(25 days)
No
The document describes a standard diagnostic ultrasound system with various imaging modes and analysis packages, but there is no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is described as a "diagnostic ultrasound system" and its function is to "acquire ultrasound data and to display the data" for diagnosis. It does not mention any therapeutic capabilities.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The HS40 diagnostic ultrasound system and probes were designed for obtaining ultrasound images and analyzing bodv fluid." and the "Device Description" section describes it as "a general purpose, mobile, software controlled, diagnostic ultrasound system." It also mentions "offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals."
No
The device description explicitly states it is a "diagnostic ultrasound system" and mentions "probes," which are hardware components essential for acquiring ultrasound data. While it is "software controlled," it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "obtaining ultrasound images and analyzing body fluid." While it analyzes body fluid, the primary function described is imaging and providing information for diagnosis by healthcare professionals.
- Device Description: The description focuses on the various ultrasound imaging modes and analysis packages used to measure anatomical structures and provide information for diagnosis.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device operates in vivo (within the body) to generate images.
- Predicate Device: The predicate device listed (K170493) is also a diagnostic ultrasound system, which are generally not classified as IVDs.
While the device does analyze "body fluid," this appears to be in the context of analyzing structures within the body that contain fluid (e.g., blood flow in vessels, fluid in organs) through ultrasound imaging and Doppler techniques, rather than analyzing a collected sample of body fluid in a laboratory setting.
N/A
Intended Use / Indications for Use
The HS40 diagnostic ultrasound system and probes were designed for obtaining ultrasound images and analyzing bodv fluid.
The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic. 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 HS40 is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B mode, M mode, Color M mode, Anatomical mode, Color Doppler mode, Pulsed Wave (PW) Spectral Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, Power Doppler (PD) mode, ElastoScan Mode, 3D/4D/XI STIC imaging mode, Freehand 3D mode, Dual mode, Dual live mode, Quad mode, Combined mode, Simultaneous mode and Zoom mode. The HS40 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 HS40 have real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.
Indicated Patient Age Range
Adult, Pediatric, Neonatal (implied by "Neonatal Cephalic" and "Cardiac Pediatric" applications)
Intended User / Care Setting
Competent health care professionals.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The device has been evaluated for acoustic output, biocompatibility effectiveness as well as thermal, electrical, electromagnetic and mechanical safety and has been been found to conform to applicable medical device safety standards.
Summary of Clinical Tests: Not applicable. The subject of this submission, HS40, 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
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular text element and a symbolic graphic. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion. The graphic features a stylized representation of three human profiles, one behind the other, suggesting a sense of community and support.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 8, 2017
Samsung Medison Co., Ltd. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street NW BUFFALO MN 55313
Re: K172129
Trade/Device Name: HS40 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: July 12, 2017 Received: July 14, 2017
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.
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.
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 of medical device
1
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/ResourcesforYou/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,
Michael D. O'Hara For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K172129
Device Name
HS40 Diagnostic Ultrasound System
Indications for Use (Describe)
The HS40 diagnostic ultrasound system and probes were designed for obtaining ultrasound images and analyzing bodv fluid.
