Ultrasound scanner and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD, CWD, Color Doppler, Vector Flow Imaging and combined mode imaging and Elastography.

Signal Analysis.

Guidance of biopsy needles, geometrical measurements and calculation of parameters. And optimal 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:

Fetal (Sometimes called Obstetrics)
Abdominal
Intra-operative
Intra-operative (Neuro) (sometimes called Neuro Surgical)
Pediatrics
Small Organ (Sometimes called Small Parts)
Neonatal Cephalic (Cephalic is sometimes called trans-cranial)
Adult Cephalic (Cephalic is sometimes called trans-cranial)
Trans-rectal
Trans-vaqinal
Trans-urethral
Musculo-skeletal (Conventional)
Musculo-skel. (Superficial)
Cardiac Adult
Peripheral Vessel (Sometimes called Peripheral Vascular)

Diagnostic ultrasound imaging or fluid flow analysis of the human body.

Device Description

Ultrasound scanner and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD, CWD, Color Doppler, Smart Flow Imaging, combined mode imaging, and Elastography.

Signal Analysis.

Guidance of biopsy needles, geometrical measurements and calculation of parameters. A 3-D unit that can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen.

An optional Smart Flow Imaqinq module: Color Flow Mapping (CFM) imaqinq mode with the ability to visualize both the axial and the transverse velocity.

AI/ML Overview

The provided document is a 510(k) Pre-market Notification from Carestream Health, Inc. for their "Touch Ultrasound" device. It outlines the device's indications for use and compares its technological characteristics to predicate devices. However, it does not contain a specific study demonstrating that the device meets explicit acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, or other quantitative measures.

The document focuses on demonstrating substantial equivalence to legally marketed predicate devices, which is the primary requirement for a 510(k) submission. This is achieved by showing that the new device has the same intended use and similar technological characteristics, or if there are differences, that these differences do not raise new questions of safety and effectiveness.

Therefore, I cannot extract the specific details you requested regarding acceptance criteria and a study that proves the device meets them, because such information is not present in this type of regulatory submission. The document explicitly states: "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..."

However, I can extract information regarding the device's characteristics and the non-clinical tests performed to ensure safety and equivalence.

Here's a breakdown of what the document does provide, addressing your numbered points where possible, and noting where information is absent:

1. A table of acceptance criteria and the reported device performance

This information is not provided in the document. The 510(k) submission establishes substantial equivalence to predicate devices, not direct performance against specific numerical acceptance criteria (e.g., sensitivity, specificity for diagnostic accuracy). The performance is implied to be equivalent to the predicate devices.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided in the document. The submission focuses on non-clinical tests (acoustic output, safety, etc.) and comparison to predicate devices, not on a clinical test set with human subjects to evaluate diagnostic performance.

3. 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)

This information is not provided in the document, as there is no described clinical test set for diagnostic performance.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not provided in the document, as there is no described clinical test set for diagnostic performance.

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

This information is not provided in the document. The device described is an ultrasound system, not an AI-powered diagnostic assistance tool.

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

This information is not provided in the document. The device is a diagnostic ultrasound system, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided in the document, as there is no described clinical test set for diagnostic performance.

8. The sample size for the training set

This information is not provided in the document, as the submission does not describe an AI/algorithm that requires a training set.

9. How the ground truth for the training set was established

This information is not provided in the document, as the submission does not describe an AI/algorithm that requires a training set.

Information that is available in the document regarding the device and its testing:

