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K Number
K161960
Device Name
bk2300
Manufacturer
BK MEDICAL APS
Date Cleared
2016-10-17

(91 days)

Product Code
IYN,ITX,IYO
Regulation Number
892.1550
Type
Traditional
Panel
Radiology
Reference & Predicate Devices
K151910,K132346,K140729,K103629
Predicate For
K173569,K180737
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The system is a diagnostic ultrasound imaging system used by qualified and trained healthcare professionals for ultrasound imaging, human body fluid flow analysis and puncture and biopsy guidance.

The clinical applications and exam types include: Fetal (including Obstetrics), Abdominal, Pediatric, Small Organ (also known as Small Parts), Adult Cephalic (also known as Adult Trans cranial), Neonatal Cephalic, Intraoperative (Neuro), Trans rectal, Trans rectal, Transvaginal, Transurethral, Musculoskeletal (Conventional and Superficial), Cardiac Adult, Trans-esophageal Cardiology, and Peripheral Vessel (also known as Peripheral Vascular).

Contraindications:

· The 2300 Ultrasound System is not intended for ophthalmic use or any use causing the acoustic beam to pass through the eve.

· The Cardiac Adult application is not intended for direct use on the heart.

Device Description

The Ultrasound Scanner System bk2300 is a multi-purpose mobile, software controlled diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms.

The transducers are all multi-frequency transducers including:

  • Phased Linear Array 0
  • o Convex/Curved linear array.

The interaction with the patients is dependent upon the transducer type which may be:

  • 0 Surface contact.
  • . Intra-operative, or
  • 0 contact through Endocavity

when used in locations as described by the indications for use.

The function of the ultrasound scanner system and its transducers is to acquire primary or secondary harmonic ultrasound echo data and display it in the scanning modes.

AI/ML Overview

The provided documents describe a submission for the BK Medical bk2300 ultrasound system, including various transducers and clinical applications. However, the details for acceptance criteria and specific study results proving the device meets these criteria are not explicitly provided in these particular documents.

The documents are a 510(k) premarket notification letter from the FDA and several "Indications for Use" forms for the bk2300 system and its various transducers. These documents state that "design validation testing was performed to ensure that the Ultrasound Scanner System bk2300 with modifications meets design specifications" and that "Performance, verification and validation testing was conducted to characterize performance of the proposed device and the predetermined acceptance criteria was met." However, the actual acceptance criteria values and the reported performance metrics of these tests are not included.

Therefore, I cannot provide the requested information for the following points based on the provided text:

  • A table of acceptance criteria and the reported device performance
  • Sample sized used for the test set and the data provenance
  • Number of experts used to establish the ground truth for the test set and the qualifications of those experts
  • Adjudication method for the test set
  • If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
  • If a standalone performance (i.e., algorithm only without human-in-the-loop performance) was done
  • The type of ground truth used
  • The sample size for the training set
  • How the ground truth for the training set was established

The documents primarily focus on:

  1. FDA clearance for the device (bk2300) and its various transducers for specific indications.
  2. Listing of the clinical applications and exam types for which the ultrasound system is intended.
  3. Contraindications for the device.
  4. Mention of the device's technological characteristics and its similarity to predicate devices.
  5. A list of voluntary standards with which the system complies (e.g., IEC 60601-1, IEC 60601-2-37, IEC 62359).

To address your request fully, the actual test reports, validation studies, and performance data from BK Medical ApS would be needed, which are not present in this set of FDA clearance documents.

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the caduceus symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 17, 2016

BK Medical ApS % Ms. Karen Provencher Sr. Regulatory Specialist Mileparken 34 Herlev 2730 DENMARK

Re: K161960 Trade/Device Name: bk2300 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: July 19, 2016 Received: July 20, 2016

Dear Ms. Provencher:

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 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) 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D.'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K161960

Device Name bk2300

Indications for Use (Describe)

The system is a diagnostic ultrasound imaging system used by qualified and trained healthcare professionals for ultrasound imaging, human body fluid flow analysis and puncture and biopsy guidance.

