(118 days)
Not Found
No
The document describes standard ultrasound imaging modes, measurements, and optional 3D reconstruction and Vector Flow Imaging. There is no mention of AI, ML, or advanced image processing techniques that would typically indicate the use of such technologies.
No
The device is described as a diagnostic ultrasound imaging system, used for visualization and measurement, not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body."
No
The device description explicitly mentions hardware components such as "Ultrasound scanner and transducers," "optional 3-D unit," and "optional Vector Flow Imaging (VFI) module," indicating it is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Function: The provided description clearly states that this device is an ultrasound scanner. Ultrasound imaging involves using sound waves to create images of structures inside the human body. It is a non-invasive imaging technique performed on the patient.
- Intended Use: The intended use is for "Diagnostic ultrasound imaging or fluid flow analysis of the human body," "Guidance of biopsy needles," and various clinical applications related to imaging internal organs and structures. None of these involve testing samples taken from the body.
Therefore, based on the provided information, this device falls under the category of diagnostic imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
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.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical applications covered include: 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, Cardiac Adult, Cardiac Pediatric, Trans-esoph. (Cardiac), Peripheral vessel.
Mode of Operation: B, M, PWD, Harmonic imaging, Color Doppler, Combined (Specify), Amplitude Doppler.
- 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
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Abdominal, Cardiac, Fetal, Intraoperative, Neurosurgery, Obstetrics, Transrectal, Small organs (Breast, testis, penis), Transvaginal, Musculoskeletal, Intra-operative (Neuro), Laparoscopic, Pediatric, Neonatal Cephalic, Adult Cephalic, Trans-urethral, Trans-esoph. (non-Card.), Intra-luminal, Peripheral vessel.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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".
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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 device
K081154,
Ultrasound scanner
Flex Focus 1202 | Predicate device
K100919,
Ultrasound scanner
Pro Focus 2202 | Modified device (this
application),
Ultrasound scanner
Flex Focus 1202 |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Modes of operation
Ref.: [1] Appendix G | B, M, PWD, CFM1)
and combinations.
Tissue harmonic
imaging. | B, M, PWD, CFM1)+2) and combinations
Tissue harmonic
imaging. | B, M, PWD, CFM1)+2) and combinations
Tissue harmonic
imaging. |
| Intended Use: | Diagnostic ultrasound
imaging or fluid flow
analysis of the human
body as follows: | Diagnostic ultrasound
imaging or fluid flow
analysis of the human
body as follows: | Diagnostic ultrasound
imaging or fluid flow
analysis of the human
body as follows: |
| Indications For Use: | Abdominal
Cardiac
Fetal (incl Obstetrics)
Intraoperative
Transurethral
Neurosurgery
Pediatrics
Transrectal
Small Parts (organs)
Transvaginal
Peripheral vascular
Muskulo-skeletal
(conventional and
superficial) | Abdominal
Cardiac
Fetal (incl Obstetrics)
Intraoperative
Transurethral
Neurosurgery
Pediatrics
Transrectal
Small Parts (organs)
Transvaginal
Peripheral vascular
Muskulo-skeletal
(conventional and
superficial) | Abdominal
Cardiac
Fetal (incl Obstetrics)
Intraoperative
Transurethral
Neurosurgery
Pediatrics
Transrectal
Small Parts (organs)
Transvaginal
Peripheral vascular
Muskulo-skeletal
(conventional and
superficial) |
| Features | | ECG (not monitoring) | |
- CFM= Color Flow Mapping=Color Doppler and Amplitude (Power) Doppler.
2
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.
3
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
4
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
5
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
6
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 | Harmonic | ||||
| imaging |
- | Color
Doppler | Combined
(Specify) | Amplitude
Doppler |
| 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) | | | | | | | |
| Peripheral
Vessel | 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
7
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