Device Name: Touch Ultrasound
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body.
New Modes Added in this Submission: Elastography, Smart Flow Imaging (also referred to as Vector Flow Imaging [VFI]), Continuous Wave Doppler (CWD/CW), Contrast Harmonic Imaging (CHI or Ci).
Non-Clinical Tests Performed (to ensure safety and equivalence):
- Acoustic output (conforming to AIUM/NEMA UD-2 & UD-3 standards; Ispta 720 mW/cm² and MI 1.9, TI ≤ 6.0)
- Thermal safety (conforming to IEC 60601-1, IEC 60601-2-37, IEC 62359)
- Electrical safety (conforming to IEC 60601-1, IEC 60601-2-37)
- Electromagnetic safety (conforming to IEC 60601-1-2)
- Mechanical safety (conforming to IEC 60601-1, IEC 60601-2-37)
- Biocompatibility (conforming to EN ISO 10993-1)
- Software lifecycle processes (conforming to IEC 62304)
- Risk Management (conforming to ISO 14971)
Comparison to Predicate Devices: The document extensively compares the "Touch Ultrasound" (modified device) to several predicate devices (e.g., K150342 Carestream Health Touch Ultrasound, K140428 bk2300, K043524 Pro Focus 2202, K100919 Pro Focus 2202, K130619 Acuson S1000) in terms of imaging modes (B, THI, M, PWD, CFM, CHI, CWD, VFI, Elastography) and clinical applications (Fetal, Abdominal, Intraoperative, Neurosurgery, Pediatrics, Small Parts, Adult Cephalic, Neonatal Cephalic, Transrectal, Transvaginal, Transurethral, Musculo-skeletal, Cardiac, Peripheral Vessel). The modified device incorporates certain modes that were previously present in one or more of the predicate devices.
Transducers: All transducers in the submission were previously cleared by FDA. No changes to physical design or patient contact materials. All patient contact materials are biocompatible. All transducers are "Track 3" transducers.

In summary, this document demonstrates the safety and substantial equivalence of the "Touch Ultrasound" device based on engineering and non-clinical performance standards, and comparison of technological characteristics and intended uses with predicate devices already on the market. It does not present clinical study data for diagnostic performance with acceptance criteria.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, with a series of curved lines above them.

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

December 9, 2015

Carestream Health, Inc. % Ms. Carolyn Wagner Supervising Sr. Manager, Regulatory Affairs & Quality Systems 150 Verona Street ROCHESTER NY 14608

Re: K152467

Trade/Device Name: Touch Ultrasound Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: November 5, 2015 Received: November 9, 2015

Dear Ms. Wagner:

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.

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 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.

{1}------------------------------------------------

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert Oakes

Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

CEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Annroved: OMB No. 0910-0120

510(k) Number (if known)

K152467

Device Name

Touch Ultrasound

Indications for Use (Describe)

Ultrasound scanner and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD, CWD, Color Doppler, Vector Flow Imaging and combined mode imaging and Elastography.

Signal Analysis.

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:

Fetal (Sometimes called Obstetrics) ●
Abdominal ●
Intra-operative
Intra-operative (Neuro) (sometimes called Neuro Surgical) ●
Pediatrics ●
Small Organ (Sometimes called Small Parts) ●
. Neonatal Cephalic (Cephalic is sometimes called trans-cranial)
Adult Cephalic (Cephalic is sometimes called trans-cranial)
Trans-rectal
Trans-vaqinal
Trans-urethral
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
. Cardiac Adult
. Peripheral Vessel (Sometimes called Peripheral Vascular)

Type of Use (Select one or both, as applicable)

[X] Prescription Use (Part 21 CFR 801 Subpart D)

Over-The Counter Use (21 CFR 801 Suppail C)

CONTINUE ON A SEPARATE PAGE IF NEEDED. PLEASE DO NOT WRITE BELOW THIS LINE

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

{3}------------------------------------------------

This section applies only to requirements of the Paperwork Recuction Act of 1995. "DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response including the time to review instructions, search existing data sources, gather and maintain the dista needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burder, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Intornation Officer Paperwork Reduction Act (PRA) Staff PRAStaff@ida.hhs.gov

