(47 days)
Not Found
No
The document describes a standard ultrasound system with various imaging modes and 3D/4D capabilities, but there is no mention of AI or ML in the intended use, device description, or specific sections for AI/ML details.
No
The device is described as a "compact console ultrasound system intended to be used by a physician to perform general diagnostic ultrasound studies," indicating its use for diagnosis rather than treatment.
Yes
The "Intended Use / Indications for Use" states that the device is "intended to be used by a physician to perform general diagnostic ultrasound studies". The "Device Description" also notes that it is "used to perform general diagnostic ultrasound studies". This explicitly defines its purpose as diagnostic.
No
The device is described as a "compact console ultrasound system" and mentions hardware components like probes, indicating it is a physical device with integrated software, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used by a physician to perform "general diagnostic ultrasound studies." Ultrasound is an imaging modality that visualizes internal structures of the body.
- Device Description: The description details the ultrasound system's modes of operation (B-Mode, M-Mode, Doppler, etc.) and its ability to produce real-time and 3D/4D images. These are all characteristics of an imaging device used for in-vivo diagnosis.
- Anatomical Site: The listed anatomical sites are all parts of the human body that are imaged directly.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or performing tests on biological specimens outside of the body, which are the defining characteristics of an In Vitro Diagnostic device.
In summary, the MyLab15/MyLab20 is an ultrasound system used for medical imaging, which is a form of in-vivo diagnosis, not in-vitro diagnosis.
N/A
Intended Use / Indications for Use
Esaote's MyLab15/MyLab20 is a compact console ultrasound system intended to be used by a physician to perform general diagnostic ultrasound studies including Fetal, Abdominal, Pediatric, Small organ, Neonatal Cephalic, Cardiac, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal (Conventional and Superficial), Intraoperative: Abdominal, and Other: Urological.
Product codes
IYO, IYN, ITX
Device Description
The MyLab15/20 is a compact console ultrasound system used to perform general diagnostic ultrasound studies. Its primary modes of operation are: B-Mode, M-Mode, PW Doppler and Color Flow Mapping and Tissue Enhancement Imaging (TEI). MyLab15/20 is able to produce real time 2D images and 3D images (in manual mode) with all probes. The system, in combination with the probe BC432P, offers the possibility to also produce automatic 3D and real time 4D images
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal, Abdominal, Pediatric, Small organ (Thyroid, Breast, Testicles), Neonatal Cephalic, Cardiac, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal (Conventional and Superficial), Intraoperative: Abdominal, Other: Urological.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician
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
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
510(k) Summary NIvLab15/20 Esaote Europe BV
K061755
510(k) Summary
AUG - 7 2006
The following safety and effectiveness summary has been prepared pursuant to requirement for 510(k) summaries specified in 21CFR 1807.92(a).
807.92(a){ })
Submitter Information
| Carri Graham, Official Correspondent | 11460 N Meridian St., Ste 150 |
|---|---|
| Carmel, Indiana 46032 | |
| Phone: | (317) 569-9500 |
| Facsimile: | (317) 569-9520 |
| Contact Person: | Carri Graham |
|---|---|
| Date: | June 21, 2006 |
| 807.92(a)(2) | |
|---|---|
| Trade Name: | MyLab15/20 New Indications Ultrasound System |
| Common Name: | Ultrasound Imaging System |
| Classification Name(s): | Ultrasonic pulsed echo imaging system 892.1560 |
| Ultrasonic pulsed Doppler imaging system 832.1550 | |
| Classification Number: | 90IYO |
| 90IYN |
| 807.92(a)(3) | Predicate Device(s) |
|---|---|
| -------------- | --------------------- |
| K014168 | Technos Esaote, S.p.A. |
|---|---|
| K043588 | MyLab15/20 Ultrasound System Pie Medical |
| K053154 | MyLab15/20 Just3D/4D Pie Medical |
Additional Substantial Equivalence Information is provided in the following substantial Equivalence Comparison Table.
1
510(k) Summary MyLab15/20 Esaote Europe BV
807.92(a)(4)
Device Description
The MyLab15/20 is a compact console ultrasound system used to perform general diagnostic ultrasound studies. Its primary modes of operation are: B-Mode, M-Mode, PW Doppler and Color Flow Mapping and Tissue Enhancement Imaging (TEI). MyLab15/20 is able to produce real time 2D images and 3D images (in manual mode) with all probes. The system, in combination with the probe BC432P, offers the possibility to also produce automatic 3D and real time 4D images
807.92(a)(5)
Intended Use(s)
Esaote's MyLab15/MyLab20 is a compact console ultrasound system intended to be used by a physician to perform general diagnostic ultrasound studies including Fetal, Abdominal, Pediatric, Small organ, Neonatal Cephalic, Cardiac, Transrectal, Transvaginal, Peripheral Vascular, Intraoperative: Abdominal, Other: Urological, Musculoskeletal (Conventional and Superficial).
