Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, or related terms, and the description focuses on standard ultrasound functionalities and measurements.

Therapeutic

No
This device is a diagnostic ultrasound system, as stated in its name and function. Its purpose is to acquire and display ultrasound data and provide information for diagnosis, not to treat or cure a condition.

Diagnostic

Yes

The "Intended Use / Indications for Use" and "Device Description" sections explicitly state "Diagnostic Ultrasound System", and its function is to acquire and display ultrasound data, measure anatomical structures, and offer software analysis performance to provide information based on which health care professionals can make a diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly lists hardware components such as the main unit, ultrasound probes, probe extender, power adapter, connecting cable, and mobile trolley. This indicates it is a hardware-based system with integrated software, not a software-only medical device.

IVD (In Vitro Diagnostic)

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

Here's why:

IVDs analyze samples taken from the human body (like blood, urine, tissue). The description clearly states this is a Diagnostic Ultrasound System that acquires and displays ultrasound data by applying ultrasound waves to the body.
The intended use and device description focus on imaging and analyzing structures within the body. The system uses ultrasound to visualize internal anatomy and provide measurements and analysis based on those images.
There is no mention of analyzing biological samples. The input is ultrasound waves, not biological material.

Therefore, while it is a diagnostic device used by healthcare professionals to aid in diagnosis, it does not fit the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in gynecology, obstetric, abdominal, pediatric, small parts (breast, testes, thyroid, etc.), neonatal cephalic, transcranial, cardiac, transvaginal, peripheral vascular, urology, orthopedic, and musculoskeletal (conventional and superficial) exams.

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

IYN, ITX, IYO

Device Description

The Piloter Exp/ Piloter P Diagnostic Ultrasound System is a touch screen controlled ultrasonic system. Its function is to acquire and display ultrasound data in B-Mode, Color Flow Doppler, Pulsed Wave Doppler, Continued Wave Doppler, Power/Dirpower mode or the combination of these modes. The system can also measure anatomical structures and offer software analysis packages performance to provide information based on which the competent health care professionals can make the diagnosis.

The Piloter Exp/ Piloter P Diagnostic Ultrasound System consists of the main unit named Piloter series, ultrasound probes, probe extender, power adapter, connecting cable and mobile trolley.

Three models for the main units are included in this submission, that is Piloter Exp. Piloter and Piloter P. there are three different models of probes are available for the Piloter series.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasonic

Anatomical Site

gynecology, obstetric, abdominal, pediatric, small parts (breast, testes, thyroid, etc.), neonatal cephalic, transcranial, cardiac, transvaginal, peripheral vascular, urology, orthopedic, and musculoskeletal (conventional and superficial)

Indicated Patient Age Range

adults, pregnant women, pediatric patients and neonates

Intended User / Care Setting

Not Found

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)

Performance testing was conducted on the Piloter Exp/ Piloter P Diagnostic Ultrasound System, to evaluate the clinic measurement accuracy and system sensitivity, and all of the tested parameters met the predefined acceptance criteria. The performance of the device was compared with the predicate devices, and it is concluded that the proposed device is substantially equivalent to the predicate device.

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.

K180461

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

§ 892.1550 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.

Summary

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 20, 2018

Shenzhen Wisonic Medical Technology Co., Ltd. Jiang Xiaosan Regulatory Engineer 1st and 5th Floor, No. 6 Building, Pingshan Tech Park, Taoyuan Street, Nanshan SHENZHEN, 518055 CHINA

Re: K182715

Trade/Device Name: Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN Dated: September 27, 2018 Received: September 27, 2018

Dear Jiang Xiaosan:

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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

1

requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

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

Indications for Use

510(k) Number (if known) K182715

Device Name

Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound System

Indications for Use (Describe)

The Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in gynecology, obstetric, abdominal, pediatric, small parts (breast, testes, thyroid, etc.), neonatal cephalic, transcranial, cardiac, transvaginal, peripheral vascular, urology, orthopedic, and musculoskeletal (conventional and superficial) exams.

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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Image /page/3/Picture/0 description: The image contains the word "wisonic" in red font. The font is bold and sans-serif. The word is written in lowercase letters. The background is white.

