The PTW T10004 MULTIDOS is a multiple-purpose, multiple-channel electrometer inlended to perform a range of measuring tasks in radiation therapy. As a stand alone dosemeter, MULTIDOS is intended to be used to measure the dose delivered to a palient during a radiation therapy treatment. Dose measurements during treatment may be accomplished by using suitable ionization chambers or solid state detectors and are used to compare and to verify treatment dose to prescribed dose.

When connected to the optional QC6PLUS, MULTIDOS is intended to be used to measure the beam characteristics of radiation therapy treatment machines. Data acquired with the MULTIDOS and the QC6PLUS is used to compile radiation beam data over time as part of a quality assurance program.

High quality dosimetry devices like the PTW T10004 MULTIDOS and the optional T42007 QC6PLUS make it possible to routinely measure, record, document and verify therapeutic amounts of ionizing radiation with an exceptionally high degree of accuracy and precision. High quality multiple purpose dosimetry devices are essential if accurate data from trealment machines that produce therapeutic amounts of ionizing radiation are to be properly monitored.

Device Description

The PTW T10004 MULTIDOS is a field class multiple-purpose multiple-channel electrometer. This device is designed to accurately measure dose, dose rate, charge, and current for photons and electrons in the therapeutic energy ranges. MULTIDOS may be configured as a stand alone 2, 6, or 12 channel electrometer and can be used with suitable ionization chambers and solid state detectors.

The PTW T42007 QC6PLUS is a therapy beam constancy device which may configured with 6 or 10 individual 0.54 cm³ ionization chambers orthogonally arranged and imbedded in a 5 cm thick PMMA slab. When the QC6PLUS is connected to MULTIDOS, therapy beam parameters like flatness, symmetry, energy stability, and central beam dose are easily monitored.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the PTW T10004 MULTIDOS and PTW T42007 QC6PLUS devices. It declares that the devices are substantially equivalent to their predicate devices and focuses on their technical specifications, intended use, and comparison to existing products.

Crucially, this document does NOT contain information about acceptance criteria or a study proving that the device meets such criteria. It's a regulatory filing for market clearance based on substantial equivalence, not a performance study report.

Therefore, I cannot provide the requested information. The text does not include:

A table of acceptance criteria and reported device performance.
Sample sizes used for test sets or data provenance.
Number or qualifications of experts used to establish ground truth.
Adjudication methods.
Information on multi-reader multi-case (MRMC) comparative effectiveness studies.
Results of a standalone (algorithm only) performance study.
The type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

The document primarily establishes that the new devices have the "same" indications for use, designs, manufacturing processes, materials, and specifications as their predicate devices, which were already on the market. This claim of "substantial equivalence" is the basis for their 510(k) clearance, not a new performance study against defined acceptance criteria.

Summary

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SEP 1 0 1997

PTW-New York Corporation 2437 Grand Avenue Bellmore, New York 11710

510(k) Premarket Notification for PTW T10004 and T42007 MULTIDOS and QC6PLUS

q72211

Manufacturer's 510(k) Summary Certification, 21 CFR 807.92:

1. Company:
  PTW-New York Corporation 2437 Grand Avenue Bellmore, New York 11710 (P) 1-516-221-4708 (F) 1-516-221-4329

Contact:

Stephen R. Szeglin General Manager PTW-New York Corporation (P) 1-516-221-4708 (F) 1-516-221-4329

Date of Submission:

June 9, 1997

2. Trade/Proprietary Name:

PTW T10004, MULTIDOS, Multiple Channel Dosemeter, PTW T42007, QC6PLUS, Therapy Beam Evaluation System.

Common/Usual Name:

Multiple channel electrometer, Therapy beam constancy check device.

Predicate Device(s): 3.

MULTIDOS:

PTW T10006, MULTIDOS ME48, 48 channel electrometer, K954165, and Nuclear Associates, 37-702 and 37-703, PC Rainbow, K900932.

QC6PLUS:

Keithley 35300, Tracker™, Therapy Beam Evaluation System, K874893

Description of Device(s): 4.

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PTW-New York Corporation 2437 Grand Avenue Bellmore, New York 11710

510(k) Premarket Notification for PTW T10004 and T42007 MULTIDOS and QC6PLUS

5. Statement of Intended Use:

: 1

The PTW T10004 MULTIDOS as a stand alone dosemeter is intended to be used to measure the dose delivered to a patient during a radiation therapy treatment. Dose measurements during treatment may be accomplished by using suitable ionization chambers or solid state detectors. Data acquired by MULTIDOS is used to compare and to verify treatment dose to prescribed dose.

The PTW T42007 QC6PLUS cable connects to MULTIDOS and is intended to be used to measure the beam characteristics of radiation therapy freatment machines. Data acquired with the MULTIDOS and the QC6PLUS is used to compile radiation beam data over time as part of a quality assurance program.

6. Comparison of Technological Characteristics to the Predicate Devices:

The indications for use of the MULTIDOS and the QC6PLUS are exactly the same as the predicate devices.

The designs are essentially the same as the predicate devices.

The manufacturing and testing, process and procedures are the same.

The materials used are the same as in the predicate devices.

The specifications are the same as the predicate devices.

The indications for use, design, materials, manufacturing, and specifications of the PTW T10004 MULTIDOS and T42007 QC6PLUS do not raise any issues with regard to safety and effectiveness.

PTW considers the T10004 MULTIDOS and T42007 QC6PLUS equivalent in all respects to the predicate devices for radiation therapy beam measurements.

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.

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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a serif font. The text is black and the background is white. The text is slightly slanted.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 0 1997

Re:

Stephen R. Szeglin General Manager PTW-New York Corporation 2437 Grand Avenue Bellmore, New York 11710

K972211 Multidos Multi Channel Electrometer and QC6PLUS Constancy Check Device Dated: June 9, 1997 Received: June 12, 1997 Regulatory class: II 21 CFR 892.5050/Procode: 90 LHN

Dear Mr. Szeglin:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Fedgral Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 809.10 for in yitre diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours

H.J.Liau Yin

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number (if known): K9722//

Device Name: MULTIDOS AND QC6 PLUS
PTW T10004 PTW T42007

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David h. Sygmm

(Division Sign-Off) Division of Reproductive. Abdominal. EN and Radiological Device 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 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.