Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard digital ultrasound imaging system with various modes and capabilities, but there is no mention of AI or ML technology in the intended use, device description, or other sections.

Therapeutic

No.
The device is described as an "ultrasonic pulsed echo imaging and measurement" system for "diagnostic ultrasonic imaging," indicating its purpose is to create images for diagnosis rather than to treat conditions.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states, "Diagnostic ultrasonic imaging for abdominal, pediatric, small organ, musculo-skeletal, cardiac, peripheral vascular applications in B, M, PWD, Color Doppler and 3D imaging modes." This directly indicates its diagnostic purpose.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "Digital Ultrasound Imaging System" and supports various "transducers," which are hardware components essential for generating and receiving ultrasound waves. This indicates it is a hardware-based medical device with accompanying software, not a software-only device.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
Device Function: The description clearly states the device is an "Ultrasonic Pulsed Echo Imaging System." It uses sound waves to create images of internal body structures. This is an in vivo (within the living body) imaging technique, not an in vitro (outside the living body) diagnostic test.
Intended Use: The intended use describes imaging and measurement of various anatomical sites within the body. This aligns with the function of an ultrasound machine, not an IVD.
No Mention of Specimens: There is no mention of analyzing blood, urine, tissue, or any other bodily specimen.

Therefore, based on the provided information, the SIUI Apogee 1000 is a medical imaging device, specifically an ultrasound system, and not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The device is intended for ultrasonic pulsed echo imaging and measurement for abdominal, pediatric, small organs, musculo-skeletal, cardiac and peripheral vascular applications.
Diagnostic ultrasonic imaging for abdominal, pediatric, small organ, musculo-skeletal, cardiac, peripheral vascular applications in B, M, PWD, Color Doppler and 3D imaging modes.

Product codes

IYN, IYO, ITX

Device Description

The SIUI Apogee 1000 is a Digital Ultrasound Imaging System capable of the following operating modes: 2D (B mode), M, Doppler (PWD mode), Color (CFM mode) and 3D. The system is designed for use in linear, convex, phased array and 3D scanning modes and supports linear, convex, phased array and 3D transducers. The system has cine review, image zoom, measurements and calculations, image storage and review, printing and recording capabilities.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

abdominal, pediatric, small organs, musculo-skeletal, cardiac, peripheral vascular, Fetal, Intra-operative, Intra-operative (Neuro), Laparoscopic, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esoph. (non-Card.), Intravascular, Prostate, Kidney, Uterus, Ovary, Thyroid, Testes, Breast

Indicated Patient Age Range

Not Found

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)

The Apogee 1000 Digital Color Doppler Ultrasound Imaging System has been tested per the FDA Guidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" issued in September 2008. The acoustic output is measured and calculated per NEMA UD 2 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment: 2004. The device conforms to applicable medical device safety standards, such as IEC 60601-1, ISO10993-5 and ISO 10993-10.

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

Not Found

Predicate Device(s)

K092907

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

510(k) Summary

JAN 1 2 2011

This summary of 510(k) safety and effectiveness information is provided in accordance

with the requirements of SMDA 1990 and 21 CFR 807.92(c).

The assigned 510(k) number is:

510(k) Owner:

Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI) 77 Jinsha Road, Shantou, Guangdong 515041, China Tel: 86-754-88250150 Fax: 86-754-88251499

Contact Person:

Flower Cai

Shantou Institute of Ultrasonic Instruments Co., Ltd.

77 Jinsha Road, Shantou, Guangdong 515041, China

Date Prepared: Oct 22, 2010

2. Device/Trade Name:

Apogee 1000 Digital Color Doppler Ultrasound Imaging System

Classification Name:

Regulatory Class: II

Diagnostic Ultrasound Transducer

Ultrasonic Pulsed Doppler Imaging System 90-IYN (per 21 CFR 892.1550)
Ultrasonic Pulsed Echo Imaging System 90-IYO (per 21 CFR 892.1560)

510(k) Summary

90-ITX (per 21 CFR 892.1570)

1

3. Predicate Device:

The subject device is substantially equivalent to the device currently having FDA 510(k) clearance SIUI CTS-8800 (K092907) with respect to intended use, principles of operation and technological characteristics.