Diagnostic Ultrasound System System:

Probe: N/A

Clinical Application		Mode of Operation
General
(Track
Only)	Specific (Track 1 & 3)	B	M	PW
D	CW
D	Color
Doppler	Amplitude
Doppler	Combine
d
(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal	N	N	N		N	N	N	Note 1, 4
	Abdominal	N	N	N	N	N	N	N	Note 1, 4
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N	N	N	N	N	Note 1,4
	Small Organ (Specify**)	N	N	N		N	N	N	Note 1,4
Fetal	Neonatal Cephalic	N	N	N	N	N	N	N	Note 1,4
Imaging
&	Adult Cephalic	N	N	N	N	N	N	N	Note 1,4
Other	Trans-rectal	N	N	N		N	N	N	Note 1,4
	Trans-vaginal	N	N	N		N	N	N	Note 1,4
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)	N	N	N		N	N	N	Note 1,4
	Musculo-skeletal
(Superficial)	N	N	N		N	N	N	Note 1,4
	Intravascular
	Cardiac Adult	N	N	N	N	N	N	N	Note 1,4
Cardiac	Cardiac Pediatric	N	N	N	N	N	N	N	Note 1,4
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel	N	N	N	N	N	N	Note 1,4
	Other (Specify***)	N	N	N	N	N	N	Note 1,4
General
(Track
Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P	P	P	P	P	Note 1, 4
	Intra-operative
(Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P	Note 1,4
	Small
Organ
(Specify**)
Fetal
Imaging
&	Neonatal Cephalic	P	P	P	P	P	P	P	Note 1,4
Other	Adult Cephalic	P	P	P	P	P	P	P	Note 1,4
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
Cardiac	Cardiac Adult	P	P	P	P	P	P	P	Note 1,4
	Cardiac Pediatric	P	P	P	P	P	P	P	Note 1,4
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral vessel	Peripheral vessel
	Other (Specify***)
N=new indication; P=previously cleared by FDA; E=added under this appendix
Additional comments: Combined modes--B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
Note1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note2: 4D(Real-time 3D)
Note3: TDI
Note4: Biopsy Guidance
Note5: Anatomic M
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
Clinical Application		Mode of Operation
	General
(Track
Only)	1 Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P	P	P	P	P	Note 1, 4
	Intra-operative
(Specify*)
	Intra-operative (Neuro)
	Laparoscopic
Fetal
Imaging
&
Other	Pediatric	P	P	P	P	P	P	P	Note 1
	Small Organ (Specify**)
	Neonatal Cephalic	P	P	P	P	P	P	P	Note 1
	Adult Cephalic	P	P	P	P	P	P	P	Note 1
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)	P	P	P	P	P	P	P	Note 1
	Intravascular
Cardiac	Cardiac Adult	P	P	P	P	P	P	P	Note 1
	Cardiac Pediatric	P	P	P	P	P	P	P	Note 1
	Intravascular (Cardiac)

4

Additional comments: Combined modes-B+M, PW+B, Color + B, PW +Color+B, PW +Color+B, Power + PW +B.

*Intraoperative includes abdominal, thoracic, and vascular etc.

**Small organ-breast, thyroid, testes.

***Other use includes Urology.

Note1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note2: 4D(Real-time 3D)

Note3: TDI

Note4: Biopsy Guidance

Note5: Anatomic M

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

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Image /page/5/Picture/0 description: The image shows the word "wisonic" in red font. The font is bold and sans-serif. The word is slightly blurred, but still legible. The background is white.

System: Diagnostic Ultrasound System

P4-1 Probe:

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

Clinical Application Mode of Operation

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Page 4 of 20 510(k) Premarket Notification Submission

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Diagnostic Ultrasound System System:

P7-3 Probe:

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	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel
	Other (Specify***)

Additional comments: Combined modes--B+M, PW+B, Color + B, PW +Color+ B, PW +Color+ B, Power + PW +B.

*Intraoperative includes abdominal, thoracic, and vascular etc.