The clinical applications and exam types include: Fetal (including Obstetrics), Abdominal, Pediatric, Small Organ (also known as Small Parts), Adult Cephalic (also known as Adult Trans cranial), Neonatal Cephalic, Intraoperative (Neuro), Trans rectal, Trans-urethral, Musculo-skeletal (Conventional and Superficial), Cardiac Adult, Trans-esophageal Cardiology, and Peripheral Vessel (also known as Peripheral Vascular).

Contraindications:

· The 2300 Ultrasound System is not intended for ophthalmic use or any use causing the acoustic beam to pass through the eve.

· The Cardiac Adult application is not intended for direct use on the heart.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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{3}------------------------------------------------

System: bk2300

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationModes
Specific(Tracks I & III)BMPWDCWD 4)TissueHarmonicImagingCHI 5)ColorDopplerAmplitudeDopplerColorVelocityImagingCombined1)Other
Ophthalmic
FetalPPPPPPPPPPP 3)
AbdominalPPPPPPPPPPP 3)
Intra-operative (Specify)PPPPPPPPPPP 3)
Intra-operative (Neuro)PPPPPPPPPPP 3)
Laparoscopic
PediatricPPPPPPPPPPP 3)
Small Organ (Specify)PPPPPPPPPPP3)
Neonatal CephalicPPPPPPPPPPP 3)
Adult CephalicPPPPPPPPPPP 3)
Trans-rectalPPPPPPPPPPP 3)
Trans-vaginalPPPPPPPPPPP 3)
Trans-urethralPPPPPPPPPPP 3)
Trans-esoph. (non-Card.)
Musculo-skel. (Conventional)PPPPPPPPPPP 3)
Musculo-skel. (Superficial)PPPPPPPPPPP 3)
Intra-luminal
Cardiac AdultPPPPPPPPPP
Cardiac Pediatric
Trans-esoph. (Cardiac)NNNNNNNNNN
Peripheral vesselPPPPPPPPPPP 2)P 3)
Other (Specify)

N= new indication; P= previously cleared by FDA in K140428; E= added under Appendix E

Additional Comments:

  1. Mode combinations:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

  1. Vector Flow Imaging (VFI): Previously cleared in K143298

  2. Elastography: Previously cleared in K143298

  3. Continuous Wave Doppler (CWD/CW): Previously cleared in K143298

  4. Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI): Previously cleared in K143298

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

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

{4}------------------------------------------------

System: bk2300

Transducer: 9027 (T7P2m)

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationModes
Specific(Tracks I & III)BMPWDCWD 2)TissueHarmonicImagingCHI 3)ColorDopplerAmplitudeDopplerColorVelocityImagingCombined1)Other
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Conventional)
Musculo-skel. (Superficial)
Intra-luminal 17)
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Trans-esoph. CardiacNNNNNNNNNN
Other (Specify)
Peripheral vessel)
Other (Specify)
Other (Specify)
Other (Specify)

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments:

    1. Mode combinations:
      B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

  1. Continuous Wave Doppler (CWD/CW): Previously cleared in K143298

  2. Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI): Previously cleared in K143298

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

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

{5}------------------------------------------------

System: bk2300

Transducer: 9002 (9C2)

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationModes
Specific(Tracks I & III)BMPWDCWDTissueHarmonicImagingCHIColorDopplerAmplitudeDopplerColorVelocityImagingCombined1)Other
Ophthalmic
FetalPPPPPPPP 2)
AbdominalPPPPPPPP 2)
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPPPPPP 2)
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Conventional)PPPPPPPP 2)
Musculo-skel. (Superficial)
Intra-luminal
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral vesselPPPPPPPP 2)

N= new indication; P= previously cleared by FDA in K140428; E= added under Appendix E

Additional Comments:

  1. Mode combinations:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

  1. Elastography: Previously cleared in K143298

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

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

{6}------------------------------------------------

System: bk2300

Transducer: 9009 (X18L5s)

