(231 days)
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No
The description details a mechanical device with a hand crank and mechanical counter. There is no mention of software, algorithms, or any terms related to AI or ML.
No.
The device is described as a water phantom used to position radiation detectors for quality assurance in radiation therapy, not for direct therapeutic application to a patient.
No
The device is described as a "water phantom" used to position radiation detectors for quality assurance and calibration, not for diagnosing medical conditions in patients.
No
The device description explicitly details physical components such as an acrylic water tank, a precision mechanism, a hand crank, and a mechanical counter. These are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is to "position various radiation detectors in water or air" and act as a "phantom according to various protocols such as the AAPM's TG-51 protocol." This describes a device used for calibrating or verifying radiation therapy equipment, not for testing biological samples from the human body.
- Device Description: The description focuses on the mechanical aspects of positioning a detector within a water tank. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
- Lack of IVD-related terms: The document does not contain any terms typically associated with IVD devices, such as "in vitro," "diagnostic," "sample," "assay," "analyte," "biological specimen," etc.
- Intended User/Care Setting: While it is Prescription Use, this is common for medical devices used in a clinical setting, not exclusively for IVDs.
- Predicate Device: The predicate device (K943199) is a "Medtec, Inc. - MT-150," which is also a water phantom used in radiation therapy. This further supports the device's use in a non-IVD context.
In summary, the Water Phantom WP-3840 and WP-3040 is a device used in the field of radiation therapy for positioning detectors and acting as a phantom for calibration and verification purposes. This is distinct from the definition and function of an In Vitro Diagnostic device.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
IYE
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left and consists of a stylized emblem. The FDA logo is on the right and includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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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Image /page/2/Picture/0 description: The image is a logo for a company called "CNMC a Best Medical International company". The logo is made up of the letters "CNMC" in a stylized font. The top half of the letters are blue, and the bottom half of the letters are green. There is a plus sign to the right of the "C" in "CNMC".
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
Image /page/2/Picture/13 description: The image features the logo for Best Healthcare for Everyone. The logo consists of a circle of green figures holding hands above the word "Best" in a stylized font. Below "Best" is the tagline "healthcare for everyone" in a smaller, simpler font. The background is a gradient of blue, with a lighter shade at the top and a darker shade at the bottom.
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Image /page/3/Picture/0 description: The image shows the logo for CNMC, which is a Best Medical International company. The letters CNMC are stacked on top of each other, with the top letters in blue and the bottom letters in green. There is a green plus sign to the right of the letters.
510(k) Premarket Notification Summary (K173848)
CNMC Model WP-3840 and WP-3840
| Submitter: | CNMC Company Incorporated
865 Easthagen Drive
Nashville, Tennessee 37217 |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Thomas Kraus
Vice President R&D
615-391-3076
tkraus@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 the
Medtec, Inc. - K943199. |
| Description and 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. |
| Intended Use: | 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. |
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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
Image /page/3/Picture/6 description: The image shows a logo for an organization that promotes healthcare for everyone. The word "Best" is written in a stylized font, with the tagline "healthcare for everyone" underneath. Above the word "Best" is a graphic of people holding hands in a circle.
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Image /page/4/Picture/0 description: The image shows the CNMC logo. The logo is split into two colors, with the top half being blue and the bottom half being green. Below the logo, the text "a Best Medical International company" is written in a smaller font.
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-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 MT-150 is a 1D stand-alone | |
| water phantom for absolute dose | ||
| measurements according to TG-51 | ||
| and IAEA TRS-398 dosimetry | ||
| protocols. | ||
| 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 H | |
| WP3040: 30cm W x 40cm L x 38cmH | 38cm W x 38cm L x 38cm H | |
| 30.5cm 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
Image /page/4/Picture/12 description: The image features a logo for "Best healthcare for everyone." The logo includes a green circle of people holding hands above the word "Best." The background is a gradient of blue and white, with the blue dominating the lower portion of the image.