Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, deep learning, or any related terms, nor does it describe functionalities typically associated with AI/ML in medical imaging (e.g., automated detection, segmentation, or analysis beyond basic measurements and 3D reconstruction).

Therapeutic

No
The device is described as an ultrasound system used for diagnostic imaging and guidance of biopsy/puncture needles, not for treating a disease or condition.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states that the system is intended for "ultrasound evaluation" for various clinical applications, indicating its role in identifying or characterizing diseases or medical conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly mentions "Transducers are linear arrays, convex arrays, and phased arrays," which are hardware components essential for generating and receiving ultrasound waves. The summary also refers to the "bk3000 ultrasound system," implying a complete hardware and software system, not just software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The description clearly states that this is an ultrasound system. Ultrasound systems use sound waves to create images of internal body structures. They do not perform tests on samples taken from the body.
Intended Use: The intended uses listed are all related to imaging and visualization of internal anatomy for diagnostic purposes, not for analyzing biological samples.

Therefore, this device falls under the category of medical imaging devices, not In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The system is intended for use by qualified physicians for ultrasound evaluation. Specific clinical applications and exam types include: Fetal (including Obstetrics), Abdominal, Intraoperative, Intraoperative Neuro (also known as Neurosugery), Pediatric, Small Organ (also known as Small Parts), Neonatal Cephalic (also known as Neonatal Transcranial), Adult Cephalic (also known as Adult Transcranial), Transrectal, Transvaginal, Transurethral, Musculoskeletal (Conventional and Superficial), Cardiac Adult, Peripheral Vessel (also known as Peripheral Vascular). Indicated uses are different for different transducers. The Product Data sheet for the system contains a table listing the indicated uses for each transducer that can be used with the system. The bk3000 ultrasound system is not intended for ophthalmic use or any use causing the acoustic beam to pass through the eye. The Cardiac Adult application is not intended for direct use on the heart.

Product codes (comma separated list FDA assigned to the subject device)

IYO, IYN, ITX

Device Description

Touch Ultrasound 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 module can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen.

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

The patient contact materials are biocompatible.

All transducers used together with bk 2300 are Track 3 transducers.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal (including Obstetrics), Abdominal, Intraoperative, Intraoperative Neuro (also known as Neurosugery), Pediatric, Small Organ (also known as Small Parts), Neonatal Cephalic (also known as Neonatal Transcranial), Adult Cephalic (also known as Adult Transcranial), Transrectal, Transvaginal, Transurethral, Musculoskeletal (Conventional and Superficial), Cardiac Adult, Peripheral Vessel (also known as Peripheral Vascular)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Qualified physicians

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Not Found

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

May 8, 2015

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

Re: K150342

Trade/Device Name: Touch Ultrasound Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, IYN, ITX Dated: March 19, 2015 Received: March 24, 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 A Ochs

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

Enclosure

2

Indications for Use

510(k) Number (if known) K150342

Device Name Touch Ultrasound

Indications for Use (Describe)
The system is intended for use by qualified physicians for ultrasound evaluation.
Specific clinical applications and exam types include:
Fetal (including Obstetrics)
Abdominal
Intraoperative
Intraoperative Neuro (also known as Neurosugery)
Pediatric
Small Organ (also known as Small Parts)
Neonatal Cephalic (also known as Neonatal Transcranial)
Adult Cephalic (also known as Adult Transcranial)
Transrectal
Transvaginal
Transurethral
Musculoskeletal (Conventional and Superficial)
Cardiac Adult
Peripheral Vessel (also known as Peripheral Vascular)
Indicated uses are different for different transducers. The Product Data sheet for the
system contains a table listing the indicated uses for each transducer that can be used
with the system.
The bk3000 ultrasound system is not intended for ophthalmic use or any use causing
the acoustic beam to pass through the eye. The Cardiac Adult application is not intended
for direct use on the heart.
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 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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

"An 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."

