(55 days)
Not Found
Not Found
No
The document describes standard ultrasound imaging modes and features, with no mention of AI, ML, or related concepts.
No
The device description clearly states "intended for the diagnostic ultrasound imaging or fluid flow analysis of the human body", indicating a diagnostic rather than therapeutic purpose.
Yes
The 'Device Description' explicitly states "intended for the diagnostic ultrasound imaging or fluid flow analysis of the human body".
No
The device description explicitly mentions "ultrasound scanner and transducers," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is an ultrasound scanner. Ultrasound is an imaging modality that uses sound waves to create images of internal body structures. It is a non-invasive procedure performed directly on the patient.
- Intended Use: The intended use describes diagnostic ultrasound imaging, fluid flow analysis, guidance of biopsy needles, and measurements. These are all functions related to imaging and procedures performed on the patient, not on samples taken from the patient.
Therefore, this device falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Ultrasound scanner and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD, Color Doppler, Vector Flow Imaging and combined mode imaging and Elastography.
Signal Analysis.
Guidance of biopsy needles, geometrical measurements and calculation of parameters. And optimal 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:
- · Fetal (Sometimes called Obstetrics)
- · Abdominal
- · Intra-operative
- · Intra-operative (Neuro) (sometimes called Neuro Surgical)
- · Pediatrics
- · Small Organ (Sometimes called Small Parts)
- · Neonatal Cephalic (Cephalic is sometimes called trans-cranial)
- · Adult Cephalic (Cephalic is sometimes called trans-cranial)
- Trans-rectal
- · Trans-vaginal
- Trans-urethral
- · Musculo-skeletal (Conventional)
- · Musculo-skeletal (Superficial)
- · Cardiac Adult
· Peripheral Vessel (Sometimes called Peripheral Vascular)
Product codes
IYN, IYO, ITX
Device Description
Ultrasound Scanner System bk2300 with the addition of an optional system with an alternate power source (battery) solution is intended for the diagnostic ultrasound imaging or fluid flow analysis of the human body and includes the following: ultrasound scanner and transducers for B. Tissue and Contrast Harmonic Imaging, M. PWD, CWD, Color Doppler, Vector Flow Imaging and combined mode imaging and Elastography.
Signal Analysis.
Guidance of biopsy needles, geometrical measurements and calculation of parameters. An optimal 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Diagnostic ultrasound imaging
Anatomical Site
Fetal, Abdominal, Intra-operative, Intra-operative (Neuro), Pediatrics, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Musculo-skeletal (Conventional), Musculo-skel. (Superficial), Cardiac Adult, Peripheral vessel.
Indicated Patient Age Range
Fetal, Neonatal, Pediatric, Adult
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)
Not Found
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.
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring three stylized human profiles facing to the right, resembling a bird in flight. The profiles are stacked on top of each other, creating a sense of depth and unity.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 16, 2015
BK Medical APS % Mr. Michael J. Doyle Global Director Regulatory & Clinical Affairs Mileparken 34 Herlev DK-2730 DENMARK
Re: K152052
Trade/Device Name: Ultrasound Scanner System bk2300 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: August 28, 2015 Received: August 31, 2015
Dear Mr. Doyle:
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,
Robert Ocks
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) K152052
Device Name Ultrasound Scanner System bk2300
Indications for Use (Describe)
Ultrasound scanner and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD, Color Doppler, Vector Flow Imaging and combined mode imaging and Elastography.
Signal Analysis.
Guidance of biopsy needles, geometrical measurements and calculation of parameters. And optimal 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:
- · Fetal (Sometimes called Obstetrics)
- · Abdominal
- · Intra-operative
- · Intra-operative (Neuro) (sometimes called Neuro Surgical)
- · Pediatrics
- · Small Organ (Sometimes called Small Parts)
- · Neonatal Cephalic (Cephalic is sometimes called trans-cranial)
- · Adult Cephalic (Cephalic is sometimes called trans-cranial)
- Trans-rectal
- · Trans-vaginal
- Trans-urethral
- · Musculo-skeletal (Conventional)
- · Musculo-skeletal (Superficial)
- · Cardiac Adult
· Peripheral Vessel (Sometimes called Peripheral Vascular)
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Diagnostic Ultrasound Indications for Use Form
Fill out one form for each ultrasound system and each transducer.