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationModes
Specific(Tracks I & III)BMPWDCWDTissueHarmonicImagingCHIColorDopplerAmplitudeDopplerColorVelocityImagingCombined1)Other
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)PPPPPPP
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify)PPPPPPP
Neonatal Cephalic)
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Conventional)PPPPPPP
Musculo-skel. (Superficial)PPPPPPP
Intra-luminal
Other (Specify)
Cardiac Adult)
Cardiac Pediatric
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral vesselPPPPPPP

N= new indication; P= previously cleared by FDA in K140428; E= added under Appendix E

Additional Comments:

  1. Mode combinations:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

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

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

{7}------------------------------------------------

Fill out one form for each ultrasound system and each transducer.

System: bk 2300

Transducer: 9011 (13L4w)

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application
Specific(Tracks I & III)BMPWDTissueHarmonicImagingColorDopplerAmplitudeDopplerColorVelocityImagingCombined(Specify 1)Other
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPPPPPP 3)
Small Organ (Specify) 2)PPPPPPPP 3)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Conventional)PPPPPPPP 3)
Musculo-skel. (Superficial)PPPPPPPP 3)
Intra-luminal
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral vesselPPPPPPPP 3)
Other (Specify)

N= new indication; P= previously cleared by FDA in K140428; E= added under Appendix E

Additional Comments:

  1. Mode combinations:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

  1. Small Organ: thyroid, breast, testes, penis, parathyroid, salivary glands, lymph nodes.
    1. Elastography: Previously cleared in K143298
      (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OlR)

{8}------------------------------------------------

System: bk2300 (bk5000)

Transducer: 9015 (114C5I)

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationModes
Specific(Tracks I & III)BMPWDCWDTissueHarmonicImagingCHI 4)ColorDopplerAmplitudeDopplerColorVelocityImagingCombined1)Other
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify) 3)PPPPPPPPP 2)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPPPPPPP 2)
Small Organ (Specify)
Neonatal Cephalic)
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Conventional)
Musculo-skel. (Superficial)
Intra-luminal
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral vessel

N= new indication; P= previously cleared by FDA in K140428; E= added under Appendix E

Additional Comments:

    1. Mode combinations:
      B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)
    1. Elastography: Previously cleared in K143298

  • Inter-operative: Liver, Biliary, Pancreas, Kidney, Stomach, Breast 3)

    1. Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI): Previously cleared in K143298

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

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

{9}------------------------------------------------

System: bk2300 (bk5000)

Transducer: 9016 (114C5T)

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationModes
Specific(Tracks I & III)BMPWDCWDTissueHarmonicImagingCHI 4)ColorDopplerAmplitudeDopplerColorVelocityImagingCombined1)Other
Ophthalmic
Fetal
AbdominalPPPPPPPPP 2)
Intra-operative (Specify) 3)PPPPPPPPP 2)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Conventional)
Musculo-skel. (Superficial)
Intra-luminal
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral vessel

N= new indication; P= previously cleared by FDA in K140428; E= added under Appendix E

Additional Comments:

    1. Mode combinations:
      B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)
    1. Elastography: Previously cleared in K143298
    1. Inter-operative: Liver, Biliary, Pancreas, Kidney
    1. Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI): Previously cleared in K143298

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

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

{10}------------------------------------------------

Fill out one form for each ultrasound system and each transducer.

System: bk2300 (bk3000, bk5000)

Transducer: 9018 (E14C4t)

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationModes
Specific(Tracks I & III)BMPWDCWDTissueHarmonicImagingCHI 3)ColorDopplerAmplitudeDopplerColorVelocityImagingCombined 1)Other
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify)
Neonatal Cephalic)
Adult Cephalic)
Trans-rectalPPPPPPPPPP2)
Trans-vaginalPPPPPPPPPP2)
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Conventional)
Musculo-skel. (Superficial)
Intra-luminal
Other (Specify)
Cardiac Adult)
Cardiac Pediatric)
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral vessel)
Other (Specify)

N= new indication; P= previously cleared by FDA in K140428; E= added under Appendix E

Additional Comments:

  1. Mode combinations:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

    1. Elastography: Previously cleared in K143298
    1. Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI): Previously cleared in K143298

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

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

{11}------------------------------------------------

Fill out one form for each ultrasound system and each transducer.

