STANDARD IMAGING IVB 1000 WELL CHAMBER by STANDARD IMAGING, INC.

The Standard Imaging IVB 1000 Well Chamber is a well-type chamber. It is specifically designed to measure the amount of radiation of high-dose-rate (HDR), low-dose-rate (LDR) and intravascular (IVB) brachytherapy (gamma and beta) sources, with the appropriate calibration from an accredited dosimetry calibration laboratory. Sources must be measured using the appropriate and specific source holder as described in the IVB 1000 labeling. To check the bremstralung component of a source, the X-Ray Contamination Test Tool, an accessory to the IVB 1000, should be used. It is recommended that the chamber be calibrated every two years, as is standard practice for other ionization chambers. Initially, the calibration factor is given in the calibration report from an Accredited Dosimetry Calibration Laboratory (ADCL). The measurement of brachytherapy sources requires an electrometer with a calibrated scale for measuring currents in the range from 10-12 A to 10-7A. Alternatively, a calibrated charge scale may be used with timed runs. If integral charge techniques are used with the time determined by the HDR irradiator timer, the contribution from the source transit-time should be taken into account. The IVB 1000 Well Chamber has a vent hole to maintain the internal air at ambient atmospheric pressure. Thus, the readings obtained must be corrected for ambient temperature and pressure to the temperature and pressure of calibration (22º C and 760 mm Hg) at "normal" relative humidity (50% ± 25%non-condensing) in the usual accepted manner. The IVB 1000 has available different inserts for IVB, HDR, LDR and X-Ray contamination measurements. The IVB 1000 Well Chamber has a conventional triax connector and cable to be connected to a suitable electrometer. A bias of 300 volts must be applied to the electrometer low-impedance connection relative to chassis ground. The voltage polarity effect is less than 0.1%. If desired, a second bias level of 150 volts can also be used to determine the ionic recombination loss at 300 V.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device, the Standard Imaging IVB 1000 Well Chamber. This document establishes substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and a standalone study for the current device's performance.

Therefore, much of the requested information regarding acceptance criteria, specific device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies is not present in this type of regulatory submission.

However, I can extract information related to the device's validation and the basis for its equivalence.

Here's a breakdown of the available information:

1. Table of acceptance criteria and the reported device performance:

This document does not specify quantitative acceptance criteria or detailed performance metrics. The submission focuses on demonstrating substantial equivalence to a previously cleared device.

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

Not applicable. There is no specific "test set" described for a standalone performance study. The validation mentioned is "calibration testing."

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. The ground truth for a dosimeter is typically established through a highly calibrated and regulated process, not by a panel of medical experts in the way, for instance, image classification ground truth would be established. The calibration testing was conducted by an "Accredited Dosimetry Calibration Laboratory."

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

Not applicable. There is no expert adjudication method described for this type of device validation.

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 an ionization chamber for measuring radiation, not an AI-powered diagnostic tool that human readers would use.

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

The device itself is a standalone measurement instrument. The document states: "The Standard Imaging IVB 1000 Well Chamber has been validated through calibration testing conducted by the University of Wisconsin - Madison, Department of Medical Physics Accredited Dosimetry Calibration Laboratory." This implies a standalone evaluation of the device's accuracy in measuring radiation. However, no specific performance metrics from this testing are provided in this regulatory summary.

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

The "ground truth" in this context would be the highly accurate and traceable measurements provided by a primary or secondary standard dosimetry laboratory during the calibration process. The device's measurements are compared against these known, precise radiation values.

8. The sample size for the training set:

Not applicable. This is a physical measurement device, not a machine learning model that requires a training set.

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

Not applicable.

Summary of what is known from the provided text:

Device: Standard Imaging IVB 1000 Well Chamber.
Purpose: To measure the amount of radiation from high-dose-rate (HDR), low-dose-rate (LDR), and intravascular (IVB) brachytherapy (gamma and beta) sources.
Validation Method: "Calibration testing conducted by the University of Wisconsin - Madison, Department of Medical Physics Accredited Dosimetry Calibration Laboratory."
Substantial Equivalence: The device is considered substantially equivalent to the Standard Imaging HDR 1000 Plus/ IVB 1000 Well Chambers (cleared under K001825) in "design concepts, technologies, materials and intended uses."
Standards: Designed to comply with applicable portions of IEC 601-1:1988 and IEC 60731:1997.
Operating Conditions: Readings must be corrected for ambient temperature and pressure (to 22ºC and 760 mm Hg at 50% ± 25% non-condensing humidity).
Bias: Requires a bias of 300 volts, with a voltage polarity effect less than 0.1%.

Conclusion:

This 510(k) summary provides evidence of substantial equivalence to a predicate device and mentions calibration testing by an accredited laboratory as its validation. It does not contain the detailed quantitative performance metrics, acceptance criteria, or study design information typically found for novel device performance studies, especially those involving AI or human interpretation. The "study" here is the calibration process, which verifies the device's accuracy against recognized dosimetry standards.

