APPLICATORS FOR AFTERLOADING BRACHYTHERAPY

K082530 · Isodose Control B.V. · JAQ · Oct 30, 2008 · Radiology

Device Facts

• Record ID: K082530
• Device Name: APPLICATORS FOR AFTERLOADING BRACHYTHERAPY
• Applicant: Isodose Control B.V.
• Product Code: JAQ · Radiology
• Decision Date: Oct 30, 2008
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Brachytherapy applicators are commonly used to facilitate the positioning of a radioactive source inside or near the patient in order to administer radiation therapy to cancerous tissue. Cervix Ring Applicator: The Cervix Ring Applicator is for gynecological Brachytherapy of cervix, endometrium and vagina, to be used only by trained physicians. The Maximum implementation per treatment application is 28 days. Trocar Needle Sets: The intended use is interstitial HDR/PDR brachytherapy treatment, to be used only by trained physicians. The maximum implantation period of the needles is 28 days. Martinez Prostate Template Set: The Martinez Prostate Template Set is for assisting interstitial HDR/PDR brachytherapy of the prostate gland, to be used only by trained physicians. The Maximum application duration per treatment application is 28 days. Bonvoisin Gerard Esophageal Applicator Set: The Bonvoisin Gerard Esopheagel Applicator is intended for brachytherapy treatment of the esophagus, to be used only by trained physicians. The maximum implementation duration per treatment application is 24 hours.

Device Story

Brachytherapy applicators facilitate radioactive source placement near cancerous tissue for radiation therapy. System includes Cervix Ring Applicator (tandem/ring tubes), Trocar Needles (stainless steel, sharp-tipped for tissue perforation), Martinez Prostate Template (grid-based needle guidance for ultrasound-stepper mounting), and Bonvoisin Gerard Esophageal Applicator (flexible tube with fixation mask). Used in clinical settings by trained physicians; accessories to Flexitron HDR/PDR remote afterloader. X-ray markers placed in channels determine dwell positions via radiographic imaging. Output is physical positioning of radioactive source; enables targeted radiation delivery to tumors; benefits include localized treatment with reduced exposure to surrounding healthy tissue.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Stainless steel needles; rigid and flexible polymer applicator tubes; fixation masks. Accessories for remote afterloading systems. No electronic components or software algorithms.

Indications for Use

Indicated for patients requiring brachytherapy for cancer of the cervix, endometrium, vagina, prostate, or esophagus. To be used only by trained physicians. Contraindications not specified.

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 CT/MR Applicator set, Ring CT/MR applicator (K983341)
• HDR CT compatible Split Ring Applicator (K063382)
• HDR Tandem /Ring applicator with rectal retractor (K011657)
• Proguide Needle set (K060349)
• Interstitial Needles (K073133)
• Prostate Stepper Template Set (K003270)
• Cet Prostate Applicator Set (K990990)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Isodose Control. The logo is black and white and features the company name in a stylized font. The "o" in "isodose" is replaced with a graphic of concentric circles. There is a registered trademark symbol in the upper right corner of the logo.

K0r2530

# 5. 510(k) Summary as required by 21 CFR 807.92

# 5.1. Submitter of 510(k)

| 510(k) owner's name | : | Isodose Control BV |
|-------------------------------|---|--------------------------------|
| address | : | Maxwellstraat 16 |
| | : | 6716 BX Ede |
| | : | The Netherlands |
| phone | : | [phone] |
| fax | : | [phone] |
| name of contactperson | : | Hub van de Bergh |
| e-mail | : | [e-mail] |
| date the summary was prepared | : | August 25, 2006 |

OCT 3 0 2008

# 5.2. Device

#### 5.2.1. Device: Cervix Ring Applicator

| Name of the device / trade or proprietary name: | Cervix Ring Applicator Set 45°<br>Cervix Ring Applicator Set 60° |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Common or usual name: | Brachytherapy Ring Applicator |
| Classification name: | Remote controlled radionuclide applicator system<br>(per 21 CFR section 892.5700 Product code JAQ) |

