(13 days)
Not Found
No
The document describes standard digital image processing for ultrasound but does not mention AI, ML, or related concepts.
No
The device is described as an ultrasound system intended for "ultrasound imaging, measurement and analysis of the human body for multiple clinical applications." Its function is diagnostic, not therapeutic.
Yes
The "Intended Use / Indications for Use" section states the device is intended for "ultrasound imaging, measurement and analysis of the human body for multiple clinical applications," which directly aligns with the purpose of a diagnostic device. Furthermore, the "Predicate Device(s)" section explicitly lists "GE LOGIQ e Diagnostic Ultrasound" as a predicate device, indicating that this device also falls under the category of diagnostic ultrasound.
No
The device description explicitly states it is a "compact and extremely portable ultrasound system consisting of a hand-carried console" and utilizes "interchangeable electronic-array transducers," indicating it includes significant hardware components beyond just software.
Based on the provided information, the Venue 40 device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "ultrasound imaging, measurement and analysis of the human body". This describes a device used on the patient to visualize internal structures, not a device used to test samples from the patient (which is the core of IVD).
- Device Description: The description details a portable ultrasound system with transducers used for imaging. This aligns with in-vivo imaging, not in-vitro testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with IVD devices.
Therefore, the Venue 40 is a diagnostic imaging device used for in-vivo procedures, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Venue 40 is intended for ultrasound imaging, measurement and analysis of the human body for multiple clinical applications including: Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult & pediatic; Peripheral Vascular; Musculoskeletal Conventional & Superficial: Intractc and perioheral; Thoracic and peripheral; ThoracicPleural for motion and fluid detection and imaging guidance of interventional procedures.
Product codes
IYO, IYN, ITX
Device Description
The Venue 40 device is a compact and extremely portable ultrasound system consisting of a hand-carried console with the ability to dock it with a stand or mobile cart. The primary means of control is a small number of dedicated push buttons and graphical user interface implemented by a touch sensitive screen over the color LCD display. It utilizes interchangeable electronic-array transducers with digital acquisition, processing and display capability operating. Powered by an integrated battery or from a separate power supply/charger in the docking station or docking cart, the Venue 40 is used primarily where portability, size and convenience are essential.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Musculoskeletal Conventional & Superficial; Intraoperative (abdominal, thoracic and peripheral); Thoracic/Pleural; Transcranial; Tissue Biopsy/Fluid Drainage; Vascular Access (IV, PICC); Nonvascular
Indicated Patient Age Range
Adult, Pediatric, Neonatal, Fetal
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)
Non-clinical Tests: The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, electromagnetic compatibility, as well as themal, electrical safety, and has been found to conform with applicable medical device safety standards.
Clinical Tests: None required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
GE LOGIQ e Diagnostic Ultrasound K072797
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
K091164
Page 1 of 1
510(k) Premarket Notification GE Venue 40 Compact Ultrasound March 20, 2009
Attachment B
Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92(c).
MAY
- 5 2009
| GE Healthcare | ||
|---|---|---|
| GE Medical Systems (China) Co., Ltd | ||
| No. 19 Changjiang Road, National Hi-Tech Development Zone | ||
| Wuxi, Jiangsu Province, CHINA 214028 | ||
| Section a): | ||
| 1. | Submitter: | GE Medical Systems (China) Co., Ltd. |
| No. 19 Changjiang Road, National Hi-Tech Development Zone, Wuxi, Jiangsu Province, | ||
| CHINA 214028 | ||
| Contact Person: | Yalan Wu, | |
| Manager, Safety and Regulatory | ||
| Telephone: 86-510-85278652; Fax: 86-510-85227347 | ||
| Date Prepared: | March 20, 2009 | |
| 2. | Device Name: | GE Venue 40 Ultrasound |
| Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYO | ||
| Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN | ||
| Diagnostic Ultrasonic Transducer, 21 CFR 892.1570, 90-ITX | ||
| 3. | Marketed Device: | GE LOGIQ e Diagnostic Ultrasound K072797 |
- Device Description: The Venue 40 device is a compact and extremely portable ultrasound system consisting of a hand-carried console with the ability to dock it with a stand or mobile cart. The primary means of control is a small number of dedicated push buttons and graphical user interface implemented by a touch sensitive screen over the color LCD display. It utilizes interchangeable electronic-array transducers with digital acquisition, processing and display capability operating. Powered by an integrated battery or from a separate power supply/charger in the docking station or docking cart, the Venue 40 is used primarily where portability, size and convenience are essential.
(90-IYO/IYN/ITX) A device currently in commercial distribution.
-
Indications for Use: The Venue 40 is intended for ultrasound imaging, measurement and analysis of the human body for multiple clinical applications including: Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult & pediatic; Peripheral Vascular; Musculoskeletal Conventional & Superficial: Intractc and perioheral; Thoracic and peripheral; ThoracicPleural for motion and fluid detection and imaging guidance of interventional procedures.
