Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard ultrasound system with hardware and software for image acquisition and processing. There is no mention of AI, ML, or related concepts in the description, intended use, or performance studies.

Therapeutic

No.
The device is described as a "basic diagnostic tool" and is intended for "real-time imaging" and "multipurpose ultrasound examinations," which are diagnostic rather than therapeutic applications.

Diagnostic

Yes

The 'Device Description' explicitly states that the "MicrUs system is intended to be a basic diagnostic tool" and "The devices referenced in this submission represent a transportable, software-controlled, diagnostic ultrasound system with accessories." Additionally, the 'Intended Use / Indications for Use' section mentions its ability to "provide diagnostic information."

SaMD (Software as a Medical Device)

No

The device description explicitly states that the MicrUs system is a "combination of proprietary hardware and software" and contains "hardware and firmware." While software runs on a separate PC, the core ultrasound engine is a hardware component.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The text clearly describes the MicrUs system as an ultrasound imaging system that uses ultrasonic pulsed echo imaging to visualize internal structures of the body.
The intended use and device description focus entirely on real-time imaging of anatomical sites within the body (fetal, abdominal, cardiac, etc.) for diagnostic purposes.
There is no mention of analyzing biological specimens or performing tests on samples taken from the patient.

The device is a diagnostic imaging system, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

MicrUs ultrasound imaging system is intended to be used for applications in fetal, abdominal, pediatric, small organ (breast, thyroid, testicles), neonatal cephalic, musculo-skeletal (conventional), musculo-skeletal (superficial), cardiac adult, peripheral vessel (B and M-mode imaging for needle guidance). It is possible to provide diagnostic information outside of an imaging lab, including at the bedside systems, for navigated medical application, in operating rooms/critical care units.

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

IYO, ITX

Device Description

MicrUs system is intended for the multipurpose ultrasound examinations, based on electronic linear and convex scanning. MicrUs system is a combination of proprietary hardware and software that has been designed for real-time imaging and is intended to be a basic diagnostic tool. The system is based on a modular and flexible architecture allowing for both mobile and stationary (installed) configurations. The system is designed for imaging with transducer ranges of 2 to 15 MHz. The devices referenced in this submission represent a transportable, software-controlled, diagnostic ultrasound system with accessories. This submission does not include technology or control feature changes nor deviations from indications for use different from those demonstrated in previously cleared devices operating in ultrasound B-Mode, inclusive of the predicate devices so claimed. The MicrUs only contains the hardware and firmware, everything else (e.g. ultrasound software, database) is located on a standard PC that is connected to the MicrUs via USB 2.0/3.0. Minimum requirements are given for the PC. All echo-images (sonograms) are saved on the PC and can there be evaluated, printed and archived. The Echo Wave II software was especially designed for the TELEMED devices. Software able to reside in a Windows-based PC. The basic modification MicrUs EXT-1H ultrasound system utilizing as hardware and firmware an ultrasound engine contained in a small stand alone enclosure for connection to a host PC via a USB port. The MicrUs can be used together with the appropriate probes for the entire ultrasound diagnostic (2MHz to 15MHz probes).

probe, linear array transducer, at a central ultrasonic frequency of approx. 7.5 MHz, ● model L12-5L40S-3;
probe, linear array at a central ultrasonic frequency of approximately 10 MHz, .model L15-6L25S-3;
probe, convex array at a central ultrasonic frequency of approximately 3.5 MHz, model C5-2R60S-3;
probe, convex array at a central ultrasonic frequency of approximately 6.5 MHz, model MC8-4R20S-3.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal, abdominal, pediatric, small organ (breast, thyroid, testicles), neonatal cephalic, musculo-skeletal (conventional), musculo-skeletal (superficial), cardiac adult, peripheral vessel.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

It is possible to provide diagnostic information outside of an imaging lab, including at the bedside systems, for navigation, in operating rooms/critical care units.

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)

No additional clinical testing is required, as the indications for use are not a novel indication as shown by the predicate devices in Section 1.5 Predicate Device Comparison.

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.

TELEMED; Echo Blaster K102253

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 shows the seal of 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 design featuring three profiles that resemble human faces, stacked on top of each other and connected by a flowing line.