# 5.2.2. Device: Trocar Needle Sets

name of the device / trade or proprietary name:

- Ø 1.5mm (17Ga), needle set, 300mm trocar point
- Ø 1.5mm (17Ga), needle set, 260mm trocar point
- Ø 1.5mm (17Ga), needle set, 200mm trocar point
- Ø 1.5mm (17Ga), needle set, 150mm trocar point
- Ø 1.5mm (17Ga), needle set, 100mm trocar point

Brachytherapy interstitial needles common or usual name: classification name: Remote controlled radionuclide applicator system (per 21 CFR section 892.5700 Product code JAQ)

## 5.2.3. Device: Martinez Prostate Template

name of the device / trade or proprietary name: Martinez Prostate Template Set common or usual name: Brachytherapy Prostate Template classification name: Remote controlled radionuclide applicator system (per 21 CFR section 892.5700 Product code JAQ)

## 5.2.4. Device: Bonvoisin Gerard Esophageal Applicator Set

name of the device / trade or proprietary name: Bonvolsin Gerard Esophageal Applicator Set common or usual name: Brachytherapy Esophageal Applicator classification name: Remote controlled radionuclide applicator system (per 21 CFR section 892.5700 Product code JAQ)

Company Confidential

Section 5: 510(k) Summary - page 1 of 4 900-5018-200800825 i_Applicators 510(k)PMNsubmission

Isodose Control B.V. @ Maxwellstraat 16, 6716 BX Ede @ The Netherlands 1 [phone] € & [phone] * @ [e-mail] € KvK: 30191600 www.isodosecontrol.com

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# Isodose () contre

# 5.3. Legally Marketed Device(s)

The devices can be shown to be substantial equivalent to the legally marketed devices cited in the tables below.

## 5.3.1. Cervix Ring applicator

| Device | Manufacturer | 510(k) # |
|---------------------------------------------------------|----------------------------------------|----------|
| Standard CT/MR Applicator set, Ring CT/MR<br>applicator | Nucletron corp | K983341 |
| HDR CT compatible Split Ring Applicator | Mick Radio-nuclear<br>Instruments, inc | K063382 |
| HDR Tandem /Ring applicator with rectal retractor | Mick Radio-nuclear<br>Instruments, inc | K011657 |

## 5.3.2. Trocar Needle sets

| Device | Manufacturer | 510(k) # |
|----------------------|-----------------------------|----------|
| Proguide Needle set | Nucletron Corp | K060349 |
| Interstitial Needles | Varian Medical Systems, Inc | K073133 |

## 5.3.3. Martinez Prostate template

| Device | Manufacturer | 510(k) # |
|-------------------------------|-----------------|----------|
| Prostate Stepper Template Set | Nucletron Corp. | K003270 |
| Cet Prostate Applicator Set | Nucletron Corp. | K990990 |

## 5.3.4. Bonvoisin Gerard Esophageal Applicator Set

| Uevice | Company Collection Colline Collection Comparis | SERIOA |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| 0101010<br>Annlicator<br>15 Prop<br>- ennnanile -<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | VACQOIL |

# 5.4. Description of the Device

The following described medical instruments are brachytherapy applicators for use with the Flexitron Brachytherapy Afterloader. Brachytherapy applicators are commonly used to facilitate the placement and positioning of a radioactive source inside or near the patient in order to administer radiation therapy to cancerous tissue. Prior to treatment radiation X-ray markers are positioned into the applicator channel(s) in order to determine source dwell positions with the help of radiographic images as part of the brachytherapy treatment planning process.

# 5.4.1. Description Cervix Ring Applicator

The Cervix Ring Applicator is a tandem and ring brachytherapy instrument. The applicator consists of 2 separately placed ridged brachytherapy channels, i.e. 1 tandem (intrauterine tube) and a ring tube.

The Cervix Ring Applicator is used as a gynaecological intracavitary instrument to assist the positioning of a radioactive source under remote control (involving HDR or PDR Flexitron Remote Afterloader system), in order to administer radiation therapy to cervix and uterus carcinoma.

