Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: OMNISENSE 7000S ULTRASOUND BONE SONOMETER
• Generic Name: Bone sonometer
• Regulation Number: 892.1180
• Applicant: BEAM-MED LTD; 8 HALAPID STR.; PETACH TIKVA 49170
• PMA Number: P990035
• Supplement Number: S001
• Date Received: 06/26/2000
• Decision Date: 06/21/2001
• Reclassified Date: 08/18/2008
• Product Code: MUA
• Advisory Committee: Radiology
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
APPROVAL FOR THE ADDITION OF TWO NEW PROBES FOR USE ON TWO ADDITIONAL SKELETAL SITES, THE PROXIMAL THIRD PHALANX AND THE FIFTH METATARSAL. THE DEVICE, AS MODIFIED, IS INDICATED AS FOLLOWS: "A NONINVASIVE DEVICE THAT IS DESIGNED FOR THE QUANTITATIVE MEASUREMENT OF THE SIGNAL VELOCITY OF ULTRASONIC WAVES ("SPEED OF SOUND" OR "SOS" IN M/SEC) PROPAGATING AT MULTIPLE SKELETAL SITES (I.E., THE DISTAL ONE-THIRD OF THE RADIUS, THE PROXIMAL THIRD PHALANX, AND THE FIFTH METATARSAL). SOS PROVIDES AN ESTIMATE OF SKELETAL FRAGILITY. THE OUTPUT IS ALSO EXPRESSED AS A T-SCORE AND A Z-SCORE, AND CAN BE USED IN CONJUNCTION WITH OTHER CLINICAL RISK FACTORS AS AN AID TO THE PHYSICIAN IN THE DIAGNOSIS OF OSTEOPOROSIS AND OTHER MEDICAL CONDITIONS LEADING TO REDUCED BONE STRENGTH AND, ULTIMATELY , IN THE DETERMINATION OF FRACTURE RISK. MULTIPLE SKELETAL SITE TESTING PROVIDES CLINICIANS WITH ALTERNATIVES IF ONE SITE IS NOT ACCESSIBLE AND WITH ADDITIONAL SKELETAL INFORMATION (I.E., FROM BONES WITH DIFFERENT COMBINATIONS OF CORTICAL AND CANCELLOUS MATERIAL AND FROM WEIGHT BEARING AND NON-WEIGHT BEARING SITES) THAT ASSISTS IN DIAGNOSING OSTEOPOROSIS AND RISK FRACTURE. THE SOS MEASUREMENT BY OMNISENSE HAS A PRECISION ERROR LOW ENOUGH IN COMPARISON WITH THE EXPECTED ANNUAL CHANGE IN A PATIENT'S MEASUREMENT TO MAKE IT SUITABLE FOR MONITORING BONE CHANGES WHICH OCCUR IN THE EARLY YEARS FOLLOWING MENOPAUSE (I.E., AGE RANGE APPROXIMATELY 50-65 YEARS)."