(128 days)
The drive unit is an electrically controlled screwdriver with adjustable torques to tighten and unscrew prosthodontic screws. Consisting of: - Cordless drive unit - Mechanical transmission instrument 80:1
The cordless Prosthodontic Screwdriver IA-400 consists of the cordless drive IA-40H, the contra-angle attachment IA-80 and a key pad (finger switch). The drive is fitted out with a 3.7 V Li-Ion battery, which can be re-charged using the provided charging station. The drive and the contra-angle attachment are connected via a special coupling, based on ISO 3964. By means of the different buttons on the drive the user controls the various settings, such as ON, forward/reverse and the torque. The attached key pad (finger switch) allows starting and stopping the screwdriver's rotation. The handpiece's application is intended in dentistry.
The provided 510(k) summary for the "Prosthodontic Screwdriver IA-400" does not contain detailed information about specific acceptance criteria or a study designed to prove the device meets those criteria in the way a clinical or performance study for an AI/CADe device would.
This submission is for a physical medical device (a dental handpiece), not a software-based or AI-powered diagnostic device. Therefore, the questions related to AI/CADe studies, sample sizes for training/test sets, ground truth establishment, expert adjudication, or MRMC studies are not applicable to this 510(k) document.
The "Performance Testing" section states: "W&H's Prosthodontic Screwdriver IA-400 was developed and is produced under consideration of all applicable technical standards and quality management directives. The product's conformance with the applicable technical standards was verified in the course of type testing. Bench testing results demonstrated substantially equivalence. Perfect functionality and accuracy of all serial devices are controlled in the final step of production."
This implies that performance was assessed against relevant technical standards and internal quality controls through bench testing. The acceptance criteria would likely be derived from these technical standards for dental handpieces, focusing on aspects like torque accuracy, power output, durability, and safety, as well as demonstrating substantial equivalence to predicate devices.
Here's a breakdown based on the provided document, acknowledging the non-AI nature of the device:
1. Table of Acceptance Criteria and Reported Device Performance:
The document summarizes the performance testing at a high level. Specific, quantifiable acceptance criteria and detailed reported performance values are not provided in this 510(k) summary. Instead, it broadly states:
| Acceptance Criteria Category (Implied) | Reported Device Performance |
|---|---|
| Conformity to Technical Standards | "Prosthodontic Screwdriver IA-400 was developed and is produced under consideration of all applicable technical standards and quality management directives." "The product's conformance with the applicable technical standards was verified in the course of type testing." |
| Substantial Equivalence | "Bench testing results demonstrated substantially equivalence [to predicate devices]." |
| Functionality and Accuracy | "Perfect functionality and accuracy of all serial devices are controlled in the final step of production." |
| Safety and Quality | "Corresponding certificates and the application of the CE-mark give evidence of the product's high quality." |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. For bench testing of a physical device like this, the 'sample' would refer to the units tested during type testing and then controls during production.
- Data Provenance: Not specified, but implied to be from W&H Dentalwerk Buermoos GmbH's internal testing facilities in Austria ("A - 5111 Buermoos Austria").
- Retrospective/Prospective: Not applicable in the context of clinical studies for this device.Bench testing is generally part of a prospective product development and verification process.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a physical device undergoing bench testing against technical standards, not a diagnostic device requiring expert interpretation of results for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. The assessment would involve direct measurement and comparison against technical specifications.
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. This is not an AI/CADe device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/CADe device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For bench testing of a physical medical device, the "ground truth" or reference standard would be the engineering specifications, established technical standards (e.g., ISO standards relevant to dental handpieces), and performance characteristics of the predicate device. Measurements taken during testing would be compared against these predefined standards.
8. The sample size for the training set:
- Not applicable. This is not a machine learning/AI device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. This is not a machine learning/AI device that requires a training set.
In summary: The 510(k) for the Prosthodontic Screwdriver IA-400 relies on bench testing against applicable technical standards and comparison to predicate devices to demonstrate substantial equivalence, rather than clinical trials or AI performance studies.
