(112 days)
Portable pressurized system to deliver a solution to a scalar. Scalar being a dental device powered by air or electricity to remove tartar from the teeth requiring a solution for its performance.
The RDH-2000 is a portable bottle system. It dispenses solution from its bottle to a scalar. It is attached to the dental unit's quick disconnect air to pressurize the system. The RDH-2000 is composed of two parts; the manifold and the bottle. The manifold has a male quick disconnect. The quick disconnect connects to the dental units air supply via a female air quick disconnect. The system becomes pressurize only when attached to the dental unit. Within the manifold after the male quick disconnect is an internal preset mini air regulator. This is preset at 35 psi. The pressurized air is vented into the bottle via the top of the manifold is a pressure relief button to allow the bottle to be depressurized before unscrewing. The threads in the manifold accept the 28 mm threads of the bottle. A pick up tube goes to the base of the bottle which allows a means for the solution to exit. The pick up tube goes into the manifold and connects to a female quick disconnect with automatic shut-off. The female quick disconnect with the automatic shut-off prevents solution from being dispensed when the system is pressurized. A scalar with a male quick disconnect can attach at this point. This allows the scalar to obtain solution from the bottle. The bottle is a one liter high density polyethylene bottle. The threads have vertical grooves which acts as a pressure relief valve.
The provided text describes a 510(k) premarket notification for the RDH-2000/C-1310 device, a portable bottle system designed to dispense solution to a dental scalar. However, the document does not contain specific acceptance criteria or a detailed study plan/results in the way one would typically find for performance evaluation of AI/ML devices or complex medical diagnostic systems.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use. The "results of in-house testing" mentioned are very brief and qualitative.
Therefore, many of the requested sections regarding acceptance criteria, sample sizes, ground truth, and expert evaluation cannot be directly extracted from the provided text. I will address each point by stating what is available and what is not.
Acceptance Criteria and Study Details for RDH-2000/C-1310
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|
| Not explicitly defined in the document with specific thresholds or quantitative metrics. | "Results of in-house testing indicated that the RDH-2000 performed to dispense a solution when air activated as designed." (Qualitative Statement) |
| Safety and Effectiveness for intended use | "I believe that the design of the RDH-2000 with the enhancements creates a safe and effective system for its intended use." (Qualitative Opinion) |
Notes: The document focuses on demonstrating substantial equivalence rather than meeting specific, quantitative performance acceptance criteria typical for diagnostic devices. The "in-house testing" description is very high-level and does not provide specific performance metrics or thresholds.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document only mentions "in-house testing" without detailing the number of units tested, solutions used, or conditions applied.
- Data Provenance: Not specified, but implied to be internal testing conducted by Anodia Systems.
- Retrospective or Prospective: Not specified.
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)
- Number of Experts: Not applicable or specified. The testing described appears to be functional or engineering-based ("performed to dispense a solution when air activated") rather than requiring expert judgment for ground truth establishment.
- Qualifications of Experts: Not applicable or specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable or specified. The nature of the "in-house testing" does not suggest a need for expert adjudication.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done.
- Effect Size of AI Improvement: Not applicable, as this device (RDH-2000) is a mechanical device for fluid delivery, not an AI-assisted diagnostic or decision-support tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: The "in-house testing" can be considered a form of standalone performance assessment of the device's basic function ("performed to dispense a solution when air activated"). However, it's not described as a formal study with statistical rigor, but rather a functional verification.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not formally established as with diagnostic devices. The "ground truth" for the in-house testing would simply be whether the device successfully dispensed solution when air activated, as intended by its engineering design. This is a functional verification against its design specifications rather than a comparison to a clinical gold standard.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This document describes a traditional medical device (fluid delivery system), not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable, as this is not an AI/ML device.
Summary of Device Performance (from the text):
The primary statement regarding performance is:
"Results of in-house testing indicated that the RDH-2000 performed to dispense a solution when air activated as designed."
The submission focuses on demonstrating substantial equivalence to predicate devices (K882491, K962665) by highlighting similar technological characteristics and enhancements that contribute to safety and effectiveness, such as:
- High-density polyethylene bottle (reservoir) with vertical grooves for pressure relief.
- Delrin material for manifolds.
- Pressure regulators.
- Pressurized by air to dispense solution.
It also notes enhancements in the RDH-2000:
- Pressure relief valve.
- Preset pressure regulator valve in the manifold.
- Male quick disconnect for portability.
- Female quick disconnect with automatic shut-off to prevent free dispensing.