**Small organ-breast, thyroid, testes.

***Other use includes Urology.

Notel: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note2: 4D(Real-time 3D)

Note3: TDI

Note4: Biopsy Guidance

Note5: Anatomic M

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

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Image /page/9/Picture/0 description: The image shows the word "wisonic" in red font. The font is bold and sans-serif. The letters are closely spaced together. The background is white.

Diagnostic Ultrasound System System:

Probe: L15-4NB/L15-4B

Clinical Application			Mode of Operation
General
(Track
1
Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other
(specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative
(Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P	Note 1,4
	Small Organ (Specify**)	P	P	P	P	P	P	P	Note 1,4
Fetal
Imaging &
Other	Neonatal Cephalic	P	P	P	P	P	P	P	Note 1,4
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)	P	P	P	P	P	P	P	Note 1,4
	Musculo-skeletal
(Superficial)	P	P	P	P	P	P	P	Note 1,4
	Intravascular
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel	P	P	P	P	P	P	Note 1,4
	Other (Specify***)
Clinical Application		Mode of Operation
General
(Track
1
Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other
(specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative
(Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N	N	N	N	N	Note 1,4
	Small Organ (Specify**)	N	N	N	N	N	N	N	Note 1,4
Fetal
Imaging &
Other	Neonatal Cephalic	N	N	N	N	N	N	N	Note 1,4
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skeletal
(Conventional)	N	N	N	N	N	N	N	Note 1,4
	Musculo-skeletal
(Superficial)	N	N	N	N	N	N	N	Note 1,4
	Intravascular
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intravascular (Cardiac)

10

Additional comments: Combined modes--B+M, PW+B, Color + B, PW +Color+ B, PW +Color+ B, Power + PW +B.

*Intraoperative includes abdominal, thoracic, and vascular etc.

**Small organ-breast, thyroid, testes.

***Other use includes Urology.

Notel: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note2: 4D(Real-time 3D)

Note3: TDI

Note4: Biopsy Guidance

Note5: Anatomic M

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

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Diagnostic Ultrasound System System:

Probe: L10-5

12

	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel	N	N	N	N	N	Note 1,4
	Other (Specify***)

Additional comments: Combined modes--B+M, PW+B, Color + B, PW +Color+ B, PW +Color+ B, Power + PW +B.

*Intraoperative includes abdominal, thoracic, and vascular etc.

**Small organ-breast, thyroid, testes.

***Other use includes Urology.

Notel: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note2: 4D(Real-time 3D)

Note3: TDI

Note4: Biopsy Guidance

Note5: Anatomic M

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

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System:

Intended Use:

Diagnostic Ultrasound System

Probe: LH15-6

Clinical Application			Mode of Operation
			General
(Track 1 Only)	Specific (Track 1 &

