The PTW T31006 and T31007 Pinpoint type ionization chambers are intended to be used for the collection of beam data in water, air, or other suitable solid state phantom material from radiation therapy treatment machines. This data is used to completely document the beam characteristics of treatment machines and to establish and maintain an on going treatment machine quality assurance program.

Device Description

The PTW T31006 and T31007 are classical waterproof ionization chambers that differ only in the lengths of their respective active volumes. The T31006 is a 0.015 cc ionization chamber with a 5 mm active length and the T31007 is a 0.005 cc ionization chamber with a 2 mm active length. Both chamber volumes are open to the atmosphere, they are waterproof, and they are vented via their connectors. These chambers are constructed of precisely the same materials, are available with a 1 m or 10 m cable for connection to an electrometer, and may be terminated in a variety of standard electrometer connectors (BNT, TNC, PTW M, or BNC banana.

AI/ML Overview

Here's an analysis of the provided text regarding the PTW T31006 and T31007 Pinpoint type ionization chambers for their acceptance criteria and study information:

This submission is a 510(k) Premarket Notification for ionization chambers, which are measurement devices. As such, the concept of "device performance" in terms of clinical outcomes or diagnostic accuracy doesn't directly apply in the same way it would to an imaging or therapeutic device for patients. Instead, the "performance" here relates to their measurement accuracy, precision, and adherence to established specifications compared to predicate devices.

The document primarily demonstrates substantial equivalence to predicate devices rather than a standalone clinical study. Therefore, many of the requested fields regarding a clinical study will not be explicitly present.

Acceptance Criteria and Reported Device Performance

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (Implied)
Indications for Use: Same as predicate devices (PTW T31002, T31003).	Met: Intended for collecting radiation beam data in water, air, or solid-state phantoms from radiation therapy treatment machines to document beam characteristics and for QA programs.
Design: Same as predicate devices.	Met: Classical waterproof ionization chambers, differing only in active volume lengths.
Manufacturing and Testing Processes/Procedures: Same as predicate devices.	Met: Manufacturing and testing processes are identical.
Materials: Same as predicate devices, except for the steel electrode.	Met: Similar materials, with a noted difference in the electrode material but deemed equivalent in safety and effectiveness.
Specifications: Same as predicate devices.	Met: The submission states specifications are the same, implying they meet the same performance benchmarks as the predicate devices.
Safety and Effectiveness: No new issues raised compared to predicate devices.	Met: The manufacturer states no issues regarding safety and effectiveness are raised by the T31006 and T31007.

Explanation of "Acceptance Criteria" for this device:

Since this is a 510(k) submission for a measurement device, the "acceptance criteria" are implicitly defined by demonstrating substantial equivalence to already cleared predicate devices. The primary acceptance criterion is that the new devices do not raise new questions of safety or effectiveness and are equivalent in indications for use, technological characteristics, and performance to the predicate devices. The study, in this context, is the comparison to the predicate device and the assertion of equivalence.

Study Information (Based on 510(k) Submission)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not describe a traditional clinical study with a "test set" of patient data.
The "test" here involves the characterization and comparison of the new devices (PTW T31006 and T31007) against the predicate devices (PTW T31002 and T31003) and their known specifications. The sample size would refer to the number of units tested, but this information is not provided in the summary.
Data provenance (country of origin, retrospective/prospective) is not applicable or stated for this type of submission.

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)

Not applicable. This is not a diagnostic device requiring expert interpretation or ground truth establishment in a clinical context. The "ground truth" for an ionization chamber's performance would be its physical measurement accuracy against traceable standards, which is not detailed in this summary, but would be part of the internal manufacturing and testing processes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical adjudication method is described. The "adjudication" is internal to the manufacturer's quality control and testing processes demonstrating adherence to specifications and equivalence.

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 is not a diagnostic or AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a passive measurement device, not an algorithm. Its operation is standalone in the sense that it collects data without human interpretation during the collection, but the interpretation of the collected data is done by humans.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For a measurement device like an ionization chamber, the "ground truth" would typically be established by comparison to primary or secondary standards in a metrology laboratory, ensuring the device accurately measures radiation dose. This is not explicitly detailed in the 510(k) summary but is implied by the assertion of "specifications are the same as the predicate devices" and "routinely measure, record, and document therapeutic amounts of ionizing radiation with an exceptionally high degree of accuracy and precision."