The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic. 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) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) No.:
Device Name: HS40 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) | N | N | N | Note 15 | Note 1 | Note 2, 7, 8, 9, 11 | ||
| Abdominal (See Note 10) | N | N | N | Note 15 | Note 1 | Note 2, 7, 8, 9, 11 | ||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | N | N | N | Note 15 | Note 1 | Note 2, 7, 8, 9, 11 | ||
| Small Organ (See Note 5) | N | N | N | Note 15 | Note 1 | Note 2, 7, 9, 11, 12 | ||
| Neonatal Cephalic | N | N | N | Note 15 | Note 1 | Note 8, 9, 11 | ||
| Adult Cephalic | N | N | N | N | Note 15 | Note 1 | Note 7 | |
| Trans-rectal | N | N | N | Note 15 | Note 1 | Note 2, 7, 8, 9, 12 | ||
| Trans-vaginal | N | N | N | Note 15 | Note 1 | Note 2, 7, 8, 9, 12 | ||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | N | N | N | Note 15 | Note 1 | Note 2, 7, 8, 9, 11, 12 | ||
| Musculo-skel. (Superfic.) | N | N | N | Note 15 | Note 1 | Note 2, 7, 9, 11 | ||
| Intra-luminal | ||||||||
| Other (See Note 13) | N | N | N | Note 15 | Note 1 | Note 2, 7, 9, 12 | ||
| Cardiac Adult | N | N | N | N | Note 15 | Note 1 | Note 4, 7, 14, 16 | |
| Cardiac | Cardiac Pediatric | N | N | N | N | Note 15 | Note 1 | Note 4, 7, 14, 16 |
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | N | N | N | N | Note 15 | Note 1 | Note 2, 7, 8, 9, 11 |
| Other (spec.) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note 1: B+M, B+PW, B+CV, B+C, B+PD, B+Elastoscan, B+C+PW, B+DPD+PW, B+DPD+PW, B+C+M, B+C+CW, B+PPJ, B+TD, B+PPI+PW, Dual/Quad (B, B+C, B+PD, B+TD, B+DPD)
Note 2: Includes imaging for guidance of biopsy
Note 3: 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
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
- Note 8: 3D imaging
- Note 9: MultiVision (Spatial Compound Imaging)
- Note 10: Includes Renal, Gynecology/Pelvis
- Note 11: Panoramic imaging
- Note 12: ElastoScan
- Note 13: Includes Urology/Prostate
- Note 14: Tissue Doppler Imaging (TDI)
- Note 15: Color Doppler includes Power (Amplitude) Doppler
- Note 16: Contrast
4
510(k) No.:
Device Name: LA3-16AD for use with HS40
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 10) | N | N | N | Note 15 | Note 1 | Note 2, 7, 9, 11 | ||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | N | N | N | Note 15 | Note 1 | Note 2, 7, 9, 11 | ||
| Small Organ (See Note 5) | P | P | P | Note 15 | Note 1 | Note 2, 7, 9, 11, 12 | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | P | P | P | Note 15 | Note 1 | Note 2, 7, 9, 11, 12 | ||
| Musculo-skel. (Superfic.) | P | P | P | Note 15 | Note 1 | Note 2, 7, 9, 11 | ||
| Intra-luminal | ||||||||
| Other (See Note 13) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | P | P | Note 15 | Note 1 | Note 2, 5, 7, 9, 11 | |
| Other (spec.) |
N= new indication; P= previously cleared by FDA K153408; E= added under Appendix E
Additional Comments:
Note 1: B+M, B+PW, B+CV, B+C, B+PD, B+Elastoscan, B+C+PW, B+DD+PW, B+DPD+PW, B+C+M, B+C+CW, B+PPJ, B+TD, B+PPI+PW, Dual/Quad (B, B+C, B+PD, B+TD, B+DPD)
Note 2: Includes imaging for guidance of biopsy
Note 3: 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
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: MultiVision (Spatial Compound Imaging)
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
Note 14: Tissue Doppler Imaging (TDI)
Note 15: Color Doppler includes Power (Amplitude) Doppler
5
510(k) No.:
Device Name: CA2-8AD for use with HS40
