Ultrasound scanner and transducers for B, M and combined mode imaging. Guidance of biopsy needles, geometrical measurements and calculation of parameters. Non monitoring ECG for superimposing the ultrasound information. Clinical applications: Abdominal, Cardiac, Fetal, Intraoperative, Neurosurgery, Obstetrics, Pediatrics, Transrectal, Small Parts (organs), Transvaginal.

Device Description

2101 supports the following scanning modes and mode combinations: B-mode and B+M-mode (M=motion). An optional ECG signal can be superimposed the ultrasound information in all modes and mode combinations. The system operates with 3 types of transducers: mechanical sector, linear array and convex array (curved linear array). The system can perform simple geometric measurements, and perform calculations in the arcas of Urology, Cardiology and OB/GYN applications.

AI/ML Overview

The provided text describes a 510(k) summary for the Ultrasound Scanner Type 2101. However, it does not contain any information regarding specific acceptance criteria, a study proving device performance against those criteria, sample sizes for test or training sets, expert qualifications, or ground truth establishment relevant to clinical efficacy or diagnostic accuracy.

The document primarily focuses on:

Device Description: Scanning modes (B-mode, M-mode, B+M-mode), optional ECG, transducer types (mechanical sector, linear array, convex array).
Intended Use: Listing clinical applications (Abdominal, Cardiac, Fetal, Intraoperative, Neurosurgery, Obstetrics, Pediatrics, Transrectal, Small Parts, Transvaginal) and modes, comparing it to a predicate device (Type 2002, K943315).
Safety and Standards Compliance: Discussion of controls affecting radiated fields (global maximum M/I and Ispta values within allowable limits for Track 3 non-ophthalmic devices), patient contact materials complying with ISO10993-1, maximum Thermal Index (TI ≤ 6.0), electrical/thermal/mechanical safety tested to IEC 60601-1, and acoustic output reporting according to FDA and NEMA standards.
510(k) Clearance Letter: A letter from the FDA confirming substantial equivalence to the predicate device (K943315) for the stated indications for use, and an "ADD-TO-FILE" request for a special report on acoustic output.

Therefore, I cannot provide the requested information, which pertains to clinical performance and validation studies, as it is not present in the given text. The text suggests that the device's accuracy for clinical measurements is described in the User Guide, but it does not report those accuracies or the studies conducted to verify them.

Summary of missing information from the provided text:

Acceptance criteria and reported device performance related to diagnostic accuracy: Not provided. The document focuses on technical and safety compliance.
Sample size for test set and data provenance: Not mentioned.
Number and qualifications of experts for ground truth: Not mentioned.
Adjudication method for test set: Not mentioned.
MRMC comparative effectiveness study results (AI vs. human): Not applicable, as this is a traditional ultrasound scanner, not an AI diagnostic device.
Standalone (algorithm-only) performance: Not applicable.
Type of ground truth used: Not mentioned.
Sample size for training set: Not applicable (no AI training data discussed).
How ground truth for training set was established: Not applicable.

Summary

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510(k)Summary of safety and effectiveness, Ultrasound Scanner 2101

Overall description

2101 supports the following scanning modes and mode combinations: B-mode and B+M-mode (M=motion).

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

The system operates with 3 types of transducers: mechanical sector, linear array and convex array (curved linear array).

The system can perform simple geometric measurements, and perform calculations in the arcas of Urology, Cardiology and OB/GYN applications.

Transducers

Transducer type	Mode	Geometrical configuration
8656	B-M	Convex Array
8660	B-M	Linear Array
8661	B-M	Convex Array
8662	B-M	Convex Array
8665	B-M	Convex Array
1880	B	Mechanical Sector

All transducers used together with 2101 are Track 3 transducers.

Intended use.

2101-intended uses are contained within 2002-intended uses:

	Predicate device,Ultrasound scanner Type 2002 (K943315)	Submitted device,Ultrasound scanner Type2101
Modes of operation	B, M, PWD, CFM and combinations	B, M and combinations
Intended use(clinicalapplication)	AbdominalCardiacFetal DopplerIntraoperativeNeurosurgeryObstetricsPediatricsTransrectalSmall Parts (organs)TransvaginalPeripheral vascular	AbdominalCardiacFetal 1)IntraoperativeNeurosurgeryObstetricsPediatricsTransrectalSmall Parts (organs)Transvaginal
Features	ECG (not monitoring)	ECG (not monitoring)

Fetal application is included in Obstetrics and Transvaginal.

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Controls that affect the radiated field

Controls that affect the radiated field
The system is designed and verified such, that neither the global maximum of M/ not The system is designed and verified such, that heldler the ground man and the more
the global maximum derated Ispta values exceed the allowable values (Track 3, non ophthalmic device).

