(84 days)
Not Found
No
The document does not mention AI, ML, or related terms, and the device description focuses on standard ultrasound imaging modes and hardware.
No.
The device is described as an ultrasound system used to perform "diagnostic general ultrasound studies" and for "imaging for guidance of biopsy and imaging to assist in the placement of needles and catheters." Its primary function is diagnostic imaging and guidance, not delivering therapy.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the device is "used to perform diagnostic general ultrasound studies" and the 'Device Description' section reiterates that it is "used to perform diagnostic general ultrasound studies."
No
The device description clearly outlines hardware components such as an arm-held system, battery, LCD color display with touch screen, internal hard disk, and ports for external media and accessories like printers and a mobile trolley. This indicates it is a physical device with integrated software, not a software-only medical device.
Based on the provided information, the Esaote MyLabOne is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The description of the MyLabOne clearly states it is an ultrasound system used to perform diagnostic studies on the human body (e.g., Cardiac, Abdominal, Fetal, etc.). It uses ultrasound waves to create images of internal structures, not to analyze biological samples like blood, urine, or tissue.
- The intended use and device description focus on imaging and guidance for procedures performed directly on the patient. This is characteristic of imaging devices, not IVDs.
Therefore, the MyLabOne falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Esaote's MyLabOne is an arm-held ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small Organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Obstetrics/Gynaecology, Transvaginal, Transrectal, Pediatric, Intraoperative Abdominal, and Other: Urology. The system provides imaging for guidance of biopsy and imaging to assist in t the placement of needles and catheters in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.
Product codes
IYN, IYO, ITX
Device Description
The MyLabOne is a battery operated, portable ultrasound system used to perform diagnostic general ultrasound studies. Its primary modes of operation are: B-Mode, M-Mode, Amplitude Doppler (AD), Tissue Enhancement Imaging (TEI), Color Flow Mapping (CFM) and Pulse Wave Doppler.
The MyLabOne is equipped with a LCD Color Display. The LCD Display includes touch screen technology for a simple and intuitive activation of functions and data entry for patient information and screen annotations.
The MyLabOne can drive phased (PA), convex (CA) and linear array (LA) probes. The MyLabOne is equipped with an internal Hard Disk and with an optional external DVD-RW disk drive that can be used for image storage. Data can also be stored directly to external archiving media (hard-disk, PC, server) via a LAN/USB port. Optional accessory devices available for the MyLabOne include a monochrome or color page printer, a desk stand (for use on a desk or cart) and a mobile trolley equipped with four swiveling wheels and peripheral holder.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small Organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Obstetrics/Gynaecology, Transvaginal, Transrectal, Pediatric, Intraoperative Abdominal, Urology.
Indicated Patient Age Range
Neonatal, Adult, Pediatric
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
AUG 31 2010
510(k) Summary
The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 1807.92(a).
807.92(a)(1)
Submitter Information
Esaote Europe B.V. Philipsweg 1 Maastricht 6227AJ The Netherlands
Contact Person:
Allison Scott, RAC 317.569.9500 x106 ascott@ansongroup.com
Date:
March 22, 2010
807.92(a)(2)
Trade Name:
MyLabOne Ultrasound System
Common Name:
Ultrasound Imaging System
Classification Name
| e(s): | Ultrasonic pulse Doppler imaging system | 892.1550 |
|---|---|---|
| Ultrasonic pulsed echo imaging system | 892.1560 | |
| Diagnostic ultrasonic transducer | 892.1570 |
Classification Number:
90IYN, 90IYO, 90ITX
l
1
807.92(a)(3)
Predicate Device(s)
| K083882 | MyLabFive | Esaote Europe B.V. |
|---|---|---|
| K092058 | NanoMaxx | SonoSite, Inc. |
Additional substantial equivalence information is provided in the following substantial equivalence comparison table.
807.92 (a)(4)
Device Description
The MyLabOne is a battery operated, portable ultrasound system used to perform diagnostic general ultrasound studies. Its primary modes of operation are: B-Mode, M-Mode, Amplitude Doppler (AD), Tissue Enhancement Imaging (TEI), Color Flow Mapping (CFM) and Pulse Wave Doppler.
The MyLabOne is equipped with a LCD Color Display. The LCD Display includes touch screen technology for a simple and intuitive activation of functions and data entry for patient information and screen annotations.
The MyLabOne can drive phased (PA), convex (CA) and linear array (LA) probes. The MyLabOne is equipped with an internal Hard Disk and with an optional external DVD-RW disk drive that can be used for image storage. Data can also be stored directly to external archiving media (hard-disk, PC, server) via a LAN/USB port. Optional accessory devices available for the MyLabOne include a monochrome or color page printer, a desk stand (for use on a desk or cart) and a mobile trolley equipped with four swiveling wheels and peripheral holder.