System: bk2300

Transducer: 9019 (E10C4)

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application
Specific(Tracks I & III)BMPWDTissueHarmonicImagingColorDopplerAmplitudeDopplerColorVelocityImagingCombined(Specify 1)Other
Ophthalmic
FetalPPPPPPPP 2)
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify )
Neonatal Cephalic
Adult Cephalic
Trans-rectalPPPPPPPP 2)
Trans-vaginalPPPPPPPP 2)
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Conventional)
Musculo-skel. (Superficial)
Intra-luminal
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral vessel
Other (Specify)

N= new indication; P= previously cleared by FDA in K140428; E= added under Appendix E

Additional Comments:

  1. Mode combinations:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

  1. Elastography: Previously cleared in K143298

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

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

{12}------------------------------------------------

Fill out one form for each ultrasound system and each transducer.

System: bk2300

Transducer: 9022 (10L2w)

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application
Specific(Tracks I & III)BMPWDTissueHarmonicImagingColorDopplerAmplitudeDopplerColorVelocityImagingCombined(Specify 1)Other
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Conventional)
Musculo-skel. (Superficial)
Intra-luminal
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral vesselPPPPPPPPP2), P 3)
Other (Specify)

N= new indication; P= previously cleared by FDA in K140428; E= added under Appendix E

Additional Comments:

  1. Mode combinations:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

  1. Elastography: Previously cleared in K143298
    1. Vector Flow Imaging (VFI): Previously cleared in K143298
      (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

{13}------------------------------------------------

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

System: bk2300 Transducer: 9023 (6C2s)

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application
Specific(Tracks I & III)BMPWDTissueHarmonicImagingColorDopplerAmplitudeDopplerColorVelocityImagingCombined(Specify 1)Other
Ophthalmic
FetalPPPPPPPP 2), P 3)
AbdominalPPPPPPPP 2), P 3)
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPPPPPP 2), P 3)
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Conventional)
Musculo-skel. (Superficial)
Intra-luminal
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral vessel
Other (Specify)

N= new indication; P= previously cleared by FDA in K140428; E= added under Appendix E

Additional Comments:

    1. Mode combinations:
      B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

  1. Elastography: Previously cleared in K143298

  2. Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI): Previously cleared in K143298

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

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OlR) Prescription Use (Per 21 CFR 801.109)

{14}------------------------------------------------

System: bk2300 (bk3500, bk5000)

Transducer: 9024 (112C5b)

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationModes
Specific(Tracks I & III)BMPWDCWDTissueHarmonicImagingCHI 4)ColorDopplerAmplitudeDopplerColorVelocityImagingCombined1)Other
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify 2)PPPPPPPPP 3)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify)
Neonatal Cephalic)
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Conventional)PPPPPPPPP 3)
Musculo-skel. (Superficial)
Intra-luminal
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral vesselPPPPPPPPP 3)

N= new indication; P= previously cleared by FDA in K140428; E= added under Appendix E

Additional Comments:

    1. Mode combinations:
      B+M, B+D, B+C, B+D+C, (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)
    1. Intra-operative: Liver, Biliary, Pancreas, Kidney
    1. Elastography: Previously cleared in K143298
    1. Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI): Previously cleared in K 143298

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

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

{15}------------------------------------------------

System: bk2300 (bk5000)

Transducer: 9026 (X12C4)