Summary

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NOV 0 9 2001

October 24, 2001

K013548

Page 1 of 2

510(k) Summary of Safety and Effectiveness Information for the Subject: Standard Imaging IVB 1000 Well Chamber

Standard Imaging IVB 1000 Well Chamber Proprietary Name:

Ion Chamber Common Name:

Class II - 21CFR892.5700, 90JAQ or Classification: Class I - 21CFR892.5650, 90IWJ

Radiology Panel:

Raymond Riddle, Vice President, Regulatory Affairs Contact Person:

Class I - 21CFR892.1940, 90LHO

The 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 1992.

The Standard Imaging IVB 1000 Well Chamber is substantially equivalent to the Standard Imaging HDR 1000 Plus/ IVB 1000 Well Chambers, which were cleared by FDA with 510(k) premarket notification K001825.

It is recommended that the chamber be calibrated every two years, as is standard practice for other ionization chambers. Initially, the calibration factor is given in the calibration report from an Accredited Dosimetry Calibration Laboratory (ADCL).

The measurement of brachytherapy sources requires an electrometer with a calibrated scale for measuring currents in the range from 10-12 A to 10-7A. Alternatively, a calibrated charge scale may be used with timed runs. If integral charge techniques are used with the time determined by the HDR irradiator timer, the contribution from the source transit-time should be taken into account.

Image /page/0/Picture/14 description: The image shows the logo for Standard Imaging. The logo features the words "Standard Imaging" in a stylized font, with the word "Standard" stacked on top of the word "Imaging". A trademark symbol is present to the right of the word "Imaging". Below the text is a graphic of lines radiating outward from a central point.

7601 Murphy Drive • Middleton, WI 53562-2532 • www.standardimaging.com

Tel (608) 831-0025 • (800) 261-4446 • Fax (608) 8

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K013548
Page 2 of 2

The IVB 1000 Well Chamber has a vent hole to maintain the internal air at ambient atmospheric pressure. Thus, the readings obtained must be corrected for ambient temperature and pressure to the temperature and pressure of calibration (22º C and 760 mm Hg) at "normal" relative humidity (50% ± 25%non-condensing) in the usual accepted manner. The IVB 1000 has available different inserts for IVB, HDR, LDR and X-Ray contamination measurements.

The IVB 1000 Well Chamber has a conventional triax connector and cable to be connected to a suitable electrometer. A bias of 300 volts must be applied to the electrometer low-impedance connection relative to chassis ground. The voltage polarity effect is less than 0.1%. If desired, a second bias level of 150 volts can also be used to determine the ionic recombination loss at 300 V.

The Standard Imaging IVB 1000 Well Chamber was designed to comply with the limited applicable portions of the following voluntary standards:

1. IEC 601-1: 1988 - Medical Electrical Equipment
IEC 60731: 1997 Medical Electrical Equipment Dosimeters with ionization chambers 2. used in radiotherapy.

The Standard Imaging IVB 1000 Well Chamber and the predicate Standard Imaging HDR 1000 Plus and IVB 1000 Ion Chambers are substantially equivalent in design concepts, technologies, materials and intended uses. The Standard Imaging IVB 1000 Well Chamber has been validated through calibration testing conducted by the University of Wisconsin - Madison, Department of Medical Physics Accredited Dosimetry Calibration Laboratory.

Image /page/1/Picture/7 description: The image shows the logo for Standard Imaging. The logo features the words "Standard Imaging" in a stylized font, with the word "Standard" stacked above the word "Imaging". A graphic of radiating lines is to the left of the text. A horizontal line is below the word "Imaging".

7601 Murphy Drive • Middleton, WI 53562-2532 • www.standardimaging.com

Tel (608) 831-0025 • (800) 261-4446 • Fax (60

EXRADIN.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is a stylized representation of three wavy lines, which symbolize the department's mission to protect and promote the health and well-being of Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 9 2001

Raymond T. Riddle, PE Vice President, Regulatory Affairs Standard Imaging™, Inc. 7601 Murphy Drive MIDDLETON WI 53562-2532

Re: K013548

Trade/Device Name: Standard Imaging IVB 1000 Well Chamber Regulation Number: 21 CFR 892.1360 Regulation Name: Radionuclide dose calibrator Regulatory Class: II Product Code: 90 KPT Dated: October 24, 2001 Received: October 24, 2001

Dear Mr. Riddle:

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. 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 (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); 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.

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Page 2

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 notheation. The I Driving of Scation 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 11 you don't specific at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, 10. questions of (301) 594-4639. Also, please note the regulation entitled, "Misbranding Other or Compination and (21 CFR Part 807.97). Other general information on by responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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NOV 0 9 2001

510(k) Number (if known):

K013548

Device Name: Standard Imaging IVB 1000 Well Chamber

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21CFR801.109)
OR
Nancy broghon
Division of Repredustive, Abdominal,
and Radiological Devices
510(k) Number K013548

Over-The-Counter Use (Optional Format 1-2-96)

Regulation Number and Section

§ 892.1360 Radionuclide dose calibrator.

(a)
Identification. A radionuclide dose calibrator is a radiation detection device intended to assay radionuclides before their administration to patients.(b)
Classification. Class II.