HDR 1000 PLUS WELL CHAMBER, MODEL 90008 by STANDARD IMAGING, INC.

The Standard Imaging HDR 1000 Plus Well Chamber is a well-type chamber. It is specifically designed to measure the amount of radiation of brachytherapy sources, including high-dose-rate (HDR), low-dose-rate (LDR), intravascular (IVB) and electronic (x-ray) 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 labeling.

Device Description

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 HDR 1000 Plus 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 HDR 1000 Plus Well Chamber has available different inserts for IVB, HDR, LDR and x-ray measurements.

The HDR 1000 Plus 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 lowimpedance 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

Here's an analysis of the provided text regarding the acceptance criteria and study for the Standard Imaging HDR 1000 Plus Well Chamber (modifications to):

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with IEC 60601-1 (Medical Electrical Equipment for general requirements)	The device was designed to comply with the limited applicable portions of IEC 60601-1.
Compliance with IEC 60601-1-2 (EMC/EMI)	The device was designed to comply with the limited applicable portions of IEC 60601-1-2.
Compliance with EN 980 (Symbols)	The device was designed to comply with the limited applicable portions of EN 980.
Compliance with EN 1041 (Manuals)	The device was designed to comply with the limited applicable portions of EN 1041.
Voltage polarity effect less than 0.1%	The device reports a voltage polarity effect of less than 0.1%.
Ability to maintain internal air at ambient atmospheric pressure (vent hole)	The device has a vent hole to maintain internal air at ambient atmospheric pressure, requiring correction for temperature and pressure.
Substantial equivalence in design concepts, technologies, materials, and intended uses to predicate devices.	Stated that the device and predicate devices are substantially equivalent in design concepts, technologies, materials and intended uses.
Validation through calibration testing	The device has been validated through calibration testing by the University of Wisconsin - Madison, Department of Medical Physics Accredited Dosimetry Calibration Laboratory.

Important Note: The document doesn't explicitly state quantitative acceptance criteria in terms of specific performance thresholds (e.g., "accuracy ±X%", "precision ≤Y%"). Instead, it focuses on compliance with standards and substantial equivalence. The "reported device performance" is primarily descriptive of design features and a general statement of validation.

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not specify a sample size for a test set. There isn't a "test set" in the traditional sense of a dataset used to evaluate an AI model or a new medical device against a known ground truth.

The data provenance is related to calibration testing performed by the University of Wisconsin - Madison, Department of Medical Physics Accredited Dosimetry Calibration Laboratory. This implies a controlled, prospective experiment or series of measurements under specific laboratory conditions. The country of origin is the USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the document describes a physical medical device (a well chamber) and its validation through calibration, not an AI or diagnostic system requiring expert interpretation of data for ground truth. The "ground truth" for this device would be established by the highly precise and traceable reference standards used by the Accredited Dosimetry Calibration Laboratory (ADCL), which are maintained by experts in dosimetry and metrology. While not explicitly numbered, the personnel at an ADCL are by definition highly qualified in radiation dosimetry.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3. Adjudication methods are typically used when subjective expert interpretation is involved in establishing ground truth for a diagnostic or AI system.

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

This information is not applicable. The device is a measurement instrument for radiation, not an AI or diagnostic tool where human readers assess cases.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

This information is not applicable. The device is a physical instrument, not an algorithm. Its operation involves a human user (a dosimetry professional) who connects it to an electrometer and performs measurements, then applies corrections.

7. The Type of Ground Truth Used

The ground truth used for the validation of the HDR 1000 Plus Well Chamber is based on traceable dosimetry standards and calibration processes maintained by an Accredited Dosimetry Calibration Laboratory (ADCL). This involves highly accurate reference sources and measurement techniques, ensuring the device's readings are accurate relative to established physical units of radiation. It's essentially a type of "metrological ground truth" rather than expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical instrument, not a machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reasons as point 8.

Summary

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APR 1 1 2006

//4600532

Subject:

510(k) Summary of Safety and Effectiveness Information for the Standard Imaging HDR 1000 Plus Well Chamber (modifications to)

Proprietary Name: Standard Imaging HDR 1000 Plus Well Chamber
Common Name: Well Chamber

Classification: Class II - 21CFR892.1360. 90 KPT

Panel: Radiology

Raymond Riddle, Vice President, Regulatory Affairs Contact Person:

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 HDR 1000 Plus Well Chamber (modifications to) is substantially equivalent to the Standard Imaging HDR 1000 Plus Well Chamber and the Standard Imaging HDR 1000 Well Chamber, which were cleared by FDA with 510(k) premarket notifications, with numbers K001825 and K922554.

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Image /page/1/Picture/0 description: The image shows the logo for Standard Imaging. The logo consists of the words "STANDARD IMAGING" in a stylized font, with the word "STANDARD" in a smaller font than "IMAGING". To the right of the words is a black circle with white lines radiating outward from the center, resembling a stylized sun or star.

'1860532

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

IEC 60601-1:	Medical Electrical Equipment (for general requirements)
IEC 60601-1-2:	EMC/EMI
EN 980:	Symbols
EN 1041:	Manuals

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

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized design of an eagle or bird with three horizontal lines forming its body and wings. The bird is facing left. Encircling the bird is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Raymond Riddle Vice President, Regulatory Affairs Standard Imaging, Inc. 7601 Murphy Drive MIDDLETON WI 53562

APR 1 1 2006

Re: K060532 Trade/Device Name: HDR 1000 Plus well Chamber (modifications to) Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: JAQ and KXK Dated: February 24, 2006 Received: February 28, 2006

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 (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.

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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This fetter 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.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Nancy C. Brigdon

Nanev 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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Indications for Use

510(k) Number (if known):

K/o b 532

Device Name:

HDR 1000 Plus Well Chamber (modifications to)

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D) and/or

Over-the-Counter-Use (Part 21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C Brogden

(Division Sig Division of Repro and Radiological D 510(k) Numbe

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Regulation Number and Section

§ 892.5700 Remote controlled radionuclide applicator system.

(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.