Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Ultrasound scanner and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD, 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.

Device Description

Flex Focus 1202 supports the following scanning modes and combinations thereof: B-mode (incl. Tissue Harmonic Imaging), M-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 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 are linear arrays, convex arrays, phased arrays and mechanical sector.

AI/ML Overview

The provided 510(k) summary for the B-K Medical Ultrasound Scanner Flex Focus 1202 focuses primarily on demonstrating substantial equivalence to predicate devices, rather than detailing a specific study to prove device performance against acceptance criteria. The document explicitly states:

"This submission introduces no new indications for use, modes, features or technologies relative to the predicate devices that require clinical testing. The clinical safety and effectiveness of ultrasound system with these characteristics are well accepted for both predicate and subject devices."

Therefore, it does not contain the information required to answer most of the questions about acceptance criteria and a specific study proving device performance. The submission relies on the established safety and effectiveness of the predicate devices and the fact that its technological characteristics are comparable.

However, based on the document, we can extract some information:

A table of acceptance criteria and the reported device performance
The document doesn't provide a specific table of acceptance criteria with corresponding performance results from a dedicated study. Instead, it highlights that the device's technical specifications and intended use are comparable to legally marketed predicate devices.

Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (Implied by Comparability)
Compliance with medical device regulations	Device is considered substantially equivalent
Acoustic output limits	Ispta ≤ 720 mW/cm² and MI ≤ 1.9 (Track 3, non ophthalmic); TI ≤ 6.0
Biocompatibility of patient contact materials	Complies with ISO10993-1
Thermal, mechanical, and electrical safety	Tested according to IEC 60601-1
Clinical measurement accuracy	Described and accuracies provided in User Guide
Intended use and indications for clinical applications	Comparable to predicate devices, including new "Neonatal Cephalic" application considered the same as predicates for that application.

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable (N/A). The submission explicitly states that "no new indications for use, modes, features or technologies" required clinical testing. Therefore, there is no specific test set of cases or related data provenance information provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
N/A. No specific test set requiring expert ground truth establishment was conducted.
Adjudication method (e.g., 2+1, 3+1, none) for the test set
N/A. No specific test set requiring adjudication was conducted.
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
N/A. This device is a diagnostic ultrasound system and does not involve AI assistance for human readers in the context of an MRMC study. The submission focuses on the system's inherent diagnostic capabilities as comparable to predicate devices.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
N/A. This is a diagnostic ultrasound system, not an algorithm being validated in a standalone manner. Its performance is intrinsically linked to human operation.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
N/A. No new clinical studies were performed that would require establishing a "ground truth" for novel features or diagnostic claims. The ground truth for ultrasound systems is implicitly established through long-standing clinical practice and the validation of predicate devices.
The sample size for the training set
N/A. As this submission describes a diagnostic ultrasound system and not an AI/ML algorithm, there is no concept of a "training set" for the device's core functionality.
How the ground truth for the training set was established
N/A. See explanation for point 8.

Summary

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510(k) Summary:

K132677
Page 1 of 4

JAN - 7 2014

This summary is provided as part of this Premarket Notification in compliance with 21 CRF. Section 807.92.

Submitters name: B-K Medical Address: Mileparken 34, DK2730 Herlev, Denmark Phone: +45 44528100 Fax: +45 44528199 Contact person: Gert Nielsen, Regulatory Manager Date updated: November 01, 2013

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: The predicate device(s) is(are):

ZONARE Medical Systems Inc .:

ZONARE ZS3 Ultrasound System (K120703) Transducer Model Number: C10-3

. Philips Healthcare, Inc.: CX50 Diagnostic Ultrasound System (K111513) Transducer Type: C8-5
Toshiba America Medical Systems, Inc .: . Diagnostic Ultrasound System (K121422)
- o Aplio 500 TUS-A500 v2.1
- o Aplio 400 TUS-A400 v2.1
- o Aplio 300 TUS-A300 v2.1

Transducer Model Number: PVT-712BT

Device description:

Flex Focus 1202 supports the following scanning modes and combinations thereof: B-mode (incl. Tissue Harmonic Imaging), M-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 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

Transducers are linear arrays, convex arrays, phased arrays and mechanical sector.

