Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Cardiac, Fetal, Intraoperative, Neurosurgery, Obstetrics, Pediatrics, Transcranial (=Adult cephalic), Transrectal, Small organs, Transvaginal, Musculoskeletal.

Device Description

2202 supports the following scanning modes and combinations thereof: B-mode, M-mode, CWD-mode, PWD mode and CFM mode. Tissue harmonic imaging, Contrast harmonic imaging. An optional ECG signal can be superimposed the ultrasound information in all modes and mode combinations. 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. 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.

AI/ML Overview

This 510(k) premarket notification describes the B-K Medical Ultrasound Scanner ProFocus 2202. The submission primarily focuses on establishing substantial equivalence to a predicate device (Siemens Acuson CV70 Cardiovascular system K032111) based on intended use, technological characteristics, and safety standards, rather than providing a detailed clinical study with specific acceptance criteria and performance metrics for the ProFocus 2202 itself.

Based on the provided text, a direct table of acceptance criteria and reported device performance for specific clinical measurements is not explicitly available as it would be for a typical diagnostic algorithm study. The document states: "Clinical measurements and calculations are described and accuracies are provided with the User Guide." However, the User Guide is not included in this extract.

The key acceptance criteria from the submission are primarily related to safety and acoustic output, and the comparison to the predicate device.

Here's the breakdown of the information requested, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria and performance below are primarily related to safety, acoustic output, and equivalence to the predicate device, as the document does not present a clinical study with performance metrics (e.g., sensitivity, specificity) for new clinical claims.

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance (ProFocus 2202)	Study/Evidence
Acoustic Output	Ispta ≤ 720 mW/cm²	Ispta ≤ 720 mW/cm²	Measured and calculated according to "Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment" (AIUM 1998) and FDA guidance (CDRH, September 30, 1997). The system asserts it will always stay below these limits.
	MI ≤ 1.9 (Track 3, non ophthalmic)	MI ≤ 1.9 (Track 3, non ophthalmic)	Measured and calculated according to "Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment" (AIUM 1998) and FDA guidance (CDRH, September 30, 1997). The system asserts it will always stay below these limits.
	TI ≤ 6.0	TI ≤ 6.0	Measured and calculated according to "Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment" (AIUM 1998) and FDA guidance (CDRH, September 30, 1997).
Safety Standards	Compliance with IEC 60601-1, AIUM/NEMA UD-3, AIUM/NEMA UD-2, 93/42/EEC Medical Devices Directive, EN/IEC 60601-1-1, EN/IEC 60601-1-2, EN/IEC 60601-2-37, EN/ISO 10993-1.	The scanner 2202 has been tested by a recognized, certified body according to IEC 60601-1. The comparison table explicitly states compliance with all listed standards for the ProFocus 2202.	Testing by a recognized, certified body. Comparison to predicate device which also complies with relevant standards.
Biocompatibility	Patient contact materials comply with ISO10993-1.	All transducers used together with 2202 comply with ISO10993-1.	Adherence to ISO10993-1.
Intended Use	Similar intended uses to predicate device (K032111), particularly for Transcranial (Adult cephalic).	The device "has similar intended uses." Specifically, "Transcranial (Adult cephalic), is the same."	Comparison table against predicate device showing similar clinical applications and modes of operation.
Technological Characteristics	Similar major technological characteristics to predicate device.	Device supports B-mode, M-mode, CWD-mode, PWD mode, CFM, THI, CHI, 3D, and various mode combinations, matching or exceeding predicate capabilities.	Comparison table against predicate device.

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

The document does not describe a clinical study with a "test set" in the context of performance evaluation for a diagnostic algorithm (e.g., images for accuracy assessment). The testing described is primarily for safety, acoustic output, and physical device characteristics. Therefore, information regarding sample size, country of origin, or retrospective/prospective nature of a clinical test set is not provided.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. This type of information would be relevant for studies evaluating diagnostic accuracy, which is not described in this 510(k) summary.

4. Adjudication Method for the Test Set

Not applicable. As no clinical test set for diagnostic performance is described, no adjudication method is mentioned.

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 is a submission for an ultrasound imaging system, not an AI-powered diagnostic algorithm designed to assist human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The device is an ultrasound imaging system, not a standalone diagnostic algorithm.

7. The Type of Ground Truth Used

For the safety and acoustic output measurements, the "ground truth" is derived from established engineering and physics standards (e.g., AIUM 1998, IEC 60601-1). For the claim of "Clinical measurement accuracy," the document states "accuracies are provided with the User Guide," implying that the ground truth for these measurements would be based on comparison to known physical standards or established medical practices, but the details are not in this document.

For establishing substantial equivalence regarding intended use and technological characteristics, the "ground truth" is the characteristics and performance of the legally marketed predicate device (Siemens Acuson CV70 Cardiovascular system K032111).

8. The Sample Size for the Training Set

Not applicable. The device is an ultrasound imaging system, not an AI/ML model that requires a training set of data.

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

Not applicable.

Summary

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Attachment 1

K070071

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: Villy Braender, Regulatory Manager Date prepared: 5 January 2007

Trade name: Ultrasound Scanner ProFocus 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: Siemens Medical Solutions USA Inc: Acuson CV70 Cardiovascular system (K032111)

Device description:

2202 supports the following scanning modes and combinations thereof:

B-mode, M-mode, CWD-mode, PWD mode and CFM mode. Tissue harmonic imaging, Contrast harmonic imaging.

An optional ECG signal can be superimposed the ultrasound information in all modes and mode combinations.

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.

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.

Transducers

Transducers are linear and convex phased arrays and mechanical sector. The patient contact materials comply with ISO10993-1 All transducers used together with 2202 are Track 3 transducers.

