(31 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard ultrasound imaging modes and analysis packages without mentioning AI/ML capabilities.
No
The device is explicitly stated as being intended for "diagnostic ultrasound imaging and fluid analysis of the human body," and its function is to "display the data as B mode. M mode, Color Doppler imaging, Power Doppler imaging, PW Spectral Doppler mode, Harmonic imaging or as a combination of these modes." It also provides "analysis packages that provide information that is used to make a diagnosis." There is no mention of treating or curing any condition.
Yes
The section "Intended Use / Indications for Use" states that the device is "intended for diagnostic ultrasound imaging." Additionally, the "Device Description" explicitly describes it as a "diagnostic ultrasound system."
No
The device description explicitly states it is a "hand-held, software controlled, diagnostic ultrasound system," indicating it includes hardware components (the hand-held system) in addition to software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The UGEO PT60A is a diagnostic ultrasound system. It uses sound waves to create images of internal structures of the human body. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states "diagnostic ultrasound imaging and fluid analysis of the human body." While it mentions "fluid analysis," this is done in vivo (within the body) using ultrasound, not by analyzing a collected sample.
- Device Description: The description focuses on how the device acquires and displays ultrasound data and provides measurement and analysis packages based on these images.
Therefore, the UGEO PT60A is a diagnostic imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The UGEO PT60A Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
The UGEO PT60A is a general purpose, hand-held, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B mode. M mode, Color Doppler imaging, Power Doppler imaging, PW Spectral Doppler mode, Harmonic imaging or as a combination of these modes. The UGEO PT60A also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The UGEO PT60A has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed
Mentions image processing
All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate on-screen display of anatomic structures and fluid flow within the body.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ (e.g. thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients, lung), Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Peripheral vessel, Intra-operative (Abdominal organs and peripheral vessel)
Indicated Patient Age Range
Adult, Pediatric, Neonatal
Intended User / Care Setting
Competent health care professionals.
Care setting not explicitly mentioned, but implied to be a clinical/medical setting.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not applicable. The subject of this submission, UGEO PT60A, did not require clinical studies to support substantial equivalence.
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.
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.
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
§ 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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are connected by a flowing line that resembles a ribbon or banner.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 3, 2014
Samsung Medison Co., Ltd. % Mr. Mark Job Responsible Third Party Official 1394 25th Street NW BUFFALO MN 55313
Re: K142466
Trade/Device Name: UGEO PT60A Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: August 28, 2014 Received: September 2, 2014
Dear Mr. Job:
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.
This determination of substantial equivalence applies to the following transducers intended for use with the UGEO PT60A Diagnostic Ultrasound System, as described in your premarket notification:
| Transducer Model Number | ||
|---|---|---|
| C2-5 | C2-8 | LN5-12 |
| LS6-15 | PN2-4 | CF4-9 |
| EVN4-9 | P4-12 |
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.
1
Page 2-Mr. Job
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.
