PRO FOCUS 2202, PRO FOCUS 2202 UV MODEL: TYPE 2202

• K Number: K100919
• Device Name: PRO FOCUS 2202, PRO FOCUS 2202 UV MODEL: TYPE 2202
• Manufacturer: B-K MEDICAL APS
• Date Cleared: 2011-12-16 ( 623 days)
• Product Code: IYN ITX IYO
• Regulation Number: 892.1550

Intended Use

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Cardiac, Fetal (incl Obstetrics), Intraoperative, Transurethral, Neurosurgery, Pediatrics, Transrectal, Small Parts (organ s), Transvaginal, Peripheral vascular, Muskulo-skeletal (conventional and superficial)

Device Description

Pro Focus 2202 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 ECG signal can be superimposed the ultrasound information in all modes and mode combinations. 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 Pro Focus 2202 are Track 3 transducers.

Predicate Devices

K043524

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes standard ultrasound imaging modes and features, with no mention of AI or ML technologies.

Therapeutic

No
The 'Intended Use' section clearly states "Diagnostic ultrasound imaging or fluid flow analysis", indicating its purpose is for diagnosis, not therapy.

Diagnostic

Yes.
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body".

SaMD (Software as a Medical Device)

No

The device description explicitly mentions hardware components such as transducers (linear arrays, convex arrays, phased arrays, mechanical sector) and optional modules (ECG signal, 3-D module, Vector Flow Imaging module), indicating it is not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body". This describes an in vivo diagnostic procedure (performed on a living organism), not an in vitro diagnostic procedure (performed on samples taken from the body).
• Device Description: The description details an ultrasound system with various scanning modes and capabilities for imaging and measurement within the body. This aligns with an in vivo diagnostic device.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or using reagents, which are hallmarks of IVD devices.

Therefore, the Pro Focus 2202 ultrasound system is an in vivo diagnostic device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Clinical applications: Abdominal, Cardiac, Fetal, Intraoperative, Neurosurgery, Obstetrics, Pediatrics, Transrectal, Small organs, Transvaginal, Musculoskeletal.

Product codes

IYN, IYO, ITX

Device Description

Pro Focus 2202 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 ECG signal can be superimposed the ultrasound information in all modes and mode combinations.

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Abdominal, Cardiac, Fetal, Intraoperative, Transurethral, Neurosurgery, Pediatrics, Transrectal, Small Parts (organs), Transvaginal, Peripheral vascular, Muskulo-skeletal (conventional and superficial)

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 measurements and calculations are described and accuracies are provided in the User Information.
The scanner Pro Focus 2202 has been tested by a recognized Certified Body.

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.

K043524

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

Regulation Number and Section

§ 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.

Summary

0

Attachment 4

DEC 1 6 2011

510(k) Summary:

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: [phone] Fax: [phone] Contact person: Randi Hauerberg, Regulatory Affairs Manager Date prepared: March 29, 2010

Trade name: Ultrasound Scanner Pro Focus 2202 Common name: Diagnostic Ultrasound System Classification names: Ultrasonic Pulsed Echo Imaging System (90 IYO, CFR 892.1560) 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 Pro Focus 2202, K043524

Device description:

Pro Focus 2202 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 ECG signal can be superimposed the ultrasound information in all modes and mode combinations.

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 Pro Focus 2202 are Track 3 transducers.

Acoustic output

The system controlling the Acoustic Output in the modified Pro Focus 2202 is the same as the system in Pro Focus 2200. 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

Clinical measurement accuracy

Clinical measurements and calculations are described and accuracies are provided in the User Information.

Thermal, mechanical and electrical safety.

The scanner Pro Focus 2202 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 K043524,
Ultrasound scanner Pro Focus
2202 | Modified device,
Ultrasound scanner Pro Focus
2202 |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Modes of operation
Ref.: [1] Appendix G | B, M, PWD, CFM 1) and
combinations
Tissue harmonic imaging. | B, M, PWD, CFM 1)+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: |
| 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) |
| Features | ECG (not monitoring) | ECG (not monitoring) |

1. CFM= Color Flow Mapping=Color Doppler and Amplitude (Power) Doppler.

2. Includes Vector Flow Imaging (modified device)

2

Attachment 4

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

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Mr. Randi Hauerberg Regulatory Affairs Manager B-K Medical ApS Mileparken 34 DK-2730 HERLEV DENMARK

Re: K100919

Trade/Device Name: Ultrasound Scanner Pro Focus 2202 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: September 9, 2011 Received: September 12, 2011

Dear Mr. 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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of

DEC 1 6 2011

4

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) 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 the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Mary Pastel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

5

Indications for Use

510(k) Number (if known): K100919

Device Name: Ultrasound Scanner Pro Focus 2202

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.

Clinical applications: Abdominal, Cardiac, Fetal, Intraoperative, Neurosurgery, Obstetrics, Pediatrics, Transrectal, Small organs, Transvaginal, Musculoskeletal.

Details on specific Indication for Use forms

Prescription Use X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of

510K K100919

6

Diagnostic Ultrasound Indications for Use Form

System: 2202

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

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

	Mode of Operation
Clinical Application	A	B	M	PWD	Tissue-and
contrast
harmonic
imaging	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(specify 1)	Continous
Wave)
Ophthalmic
Fetal 2)		P	P	P	P	P	P		P
Abdominal		P	P	P	P	P	P		P
Intraoperative (specify)		P	P	P	P	P	P		P
Intraoperative Neurological		P	P	P	P	P	P		P
Pediatric		P	P	P	P	P	P		P
Small Organ (specify)		P	P	P	P	P	P		P
Neonatal Cephalic
Adult Cephalic
Cardiac		P	P	P	P	P	P		P
Transesophageal
Transrectal		P	P	P	P	P	P		P
Transvaginal		P	P	P	P	P	P		P
Transurethral		P	P	P	P	P	P		P
Intravascular
Peripheral Vascular		P	P	P	P	N³	P		P
Laparoscopic
Musculo-skeletal
Conventional		P	P	P	P	P	P		P
Musculo-skeletal Superficial		P	P	P	P	P	P		P
Other (specify)

N= new indication; P= previously cleared by FDA K043524 E= added under Appendix E

Additional Comments:

B+M, B+D, B+C, B+D+C. B mode includes Tissue Harmonic Imaging.

• D is PWD, C is Color Doppler.
• Fetal is often called Obstetrics
• 2. Vector Flow Imaging 3)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

SIOK

(Division Sign-Off)

Division of Radiological Devices Office of In Vi nostic Device Evaluatio

Prescription Use (Per 21 CFR 801.109)