Size function: (Size up and Size Down). In general, smaller size gives higher acoustic intensity. Zoom function: (Zoom in or Zoom out around a specific area).
Zoom function: (Zoom in or Zoom out around a specific area). Zoom function: (Zoom in or Zoom our around a spective area).
In general, smaller zoomed areas give higher acoustic intensity through higher pulse repetition frequency. Focus: (Strong focus and focus point selection). Focus: (Strong focus and focus point selection).
In general, selecting a Focus point in combination with Strong Focus gives higher acoustic intensity. Frame Rate:

Frame Rate.
In general, higher rate gives higher acoustic intensity.

Patient contact materials

Patient contact materials
The patient contact materials comply with ISO10993-1

Acoustic output and device settings used

Acoustic output and device settings used The system controlling the Acoustic ournit always will stay below the pre-The system will assure that the acoustic output arways we only ophthalmic).

The Thermal Index values are maximum 6.0, i.e. TI ≤ 6.0

Clinical measurement accuracy.

Clinical measurement access. It is a calculations are described and accuracies are provided in the User Guide.

Thermal, mechanical and clectrical safety.

Thermal, mechanical and clectrical salety.
The scanner 2101 has been tested by a recognized, certified body according to IEC 60601-1 .

Acoustic Output Reporting

Acoustic Output Reporting is made according to the standards required by The Acoustic Output Reporting is made accounting of Diagnostic Ultrasound Systems
"Information for Manufacturers Seeking Clearance of Diagnostic Ultrasound Systems
1997 - Man Information for Nitalian Rolling September 30, 1997"

and Transducers, FDA, CDRT, September 30, according to: "Acoustic Output
The acoustic output is measured and calculated and calculation was 1007) The acoustic output is measured and calculated and Equipment" (NEMA 1997).

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Image /page/2/Picture/1 description: The image shows a circular logo for the Department of Health & Human Services - USA. The logo features a stylized abstract symbol resembling three curved lines or strokes, possibly representing human figures or elements of health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle, framing the central symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 30 1999

Villy Braender Official Correspondent B-K Medical A/S Sandtoften 9 DK 2820, Gentofte DENMARK

K991937 Re : K99195
Ultrasound Scanner Type 2101 Dated: July 2, 1999 Received: July 6, 1999 Regulatory Class: II 90 IYO Regula 892.1560/Procode: 90 ITX 21 CFR 892.1570/Procode:

Dear Mr. Braender:

Bear in all
We have reviewed your Section 510(k) notification of intent to market the We have referenced above and we have determined the device is substances in 100 learly we nave betered above and we have determined the development of the enclosure) to legally
equivalent (for the indications for use stated in interstate commerce prior to equivalent (for the indications for use scatced in interstate commerce prior to our 28, 1976, the enactment date of the Medical Device Amendments, or to
May 28, 1976, the enactment date of the Medical Device Americains of devices that have been reclassified in accordance with the prov, the of the devices that have been reclassified in accordance wasn'therefore, market the Federal Food, Drug, and Cosmetic Acc (Rec), as any in the Act.
device, subject to the Act include requirements for annual m device, subject control include requirements for annual registration,
controls provisions of the Act include requirements for annual registration, acontrols provisions of the Act include requirements 101 amball broyelly of the more of the many of the many listing or devices, god adulteration.

against meeting of substantial equivalence applies to the following This determination of substantial equivalence appress of the more of the country.
transducers intended for use with the Ultrasound Scanner, Type 2001, as
transducers intended transducers incomment notification:

Transducer Model Number

Type 1880, Type 8656, Type 8660 Type 8661, Type 8663, Type 8665

If your device is classified (see above) into either class II (Special If your device is classified (see above) inco errainer country of such 2011-08-08 additional controls. Bristing major cegazations, Title 21, Parts 800 to 895.
found in the Code of Pederal Regulations, Title 21, Parts 800 to found in the Code of Federal Regulation assumes compliance with the Good
substantially equivalent determination assumes compliance with the Good substantially equivalent determination asset forth in the Quality System Manufacturing Practice requirement, as sec 10thP regulation (21 CFR Part Regulation (QS) for Modical Devices: General (che FDA will werify such Failure to comply with the GMP regulation may result in assumptions. In addition, the Tood and Drug Administration (FDA) may regulatory action. In addition, the food and device in the Federal Register.
publish further announcements concerning your devices any publish further announcements concerning your actication does not affect any
Please note: this response to your premarket notification does not for devices Please note: this response to your premarket nottring on the more of obligation you may have under sections 351 and 642 or one 1991
under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page -2 - Mr. Braender

rolled be advised that the determination above is based on the fact that no Please be advised that the detemination above in the case in witron
medical devices have been demonstrated to be safe and effect very devices in vitro Please be advised that the decembrical bod sampling nor have any develope for an-ordio.
medical devices have bem demonstrated bod sampling on bare any 1976, only iredical devon or percutanous umbilizal blood sampling, nor nave any 2016, 2016, 2016, 2016, 2016, 2016, 2016, 2016, 2018, 2018, 2018, 2014, 2014, 2014, 2014, 2014, 2014, 201 ക്ഷേത്രം സ്വാസ്മലയാട് been marketed for these uses in enemal for in viters in viters startend onders of the market in orner inder inder inder inder inder inder indersted in die beginen in for reclassified into class i (Geleto intended investigational, and more of the comments of the comments of the constitues of the constitues of the former of the films, 22
percur 2007-10-12 devices devices specifications (1961-1911) and Subject of the investigational device exemptions (IDE) Tegardessons, Productions (1)
Therefore, your product labeling must be consistent with EDA's CFR, Part 812 . CrR, Fare on this use.