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,
Smh.f)
for
Janine M. Morris 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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
K142466
Device Name UGEO PT60A Diagnostic Ultrasound System
Indications for Use (Describe)
The UGEO PT60A Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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3
510(k) No .: K142466
Device Name: UGEO PT60A Diagnostic Ultrasound System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler* | Combined* | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal/Obstetrics (See Note 3) | P | P | P | P | Note 1 | Notes 2, 7 | ||
| Abdominal (See Note 8) | P | P | P | P | Note 1 | Notes 2, 7 | ||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | P | P | P | P | Note 1 | Notes 2, 7 | ||
| Small Organ (See Note 5) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9 | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | P | P | P | P | Note 1 | Note 7 | ||
| Trans-rectal | P | P | P | P | Note 1 | Notes 2 | ||
| Trans-vaginal | P | P | P | P | Note 1 | Notes 2 | ||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | P | P | P | P | Note 1 | Note 2, 5, 6, 9 | ||
| Musculo-skel. (Superfic.) | P | P | P | P | Note 1 | Note 2, 5, 6, 9 | ||
| Intra-luminal | ||||||||
| Other (See Note 10) | P | P | P | P | Note 1 | Notes 2 | ||
| Cardiac Adult | P | P | P | P | Note 1 | Notes 2, 7 | ||
| Cardiac | Cardiac Pediatric | P | P | P | P | Note 1 | Notes 2, 7 | |
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9 | |
| Other (spec.) |
N= new indication; P= previously cleared by FDA K132228; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+C+PW, B+PD+PW, Dual(B, B/C, B/PD)
Note 2: Includes imaging for guidance of biopsy Note 3: Obstetrics and Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients, lung
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: Includes Gynecology
Note 9: MultiVision (Spatial Compound Imaging)
Note 10: Includes Urology/Prostate
4
510(k) No .: K142466 Device Name: C2-5 for use with UGEO PT60A
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation (*includes simultaneous B-mode)
| General
(Track I only) | Specific
(Tracks I & III) | B | M | PWD | CWD | Color
Doppler* | Combined*
(Spec.) | Other
(Spec.) |
|---------------------------|-------------------------------|---|---|-----|-----|-------------------|----------------------|------------------|
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal/Obstetrics (See Note 3) | P | P | P | | P | Note 1 | Notes 2, 7 |
| | Abdominal (See Note 8) | P | P | P | | P | Note 1 | Notes 2, 7 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging
& Other | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (See Note 5) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (See Note 10) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |
N= new indication; P= previously cleared by FDA K132228; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+C+PW, B+PD+PW, Dual(B, B/C, B/PD)
Note 2: Includes imaging for guidance of biopsy
Note 3: Obstetrics and Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients, lung
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: Includes Gynecology
Note 9: MultiVision (Spatial Compound Imaging)
Note 10: Includes Urology/Prostate
5
510(k) No .: K142466 Device Name: C2-8 for use with UGEO PT60A Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler* | Combined* | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal/Obstetrics (See Note 3) | P | P | P | P | Note 1 | Notes 2, 7 | ||
| Abdominal (See Note 8) | P | P | P | P | Note 1 | Notes 2, 7 | ||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | ||||||||
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (See Note 10) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA K132228; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+C+PW, B+PD+PW, Dual(B, B/C, B/PD)
Note 2: Includes imaging for guidance of biopsy
Note 3: Obstetrics and Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients, lung
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: Includes Gynecology
Note 9: MultiVision (Spatial Compound Imaging)
Note 10: Includes Urology/Prostate
6
510(k) No .: K142466
Device Name: LN5-12 for use with UGEO PT60A
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track I only) | Specific | ||||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | ||||
| Doppler* | Combined* | ||||||||
| (Spec.) | Other | ||||||||
| (Spec.) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal/Obstetrics (See Note 3) | |||||||||
| Abdominal (See Note 8) | |||||||||
| Intra-operative (See Note 6) | |||||||||
| Intra-operative (Neuro.) | |||||||||
| Fetal Imaging | |||||||||
| & Other | Laparoscopic | ||||||||
| Pediatric | |||||||||
| Small Organ (See Note 5) | P | P | P | P | Note 1 | Notes 2,5,6,9 | |||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Cardiac) | |||||||||
| Musculo-skel. (Convent.) | P | P | P | P | Note 1 | Notes 2,5,6,9 | |||
| Musculo-skel. (Superfic.) | P | P | P | P | Note 1 | Notes 2,5,6,9 | |||
| Intra-luminal | |||||||||
| Other (See Note 10) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | |||||||||
| Other (spec.) | |||||||||
| Peripheral | Peripheral vessel | P | P | P | P | Note 1 | Notes 2,5,6,9 | ||
| Vessel | Other (spec.) |
N= new indication; P= previously cleared by FDA K132228; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+C+PW, B+PD+PW, Dual(B, B/C, B/PD)
Note 2: Includes imaging for guidance of biopsy
Note 3: Obstetrics and Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients, lung
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: Includes Gynecology
Note 9: MultiVision (Spatial Compound Imaging)
Note 10: Includes Urology/Prostate