Ar agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number

{4}------------------------------------------------

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

System: Touch Ultrasound

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

Clinical Application		Modes
Specific(Tracks I & III)	B	M	PWD	CWD25)	TissueHarmonicImaging	ContrastHarmonicImaging26)	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined1)	Other
Ophthalmic
Fetal 2)	P	P	P	N	P	N	P	P	P	P	N24)
Abdominal 3)	P	P	P	N	P	N	P	P	P	P	N24)
Intra-operative (Specify 4)	P	P	P	N	P	N	P	P	P	P	N24)
Intra-operative (Neuro 5)	P	P	P	N	P	N	P	P	P	P	N24)
Laparoscopic 6)
Pediatric 7)	P	P	P	N	P	N	P	P	P	P	N24)
Small Organ (Specify 8)	P	P	P	N	P	N	P	P	P	P	N24)
Neonatal Cephalic 9)	P	P	P	N	P	N	P	P	P	P	N24)
Adult Cephalic 10)	P	P	P	N	P	N	P	P	P	P	N24)
Trans-rectal 11)	P	P	P	N	P	N	P	P	P	P	N24)
Trans-vaginal 12)	P	P	P	N	P	N	P	P	P	P	N24)
Trans-urethral 13)	P	P	P	N	P	N	P	P	P	P	N24)
Trans-esoph. (non-Card.) 14)
Musculo-skel. (Conventional 15)	P	P	P	N	P	N	P	P	P	P	N24)
Musculo-skel. (Superficial 16)	P	P	P	N	P	N	P	P	P	P	N24)
Intra-luminal 17)
Other (Specify 18)
Cardiac Adult 19)	P	P	P	N	P	N	P	P	P	P	N24)
Cardiac Pediatric 20)
Trans-esoph. (Cardiac 21)
Other (Specify 22)
Peripheral vessel 23)	P	P	P	N	P	N	P	P	P	P	N23)N24)
Other (Specify 24)											N

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. Tissue Harmonic Imaging.

The numbering in the table above refers to the comments provided below and, in case it is considered relevant, further comments and history in the Attachment 006 Instructions For Use - Attachment. Please do observe that the numbering from 1 to 24 is fixed to make the document more consistent meaning that comments are only provided in the table below if relevant.

Additional Comments:

1.	Mode combinations:	B+M,B+D,B+C,B+D+C.B includes Tissue Harmonic ImagingD:PWD.C: Color Flow mapping Doppler incl.Amplitude(power)Doppler
----	--------------------	--------------------------------------------------------------------------------------------------------------------------------------------------

Vector Flow Imaging (VFI) 23)

Elastography.

(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)

{5}------------------------------------------------

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

System: Touch Ultrasound

Transducer: 9018

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

Clinical Application	B	M	PWD	CWD	TissueHarmonicImaging	ContrastHarmonicImaging	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined 1)	Other
Specific(Tracks I & III)
Ophthalmic
Fetal 2)
Abdominal 3)
Intra-operative (Specify 4)
Intra-operative (Neuro 5)
Laparoscopic 6)
Pediatric 7)
Small Organ (Specify 8)
Neonatal Cephalic 9)
Adult Cephalic 10)
Trans-rectal 11)	P	P	P	P	P	P	P	P	P	P	N24)
Trans-vaginal 12)	P	P	P	P	P	P	P	P	P	P	N24)
Trans-urethral 13)
Trans-esoph. (non-Card.) 14)
Musculo-skel. (Conventional 15)
Musculo-skel. (Superficial 16)
Intra-luminal 17)
Other (Specify 18)
Cardiac Adult 19)
Cardiac Pediatric 20)
Trans-esoph. (Cardiac 21)
Other (Specify 22)
Peripheral vessel 23)
Other (Specify 24)											N

The numbering in the table above refers to the comments provided below and, in case it is considered relevant, further comments and history in the Attachment 006_Instructions For Use - Attachment. Please do observe that the numbering from 1 to 24 is fixed to make the document more consistent meaning that comments are only provided in the table below if relevant.

Additional Comments:

1. Mode combinations:	B+M,B+D,B+C,B+D+C.B includes Tissue Harmonic ImagingD:PWD.C: Color Flow mapping Doppler incl.Amplitude(power)Doppler
-----------------------	--------------------------------------------------------------------------------------------------------------------------------------------------

Elastography.