| B | M | PWD | CWD | Color
Doppler |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative
(Specify*) | P | P | P | | P | P | P | Note 1 |
| | Intra-operative
(Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | | P | P | P | Note 1,4 |
| | Small
Organ
(Specify**) | P | P | P | | P | P | P | Note 1,4 |
| Fetal Imaging
& Other | Neonatal Cephalic | P | P | P | | P | P | P | Note 1,4 |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.
(non-Card.) | | | | | | | | |
| | Musculo-skeletal
(Conventional) | P | P | P | | P | P | P | Note 1,4 |
| | Musculo-skeletal
(Superficial) | P | P | P | | P | P | P | Note 1,4 |
| | Intravascular | | | | | | | | |
| Cardiac | Intravascular | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular
(Cardiac) | | | | | | | | |
| | Trans-esoph.
(Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| Peripheral
vessel | Peripheral vessel | P | P | P | P | P | P | Note 1,4 | |
| | Other (Specify***) | | | | | | | | |
| Clinical Application | | Mode of Operation | | | | | | | |
| General
(Track
1
Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Combined
(specify) | Other
(specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | N | N | N | | N | N | N | Note 1, 4 |
| | Abdominal | N | N | N | | N | N | N | Note 1, 4 |
| | Intra-operative
(Specify*) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | N | N | N | | N | N | N | Note 1,4 |
| | Small Organ (Specify**) | | | | | | | | |
| Fetal
Imaging &
Other | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal
(Conventional) | | | | | | | | |
| | Musculo-skeletal
(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| Peripheral
vessel | Peripheral vessel | N | N | N | N | N | N | Note 1,4 | |
| | Other (Specify***) | | | | | | | | |
| Clinical Application | | | Mode of Operation | | | | | | |
| General
(Track
1
Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Combined
(specify) | Other
(specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | N | N | N | | N | N | N | Note 1, 4 |
| | Abdominal | N | N | N | | N | N | N | Note 1, 4 |
| | Intra-operative
(Specify*) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | N | N | N | | N | N | N | Note 1,4 |
| | Small Organ (Specify**) | | | | | | | | |
| Fetal
Imaging &
Other | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal
(Conventional) | | | | | | | | |
| | Musculo-skeletal
(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| Peripheral
vessel | Peripheral vessel | N | N | N | N | N | N | Note 1,4 | |
| | Other (Specify***) | | | | | | | | |
| Clinical Application | | Mode of Operation | | | | | | | |
| General
(Track
1
Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Combined
(specify) | Other
(specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | P | P | P | | P | P | P | Note 1 |
| | Abdominal | P | P | P | | P | P | P | Note 1 |
| | Intra-operative
(Specify*) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | | P | P | P | Note 1 |
| | Small Organ (Specify**) | | | | | | | | |
| Fetal
Imaging &
Other | Neonatal Cephalic | P | P | P | | P | P | P | Note 1 |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal
(Conventional) | | | | | | | | |
| | Musculo-skeletal
(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Cardiac Adult | P | P | P | | P | P | P | Note 1 |
| Cardiac | Cardiac Pediatric | P | P | P | | P | P | P | Note 1 |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| Peripheral
vessel | Peripheral vessel | P | P | P | | P | P | Note 1,4 | |
| | Other (Specify***) | | | | | | | Note 1,4 | |
| Clinical Application | | Mode of Operation | | | | | | | |
| General
(Track
1
Only) | Specific (Track 1 & 3) | B | M | PW
D | CW
D | Color
Doppler | Amplitud
e
Doppler | Combine
d
(specify) | Other (specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | P | P | P | | P | P | P | Note 1, 4 |
| | Abdominal | | | | | | | | |
| | Intra-operative (Specify*) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (Specify**) | | | | | | | | |
| Fetal
Imaging
&
Other | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | P | P | P | | P | P | P | Note 1,4 |
| | Trans-vaginal | P | P | P | | P | P | P | Note 1,4 |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal
(Conventional) | | | | | | | | |
| | Musculo-skeletal
(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | |

14

Additional comments: Combined modes-B+M, PW+B, Color + B, PW +Color+B, PW +Color+B, Power + PW +B.

*Intraoperative includes abdominal, thoracic, and vascular etc.

**Small organ-breast, thyroid, testes.

***Other use includes Urology.

Note1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note2: 4D(Real-time 3D)

Note3: TDI

Note4: Biopsy Guidance

Note5: Anatomic M

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

15

Image /page/15/Picture/0 description: The image shows the word "wisonic" in red font. The font is sans-serif and appears to be bolded. The word is all lowercase. The background is white.

Diagnostic Ultrasound System System:

C5-2 Probe:

16

Additional comments: Combined modes--B+M, PW+B, Color + B, PW +Color+ B, PW +Color+ B, Power + PW +B.

*Intraoperative includes abdominal, thoracic, and vascular etc.

**Small organ-breast, thyroid, testes.

***Other use includes Urology.

Notel: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note2: 4D(Real-time 3D)

Note3: TDI

Note4: Biopsy Guidance

Note5: Anatomic M

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

17

Image /page/17/Picture/0 description: The image contains the word "wisonic" in red font. The font is bold and sans-serif. The word is horizontally oriented and appears to be a logo or brand name.

Diagnostic Ultrasound System System:

C5-2B Probe:

18

Additional comments: Combined modes--B+M, PW+B, Color + B, PW +Color+ B, PW +Color+ B, Power + PW +B.