4. Device Description:

The SIUI Apogee 1000 is a Digital Ultrasound Imaging System capable of the following operating modes: 2D (B mode), M, Doppler (PWD mode), Color (CFM mode) and 3D. The system is designed for use in linear, convex, phased array and 3D scanning modes and supports linear, convex, phased array and 3D transducers. The system has cine review, image zoom, measurements and calculations, image storage and review, printing and recording capabilities.

5. Intended Use:

The device is intended for ultrasonic pulsed echo imaging and measurement for abdominal, pediatric, small organs, musculo-skeletal, cardiac and peripheral vascular applications.

6. Safety Considerations:

The Apogee 1000 Digital Color Doppler Ultrasound Imaging System has been tested per the FDA Guidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" issued in September 2008. The acoustic output is measured and calculated per NEMA UD 2 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment: 2004. The device conforms to applicable medical device safety standards, such as IEC 60601-1, ISO10993-5 and ISO 10993-10.

7. Conclusion:

The conclusions drawn from testing of the Apogee 1000 Digital Color Doppler Ultrasound Imaging System demonstrates that the device is as safe and effective as the legally marketed predicate device.

2

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized symbol that resembles a bird or a human figure with outstretched arms, composed of three curved lines.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI)
% Mr. Bob Leiker
QRS Representative
Quality and Regulatory Services, Inc.
7263 Cronin Circle
DUBLIN CA 95648

JAN 1 2 2311

Re: K103144

Trade/Device Name: Apogee 1000 Digital Color Doppler Ultrasound System with Convex Array Transducer C3L60C, Linear Array Transducer L8L38C, Convex Array Transducer C5L40C, and Phased Array Transducer P3F14C Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: December 30, 2010 Received: January 3, 2011

Dear Mr Leiker:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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.

This determination of substantial equivalence applies to the following transducers intended for ruse with the Apogee 1000 Digital Color Doppler Ultrasound System, as described in your premarket notification:

Transducer Model Number

Convex Array Transducer C3L60C Linear Array Transducer L8L38C

Convex Array Transducer C5L40C Phased Array Transducer P3F14C

3

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. 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): good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.

If you have any questions regarding the content of this letter, please contact Lauren Hefner at (301) 796-6881.

Sincerely yours,

David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

4

Indications for Use Statement

Device Name:

JAN 1 2 2011

Apogee 1000 Digital Color Doppler Ultrasound Imaging System with

Convex Array Transducer C3L60C

Linear Array Transducer L8L38C

Convex Array Transducer C5L40C

Phased Array Transducer P3F14C

Indications for Use:

Diagnostic ultrasonic imaging for abdominal, pediatric, small organ, musculo-skeletal, cardiac,

peripheral vascular applications in B, M, PWD, Color Doppler and 3D imaging modes.

Prescription Use (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

(Division Sign-Off)

(Division Sign-On)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K K103144

5

3.1 System Indications for Use Form

System: Apogee 1000

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

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

Other modes of operation include: 3-D Imaging;

Additional Comments: Other uses include: Prostate, Kidney, Uterus, Ovary Small organs include: Thyroid, Testes, Breast

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K. K103144

Indications For Use

6

3.2 Transducer Indications for Use Form Transducer: Convex Array C3L60C

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Additional Comments: Other uses include: Prostate, Kidney, Uterus, Qvary

Prescription Use (Per 21 CFR 801.109)

(Division Sign)

(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

TAB 3

610K

:

7

3.3 Transducer Indications for Use Form Transducer: Linear Array L8L38C

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

Peripheral
Vessel	Peripheral vessel	N	N	N		N
	Other (Specify)

N = new indication: P = previously cleared by FDA: E = added under this appendix Additional Comments: Small organs include: Thyroid, Testes, Breast

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)

(Division of Radiological Devices
Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Devices Evaluation and Safety

510K. K103141

. .

,

..

.

..

:

8

3.4 Transducer Indications for Use Form Transducer: Convex Array C5L40C

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

Additional Comments: Other uses include: Prostate, Kidney, Uterus, Ovary

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Radiological Devices

Office of In Vitro Diagnostic Device Evaluation and Safety

610K K103/4C/

Indications For Use

. . "

··

9

3.5 Transducer Indications for Use Form Transducer: Phased Array P3F14C

ﻮﻧ

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

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

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)

610K K103/4/

Indications For Use