(9 days)
Not Found
No
The document describes a standard ultrasound system with various imaging modes and post-processing capabilities, but there is no mention of AI, ML, or related terms. The predicate devices are also from a time period where AI/ML in medical imaging was less common.
No
The device is described as a "diagnostic ultrasound system" and its function is to "acquire primary or secondary harmonic ultrasound echo data and display it," and is used for "clinical diagnosis purposes." There is no mention of treating or preventing disease.
Yes
The "Device Description" explicitly states, "The Sequoia is a general purpose, mobile, software-controlled, diagnostic ultrasound system." Additionally, the "Intended Use / Indications for Use" section mentions "analysis packages that provide information that is used for clinical diagnosis purposes."
No
The device description explicitly states it is a "diagnostic ultrasound system," which inherently includes hardware components (transducer, processing unit, display, etc.) to acquire and display 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:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is a "diagnostic ultrasound system." Ultrasound imaging is a non-invasive technique that uses sound waves to create images of internal body structures. It does not involve testing samples taken from the body.
- Intended Use: The intended use describes imaging and fluid flow analysis of the human body, not analysis of samples from the human body.
- Device Description: The description focuses on the technical aspects of generating and displaying ultrasound images.
Therefore, this device falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Sequoia platform is intended for use in the following applications:
General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breast, testes, thyroid, penis and prostate), Neonatal/Adult Cephalic, Cardiac (adult, pediatric, and neonatal), Trans-esophageal, Transrectal, Transvaginal, Peripheral Vessel, and Musculo-sceletal (superficial and conventional) applications, and intended uses as defined in the FDA guidance document.
The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
Ultrasound imaging or fluid flow analysis of the human body
Product codes (comma separated list FDA assigned to the subject device)
90-IYN, 90-IYO, 90-ITX
Device Description
The Sequoia with Real Time 3D Imaging is substantially equivalent to the predicates listed herein. The Sequoia is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PWD) Doppler Mode, Continuous (CWD) Doppler Mode, Color Doppler Mode, Power (Amplitude) Doppler Mode, a combination of these modes, Harmonic Imaging, 3D imaging, or Clarify VE imaging, and Real Time 3D Imaging.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breast, testes, thyroid, penis and prostate), Neonatal/Adult Cephalic, Cardiac (adult, pediatric, and neonatal), Trans-esophageal, Transrectal, Transvaginal, Peripheral Vessel, Musculo-sceletal (superficial and conventional), Ophthalmic, Transurethral, Intravascular, Laparoscopic
Indicated Patient Age Range
Neonatal, Pediatric, Adult
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): 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.
Not Found
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
Siemens Medical Solutions USA, Inc. Ultrasound Division
ACUSON® Sequoia Diagnostic Ultrasound System 510(k) Submission
510(k) Summary of Safety and Effectiveness
Sequoia Diagnostic Ultrasound System
MAY 1 3 2005
This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with the Safe Medical Device Act of 1990 revisions to 21 CFR, Part 807.92, Content and Format of a 510(k) Summary.
1. Submitted By:
Siemens Medical Solutions USA, Inc., Ultrasound Division 1230 Shorebird Way P.O. Box 7393 Mountain View, California 94039-7393
Contact Person:
Iskra Mraković Manager, Regulatory Affairs Telephone:(650) 694-5004 (650) 943-7053 Fax:
Date Prepared:
April 18, 2005
2. Proprietary Name:
Sequoia Diagnostic Ultrasound System
Common Name:
Diagnostic Ultrasound System with Accessories
Classification Name:
21 CFR 892.1550
| FR # | Product Code | |
|---|---|---|
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | 90-IYN |
| Ultrasonic Pulsed Echo Imaging System | 892.1560 | 90-IYO |
| Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX |
| Diagnostic Intravascular Catheter | 870.1200 | 74-DQO |
3. Predicate Devices:
-
K041319 (June 7, 2004), cleared as Sequoia Diagnostic Ultrasound . System.
- #K022303 (July 30, 2002), cleared as Philips M2424 Diagnostic Ultrasound . System with 21315 ultrasound transducer.
1
- #K041552 (July 2, 2004), cleared as GE Vivid 7Diagnostic Ultrasound System . with EchoPAC BT04.