2
510(k) Summary MyLab15/20 Esaote Europe BV
Comparison Chart for Substantial Equivalence
| General
Characteristics | Esaote MyLab15/20
K043588, K053154 | Esaote Technos
K014168 | Esaote MyLab15/20
Current 510(k) |
|------------------------------|---------------------------------------|---------------------------|-------------------------------------|
| Applications | | | |
| Intraoperative:
Abdominal | No | Yes | Yes |
| Other: Urological | No | Yes | Yes |
3
510(k) Summary
MyLab15/20
Esaote Europe BV
| | 1
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| -----------------------------------
Un 12 1 1 1 1 1 1 1 1 1 | 400000
annono | Frenta Mul 2115/20 |
| General
Characteristics | Esaote MyLab15/20
K043588, K053154 | Esaote Technos
K014168 | Esaote MyLab15/20
Current 510(k) |
|----------------------------------|-------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| Transducer Type | | | |
| Linear | Yes | Yes | Yes |
| Convex | Yes | Yes | Yes |
| 2D Freq MHz | 2.7 - 15 | 2.8 - 12.5 | 2.7 - 15 |
| Multifrequency | Yes | Yes | Yes |
| Special probes | • Endocavity probe
• Mechanically
Driven 3D Convex
Array | • Endocavity
probe
• Mechanically
Driven 3D
Convex Array
• CW Doppler
Probe | • Endocavity probe
• Mechanically
Driven 3D Convex
Array |
| Biopsy attachments | | | |
| Convex | Yes | Yes | Yes |
| Linear | Yes | Yes | Yes |
| Imaging modes | | | |
| Real Time 2D | Yes | Yes | Yes |
| M-mode | Yes | Yes | Yes |
| PW Doppler | Yes | Yes | Yes |
| CW Doppler | No | Yes | No |
| CFM Doppler | Yes | Yes | Yes |
| Amplitude Doppler | Yes | Yes | Yes |
| Triplex | Yes | Yes | Yes |
| 3D/4D | Yes | Yes | Yes |
| Monitor size (inches) | • 15" CRT
monitor
• 15" LCD | 15" Color VGA
CRT Monitor | • 15" CRT
monitor
• 15" LCD
• 19" LCD |
| ECG | Optional | Optional | Optional |
| Digital archival
capabilities | Yes | Yes | Yes |
| VCR & Video
printers | Yes | Yes | Yes |
| M&A capabilities | Yes | Yes | Yes |
| Safety | | | |
| Electrical safety | EN60601-1 | EN60601-1 | EN60601-1 |
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
AUG - 7 2006
Esaote Europe BV % Ms. Carri Graham Consultant The Anson Group 11460 N Meridian St, Ste 150 CARMEL IN 46032
Re: K061755
·
Trade Name: MyLab 15/MyLab 20 Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: IYO, IYN, and ITX Dated: June 19, 2006 Received: June 21, 2006
Dear Ms. Graham:
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 MyLab 15/MyLab 20 Systems, as described in your premarket notification:
Image /page/4/Picture/10 description: The image shows a logo for the FDA Centennial 1906-2006. The logo is circular and contains the letters FDA in the center. The words "Centennial" are below the letters FDA. The text below the logo reads "Protecting and Promoting Public Health."
5
Transducer Model Number
| IOE323 |
|---|
| CA123 |
| C5-2 R13 |
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. may publish hat FDA's issuance of a substantial equivalence determination does not mean r loase be devices and i bre broundevice complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any 1 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 CI It Fat 607); adoning (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
This letter will allow you to begin marketing your device as described in your premarket I notification. The FDA finding of substantial equivalence of your device to a legally marketed nonification. - 11.0 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
6
Page 3 - Ms. Graham
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/cdrh/industry/support/index.html
If you have any questions regarding the content of this letter, please contact Ralph Shuping at (301) 594-1212.
Sincerely yours,
Daniel B. Leyron
for
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
7
Indications for Use
510(k) Number (if known):
K 061755
MyLab15/MyLab20 Systems Device Name:
Indications For Use:
Esaote's MyLab15/MyLab20 is a compact console ultrasound system intended to be used by a physician to perform general diagnostic ultrasound studies including Fetal, Abdominal, Pediatric, Small organ, Neonatal Cephalic, Cardiac, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal (Conventional and Superficial), Intraoperative: Abdominal, and Other: Urological.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel A. Severson
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K061755
.
8
Image /page/8/Picture/0 description: The image shows the text "K061755" in a handwritten style on the top line. Below that, the text "MyLab15/20 Systems" is printed in a clear, sans-serif font. The handwritten text appears to be a code or identifier, while the printed text likely refers to a product or system name.
