(231 days)
The 1D Water Phantom WP-3840 and WP-3040 is used to position various radiation detectors in water or air. It consists of a cubic acrylic tank and a precision one-dimensional hand crank. By design it is suitable to act as a phantom according to various protocols such as the AAPM's TG-51protocol.
The Water Phantom WP-3840 and WP-3040 comprises of a one-dimensional precision mechanism attached to an Acrylic water tank. Various radiation detectors can be positioned along a vertical guide rail in different depths according to the application needs. The WP-3840 and WP-3040 consist of the basic acrylic water tank phantom, equipped with a hand crank to move the detector. That hand crank is coupled to a mechanical counter, reset-able position indicator that displays the depth.
This document, a 510(k) Premarket Notification Summary (K173848) for the CNMC Model WP-3840 and WP-3040, primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study or performance evaluation with a dedicated test set and ground truth.
Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and ground truth establishment are not present in this type of regulatory submission.
However, based on the provided text, we can infer the "acceptance criteria" through the comparison made to the predicate device and the "study" by the comparison table and conclusion.
Here's how we can address the questions based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The "acceptance criteria" for equivalency are implicitly defined by the characteristics of the predicate device (Medtec, Inc. - K943199, Model MT-150). The "reported device performance" is a statement of the CNMC Model WP-3840/WP-3040's characteristics.
| Acceptance Criteria (Predicate Device MT-150) | Reported Device Performance (CNMC WP-3840/WP-3040) |
|---|---|
| How the device is used: 1D stand-alone water phantom for absolute dose measurements according to TG-51 and IAEA TRS-398 dosimetry protocols. | How the device is used: Comprises a one-dimensional precision mechanism attached to an Acrylic water tank. Various radiation detectors can be positioned along a vertical guide rail in different depths according to the application needs. |
| Intended use: Radiation dosimetry | Intended use: Radiation dosimetry |
| Detectors: ion chambers, diodes | Detectors: ion chambers, diodes |
| Manual Control: Yes | Manual Control: Yes |
| Travel Range: 0 – 25cm | Travel Range: 0 – 25cm |
| Resolution: 0.1mm | Resolution: 0.1mm |
| Position Indicator: Yes (Mechanical) | Position Indicator: Yes (Mechanical) |
| Position Indicator Resettable: Yes | Position Indicator Resettable: Yes |
| Acrylic Tank Dimensions: 38cm W x 38cm L x 38cm H; 30.5cm W x 38cm L x 38cm H | Acrylic Tank Dimensions: WP3840: 38cm W x 40cm L x 38cm H; WP3040: 30cm W x 40cm L x 38cm H |
| Drain Valve: Yes | Drain Valve: Yes |
| Manufacturing Material: Same as predicate | Manufacturing Material: Exact material as predicate |
| Protocol Compatibility: AAPM TG-51 protocol | Protocol Compatibility: AAPM TG-51 protocol |
Note: The "acceptance criteria" here are not numerical thresholds for performance metrics but rather a qualitative comparison to the established characteristics of the predicate device for demonstrating substantial equivalence.
2. Sample size used for the test set and the data provenance:
This document describes a comparison of device specifications and intended use, not a study involving a "test set" of data or patient samples. Therefore, there is no information about sample size or data provenance (country of origin, retrospective/prospective). The "test" is a comparison of product specifications against a predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is not a study requiring expert-established ground truth on a test set. The "ground truth" for the comparison is the published specifications of the predicate device and the design specifications of the new device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. There is no test set or adjudication process described as this is a comparison of 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 device is a water phantom used for radiation dosimetry, not an AI-assisted diagnostic device for human readers. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device (water phantom), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" in this context is the technical specifications and intended use of the legally marketed predicate device (Medtec, Inc. - K943199, Model MT-150), along with the design and manufacturing specifications of the new device (CNMC WP-3840/WP-3040). There's no biological or clinical ground truth involved.
8. The sample size for the training set:
Not applicable. This document does not describe a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. No training set is described.
In summary:
This 510(k) notification demonstrates substantial equivalence to a predicate device based on comparison of engineering specifications and intended use, rather than a clinical performance study with defined acceptance criteria and a test set like those typically used for diagnostic or AI-based medical devices. The "study" is the comparative analysis presented in the "Similarities/Differences" table.
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August 7, 2018
CNMC Co., Inc. % Mr. Thomas Kraus Vice President R&D 865 Easthagen Drive NASHVILLE TN 37217
Re: K173848
Trade/Device Name: Model WP-3840 and WP-3040 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: July 2, 2018 Received: July 9, 2018
Dear Mr. Kraus:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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,
Michael D. O'Hara
For
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): K173848
Device Name:
Model WP-3840 and WP-3040
Indication for Use:
The Water Phantom WP-3840 and WP-3040 comprises of a one-dimensional precision mechanism attached to an Acrylic water tank. Various radiation detectors can be positioned along a vertical guide rail in different depths according to the application needs. The WP-3840 and WP-3040 consist of the basic acrylic water tank phantom, equipped with a hand crank to move the detector. That hand crank is coupled to a mechanical counter, reset-able position indicator that displays the depth.