7
510(k) No .: K142466
Device Name: LS6-15 for use with UGEO PT60A
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler* | Combined* | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal/Obstetrics (See Note 3) | ||||||||
| Abdominal (See Note 8) | ||||||||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | ||||||||
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | P | P | P | P | Note 1 | Note 9 | ||
| Musculo-skel. (Superfic.) | P | P | P | P | Note 1 | Note 9 | ||
| Intra-luminal | ||||||||
| Other (See Note 10) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | P | P | P | P | Note 1 | Note 9 |
| Other (spec.) |
N= new indication; P= previously cleared by FDA K132228; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+C+PW, B+PD+PW, Dual(B, B/C, B/PD)
Note 2: Includes imaging for guidance of biopsy
Note 3: Obstetrics and Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients, lung
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: Includes Gynecology
Note 9: MultiVision (Spatial Compound Imaging)
Note 10: Includes Urology/Prostate
8
510(k) No .: K142466 Device Name: PN2-4 for use with UGEO PT60A Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation (*includes simultaneous B-mode) | ||||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler* | Combined* | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal/Obstetrics (See Note 3) | ||||||||
| Abdominal (See Note 8) | P | P | P | P | Note 1 | Note 7 | ||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | ||||||||
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | P | P | P | P | Note 1 | Note 7 | ||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (See Note 10) | ||||||||
| Cardiac Adult | P | P | P | P | Note 1 | Note 7 | ||
| Cardiac | Cardiac Pediatric | P | P | P | P | Note 1 | Note 7 | |
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA K132228; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+C+PW, B+PD+PW, Dual(B, B/C, B/PD)
Note 2: Includes imaging for guidance of biopsy
Note 3: Obstetrics and Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients, lung.
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: Includes Gynecology
Note 9: MultiVision (Spatial Compound Imaging)
Note 10: Includes Urology/Prostate
9
510(k) No.: K142466 Device Name: CF4-9 for use with PT60A Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler* | Combined* | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal/Obstetrics (See Note 3) | ||||||||
| Abdominal (See Note 8) | P | P | P | P | Note 1 | Notes 2, 7 | ||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | P | P | P | P | Note 1 | Notes 2, 7 | ||
| Small Organ (See Note 5) | P | P | P | P | Note 1 | Notes 2, 7 | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (See Note 10) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | P | P | P | Note 1 | Notes 2, 7 | |
| Other (spec.) |
N= new indication; P= previously cleared by FDA K132861; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+C+PW, B+PD+PW, Dual(B, B/C, B/PD)
Note 2: Includes imaging for guidance of biopsy
Note 3: Obstetrics and Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients, lung
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: Includes Gynecology
Note 9: MultiVision (Spatial Compound Imaging)
Note 10: Includes Urology/Prostate
10
510(k) No .: K142466
Device Name: EVN4-9 for use with PT60A
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler* | Combined* | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal/Obstetrics (See Note 3) | P | P | P | P | Note 1 | Notes 2 | ||
| Abdominal (See Note 8) | P | P | P | P | Note 1 | Notes 2 | ||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | Laparoscopic | |||||||
| & | ||||||||
| Other | Pediatric | |||||||
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | P | P | P | P | Note 1 | Notes 2 | ||
| Trans-vaginal | P | P | P | P | Note 1 | Notes 2 | ||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (See Note 10) | P | P | P | P | Note 1 | Notes 2 | ||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | Peripheral vessel | |||||||
| Vessel | Other (spec.) |
N= new indication; P= previously cleared by FDA K132861; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+C+PW, B+PD+PW, Dual(B, B/C, B/PD)
Note 2: Includes imaging for guidance of biopsy
Note 3: Obstetrics and Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients, lung
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: Includes Gynecology
Note 9: MultiVision (Spatial Compound Imaging)
Note 10: Includes Urology/Prostate
11
510(k) No .: K142466 Device Name: P4-12 for use with PT60A Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler* | Combined* | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal/Obstetrics (See Note 3) | ||||||||
| Abdominal (See Note 8) | P | P | P | P | Note 1 | Note 2, 7 | ||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | ||||||||
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (See Note 10) | ||||||||
| Cardiac Adult | P | P | P | P | Note 1 | Note 2, 7 | ||
| Cardiac | Cardiac Pediatric | P | P | P | P | Note 1 | Note 2, 7 | |
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | P | P | P | Note 1 | Note 2, 7 | |
| Other (spec.) |
N= new indication; P= previously cleared by FDA K103397; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+C+PW, B+PD+PW, Dual(B, B/C, B/PD)
Note 2: Includes imaging for guidance of biopsy
Note 3: Obstetrics and Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients, lung
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: Includes Gynecology
Note 9: MultiVision (Spatial Compound Imaging)
Note 10: Includes Urology/Prostate
12
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR, Part 807, Subpart E, Section 807.92.
