(118 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body.
Ultrasound scanner and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD, CWD, Color Doppler, Vector Flow Imaging and combined mode imaging.
Signal analysis and display.
Guidance of biopsy needles, geometrical measurements and calculation of parameters.
Non monitoring ECG for superimposing the ultrasound information.
An optional 3-D unit can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen.
An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity.
Clinical applications: Abdominal, Cardiac, Fetal, Intraoperative, Neurosurgery, Obstetrics, Transrectal, Small organs, Transvaginal, Musculoskeletal.
Flex Focus 1202 supports the following scanning modes and combinations thereof: B-mode (incl.Tissue Harmonic Imaging), M-mode, PWD mode, CFM mode, Amplitude (Power) Doppler mode.
The system can perform simple geometric measurements, and perform calculations in the areas of Vascular, Urology, Cardiology and OB/GYN applications.
The system can guide biopsy- and puncture needles.
An optional 3-D module can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen.
An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity.
Transducers are linear arrays, convex arrays, phased arrays and mechanical sector. The patient contact materials are biocompatible.
All transducers used together with Flex Focus 1202 are Track 3 transducers.
The provided text describes a 510(k) summary for the B-K Medical Ultrasound Scanner Flex Focus 1202. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study to prove a device meets specific clinical performance acceptance criteria.
The information primarily discusses the device's technical specifications, modes of operation, intended use, indications for use, and safety aspects (thermal, mechanical, electrical, and acoustic output). It leverages existing standards and prior clearances for similar devices.
Therefore, many of the requested details regarding acceptance criteria for device performance and an accompanying study or analysis are not present in the provided text.
Here's a breakdown of what can and cannot be extracted:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative clinical performance acceptance criteria for the device in terms of accuracy, sensitivity, or specificity. Instead, it relies on technical and safety compliance.
| Acceptance Criteria (Stated or Implied) | Reported Device Performance / Compliance |
|---|---|
| Acoustic Output: | |
| Ispta ≤ 720 mW/cm² | Stated to stay below this limit |
| MI ≤ 1.9 (Track 3, non-ophthalmic) | Stated to stay below this limit |
| TI ≤ 6.0 | Maximum 6.0 |
| Clinical Measurement Accuracy: | Described and accuracies provided in User Information (details not provided in this document) |
| Safety: | |
| Thermal, mechanical, electrical safety | Tested by a recognized Certified Body |
| Acoustic Output Reporting: | Made according to FDA standards |
| Modes of Operation: | B, M, PWD, CFM, Tissue Harmonic Imaging, and combinations (including optional VFI module) |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body |
| Indications For Use: | Abdominal, Cardiac, Fetal, Intraoperative, Transurethral, Neurosurgery, Pediatrics, Transrectal, Small Parts, Transvaginal, Peripheral vascular, Musculoskeletal |
| Biocompatibility: | Patient contact materials are biocompatible |
| Substantial Equivalence: | Determined by FDA to be substantially equivalent to predicate devices K081154 and K100919 |
No information is provided for the following points related to a performance study:
- 2. Sample size used for the test set and the data provenance: Not applicable as no clinical performance study is detailed.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an ultrasound scanner, not an AI-assisted diagnostic tool.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for clinical performance as described in the prompt. For technical and safety aspects, the ground truth is often established by adherence to recognized standards and validated testing procedures.
- 8. The sample size for the training set: Not applicable as it's not a machine learning/AI device.
- 9. How the ground truth for the training set was established: Not applicable.
In summary, this document is a regulatory submission for premarket clearance (510(k)) based on substantial equivalence, not a clinical trial report detailing performance criteria and a study to meet them. The "acceptance criteria" here largely pertain to technical specifications, safety limits, and intended/indicated uses matching those of previously cleared devices, rather than quantitative clinical efficacy metrics.
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Attachment 4
510(k) Summary:
FEB 1 3 2013
This summary is provided as part of this Premarket Notification in compliance with 21CRF, Section 807.92.
Submitters name: B-K Medical Address: Mileparken 34, DK2730 Herlev, Denmark Phone: +45 44528100 Fax: +45 44528199 Contact person: Randi Hauerberg, Regulatory Affairs Manager Date prepared: May 9, 2012
Trade name: Ultrasound Scanner Flex Focus 1202 Common name: Diagnostic Ultrasound System Classification names: (90 IYO, CFR 892.1560) Ultrasonic Pulsed Echo Imaging System Ultrasonic Pulsed Doppler Imaging System (90 IYN, CFR 892.1560) Diagnostic Ultrasonic Transducer (90 ITX, CFR 892.1570)
Identification of predicate, legally marketed device: B-K Medical Ultrasound Scanner Flex Focus 1202, K081154 B-K Medical Ultrasound Scanner Pro Focus 2202, K100919
Device description:
Flex Focus 1202 supports the following scanning modes and combinations thereof: B-mode (incl.Tissue Harmonic Imaging), M-mode, PWD mode, CFM mode, Amplitude (Power) Doppler mode.
The system can perform simple geometric measurements, and perform calculations in the areas of Vascular, Urology, Cardiology and OB/GYN applications.
The system can guide biopsy- and puncture needles.
An optional 3-D module can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen.
An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity.
Transducers
Transducers are linear arrays, convex arrays, phased arrays and mechanical sector. The patient contact materials are biocompatible.
All transducers used together with Flex Focus 1202 are Track 3 transducers.