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The patient contact materials are biocompatible and comply with ISO10993-1. 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 the Flex Focus 1202.

The system will assure that the acoustic output alwavs will stav below the pre-amendments upper limits i.e. Ispta ≤ 720 m W/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 1202 has been tested by a recognized, certified body according to IEC 60601-1.

Acoustic Output Reporting

The Acoustic Qutput Reporting is made according to the standards required by "Information for Manufacturers Seeking Clearance of Diagnostic Ultrasound Systems and Transducers, FDA, CDRH, September 30, 2008"

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

Intended use.

See comparison below

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Technological characteristics compared to the predicate device(s).

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

Supplier	BK Medical Systems	ZONAREMedical Systems	Philips	Toshiba	Comparison
510K No.	K081154, K123254	K120703	K123754	K121422	Comparable
Intended use	Diagnostic ultrasoundimaging or fluid flowanalysis of the humanbody as follows	Diagnostic UltrasoundImaging and fluidflow analysis in thefollowing applications:	Diagnostic UltrasoundImaging and fluidflow analysis in thefollowing applications.	Visualization ofstructures and dynamicprocess with thehuman body usingultrasound and toprovide imageinformation fordiagnosis in thefollowing clinicalapplications:	Comparable
Indicationsfor use	AbdominalFetal (incl Obstetrics)IntraoperativeTransurethralNeurosurgeryPediatricsSmall Parts (organs)Neonatal CephalicCardiacTransrectalTransvaginalPeripheral vascularMuskulo-skeletal(conventional andsuperficial)	Opthalmic.Fetal/Obstetric.Gynecological,Abdominal (renal,TYN/Pelvic: Intra-operative (abdominal,thoracic, and vascular,Intra-operativeneurological,Pedicatric,Small organ (thyroid,breast, testes, etc).Adult Cephalic.Neonatal Cephalic,Trans-rectal,Trans-vaginal,Trans-cranial,Trans-esophageal(non-cardiac andcardiac).Musculoskeletal(conventional &Superficial).3D/4D. CardiacAdult/Pediatrics/Fetal.Echo, Intra-Cardiac.Pelvic,Perpheral vasuclar,harmonic tissue andcontrast imaging andtissue elasticity, Vetand others	Opthalmic,Intracardiac echo.Intraoperative,Laparoscopic.Fetal, Abdominal,Pediatric,Small organ, AdultCephalic, NeonatalCephalic.Transvaginal,Musculosceletal.Gynecological,Cardiac Adult.Cardiac Pediatric.Trans-Esophogeal(Cardiac),Peripheral Vessel.Other (Carotid)	abdominal, intra-operative (abdominal).Pediatric,Small organs,Neonatal CephalicAdult CephalicTrans-vaginal,Trans-rectalMusculoskeletal(conventional andsuperficial)Cardiac PediatricCardiac AdultPeripheral VascularTransesophageal	Comparable
Transducerspecific
510K No.	K043524	K120703	K123754	K121422	Comparable
Indicationfor use	Neonatal Cephalic	Neonatal Cephalic	Neonatal Cephalic	Neonatal Cephalic	Comparable
Frequency	10-3.8 MHz	10-3 MHz	8-5 MHz	10-3 MHz	Comparable

Comparison with the predicate devices mentioned above from:

Summary of Clinical Tests:

This submission introduces no new indications for use, modes, features or technologies relative to the predicate devices that require clinical testing. The clinical safety and effectiveness of ultrasound system with these characteristics are well accepted for both predicate and subject devices.

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K132677
Page 4 of 4

4/4

Conclusion: The device Flex Focus 1202 and the probe N13C5 type 8862 in this application has similar intended uses, and in particular the subject for the submission, the addition of the new application Neonatal Cephalic, is the same.