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

November 3, 2016

TELEMED % Mr. Yury Sokolov Engineering Manager Dariaus ir Gireno str. 42 Vilnius. LT-02189 LITHUANIA

Re: K161968 Trade/Device Name: MicrUs Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, ITX Dated: October 20, 2016 Received: October 24, 2016

Dear Mr. Sokolov:

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,

Michael D. O'Hara

For

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K161968

Device Name MicrUs

Indications for Use (Describe)

MicrUs ultrasound imaging system is intended to be used for applications in fetal, abdominal, pediatric, small organ (breast, thyroid, testicles), neonatal cephalic, musculo-skeletal (conventional), musculo-skeletal (superficial), cardiac adult, peripheral vessel (B and M-mode imaging for needle guidance). It is possible to provide diagnostic information outside of an imaging lab, including at the bedside systems, for navigated medical application, in operating rooms/critical care units.

Type of Use (Select one or both, as applicable)	Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
-------------------------------------------------	---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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3

1.3 Indications for Use

All indications for use of subject devices and probes are identified in the table forms:

System
MicrUs EXT-1H	Fetal, Abdominal, Pediatric, Small Organ
(Breast, Thyroid, Testicles), Neonatal Cephalic*,
Adult Cephalic, Musculo-skeletal (Conventional),
Musculo-skeletal* (Superficial), Cardiac Adult*,
Peripheral vessel*	Table 1.3-1
Transducers	L12-5L40S-3	Pediatric, Small Organ (Breast, Thyroid,
Testicles), Neonatal Cephalic, Adult Cephalic,
Musculo-skeletal* (Conventional), Musculo-
skeletal* (Superficial), Peripheral vessel*	Table 1.3-2
	L15-6L25S-3	Pediatric, Small Organ (Breast, Thyroid,
Testicles), Neonatal Cephalic, Adult Cephalic,
Musculo-skeletal* (Conventional), Musculo-
skeletal* (Superficial), Peripheral vessel*	Table 1.3-3
	C5-2R60S-3	Fetal, Abdominal, Pediatric *	Table 1.3-4
	MC8-4R20S-3	Small Organ* (Breast, Thyroid, Testicles), Cardiac
Adult, Peripheral vessel	Table 1.3-5

*Including Imaging for needle guidance

4

Diagnostic Ultrasound Indications for Use Form

MicrUs EXT-1H System:

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

Table 1.3-1

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Combined
(specify)	Other*
(specify)
Ophthalmic	Ophthalmic
	Fetal²	N	N				N B+M
	Abdominal²	N	N				N B+M
	Intraoperative (specify)
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric²	N	N				N B+M
	Small Organ (specify)²	N¹	N¹				N B+M
	Neonatal Cephalic	N	N				N B+M
Fetal Imaging
& Other	Adult Cephalic	N	N				N B+M
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (Non-Card)
	Musculo-skeletal
(Conventional) ²	N	N				N B+M
	Musculo-skeletal
(Superficial) ²	N	N				N B+M
	Intravascular
	Other (specify)
	Cardiac Adult	N	N				N B+M
	Cardiac Pediatric
	Intravascular (Cardiac)
Cardiac	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral
Vessel	Peripheral vessel²	N	N				N B+M
	Other (specify)

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

Note 1 - Small Organs (specifically Breast, Thyroid, Testicles)

Note 2 - Includes Imaging for Needle Guidance

5

Diagnostic Ultrasound Indications for Use Form

System: MicrUs EXT-1H

Transducer: Linear array L12-5L40S-3

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

Table 1.3-2
Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Combined
(specify)	Other*
(specify)
Ophthalmic	Ophthalmic
	Fetal2
	Abdominal2
	Intraoperative (specify)
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric2	N	N				N B+M
	Small Organ (specify)2	N1	N1				N B+M
	Neonatal Cephalic	N	N				N B+M
Fetal Imaging
& Other	Adult Cephalic	N	N				N B+M
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (Non-Card)
	Musculo-skeletal
(Conventional) 2	N	N				N B+M
	Musculo-skeletal
(Superficial) 2	N	N				N B+M
	Intravascular
	Other (specify)
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)

Peripheral
Vessel	Peripheral vessel2	N	N				N B+M
	Other (specify)

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

Note 1 - Small Organs (specifically Breast, Thyroid, Testicles)

Note 2 - Includes Imaging for Needle Guidance

6

Diagnostic Ultrasound Indications for Use Form

MicrUs EXT-1H System:

Transducer: Linear array L15-6L25S-3

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

Table 1.3-3
Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Combined
(specify)	Other*
(specify)
Ophthalmic	Ophthalmic
	Fetal2
	Abdominal2
	Intraoperative (specify)
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric2	N	N				N B+M
	Small Organ (specify)2	N1	N1				N B+M
	Neonatal Cephalic	N	N				N B+M
Fetal Imaging
& Other	Adult Cephalic	N	N				N B+M
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (Non-Card)
	Musculo-skeletal
(Conventional) 2	N	N				N B+M
	Musculo-skeletal
(Superficial) 2	N	N				N B+M
	Intravascular
	Other (specify)
	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
Cardiac	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral
Vessel	Peripheral vessel2	N	N				N B+M
	Other (specify)