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 | Note 15 | Note 1 | Note 2, 7, 9, 11 | ||
| Abdominal (See Note 10) | P | P | P | Note 15 | Note 1 | Note 2, 7, 9, 11 | ||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | N | N | N | Note 15 | Note 1 | Note 2, 7, 9, 11 | ||
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | N | N | N | Note 15 | Note 1 | Note 2, 7, 9, 11 | ||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (See Note 13) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | N | N | N | Note 15 | Note 1 | Note 2, 7, 9, 11 | |
| Other (spec.) |
N= new indication; P= previously cleared by FDA K143264; E= added under Appendix E
Additional Comments:
Note 1: B+M, B+PW, B+CV, B+C, B+PD, B+Elastoscan, B+C+PW, B+DD+PW, B+DPD+PW, B+C+M, B+C+CW, B+PPJ, B+TD, B+PPI+PW, Dual/Quad (B, B+C, B+PD, B+TD, B+DPD)
Note 2: Includes imaging for guidance of biopsy
Note 3: 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
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: MultiVision (Spatial Compound Imaging)
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
Note 14: Tissue Doppler Imaging (TDI)
Note 15: Color Doppler includes Power (Amplitude) Doppler
6
510(k) No.:
Device Name: CF4-9 for use with HS40
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 | Note 15 | Note 1 | Note 8, 9, 11 | ||
| Abdominal (See Note 10) | P | P | P | Note 15 | Note 1 | Note 8, 9, 11 | ||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | P | P | P | Note 15 | Note 1 | Note 8, 9, 11 | ||
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | P | P | P | Note 15 | Note 1 | Note 8, 9, 11 | ||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | N | N | N | Note 15 | Note 1 | Note 8, 9, 11 | ||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (See Note 13) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | P | P | Note 15 | Note 1 | Note 8, 9, 11 | |
| Other (spec.) |
N= new indication; P= previously cleared by FDA K133505; E= added under Appendix E
Additional Comments:
Note 1: B+M, B+PW, B+CV, B+C, B+PD, B+Elastoscan, B+C+PW, B+DPD+PW, B+DPD+PW, B+C+M, B+C+CW, B+PPJ, B+TD, B+PPI+PW, Dual/Quad (B, B+C, B+PD, B+TD, B+DPD)
Note 2: Includes imaging for guidance of biopsy
Note 3: 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
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: MultiVision (Spatial Compound Imaging)
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
Note 14: Tissue Doppler Imaging (TDI)
Note 15: Color Doppler includes Power (Amplitude) Doppler
Note 16: Strain+
Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109)
7
510(k) No.:
Device Name: PN2-4 for use with HS40
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 Imaging | ||||||||
| & Other | Fetal/Obstetrics (See Note 3) | |||||||
| Abdominal (See Note 10) | P | P | P | Note 15 | Note 1 | Note 7 | ||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | P | P | P | Note 15 | Note 1 | Note 7 | ||
| Trans-rectal (See Note 13) | ||||||||
| Trans-vaginal (See Note 13) | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (See Note 13) | ||||||||
| Cardiac | Cardiac Adult | P | P | P | Note 15 | Note 1 | Note 4, 7, 14, 16 | |
| Cardiac Pediatric | P | P | P | Note 15 | Note 1 | Note 4, 7, 14, 16 | ||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA K133505; E= added under Appendix E
Additional Comments:
Note 1: B+M, B+PW, B+CV, B+C, B+PD, B+Elastoscan, B+C+PW, B+DPD+PW, B+DPD+PW, B+C+M, B+C+CW, B+PPJ, B+TD, B+PPI+PW, Dual/Quad (B, B+C, B+PD, B+TD, B+DPD)
Note 2: Includes imaging for guidance of biopsy
Note 3: 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 -