System: bk2300
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Modes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | |||||||||||
| (Tracks I & III) | B | M | PWD | CWD |
- | Tissue
Harmonic
Imaging | Contrast
Harmonic
Imaging - | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined - | Other |
| Ophthalmic | | | | | | | | | | | |
| Fetal 2) | P | P | P | P | P | P | P | P | P | P | P24) |
| Abdominal 3) | P | P | P | P | P | P | P | P | P | P | P24) |
| Intra-operative (Specify 4) | P | P | P | P | P | P | P | P | P | P | P24) |
| Intra-operative (Neuro 5) | P | P | P | P | P | P | P | P | P | P | P24) |
| Laparoscopic 6) | | | | | | | | | | | |
| Pediatric 7) | P | P | P | P | P | P | P | P | P | P | P24) |
| Small Organ (Specify 8) | P | P | P | P | P | P | P | P | P | P | P24) |
| Neonatal Cephalic 9) | P | P | P | P | P | P | P | P | P | P | P24) |
| Adult Cephalic 10) | P | P | P | P | P | P | P | P | P | P | P24) |
| Trans-rectal 11) | P | P | P | P | P | P | P | P | P | P | P24) |
| Trans-vaginal 12) | P | P | P | P | P | P | P | P | P | P | P24) |
| Trans-urethral 13) | P | P | P | P | P | P | P | P | P | P | P24) |
| Trans-esoph. (non-Card.) 14) | | | | | | | | | | | |
| Musculo-skel. (Conventional 15) | P | P | P | P | P | P | P | P | P | P | P24) |
| Musculo-skel. (Superficial 16) | P | P | P | P | P | P | P | P | P | P | P24) |
| Intra-luminal 17) | | | | | | | | | | | |
| Other (Specify 18) | | | | | | | | | | | |
| Cardiac Adult 19) | P | P | P | P | P | P | P | P | P | P | |
| Cardiac Pediatric 20) | | | | | | | | | | | |
| Trans-esoph. (Cardiac 21) | | | | | | | | | | | |
| Other (Specify 22) | | | | | | | | | | | |
| Peripheral vessel 23) | P | P | P | P | P | P | P | P | P | P | P23)
P24) |
| Other (Specify 24) | | | | | | | | | | | P |
| Other (Specify 25) | | | | | | | | | | | 25) |
N = new indication; P = previously cleared by FDA; E = added under Appendix E. *Examples may include: Amode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, Color Velocity Imaging Tissue Harmonic Imaging.
The numbering in the table above refers to the comments provided below. Note that the numbering 1 to 25 is fixed to make the document more consistent meaning that comments are only provided in the table below if relevant.
Additional Comments:
| 1. | B+M, |
|---|---|
| Mode combinations: | B+D, |
| B+C, | |
| B+D+C | |
| B includes Tissue Harmonic Imaging | |
| D: PWD | |
| C: Color Flow mapping Doppler incl. Amplitude(power)Doppler |
-
- Vector Flow Imaging (VFI)
-
- Elastography
-
- Battery
(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)
5
Image /page/5/Picture/0 description: The image shows the logo for BK Medical, a company that is part of the Analogic Ultrasound Group. The logo features the text "bk medical" in a green sans-serif font, with "bk" in lowercase and "medical" in lowercase. Above and to the right of the text is a green circular graphic with a white waveform design inside. Below the text is the phrase "Analogic Ultrasound Group" in a smaller, sans-serif font.
510(K) SUMMARY 8.
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 |
|---|---|
| Address: | Mileparken 34, DK-2730 Herlev, Denmark |
| FDA Establishment | |
| Owner/Operator Number: | 9680269 |
| Contact Person: | Michael Doyle |
| Global Director Regulatory & Clinical Affairs | |
| Phone: | |
| Fax: | |
| Manufacturer: | (978) 326 - 4410 |
| (978) 977 - 6811 | |
| Analogic Corporation | |
| 8 Centennial Drive | |
| Peabody, MA 01960 | |
| United States | |
| FDA Establishment | |
| Registration Number: | 1220672 |
| B. Device Name: | |
| Trade/Proprietary Name: | |
| Device: | Ultrasound Scanner System bk2300 |
| System, Imaging, Pulsed Doppler, Ultrasonic | |
| System, Imaging, Pulsed Echo, Ultrasonic | |
| Transducer, Ultrasonic, Diagnostic | |
| Regulation Description: | Ultrasonic Pulsed Doppler Imaging |
| Ultrasonic pulsed echo imaging system | |
| Diagnostic ultrasonic transducer | |
| Regulation Medical | |
| Specialty: | Radiology |
| Review Panel: | Radiology |
| Product Code: | IYO |
| IYN | |
| ITX | |
| Submission Type: | Special 510(k) |
BK Medical • Mileparken 34 • DK-2730 Herlev • Tel.: +45 4452 8100 • Fax: +45 4452 8199 • www.bkmed.com
6
Image /page/6/Picture/0 description: The image shows the logo for BK Medical. The logo consists of the text "bk medical" in a green sans-serif font. Below the text is the phrase "Analogic Ultrasound Group" in a smaller, lighter font. To the right of the text is a green circular graphic with white lines inside.
| Regulation Number: | 892.1550 |
|---|---|
| 892.1560 | |
| 892.1570 | |
| Device Class: | 2 |
C. Substantial Equivalence:
The proposed Ultrasound Scanner System bk2300 with the addition of an optional system with an alternate power source (battery) solution is substantially equivalent to the identified predicates. .
D. Device Description/Indications for Use:
Ultrasound Scanner System bk2300 with the addition of an optional system with an alternate power source (battery) solution is intended for the diagnostic ultrasound imaging or fluid flow analysis of the human body and includes the following: ultrasound scanner and transducers for B. Tissue and Contrast Harmonic Imaging, M. PWD, CWD, Color Doppler, Vector Flow Imaging and combined mode imaging and Elastography.
Signal Analysis.
Guidance of biopsy needles, geometrical measurements and calculation of parameters. An optimal 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.
Transducers
All the transducers in this submission have been previously cleared. There are no changes to the physical design of the transducers or the patient contact materials. Existing transducer patient contact materials are considered biocompatible. All transducers used together with Ultrasound Scanner System bk2300 are Track 3 transducers.
Acoustic output
The system controlling the Acoustic Output in the Ultrasound Scanner System bk2300 is the same as the predicate devices. The system will assure that the acoustic output always will stay below the pre-amendments upper limits i.e. Ispta