(11 days)
K935595/S1
No
The document describes a standard diagnostic ultrasound system and does not mention AI, ML, or related technologies in the device description, intended use, or any other section.
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 to "generate on-screen display of anatomic structures and fluid flow within the body," for "clinical diagnosis purposes." There is no mention of treating or preventing a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system "provides information that is used for clinical diagnosis purposes." Additionally, the "Device Description" section refers to the Sequoia as a "diagnostic ultrasound system."
No
The device description explicitly states it is a "diagnostic ultrasound system" and describes the acquisition and processing of ultrasound echo data, which inherently involves hardware components (transducers, processing units, etc.) beyond just software.
Based on the provided information, the Sequoia system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body. The description of the Sequoia system clearly states that it transmits ultrasonic energy into patients and receives echoes from within the body to generate images. This is an in vivo process, not in vitro.
- The intended use and device description focus on imaging and visualization of internal anatomical structures and physiological processes within the patient. This is the core function of a diagnostic ultrasound system, which is not an IVD.
The information provided describes a standard diagnostic ultrasound system used for imaging various parts of the body.
N/A
Intended Use / Indications for Use
The Sequoia system is intended for 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, Transvaginal, Peripheral Vessel, and Musculoskeletal (Superficial and Conventional) applications.
The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
The AcuNay diagnostic ultrasound catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, and visualization of other devices in the heart - for use in the right heart only.
Product codes (comma separated list FDA assigned to the subject device)
90-IYN, 90-IYO, 90-ITX, 90-DQO
Device Description
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 (PW) Doppler mode, Continuous (CW) wave Doppler mode, color Doppler mode, Power Amplitude Doppler mode, a combination of these modes, Harmonic Imaging, or 3D imaging, on a CRT display.
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, Transvaginal, Peripheral Vessel, Musculoskeletal (Superficial and Conventional), intra-cardiac, intra-luminal, great vessel
Indicated Patient Age Range
Fetal, Pediatrics, Neonatal/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.
K935595/S1
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.
K973767, K992580, K992631, K002807, K991805, K002470
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).
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.
§ 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
Acuson Corporation
510(k) SUMMARY
Sequoia Diagnostic Ultrasound System Signature II
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.
Submitted By: 1.
Acuson Corporation 1220 Charleston Road PO Box 7393 Mt. View, California 94039-7393
Contact Person Mr. Jerrv W. Tsutsumi Regulatory Affairs Department Phone: (650) 943-7286 (650) 961-6168 Fax:
Date Prepared
26 June 2002
2. Proprietary Name:
Sequoia Diagnostic Ultrasound System Signature II
Common/ Usual Name:
Diagnostic Ultrasound System with Accessories
Classification Name:
| 21 CFR 892.1550 | ||
|---|---|---|
| Ultrasonic Pulsed Doppler Imaging System | FR# 892.1550 | Product Code 90-IYN |
| Ultrasonic Pulsed Echo Imaging System | FR# 892.1560 | Product Code 90-IYO |
| Diagnostic Ultrasound Transducer | FR# 892.1570 | Product Code 90-ITX |
| Diagnostic Intravascular Catheter | FR# 870.1200 | Product Code 90-DQO |
Predicate Device: 3.
K935595/S1 (3/2/1995) cleared as Model 3001 system, marketed as the Sequoia diagnostic ultrasound system with subsequent modifications.
4. Device Description:
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 (PW) Doppler mode, Continuous (CW) wave Doppler mode, color Doppler mode, Power Amplitude Doppler mode, a combination of these modes, Harmonic Imaging, or 3D imaging, on a CRT display.
The Sequoia system has been designed to meet the following product safety standards:
- I UL 2601-1, Safety Requirements for Medical Equipment
- CSA C22.2 No. 601-1. Safety Requirements for Medical Equipment I
- . AIUM/NEMA UD-2. 1998. Acoustic Output Measurement Standard for Diagnostic Ultrasound
- 에 AIUM/NEMA UD-3, 1998, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- 93/42/EEC Medical Devices Directive
- l Safety and EMC Requirements for Medical Equipment
- EN 60601-1
1
- l EN 60601-1-1
- I EN 60601-1-2
- IEC 1157 Declaration of Acoustic Power l
- ISO 10993 Biocompatibility 트
5. Intended Uses:
The Sequoia system is intended for 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, Transvaginal, Peripheral Vessel, and Musculoskeletal (Superficial and Conventional) applications.
The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
The AcuNay diagnostic ultrasound catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, and visualization of other devices in the heart - for use in the right heart only.
Technological Comparison to Predicate Device: 6.
The Sequoia is substantially equivalent to Model 3001, K935595/S1/S1, and to products that are already cleared for USA distribution with the following 510(k) premarket notification numbers K973767, K992580, K992631, K002807, K991805, and K002470. 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 systems allow for specialized measurements of structures and flow, and calculations.
End of 510(k) Summary
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle or bird with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 3 2002
Acuson Corporation % Mr. Mark Job Program Manager TÜV Product Service 1775 Old Highway 8 NW, Suite 104 NEW BRIGHTON MN 55112-1891
Re: K022567
Trade Name: Sequoia® Diagnostic Ultrasound System Signature II 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: 90 IYN, IYO, and ITX Dated: August 1, 2002 Received: August 2, 2002
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, labeline, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the Sequoia® Diagnostic Ultrasound System Signature II, as described in your premarket notification:
Transducer Model Number
4C1 5C2
3
| Page 2 | Mr. Job | |
|---|---|---|
| 6C2 |
|---|
| 8C4 |
| EC10c5 |
| EV8C4 |
| 6L3 |
| AcuNav (IC10V5) |
| 8L5 |
| 8L5T |
| 13L5SP |
| 15L8 |
| 15L8w |
| V5M TEE |
| V7M TEE |
| V7B TEE |
| Sirius |
| 3V2c |
| 4V1 |
| 4V2 |
| 5V2c |
| 7V3c |
| 8V5 |
| 10V4 |
| AUX CW |
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.
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 (OS) 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 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.
4
Page 3 - Mr. Job
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 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 contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours.
David G. Lyron
in
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
5
Acuson Corporation
Sequoia Diagnostic Ultrasound System Signature II the state of the state of the states and 510(k) Submission
Page 1 of 1
510(k) Number (if known): KO YO S67
Sequoia Diagnostic Ultrasound System Signature II Device Name:
Indications for Use:
The Sequoia system is intended for 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 and pediatric), Trans-esophageal, Transvaginal, Peripheral Vessel, and Musculo-skeletal (Superficial and Conventional) applications.
The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
The AcuNav diagnostic ultrasound catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, and visualization of other devices in the heart - for use in the right heart only.
(PLEASE 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)
or
Over-the-Counter-Use (Optional Format 1-2-96)
David A. Pearson
(Division Sign-Off) Division of Reproductive, Abo and Radiological Device 510(k) Numbe