1. Submitter's Information: 21 CFR 807.92(a)(1)
SAMSUNG MEDISON CO., LTD. 42, Teheran-ro 108-gil, Gangnam-gu, Seoul. Korea
Contact Person: Kyeong-Mi, Park Regulatory Affairs Manager
| Telephone: | 82.2.2194.1373 |
|---|---|
| Facsimile: | 82.2.556.3974 |
Data Prepared: July 2, 2014
2. Name of the device:
Common/Usual Name: Diagnostic Ultrasound System and Accessories Proprietary Name: UGEO PT60A Diagnostic Ultrasound System Classification Names: Product Code FR Number Ultrasonic Pulsed Doppler Imaging System 892.1550 IYN Ultrasound Pulsed Echo Imaging System 892.1560 IYO Diagnostic Ultrasound Transducer 892.1570 ITX
3. Identification of the predicate or legally marketed device:
- UGEO PT60A Diagnostic Ultrasound System (K132228) -
- UGEO H60 Diagnostic Ultrasound System (K132861) -
- ACCUVIX XG Diagnostic Ultrasound System (K103397) -
- -GE Venue 40 Diagnostic Ultrasound System (K112122)
13
4. Device Description:
The UGEO PT60A is a general purpose, hand-held, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B mode. M mode, Color Doppler imaging, Power Doppler imaging, PW Spectral Doppler mode, Harmonic imaging or as a combination of these modes. The UGEO PT60A also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The UGEO PT60A has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed,
The UGEO PT60A has been designed to meet the following product safety standards:
- UL 60601-1, Safety requirements for Medical Equipment
- CSA C22.2 No. 601.1. Safety requirements for Medical Equipment
- IEC60601-2-37. Diagnostic Ultrasound Safety Standards
- EN/IEC60601-1, Safety requirements for Medical Equipment
- EN/IEC60601-1-2. EMC requirements for Medical Equipment
- NEMA UD-2. Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
- NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- ISO10993-1. Biocompatibility
- ISO14971, Application of risk management to medical devices
5. Intended Uses:
The UGEO PT60A Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
The clinical applications include: Fetal/Obstetrics. Abdominal, Gynecology, Pediatric, Small Organ, Adult Cephalic, Trans-rectal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult. Cardiac Pediatric and Peripheral vessel.
6. Technological Characteristics:
The UGEO PT60A is substantially equivalent with respect to safety, effectiveness, and functionality to the UGEO PT60A Diagnostic Ultrasound System (K132228), UGEO H60 Diagnostic Ultrasound System (K132861) and ACCUVIX XG Diagnostic Ultrasound System (K103397).
All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate on-screen display of anatomic structures and fluid flow within the body. All system allow for specialized measurements of structures and flow, and calculations.
These are described in detail in the technological characteristics comparison table as below.
