(63 days)
Not Found
No
The description explicitly states the software is "for recording or logging measurement data only" and there are no mentions of AI, ML, or related concepts.
No
The device is described as an IMRT QC check device for verifying radiation beam data and leaf positions from medical accelerators, not for direct therapeutic application to a patient.
No
The device is used for quality assurance of medical accelerators, specifically for verifying treatment doses and leaf positions in IMRT radiotherapy, not for diagnosing a patient's medical condition.
No
The device description explicitly states it is a "transparent, segmented, multi-wire ionization chamber" with attached electronics, which are hardware components. While it includes software for data logging, it is not solely software.
Based on the provided information, the PTW DAVID is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used for IMRT QC checks and verification measurements of leaf positions and doses from medical accelerators used for radiotherapy. It's about measuring radiation output and verifying treatment delivery, not analyzing biological samples from the human body.
- Device Description: The description details a transparent, segmented, multi-wire ionization chamber designed for use with medical linear accelerators. This is a device for measuring radiation, not for performing tests on biological specimens.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or prognosis of diseases or conditions
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. The PTW DAVID is designed to measure and verify the performance of a medical device (the linear accelerator) used on the human body.
N/A
Intended Use / Indications for Use
The PTW DAVID is a transparent, multiple wire or multiple segment ionization chamber intended to be used for QC verification measurements and documentation of the leaf positions and doses from medical accelerators used for IMRT radiotherapy sequences. Data acquired by the PTW DAVID is used to compare and to verify a treatment dose to a prescribed dose and to compile radiation beam data, consistency, over time as part of a quality assurance program.
Product codes
IYE
Device Description
The PTW DAVID system MLC-29 is a transparent, segmented, multi-wire ionization chamber with 37 wires or segments. It is designed for operation in medical hierar accelerators with 29 multi-leaf collimator pairs.
The PTW DAVID system MLC-80 is a transparent, segmented, multi-wire ionization chamber with 40 wires or segments. It is designed for operation in medical hiear accelerators with 40 multi-leaf collimator pairs.
The PTW DAVID system MLC-120 and MLC-80 are transparent, segmented, multiwire ionization chamber with 80 and 40 wires or segments. They are desioned for operation in medical linear accelerators with 60 or 40 multi-leaf collimator pairs.
The software for the PTW DAVID is for recording or logging measurement data only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows a series of handwritten alphanumeric characters. The characters appear to be "K062817". The characters are written in black ink on a white background. The handwriting is somewhat stylized, with some characters slightly distorted or overlapping.
PTW-New York Corporation 205 Park Ave., Hicksville, New York 11801 (P) 1-516-827-3181 (F) 1-516-827-3184
510(k) Premarket Notification for the PTW DAVID, an IMRT QC Check Device
Manufacturer's 510(k) Summary Certification, 21 CFR 807.92(h):
-
- Company:
PTW-New York Corporation 205Park Avenue Hicksville, New York 11801 (P) 1-516-827-3181 (F) 1-516-827-3184
- Company:
NOV 2 2 2005
Contact:
Richard D. Barker PTW-New York Corporation (P) 1-516-827-3181 (F) 1-516-827-3184
Date of Submission: July 18, 2006
-
- Trade/Proprietary Name: PTW DAVID
Common/Usual Name: IMRT QC check device
- Trade/Proprietary Name: PTW DAVID
-
- Predicate Device(s): PTW QC6Plus, K972211
4. Description(s) of Device:
The PTW DAVID system MLC-29 is a transparent, segmented, multi-wire ionization chamber with 37 wires or segments. It is designed for operation in medical hierar accelerators with 29 multi-leaf collimator pairs.
The PTW DAVID system MLC-80 is a transparent, segmented, multi-wire ionization chamber with 40 wires or segments. It is designed for operation in medical hiear accelerators with 40 multi-leaf collimator pairs.