In conclusion, the provided document does not contain the detailed, quantitative acceptance criteria and study results typically found for performance studies of diagnostic or AI/ML devices. It is a 510(k) summary focused on demonstrating substantial equivalence of a general dental operative unit and accessories (a fluid delivery system) through a comparison of technological characteristics and a qualitative statement about in-house functional testing.
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ANODIA SYSTEMS
Dr. Thad Overmyer 514 South Third Street Danville, Ky 40422
Phone: 1-866-246-2548 Fax: 1-866-926-8246
510 (k) Summary
Anodia Systems Dr. Thad Overmyer General Manager/Owner 514 South Third Street Danville, Kentucky 40422 TEL: 859-236-4778 FAX: 859-236-9136 Dr. Thad Overmyer September 18, 2002
JAN 16 2003
Device:
- Trade Name-RDH-2000 �
- Common Name-Bottle System �
- Classification-Dental operative unit and accessories (per 21CFR section 872.6640) �
Legally Market Devices of Equivalence
- K882491, Cutting Fluid System for Dental High Speed Drills, Steri-Sol Inc. �
- K962665, A-Dec Self-Contained Water System A-Dec, Inc. �
Description: The RDH-2000 is a portable bottle system. It dispenses solution from its bottle to a scalar. It is attached to the dental unit's quick disconnect air to pressurize the system.
The RDH-2000 is composed of two parts; the manifold and the bottle. The manifold has a male quick disconnect. The quick disconnect connects to the dental units air supply via a female air quick disconnect. The system becomes pressurize only when attached to the dental unit. Within the manifold after the male quick disconnect is an internal preset mini air regulator. This is preset at 35 psi. The pressurized air is vented into the bottle via the top of the manifold is a pressure relief button to allow the bottle to be depressurized before unscrewing. The threads in the manifold accept the 28 mm threads of the bottle. A pick up tube goes to the base of the bottle which allows a means for the solution to exit. The pick up tube goes into the manifold and connects to a female quick disconnect with automatic shut-off. The female quick disconnect with the automatic shut-off prevents solution from being dispensed when the system is pressurized. A scalar with a male quick disconnect can attach at this point. This allows the scalar to obtain solution from the bottle.
The bottle is a one liter high density polyethylene bottle. The threads have vertical grooves which acts as a pressure relief valve.
Intended Use: The RDH-2000 is designed for the use of furnishing a scalar which does not have a reservoir for solutions. The RDH-2000 connects to air quick disconnect of the dental unit to pressurize the RDH-2000. The quick disconnect makes the system portable and convenient to store when not in use.
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Technological Characteristics: The RDH-2000 has a high density polyethylene bottle (reservoir) as the Adec Self-Contained Water System ( K 962665). The both have vertical grooves to act as a pressure relief valve. The manifolds of Adec and RDH-2000 are constructed from delrin material. The Adec Self-Contained Water System, Cutting Fluid System (K882491), and the RDH-2000 have pressure regulators. These devices are pressurized by air to dispense a solution.
The RDH-2000 has the following enhancements: 1) pressure relief valve to allow release of pressure from bottle before unscrewing the bottle; 2. preset pressure regulator valve built into the manifold to prevent tampering; 3. male quick disconnect for attachment to dental unit allowing RDH-2000 to be removed and stored when not in use; and 4. female quick disconnect with automatic shut off preventing solution from being dispensed freely from reservoir when RDH-2000 is pressurized.
Results of in-house testing indicated that the RDH-2000 performed to dispense a solution when air activated as designed.
I believe that the design of the RDH-2000 with the enhancements creates a safe and effective system for its intended use.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected and appear to be part of a single, flowing design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the image.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
.Dr. Thad Overmyer Anodia Systems 514 South Third Street Danville, Kentucky 40422
JAN 16 2003
Re: K023213
Trade/Device Name: RDH-2000/C-1310 Regulation Number: 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: December 30, 2002 Received: January 3, 2003
Dear Dr. Overmyer:
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 - Dr. Overmyer
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 (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) you may obtain. Other general information on vour 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.gov/cdrh/dsma/dsmamain.html
Sincerely yours
Timothy 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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510(k) Number (if known): _ K023213
Device Name: RDH-2000/C-1310
Indications For Use:
Portable pressurized system to deliver a solution to a scalar. Scalar being a dental device powered by air or electricity to remove tartar from the teeth requiring a solution for its performance.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use (Per 21 CFR 801.109
Over-The-Counter Use
(Optional Format 1-2-9)
Susan Dunne
ign-Off)
Anesthesiology, General Hospital,
Anesthesiology, General Devices
510(k) Number
§ 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.