BOLUS COMPENSATOR

K091911 · .Decimal, Inc. · IXI · Jul 21, 2009 · Radiology

Device Facts

• Record ID: K091911
• Device Name: BOLUS COMPENSATOR
• Applicant: .Decimal, Inc.
• Product Code: IXI · Radiology
• Decision Date: Jul 21, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5710
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

.decimal's Bolus Compensator manufacturing service manufactures the solid Bolus Compensators for intensity modulation of external beam radiation therapy. The Bolus Compensators are designed by the customer's treatment planning system to block radiation from hitting critical structures and healthy tissue while guiding the radiation to the targeted area.

Device Story

Custom-manufactured solid bolus compensators for external beam radiation therapy; designed via customer treatment planning systems to modulate radiation intensity; blocks radiation from healthy tissue while guiding it to target areas. Manufactured from machinable wax; used in clinical radiation oncology settings; operated by radiation therapy professionals. Output is a physical patient-specific device; healthcare providers use the compensator to optimize dose distribution; benefits patients by sparing critical structures and healthy tissue during cancer treatment.

Clinical Evidence

No clinical data. Bench testing only. Clinically oriented validation test cases were executed in-house by .decimal personnel, including Board Certified Medical Physicists, to confirm fitness for clinical use.

Technological Characteristics

Material: Machinable wax. Sensing/Actuation: None (passive beam-shaping). Energy Source: None. Form Factor: Patient-specific custom geometry. Connectivity: None. Sterilization: Not specified. Software: None (manufactured based on external treatment planning system designs).

Indications for Use

Indicated for cancer patients undergoing external beam radiation therapy. Used by radiation therapy professionals to modify radiation beam shape for individual patient anatomy. Requires validation and approval by a radiation therapy professional prior to use.

Regulatory Classification

Identification

A radiation therapy beam-shaping block is a device made of a highly attenuating material (such as lead) intended for medical purposes to modify the shape of a beam from a radiation therapy source.

Predicate Devices

• .decimal Range Compensator (K071078)

Submission Summary (Full Text)

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K091911/

JUL 21 2009

#### Section 7 510(k) Summary or 510(k) Statement

Section 807.87 (h) A 510(k) Summary as described in Section 807.92 or a 510(k) statement as described in 807.93

# Premarket Notification [510(k)] Summary as required by 21 CFR 807.92

#### Date summary was prepared:

June 2009

### Submitter's Name:

.decimal, Inc. 121 Central Park Pl Sanford, Florida 32771

#### Contact Person:

Daniel L. Bennett Director of Quality and Regulatory Affairs Phone: [phone] Fax: Email:dbennett(@dotdecimal.com

#### Device Name:

Bolus Compensator

#### Classification Name:

IXI 21 CFR892.5710 Class II

#### Predicate Device(s):

.decimal Range Compensator (K071078)

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Image /page/1/Picture/0 description: The image shows the word "decimal" in a stylized font, with a small circle and line above the "l". Below the word "decimal" is the phrase "the benchmark for custom radiation therapy". The text is black and the background is white. The image appears to be a logo or advertisement for a company or product related to radiation therapy.

#### Intended Use:

.decimal's Bolus Compensator manufacturing service manufactures the solid Bolus Compensators for intensity modulation of external beam radiation therapy. The Bolus Compensators are designed by the customer's treatment planning system to block radiation from hitting critical structures and healthy tissue while guiding the radiation to the targeted area.

#### Summary of Technological Characteristics:

The device features of Bolus Compensators are similar to the predicate device (.decimal Range Compensators K071078 cleared in 2007). They both are designed by radiation therapy professionals for a unique patient and are intended to modify the shape of a beam from a radiation therapy source. Whereas the Bolus Compensator is made using machinable wax, the Range Compensator is made using acrylic, despite the difference in materials they both share very similar densities. Like Range Compensators Each Bolus Compensator must be validated and approved by the radiation therapy professional prior to use on a patient. The target population is identical and the use parameters are also very similar.

A detailed comparison can be found in section 11 of this submittal.

#### Summary of Clinical Testing:

Clinical testing was not performed as part of the development of this product. Clinical testing is not advantageous in demonstrating substantial equivalence or safety and effectiveness of the device since testing can be performed such that no human subjects are exposed to risk. Clinically oriented validation test cases were written and executed in house .decimal personnel including Board Certified Medical Physicists where Bolus Compensators was deemed fit for clinical use. A declaration of conformity to this requirement can be found in section 12 of this document.

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Image /page/2/Picture/0 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol consisting of three curved lines that resemble a person embracing another person. The logo is black and white and appears to be a seal or emblem.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 21 2009

Mr. Daniel L. Bennett Director of Quality and Regulatory Affairs .decimal, Inc. 121 Central Park Pl. SANFORD FL 32771

Re: K091911

Trade/Device Name: Bolus Compensator Regulation Number: 21 CFR 892.5710 · Regulation Name: Radiation therapy beam-shaping block Regulatory Class: II Product Code: IXI Dated: June 24, 2009 Received: June 25, 2009

#### Dear Mr. Bennett:

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); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrl/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 yours,

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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he benchmark for custom radiation therapy

| Section 6 | Indications for Use Statement |
|--------------------------|-------------------------------|
| 510(k) Number (if known) | K091911 |

Device Name: Bolus Compensator

Indication for Use: Bolus Compensators are used by radiation therapy professionals for the treatment of cancer patients. They are designed by radiation therapy professionals for a unique patient and are intended to modify the shape of a beam from a radiation therapy source. Each Bolus Compensator must be validated and approved by the radiation therapy professional prior to use on a patient.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | <div style="display:flex; align-items:center;">✓</div> |
|------------------------------------------|--------------------------------------------------------|
|------------------------------------------|--------------------------------------------------------|

OR

| Over-The-Counter Use | ________________ |
|----------------------|------------------|
|----------------------|------------------|

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices

| 510(k) Number | K091911 |
|---------------|---------|
|---------------|---------|