Device | Powertome periotom |
|---|---|---|
| Maximum amount of force/stroke | 122 lb | 90 lb |
| Minimum amount of force/stroke | 16 lb | 21 lb |
| Standard deviation force/stroke | 27 lb | 15 lb |
| Mean force/stroke | 79 lb | 52 lb |
| Frequency | 200 milliseconds/stroke | 50 milliseconds/stroke |
| Duration of impact | 420 ms | 70 ms |
| Force controlled by professional | No | Yes |
| Max/Min length of power1 stroke | 1/3 - 10" | .01" max., .01" min. |
Clinical data: We have not used clinical data to support our claim of substantial equivalence.
Anecdotal data: Two dental professionals have been using prototype versions of the product. Neither practitioner wishes to return to the manual periotome with mallet, as the Powertome periotome provides significantly increased control over the outcome.
Conclusions:
| Characteristic | Predicate Device | Powertome periotome |
|---|---|---|
| Success in cutting periodontalligament | Yes, with verbal control | Yes, with electronic control |
| Success in expanding toothsocket by movement of alveolarbone | Yes, with verbal control | Yes, with electronic control |
| Repeatability | Low | High |
| Safety: Force controlled byprofessional | No | Yes |
The Powertome periotome is as safe and as effective as the predicate device in performing it's indicated use.
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Image /page/3/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 17 2008
Westport Medical, Incorporated C/O Ms. Michelle S. Lee Responsible Third Party Official Underwriters Laboratories. Incorporated 2600 N.W. Lake Road Camas, Washington 98607-8542
Re: K063007
Trade/Device Name: Powertome Periotome Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EKX Dated: September 29, 2006 Received: October 2, 2006
Dear Ms. Lee:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Ms. Lee
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR-Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Clive
Thio Li-Ann, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): _ KOODO
Powertome Periotome Device Name:
Indications for Use: This device is to be used to expand the tooth socket to facilitate tooth easth and least thinkations for Ose. This device is to be acod of expans the malformation of the tooth, and/or to to other the site for placement of endosseous dental implants or abutments.
Prescription Use _ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Susan Ruane
n Offi Ji Anasthasinlogy Ganeral Hos n Control, Dantal Dav
K663cc7
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.