# 5.4.2. Description Trocar Needle Sets

The trocar Needles are straight ridged needles made out of stainless steel and have closed end sharp tip for skin and tissue perforation.

The Trocar Needles are used as interstitial brachytherapy instruments to assist the positioning of a radioactive source under remote control (involving HDR or PDR Flexitron Remote Afterloader system), in order to administer radiation therapy to tissue and organ carcinoma.

Company Confidential

Section 5: 510(k) Summary - page 2 of 4 900-5018-200800825 i_Applicators 510(k)PMNsubmiss

Isodose Control B.V. » Maxwellstraat 16, 6716 BX Ede @ The Netherlands 2 [phone] % @ [phone] %@ [e-mail] * KvK: 30191600 www.isodosecontrol.com

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# 5.4.3. Description Martinez Prostate Template Set

The Martinez Prostate template is to be used for HDR/PDR brachytherapy of the prostate gland. In order to administer brachytherapy to the prostate, needles are inserted interstitially into the prostate with the guidance of a prostate template. The prostate template can be mounted on an Ultra Sound probe stepper device in such a manner that the US grid coordinates projected over the images of the prostate are corresponding to the grid indication of the prostate template and its holder.

# 5.4.4. Description Bonvoisin Gerard Esophageal Applicator Set

The Bonvoisin Gerard Esophageal Applicator consists of a flexible tube with a tapered distal tip. This applicator tube is advanced through the mouth into the esophagus, the tapered distal tip gently dilitates the esophagus, in order to facilitate the placement of the applicator tube. When the applicator tube is in position the tube is to be immobilised in relation to the patient's mouth with the accompanied fixation mask. For connection and treatment with the brachytherapy remote afterloader a separate flexible treatment catheter is provided in the set. The distal end of the treatment catheter is to be inserted into the applicator tube and the proximal end is to be connected to the afterloader device.

In order to fit different esophagus anatomy sizes and/or treatment requirements the applicator tube is provided in different diameter sizes, ranging in diameter from 5 mm to 20 mm. Both the fixation mask and the treatment catheter can be applicator tube sizes.

# 5.5. Intended use of the Device

## 5.5.1. Intended Use Cervix Ring Applicator

The Cervix Ring Applicator is for gynecological HDR or PDR brachytherapy of cevrix, endometrium and vagina, to be used only by trained physicians. The Maximum implementation duration per treatment application is 28 days.

## 5.5.2. Intended Use Trocar Needle Sets

The intended use is interstitial HDR or PDR brachytherapy treatment, to be used only by trained physicians. The maximum implantation period of the needles is 28 days.

## 5.5.3. Intended Use Martinez Prostate Template Set

The Martinez Prostate Template Set is for assisting interstitial HDR or PDR brachytherapy of the prostate gland, to be used only by trained physicians. The Maximum application duration per treatment application is 28 days.

# 5.5.4. Intended Use Bonvoisin Gerard Esophageal Applicator Set

The Bonvoisin Gerard Esophageal Applicator is intended for HDR or PDR brachytherapy treatment of the esophagus, to be used only by trained physicians. The Bonvoisin Gerard Esophageal Applicator is to be used as an accessory in conjunction with the Flexitron brachytherapy afterloading device.

The maximum implementation duration per treatment application is 24 hours.

# 5.6. Technological characteristics of the devices compared to the predicate device

The described brachytherapy applicators have similar technological characteristics compared to the legally marketed predicate devices listed above.

All these devices are also considered to be brachytherapy applicator instruments and are accessories to a brachytherapy remote aftertoading system.

Company Confidential

Isodose Control B.V. » Maxwellstraat 16, 6716 BX Ede » The Netherlands 2 [phone] * 1 [phone] *@ [e-mail] * KvK: 30191600 www.lsodosecontrol.com

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# isodose (O) control

# 5.7. Substantial Equivalence

From the discussion in previous paragraphs it can be concluded that the brachytherapy applicator devices have similar technological characteristics compared to the legally marketed predicate devices listed in paragraph 5.2.4.