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

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OlR)

{6}------------------------------------------------

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

System: Touch Ultrasound

Transducer: 9051

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

Clinical Application						Modes
Specific(Tracks I & III)	B	M	PWD	CWD	TissueHarmonicImaging	ContrastHarmonicImaging	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined 1)	Other
Ophthalmic
Fetal 2)
Abdominal 3)
Intra-operative (Specify 4)
Intra-operative (Neuro 5)
Laparoscopic 6)
Pediatric 7)	P	P	P	P	P	P	P	P		P	N24)
Small Organ (Specify 8)	P	P	P	P	P	P	P	P		P	N24)
Neonatal Cephalic 9)
Adult Cephalic 10)
Trans-rectal 11)
Trans-vaginal 12)
Trans-urethral 13)
Trans-esoph. (non-Card.) 14)
Musculo-skel. (Conventional 15)	P	P	P	P	P	P	P	P		P	N24)
Musculo-skel. (Superficial 16)	P	P	P	P	P	P	P	P		P	N24)
Intra-luminal 17)
Other (Specify 18)
Cardiac Adult 19)
Cardiac Pediatric 20)
Trans-esoph. (Cardiac 21)
Other (Specify 22)
Peripheral vessel 23)	P	P	P	P	P	P	P	P		P	N23)N24)
Other (Specify 24)											N

Additional Comments:

1.	Mode combinations:	B+M,B+D,B+C,B+D+C.B includes Tissue Harmonic ImagingD:PWD.C: Color Flow mapping Doppler incl.Amplitude(power)Doppler
----	--------------------	--------------------------------------------------------------------------------------------------------------------------------------------------

Vector Flow Imaging (VFI) 23)

Elastography.

(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)

{7}------------------------------------------------

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

System: Touch Ultrasound

Transducer: 9062

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

Clinical Application	Modes
Specific(Tracks I & III)	B	M	PWD	CWD25)	TissueHarmonicImaging	ContrastHarmonicImaging26)	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined 1)	Other
Ophthalmic
Fetal 2)
Abdominal 3)
Intra-operative (Specify 4)	P	P	P		P		P	P		P	N24)
Intra-operative (Neuro 5)	P	P	P		P		P	P		P	N24)
Laparoscopic 6)
Pediatric 7)	P	P	P		P		P	P		P	N24)
Small Organ (Specify 8)
Neonatal Cephalic 9)	P	P	P		P		P	P		P	N24)
Adult Cephalic 10)
Trans-rectal 11)
Trans-vaginal 12)
Trans-urethral 13)
Trans-esoph. (non-Card.) 14)
Musculo-skel. (Conventional 15)
Musculo-skel. (Superficial 16)
Intra-luminal 17)
Other (Specify 18)
Cardiac Adult 19)
Cardiac Pediatric 20)
Trans-esoph. (Cardiac 21)
Other (Specify 22)
Peripheral vessel 23)
Other (Specify 24)											N

Additional Comments:

1.	Mode combinations:	B+M,B+D,B+C,B+D+C.B includes Tissue Harmonic ImagingD:PWD.C: Color Flow mapping Doppler incl.Amplitude(power)Doppler
----	--------------------	--------------------------------------------------------------------------------------------------------------------------------------------------

Elastography.

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

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OlR)

{8}------------------------------------------------

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

System: Touch Ultrasound

Transducer: 9077

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

Clinical Application	Modes
Specific	B	M	PWD	CWD	TissueHarmonic	ContrastHarmonic	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined 1)	Other
(Tracks I & III)				25)	Imaging	Imaging26)
Ophthalmic
Fetal 2)
Abdominal 3)	P	P	P	N	P	P	P	P	P	P
Intra-operative (Specify 4)
Intra-operative (Neuro 5)
Laparoscopic 6)
Pediatric 7)
Small Organ (Specify 8)
Neonatal Cephalic 9)
Adult Cephalic 10)	P	P	P	N	P	P	P	P	P	P
Trans-rectal 11)
Trans-vaginal 12)
Trans-urethral 13)
Trans-esoph. (non-Card.) 14)
Musculo-skel. (Conventional 15)
Musculo-skel. (Superficial 16)
Intra-luminal 17)
Other (Specify 18)
Cardiac Adult 19)	P	P	P	N	P	P	P	P	P	P
Cardiac Pediatric 20)
Trans-esoph. (Cardiac 21)
Other (Specify 22)
Peripheral vessel 23)
Other (Specify 24)

