RE-ENTRANT CHAMBER

K013689 · Sun Nuclear Corp. · KPT · Jul 2, 2002 · Radiology

Device Facts

• Record ID: K013689
• Device Name: RE-ENTRANT CHAMBER
• Applicant: Sun Nuclear Corp.
• Product Code: KPT · Radiology
• Decision Date: Jul 2, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1360
• Device Class: Class 2

Intended Use

The Model 1008 (44D as marketed under CNMC) is a well-type, re-entrant ionization chamber intended for measurement of source strength of both clinical HDR and LDR brachytherapy sources and intravascular brachytherapy (IVB) sources. Both types of IVB sources can be measured; those designed to deliver a gamma dose and those designed to deliver a beta dose. The chamber must be calibrated before any measurement of a clinical source takes place. Source strength calculation must be done with the accompanying calibration certificate from the calibration laboratory. The calibration must be performed by an accredited dosimetry calibration laboratory, with the same source type and isotope that is used clinically. The chamber constancy must be monitored after calibration with a proper Measurement Quality Assurance program in order to validate the chamber calibration over a period of time.

Device Story

Well-type re-entrant ionization chamber; measures source strength of HDR, LDR, and intravascular brachytherapy sources (gamma/beta). Device is hermetically sealed; filled with pure argon at 23.5 psi to enhance low-energy photon response and ion collection efficiency. Connects to dosimetry electrometer via 1.5m low-noise triaxial cable; triaxial collection electrode design ensures floating electrode with guarded housing to prevent shock. Used in clinical physics/dosimetry settings by qualified personnel. Output is electrical signal proportional to radiation dose, processed by external electrometer to calculate source strength. Enables verification of brachytherapy source activity, ensuring accurate patient dose delivery.

Clinical Evidence

No clinical data. Bench testing only; device performance validated through technical specifications, hermetic seal integrity, and ion collection efficiency measurements.

Technological Characteristics

Well-type re-entrant ionization chamber; hermetically sealed; pure argon fill gas at 23.5 psi; triaxial signal cable/electrode configuration; guarded housing. No air density correction required.

Indications for Use

Indicated for measurement of source strength for clinical HDR, LDR, and intravascular brachytherapy (IVB) sources (gamma and beta emitters). Requires calibration by an accredited laboratory using the specific source type/isotope prior to clinical use.

Regulatory Classification

Identification

A radionuclide dose calibrator is a radiation detection device intended to assay radionuclides before their administration to patients.

Predicate Devices

• Standard Imaging HDR-1000 Ion Chamber (K922554)
• Standard Imaging IVB 1000 Ion Chamber (K001825)

Submission Summary (Full Text)

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- 2 2002

Image /page/0/Picture/1 description: The image shows the logo and contact information for Sun Nuclear Corporation. The logo features a stylized sun graphic next to the company name in bold, sans-serif font. Below the logo is the address: 425-A Pineda Court, Melbourne, FL 32940-7508 U.S.A. The fax numbers are listed as 321 259 7979 and 321 259 6862.

K013689
Page 1 of 2

| Date: | October 26, 2001 |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Subject: | 510(k) Safety and Effectiveness Summary (SMDA Summary) for the Model 1008 Re-entrant Chamber / Model 44D Re-entrant Chamber |
| Trade Name: | Model 1008 Re-entrant Chamber or Model 44D Re-entrant Chamber |
| Common Name: | Ion Chamber |
| Product Code: | 90JAQ |
| Classification Name: | System, Applicator, Radionuclide, Remote-Controlled |
| Substantial Equivalence: | Standard Imaging HDR-1000 Ion Chamber, K922554<br>Standard Imaging IVB 1000 Ion Chamber, K001825 |
| Contact: | Jim Mixon, Quality Assurance Manager |

The 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Devices Act of 1990 and 1992 also referred to as SMDA.

#### Description and Use:

The Model 1008 / Model 44D is a well-type re-entrant ionization chamber designed for application with brachytherapy and intravascular brachyterapy source measurement. The chamber is hermetically sealed, there is no air density correction requirement. The fill gas is pure argon at an absolute pressure of 23.5 psi, which provides several distinct benefits. These include enhancing the response at low photon energies from both gamma and Bremsstahlung from beta radiation. higher ion collection efficiency and long term constancy measurements.

The Model 1008/44D is fully guarded into the chamber and is equipped with a 1.5 meter low-noise triaxial signal cable terminated with a triaxial collection electrode inside the chamber. When properly connected to a dosimetry electrometer, the chamber housing will be common to the electrometer housing: the collection electrode will be floating with the guard at the chamber bias potential. Therefore, no shock hazard should exist. However, prudent handling of the connectors and equipment is always recommended whenever there is chamber bias being applied.

Sun Nuclear has deemed the device safe and effective for its intended uses as long as it is operated in accordance with all of the accompanying labeling and instructions. Sun Nuclear believes that responsible design and quality assurance practices were followed during the development and manufacture of the Model 1008 / Model 44D Re-entrant Chamber.

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Ko 13689
Page 2 of 2

# SAFETY FEATURE LIST FOR MODEL 1008 / 44D

## FEATURE

## PURPOSE

| 1. | Hermetically sealed chamber | No air density correction necessary |
|----|-------------------------------|-------------------------------------|
| 2. | Positive Pressure | Long term constancy measurements |
| 3. | Floating collection electrode | Eliminate shock hazard |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL = 2 2002

Mr. William E. Simon President Sun Nuclear Corporation 425-A Pineda Court MELBOURNE FL 32940

Re: K013689

Trade/Device Name: Model 1008 Re-entrant Chamber Model 44D Re-entrant Chamber Regulation Number: 21 CFR 892.1360 Regulation Name: Radio-nuclide dose calibrator Regulatory Class: II Product Code: 90 KPT Dated: April 1, 2002 Received: April 3, 2002

Dear Mr. Simon:

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.

Image /page/2/Picture/11 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/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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# Indications for Use Statement

Edited 07-02-02

| 510(k)<br>Number<br>(if known) | K 013689 |
|-------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Sun Nuclear Corporation |
| Model 1008 Re-Entrant Chamber /Model 44D Re-entrant Chamber | |
| Indications<br>for Use | The Model 1008 (44D as marketed under CNMC) is a well-type, re-<br>entrant ionization chamber intended for measurement of source<br>strength of both clinical HDR and LDR brachytherapy sources and<br>intravascular brachytherapy (IVB) sources. Both types of IVB sources<br>can be measured; those designed to deliver a gamma dose and those<br>designed to deliver a beta dose. The chamber must be calibrated<br>before any measurement of a clinical source takes place. Source<br>strength calculation must be done with the accompanying calibration<br>certificate from the calibration laboratory. The calibration must be<br>performed by an accredited dosimetry calibration laboratory, with the<br>same source type and isotope that is used clinically. The chamber<br>constancy must be monitored after calibration with a proper<br>Measurement Quality Assurance program in order to validate the<br>chamber calibration over a period of time. |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daind b. Syerom

(Division Sign-Off) Division of Reproductive. and Radiological Devic 510(k) Number

Prescription Use (Per 21 CFR 801, 109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

KOJ 3689 Edited 07-02-02 2 G - 1