ACUSON P50 DIAGNOSTIC ULTRASOUND SYSTEM

{0}------------------------------------------------ K072266 page 1 of 2 AUG 2 9 2007 # 510(k) Summary Siemens Medical Solutions Siemens P50 ™ Ultrasound System - Siemens Medical Solutions SPONSOR 1. Ultrasound Division 1230 Shorebird Way Mountain View, California - Sheila W. Pickering Ph.D. Contact Person: Regulatory Affairs 650 943 7187 Telephone: July 31 2007 Date Prepared: ### DEVICE NAME 2. | Proprietary Name: | Acuson P50 ™ Ultrasound System | |----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common/Usual Name: | Diagnostic Ultrasound System | | Classification Name: | Diagnostic Ultrasound Transducer<br>(21 CFR 892.1570, 90-ITX)<br>Ultrasonic Pulsed Echo Imaging System<br>(21 CFR 892.1560, 90-IYO)<br>Diagnostic Ultrasonic Transducer<br>(21 CFR 892.1570, 90-ITX) | ### PREDICATE DEVICES 3. | K992505 | TERATECH Model 2000 Imaging System | |---------|------------------------------------------------------| | K010833 | TERATECH Model 8C4 Endocavity Smart Probe | | K012191 | TERATECH Model 2000 Handheld Ultrasound System with | | | Doppler and Harmonic Imaging Modes | | K030191 | SIEMENS ™ Model 2000/BAS Portable Ultrasound Systems | | K040840 | TERATECH Model 10V5 Smart Probe | | K043278 | TERATECH Model 8IOC4, 8IOL4, and 10LAP4 Probes | | K051334 | TERASON™ Ultrasound System with Continuous Wave (CW) | | | Doppler and add-to-file submissions | {1}------------------------------------------------ K072266 Page 2 of 2 ### Intended Use 4. The Acuson P50 ™ Ultrasound System is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body; specific indications for use are tabulated in Section 4.3 of this submission. #### DEVICE DESCRIPTION 5. The Acuson P50 ™ Ultrasound System is identical to the Teratech 2000 and previous Teratech models as identified in the predicate device section. | | TERATECH 2000 | Acuson P50 | |-------------|----------------------|------------------------------------------------------| | Hardware | Specified in K051334 | No change | | Transducers | Specified in K051334 | Increase number of<br>transducers | | Software | Specified in K051334 | No change | | Labeling | Specified in K051334 | Changed only to<br>reflect additional<br>transducers | ### BASIS FOR SUBSTANTIAL EQUIVALENCE 6. The Siemens P50 ™ Ultrasound System is substantially equivalent to the Teratech devices listed above which are currently in commercial distribution in the United States. It is equivalent in modes of operation, and intended for the same clinical applications. {2}------------------------------------------------ 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 stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the symbol. The text is in all caps and is evenly spaced around the circle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Siemens Medical Solutions USA, Inc. c/o Mr. Mark Job Responsible Third Party Official Regulatory Technology Services 1394 25th Street, NW BUFFALO MN 55313 AUG 2 9 2007 Re: K072266 Trade/Device Name: Acuson P50TM Ultrasound System Regulation Number: 21 CFR §892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, IYN, ITX Dated: August 14, 2007 Received: August 15, 2007 Dear Mr. Job: We have reviewed your Section 510(k) premarket 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 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). 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. This determination of substantial equivalence applies to the following transducers intended for use with the ACUSON P50 Ultrasound System, as described in your premarket notification: ## Transducer Model Number | 4V2 Phased Array | 7L3 Linear Array | 12HL7 Hockeystick Linear Array | |-------------------|------------------|--------------------------------| | 12L5 Linear Array | AuxCW 2MHz Pedof | | If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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. {3}------------------------------------------------ Page 2 - Mr. Mark Job 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic 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 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 market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html If you have any questions regarding the content of this letter, please contact Mr. Paul Hardy at (240) 