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationModes
Specific(Tracks I & III)BMPWDCWDTissueHarmonicImagingCHI 4)ColorDopplerAmplitudeDopplerColorVelocityImagingCombined1)Other
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify 2)PPPPPPPPP 3)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Conventional)
Musculo-skel. (Superficial)
Intra-luminal
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral vessel

N= new indication; P= previously cleared by FDA in K140428; E= added under Appendix E

Additional Comments:

    1. Mode combinations:
      B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)
    1. Intra-operative: Pancreas, Kidney, Liver
    1. Elastography: Previously cleared in K143298

  • Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI): Previously cleared in K143298 4)

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

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

{16}------------------------------------------------

System: bk2300

Transducer: 9032 (8L2)

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationModes
Specific(Tracks I & III)BMPWDCWDTissueHarmonicImagingCHI 4)ColorDopplerAmplitudeDopplerColorVelocityImagingCombined1)Other
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPPPPPPP 3)
Small Organ (Specify 2)PPPPPPPPP 3)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Conventional)PPPPPPPPP 3)
Musculo-skel. (Superficial)PPPPPPPPP 3)
Intra-luminal
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral vesselPPPPPPPPP 3)

N= new indication; P= previously cleared by FDA in K140428; E= added under Appendix E

Additional Comments:

    1. Mode combinations:
      B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)
    1. Small Organ: Thyroid, Breast, Testes
    1. Elastography: Previously cleared in K143298
  1. Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI): Previously cleared in K143298

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

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

{17}------------------------------------------------

Fill out one form for each ultrasound system and each transducer.

System: bk2300

Transducer: 9040 (6C2)

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application
Specific(Tracks I & III)BMPWDTissueHarmonicImagingColorDopplerAmplitudeDopplerColorVelocityImagingCombined(Specify 1)Other
Ophthalmic
FetalPPPPPPPP 2)
AbdominalPPPPPPPP 2)
Intra-operative (Specify )
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify )
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Conventional)PPPPPPPP2)
Musculo-skel. (Superficial)
Intra-luminal
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral vessel
Other (Specify)

N= new indication; P= previously cleared by FDA in K140428; E= added under Appendix E

Additional Comments:

  1. Mode combinations:

B+M. B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

  1. Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI): Previously cleared in K143298

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

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

{18}------------------------------------------------

Fill out one form for each ultrasound system and each transducer.

System: bk 2300 (bk3000, bk5000)

Transducer: 9048 (E14CL4b)

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application
Specific(Tracks I & III)BMPWDTissueHarmonicImagingColorDopplerAmplitudeDopplerColorVelocityImagingCombined(Specify 1)Other
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Trans-rectalPPPPPPPP 2), P 3)
Trans-vaginalPPPPPPPP 2), P 3)
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Conventional)
Musculo-skel. (Superficial)
Intra-luminal
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral vessel)
Other (Specify)

N= new indication; P= previously cleared by FDA in K140428; E= added under Appendix E

Additional Comments:

  1. Mode combinations:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

  1. Elastography: Previously cleared in K143298

  2. Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI): Previously cleared in K 143298

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

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

{19}------------------------------------------------

Fill out one form for each ultrasound system and each transducer.

System: bk2300

Transducer: 9051 (14L3)

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationModes
Specific(Tracks I & III)BMPWDCWDTissueHarmonicImagingContrastHarmonicImagingColorDopplerAmplitudeDopplerColorVelocityImagingCombined 1)Other
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPPPPPP3)
Small Organ (Specify 2)PPPPPPPP3)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Conventional)PPPPPPPP3)
Musculo-skel. (Superficial)PPPPPPPP3)
Intra-luminal
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac )
Other (Specify)
Peripheral vesselPPPPPPPP3)P4)
Other (Specify )

N= new indication; P= previously cleared by FDA in K140428; E= added under Appendix E

Additional Comments:

  1. Mode combinations:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

    1. Small Organ: Breast, Thyroids, Testes
    1. Elastography: Previously cleared in K 143298
    1. Vector Flow Imaging (VFI): Previously cleared in K143298