2
807.92(a)(5)
Intended Use(s)
Esaote's MyLabOne is an arm-held ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small Organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Obstetrics/Gynaecology, Transvaginal, Transrectal, Pediatric, Intraoperative Abdominal, and Other: Urology. The system provides imaging for guidance of biopsy and imaging to assist in t the placement of needles and catheters in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.
807.92(a)(6)
Technological Characteristics
Esaote believes that the MyLabOne is substantial equivalent to Esaote's MyLabFive product (K083882) and SonoSite's Nanomaxx product (K092058).
- · Clinical uses for which the MyLabOne is designed are equivalent to those cleared for the Esaote MyLabFive and the SonoSite NanoMaxx.
- · The MyLabOne, the Esaote MyLabFive and the SonoSite NanoMaxx are designed to meet the IEC60601-1 and the IEC60601-2-37 safety requirements.
- · The MyLabOne, the Esaote MyLabFive and the SonoSite NanoMaxx provide an Acoustic Output Display feature per AIUM / NEMA standards, with equivalent Ispta and MI maximal values.
- · The MyLabOne, the Esaote MyLabFive and the SonoSite NanoMaxx provide a similar measurements and analysis package, with equal accuracy and precision.
- · The MyLabOne, the Esaote MyLabFive and the SonoSite NanoMaxx have digital storage capabilities, including Network connectivity.
- · The MyLabOne, the Esaote MyLabFive and the SonoSite NanoMaxx are designed to be powered by battery when no main power is available.
- · The MyLabOne image modes are available on other FDA cleared ultrasound systems. for instance the Esaote MyLabFive and Sonosite NanoMaxx.
3
3
807.92(b)(1)
Non-Clinical Testing
Verification and validation tests have been conducted in accordance with design controls per CFR 820.30.
The system has been designed to meet the following standards:
- . IEC 60601-I
- IEC 60601-1-2 .
- IEC 60601-2-37 .
- ISO 10993-1 .
- AIUM/NEMA UD-3 Standard for Real Time Display of Thermal and Mechanical . Acoustic Output Indices on Diagnostic Ultrasound Equipment
- AIUM/NEMA UD-2 Acoustic Output Measurement Standard for Diagnostic . Ultrasound .
. .. .. . .
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/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" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Esaote Europe B.V. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services 1394 25th Street NW BUFFALO MN 55313
2010 3 1
Re: K101605
Trade/Device Name: MyLabOne Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: August 18, 2010 Received: August 19, 2010
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 MyLabOne, as described in your premarket notification:
Transducer Model Number
5
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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/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 Shahram Vaezy at (301) 796-6242.
Sincerely yours.
signature
Jonald St. Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
6
510(k) Number (if known): | Prescription Use Only (Per 21 CFR 801 Part D) Concurrence of CDRH, Office of In Vitro Diagnostics Devices (OIVD)
(Division Sign-Off) Division of Radiological De Office of In ce Evaluation and Safety
510K K101605
10
SC3121
| Mode of Operations | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined [3] | TVM | Tissue | |||||||
| Enhancement | ||||||||||
| Imaging (TEI) | Other (specify) | |||||||||
| Ophthalmic | ||||||||||
| Fetal/Obstetrics/Gyn | N | N | N | N | N | N | N | 4 | ||
| Abdominal | N | N | N | N | N | N | N | 4 | ||
| Intraoperative (Abdominal) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | N | N | N | N | N | N | N | 4 | ||
| Small Organ [1] | ||||||||||
| Neonatal Cephalic | N | N | N | N | N | N | N | 4 | ||
| Adult Cephalic | ||||||||||
| Cardiac [2] | N | N | N | N | N | N | N | 4 | ||
| Transesophageal (Cardiac) | ||||||||||
| Transesophageal (Non Cardiac) | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular (including | ||||||||||
| vascular access) | N | N | N | N | N | N | N | 4 | ||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| (including Nerve Blocking) | N | N | N | N | N | N | N | 4 | ||
| Musculo-skeletal Superficial | ||||||||||
| (including Nerve Blocking) | N | N | N | N | N | N | N | 4 | ||
| Other (Urological) | N | N | N | N | N | N | N | 4 |
The SC3121 probe is to be cleared via
this submssion
Nenew indication; P=previously cleared by FDA; E= added under Appendix E Additional Comments:
-
(1) Small Organs includes Breast, Thyroid and Testicles (기 Cardiac is Adult and Pediatric (ર) Combined modes are: B + M + PW + CFM + PD
XView -
|4)
Prescription Use Only (Per 21 CFR 801 Part D) Concurrence of CDRH, Office of In Vitro Diagnostics Devices (OIVD)