Note 6: Abdominal organs and peripheral vessel
-
Note 8: 3D imaging
-
Note 9: MultiVision (Spatial Compound Imaging)
-
Note 10: Includes Renal, Gynecology/Pelvis
-
Note 11: Panoramic imaging
-
Note 12: ElastoScan
-
Note 13: Includes Urology/Prostate
-
Note 14: Tissue Doppler Imaging (TDI)
-
Note 15: Color Doppler includes Power (Amplitude) Doppler
Note 7: Tissue Harmonic Imaging (THI)
8
510(k) No.:
Device Name: EVN4-9 for use with HS40
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 | Note 15 | Note 1 | Note 2, 7, 9 | ||
| Abdominal (See Note 10) | P | P | P | Note 15 | Note 1 | Note 2, 7, 9 | ||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | ||||||||
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | P | P | P | Note 15 | Note 1 | Note 2, 7, 9, 12 | ||
| Trans-vaginal | P | P | P | Note 15 | Note 1 | Note 2, 7, 9, 12 | ||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) (See Note 13) | P | P | P | Note 15 | Note 1 | Note 2, 7, 9, 12 | ||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA K153408; E= added under Appendix E
Additional Comments:
Note 1: B+M, B+PW, B+CV, B+C, B+PD, B+Elastoscan, B+C+PW, B+DPD+PW, B+DPD+PW, B+C+M, B+C+CW, B+PPJ, B+TD, B+PPI+PW, Dual/Quad (B, B+C, B+PD, B+TD, B+DPD)
Note 2: Includes imaging for guidance of biopsy
Note 3: 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 -
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI) -
Note 8: 3D imaging
-
Note 9: MultiVision (Spatial Compound Imaging)
-
Note 10: Includes Renal, Gynecology/Pelvis
-
Note 11: Panoramic imaging
-
Note 12: ElastoScan
-
Note 13: Includes Urology/Prostate
-
Note 14: Tissue Doppler Imaging (TDI)
-
Note 15: Color Doppler includes Power (Amplitude) Doppler
Note 16: Strain+
Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109)
9
510(k) No.:
Device Name: VN4-8 for use with HS40
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 | Note 15 | Note 1 | Note 2, 7, 8, 9, 11 | ||
| Abdominal (See Note 10) | P | P | P | Note 15 | Note 1 | Note 2, 7, 8, 9, 11 | ||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | P | P | P | Note 15 | Note 1 | Note 2, 7, 8, 9, 11 | ||
| 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 13) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by K153408; E= added under Appendix E
Additional Comments:
Note 1: B+M, B+PW, B+CV, B+C, B+PD, B+Elastoscan, B+C+PW, B+DPD+PW, B+DPD+PW, B+C+M, B+C+CW, B+PPJ, B+TD, B+PPI+PW, Dual/Quad (B, B+C, B+PD, B+TD, B+DPD)
Note 2: Includes imaging for guidance of biopsy
Note 3: 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 -
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: MultiVision (Spatial Compound Imaging)
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
Note 14: Tissue Doppler Imaging (TDI)
Note 15: Color Doppler includes Power (Amplitude) Doppler
10
510(k) No.:
Device Name: V5-9 for use with HS40
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 | Note 15 | Note 1 | Note 2, 7, 8, 9 | |||
| Abdominal (See Note 10) | P | P | P | Note 15 | Note 1 | Note 2, 7, 8, 9 | |||
| 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 | Note 15 | Note 1 | Note 2, 7, 8, 9, 12 | |||
| Trans-vaginal | P | P | P | Note 15 | Note 1 | Note 2, 7, 8, 9, 12 | |||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Cardiac) | |||||||||
| Musculo-skel. (Convent.) | |||||||||
| Musculo-skel. (Superfic.) | |||||||||
| Intra-luminal | |||||||||
| Other (See Note 13) | P | P | P | Note 15 | Note 1 | Note 2, 7, 8, 9, 12 | |||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | |||||||||
| Other (spec.) | |||||||||
