AUTOMATED MEDICAL REPORT WRITER

K981553 · Woodson and Associates, LLC · KPS · Sep 29, 1998 · Radiology

Device Facts

• Record ID: K981553
• Device Name: AUTOMATED MEDICAL REPORT WRITER
• Applicant: Woodson and Associates, LLC
• Product Code: KPS · Radiology
• Decision Date: Sep 29, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Oasis 4.0 is an automated Medical Report Writer intended to be used with the Sahara Bone Sonometer to help communicate the results of the test in a uniform, accurate, and consistent manner. The results are expressed as QUI (Quantitative Ultrasound Index), estimated bone mineral density (BMD), T-score, and Z-score. The estimated BMD is calculated from the QUI. The results are also translated into one of the diagnostic categories - Normal, Osteopenia, or Osteoporosis - based upon the WHO criteria and the normative reference data base. There is standardized language for the estimated risk of fracture and for the therapeutic options which the attending physician may recommend.

Device Story

Oasis 4.0 is an automated medical report writer software designed for use with the Sahara Bone Sonometer. It ingests quantitative ultrasound index (QUI) data from the sonometer; transforms this input into estimated bone mineral density (BMD), T-scores, and Z-scores using a normative reference database; and classifies results into diagnostic categories (Normal, Osteopenia, Osteoporosis) per WHO criteria. The software generates standardized reports containing fracture risk assessments and therapeutic options. Used in clinical settings by physicians to facilitate consistent, accurate communication of bone density test results, the device aids in clinical decision-making regarding patient bone health and fracture risk management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based medical report writer. Operates as an add-on to the Sahara Bone Sonometer. Utilizes normative reference databases and WHO diagnostic thresholds to calculate BMD, T-scores, and Z-scores from QUI inputs. Standardized reporting format.

Indications for Use

Indicated for use with the Sahara Bone Sonometer to generate standardized medical reports for patients undergoing bone density assessment. Reports categorize results (Normal, Osteopenia, Osteoporosis) based on WHO criteria to assist physicians in fracture risk assessment and therapeutic decision-making.

Regulatory Classification

Identification

An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.

Reference Devices

• Sahara Bone Sonometer

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the most prominent. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 9 1998

Grattan C. Woodson, Jr. M.D. Woodson and Associates L.L.C. P.O. Box 421397 Atlanta, GA 30342-8397

Re:

K981553 Oasis 4.0 Automated Medical Report Writer Dated: August 19, 1998 Received: August 21, 1998 Regulatory class: II 21 CFR 892.1170/Procode: 90 KPS

Dear Dr. Woodson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 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 895. A substanially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".

Sincerely yours,

Killian Yh~

Lillian Yin, Ph.D Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{1}------------------------------------------------

Page_1___ of_l________________________________________________________________________________________________________________________________________________________________

510(k) Number: K981553

Device Name: Oasis 4.0 Automated Medical Report Writer

INDICATIONS FOR USE: Oasis 4.0 is an automated Medical Report Writer intended to be used with the Sahara Bone Sonometer to help communicate the results of the test in a uniform, accurate, and consistent manner. The results are expressed as QUI (Quantitative Ultrasound Index), estimated bone mineral density (BMD), T-score, and Z-score. The estimated BMD is calculated from the QUI. The results are also translated into one of the diagnostic categories - Normal, Osteopenia, or Osteoporosis - based upon the WHO criteria and the normative reference data base. There is standardized language for the estimated risk of fracture and for the therapeutic options which the attending physician may recommend.

YS Cleood

Grattan C. Woodson, Jr. M.D.

David C. Segura
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Deyiges 510(k) Number

Prescription Use ***_***_
(Per 21 CFR 801.109)