B-K Medical ApS therefore considers, that 1202 is substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. To the left of the eagle is a circular inscription that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Public Health Service

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

January 7, 2014

B-K Medical ApS % Mr. Gert Nielsen Regulatory Affairs Manager Mileparken 34 Herlev DK-2730 DENMARK

Re: K132677

Trade/Device Name: Ultrasound Scanner Flex Focus 1202 Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, IYN, ITX Dated: December 5, 2013 Received: December 19, 2013

Dear Mr. Nielsen:

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.

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

N13C5 Type 8862

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

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Page 2-Mr. Nielsen

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

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/MedicalDevices/ResourcesforYou/Industrv/default.htm.

Sincerely yours,

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K132677

Device Name: Ultrasound Scanner Flex Focus 1202 Ultrasound Transducer N13C5, Type 8862

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.

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:

Ultrasound Scanner Flex Focus 1202:

Fetal. Obstetrics. Abdominal, Intraoperative, Neurosurgery, Small organ, Pediatric, Neonatal Cephalic, Cardiac, Transvaginal, Transvaginal, Transurethral, Peripheral Vascular, Musculoskeletal.

Ultrasound Transducer N13C5, Type 8862: Neonatal Cephalic.

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)

fmh.p)

Page 1 of 1

(Division Sign-Off) Division of Radiological Health/OIR 510(k)

K132677

Page 001 of 003

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Diagnostic Ultrasound Indications for Use Form

System: 1202

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

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

	Mode of Operation
Clinical Application	A	B	M	PWD	Tissue-harmonicimaging	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify 1)	Other 3)
Ophthalmic
Fetal 2) (K081154)	P	P	P	P	P	P	P		P
Abdominal (K081154)	P	P	P	P	P	P	P		P
Intraoperative (specify)(K081154)	P	P	P	P	P	P	P		P
Intraoperative Neurological(K081154)	P	P	P	P	P	P	P		P
Pediatric (K081154)	P	P	P	P	P	P	P		P
Small Organ (specify)(K081154)	P	P	P	P	P	P	P		P
Neonatal Cephatic	N	N	N	N	N	N	N		N
Adult Cephalic
Cardiac (K081154)	P	P	P	P	P	P	P		P
Transesophageal
Transrectal (K081154)	P	P	P	P	P	P	P		P
Transvaginal (K081154)	P	P	P	P	P	P	P		P
Transurethral (K081154)	P	P	P	P	P	P	P		P
Intravascular
Peripheral Vascular((K081154 except other 3))(K123254 other 3)	P	P	P	P	P	P	P		P	P
Laparoscopic
Musculo-skeletalConventional (K081154)	P	P	P	P	P	P	P		P
Musculo-skeletal Superficial(K081154)	P	P	P	P	P	P	P		P
Other (specify)

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

Additional Comments:_ 1) B+M. B+D. B+C. B+D+C. D is PWD, C is Color Doppler,

Fetal is often called Obstetrics
Vector Flow Imaging

(PLEASE DO NOT WRITE BELOW THIS LINE · CONTINUE ON 4NOTHER PAGE IF NEEDED)

Concurrence of CDRH: Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)

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DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

System:	1202_
Transducer:	8862_

1202
cer: 8862

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	CWD	ColorDoppler	Combined(Specify 1)	AmplitudeDoppler
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify 2)(K081154)	E	E	E		E	E	E
	Intra-operative (Neuro)(K081154)	E	E	E		E	E	E
	Laparoscopic
Fetal Imaging& Other	Pediatric(K081154)	E	E	E		E	E	E
	Small Organ (Specify)
	Neonatal Cephalic	N	N	N		N	N	N
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel.(Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esoph. (Cardiac)
	Other (Specify)
PeripheralVessel	Peripheral vessel
	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

Mode combinations: B+M, B+D, B+C, B+D+C. (D is PWD, C is Color Flow Additional Comments:_ mapping Doppler including Amplitude(power)Doppler)_ 2)Intraoperative: Gall bladder_

(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)

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.