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.

AI/ML Overview

The provided document is a 510(k) Summary for an Ultrasound Scanner Pro Focus 2202. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain information about acceptance criteria or a specific study proving the device meets acceptance criteria in the way a clinical performance study would.

Instead, the document details the device's technical specifications, intended use, and substantial equivalence to a previously cleared device (K043524). The "acceptance criteria" discussed are largely related to regulatory compliance and safety standards, rather than clinical performance metrics for a novel algorithm or feature.

Here's a breakdown of the available information based on your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the document, the "acceptance criteria" are primarily related to safety, acoustic output, and functional equivalence to the predicate device. There isn't a table of clinical performance metrics with pre-defined acceptance thresholds and observed values in the provided text. The document states:

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

This suggests that accuracy specifications for measurements are available but not provided within this 510(k) summary. The document focuses on regulatory compliance:

Acceptance Criteria Category	Reported Device Performance/Compliance
Acoustic Output Limits	Acoustic output always stays below pre-amendment upper limits: Ispta ≤ 720 mW/cm² and MI ≤ 1.9 (Track 3, non-ophthalmic). Thermal Index values: TI ≤ 6.0
Acoustic Output Reporting	Made according to "Information for Manufacturers Seeking Clearance of Diagnostic Ultrasound Systems and Transducers, FDA, CDRH, September 9, 2008"
Thermal, Mechanical, Electrical Safety	Tested by a recognized Certified Body.
Biocompatibility	Patient contact materials are biocompatible.
Functional Equivalence	Same major technological characteristics as predicate K043524. Minor difference: Optional Vector Flow Imaging (VFI) module.
Clinical Measurement Accuracy	"Described and accuracies are provided in the User Information" (details not in this document).

2. Sample Size Used for the Test Set and Data Provenance

Not applicable as this document does not describe a clinical performance study with a distinct "test set" in the context of algorithm evaluation. The document discusses regulatory validation against predicate devices and safety standards.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. Ground truth, in the context of clinical studies, is not mentioned for this submission. The "ground truth" for regulatory clearance is essentially compliance with standards and equivalence to a predicate device.

4. Adjudication Method

Not applicable for a clinical performance study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This document does not mention an MRMC study or any comparison of human readers with vs. without AI assistance. The device is a diagnostic ultrasound system, and the AI component (if any) is not explicitly detailed as a reader assistance tool from this summary. The "Vector Flow Imaging (VFI)" is a new imaging mode, not an AI interpretation aid.

6. Standalone (Algorithm Only) Performance Study

No. The document describes a diagnostic ultrasound system, not a standalone algorithm. The VFI module is an integrated imaging mode.

7. Type of Ground Truth Used

Not applicable for a clinical performance study. For regulatory purposes, the "ground truth" is that the device meets safety standards and is substantially equivalent to a previously cleared device.

8. Sample Size for the Training Set

Not applicable. This document does not describe the development or training of a specific algorithm that would require a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary

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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: +45 44528100 Fax: +45 44528199 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

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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 Focus2202	Modified device,Ultrasound scanner Pro Focus2202
Modes of operationRef.: [1] Appendix G	B, M, PWD, CFM 1) andcombinationsTissue harmonic imaging.	B, M, PWD, CFM 1)+2) andcombinationsTissue harmonic imaging.
Intended Use:	Diagnostic ultrasound imaging orfluid flow analysis of the humanbody as follows:	Diagnostic ultrasound imaging orfluid flow analysis of the humanbody as follows:
Indications For Use:	AbdominalCardiacFetal (incl Obstetrics)IntraoperativeTransurethralNeurosurgeryPediatricsTransrectalSmall Parts (organs)TransvaginalPeripheral vascularMuskulo-skeletal (conventionaland superficial)	AbdominalCardiacFetal (incl Obstetrics)IntraoperativeTransurethralNeurosurgeryPediatricsTransrectalSmall Parts (organs)TransvaginalPeripheral vascularMuskulo-skeletal (conventional andsuperficial)
Features	ECG (not monitoring)	ECG (not monitoring)

CFM= Color Flow Mapping=Color Doppler and Amplitude (Power) Doppler.
Includes Vector Flow Imaging (modified device)

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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.

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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

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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 (301) 796-5450. 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 (800) 638-2041 or (301) 796-7100 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

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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

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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-andcontrastharmonicimaging	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify 1)	ContinousWave)
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-skeletalConventional		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
1. 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)

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.