(108 days)
Transport II offers the dental professional the capability of carrying a complete dental operative system in one transportable case. The system is ideally suited for performing general dental procedures anywhere there is a suitable power source.
Portable Electrical Dental System that combine an autoclavable micro motor, dental irrigation, high and low volume suction and Ultrasonic scaler into a single transportable carrying case into which all features have been integrated.
The provided text describes a 510(k) summary for a dental operative system, not a study involving AI or complex performance metrics. Therefore, many of the requested categories for acceptance criteria and study details are not applicable as this is a traditional medical device submission focused on substantial equivalence to a predicate device.
Here's an analysis based on the provided text, indicating where information is present or not applicable:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the way one would for an AI/CADe system with performance metrics like sensitivity, specificity, or AUC. Instead, it focuses on substantial equivalence to predicate devices and compliance with safety standards.
| Criterion | Reported Device Performance / Compliance |
|---|---|
| Electrical and Mechanical Safety (Handpiece Drive System) | Complies with IEC 601.1. Tested and listed under UL 2601.1 (UL File number E208087). |
| Irrigation and Suction System Equivalence | Substantially equivalent to previously marketed device "Asepti-mini" ADU-10 (K905401). |
| Material Compatibility (Water/Wastewater lines, Containers) | Made of polyethylene or polyurethane (lines), PET or Polypropylene (containers). Materials are commonly used in similar dental applications and are able to be disinfected using common bleach/water rinsing without deterioration. |
| Sterilization of Motor Exterior | Designed so that the exterior surface can be sterilized in a steam autoclave between each patient use. |
| Ultrasonic Scaler Safety (if included) | Provided with all accompanying labels and instructions for use from the original manufacturer's packaging. Additionally evaluated along with the entire system by Underwriter's Laboratories to internationally recognized safety standards for medical devices (ref UL 2601.1). |
| Performance - Handpiece Motor (Torque, Cooling, Connection) | More powerful electric Handpiece motor offers more torque and runs cooler than previous models. Uses the same methods for powering and connecting contra angles used in previously marketed devices (K882526/A). |
| Indications for Use / Intended Purpose | "Offers the dental professional the capability of carrying a complete dental operative system in one transportable case. The system is ideally suited for performing general dental procedures anywhere there is a suitable power source." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable to this type of device submission. There is no "test set" in the context of clinical data for performance evaluation as would be seen for an AI/CADe device. The assessment is based on engineering specifications, material properties, safety testing, and substantial equivalence claims to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable. There is no "ground truth" in the clinical sense mentioned in this 510(k) summary. The evaluation focuses on adherence to engineering standards and comparisons to physical properties of previously cleared devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. No clinical test set requiring adjudication is described.
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
This is not applicable. This device is a dental operative system, not an AI or imaging diagnostic tool. An MRMC study is not relevant to its type of evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This is not applicable. Performance is assessed against engineering standards (e.g., IEC 601.1, UL 2601.1) and by demonstrating substantial equivalence to predicate devices, not by clinical ground truth.
8. The sample size for the training set
This is not applicable. The device is not an AI/machine learning system that requires a training set.
9. How the ground truth for the training set was established
This is not applicable. There is no training set mentioned or implied.
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022217
OCT 2 4 2002
510(k) Summary
Contact: Grant Ramaley
Date Prepared: May 23, 2002
| Trade or Proprietary Name: | Transport II - Model Number: AEU-425 |
|---|---|
| Portable Electronic Dental Operative System |
Classification Name: D Dental Operative Unit (872.6640)
Description of Transport II's characteristics
Portable Electrical Dental System that combine an autoclavable micro motor, dental irrigation, high and low volume suction and *Ultrasonic scaler into a single transportable carrying case into which all features have been integrated.
Features
-
- Low voltage electric handpiece motor with forward, reverse and speed control.
- a. More powerful electric Handpiece motor offers more torque and runs cooler than previous models.
- b. Uses the same methods for powering and connecting contra angles used in the previously marketed devices covered by Aseptico's previous approval under K882526/A
- c. The electrical and mechanical safety of the handpiece drive system complies with IEC 601.1 and is to be Classified under the U.S. version of Underwriters Laboratories UL 2601.1 - This product is tested and listed under UL File number E208087.
- d. The motor is designed so that the exterior surface can be sterilized in a steam autoclave between each patient use.
-
- Irrigation and suction.
- a. The irrigation and suction systems employed by the AEU-425 are substantially equivalent to the previously marketed device "Asepti-mini" ADU-10 covered by 510(k) K905401.
- b. All water, waste water lines are made of polyethylene or polyurethane. Containers are made form either PET or Polyproplyene. All materials are commonly used in similar dental applications and are able to be disinfected using common bleach/water rinsing without suffering deterioration.
-
- *Can be provided with an Ultrasonic Scaler.
*The optional ultrasonic Scaler is provided with all accompanying labels and instructions for use that are part of the original manufacturer's packaging . Any scaler sold with the Transport II is additionally evaluated along with the entire system by Underwriter's Laboratories to internationally recognized safety standards for medical devices (ref UL 2601.1).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol consists of three stylized human profiles facing right, stacked on top of each other. The profiles are rendered in black and have a flowing, ribbon-like appearance.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 4 2002
Mr. Grant Ramaley Quality Assurance and Regulatory Affairs Aseptico, Incorporated 833 216th Street S.E. Woodinville, Washington 98072
Re: K022217
Trade/Device Name: Transport II Model Number AEU-425 Portable Electronic Dental Operative System Regulation Number: 872.6640 and 872.4200 Regulation Name: Dental Operative Unit and Accessories and Dental Handpiece and Accessories Regulatory Class: I Product Code: EIA and EKX Dated: October 10, 2002 Received: October 10, 2002
Dear Mr. Ramsey:
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 - Mr. Ramsey
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 (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.
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html
Sincerely vou
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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KC22217
Page
510(k) Number (if known)
Device Name:
Transport II Model Number AEU-425 Portable Electronic Dental Operative System
Indications For Use:
Transport II offers the dental professional the capability of carrying a complete dental operative system in one transportable case. The system is ideally suited for performing general dental procedures anywhere there is a suitable power source.
Kshetz DDS for Dr Susan Renner
eneral Hospital.
510(k) Number: K022217
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per CFR 801.109) OR
Over-The-Countern Use_
(Optional Format 1-2-96)
§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.