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

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OlR)

{20}------------------------------------------------

System: bk2300 (bk3000, bk5000)

Transducer: 9052 (20R3)

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationModes
Specific(Tracks I & III)BMPWDCWDTissueHarmonicImagingCHIColorDopplerAmplitudeDopplerColorVelocityImagingCombined1)Other
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify)
Neonatal Cephalic)
Adult Cephalic
Trans-rectalP
Trans-vaginalP
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Conventional)
Musculo-skel. (Superficial)
Intra-luminal
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral vessel

N= new indication; P= previously cleared by FDA in K140428; E= added under Appendix E

Additional Comments:

  1. Mode combinations:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

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

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

{21}------------------------------------------------

Fill out one form for each ultrasound system and each transducer.

System: bk2300

Transducer: 9062 (N13C5)

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationModes
Specific(Tracks I & III)BMPWDCWDTissueHarmonicImagingContrastHarmonicImagingColorDopplerAmplitudeDopplerColorVelocityImagingCombined 1)Other
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify 2)PPPPPPPPP3)
Intra-operative (Neuro)PPPPPPPPP3)
Laparoscopic
PediatricPPPPPPPPP3)
Small Organ (Specify)
Neonatal CephalicPPPPPPPPP3)
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Conventional)
Musculo-skel. (Superficial)
Intra-luminal
Other (Specify)
Cardiac Adult)
Cardiac Pediatric
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral vessel)
Other (Specify)

N= new indication; P= previously cleared by FDA in K140428; E= added under Appendix E

Additional Comments:

    1. Mode combinations:
      B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

  • Inter-operative: Gallbladder 2)

    1. Elastography: Previously cleared in K143298

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

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

{22}------------------------------------------------

Fill out one form for each ultrasound system and each transducer.

System: bk2300 (bk5000)

Transducer: 9063 (N11C5s)

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationModes
Specific(Tracks I & III)BMPWDCWDTissueHarmonicImagingCHI 3)ColorDopplerAmplitudeDopplerColorVelocityImagingCombined 1)Other
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify 2)PPPPPPPP
Intra-operative (Neuro)PPPPPPPP
Laparoscopic
Pediatric
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Conventional)
Musculo-skel. (Superficial)
Intra-luminal
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral vessel

N= new indication; P= previously cleared by FDA in K140428; E= added under Appendix E

Additional Comments:

  1. Mode combinations:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

    1. Intra-operative: Gall Bladder
    1. Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI): Previously cleared in K143298

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

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

{23}------------------------------------------------

System: bk2300 (bk5000)

Transducer: 9066 (112C4f)

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationModes
Specific(Tracks I & III)BMPWDCWDTissueHarmonicImagingCHI 3)ColorDopplerAmplitudeDopplerColorVelocityImagingCombined1)Other
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify 2)PPPPPPPPPP 4)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Conventional)
Musculo-skel. (Superficial)
Intra-luminal
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral vessel

N= new indication; P= previously cleared by FDA in K140428; E= added under Appendix E

Additional Comments:

    1. Mode combinations:
      B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)
    1. Intra-operative: Liver, Biliary, Pancreas, Kidney, Stomach
    1. Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI): Previously cleared in K143298
    1. Elastography: Previously cleared in K143298

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

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

{24}------------------------------------------------

Fill out one form for each ultrasound system and each transducer.

System: bk2300 (bk3000)

Transducer: 9067 (E14C4)

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application Specific(Tracks I & III)BMPWDTissueHarmonicImagingColorDopplerAmplitudeDopplerColorVelocityImagingCombined(Specify 1)Other
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Trans-rectalPPPPPPPP 2)
Trans-vaginalPPPPPPPP 2)
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Conventional)
Musculo-skel. (Superficial)
Intra-luminal
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral vessel
Other (Specify)

N= new indication; P= previously cleared by FDA in K140428; E= added under Appendix E

Additional Comments:

  1. Mode combinations:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

  1. Elastography: Previously cleared in K143298

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

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

{25}------------------------------------------------

Fill out one form for each ultrasound system and each transducer.