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (specify) | Other (specify) | |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | |||||||||||
| Fetal | P | P | P | P | P | P [2] | P[3], P[4], | ||||
| P[5] | |||||||||||
| Abdominal | P | P | P | P | P | P [2] | P[3], P[4], | ||||
| P[5] | |||||||||||
| Intraoperative Abdominal | N | N | N | N | N | N[2] | N[3], N[4] | ||||
| Intraoperative Neurological | |||||||||||
| Pediatric | P | P | P | P | P | P [2] | P[3], P[4], | ||||
| P[5] | |||||||||||
| Small Organ (specify) [1] | P | P | P | P | P | P [2] | P[3], P[4] | ||||
| Neonatal Cephalic | P | P | P | P | P | P [2] | P[3], P[4] | ||||
| Adult Cephalic | |||||||||||
| Cardiac | P | P | P | P | P | P [2] | P[3] | ||||
| Transesophageal | |||||||||||
| Transrectal | P | P | P | P | P | P [2] | P[3], P[4] | ||||
| Transvaginal | P | P | P | P | P | P [2] | P[3], P[4] | ||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | P | P | P | P | P | P [2] | P[3], P[4] | ||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | P | P | P | P | P | P [2] | P[3], P[4] | ||||
| Musculo-skeletal Superficial | P | P | P | P | P | P [2] | P[3], P[4] | ||||
| Other: Urological | N | N | N | N | N | N[2] | N[3], N[4] |
N=new indication; P=previously cleared by FDA; E= added under Appendix E Additional Comments:
[1] Small organs include Thyroid, Breast and Testicles.
[2] Applicable combined modes: B+M+PW+ CFM+Amplitude Doppler
[3] Tissue Enhancement Imaging (TEI)
[4] 3D Imaging
(5) 4D Imaging
Daniel H. Ingram
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number .
9
K061755
IOE323
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | |||||||
| (PW) | CWD | |||||||||
| (CW) | Color | |||||||||
| Doppler | ||||||||||
| (CFM) | Amplitude | |||||||||
| Doppler | ||||||||||
| (PD) | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | N | N | N | N | N | N (2) | N (3) | |||
| Intraoperative (Abdominal) | N | N | N | N | N | N (2) | N (3) | |||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) [1] | N | N | N | N | N | N [2] | N [3] | |||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | N | N | N | N | N | N [2] | N [3] | |||
| Laparoscopic | ||||||||||
| Muscolo-skeletal | ||||||||||
| Conventional | N | N | N | N | N | N [2] | N [3] | |||
| Muscolo-skeletal | ||||||||||
| Superficial | N | N | N | N | N | N [2] | N [3] |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
[1] Small organs include Thyroid, Breast and Testicles.
(2) Applicable combined modes: B+M+PW+CFM+PD
[3] Tissue Enhancement Imaging (TEI)
iplease do not write below this line. Continute on another Page if needed)
concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
David be. Semon
(Division Sign-Off) Division of Reproductive, Abdoo and Radiological Devices 510(k) Numb
ート アルバイト (1) 2017 - 10:20
10
K061755
CA123
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | ||||||
| (PW) | CWD | |||||||||
| (CW) | Color | |||||||||
| Doppler | ||||||||||
| (CFM) | Amplitude | |||||||||
| Doppler | ||||||||||
| (PD) | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | N | N | N | N | N | N (2) | N [3] | |||
| Abdominal | N | N | N | N | N | N (2) | N (3) | |||
| Intraoperative (Adominal) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) [1] | N | N | N | N | N | N (2) | N [3] | |||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | N | N | N | N | N | N (2) | N [3] | |||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | N | N | N | N | N | N (2) | N [3] | |||
| Laparoscopic | ||||||||||
| Muscolo-skeletal | ||||||||||
| Conventional | ||||||||||
| Muscolo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other: Urological | N | N | N | N | N | N (2) | N [3] |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
[1] Small organs include Thyroid, Breast and Testicles.
[2] Applicable combined modes: B+M+PW+CFM+PD
[3] Tissue Enhancement Imaging (TEI)
(PLEASE DO NOT WRITE BELOW THIS LIKE. CONTINUE OF ANOTHER PAGE IF KELDED)
concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
David A. Severson
(Division Sign-Off) Division of Reproductive, Abdo and Radiological Devices 510(k) Number
ા ર
11
Ko61755
C5-2 R13
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | ||||||
| (PW) | CWD | |||||||||
| (CW) | Color | |||||||||
| Doppler | ||||||||||
| (CFM) | Amplitude | |||||||||
| Doppler | ||||||||||
| (PD) | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | N | N | N | N | N | N [2] | N [3] | |||
| Abdominal | N | N | N | N | N | N [2] | N [3] | |||
| Intraoperative (Adominal) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) [1] | N | N | N | N | N | N [2] | N [3] | |||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | N | N | N | N | N | N [2] | N [3] | |||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | N | N | N | N | N | N [2] | N [3] | |||
| Laparoscopic | ||||||||||
| Muscolo-skeletal | ||||||||||
| Conventional | ||||||||||
| Muscolo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other: Urological | N | N | N | N | N | N [2] | N [3] |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
[1] Small organs include Thyroid, Breast and Testicles.
[2] Applicable combined modes: B+M+PW+CFM+PD
[3] Tissue Enhancement Imaging (TEI)
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEBOED)
concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
David A. Styrone
(Division Sign-Off) Division of Reproductive, Abdo and Radiological Devices 510(k) Number
16