The differences between the brachytherapy applicator devices and predicate devices do not concern the basic principle of operation and usage nor does it adversely affect the safety or effectiveness of the device.

The intended uses of Cervix Ring Applicator Set, the Trocar Needle sets, the Martinez Prostate Template Set and the Bonvoisin Gerard Esophageal Applicator Set are the same as their mentioned corresponding predicate devices.

#### 5.7.1. Conclusion Substantial Equivalence

The Cervix Ring Applicator Sets are substantial equivalent to the legally marketed predicate devices.

The Trocar Needle Sets are substantial equivalent to the legally marketed predicate devices.

The Martinez Prostate Template Set is substantial equivalent to the legally marketed predicate devices.

The Bonvoisin Gerard Esophageal Applicator Set is substantial equivalent to its legally marketed predicate device.

Company Confidential

Section 5: 510(k) Summary - page 4 of 4 900-5018-200800825 i_Applicators 510(k)PMNsubmission

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Hub van de Bergh Quality Assurance & Regulatory Affairs Officer Isodose Control B.V. Maxwellstraat 16, 6716 BX Ede THE NETHERLANDS

OCT 3 0 2008

Re: K082530

Trade/Device Name: Applicators for Afterloading Brachytherapy: Cervix Ring Applicator,

Trocar Needle Sets, Martinez Prostate Template, and Bonvoisin Gerard Esophageal Applicator Set

Regulation Number: 21 CFR 892.5700

Regulation Name: Remote controlled radio-nuclide applicator system Regulatory Class: II Product Code: JAQ Dated: August 25, 2008 Received: September 2, 2008

Dear Mr. van de Bergh:

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 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.

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#### Page 2

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.

This letter 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.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 |
|----------------|---------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

lope M. Zhang

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/6/Picture/0 description: The image shows the logo for Isodose Control. The logo is in black and white and features the company name in a bold, sans-serif font. The "O" in "Isodose" is replaced with a circular symbol that appears to be a stylized atom or radiation symbol. There is a registered trademark symbol in the upper right corner of the logo.

# Indications for Use

510(k) Number (if known): Ko82530

Device Name: _________________________________________________________________________________________________________________________________________________________________

- Cervix Ring Applicator

- Trocar Needle Sets

- Martinez Prostate Template

- Bonvoisin Gerard Esophageal Applicator Set

Indications for Use:

Brachytherapy applicators are commonly used to facilitate the positioning of a radioactive source inside or near the patient in order to administer radiation therapy to cancerous tissue.

#### Cervix Ring Applicator

The Cervix Ring Applicator is for gynecological Brachytherapy of cervix, endometrium and vagina, to be used only by trained physicians. The Maximum implementation per treatment application is 28 days.

#### Trocar Needle Sets

The intended use is interstitial HDR/PDR brachytherapy treatment, to be used only by trained physicians. The maximum implantation period of the needles is 28 days.

#### Martinez Prostate Template Set

The Martinez Prostate Template Set is for assisting interstitial HDR/PDR brachytherapy of the prostate gland, to be used only by trained physicians. The Maximum application duration per treatment application is 28 days.

#### Bonvoisin Gerard Esophageal Applicator Set

The Bonvoisin Gerard Esopheagel Applicator is intended for brachytherapy treatment of the esophagus, to be used only by trained physicians. The maximum implementation duration per treatment application is 24 hours.

| Prescription Use | ✓ |
|-----------------------------|---|
| (Part 21 CFR 801 Subpart D) | A |

ND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sian-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

Company Confidential

Section 4: Indications for Use Statement - page 2 of 2 900-5018-200800825 i_Applicators 510(K)PMNsubmissio

Isodose Control B.V. ● Maxwellstraat 16, 6716 BX Ede ● The Netherlands 431 318 502950 € § [phone] ●@ [e-mail] ● KvK: 30191600 www.isodosecontrol.com