System: bk2300

Transducer: 9070 (18L5)

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application
Specific(Tracks I & III)BMPWDTissueHarmonicImagingColorDopplerAmplitudeDopplerColorVelocityImagingCombined(Specify 1)Other
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPPPPPP 3)
Small Organ (Specify 2)PPPPPPPP 3)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Conventional)PPPPPPPP 3)
Musculo-skel. (Superficial)PPPPPPPP 3)
Intra-luminal
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral vesselPPPPPPPP 3)
Other (Specify)

N= new indication; P= previously cleared by FDA in K140428; E= added under Appendix E

Additional Comments:

  1. Mode combinations:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

  1. Small Organ: thyroid, breast, testes, superficial anatomy.
    1. Elastography: Previously cleared in K143298
      (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

{26}------------------------------------------------

Fill out one form for each ultrasound system and each transducer.

System: bk2300

Transducer: 9077 (5P1)

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationSpecific(Tracks I & III)BMPWDCWD2)TissueHarmonicImagingContrastHarmonicImagingColorDopplerAmplitudeDopplerColorVelocityImagingCombined 1)Other
Ophthalmic
Fetal
AbdominalPPPPPPPP
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify)
Neonatal Cephalic
Adult CephalicPPPPPPPP
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Conventional)
Musculo-skel. (Superficial)
Intra-luminal
Other (Specify)
Cardiac AdultPPPPPPPP
Cardiac Pediatric
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral vessel)
Other (Specify)

N= new indication; P= previously cleared by FDA in K140428; E= added under Appendix E

Additional Comments:

  1. Mode combinations:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

  1. Continuous Wave Doppler (CWD/CW): Previously cleared in K143298

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

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

{27}------------------------------------------------

Image /page/27/Picture/0 description: The image shows the logo for BK Medical, a company that specializes in ultrasound technology. The logo consists of the text "bk medical" in a sans-serif font, with the "bk" in a darker shade of green than the "medical". Below the company name is the text "Analogic Ultrasound Group" in a smaller font. To the right of the company name is a green and white circular graphic.

510(k) Summary 7.

This 510(k) Summary is being submitted in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content contained in this 510(k) summary has been provided in conformance with 21 CFR 807.92

  • A. Submitter's information
Name:BK Medical ApS
Address:Mileparken 34
Herlev 2730
Denmark
FDA Establishment Owner /Operator Number:9680269
Contact person:Karen Provencher
Phone:978-326-4668
Fax:978-977-6809
Manufacturer:BK Medical ApS
Mileparken 34
Herlev 2730
Denmark
Device Name:
  • B.
    Trade/Proprietary Name: bk2300 Common Name: Ultrasound system Classification name: Doppler Imaging System and Ultrasonic Pulsed Echo Regulation Medical Specialty: Radiology Review Panel: Radiology Product Code: IYN, IYO, ITX Regulation Number: 892.1550, 892.1560, and 892.1570 Device Classification: 2 Submission type: Traditional 510(k)

C. Substantial Equivalence:

This submission is a Traditional 510(k) device modification as described in the FDA's Guidance document entitled, "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications". In support of this Traditional 510(k), BK Medical ApS has provided certification of compliance to 21 CFR $820.30 Design Control requirements. Design validation testing was performed to ensure that the Ultrasound Scanner System bk2300 with modifications meets design specifications. The Ultrasound Scanner System bk2300 with modifications has been compared to the legally marketed predicate devices as cleared through K151910 (October 5, 2015), K132346 (January 10, 2014), K140729 (5/23/2014), and K103629 (2/2/2011) respectively and is found to be substantially equivalent.