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System: Touch Ultrasound

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

Clinical Application	Mode of Operation
			PW	Tissue	Color	Amplitude	Color	Combined	Other
Specific
(Tracks I & III)	B	M	D	Harmonic
Imaging	Doppler	Doppler	Velocity
Imaging	(Specify 1)
Ophthalmic
Fetal 2)	N	N	N	N	N	N	N	N
Abdominal	N	N	N	N	N	N	N	N
Intra-operative (Specify)	N	N	N	N	N	N	N	N
Intra-operative (Neuro) 6)	N	N	N	N	N	N	N	N
Laparoscopic
Pediatric	N	N	N	N	N	N	N	N
Small Organ (Specify) 3)	N	N	N	N	N	N	N	N
Neonatal Cephalic 4)	N	N	N	N	N	N	N	N
Adult Cephalic 4)	N	N	N	N	N	N	N	N
Trans-rectal	N	N	N	N	N	N	N	N
Trans-vaginal	N	N	N	N	N	N	N	N
Trans-urethral	N	N	N	N	N	N	N	N
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)	N	N	N	N	N	N	N	N
Musculo-skeletal (Superficial)	N	N	N	N	N	N	N	N
Intra-luminal
Other (Specify)
Cardiac Adult 5)	N	N	N	N	N	N	N	N
Cardiac Pediatric
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral vessel	N	N	N	N	N	N	N	N
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

Additional Comments:

==============================================================================================================================================================================

1. Mode combinations:
  B+M, B+D, B+C, B+D+C. B mode includes Tissue Harmonic Imaging

(D is PWD, C is Color Flow mapping Doppler including Amplitude(power)Doppler)

1. "Fetal" (including Obstetrics).
1. "Small organ" also known as "Small parts".
1. "Cephalic" is sometimes called "Trans-cranial".
1. Not for direct use on the heart.
1. Intra-operative (Neuro) also known as "Neurosurgery"

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

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System: Touch Ultrasound______________ Transducer: 9018

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

Clinical Application
Specific
(Tracks I & III)	B	M	PWD	Tissue
Harmonic
Imaging	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify 1)	Other
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Trans-rectal 2)	N	N	N	N	N	N	N	N
Trans-vaginal 3)	N	N	N	N	N	N	N	N
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
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

Additional Comments:

1. Mode combinations:
  B+M, B+D, B+C, B+D+C. (D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler). Tissue Harmonic Imaging.
1. Trans-rectal: Prostate.

1. Trans-vaginal: Ovaries, Uterus.
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Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OlR)

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System: Touch Ultrasound Transducer: 9023

| Clinical Application
Specific
(Tracks I & III) | B | M | PWD | Tissue
Harmonic
Imaging | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify 1) | Other |
|------------------------------------------------------|---|---|-----|-------------------------------|------------------|----------------------|------------------------------|-------------------------|-------|
| Ophthalmic | | | | | | | | | |
| Fetal 4) | N | N | N | N | N | N | N | | |
| Abdominal 2) | N | N | N | N | N | N | N | | |
| Intra-operative (Specify) | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | |
| Laparoscopic | | | | | | | | | |
| Pediatric 3) | N | N | N | N | N | N | N | | |
| 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 | | | | | | | | | |
| Other (Specify) | | | | | | | | | |

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

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.

Additional Comments:

1. Mode combinations: B+M, B+D, B+C, B+D+C. (D is PWD, C is Color Flow mapping Doppler including Amplitude(power)Doppler)
1. Abdominal: Kidney, Liver, Pancreas, Spleen, Lymph Nodes, Gastrointestinal tract, Adrenal glands, Bladder and Aorta:
1. Pediatric: Kidney, Liver, Pancreas, Spleen, Lymph Nodes, Gastrointestinal tract, Adrenal glands, Bladder and Aorta
1. Fetal (including obstetrics): Gastrointestinal tract, Bladder, Spleen, Head, Liver, Umbilical cord, Kidneys, Vasculature, Aorta, Brain, Limbs, Heart, Adrenal glands, Diaphragm, Facial features, Soft tissue and Spine

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

II

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System: Touch Ultrasound Transducer: 9051