Additional Comments:

1.	Mode combinations:	B+M,B+D,B+C,B+D+C.B includes Tissue Harmonic ImagingD:PWD.C: Color Flow mapping Doppler incl.Amplitude(power)Doppler
----	--------------------	--------------------------------------------------------------------------------------------------------------------------------------------------

Continuous Wave Doppler (CWD/CW)

(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)

{9}------------------------------------------------

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

System: bk2300_ Transducer: 9022 (Product Name 10L2w)

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

Clinical ApplicationSpecific	B	M	PWD	CW	TissueHarmonicImaging	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify 1)	Other
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Conventional)
Musculo-skel. (Superficial)
Intra-luminal
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral vessel	N	N	N	N	N	N	N	N	N
Other (Specify) 2)										N

N= new indication; P= previously approved.

*Examples may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, Color Velocity Imaging. Tissue Harmonic Imaging.

Additional Comments:

Mode combinations: B+M, B+D, B+C, B+D+C. (D is PWD, C is Color Flow mapping Doppler including Amplitude(power)Doppler)
Elastography

{10}------------------------------------------------

510(k) Summary:

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

Submitters name: Carestream Health, Inc. Address: 150 Verona St., Rochester, NY 14608 Phone: 585-627-6588 Fax: 585-323-7643 Contact person: Carolyn Wagner, Sr. Supervising Manager, Regulatory Affairs & Quality Systems Date prepared: August 25, 2015

Trade name: Touch Ultrasound 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 892.1550) Diagnostic Ultrasonic Transducer (90 ITX, CFR 892.1570)

Identification of predicate, legally marketed devices: B-K Medical Ultrasound Scanner Pro Focus 2202, K043524 B-K Medical Ultrasound Scanner Pro Focus 2202, K100919 BK Medical Ultrasound Scanner bk2300, K140428 Carestream Health Touch Ultrasound, K150342 Siemens Ultrasound Scanner System Acuson S1000, K130619

Device description:

Ultrasound scanner and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD, CWD, Color Doppler, Smart Flow Imaging, combined mode imaging, and Elastography.

Signal Analysis.

Guidance of biopsy needles, geometrical measurements and calculation of parameters. A 3-D unit that can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen.

An optional Smart Flow Imaqinq module: Color Flow Mapping (CFM) imaqinq mode with the ability to visualize both the axial and the transverse velocity.

{11}------------------------------------------------

Transducers

All the transducers in this submission have previously been cleared by FDA.

In this 510(k) application the new modes:

1. Elastography
1. Smart Flow Imaging (referred to as Vector Flow Imaging [VFI] in K100919)
1. Continuous Wave Doppler (CWD/CW)
1. Contrast Harmonic Imaging (CHI or Ci)

have been added to the functionality of relevant transducers as indicated in the Instructions For Use Section in VOL 004.

There are no changes to the physical design of the transducers.

There are no changes to the patient contact materials. All patient contact materials are biocompatible.

All transducers used together withTouch Ultrasound are Track 3 transducers.

Acoustic output

The system controlling the Acoustic Output in the modified Touch US is the same as the system in the predicate device Pro Focus 2202. 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 in the User Information.

Thermal, mechanical and electrical safety.

The ultrasound scanner system Touch Ultrasound 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.

{12}------------------------------------------------

Summary of Technological Characteristics - Predicate Devices Compared to Modified Device

Devices andPredicates	Predicate DeviceK150342, TouchUltrasound	Predicate DeviceK140428,Ultrasound scannerbk2300	Predicate DeviceK043524,Ultrasound scannerPro Focus 2202	Predicate DeviceK100919,Ultrasound scannerPro Focus 2202	Predicate DeviceK130619,Ultrasound scannersystem AcusonS1000	Modified Device(this application),Touch Ultrasound

