(185 days)
NeoVision Sonopsy System, Siemens SONOLINE Prima Digital Ultrasound System
Not Found
No
The summary describes a standard ultrasound imaging system with automatic scanning and needle guidance features. There is no mention of AI, ML, or advanced image processing techniques that would suggest the use of such technologies. The description focuses on the hardware and basic imaging modes.
No.
The document indicates that the device is a "diagnostic ultrasound imaging system" used for imaging and guidance during procedures, not for treatment.
Yes
The intended use explicitly states, "The intended use of the Sonopsy LA System is as a diagnostic ultrasound imaging system of the human body." It further specifies use for "diagnostic ultrasound B-mode imaging of small organs (breast, thyroid, testes) and the abdomen." The "Device Description" also mentions its role in imaging to "determine the position of a suspect target," which is a diagnostic function.
No
The device description explicitly mentions and relies on hardware components such as an "automatic scanning annular array transducer" and a "hand-held linear array scanhead" for image acquisition. It is a system that includes both hardware and software.
Based on the provided information, the Sonopsy LA System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body. This includes things like blood, urine, tissue samples, etc.
- The Sonopsy LA System is an ultrasound imaging system. It uses sound waves to create images of internal organs and structures within the human body. It does not analyze samples taken from the body.
The intended use and device description clearly state that it is a diagnostic ultrasound imaging system for visualizing the human body and guiding procedures in vivo (within the living body).
N/A
Intended Use / Indications for Use
The intended use of the Sonopsy LA System is as a diagnostic ultrasound imaging system of the human body as follows:
Mode of Operation: B-Mode
Clinical Application:
Small Organ (breast, thyroid, testes) Abdominal
The Sonopsy LA System is indicated for use as an adjunct to mammography for B-mode ultrasonic imaging of a patient's breast when used with an automatic scanning annular array transducer. Automatic scanning obtains multiple, sequential two-dimensional images which can be compiled into a three-dimensional data set for viewing in three planes. The system is intended to be used for the real-time ultrasonic guidance of needle aspiration and biopsy procedures of breast lesions.
The Sonopsy LA System is indicated for use for the diagnostic ultrasound B-mode imaging of small organs (breast, thyroid, testes) and the abdomen when used with the hand-held linear array scanhead.
Prescription Use (Per 21 CFR 801.109)
Product codes (comma separated list FDA assigned to the subject device)
90-IYO, 90-ITX
Device Description
The Sonopsy LA System provides a means for performing a volumetric scan of the breast to image and determine the position of a suspect target. For biopsy procedures, the Sonopsy LA System allows the alignment of an integral needle guidance device that insures that the needle will sample along a line that includes the determined target. The real-time ultrasound image is aligned such that the scan plane corresponds to the plane that the needle will penetrate, which enables the user to make a determination that the needle penetrated to the target area (by virtue of the real-time image).
... The system operates in B-mode with an automatic scanning annular array • transducer for breast applications and a hand-held linear array scanhead for small organ and abdominal imaging.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
B-Mode Ultrasound
Anatomical Site
breast, thyroid, testes, abdomen, small organ
Indicated Patient Age Range
Not Found
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.
NeoVision Sonopsy System, Siemens SONOLINE Prima Digital Ultrasound System
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
§ 892.1560 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
SECTION 3
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
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 807, Subpart E, Section 807.7.
1. Classification Name
Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560 Product Code: 90-IYO #
Diagnostic Ultrasonic Transducer, 21 CFR 892.1570 Product Code: 90-ITX
Common/ Usual Name
Diagnostic Ultrasound System with Accessories
Proprietary Name
Sonopsy LA System
Establishment Information 2.
The Sonopsy LA System was designed and developed by NeoVision, a Division . of United States Surgical Corporation, of 1700 Westlake Avenue North, Seattle, WA 98109. The FDA has assigned Neo Vision an establishment registration number of 3029061.
-
- Class
Class II, Tier 2.
NeoVision believes that the Sonopsy LA System is substantially equivalent to the following products FDA has classified as Class II devices:
- Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560 .