of the determination of substantial equivalence is granted on the condition that possed of substantial equivalence is granted on the courted. Contribut on the contribution of the contribution of the first and the counter of the first of the first of the f This determination of subscances, your submit and the appear but prix to shipping the trise devices, reguested 1999 - Ments based on production 2017 "Information Tot Manacount of Concerner of Concerner of Concerner of Concerner of Concerned Concerned Corner of Produces of Production o (seeking Marketing Clarance of Diagnostic Ultrasound Systems of .
Seeking Marketing Clearane of Diagnostial Child Clearanee manus and in and manus manus manus manus manus man Seeking Marketing Crearance of belay - contains unacceptable - (1) - 1
If the special report is incomplete or contains unacceptade may
acoustic output greater than approved L If the special than approved levels), then the oresult may be considered
not apply to the production units which as a result may be considered
not apply to the production uni not apply co and isbranded.
adulterated or misbranded. It

adultered of manufacturer the manufacturer's 510 kN number.
The special report should reference the marked "ADD-TO-FILE" and should be su The special report anould reference the manufacturer. 3 101K, number 2017-01-11
should be clearly and prominently marked "ADD-TO-EILE" and should be anpuitted in duplicate to:

Food and Drug Administration Food and Drug Administration
Center for Devices and RadioLogical Health
Center for the Santon (HEZ-40)) Center 101 Devieoter (HFZ-401) 9200 Corporate Boulevard 9200 Corporate
Rockville, Maryland 20050

This letter will allow you to begin marketing your device as described in your This Letter will allow you to begin marketing your device are your and of your comments of your comments of your colors for the started by four for the four for results notification. The EDA finding of substantial premier

your device specific advice for your device on our labeling regulation (21)
If you desire specific advice for your device diagnostic devices and If you desire specific advice for your device on our family regardic evely, please
CFR Part 801 and additionally 809.10 for in vitro diagnostic development the CFR Part 801 and additionally 807:10 2011-10-11
contact the Office of Compliance at (301) 594-4591.
Contact the Office of Compliance at (301) 594-4591. contact the of Complance at (301) 594-4691. Addreining of your devices the
questions on the promotion and advertising of your device and actualized de lease contact the contact on the promotion and advertising of your active the regulation
Office of Compliance at (301) 594–4639. Also, please note the 122 City office of Compliance at (301) 594-4639. Also, premarket notification" (2) Crk
entitled, "Misbranding by reference to premarket notification" (2) Crk Other general information on your responsibilities under the Act may
Other general information on your responsibilities under the tollentress of the general information of Small Manufacturers Assistance at its tollar
be obtained from the Division of Small Manufacturers Assistance at its todiress 607.777 - 0002 - 530-2041 or at (301) 443-6597 or at its internet addess
free andmoer (800) 638-2041 or at (301) 443-6597 or at its internet addess
free and and and data excl free number (800) 050 2012smamain.html".
"http://www.fda.gov/cdrh/dsmamain.html".

$\nu$

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Page - 3 - Mr. Braender

If you have any questions regarding the content of this letter, please contact
ride to Philling, Ph.D., at (301) 594-1212. If you have any questions rogaling of

Sipcerely yours,

David A. Seymore

CAPT Daniel Schultz, M.D. ੇ Acting Director Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k)Number: (if known)

Ultrasound scanner Type 2101 Device Name :

Indications for Use :

Ultrasound scanner and transducers for B, M and combined mode imaging.
The supportunity of the starter strict measurements and calculation of pa Ultrasound scanner and transfucers for B, M and connection anothers.
Guidance of biopsy needles, geometrical measurements and calculation of parameters.
The are and the first Guidance of biopsy needles, geomentical includes and information.
Non monitoring ECG for superimposing the ultrasound information.

Clinical applications: Abdominal, Cardiac, Fetal, Intraoperative, Neurosurgery, a
nd Cardian Cardian Transat J. Small ergans, Transvaginal, Clinical applications. Abdolinial, SEF 2017, ---------------------------------------------------------------------------------------------------------------------------------

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Segerson

on Sion-Off Radiological Devic 510(k) Number

Prescription Use
(Per 21 CFR 801.109)
✓

OR Over-The-Counter Use

Regulation Number and Section

N/A