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

Note 1 - Small Organs (specifically Breast, Thyroid, Testicles)

Note 2 - Includes Imaging for Needle Guidance

7

Diagnostic Ultrasound Indications for Use Form

System: MicrUs EXT-1H

12

Cl

Transducer: Convex array C5-2R60S-3

Mode of Operation

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

Table 1.3-4
Clinical Application
General
(Track 1 Only)	Specific
(Track 1 & 3)	B
Ophthalmic	Ophthalmic

| General
(Track 1 Only) | Specific
(Track 1 & 3) | B | Doppler | Combined
(specify) | Other*
(specify) |
|---------------------------|-------------- | Ophthalmic | Ophthalmic | | Fetal² | | Abdominal² | | Intraoperative (specify) | | Intraoperative (Neuro) | | Laparoscopic | | Pediatric² | | Small Organ (specify)² | | Neonatal Cephalic | Fetal Imaging
& Other | Adult Cephalic | | Trans-rectal | | Trans-vaginal | | Trans-urethral | | Trans-esoph. (Non-Card) | | Musculo-skele (Conventional) ² | | | | | | | Musculo-skele (Superficial) ² | | | | | | | Intravascular | | Other (specify) | Cardiac | Cardiac Adult | | Cardiac Pediatric | | Intravascular (Cardiac) | | Trans-esoph. (Cardiac) | | Intra-cardiac | | Other (specify) | Peripheral
Vessel | Peripheral vessel² | | Other (specify) M | PWD | CWD | Color
------------------------|---|---|-----|-----|------------------|-----------------------|---------------------|
| | | | | | | |
| N | N | | | | N B+M | |
| N | N | | | | N B+M | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| N | N | | | | N B+M | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
tal
| | |
tal
| | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |

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

Note 1 - Small Organs (specifically Breast, Thyroid, Testicles)

Note 2 - Includes Imaging for Needle Guidance

8

Diagnostic Ultrasound Indications for Use Form

MicrUs EXT-1H System:

Transducer: Convex array MC8-4R20S-3

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

Table 1.3-5

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Combined
(specify)	Other*
(specify)
Ophthalmic	Ophthalmic
	Fetal²
	Abdominal2
	Intraoperative (specify)
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric2
	Small Organ (specify)2	N1	N1			N B+M
	Neonatal Cephalic
Fetal Imaging	Adult Cephalic
& Other	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (Non-Card)
	Musculo-skeletal
(Conventional) 2
	Musculo-skeletal
(Superficial) ²
	Intravascular
	Other (specify)
Cardiac	Cardiac Adult	N	N			N B+M
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral
Vessel	Peripheral vessel2	N	N			N B+M
	Other (specify)

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

Note 1 - Small Organs (specifically Breast, Thyroid, Testicles)

Note 2 - Includes Imaging for Needle Guidance

9

Pg. 1.2-3

510k Summary

1. Identifying information

Manufacturer	TELEMED
Address	Dariaus ir Gireno str. 42 Vilnius LT-02189 Lithuania
Telephone	+370-5 2106272 +370-5 2106273
Fax	+370-5 2306733
Web	http://www.pcultrasound.com/ www.telemed.lt
E-mail	info@telemed.lt yury@telemed.lt
Contact	Yury Sokolov / Engineering Manager
Name of Device	MicrUs

2. Class and Predicate Information

Classification Name	FR Number	Product Code
Ultrasonic Pulsed Echo Imaging System	892.1560	IYO
Diagnostic Ultrasonic Transducer	892.1570	ITX

Common Name	Ultrasound imaging system
Proprietary Name	MicrUs
Class	Regulatory Class II
Predicate Device	TELEMED; Echo Blaster K102253

3. Performance Standards

The MicrUs has been designed to meet the following: Safety and EMC Requirements for Medical Equipment:

IEC 60601-1: 2005, Part 1: General requirements for basic safety and essential performance. IEC 60601-1-2: 2007, Part 1: General requirements for basic safety and essential performance, 2.Collateral standard: Electromagnetic compatibility - Requirements and tests IEC 60601-2-37:2007 Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment ISO-10993-1:2009, Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing within a risk management process. ISO-10993-5, Biological Evaluation of Medical Devices Part 5: Tests for in vitro cytotoxicity, 1999 ISO-10993-10:2010, Biological Evaluation of Medical Devices, Part 10: Tests for irritation and skin sensitization IEC 62304: 2006 Medical device software -- Software life cycle processes NEMA UD 2-2004: 2003, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment NEMA UD 3-2004: 2004, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment AIUM MUS: 2002, Medical Ultrasound Safety