| Peripheral | Peripheral vessel | ||||||||
| Vessel | Other (spec.) |
N= new indication; P= previously cleared by FDA K153408; E= added under Appendix E
Additional Comments:
Note 1: B+M, B+PW, B+CV, B+C, B+PD, B+Elastoscan, B+C+PW, B+DPD+PW, B+DPD+PW, B+C+M, B+C+CW, B+PPJ, B+TD, B+PPI+PW, Dual/Quad (B, B+C, B+PD, B+TD, B+DPD)
Note 2: Includes imaging for guidance of biopsy
Note 3: 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 -
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI) -
Note 8: 3D imaging
-
Note 9: MultiVision (Spatial Compound Imaging)
-
Note 10: Includes Renal, Gynecology/Pelvis
-
Note 11: Panoramic imaging
-
Note 12: ElastoScan
-
Note 13: Includes Urology/Prostate
-
Note 14: Tissue Doppler Imaging (TDI) Note 15: Color Doppler includes Power (Amplitude) Doppler
11
510(k) No.:
Device Name: DP2B for use with HS40
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 Imaging | ||||||||
| & Other | Fetal/Obstetrics (See Note 3) | |||||||
| Abdominal (See Note 10) | ||||||||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | P | |||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (See Note 13) | ||||||||
| Cardiac | Cardiac Adult | P | ||||||
| Cardiac Pediatric | P | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | ||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA K143264; E= added under Appendix E
Additional Comments:
Note 1: B+M, B+PW, B+CV, B+C, B+PD, B+Elastoscan, B+C+PW, B+DPD+PW, B+DPD+PW, B+C+M, B+C+CW, B+PPJ, B+TD, B+PPI+PW, Dual/Quad (B, B+C, B+PD, B+TD, B+DPD)
Note 2: Includes imaging for guidance of biopsy
Note 3: 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
Note 6: Abdominal organs and peripheral vessel
- Note 7: Tissue Harmonic Imaging (THI)
- Note 8: 3D imaging
- Note 9: MultiVision (Spatial Compound Imaging)
- Note 10: Includes Renal, Gynecology/Pelvis
- Note 11: Panoramic imaging
- Note 12: ElastoScan
- Note 13: Includes Urology/Prostate
- Note 14: Tissue Doppler Imaging (TDI)
- Note 15: Color Doppler includes Power (Amplitude) Doppler
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:
Jiyeon, Cho Regulatory Affairs Specialist
| Telephone: | 82.2.2194.5431 |
|---|---|
| Facsimile: | 82.2.556.3974 |
Data Prepared: Apr 13, 2017
2. Name of the device:
| Common/Usual Name: | ||
|---|---|---|
| Diagnostic Ultrasound System and Accessories | ||
| Proprietary Name: | ||
| HS40 Diagnostic Ultrasound System | ||
| Classification Names: | FR Number | Product Code |
| 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:
- -HS50 / HS60 Diagnostic Ultrasound System (K170493)
13
4. Device Description:
The HS40 is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B mode, M mode, Color M mode, Anatomical mode, Color Doppler mode, Pulsed Wave (PW) Spectral Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, Power Doppler (PD) mode, ElastoScan Mode, 3D/4D/XI STIC imaging mode, Freehand 3D mode, Dual mode, Dual live mode, Quad mode, Combined mode, Simultaneous mode and Zoom mode. The HS40 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 HS40 have real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
5. Intended Uses:
The HS40 diagnostic ultrasound system and probes were designed for obtaining ultrasound images and analyzing body fluid.
The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.
6. Technological Characteristics:
The HS40 are substantially equivalent with respect to safety, effectiveness, and functionality to the HS50 / HS60 (K170493). There is no new functionality that of predicate device of HS40.
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.