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વર્ષના વિદ્યાર્થો વિભાગના પાકની ખેત
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Section 5
Page 1 of 2
JUL·- 9 2010
510(k) SUMMARY
| Applicant and Owner | W&H Dentalwerk Buermoos GmbHIgnaz-Glaser-Strasse 53A - 5111 BuermoosAustriaTel.: 0043 -6274 / 6236 -297Fax: 0043 -6274 / 6236 -234 |
|---|---|
| Contact Person | Johann Georg SCHARL |
| Date of Submission | March 1st, 2010 |
| Device Name | Prosthodontic Screwdriver IA-400 |
| Classification Name | Handpiece, Direct Drive, Ac-Powered |
| Regulation Number | 21 CFR872.4200 |
| Product Code | EKX |
| Predicate Devices | - "implantMED SI-915", cleared by W&H Dentalwerk Buermoos under K052741+ "WS-75 E/KM", cleared by W&H Dentalwerk Buermoos as an accessory to the"implantMED SI-915" in file K052741- Cordless Endo Handpc. "ENTRAN", W&H Dentalwerk Buermoos, K090931 |
| Device Description | The cordless Prosthodontic Screwdriver IA-400 consists of thecordless drive IA-40H, the contra-angle attachment IA-80 and akey pad (finger switch).The drive is fitted out with a 3.7 V Li-Ion battery, which can be re-charged using the provided charging station.The drive and the contra-angle attachment are connected via aspecial coupling, based on ISO 3964.By means of the different buttons on the drive the user controlsthe various settings, such as ON, forward/reverse and the torque.The attached key pad (finger switch) allows starting and stoppingthe screwdriver's rotation.The handpiece's application is intended in dentistry. |
| Intended Use: | The drive unit is an electrically controlled screwdriver withadjustable torques to tighten and unscrew prosthodontic screws.Consisting of:- Cordless drive unit- Mechanical transmission instrument 80:1 |
July 8th, 2010
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| Image: W&H logo | 510(k)Prosthodontic Screwdriver IA-400 | Section 5Page 2 of 2 |
|---|---|---|
| ----------------- | -------------------------------------------- | -------------------------- |
| TechnologicalCharacteristics | W&H's "Prosthodontic Screwdriver IA-400" represents a devicecombining the technical principle of the cordless ENDO-Handpiece "ENTRAN" (510(k) no. K090931) with a special field ofapplicability of W&H's drive unit "implantMED SI-915", providedwith the contra-angle handpiece attachment type WS-75 E/KM(both cleared for market under 510(k) K052741). |
|---|---|
| Comparison of thedevice to the predicatedevice | The advantage of the new product is based, above all, on the factthat the "Prosthodontic Screwdriver IA-400" was designed for adetail of the "implantMED's" applicability. So it offers advantageswith respect to usability and flexibility: cordless, less weight,smaller size, better balanced, ergonomically designed. |
| The intended purpose of the predicate device "implantMED"covers the new device's intended use; "implantMED's"performance parameters are very similar in this respect to thenew device's ones.The technological characteristics and materials, on the otherhand, are very similar to those of the predicate device "ENTRAN". | |
| With respect to the functions considered as intended use, the newdevice can be judged to be substantially equivalent to thepredicate devices. | |
| Performance Testing | W&H's Prosthodontic Screwdriver IA-400 was developed and isproduced under consideration of all applicable technicalstandards and quality management directives. |
| The product's conformance with the applicable technicalstandards was verified in the course of type testing. Bench testingresults demonstrated substantially equivalence. Perfectfunctionality and accuracy of all serial devices are controlled in thefinal step of production. | |
| Corresponding certificates and the application of the CE-markgive evidence of the product's high quality. | |
| Clinical Testing | Clinical data were not needed for this new product. |
July 8th, 2010
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Johann G. Scharl Regulatory Affairs Manager W & H Dentalwerk Buermoos GMBH 53 Ignaz-Glaser- Strasse Buermoos Austria 5111
JUL - 9 2010
Re: K100600
Trade/Device Name: Prosthodontic Screwdriver IA-400 Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EKX Dated: June 25, 2010 Received: June 25, 2010
Dear Mr. Scharl:
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.
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Page 2- Mr. Scharl
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 go to
http://www.fda.goy/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
h for
Anthony D. Watson, B.S., M.S., M.B.A. 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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[W&H]
510(k)
Prosthodontic Screwdriver IA-400
Section 4
Page 1 of 1
`[K100600](https://510k.innolitics.com/search/K100600)`
Indications for Use
| <strong>Labels</strong> | <strong>Values</strong> |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number: | not known yet |
| Device Name: | Prosthodontic Screwdriver IA-400 |
| Indication for Use: | The drive unit is an electrically controlled screwdriver with adjustable torques to tighten and unscrew prosthodontic screws. Consisting of: - Cordless drive unit - Mechanical transmission instrument 80:1 |
| <strong>Labels</strong> | <strong>Values</strong> |
|--------------------------------------------------|-------------------------|
| Prescription Use (Part 21 CFR 801 Subpart D) | X |
| Over The Counter Use (Part 21 CFR 807 Subpart C) | |
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kein Muluy for MSR
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: [K100600](https://510k.innolitics.com/search/K100600)
.. '
§ 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.