Type of Use (Select one or both, as applicable) This devices is not used by individuals.
図Prescription Use (Part 21 CFR 801 Subpart D)
□Over-The-Counter Use (21 CFR 801 Subpart C)
CNMC Company Incorporated 865 Easthagen Drive Nashville, Tennessee 37217
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865 Easthagan Drive, Nashville, TN 37217 phone 615 391 3076 800 635 2662 fax 615 885 0285 www.cnmcco.com www.teambest.com
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510(k) Premarket Notification Summary (K173848)
CNMC Model WP-3840 and WP-3840
| Submitter: | CNMC Company Incorporated865 Easthagen DriveNashville, Tennessee 37217 |
|---|---|
| Contact: | Thomas KrausVice President R&D615-391-3076tkraus@cnmcco.com |
| Date: | July 2, 2018 |
| Trade Names: | Model WP-3840 and WP-3040 |
| Common Name: | 1D Water Phantom |
| Classification Name: | Medical charged-particle radiation therapy system (21 CFR 892.5050) |
| Classification: | Class II |
| Product Code: | IYE |
| Substantial Equivalence: | The CNMC Model WP-3840 and WP-3040 is substantially equivalent to theMedtec, Inc. - K943199. |
| Description and Use: | The Water Phantom WP-3840 and WP-3040 comprises of a one-dimensionalprecision mechanism attached to an Acrylic water tank. Various radiationdetectors can be positioned along a vertical guide rail in different depthsaccording to the application needs. The WP-3840 and WP-3040 consist of thebasic acrylic water tank phantom, equipped with a hand crank to move thedetector. That hand crank is coupled to a mechanical counter, reset-ableposition indicator that displays the depth. |
| Intended Use: | The 1D Water Phantom WP-3840 and WP-3040 is used to position variousradiation detectors in water or air. It consists of a cubic acrylic tank and aprecision one-dimensional hand crank. By design it is suitable to act as aphantom according to various protocols such as the AAPM's TG-51protocol. |
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865 Easthagan Drive, Nashville, TN 37217 phone 615 391 3076 800 635 2662 fax 615 885 0285 www.cnmcco.com www.teambest.com
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Similarities/Differences of the CNMC Model WP3840/WP3040 to their predicate device:
| Model WP-3840/WP-3040 | Model MT-150 | |
|---|---|---|
| How the device is used. | The Water Phantom WP-3840 and WP-3040 comprises of a one-dimensionalprecision mechanism attached to anAcrylic water tank. Various radiationdetectors can be positioned along avertical guide rail in different depthsaccording to the application needs. | The MT-150 is a 1D stand-alonewater phantom for absolute dosemeasurements according to TG-51and IAEA TRS-398 dosimetryprotocols. |
| Intended use | Radiation dosimetry | Radiation dosimetry |
| Detectors | ion chambers, diodes | ion chambers, diodes |
| Manual Control | Yes | Yes |
| Travel Range | 0 – 25cm | 0 – 25cm |
| Resolution | 0.1mm | 0.1mm |
| Position Indicator | Yes (Mechanical) | Yes (Mechanical) |
| Position Indicator Resettable | Yes | Yes |
| Acrylic Tank Dimensions | WP3840: 38cm W x 40cm L x 38cm HWP3040: 30cm W x 40cm L x 38cmH | 38cm W x 38cm L x 38cm H30.5cm W x 38cm L x 38cm H |
| Drain Valve | Yes | Yes |
Brief Comparison: Both the predicate device and the WP-3840/WP-3040 have been developed for use per AAPM TG-51 protocol. Both devices are manufactured from the exact material. Both devices use a manual hand crank for positioning the detectors to the desired position. Both devices have a mechanical counter to give the position of the detector.
- The model WP-3840 and WP-3040 is substantially equivalent to the Conclusion: predicate device for the following reasons:
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- The indication for use of the Model WP-3840 and WP-3040 is exactly the same as the predicate device.
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- The units are very similar in design.
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- The Model WP-3840/WP-3040 and the predicate device are used for the same protocol.
- The Model WP-3840/WP-3040 and the predicate device uses the 4. same material for manufacturing
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- CNMC considers the Model WP-3840/WP-3040 equivalent in all areas to the predicate device.
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865 Easthagan Drive, Nashville, TN 37217 phone 615 391 3076 800 635 2662 fax 615 885 0285 www.cnmcco.com www.teambest.com
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§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.