4. Device Description:
The Sequoia with Real Time 3D Imaging is substantially equivalent to the predicates listed herein. The Sequoia is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PWD) Doppler Mode, Continuous (CWD) Doppler Mode, Color Doppler Mode, Power (Amplitude) Doppler Mode, a combination of these modes, Harmonic Imaging, 3D imaging, or Clarify VE imaging, and Real Time 3D Imaging.
The Sequoia Diagnostic Ultrasound System has been designed to conform to the following product safety standards:
- UL 60601-1, Medical Electrical Equipment, Part 1: General Requirements for . Safety
- CSA C22.2 No. 60601-1, Safety Requirements for Medical Equipment ●
- NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound .
- NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical . Acoustic Output Indices on Diagnostic Ultrasound Equipment
- 93/42/EEC Medical Device Directive .
- . Safety and EMC Requirements for Medical Equipment
- . EN 60601-1
- EN 60601-1-1 .
- . EN 60601-1-2
- ISO 10993 Biocompatibility .
- The system's acoustic output is in accordance with ALARA principle (as low as . reasonably achievable)
5. Intended Uses:
The Sequoia platform is intended for use in the following applications:
General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breast, testes, thyroid, penis and prostate), Neonatal/Adult Cephalic, Cardiac (adult, pediatric, and neonatal), Trans-esophageal, Transrectal, Transvaginal, Peripheral Vessel, and Musculo-sceletal (superficial and conventional) applications, and intended uses as defined in the FDA guidance document.
The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
2
6. Technological Comparison to Predicate Devices:
The Sequoia is substantially equivalent in its technologies and functionality to the Sequoia Diagnostic Ultrasound System that is already cleared under 510(k) premarket notification number K041319, Philips's M2424 Diagnostic Ultrasound System with 21315 ultrasound transducer (#K022303), and GE's Vivid 7Diagnostic Ultrasound System with EchoPAC BT04 (#K041552).
The Sequoia functions in the same manner as other diagnostic ultrasound systems, in that they transmit ultrasonic energy into the body via a transducer. In the body, acoustic impedance of different tissues reflect different amounts of ultrasound energy back to the transducer, where post processing of received echoes is performed to generate two-dimensional or three-dimensional on-screen images of anatomic structures and fluid flow within the body. Doppler principles are used to process reflected ultrasound energy to display moving blood as a spectrum, or as color-coded two-dimensional images. All predicate devices listed above, allow for specialized measurements of structures and flow, and provide various calculations' functions.
End of 510(k) Summary.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. 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.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Siemens Medical Solutions, USA, Inc. c/o Mr. Mark Job Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 53313
MAY 1 3 2005
Re: K051139
Trade Name: ACUSON Sequoia Diagnostic Ultrasound System Regulation Number: 21 CFR §892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Product Code: IYN Regulation Number: 21 CFR §892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Product Code: IYO Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Product Code: ITX Regulatory Class: II Dated: May 2, 2005 Received: May 4, 2005
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(x) pro(x) promantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in indications for use stated in the enotesting to the enactment date of the Medical Device interstate commerce prior to May 20, 1978, the entine with the provisions of the davice, subject to Amendments, or to devices mat have book for therefore, market the device, subject to
Federal Food, Drug, and Cosmetic Act (Act). You may, therefore of the Act include Federal Food, Drug, and Cosmetic Act. The general controls provisions of the Act include the general controls provisions of the Fre." The general some of the practice, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for l his determination of Substannal equivated appears as a common as described in your premarket notification:
Transducer Model Number
Apollo
4
Page 2 - Mr. Mark Job
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (soc aberty) als. Existing major regulations affecting your device can may be subject to such additional controller Linkstageman - - - - - - - - - - - - - - - - - - - - - 800 to 898. In addition, FDA may be found in the Outs announcements concerning your device in the Federal Register. publish lurtuel announcements concerning your two in in equivalence determination does not mean Please oe advised that I Dri 3 issuance or a sevice complies with other requirements of the Act that TDA has made a decormination administered by other Federal agencies. You must of ally if edital statutes and regulations and limited to: registration and listing (21 comply with an the Act 3 requirements, november ing practice requirements as set CFK Fart 607), labeling (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
This determination of substantial equivalence is granted on the condition that prior to shipping I this determination of Substantial equiralers in this 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" In Appellulx U, (chelosca) of the Semse of Diagnostic Ultrasound Systems and Transducers." If the special Seeking Marketing Clearantee of Diagnobile values (e.g., acoustic output greater than approved report is incomplete of commis anacoopulars (1) and (1) (1) = )
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 The special report should rolers. 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 mis letter will anow you to begin manuting your device to a legally marketed noutication. The FD7F inating of vacementary 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 If you desire specific advice for your act (240) 276-0120. Also, please mote the regulation entitled, and Colliact the Office of Compulline in (21CFR Part 807.97). You may obtain " Misbranding by relevelec to premance notificanted in the Act from the Division of Small other general Informational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Ocess http://www.fda.gov/cdrh/industry/support/index.html
5
Page 3 - Mr. Mark Job
If you have any questions regarding the content of this letter, please contact Mr. Rodrigo C. Perez, at (301)594-1212.