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K.K101665
11
SC3123
| Mode of Operations | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined | |||||||||
| [3] | TVM | Tissue | ||||||||
| Enhancement | ||||||||||
| Imaging (TEI) | Other (specify) | |||||||||
| Ophthalmic | ||||||||||
| Fetal/Obstetrics/Gyn | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (Abdominal) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | N | N | N | N | N | N | N | N | 4 | |
| Small Organ [1] | N | N | N | N | N | N | N | N | 4 | |
| Neonatal Cephalic | N | N | N | N | N | N | N | N | 4 | |
| Adult Cephalic | ||||||||||
| Cardiac [2] | N | N | N | N | N | N | N | N | 4 | |
| Transesophageal (Cardiac) | ||||||||||
| Transesophageal (Non Cardiac) | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular (including | ||||||||||
| vascular access) | N | N | N | N | N | N | N | N | 4 | |
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| (including Nerve Blocking) | N | N | N | N | N | N | N | N | 4 | |
| Musculo-skeletal Superficial | ||||||||||
| (including Nerve Blocking) | N | N | N | N | N | N | N | N | 4 | |
| Other (Urological) |
The SC3123 probe is to be cleared via
this submssion
[1]
[기
(3)
(ব)
N=new indication; P=previously cleared by FDA; E= added under Appendix E Additional Comments:
- Small Organs includes Breast, Thyroid and Testicles Cardiac is Adult and Pediatric Combined modes are: B + M + PW + CFM + PD XView
Prescription Use Only (Per 21 CFR 801 Part D) Concurrence of CDRH. Office of In Vitro Diagnostics Devices (OIVD)
S.D.R.
(Division Sign-Off)
Division of Radiological Devices Office of in Vitro Diagnostic Devices
Office of in Vitro Diagnostic Device Evaluation and Safety
510K Ki6605
12
SC3421
| Mode of Operations | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined | |||||||||
| [3] | TVM | Tissue | ||||||||
| Enhancement | ||||||||||
| Imaging (TEI) | Other (specify) | |||||||||
| Ophthalmic | ||||||||||
| Fetal/Obstetrics/Gyn | N | N | N | N | N | N | N | 4 | ||
| Abdominal | N | N | N | N | N | N | N | 4 | ||
| Intraoperative (Abdominal) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | N | N | N | N | N | N | N | 4 | ||
| Small Organ [1] | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac [2] | ||||||||||
| Transesophageal (Cardiac) | ||||||||||
| Transesophageal (Non Cardiac) | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular (including | ||||||||||
| vascular access) | N | N | N | N | N | N | N | 4 | ||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| (including Nerve Blocking) | N | N | N | N | N | N | N | 4 | ||
| Musculo-skeletal Superficial | ||||||||||
| (including Nerve Blocking) | N | N | N | N | N | N | N | 4 | ||
| Other (Urological) | N | N | N | N | N | N | N | 4 |
The SC3421 probe is to be cleared via
this submasion
N=new indication; P=previously cleared by FDA; E= added under Appendix E Additional Comments:
.
- (1) Small Organs includes Breast, Thyroid and Testicles Cardiac is Adult and Pediatric (2) (3) Combined modes are: B + M + PW + CFM + PD (4) XVicw
Prescription Use Only (Per 21 CFR 801 Part D) Concurrence of CDRH, Office of In Vitro Diagnostics Devices (OIVD)
(Drision Sign-Off) (Simsion of Radiological Devices Office of the Diagnostic Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K16605
13
SE3123
| Mode of Operations | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined | |||||||||
| [3] | TVM | Tissue | ||||||||
| Enhancement | ||||||||||
| Imaging (TEI) | Other (specify) | |||||||||
| Ophthalmic | ||||||||||
| Fetal/Obstetrics/Gyn | N | N | N | N | N | N | N | N | 4 | |
| Abdominal | ||||||||||
| Intraoperative (Abdominal) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ [1] | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac [2] | ||||||||||
| Transesophageal (Cardiac) | ||||||||||
| Transesophageal (Non Cardiac) | ||||||||||
| Transrectal | N | N | N | N | N | N | N | N | 4 | |
| Transvaginal | N | N | N | N | N | N | N | N | 4 | |
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular (including | ||||||||||
| vascular access) | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| (including Nerve Blocking) | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| (including Nerve Blocking) | ||||||||||
| Other (Urological) | N | N | N | N | N | N | N | N | 4 |
The SE3123 probe is to be cleared via
this submssion
Nenew indication; P=previously cleared by FDA; E= added under Appendix E Additional Comments:
- (1) Small Organs includes Breast, Thyroid and Testicles (2) Cardiac is Adult and Pediatric (3) Combined modes are: B + M + PW + CFM + PD ' [4] XVicw
Prescription Use Only (Per 21 CFR 801 Part D) Concurrence of CDRH, Office of In Vitro Diagnostics Devices (OIVD)
Signature
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K116605