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

ഗ്നിശ്വീ പുഴുത്ത് പ്രസ്സി
Specific	B	M	PWD	Tissue	Color	Amplitude	Color	Combined	Other
(Tracks I & III)				Harmonic	Doppler	Doppler	Velocity	(Specify 1)
				Imaging			Imaging
Ophthalmic
Fetal 4)
Abdominal 2)
Intra-operative (Specify
Intra-operative (Neuro)
Laparoscopic
Pediatric 2)	N	N	N	N	N	N		N
Small Organ (Specify 3)	N	N	N	N	N	N		N
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Conventional) 4)	N	N	N	N	N	N		N
Musculo-skel. (Superficial) 5)	N	N	N	N	N	N		N
Intra-luminal
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral vessel 6)	N	N	N	N	N	N		N
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. Tissue Harmonic Imaging.

Additional Comments:

1. Mode combinations: B+M, B+D, B+C, B+D+C. (D is PWD, C is Color Flow mapping Doppler including Amplitude(power)Doppler)
1. Pediatric: hip, spine (except neonatal), renal
1. Small Organs: breast, thyroids, testes
1. Musculoskeletal ultrasound (conventional), shoulder, hip, spine, knee
1. Musculoskeletal ultrasound (superficial), wrist, finger, toes
1. Peripheral vessel neck, carotid, vertebra, extremities, venous, arterial

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

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System: Touch Ultrasound Transducer: 9062

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

| Clinical Application
Specific
(Tracks I & III) | B | M | PWD | Tissue
Harmonic
Imaging | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify 1) | Other |
|------------------------------------------------------|---|---|-----|-------------------------------|------------------|----------------------|------------------------------|-------------------------|-------|
| Ophthalmic | | | | | | | | | |
| Fetal | | | | | | | | | |
| Abdominal | | | | | | | | | |
| Intra-operative (Specify 2 ) | N | N | N | N | N | N | | N | |
| Intra-operative (Neuro) 3) | N | N | N | N | N | N | | N | |
| Laparoscopic | | | | | | | | | |
| Pediatric | N | N | N | N | N | N | | N | |
| Small Organ (Specify) | | | | | | | | | |
| Neonatal Cephalic | N | 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 Adult | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | |
| Other (Specify) | | | | | | | | | |
| 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. Tissue Harmonic Imaging.

Additional Comments:

1. Mode combinations: B+M, B+D, B+C, B+D+C. (D is PWD, C is Color Flow mapping Doppler including Amplitude(power)Doppler)
1. Intraoperative: Gall bladder
1. Intra-operative (Neuro) also known as "Neurosurgery" Includes spinal cord

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

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System: Touch Ultrasound
Transducer:	9077

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

| Clinical Application
Specific
(Tracks I & III) | B | M | PWD | Tissue
Harmonic
Imaging | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify 1) | Other |
|------------------------------------------------------|---|---|-----|-------------------------------|------------------|----------------------|------------------------------|-------------------------|-------|
| Ophthalmic | | | | | | | | | |
| Fetal | | | | | | | | | |
| Abdominal 2) | N | N | N | N | N | N | | N | |
| Intra-operative (Specify) | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | |
| Laparoscopic | | | | | | | | | |
| Pediatric | | | | | | | | | |
| Small Organ (Specify) | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | |
| Adult Cephalic | N | N | N | N | N | N | | N | |
| Trans-rectal | | | | | | | | | |
| Trans-vaginal | | | | | | | | | |
| Trans-urethral | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | |
| Musculo-skel. (Conventional) | | | | | | | | | |
| Musculo-skel. (Superficial) | | | | | | | | | |
| Intra-luminal | | | | | | | | | |
| Other (Specify) | | | | | | | | | |
| Cardiac Adult 3) | N | N | N | N | N | N | | N | |
| Cardiac Pediatric | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | |
| Other (Specify) | | | | | | | | | |
| 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. Tissue Harmonic Imaging.