Ref: [1] Appendix G	B	B	B	B	B
	THI	THI	THI	THI	THI
	M,	M,	M,	M,	M,
	PWD,	PWD,	PWD,	PWD,	PWD,
	CFM1)	CFM1)	CFM1)	CFM1)	CFM1)
	and combinations	and combinations	and combinations	and combinations	and combinations
			CHI
			CWD,
				VFI
					Elastography
Intended Use:	DiagnosticUltrasoundimaging or fluidflow analysis ofthe human bodyas follows:	DiagnosticUltrasound imagingor fluid flowanalysis of thehuman body asfollows:	DiagnosticUltrasound imagingor fluid flowanalysis of thehuman body asfollows:	DiagnosticUltrasound imagingor fluid flowanalysis of thehuman body asfollows:	DiagnosticUltrasound imagingor fluid flowanalysis of thehuman body asfollows:	DiagnosticUltrasoundimaging or fluidflow analysis ofthe human bodyas follows:
	Fetal (incl	Fetal (incl	Fetal (incl	Fetal (incl	Fetal (incl	Fetal (incl
Indications for Use	Obstetrics)	Obstetrics)	Obstetrics)	Obstetrics)	Obstetrics)	Obstetrics)
	Abdominal	Abdominal	Abdominal	Abdominal	Abdominal	Abdominal
	Intraoperative	Intraoperative	Intraoperative	Intraoperative	Intraoperative	Intraoperative
	Neurosurgery	Neurosurgery	Neurosurgery	Neurosurgery	Neurosurgery	Neurosurgery
	Pediatrics	Pediatrics	Pediatrics	Pediatrics	Pediatrics	Pediatrics
	Small Parts(organs)	Small Parts (organs)	Small Parts (organs)	Small Parts (organs)	Small Parts (organs)	Small Parts(organs)
	Adult Cephalic	Adult Cephalic	Adult Cephalic	Adult Cephalic	Adult Cephalic	Adult Cephalic
	Neonatal Cephalic	Neonatal Cephalic			Neonatal Cephalic	Neonatal Cephalic
	Transrectal	Transrectal	Transrectal	Transrectal	Transrectal	Transrectal
	Transvaginal	Transvaginal	Transvaginal	Transvaginal	Transvaginal	Transvaginal
	Transurethral	Transurethral	Transurethral	Transurethral	Transurethral	Transurethral
	Muskulo-skeletal(conventional andsuperficial)	Muskulo-skeletal(conventional andsuperficial)	Muskulo-skeletal(conventional andsuperficial)	Muskulo-skeletal(conventional andsuperficial)	Muskulo-skeletal(conventional andsuperficial)	Muskulo-skeletal(conventional andsuperficial)
	Cardiac	Cardiac	Cardiac	Cardiac	Cardiac	Cardiac
	Peripheral Vessel	Peripheral Vessel	Peripheral Vessel	Peripheral Vessel	Peripheral Vessel	Peripheral Vessel
Features			ECG (notmonitoring)	ECG (notmonitoring)

{13}------------------------------------------------

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

{14}------------------------------------------------

A brief discussion of non-clinical tests submitted, referenced, or relied on in the 510(k) for a determination of substantial equivalence.

The device has been evaluated for acoustic output, thermal, electrical, electromagnetic and mechanical safety, biocompatibility and has been found to conform with applicable medical device safety standards. The system complies with the following voluntary standards:

Σ AIUM/NEMA UD-2, Acoustic Output Measurement Standard For Diagnostic Ultrasound Equipment
2 AIUM/NEMA UD-3, Real-time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
ル IEC 60601-1, Medical Electrical Equipment, Part 1: General requirements for safety
IEC 60601-1-2, General requirements for safety, Collateral Standard, Electromagnetic ど Compatibility - Requirements and tests
人 IEC 60601-2-37, Particular requirements for the safety of ultrasonic diagnostic medical and monitoring equipment
Z ISO 14971, Application of Risk Management of Medical Devices
EN ISO 10993-1. Biocompatibility
IEC 62304, Medical Device Software Software lifecycle processes
IEC 62359, Ultrasonics Field characterization Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields

Thermal, electrical, electromagnetic, mechanical and biocompatibility safety is unchanged.

Technological characteristics compared to the predicate device

The predicate devices have the same major technological characteristics as the subject device described above.

Minor differences with respect to the Ultrasound Scanner System consist of: Addition of new modes.

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.