276-3666. Sincerely yours, Nancy C. Brogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosures {4}------------------------------------------------ ## Attachment 1 ## DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM | System: | ACUSON P50 Ultrasound System | | | | | | | | |-----------------------------|--------------------------------------------------------------------------------------------------|-------------------|---|-----|-----|----------------|-----------------|-------| | Transducer: | (see comments) | | | | | | | | | | Intended Use: Diagnostic ultrasound Imaging or fluid flow analysis of the human body as follows: | | | | | | | | | Clinical Application | | Mode of Operation | | | | | | Other | | General<br>(Track I Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppa | Comb.<br>Modesb | | | | Ophthalmic | | | | | | | | | Fetal<br>Imaging<br>& Other | Fetal | Nd | N | N | N | Nd | N | Nd | | | Abdominal | Nd | N | N | N | Nd | N | Nd | | | intra-operative (Spec.)e | Nd | N | N | N | Nd | N | Nd | | | Intra-operative (Neuro) | N | N | N | N | N | N | N | | | Laparoscopic | | | | | | | | | | Pediatric | Nd | N | N | N | Nd | N | Nd | | | Small Organ (Thyroid,<br>Breast, Testes, etc.) | Nd | N | N | N | Nd | N | Nd | | | Neonatal Cephalic | N | N | N | N | N | N | N | | | Adult Cephalic | N | N | N | N | N | N | N | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | Musculo-skel. (Convent.) | Nd | N | N | N | Nd | N | Nd | | | Musculo-skel. (Superfic) | Nd | N | N | N | Nd | N | Nd | | | Intra-luminall | N | N | N | N | Nd | N | N | | | Other (Specify) | | | | | | | | | Cardiac | Cardiac Adult | N | N | Nf | N | Nd | N | N | | | Cardiac Pediatric | N | N | Nf | N | Nd | N | N | | | Trans-esoph. (Cardiac) | N | N | Nf | N | Nd | N | N | | | Other (Specify) | | | | | | | | | Peripheral<br>Vessel | Peripheral vessel | Nd | N | N | N | N | N | Nd | | | Other (Specify) | | | | | | | | N= new indication; P= previously cleared by FDA; E= added under Appendix E " Includes Color Doppler (CD) and (non-directional) Power Doppler. B+M; B+PWD; B+CWD; B+CD; B+PD; ° Harmonic Imaging (HI) 4 Includes ultrasound guidance for placement of needles & catheters. · Abdominal organs and peripheral vessel. PW includes PW Doppler Tissue Imaging (DTI). 9 includes Doppler Tissue Imaging (DT)} Includes uses in milltary field settings in addition to hospital/clinic settings. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation Prescription Use (Per 21 CFR 801.109) Nancy C. Brogdon (Division Siğn-Off) Division of Reproductive, Abdominal, an Radiological Devices 510(k) Number {5}------------------------------------------------ | System: | ACUSON P50 Ultrasound System | | | | | | | | |--------------------------------------------------------------------------------------------------|------------------------------------------------|-------------------|---|-----|-----|----------------|----------------|-------| | Transducer: | 4V2 Phased Array (K063085) | | | | | | | | | Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | | Clinical Application | | Mode of Operation | | | | | | Other | | General<br>(Track I Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppa | Comb<br>Modesb | | | Ophthalmic | Ophthalmic | Pd | P | | | Pd | P | Pd | | | Fetal | Pd | P | P | | Pd | P | Pd | | | Abdominal | Pd | P | P | P | Pd | P | Pd | | | Intra-operative (Spec.) | Pd | P | P | P | Pd | P | Pd | | | Intra-operative (Neuro) | | | | | | | | | | Laparoscopic | | | | | | | | | Fetal<br>Imaging<br>& Other | Pediatric | Pd | P | P | P | Pd | P | Pd | | | Small Organ (Thyroid,<br>Breast, Testes, etc.) | | | | | | | | | | Neonatal Cephalic | P | P | P | P | P | P | P | | | Adult Cephalic: | P | P | P | P | P | P | P | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | Musculo-skel. (Convent.) | | | | | | | | | | Musculo-skel. (Superfic) | | | | | | | | | | Intra-luminal | | | | | | | | | | Other (Specify) | | | | | | | | | Cardiac | Cardiac Adult | P | P | P | P | P | P | P | | | Cardiac Pediatric | P | P | P | P | P | P | P | | | Trans-esoph. (Cardiac) | | | | | | | | | | Other (Specify) | | | | | | | | | Peripheral<br>Vessel | Peripheral vessel | | | | | | | | | | Other (Specify) | | | | | | | | N= new indication; P= praviously cleared by FDA; E= added under Appendix E " Includes Color Doppler (CD) and (non-directional) Power Doppler. 