*Intraoperative includes abdominal, thoracic, and vascular etc.

**Small organ-breast, thyroid, testes.

***Other use includes Urology.

Notel: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note2: 4D(Real-time 3D)

Note3: TDI

Note4: Biopsy Guidance

Note5: Anatomic M

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

19

Image /page/19/Picture/0 description: The image contains the word "wisonic" in red font. The font is bold and sans-serif. The word is written in lowercase letters. The background is white.

Diagnostic Ultrasound System System:

Probe: C8-3

20

Additional comments: Combined modes--B+M, PW+B, Color + B, PW +Color+ B, PW +Color+ B, Power + PW +B.

*Intraoperative includes abdominal, thoracic, and vascular etc.

**Small organ-breast, thyroid, testes.

***Other use includes Urology.

Notel: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note2: 4D(Real-time 3D)

Note3: TDI

Note4: Biopsy Guidance

Note5: Anatomic M

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

21

Image /page/21/Picture/0 description: The image shows the word "wisonic" in red font. The font is bold and sans-serif. The word is slightly blurred, but still legible. The background is white.

Diagnostic Ultrasound System System:

Probe: EV10-4

22

Image /page/22/Picture/0 description: The image shows the word "wisonic" in red font. The font is a bold sans-serif style. The letters are closely spaced together.

	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel
	Other (Specify***)	P	P	P	P	P	Note 1,4

Additional comments: Combined modes-B+M, PW+B, Color + B, PW +Color+B, PW +Color+B, Power + PW +B.

*Intraoperative includes abdominal, thoracic, and vascular etc.

**Small organ-breast, thyroid, testes.

***Other use includes Urology.

Note1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note2: 4D(Real-time 3D)

Note3: TDI

Note4: Biopsy Guidance

Note5: Anatomic M

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

23

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

1. Submitter

Submitter:	Shenzhen Wisonic Medical Technology Co., LTD.
Address:	1st and 5th Floor, NO.6 Building, Pingshan Technology Park, Taoyuan Street
Nanshan, Shenzhen. Guangdong, 518055, P.R. CHINA
Contact Person:	Jiang Xiaosan
Tel:	(+86) 755 86007788
Fax:	(+86) 755 86007799
Email:	jiangxiaosan@wisonic.cn
Date prepared	Aug 30, 2018
2. Device
Device Name:	Piloter Exp/ Piloter/ Piloter P Diagnostic Ultrasound System
Common/Usual
Name:	Diagnostic Ultrasound System
Regulation number:	21 CFR 892.1550
Regulation Name:	Ultrasonic pulsed doppler imaging system
Regulation Class:	II
Product Code:	IYN, ITX, IYO
Classification Name:	System, Imaging, Pulsed Doppler, Ultrasonic
Model:	Piloter Exp/Piloter/Piloter P

3. Predicate Device

Predicate device: K180461, Navi e/ Navi X Diagnostic Ultrasound System

The predicate device has not been subject to a design-related recall.

4. Device Description

The Piloter Exp/ Piloter P Diagnostic Ultrasound System is a touch screen controlled ultrasonic system. Its function is to acquire and display ultrasound data in B-Mode, Color Flow Doppler, Pulsed Wave Doppler, Continued Wave Doppler, Power/Dirpower mode or the combination of these modes. The system can also measure anatomical structures and offer software analysis packages performance to provide information based on which the competent health care professionals can make the diagnosis.

24

The Piloter Exp/ Piloter P Diagnostic Ultrasound System consists of the main unit named Piloter series, ultrasound probes, probe extender, power adapter, connecting cable and mobile trolley.

Three models for the main units are included in this submission, that is Piloter Exp. Piloter and Piloter P. there are three different models of probes are available for the Piloter series.

5.Indication for Use

The Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in gynecology, obstetric, abdominal, pediatric, small parts (breast, testes, thyroid, etc.), neonatal cephalic, transcranial, cardiac, transvaginal, peripheral vascular, urology, orthopedic, and musculoskeletal (conventional and superficial) exams.