Additional Comments:

onlin

1. Mode combinations:
  B+M, B+D, B+C, B+D+C. (D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler,
1. Abdominal:
  ==============================================================================================================================================================================
Liver, kidney, vessels, spleen etc. and FAST
1. Cardiac Adult:

Not for direct use on the heart.

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

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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 Street, Rochester, NY 14608, USA

Phone: 585-627-6588

Fax: 585-323-7643

Contact person: Carolyn L Wagner, Senior Manager, Regulatory Affairs & Quality Systems

Date prepared: March 14, 2015

Trade name: Touch Ultrasound 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:

B-K Medical Ultrasound Scanner bk 2300

Device description:

Touch Ultrasound 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 module can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen.

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

The patient contact materials are biocompatible.

All transducers used together with bk 2300 are Track 3 transducers.

Acoustic output

The system controlling the Acoustic Output in the Touch Ultrasound 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).

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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 scanner bk 2300 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.

11

Comparison of Technological Characteristics: Predicate Device Compared to New Device:

	Predicate Device	New Device
Product Name	bk 2300	Touch Ultrasound
Modes of operation
Ref.: [1]	B, M, PWD, CFM1) and combinations	B, M, PWD, CFM1) and combinations
Intended Use:	Tissue harmonic imaging. Diagnostic ultrasound imaging or
image flow analysis of the human body.	Tissue harmonic imaging. Diagnostic ultrasound imaging or
image flow analysis of the human body.
Indications for Use:	The system is intended for use by qualified physicians for
ultrasound evaluation.
Specific clinical applications and exam types include:
Fetal (including Obstetrics)
Abdominal
Intraoperative
Intraoperative Neuro (also known as Neurosugery)
Pediatric
Small Organ (also known as Small Parts)
Neonatal Cephalic (also known as Neonatal Transcranial)
Adult Cephalic (also known as Adult Transcranial)
Transrectal
Transvaginal
Transurethral
Musculoskeletal (Conventional and Superficial)
Cardiac Adult
Peripheral Vessel (also known as Peripheral Vascular)
Indicated uses are different for different transducers. The
Product Data sheet for the
system contains a table listing the indicated uses for each
transducer that can be used
with the system.
The bk3000 ultrasound system is not intended for ophthalmic
use or any use causing the acoustic beam to pass through the
eye. The Cardiac Adult application is not intended for direct
use on the heart.	The system is intended for use by qualified physicians for
ultrasound evaluation.
Specific clinical applications and exam types include:
Fetal (including Obstetrics)
Abdominal
Intraoperative
Intraoperative Neuro (also known as Neurosugery)
Pediatric
Small Organ (also known as Small Parts)
Neonatal Cephalic (also known as Neonatal Transcranial)
Adult Cephalic (also known as Adult Transcranial)
Transrectal
Transvaginal
Transurethral
Musculoskeletal (Conventional and Superficial)
Cardiac Adult
Peripheral Vessel (also known as Peripheral Vascular)
Indicated uses are different for different transducers. The
Product Data sheet for the
system contains a table listing the indicated uses for each
transducer that can be used
with the system.
The bk3000 ultrasound system is not intended for ophthalmic
use or any use causing the acoustic beam to pass through the
eye. The Cardiac Adult application is not intended for direct use
on the heart.

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

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:

12

AIUM/NEMA UD-2. Acoustic Output Measurement Standard For Diagnostic Ultrasound Equipment
AIUM/NEMA UD-3, Real-time Display of Thermal and Mechanical Acoustic Output ● Indices on Diagnostic Ultrasound Equipment
IEC 60601-1, Medical Electrical Equipment, Part 1: General requirements for safety ●
IEC 60601-1-2, General requirements for safety, Collateral Standard, Electromagnetic Compatibility - Requirements and tests
IEC 60601-2-37, Particular requirements for the safety of ultrasonic diagnostic medical and monitoring equipment
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 and mechanical safety is unchanged.

Technological characteristics compared to the predicate device

The predicate device has the same technological characteristics as the subject device described above.

Minor differences consist of: Modified trade dress from BK/Analogic to Carestream Health.