8 +M; B+PWD; B+CWD; B+CD; B+PD. ് Harmonic Imaging (HI) Harmonic infaging (11) 9 Includes ultrasound guidance for placement of needles, catheters. * Abdominal organs and peripheral vessel. PW includes PW Doppler Tissue Imaging (DTI). 9 includes Doppler Tissue Imaging (DTI) . Includes uses in military lieid settings in addition to hospital/clinic settings. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation VPrescription Use (Per 21 CFR 801.109) Nancy Brogdon (Division Sign-Off) () Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number {6}------------------------------------------------ | System: | ACUSON P50 Ultrasound Systems | | | | | | | | |--------------------------------------------------------------------------------------------------|------------------------------------------------|----|-------------------|-----|-----|----------------|-----------------|--------| | Transducer: | 7L3 Linear Array (K042055) | | | | | | | | | Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | | Clinical Application | | | Mode of Operation | | | | | | | General<br>(Track I Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppa | Comb.<br>Modesb | Otherc | | Ophthalmic | Ophthalmic | | | | | | | | | Fetal<br>Imaging<br>& Other | Fetal | | | | | | | | | | Abdominal | | | | | | | | | | Intra-operative (Spec.)a | Pa | P | P | | Pa | P | Pa | | | Intra-operative (Neuro) | | | | | | | | | | Laparoscopic | | | | | | | | | | Pediatric | | | | | | | | | | Small Organ (Thyroid,<br>Breast, Testes, etc.) | Pa | P | P | | Pa | P | Pa | | | Neonatal Cephalic | | | | | | | | | | Adult Cephalic | | | | | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | Musculo-skel. (Convent.) | Pa | P | P | | Pa | P | Pa | | | Musculo-skel. (Superfic) | Pa | P | P | | Pa | P | Pa | | | Intra-luminal | | | | | | | | | | Other (Specify) | | | | | | | | | Cardiac | Cardiac Adult | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | Other (Specify) | | | | | | | | | Peripheral<br>Vessel | Peripheral vessel | Pa | P | P | | Pa | P | Pa | | | Other (Specify) | | | | | | | | N= new indication; P= previously cleared by FDA; E= added under Appendix E 4 Includes Color Doppler (CD) and (non-directional) Power Doppler. ° B+M; B+PWD; B+CWD; B+CD; B+PD. ° Harmonic Imaging (HI) 6 Includes ultrasound guidance for placement of needles, catheters. Abdominal organs and peripheral vessel. PW includes PW Doppier Tissue Imaging (DTI). & includes Doppler Tissue Imaging (DTI) . (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation Prescription Use (Per 21 CFR 801. 109) Nancy C. Brogdon (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number {7}------------------------------------------------ System: ACUSON P50 Ultrasound Systems Transducer 12HL7 Hockeystlck Linear Array (K051334) Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Mode of Operation Clinical Application Other Comb. Specific B દિવેલા ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં મુખ્યત્વે ખેત-ઉત PWD CWD Color General Dopp® Modes (Track I Only) (Tracks 1 & III) Ophthalmic Ophthalmic Felal Abdominal p P pr P P P Intra-operative (Spec.) P P P P P P Intra-operative (Neuro) Laparoscopic Pediatric Fetal P P a P P ರಿ Small Organ (Thyroid, Imaging & Other Breast, Testes, etc.) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Card.) pa p ﺔ ﺍﻟﻤ P P p Musculo-skel. (Convent.) ਨਾਂ ിച്ച് p Musculo-skel. (Superfic) P P P Intra-luminal Other (Specify) Cardiac Adult Cardiac Pediatric Cardiac Trans-esoph. (Cardiac) Other (Specify) p " ﺔ ﺍﻟﻤ P p Peripheral Peripheral vessel P P Vessel Other (Specify) N = new indication; P = previously cleared by FDA; E = added under Appendix E Includes Color Doppler (CD) and (non-directional) Power Doppler. B+M; B+PWD; B+CWD; B+CD; B+PD. ° Harmonic Imaging (HI) 4 Includes ultrasound guidance for placement of needles, catheters. * Abdominal organs and peripheral vessel. PW includes PW Doppler Tissue Imaging (DTI). 8 includes Doppler Tissue Imaging (DTI) . Includes uses in military lield settings in addition to hospital/clinic settings. