P.D

K061440 · .Decimal, Inc. · MUJ · Jun 27, 2006 · Radiology

Device Facts

• Record ID: K061440
• Device Name: P.D
• Applicant: .Decimal, Inc.
• Product Code: MUJ · Radiology
• Decision Date: Jun 27, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

.decimal created a software translator to be used with a Radiation Therapy Treatment Planning Systems (TPS). The software takes the TPS design of a compensating filter used for radiation therapy which contains steep, narrow, and unmachinable areas and then smoothes them out into a machinable surface. The customer will use the software in-house before sending the file to .decimal to be manufactured. Each filter must be verified as being correct by the customer prior to use on a patient.

Device Story

p.d is a software translator for radiation therapy treatment planning systems (TPS). It accepts digital designs of compensating filters that contain steep, narrow, or unmachinable geometries. The software algorithm smooths these designs into surfaces suitable for physical manufacturing. Used in-house by clinical staff at radiation oncology centers prior to submitting files to .decimal for fabrication. The output is a modified filter design file. Clinicians must perform quality assurance verification on the resulting filter before clinical use on a patient. The device facilitates the production of physical compensating filters used to shape radiation beams, potentially improving treatment delivery accuracy.

Clinical Evidence

No clinical data provided. The submission relies on software validation and device master record documentation.

Technological Characteristics

Software-based translator for radiation therapy treatment planning. Operates by smoothing geometric data for compensating filters. Connectivity involves file transfer to a manufacturing facility. No specific hardware or material standards are cited; the device is a software utility.

Indications for Use

Indicated for use in radiation therapy treatment planning to process compensating filter designs containing steep, narrow, or unmachinable areas into machinable surfaces. Intended for use by clinical staff in a radiation oncology setting.

Regulatory Classification

Identification

A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

Predicate Devices

• Computerized Medical Systems Inc. (CMS) Xio Radiation Treatment Planning System (K032762)

Submission Summary (Full Text)

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K061440

JUN 2 7 2006

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:

May 2006

#### Submitter's Name:

.decimal, Inc. 121 Central Park Pl Sanford, Fl 32771 Contact Person:

Daniel L. Bennett Quality Manager Phone: [phone] Fax: [phone] Email:dbennett(@dotdecimal.com

#### Device Name:

p.d

#### Classification Name:

90 MUJ 21 CFR892.5050 Class II

#### Predicate Device(s):

Computerized Medical Systems Inc. (CMS) Xio Radiation Treatment Planning System, K032762

#### Intended Use:

.decimal created a software translator to be used with a Radiation Therapy Treatment Planning Systems (TPS). The software takes the TPS design of a compensating filter used for radiation therapy which contains steep, narrow, and unmachinable areas and

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then smoothes them out into a machinable surface. The customer will use the software in-house before sending the file to .decimal to be manufactured. Each filter must be verified as being correct by the customer prior to use on a patient.

### Summary of Technological Characteristics:

The technological characteristics of p.d are listed below and attached in section 11 of this document:

PD-11 p.d Software Validation DMR-04 p.d Device Master Record

## Summary of Clinical Testing:

Please see Section 12 of this document for the summary of clinical testing.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human services.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

JUN 2 7 2006

Mr. Daniel L. Bennett Quality Manager .Decimal, Inc. 121 Central Park Place SANFORD FL 32771

Re: K061440

Trade/Device Name: p.d Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: May 16, 2006 Received: May 24, 2006

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 ica 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 thei have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmen 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.

Image /page/2/Picture/10 description: The image shows a circular logo with the letters "FDA" in large, bold font in the center. Above the letters, the years "1906 - 2006" are printed. Below the letters, the word "Centennial" is written in cursive, with three stars underneath. The logo is surrounded by text that follows the circular shape, but the text is too blurry to read. The logo appears to be a commemorative emblem for the FDA's centennial anniversary.

Protecting and Promoting Public Health

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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 muz. 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 us set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the elections 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 51011 } premarket notification. The FDA finding of substantial equivalence of your device to a legal|y marketed predicate device results in a classification for your device and thus, permits you follow to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). ‫(1) blease 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) | 240-276-0122 |
| Other | | 240-276-0122 |

Also, please note the regulation entitled. "Misbranding by reference to premarket natified icre (21CFR Part 807.97). You may obtain other general information on woman within the Act from the Division of Small Manufacturers, International and Comment Assista - - Lin toll-free number [phone] or [phone]

or at its Internet address http://www.fda.gov/edrh/industry/support/index.in-

Sincerely yours,

Nancy C.Bogden

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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510(k) Number (if known)

Device Name: p.d

Indication for Use: The p.d software takes a Treatment Planning System design of a compensating filter used for radiation therapy which contains steep, narrow, and unmachinable areas and then smoothes them out into a machinable surface. The customer will use the software in-house before sending the file to .decimal to be manufactured. Each filter must be QA'd by the customer before use on a patient.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (Per 21 CFR 801.109) | ✓ |
|---------------------------------------|-------------------------------|
| | OR |
| | Over-The-Counter Use ________ |

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number: K061440
510(k) Number ________________________________________________________________________________________________________________________________________________________________