10

Essential Requirements of Council Directive 93/42/EEC (Medical Device Directive)

The system's acoustic output is in accordance with ALARA principle (as low as reasonably achievable)

4. Indication for Use

MicrUs ultrasound imaging system is intended to be used for applications in fetal, abdominal, pediatric, small organ (breast, thyroid, testicles), neonatal cephalic, musculo-skeletal (conventional), musculo-skeletal (superficial), cardiac adult, peripheral vessel (B and M-mode imaging, including imaging for needle guidance). It is possible to provide diagnostic information outside of an imaging lab, including at the bedside systems, for navigation, in operating rooms/critical care units.

5. Device Description

MicrUs system is intended for the multipurpose ultrasound examinations, based on electronic linear and convex scanning.

MicrUs system is a combination of proprietary hardware and software that has been designed for real-time imaging and is intended to be a basic diagnostic tool. The system is based on a modular and flexible architecture allowing for both mobile and stationary (installed) configurations. The system is designed for imaging with transducer ranges of 2 to 15 MHz.

The devices referenced in this submission represent a transportable, software-controlled, diagnostic ultrasound system with accessories. This submission does not include technology or control feature changes nor deviations from indications for use different from those demonstrated in previously cleared devices operating in ultrasound B-Mode, inclusive of the predicate devices so claimed.

The MicrUs only contains the hardware and firmware, everything else (e.g. ultrasound software, database) is located on a standard PC that is connected to the MicrUs via USB 2.0/3.0. Minimum requirements are given for the PC. All echo-images (sonograms) are saved on the PC and can there be evaluated, printed and archived.

The Echo Wave II software was especially designed for the TELEMED devices. Software able to reside in a Windows-based PC.

The basic modification MicrUs EXT-1H ultrasound system utilizing as hardware and firmware an ultrasound engine contained in a small stand alone enclosure for connection to a host PC via a USB port.

The MicrUs can be used together with the appropriate probes for the entire ultrasound diagnostic (2MHz to 15MHz probes).

probe, linear array transducer, at a central ultrasonic frequency of approx. 7.5 MHz, ● model L12-5L40S-3;
probe, linear array at a central ultrasonic frequency of approximately 10 MHz, .

11

model L15-6L25S-3;

. probe, convex array at a central ultrasonic frequency of approximately 3.5 MHz, model C5-2R60S-3;

. probe, convex array at a central ultrasonic frequency of approximately 6.5 MHz, model MC8-4R20S-3.

6. General Safety and Effectiveness

The MicrUs ultrasound system is similar to currently distributed ultrasonic pulsed echo imaging systems.

There are no technological characteristics or features or indications for use in this Submission that are not previously evaluated and approved in the predicate devices, nor are there such technologies, features and indications for use not commonly used in the practice of diagnostic ultrasound.

The MicrUs ultrasound system and its accessories are designed for compliance to all applicable medical devices safety standards, as referenced in DECLARATION OF CONFORMITY (Appendix 05). Prior release for manufacturing, all such devices, so designed, are tested and determined to be in full compliance with acoustic output, biocompatibility, cleaning and disinfection effectiveness. No additional clinical testing is required, as the indications for use are not a novel indication as shown by the predicate devices in Section 1.5 Predicate Device Comparison.

Maximum acoustic output level is under by the FDA recommended limit and power level is displayed all the time.

7. Patient Contact Materials

The materials of probes, coming in contact with patient are:

. RTV Silicone
ABS+PC (Acrylonitrile Butadiene Styrene + polycarbonate)

Standards for the biological evaluation:

ISO-10993-1:2009, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process

ISO-10993-5:2009, Biological Evaluation of Medical Devices Part 5: Tests for in vitro cytotoxicity ISO-10993-10:2010, Biological Evaluation of Medical Devices Part 10: Tests for irritation and skin sensitization

12

Pg. 1.2-6

8. Software

The MicrUs system contains the hardware and software which collect and pro-processes 'rough'' data and send it via USB 2.0/3.0 connection to a Windows® based PC.

The main application software is Echo Wave II software running on the PC, it is receiving data, processing and showing image/data on the screen. The main user interface shows an ultrasound image, controls and drop-out menus. The ultrasound images and calculated/measured data can be stored in memory.

9. Conclusion

In accordance with the FDA and based on the information provided in this Premarket notification, TELEMED concludes that the MicrUs is safe and effective and substantially equivalent to predicate devices described herein.