This proposed device is identical to the identified predicates except for the proposed integration of software and transducer for the following:

{28}------------------------------------------------

Image /page/28/Picture/0 description: The image shows the logo for BK Medical. The logo consists of the text "bk medical" in a lowercase, sans-serif font, with the letters in a dark teal color. To the right of the text is a circular graphic, which is green and has a white line drawing of a waveform inside of it.

Analogic Ultrasound Group

  • Electrocardiograph (ECG) display of the electrical and muscular activity of the heart. o Impulses from the heart are relayed via electrodes to the system and appear as a waveform on the screen measurement display.
  • Trans-esophageal visualization of the heart (and other organs) with an ultrasound . transducer. The transducer is inserted into the esophagus through the mouth to visualize a plane of the heart through the esophageal wall.

D. Device Description/Indications for Use:

The Ultrasound Scanner System bk2300 is a multi-purpose mobile, software controlled diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms.

The transducers are all multi-frequency transducers including:

  • Phased Linear Array 0
  • o Convex/Curved linear array.

The interaction with the patients is dependent upon the transducer type which may be:

  • 0 Surface contact.
  • . Intra-operative, or
  • 0 contact through Endocavity

when used in locations as described by the indications for use.

The function of the ultrasound scanner system and its transducers is to acquire primary or secondary harmonic ultrasound echo data and display it in the scanning modes.

Indications for Use:

The system is a diagnostic ultrasound imaging system used by qualified and trained healthcare professionals for ultrasound imaging, human body fluid flow analysis and puncture and biopsy guidance.

The clinical applications and exam types include: Fetal (including Obstetrics), Abdominal, Pediatric, Small Organ (also known as Small Parts), Adult Cephalic (also known as Adult Trans cranial), Neonatal Cephalic, Intraoperative (Neuro), Trans rectal, Trans rectal, Transvaginal, Transurethral, Musculoskeletal (Conventional and Superficial), Cardiac Adult, Trans-esophageal Cardiology, and Peripheral Vessel (also known as Peripheral Vascular).

Contraindications:

  • The 2300 Ultrasound System is not intended for ophthalmic use or any use causing 0 the acoustic beam to pass through the eye.
  • The Cardiac Adult application is not intended for direct use on the heart. .

{29}------------------------------------------------

Image /page/29/Picture/0 description: The image contains the logo for BK Medical, an Analogic Ultrasound Group. The logo features the text "bk medical" in a sans-serif font, with the letters in a dark green color. Below the company name, the text "Analogic Ultrasound Group" is written in a smaller, lighter green font. To the upper right of the company name is a circular graphic with a green and white design.

Options:

  • 0 Vector Flow Imaging (VFI) module is available: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity.
  • . Alternate power source (battery) solution.
  • . RF wireless function with the ability to transmit for printing and archive connectivity purposes.
  • . Electrocardiograph display of the electrical and muscular activity of the heart. Impulses from the heart are relayed via electrodes to the system and appear as a waveform on the screen.

E. Technological Characteristics

The proposed device has the same technological characteristics and is similar in design and configuration as compared to the currently marketed predicate devices.

F. Summary of Non-clinical Test/Performance Testing - Bench:

BK Medical ApS believes that the information and data provided in this submission clearly describes the proposed device and demonstrates that the device is adequately designed for the labeled indications for use. Performance, verification and validation testing was conducted to characterize performance of the proposed device and the predetermined acceptance criteria was met. Results of this testing have confirmed that the proposed device is substantially equivalent to the predicate devices and is suitable for the labeled indications for use.

The system complies with the following voluntary standards:

  • EN IEC 62304:2006 + AC:2008 Medical Device Software Life-Cycle Processes .
  • o EN 60601-1:2006 (Ed.3)+AC:2010, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005 (Ed.3) + Cor1:2006 + Cor2:2010)
  • . EN 60601-1-2:2007+AC:2010, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (IEC 60601-1-2:2007)
  • 0 EN 60601-2-37:2008 Medical electrical equipment - Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment (IEC 60601-2-37:2007)
  • . EN 62359:2010 Ultrasonic - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields (IEC 62359:2010)

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.