6. Comparison of Technology Characteristics with the Predicate device

Piloter Exp/ Piloter P Diagnostic Ultrasound System is comparable with and substantially equivalent to these predicate devices:

Predicate Device	Manufacturer	Model	510(k) Control Number
Predicate	Wisonic	Navi e/ Navi s/Navi X	K180461

Indication use comparison:

Compared to the predicate devices Navi e/ Navi X (K180461), The proposed device has the same intended use.

Technology characteristics comparison:

The proposed device has the same image scan modes, operation modes and image parameters.

The proposed device has the similar type probes as the predicate device.

Compared with the predicate device, there are five probes C5-2, C5-2B, P7-3, L15-4B and L10-5 newly added in the proposed device.

The new probes C5-2 and C5-2B are similar with the probe C5-1B cleared in predicate device O Navi s/Navi e/Navi X Diagnostic Ultrasound System (K180461).
The new probe P7-3 is similar with the probe P4-1 cleared in predicate device Navi s/Navi e/Navi X Diagnostic Ultrasound System(K180461).
O The new probes L15-4B and L10-5 are similar with the probe L15-4B cleared in predicate device Navi s/Navi e/Navi X Diagnostic Ultrasound System(K180461).

The clinical application of newly added probes is the same, the performance and work frequency is similar, both of them comply with the requirements of IEC 60601-1, IEC 60601-2-37, biocompatibility and acoustic output. The difference dose not affect the safety, effectiveness and clinical use.

The proposed device has the same capability in term of measurements and calculation functions.

25

The proposed device has the same basic specification, except for the ECG module and Ethernet port. A new added function is screen rotate.

All the above differences in technological characteristics do not rise different questions of safety and effectiveness as compared to the predicate device.

7. Non-clinical data

The following non-clinical data were provided in support of the substantial equivalence determination.

Biocompatibility testing

The biocompatibility evaluation for the Piloter Exp/ Piloter P Diagnostic Ultrasound System was conducted in accordance with the International Standard ISO 10993-1:2009/(R)2013, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" as recognized by FDA. The biocompatible testing included the following tests:

O Cytotoxicity
Sensitization O
O Skin Irritation

The ultrasonic probes and glue of the Diagnostic Ultrasound System are considered to contact directly with human body for a duration of less than 24 hours. The test results of cytotoxicity, sensitization and skin irritation complied with ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity and ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization. It demonstrates substantial equivalences to the predicate device.

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the Diagnostic Ultrasound System. The device complies with the IEC 60601-1:2012, standard for safety and the IEC 60601-1-2:2007, standard for EMC. It demonstrates substantial equivalences to the predicate device.

Performance testing

The Diagnostic Ultrasound System, was tested according to IEC 60601-2-37:2007 Medical Electrical Equipment – Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment, and met the same standard, Performance testing was conducted on the Piloter Exp/ Piloter P Diagnostic Ultrasound System, to evaluate the clinic measurement accuracy and system sensitivity, and all of the tested parameters met the predefined acceptance criteria. The comparisons of performance of Piloter/ Piloter/ Piloter P Diagnostic Ultrasound System to predicate devices are listed in the table below.

The performance of the device was compared with the predicate devices, and it is concluded that the proposed device is substantially equivalent to the predicate device.

Software Verification and Validation Testing

26

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider. It demonstrates substantial equivalences to the predicate device.

Animal Study

The subject of this premarket submission, Piloter/ Piloter/ Piloter P Diagnostic Ultrasound System, does not require animal studies to support substantial equivalence.

8. Clinical data

The subject of this premarket submission, Piloter/ Piloter/ Piloter P Diagnostic Ultrasound System, did not require clinical studies to support substantial equivalence.

9. Conclusion

The non-clinical data support the safety of the device and the performance testing report demonstrate that the Piloter Exp/ Piloter P Diagnostic Ultrasound System should perform as intended in the specified use conditions and conform to applicable medical device safety standards. In accordance with the 21 CFR Part 807 and based on the information provided in this premarket notification. Shenzhen Wisonic concludes that the Piloter Piloter/ Piloter P Diagnostic Ultrasound System is as safe and as effective as the predicate devices.