-
Comparison with Predicate Device: The GE Venue 40 is of a comparable type and substantially equivalent to the current GE LOGIQ e with overall performance in a small and compact package. It has the same overall characteristics, key safety and effectiveness features, physical overall construction, and materials, and has the less intended uses and operating modes as the predicate device.
Section b):
-
Non-clinical Tests: The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, electromagnetic compatibility, as well as themal, electrical safety, and has been found to conform with applicable medical device safety standards.
-
Clinical Tests: None required.
-
Conclusion: Intended uses and other key fealures are consistent with traditional clinical practice, FDA quidelines, and established methods of patient examination. The design and development process of the manufacturer conforms with 21 CFR 820, ISO 9001:2000 and ISO 13485 quality systems. The device conforms to applicable medical device safety standards and compliance is ventied through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore, it is the opinion of GE Healthcare that the GE Venue 40 Ultrasound imaging device is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The text is in all capital letters and is written in a sans-serif font. The logo is black and white.
Public Health Service
MAY - 5 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
GE Medical Systems (China) Co., Ltd. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street NW BUFFALO MN 55313
Re: K091164
Trade/Device Name: GE Venue 40 Compact Ultrasound Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYO, IYN, and ITX Dated: April 21, 2009 Received: April 22, 2009
Dear Mr. Job:
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 use with the GE Venue 40 Compact Ultrasound, as described in your premarket notification:
Transducer Model Number
12L-SC Transducer 3S-SC Transducer
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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
2
Page 2 -- Mr. Job
Enclosure(s)
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 (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.
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 contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html
If you have any questions regarding the content of this letter, please contact Lauren Hefner at (240) 276-3666. .
Sincerely yours,
Carolyn 4 Neuland
Janine M Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
3
K09//64
510(k) Premarket Notification GE Venue 40 Compact Ultrasound . March 20, 2009
Diagnostic Ultrasound Indications for Use Form
GE Venue 40 Ultrasound
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PW | CW | Color | Color M | Power | Combined Modes | Harmonic Imaging | Coded Pulse | |||
| Anatomy/Region of Interest | ||||||||||||
| Ophthalmic | ||||||||||||
| Fetal/OB | N | N | N | N | N | N | ||||||
| Abdominal [1] | N | N | N | N | N | N | ||||||
| Pediatric | N | N | N | N | N | N | ||||||
| Small Organ (specify)[2] | N | N | N | N | N | N | ||||||
| Neonatal Cephalic | N | N | N | N | N | N | ||||||
| Adult Cephalic | N | N | N | N | N | N | ||||||
| Cardiac [3] | N | N | N | N | N | N | ||||||
| Peripheral Vascular | N | N | N | N | N | N | ||||||
| Musculo-skeletal Conventional | N | N | N | N | N | N | ||||||
| Musculo-skeletal Superficial | N | N | N | N | N | N | ||||||
| Thoracic/Pleural (specify) [4] | N | N | N | N | N | N | ||||||
| Other (specify) | ||||||||||||
| Exam Type, Means of Access | ||||||||||||
| Transcranial | N | N | N | N | N | N | ||||||
| Transorbital | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Intraoperative (specify) [5] | N | N | N | N | N | N | ||||||
| Intraoperative Neurological | ||||||||||||
| Intravascular/Intraluminal | ||||||||||||
| Intracardiac | ||||||||||||
| Laparoscopic | ||||||||||||
| Interventional Guidance | ||||||||||||
| Tissue Biopsy/Fluid Drainage | N | N | N | N | N | N | ||||||
| Vascular Access (IV, PICC) | N | N | N | N | N | N | ||||||
| Nonvascular (specify) [6] | N | N | N | N | N | N | ||||||
| Brachytherapy |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes GYN and Urological:
[2] Small Organ includes breast, testes, thyroid;
[3] Cardiac is Adult and Pediatric;
[4] For detection of fluid and pleural motion/sliding;
[5] Intraoperative includes abdominal, thoracic and peripheral;
[6] Nonvascular is image guidance for freehand needle/catheter placement, including nerve block;
[*] Combined modes are color/power Doppler with B-mode
| (Division Sign-Off) | Carolyn Y. Newland |
|---|---|
| --------------------- | -------------------- |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Division of Reproductive, Abdominal and Radiological Devices | Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|---|
| Prescription User (Per 21 CFR 801.109) | |
| 510(k) Number | K091164 |
4
510(k) Premarket Notification GE Venue 40 Compact Ultrasound March 20, 2009
Diagnostic Ultrasound Indications for Use Form