14
:
:
| Feature / Characteristics | The subject device
UGEO PT60A | UGEO PT60A
(K132228) | The predicate devices
UGEO H60
(K132861) | ACCUVIX XQ
(K103397) |
|-----------------------------------|----------------------------------|-------------------------|------------------------------------------------|-------------------------|
| Indication for Use | | | | |
| - Fetal/Obstetrics | √ | √ | √ | √ |
| - Abdominal | √ | √ | √ | √ |
| - Gynecology | √ | √ | √ | √ |
| - Pediatric | √ | | √ | √ |
| - Small Organ | √ | √ | √ | √ |
| - Neonatal Cephalic | | | √ | √ |
| - Adult Cephalic | √ | √ | √ | √ |
| - Trans-rectal | √ | | √ | √ |
| - Trans-vaginal | √ | | √ | √ |
| - Musculo-skeletal (Conventional) | √ | √ | √ | √ |
| - Musculo-skeletal (Superficial) | √ | √ | √ | √ |
| - Urology | √ | | √ | √ |
| - Cardiac Adult | √ | √ | √ | √ |
| - Cardiac Pediatric | √ | √ | √ | √ |
| - Peripheral vessel | √ | √ | √ | √ |
| Scanhead Types | | | | |
| - Linear Array | √ | √ | √ | √ |
| - Curved Linear Array | √ | √ | √ | √ |
| - Endocavity | √ | | √ | √ |
| - Phased Array | √ | √ | √ | √ |
| - Static Probes | | | √ | √ |
| Scanhead Frequency | | | | |
| 1.0~20.0 MHz | √ | √ | √ | √ |
| Modes of Operation | | | | |
| - B-mode | √ | √ | √ | √ |
| M-mode | √ | √ | √ | √ |
| - Pulsed wave (PW) Doppler | √ | √ | √ | √ |
| - Continuous wave (CW) Doppler | | | √ | √ |
| - Color Doppler | √ | √ | √ | √ |
| - Power Amplitude Doppler | √ | √ | √ | √ |
| - Tissue Harmonic Imaging | √ | √ | √ | √ |
| - 3D/4D imaging mode | | | √ | √ |
| - Combined modes | √ | √ | √ | √ |
| Safety & EMC Compliance | | | | |
| - IEC60601-1
- UL 60601-1 | √ | √ | √ | √ |
| Feature / Characteristics | The subject device
UGEO PT60A | The predicate devices | | |
| | | UGEO PT60A
(K132228) | UGEO H60
(K132861) | ACCUVIX XQ
(K103397) |
| - CSA C22.2 No.601.1 | | | | |
| - IEC 60601-2-37 | √ | √ | √ | √ |
| - IEC 60601-1-2 | √ | √ | √ | √ |
| Acoustic Output Display Standard | | | | |
| Track 3 | √ | √ | √ | √ |
| Patient Contact Materials | | | | |
| Tested to ISO 10993-1 | √ | √ | √ | √ |
| Functionality | | | | |
| - Quick Scan (Q Scan) | √ | √ | √ | √ |
| - Spatial Compound Imaging | √1) | √ | √ | √ |
| - SMDR | √2) | √ | √ | √ |
510(k) Summary / Statement Certification
ATTACHEMENT 1
15
510(k) Premarket Notification
-
The name of the feature is changed to Multi Vison.
-
The name of the feature is changed to ClearVision.
7. A brief discussion of the bench and non-clinical tests conducted on the subject device
The device has been evaluated for acoustic output, biocompatibility effectiveness as well as thermal, electrical, electromagnetic and mechanical safety and has been found to conform to applicable medical device safety standards.
The UGEO PT60A and its application comply with voluntary standards as below:
- UL 60601-1. Safety requirements for Medical Equipment
- CSA C22.2 No. 601.1, Safety requirements for Medical Equipment
- IEC60601-2-37, Diagnostic Ultrasound Safety Standards
- EN/IEC60601-1, Safety requirements for Medical Equipment
- EN/IEC60601-1-2. EMC requirements for Medical Equipment
- NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
- NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- ISO10993-1, Biocompatibility
- ISO14971, Application of risk management to medical devices
Summary of Clinical Tests:
Not applicable. The subject of this submission, UGEO PT60A, did not reguire clinical studies to support substantial equivalence.
8. Conclusion
Intended uses and other key features are consistent with traditional clinical practices and FDA guidelines. The design, development and quality process of the manufacturer confirms with 21 CFR 820 and ISO 13485. The device is designed to conform to applicable medical device safety standards and compliance. Therefore, SAMSUNG MEDISON CO., LTD. considers the UGEO PT60A to be as safe, as effective, and performance is substantially equivalent to the predicate devices.