8. The sample size for the training set

Not applicable. There is no machine learning or AI algorithm involved, so no training set.

9. How the ground truth for the training set was established

Not applicable. No training set.

Summary

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K972212

SEP 1 0 1997

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

510(k) Premarket Notification for PTW T31006 and T31007 Pinpoint type ionization chambers

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

1. Company:
  PTW-New York Corporation 2437 Grand Avenue Belimore, 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

1. Trade/Proprietary Name:
  PTW T31006. 0.015 cc Pinpoint type ionization chamber. waterproof. PTW T31007, 0.005 cc Pinpoint type ionization chamber, waterproof.

Common/Usual Name:

0.015 cc waterproof ionization chamber, 0.005 cc waterproof ionization chamber.

3. Predicate Device(s):

PTW T31002. 0.125 cc waterproof ionization chamber, K954165, and PTW T31003, 0.03 cc waterproof ionization chamber, K954165.

4. Description of Device(s):

The Pinpoint type ionization chamber, when connected to an appropriate electrometer like the PTW-UNIDOS, K951764, are used to collect beam data from radiation therapy treatment machines.

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

510(k) Premarket Notification for PTW T31006 and T31007 Pinpoint type ionization chambers

5. Statement of Intended Use:

Comparison of Technological Characteristics to the Predicate Devices: 6.

The indications for use are exactly the same as the predicate devices, the PTW T31002 - 0.125 cc waterproof ionization chamber, and the PTW T31003 - 0.03 cc waterproof ionization chamber, which were both cleared to market by the FDA under K954165, 5 December 1995, as accessories to the PTW MP3 and MP3S Automatic Water Phantom.

The designs are exactly the same.

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

The materials used are the same as in the predicate devices with the exception of the steel electrode.

The specifications are the same as the predicate devices.

The indications for use, design, materials, manufacturing, and specifications of the PTW T31006 and T31007 Pinpoint ionization chambers do not raise any issues with regard to safety and effectiveness.

PTW considers the T31006 and T31007 Pinpoint ionization chambers equivalent in all respects to the predicate devices for radiation therapy beam data acquisition.

Note: Any statement made in conjunction with this Summary regarding substantial equivalence 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 logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 0 1997

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

Re: K972212

PTW T31006 0.015 cc Pinpoint Type Ionization Chamber PTW T31007 0.005 cc Pinpoint Type Ionization Chamber 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, 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 misbranion.

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 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 Federal 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 vitro 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 vours

W.Liau Yu

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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PTW-New York Corporation 2437 Grand Avenue Bellmore, New York 11701 (P) 1-516-221-4708 (F) 1-516-221-4329

510(k) Premarket Notification for PTW T31006 and T31007 Pinpoint type ionization chambers

June 9, 1997

Premarket Notification Indication For Use Statement

510(k) Number (if known): Not assigned as of June 9, 1997

0.015 cc Pinpoint type ionization chamber, Device Name: 0.005 cc Pinpoint type ionization chamber.

Indications For Use:

High quality ionization chambers, like the PTW T31006 and T31007 Pinpoint type ionization chambers make it possible to routinely measure, record, and document therapeutic amounts of ionizing radiation with an exceptionally high degree of accuracy and precision.

This type of lonization chamber is intended to be used for the collection of radiation beam data from radiation therapy treatment machines in water, air, or other suitable solid state phantoms. Since the T31006 and T31007 Pinpoint chambers are waterproof, they are ideally suited for measurements of high energy photons and electrons in a water phantom.

The data acquired with this type of chamber can be used to completely document the beam characteristics of treatment machines, compile radiation beam data over time as part of a quality assurance program, and to establish an initial baseline for the radiation therapy beams generated by the treatment unit.

High quality ionization chambers, like the PTW Pinpoint type chambers, are essential if accurate data from treatment machines that produce therapeutic amounts of ionizing radiation are to be properly monitored.

tgl.R.Sgl.

Signature:

Date:

Typed Name:

Stephen R. Szeglin

JUNE 9, 199

David A. Seaman

Prescription Use

(Per 21 CFR 801.109)

(Division Sign-Off) Division of Reproductive, Abdominal, ENT. and Radiological Dev 510(k) Number

Attachment B

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.