Sincerely yours,
Nancy C. Bugdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
6
Diagnostic Ultrasound Indications for Use Form
510(k) Number (if known):
Device Name:
Apollo
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify)* | Other:
Harmonic
Imaging | Other:
3D | Other:
Real
Time
3D | |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|------------------------|-------------------------------|--------------|------------------------------|---|
| Ophthalmic | | | | | | | | | N* | N | | N | |
| Fetal | | N | N | N | N | N | N | | N* | N | | N | |
| Abdominal | | N | N | N | N | N | N | | N* | N | | N | |
| Intraoperative
Abdominal | | N | N | N | N | N | N | | N* | N | | N | |
| Intraoperative
Neurological | | | | | | | | | | N* | N | | N |
| Pediatric | | N | N | N | N | N | N | | N* | N | | N | |
| Small Organ (specify) ** | | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | N* | N | | N | |
| Cardiac | | N | N | N | N | N | | | | N* | N | | N |
| Trans-esophageal | | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | | |
| Transurethral | | | | | | | | | N* | N | | N | |
| Peripheral Vessel | | N | N | N | N | N | N | | | N* | N | | N |
| Laparoscopic | | | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | | | N | |
| Other (specify) *** | | N | N | N | N | N | N | | | N* | N | | N |
N=new indication.
Additional Comments:
Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+Color Doppler, B+CWD) Power Dogpler, *Combinations include: B+W, B+CWD, B+CWD, B+CwD, D+Colder D+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE
**small organs (breast, testes, thyroid, penis, prostate) ***neonatal cardiac
(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Danaye Broadin
(Division Sign-Off
Division of Reprov
dominal,
and Radiological
510(k) Numbe......... K051139
7
Diagnostic Ultrasound Indications for Use Form
510(k) Number (if known):
Device Name:
Sequoia Diagnostic Ultrasound System
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other:
Harmonic
Imaging | Other:
3D | Other:
Real
Time
3D |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|--------------|------------------------------|
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | P* | P | P | N |
| Abdominal | | P | P | P | P | P | P | | P* | P | P | N |
| Intraoperative
Abdominal | | P | P | P | P | P | P | | P* | P | P | N |
| Intraoperative
Neurological | | P | P | P | P | P | P | | P* | P | P | |
| Pediatric | | P | P | P | P | P | P | | P* | P | P | N |
| Small Organ
(specify)** | | P | P | P | P | P | P | | P* | P | P | |
| Neonatal Cephalic | | P | P | P | P | P | P | | P* | P | P | |
| Adult Cephalic | | P | P | P | P | P | P | | P* | P | P | |
| Cardiac | | P | P | P | P | P | P | | P* | P | P | N |
| Trans-esophageal | | P | P | P | P | P | P | | P* | P | P | |
| Transrectal | | P | P | P | P | P | P | | P* | P | P | |
| Transvaginal | | P | P | P | P | P | P | | P* | P | P | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vessel | | P | P | P | P | P | P | | P* | P | P | N |
| Laparoscopic | | | | | | | | | | | P | |
| Musculo-skeletal
Conventional | | P | P | P | P | P | P | | P* | P | P | |
| Musculo-skeletal
Superficial | | P | P | P | P | P | P | | P* | P | P | |
| Other (specify) *** | | P | P | P | P | P | P | | P* | P | P | N |
One (specif)
P-previously cleared by the FDA under K041319, K032114, K022567, K002807, K992580, K9973767 and K935595/S1. N=new indication.
Additional Comments:
*Combinations include: B+M, B+PWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE
** small organs (breast, testes, thyroid, penis) ***neonatal cardiac
(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Nancy C. Brogdon
(Division Sign-Off)
Division of Reprodu and Radiologica: 510(k) Number _