| Feature /
| Characteristics | The subject device | The predicate device. |
|---|---|---|
| HS40 | HS50 / HS60 | |
| (K170493) | ||
| Indications for use | ||
| Fetal/Obstetrics | V | V |
| Abdominal | V | V |
| Gynecology | V | V |
| Pediatric | V | V |
| Small Organ | V | V |
| Neonatal Cephalic | V | V |
| Adult Cephalic | V | V |
| Trans-rectal | V | V |
| Trans-vaginal | V | V |
| Musculo-skeletal | ||
| (Conventional) | V | V |
| Musculo-skeletal | ||
| (Superficial) | V | V |
| Urology | V | V |
| Cardiac Adult | V | V |
| Cardiac Pediatric | V | V |
| Peripheral vessel | V | V |
| Scanhead Types | ||
| Linear Array | V | V |
| Curved Linear Array | V | V |
| Feature / | ||
| Characteristics | The subject device | |
| HS40 | The predicate device. | |
| HS50 / HS60 | ||
| (K170493) | ||
| Endocavity | ✓ | ✓ |
| Phased Array | ✓ | ✓ |
| Static Probes | ✓ | ✓ |
| Scanhead Frequency | ||
| 1.0 ~ 20.0 MHz | ✓ | ✓ |
| Modes of Operation | ||
| B-mode | ✓ | ✓ |
| M-mode | ✓ | ✓ |
| Pulsed wave (PW) | ||
| Spectral Doppler | ✓ | ✓ |
| Continuous wave (CW) | ||
| Doppler | ✓ | ✓ |
| Color Doppler | ✓ | ✓ |
| Power Amplitude | ||
| Doppler | ✓ | ✓ |
| Tissue Harmonic | ||
| Imaging | ✓ | ✓ |
| 3D/4D imaging mode | ✓ | ✓ |
| Combined modes | ✓ | ✓ |
| Safety & EMC | ||
| Compliance | ||
| IEC 60601-1 | ||
| UL 60601-1 | ||
| 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) | ✓ | ✓ |
| ClearVision | ✓ | ✓ |
| MultiVision | ✓ | ✓ |
| Needle Mate+ | ✓ | ✓ |
| Auto IMT+ | ✓ | ✓ |
| Strain+ | ✓ | ✓ |
| Elastoscan | ✓ | ✓ |
| Panoramic | ✓ | ✓ |
| 3D Imaging (Volume | ||
| Data Acquisition) | ✓ | ✓ |
| 3D Imaging presentation | ||
| 3D Cine/4D Cine | ✓ | ✓ |
| 3D Rendering MPR | ✓ | ✓ |
| 3D XI | ✓ | ✓ |
| 3D MSV/Oblique View | ✓ | ✓ |
| 3D MXI Volume | ||
| Slice/Mirror View | ✓ | ✓ |
| Volume CT | ✓ | ✓ |
| 3D MagiCut | ✓ | ✓ |
| Volume Calculation | ||
| (VOCAL, | ||
| XI VOCAL) | ✓ | ✓ |
| XI STIC | ✓ | ✓ |
| Realistic Vue | ✓ | ✓ |
| Ez Exam+ | ✓ | ✓ |
| Feature / | ||
| Characteristics | The subject device | The predicate device. |
| HS40 | HS50 / HS60 | |
| (K170493) | ||
| 5D Follicle | V | V |
510(k) Summary / Statement Certification
14
15
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 HS40 and their applications comply with voluntary standards as below:
| Reference No. | Title |
|---|---|
| IEC 60601-1 | AAMI ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and |
| A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General | |
| requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) | |
| IEC 60601-1-2 | AAMI / ANSI / IEC 60601-1-2:2007, Medical electrical equipment - Part 1-2: General |
| requirements for basic safety and essential performance – Collateral standard: | |
| Electromagnetic compatibility - Requirements and tests (Edition 3) | |
| IEC 60601-2-37 | IEC 60601-2-37:2007 Edition 2.0 2007-08, Medical electrical equipment – Part 2-37: |
| Particular requirements for the basic safety and essential performance of ultrasonic | |
| medical diagnostic and monitoring equipment | |
| ISO10993-1 | AAMI / ANSI / ISO 10993-1:2009/(R)2013, Biological evaluation of medical devices |
- Part 1: Evaluation and testing within a risk management process |
| ISO14971 | ISO 14971:2007, Medical devices - Application of risk management to medical
devices |
| NEMA UD 2-2004 | NEMA UD 2-2004 (R2009)
Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
Revision 3 |
| NEMA UD 3-2004 | NEMA UD 3-2004 (R2009)
Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices
on Diagnostic Ultrasound Equipment, Revision 2 |
Summary of Clinical Tests:
Not applicable. The subject of this submission, HS40, did not require 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 HS40 to be as safe, as effective, and performance is substantially equivalent to the predicate devices.