Acoustic output

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

Clinical measurement accuracy.

Clinical measurements and calculations are described and accuracies are provided with the User Guide.

Thermal, mechanical and electrical safety.

The scanner 2202 has been tested by a recognized, certified body according to IEC 60601-1.

MAR 0 5 2007

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Attachment 1

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 30, 1997"

The acoustic output is measured and calculated according to: "Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment" (AIUM 1998).

Intended use.

See comparison below

Technological characteristics compared to the predicate device.

The predicate device has the same major technological characteristics as the subject device, see comparison below.

Comparison with Siemens Medical Solutions USA Inc: Acuson CV70 Cardiovascular system (K032111)

	ProFocus 2202 in this application	K032111
Intended uses	Abdominal, Cardiac, Fetal,Intraoperative, Neurosurgery,Obstetrics, Pediatrics,Transrectal, Small organs,Transvaginal, Musculoskeletal(superficial, conventional),Peripheral Vascular.Transcranial (Adult cephalic)	Abdominal. Intraoperative,Small Parts, Transcranial,OB/GYN, Cardiac,Transesophageal. Pelvic,Neonatal/Adult Cephalic,Vascular, Musculoskeletal,Superficial Musculoskeletal,and Peripheral Vascularapplications.
General device description	Measurements and calculationsTrack 3 (Index display).Scanning modes and modecombinations: B, B+M,B+CWD, B+D, B+C, B+D+C.(CWD is continuous waveDoppler, D is PWD, C is ColorFlow mapping Doppler includingVelocity+Variance display,Amplitude (power) Doppler.B mode includes TissueHarmonic Imaging (THI) andContrast Harmonic Imaging(CHI).3D imaging	Measurements and analysisTrack 3 (Index display)B-Mode, M-Mode, Pulsed(PW) Doppler Mode,Continuous (CW) DopplerMode, Color Doppler Mode,Amplitude Doppler Mode, acombination of modes, orHarmonic Imaging, or3D imaging
Acoustic output	Ispta ≤ 720 mW/cm² and MI ≤1.9 (Track 3, non ophthalmic).TI ≤ 6.0	Not in 510(k)summary, exceptthat it has index displayaccording to Display standard.
General safety andeffectiveness	AIUM/NEMA UD-3AIUM/NEMA UD-2	UL 2601-1CSA C22.2 No. 601-1AIUM/NEMA UD-3AIUM/NEMA UD-2
	93/42/EEC Medical DevicesDirective,EN/IEC 60601-1EN/IEC 60601-1-1EN/IEC 60601-1-2EN/IEC 60601-2-37EN/ISO 10993-1	93/42/EEC Medical DevicesDirectiveEN/IEC 60601-1EN/IEC 60601-1-1EN/IEC 60601-1-2IEC 1157ISO 10993
Labeling	Please refer to section 4.8	Not in 510(k) summary)

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Attachment 1

Conclusion: The device ProFocus 2202 in this application has similar intended uses, and in particular the subject for the application Transcranial (Adult cephalic), is the same.

B-K Medical ApS therefore believes, that 2202 is substantially equivalent to K032111.

: 100 : 100 : 100 : 100 : 100

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Villy Brænder Official Correspondent B-K Medical Mileparken 34, DK-2730 Herlev DENMARK

MAR C 5 2007

Re: K070077

Trade Name: Ultrasound Scanner Profocus 2202 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulations Name: Ultrasound pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasound transducer Regulatory Class: II Product Code: IYO, IYN, and ITX Dated: January 5, 2007 Received: January 10, 2007

Dear Mr. Brænder:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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 Profocus 2202, as described in your premarket notification:

Transducer Model Number

8827

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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 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); good manufacturing practice requirements as set forth in the quality systems (OS) 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 determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

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 contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

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If you have any questions regarding the content of this letter, please contact Andrew Kang, M.D. at (240) 276-3666.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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Indications for Use

510(k) Number (if known):

K070077

Device Name: Ultrasound Scanner Profocus 2202

Indications For Use:

Ultrasound scanner and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD,CWD, Color Doppler and combined mode imaging. 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, Transcranial (=Adult cephalic), Transrectal, Small organs, Transvaginal, Musculoskeletal.

Details on specific Indication for Use forms

Prescription Use / 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

Nancy C. Brogdon

(Division Sign Off) Division of Reproductive. Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

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Diagnostic Ultrasound Indications for Use Form

System: 2202

K070077

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		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		N	N	N	N	N	N		N	N
Cardiac		P	P	P	P	P	P		P	N
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	P	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; E= added under Appendix E

B+M, B+D, B+C, B+D+C. B mode includes Tissue-and Contrast Harmonic Imaging. Additional Comments:_ D is PWD, C is Color Doppler. Fetal is often called Obstetrics

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

Prescription Use (Per 21 CFR 801.109)

Nancy C. Swedon

li ingeinn Ovision of Reproductive, Abdominal, and Radiological Devi 570(k) Number _

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Diagnostic Ultrasound Indications for Use Form

System: 2202

Transducer 8827

K070077

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)	ContinousWaveCW
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic		N	N	N	N	N	N		N	N
Cardiac		E	E	E	E	E	E		E	N
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other (specify)

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

B+M, B+D, B+CW, B+C, B+C, B mode includes Tissue-and Contrast Harmonic Imaging. Additional Comments: D is PWD, C is Color Doppler. Fetal is often called Obstetrics

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

Prescription Use (Per 21 CFR 801.109)

Invision Sidn-Off) of Reproductive, Abdomin olomcal Devices

anda

KD702

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.