The PTW DAVID system MLC-120 and MLC-80 are transparent, segmented, multiwire ionization chamber with 80 and 40 wires or segments. They are desioned for operation in medical linear accelerators with 60 or 40 multi-leaf collimator pairs.
The software for the PTW DAVID is for recording or logging measurement data only.
1
PTW-New York Corporation 205 Park Ave., Hicksville, New York 11801 (P) 1-516-827-3181 (F) 1-516-827-3184
510(k) Premarket Notification for the PTW DAVID, an IMRT QC Check Device
Manufacturer's 510(k) Summary Certification, 21 CFR 807.92(h) (continued):
5. Statement of Intended Use:
The PTW DAVID is a transparent, multiple wire or multiple segment ionization chamber intended to be used for QC verification measurements and documentation of the leaf positions and doses from medical accelerators used for IMRT radiotherapy sequences. Data acquired by the PTW DAVID is used to compare and to verify a treatment dose to a prescribed dose and to compile radiation beam data, consistency, over time as part of a quality assurance program.
6. Comparison of Technological Characteristics to the Predicate Devices:
The technological specifications of the PTW DAVID meet or exceed that of the predicate device since both devices are produced by the same manufacturer.
Safety and effectiveness between the Dosimetry Diode and the predicate device is not an issue since the PTW DAVID is designed in full accordance with the applicable sections of the following standards:
| IEC 60601-1: | Medical Electrical Equipment - Part 1: General requirements
for safety and essential performance, |
|----------------|------------------------------------------------------------------------------------------------------|
| IEC 60601-1-2: | Medical Electrical Equipment - Electromagnetic emissions
compatibility – Requirements and tests |
| UL 60601-1: | US Medical Equipment -Part 1: General requirements safety
and essential performance. |
The manufacturing, testing, and the process and procedures that are used to produce the PTW DAVID and the predicate device are in full compliance with our ISO 9001 certification. Both devices are CE marked with CE 0124.
It is our opinion that the indications for use, design, materials, manufacturing, and specifications of the PTW DAVID do not raise any issues with regard to safety and effectiveness
PTW considers the PTW DAVID to be substantially equivalent to the predicate device.
- Any statement made in conjunction with this Summary regarding substantial equivalence Note: to another product was made in relation to the 510(k) premarket approval process and should not be interpreted as an admission or used as evidence in patient infringement litigation.
2
Image /page/2/Picture/1 description: The image shows a circular seal or logo. The text "DEPARTMENT OF HEALTH & HUMAN" is arranged around the left side of the circle. To the right of the text is a symbol consisting of three abstract human figures or shapes, stacked vertically. The overall design is simple and monochromatic.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
NOV 2 2 2006
Mr. Richard D. Barker Official Correspondent PTW- New York Corporation 205 Park Avenue NICKSVILLE NY 11801
Re: K062817
Trade/Device Name: PTW-DAVID Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: September 12, 2006 Received: September 26, 2006
Dear Mr. Barker:
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, or and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You most, therefore, market the device, subject to the general controls provisions of the Act. That. 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 (Premarket Approval), 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.
Image /page/2/Picture/10 description: The image is a circular logo with the text "1906-2006" at the top and "Centennial" in the middle. The letters "FDA" are prominently displayed in the center of the logo. There are three stars below the word "Centennial". The text around the circle is difficult to read due to the image quality.
Protecting and Promoting Public Health
3
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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2 -
4
510(k) Number (if known):
Device Name:
PTW DAVID
Indications For Use:
The PTW DAVID is a transparent multiple wire or multiple segment ionization chamber with attached electronics. It is intended to be used as an IMRT QC check device to make verification measurements and provide documentation of the leaf positions and doses from medical accelerators used for IMRT radiotherapy sequences. Data acquired by the PTW DAVID is used to compare and to verify a treatment dose to a prescribed dose and to compile radiation bear data, consistency, over time as part of a quality assurance program.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ✓
Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K062817
(Optional Format 3-10-98)