(151 days)
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No
The description focuses on automated report generation based on calculated indices and established criteria (WHO), without mentioning any learning or adaptive algorithms.
No
Explanation: The device is an automated medical report writer that helps communicate test results. It does not directly treat or alleviate a medical condition.
No
The device is a "Medical Report Writer" that helps communicate the results of a test from a bone sonometer and translates them into diagnostic categories. It does not perform the diagnostic test itself but processes and communicates the results obtained from another diagnostic device.
No
The device is described as an "Automated Medical Report Writer intended to be used with the Sahara Bone Sonometer". This indicates it is software that processes data from a separate hardware device (the bone sonometer), making it a component of a system rather than a standalone software-only medical device.
Based on the provided information, it is unlikely that Oasis 4.0 is an IVD (In Vitro Diagnostic) device. Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Oasis 4.0's Function: Oasis 4.0 is a Medical Report Writer that processes data from a Bone Sonometer. A bone sonometer is a device that uses ultrasound to assess bone properties in vivo (on the living body), not on a specimen taken from the body.
- Intended Use: The intended use clearly states it's for communicating the results of a test performed with the Sahara Bone Sonometer. This test is an in vivo measurement.
- Lack of Specimen Handling: There is no mention of Oasis 4.0 handling or analyzing any biological specimens.
In summary, Oasis 4.0 is a software tool that processes and reports data from an in vivo diagnostic device (the bone sonometer). It does not perform analysis on in vitro specimens.
Therefore, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
90 KPS
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 892.1200 Emission computed tomography system.
(a)
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.(b)
Classification. Class II.
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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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)