GE Venue 40 with 3S-SC Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Anatomy/Region of Interest | B | M | PW | CW | Color | Color | |||||||
| M | Power | Combined | |||||||||||
| Modes | Harmonic | ||||||||||||
| Imaging | Coded | ||||||||||||
| Pulse | Elasto- | ||||||||||||
| graphy | |||||||||||||
| Ophthalmic | |||||||||||||
| Fetal/OB | N | N | N | N | N | ||||||||
| Abdominal[1] | N | N | N | N | N | ||||||||
| Pediatric | N | N | N | N | N | ||||||||
| Small Organ (specify)[2] | |||||||||||||
| Neonatal Cephalic | N | N | N | N | N | ||||||||
| Adult Cephalic | N | N | N | N | N | ||||||||
| Cardiac[3] | N | N | N | N | N | ||||||||
| Peripheral Vascular | |||||||||||||
| Musculo-skeletal Conventional | N | N | N | N | N | ||||||||
| Musculo-skeletal Superficial | |||||||||||||
| Thoracic/Pleural (specify) [4] | N | N | N | N | N | ||||||||
| Other (specify) | |||||||||||||
| Exam Type, Means of Access | |||||||||||||
| Transcranial | N | N | N | N | |||||||||
| Transorbital | |||||||||||||
| Transesophageal | |||||||||||||
| Transrectal | |||||||||||||
| Transvaginal | |||||||||||||
| Intraoperative (specify) [5] | N | N | N | N | |||||||||
| Intraoperative Neurological | |||||||||||||
| Intravascular/Intraluminal | |||||||||||||
| Intracardiac | |||||||||||||
| Laparoscopic | |||||||||||||
| Interventional Guidance | |||||||||||||
| Tissue Biopsy/Fluid Drainage | N | N | N | N | |||||||||
| Vascular Access (IV, PICC) | |||||||||||||
| Nonvascular (specify) [6] | |||||||||||||
| Brachytherapy |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes GYN and Urological;
- [2] Small Organ includes breast, testes, thyroid;
3] Cardiac is Adult and Pediatric;
4] For detection of fluid and pleural motion/sliding;
5] Intraoperative includes abdominal, thoracic and peripheral;
6] Nonvascular is image guidance for freehand needle/catheter placement, including nerve block
"] Combined modes are color/power Doppler with B-mode
Cinda Y. Neuland for Im Moms
Division Sign Off
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER QUE SIRE All-Chi
-Concurrence of CDRH, Office of Device Evaluationistics of Reproductive.
Prescription User (Per 21 CFR 801.109)
Radiological Devices
510(k) Number _
5
K09//64
510(k) Premarket Notification GE Venue 40 Compact Ultrasound March 20, 2009
Diagnostic Ultrasound Indications for Use Form
GE Venue 40 with 12L-SC Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Doppler Modes | ||||||||||||
| Anatomy/Region of Interest | B | M | PW | CW | Color | Color M | Power | Combined Modes | Harmonic Imaging | Coded Pulse | Elasto-graphy | Other |
| Ophthalmic | ||||||||||||
| Fetal/OB | ||||||||||||
| Abdominal [1] | N | N | N | N | N | N | ||||||
| Pediatric | N | N | N | N | N | N | ||||||
| Small Organ (specify) [2] | N | N | N | N | N | N | ||||||
| Neonatal Cephalic | N | N | N | N | N | N | ||||||
| Adult Cephalic | ||||||||||||
| Cardiac [3] | ||||||||||||
| Peripheral Vascular | N | N | N | N | N | N | ||||||
| Musculo-skeletal Conventional | N | N | N | N | N | N | ||||||
| Musculo-skeletal Superficial | N | N | N | N | N | N | ||||||
| Thoracic/Pleural (specify) [4] | N | N | N | N | N | N | ||||||
| Other (specify) | ||||||||||||
| Exam Type, Means of Access | ||||||||||||
| Transcranial | ||||||||||||
| Transorbital | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Intraoperative (specify) [5] | N | N | N | N | N | N | ||||||
| Intraoperative Neurological | ||||||||||||
| Intravascular/Intraluminal | ||||||||||||
| Intracardiac | ||||||||||||
| Laparoscopic | ||||||||||||
| Interventional Guidance | ||||||||||||
| Tissue Biopsy/Fluid Drainage | N | N | N | N | N | N | ||||||
| Vascular Access (IV, PICC) | N | N | N | N | N | N | ||||||
| Nonvascular (specify) [6] | N | N | N | N | N | N | ||||||
| Brachytherapy |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes GYN and Urological;
- [2] Small Organ includes breast, testes, thyroid;
[3] Cardiac is Adult and Pediatric;
(4) For detection of fluid and pleural motion/sliding;
[5] Intraoperative includes abdominal, thoracic and peripheral;
(6) Nonvascular is image guldance for freehand needle/catheter placement, including nerve block
["] Combined modes are color/power Doppler with B-mode
Cecelia Y. Newbold for J.m. Morris
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTH -Concurrence of CDRH, Office of Device Evaluati
Prescription User (Per 21 CFR 801.109)
Uivision of
6
Indications for Use
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: GE Venue 40 Compact Ultrasound
Indications For Use:
The Venue 40 is intended for ultrasound imaging, measurement and analysis of the human body for multiple clinical applications including: Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult & pediatric); Peripheral Conventional & Superficial; Intraoperative Vascular: Musculoskeletal (abdominal, thoracic and peripheral); Thoracic/Pleural for motion and fluid detection and imaging guidance of interventional procedures.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Carole Y. Newland for J.M. Morris
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
Page 1 of 1