HDR 1000 PLUS WELL CHAMBER, MODEL 90008

K060532 · Standard Imaging, Inc. · JAQ · Apr 11, 2006 · Radiology

Device Facts

• Record ID: K060532
• Device Name: HDR 1000 PLUS WELL CHAMBER, MODEL 90008
• Applicant: Standard Imaging, Inc.
• Product Code: JAQ · Radiology
• Decision Date: Apr 11, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5700
• Device Class: Class 2

Intended Use

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 Story

Well-type ionization chamber designed to measure radiation output of brachytherapy sources; inputs include ionizing radiation from HDR, LDR, IVB, or electronic x-ray sources; device requires specific source holders for measurement; connects to external electrometer via triax cable; requires 300V bias voltage; readings must be corrected for ambient temperature and pressure; used by medical physicists or radiation oncology staff in clinical dosimetry environments; output provides current or charge measurements used to verify source strength against calibration factors provided by Accredited Dosimetry Calibration Laboratories (ADCL); ensures accurate radiation delivery for patient treatment.

Clinical Evidence

Bench testing only. Validation performed via calibration testing conducted by the University of Wisconsin - Madison, Department of Medical Physics Accredited Dosimetry Calibration Laboratory.

Technological Characteristics

Well-type ionization chamber; triax connector; 300V bias voltage requirement; ambient pressure vent; compatible with various source inserts; complies with IEC 60601-1 (general safety), IEC 60601-1-2 (EMC/EMI), EN 980, and EN 1041.

Indications for Use

Indicated for measuring radiation output of brachytherapy sources (HDR, LDR, IVB, and electronic x-ray sources) in clinical settings requiring dosimetry calibration.

Regulatory Classification

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.

Predicate Devices

• Standard Imaging HDR 1000 Plus Well Chamber (K001825)
• Standard Imaging HDR 1000 Well Chamber (K922554)

Submission Summary (Full Text)

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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.

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.

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.

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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 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.

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 [phone] or [phone] 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:

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.

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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