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation Prescription Use (Per 21 CFR 801.109) Nancy C. Brogdon (Division Sign-Off) Division of Reproductive, Abdominal, Radiological Devices 510(k) Number {8}------------------------------------------------ | System:<br>Transducer. | ACUSON P50 Ultrasound Systems<br>12L5 Linear Array (K051334)<br>Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | |-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|---|-----|-----|----------------|-----------------|--------| | Clinical Application | | Mode of Operation | | | | | | | | General<br>(Track I Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppa | Comb.<br>Modesb | Otherc | | | Ophthalmic | | | | | | | | | | Fetal<br>Abdominal<br>Intra-operative (Spec.) | Pd | P | P | | Pd | P | Pd | | Fetal<br>Imaging<br>& Other | Intra-operative (Neuro)<br>Laparoscopic<br>Pediatric | | | | | | | | | | Small Organ (Thyroid,<br>Breast, Testes, etc.)<br>Neonatal Cephalic | Pd | P | P | | Pd | P | Pd | | | Adult Cephalic | | | | | | | | | | Trans-rectal<br>Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Card.)<br>Musculo-skel. (Convent.) | Pd | P | P | | Pd | P | Pd | | | Musculo-skel. (Superfic) | Pd | P | P | | Pd | P | Pd | | | Intra-luminal<br>Other (Specify) | | | | | | | | | Cardiac | Cardiac Adult | | | | | | | | | | Cardiac Pediatric<br>Trans-esoph. (Cardiac) | | | | | | | | | | Other (Specify) | | | | | | | | | Peripheral<br>Vessel | Peripheral vessel | Pd | P | P | | Pd | P | Pd | | | Other (Specify) | | | | | | | | N = new indication; P = previously cleared by FDA; E= added under Appendix E Includes Color Doppler (CD) and (non-directional) Power Doppler. 8 + M; B+PWD; B+CWD; B+CD; B+PD. ° Harmonic Imaging (HI) I hamments maging ( ... ) 4 Includes ultrasound guidance for placement of needles, catheters. * Abdominal organs and peripheral vessel. PW includes PW Doppler Tissue Imaging (DTI). 9 includes Doppler Tissue Imaging (DTI) . Includes uses in military field settings in addition to hospital/clinic settings. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Goncurrence of Center for Devices and Radiological Health, Office of Device Evaluation Prescription Use (Per 21 CFR 801.109) Nancy C. Brogdon (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number {9}------------------------------------------------ | System: | ACUSON P50 Ultrasound Systems | | | | | | | | |-----------------------------|--------------------------------------------------------------------------------------------------|-------------------|---|-----|-----|------------|----------------|-------| | Transducer: | AuxCW 2MHz Pedof (K063085) | | | | | | | | | | Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | Clinical Application | | Mode of Operation | | | | | | Other | | General<br>(Track I Only) | Specific<br>(Tracks I & II) | B | M | PWD | CWD | Color Dopp | Comb.<br>Modes | | | Ophthalmic | Ophthalmic | | | | | | | | | Fetal<br>Imaging<br>& Other | Fetal | | | | | | | | | | Abdominal | | | | | | | | | | Intra-operative (Spec.) | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | Laparoscopic | | | | | | | | | | Pediatric | | | | | | | | | | Small Organ (Thyroid,<br>Breast, Testes, etc.) | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | Adult Cephalic | | | | | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | Musculo-skel. (Convent.) | | | | | | | | | | Musculo-skel. (Superfic) | | | | | | | | | | Intra-luminal | | | | | | | | | | Other (Specify) | | | | | | | | | Cardiac | Cardiac Adult | | | | P | | | | | | Cardiac Pediatric | | | | P | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | Other (Specify) | | | | | | | | | Peripheral<br>Vascular | Peripheral vessel | | | | | | | | | | Other (Specify) | | | | | | | | ACUSON P50 Ultrasound Systems N= new indication; P= previously cleared by FDA; E= added under Appendix E Includes Color Doppler (CD) and (non-directional) Power Doppler. 8 +M; B+PWD; B+CWD; B+CD; B+PD. ° Harmonic Imaging (Hi) Includes ultrasound guidance for placement of needles, catheters. * Abdominal organs and peripheral vessel. PW includes PW Doppler Tissue Imaging (DTI). 9 includes Doppler Tissue Imaging (DTI) . Includes uses in military field settings in addition to hospital/clinic settings. - Includes uses in military (11) : (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Goncurrence of Center for Devices and Radlological Health, Office of Device Evaluation Prescription Use (Par 21 CFR 801.1 V Nancy C. Brogdon (Division Sigh-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number