Acoustic output
The system controlling the Acoustic Output in the modified Flex Focus 1202 is the same as the system in Flex Focus 1200. The system will assure that the acoustic output always will stay below the pre-amendments upper limits i.e. Ispta ≤ 720 mW/cm² and MI ≤ 1.9 (Track 3, non ophthalmic).
The Thermal Index values are maximum 6.0, i.e. TI ≤ 6.0
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Attachment 4
Clinical measurement accuracy
Clinical measurements and calculations are described and accuracies are provided in the User Information.
Thermal, mechanical and electrical safety.
The scanner Flex Focus 1202 has been tested by a recognized Certified Body.
Acoustic Output Reporting
The Acoustic Output Reporting is made according to the standards required by "Information for Manufacturers Seeking Clearance of Diagnostic Ultrasound Systems and Transducers, FDA, CDRH, September 9, 2008"
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body.
Summary of Technological Characteristics – Predicate Device Compared to Modified Device
| Predicate deviceK081154,Ultrasound scannerFlex Focus 1202 | Predicate deviceK100919,Ultrasound scannerPro Focus 2202 | Modified device (thisapplication),Ultrasound scannerFlex Focus 1202 | |
|---|---|---|---|
| Modes of operationRef.: [1] Appendix G | B, M, PWD, CFM1)and combinations.Tissue harmonicimaging. | B, M, PWD, CFM1)+2) and combinationsTissue harmonicimaging. | B, M, PWD, CFM1)+2) and combinationsTissue harmonicimaging. |
| Intended Use: | Diagnostic ultrasoundimaging or fluid flowanalysis of the humanbody as follows: | Diagnostic ultrasoundimaging or fluid flowanalysis of the humanbody as follows: | Diagnostic ultrasoundimaging or fluid flowanalysis of the humanbody as follows: |
| Indications For Use: | AbdominalCardiacFetal (incl Obstetrics)IntraoperativeTransurethralNeurosurgeryPediatricsTransrectalSmall Parts (organs)TransvaginalPeripheral vascularMuskulo-skeletal(conventional andsuperficial) | AbdominalCardiacFetal (incl Obstetrics)IntraoperativeTransurethralNeurosurgeryPediatricsTransrectalSmall Parts (organs)TransvaginalPeripheral vascularMuskulo-skeletal(conventional andsuperficial) | AbdominalCardiacFetal (incl Obstetrics)IntraoperativeTransurethralNeurosurgeryPediatricsTransrectalSmall Parts (organs)TransvaginalPeripheral vascularMuskulo-skeletal(conventional andsuperficial) |
| Features | ECG (not monitoring) |
- CFM= Color Flow Mapping=Color Doppler and Amplitude (Power) Doppler.
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Attachment 4
- Includes Vector Flow Imaging
Technological characteristics compared to the predicate device
The predicate device has the same major technological characteristics as the subject device described above.
Minor differences consist: Optional Vector Flow Imaging (VFI) module.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle emblem with three wavy lines representing the department's mission.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
February 13, 2013
B-K MEDICAL APS C/O Randi Hauerberg Regulatory Affairs Manager MILEPARKEN 34 DENMARK DK-2730
Re: K123254
Trade/Device Name: Ultrasound Scanner Flex Focus Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, and ITX Dated: January 14, 2013 Received: January 16, 2013
Dear Randi Hauerberg:
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.
This determination of substantial equivalence applies to the following transducers intended for use with the Ultrasound Scanner Flex Focus 1202, as described in your premarket notification:
Transducer Model Number 8670
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 895. 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
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Page 2 - Randi Hauerberg
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 (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.
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.
If you have any questions regarding the content of this letter, please contact Robert Ochs at (301) 796-6661.
Sincerely yours,
Sean M. Boyd -S for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K123254
Device Name: Ultrasound Scanner Flex Focus 1202
Indications for Use:
Ultrasound scanner and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD, CWD, Color Doppler, Vector Flow Imaging and combined mode imaging.
Signal analysis and display.
Guidance of biopsy needles, geometrical measurements and calculation of parameters.
Non monitoring ECG for superimposing the ultrasound information.
An optional 3-D unit can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen.
An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity.
Clinical applications: Abdominal, Cardiac, Fetal, Intraoperative, Neurosurgery, Obstetrics, Transrectal, Small organs, Transvaginal, Musculoskeletal.
Details on specific Indication for Use forms
Prescription Use > (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(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)
Sean M. Boyd -S
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
K123254 510(k)
Page 1 of 3
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Indications for Use
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
System:1202 Transducer: 8670
Intended Use; Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I Only) | Specific(Tracks I & III) | B | M | PWD | Harmonicimaging2) | ColorDoppler | Combined(Specify) | AmplitudeDoppler |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal 2) | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Fetal Imaging& Other | Pediatric | E | E | E | E | E | E 1) | E |
| Small Organ (Specify) 3) | E | E | E | E | E | E 1) | E | |
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel.(Conventional) | E | E | E | E | E | E 1) | E | |
| Musculo-skel. (Superficial) | E | E | E | E | E | E 1) | E | |
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| PeripheralVessel | Peripheral vessel | E | E | E | E | N4) | E 1) | E |
| Other (Specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E *Examples may include: A-mode. Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, Color Velocity Imaging
(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)
Sean M. Boyd -S
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
K123254 510(k)
Page 2 of 3
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Indications for Use
-
Mode combinations: B+M, B+D, B+C, B+D+C. Additional Comments: (D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler).
-
Includes tissue harmonic imaging.
-
Small part: Breast, testis and penis
-
Vector Flow Imaging
(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)
Sean M. Boyd -S
(Division Sign Off) . Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
K123254 510(k)_
Page 3 of 3
§ 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.