- Diagnostic Ultrasonic Transducer, 21 CFR 892.1570
1
4. Performance Standards
None established under Section 514. However, the Sonopsy LA System has been designed to comply with the following voluntary performance standards:
- Medical Electrical Equipment, Part 1: General Requirement UL-2601 . for Safety
- Electromedical Devices. National Deviations CSA C22.2 . No. 125-601.1
- Safety of Medical Equipment, Type B, Class 1 IEC 601-1-1 .
న్. Special Controls
The Sonopsy LA System is subject to the 510(k) Special Report requirement that applies to all diagnostic ultrasound systems.
6. Device Description
The Sonopsy LA System provides a means for performing a volumetric scan of the breast to image and determine the position of a suspect target. For biopsy procedures, the Sonopsy LA System allows the alignment of an integral needle guidance device that insures that the needle will sample along a line that includes the determined target. The real-time ultrasound image is aligned such that the scan plane corresponds to the plane that the needle will penetrate, which enables the user to make a determination that the needle penetrated to the target area (by virtue of the real-time image).
- ... The system operates in B-mode with an automatic scanning annular array • transducer for breast applications and a hand-held linear array scanhead for small organ and abdominal imaging.
7. General Safety and Effectiveness
The device labeling contains instructions for use to assure the safe and effective use of the device. The device is a prescription device and the labeling indicates the device must be used by or on the order of a physician. Testing of patient contact materials in accordance with the FDA memorandum Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" indicates that none of the patient or user contact materials pose a biocompatibility risk.
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8. Acoustic Output
The Sonopsy LA System is a Track 1 device with application specific maximum limits as follows:
94 mW/cm2 ISPTA.3 and 190 W/cm-ISPPA.3 Or Mechanical Index (MI) 1.9
The acoustic output will be measured and calculated per the December, 1985, 510(k) Guide for Measuring and Reporting Acoustic Output of Diagnostic Ultrasound Medical Devices, except that the hydrophone will meet the requirements of the Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment (NEMA, UD 2, revision 2). Measurement results will be maintained in the Device Master Record for this device and maximum output values will also be reported in the Operator's Manual.
Substantial equivalence for output reporting will follow the TRACK 1 path per FDA's Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, dated September 30, 1997.
9. Predicate Device
Neo Vision believes that the Sonopsy LA System, with the features described in this notification and when used in combination with the transducers included in
- ﮯ this notification, is substantially equivalent to the NeoVision Sonopsy System and
. the Siemens SONOLINE Prima Digital Ultrasound System.
10. Software
Software development for the Sonopsy LA System follows NeoVision's documented process for software design, verification and validation testing. A hazards analysis has been conducted to identify potential equipment design hazards that could cause a diagnostic error or injury to the patient, user, or service personnel and appropriate steps have been taken to control all identified risks for this type of ultrasound equipment.
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11. Conclusions
Neo Vision's Sonopsy LA System diagnostic ultrasound device and transducers are designed and manufactured to meet United States and international diagnostic ultrasound and electromedical equipment safety standards. The system and its transducers have essentially the same intended uses and technological characteristics and are substantially equivalent to previously 510(k)-cleared diagnostic ultrasound systems.
12. Submitted by
Jamie Yieh Regulatory Affairs, Associate
Contact Person
Victor M. Clavelli Manager, Regulatory Affairs
United States Surgical Corporation 150 Glover Avenue Norwalk, Connecticut 06856
(203) 845-4543 - Phone (203) 845-4503 - Fax
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Image /page/4/Picture/1 description: The image shows the text "Public Health Service". The text is in a simple, sans-serif font and is horizontally aligned. The words are stacked on a single line.
Image /page/4/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
AUG - 7 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Victor M. Clavelli Program Manager, Requlatory Affairs United States Surgical Corporation 150 Glover Avenue Norwalk, Connecticut 06856
K980423 Re : Sonopsy™ LA System Regulatory Class: II/21 CFR 892.1560 Product Code: 90 IYO Dated: July 1, 1998 Received: July 2, 1998
Dear Mr. Clavelli:
We have reviewed your Section 510(k) 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 Sonospy LA System, as described in your premarket notification:
Transducer Model Number
7.5 MHz Annular Array 7.5/5.0 MHz Linear Array
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register.
Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Victor M. Clavelli
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 ric bpoint ropor chouse issuely marked "ADD-TO-FILE" and should be submitted in duplicate to:
Food and Drug Administration Center for Devices and Radioloqical 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 leqally 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 and additionally 809.10 for in vitro diagnostic devices), 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 Other general information on your responsibilities under the Act may 807.97). be obtained from the Division of Small Manufacturers Assistance at its tollfree 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,
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
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4.3 INDICATIONS FOR USE
The intended use of the Sonopsy LA System is as a diagnostic ultrasound imaging system of the human body as follows:
Mode of Operation: B-Mode
Clinical Application:
Small Organ (breast, thyroid, testes) Abdominal
The Sonopsy LA System is indicated for use as an adjunct to mammography for B-mode ultrasonic imaging of a patient's breast when used with an automatic scanning annular array transducer. Automatic scanning obtains multiple, sequential two-dimensional images which can be compiled into a three-dimensional data set for viewing in three planes. The system is intended to be used for the real-time ultrasonic guidance of needle aspiration and biopsy procedures of breast lesions.
The Sonopsy LA System is indicated for use for the diagnostic ultrasound B-mode imaging of small organs (breast, thyroid, testes) and the abdomen when used with the hand-held linear array scanhead.
Prescription Use (Per 21 CFR 801.109)
Wilcauth
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
7
Diagnostic Ultrasound Indications for Use Form
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Device: | Sonopsy LA System | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Mode of Operation | |||||||||||
| Clinical application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) | |
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | N | ||||||||||
| Intraoperative | |||||||||||
| (Specify) | |||||||||||
| Intra-operative | |||||||||||
| Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ | |||||||||||
| (Specify) | P | ||||||||||
| N | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral | |||||||||||
| Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-sketetal | |||||||||||
| Conventional | |||||||||||
| Musculo-sketetal | |||||||||||
| Superficial | |||||||||||
| Other (Specify) | P |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Additional comments: Small organ: P = breast (K951999); N = thyroid, testes
Other: P = real-time biopsy guidance for breast lesions (K951999)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
CONCURRENCE of CDRH, Office of Device Eyaluation (ODE)
I, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number_K 9804 23 Rg. 2
Indications for Use REVISED
Prescription Use (Per 21 CFR 801.109)
8
Diagnostic Ultrasound Indications for Use Form
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical | ||||||||||
| application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Other | |||||||||
| (Specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| (Specify) | ||||||||||
| Intra-operative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| (Specify) | P | |||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral | ||||||||||
| Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-sketetal | ||||||||||
| Conventional | ||||||||||
| Musculo-sketetal | ||||||||||
| Superficial | ||||||||||
| Other (Specify) | P |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Additional comments: Small organ: P = breast (K951999)
Other: P = real-time biopsy guidance for breast lesions (K951999)
7.5 MHz Annular Array_________________________________________________________________________________________________________________________________________________________ Device: ______________________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
1
CONCURRENCE of CDRH, Office of Device Exa
W. Maul
Prescription Use (Per 21 CFR 801.109)
Division of Reproductive, Abdominal. ENT. and Radiological D
510(k) Number
Indications for Use REVISED
9
Diagnostic Ultrasound Indications for Use Form
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) | |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | N | ||||||||||
| Intraoperative (Specify) | |||||||||||
| Intra-operative Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (Specify) | N | ||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-sketetal Conventional | |||||||||||
| Musculo-sketetal Superficial | |||||||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Device:_______________________________________________________________________________________________________________________________________________________________________
មក Additional comments: Small Organ: N = breast, thyroid, testes
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
CONCURRENCE of CDRH, Office of Device Rivaluation ((
Prescription Use (Per 21 CFR 801.109)
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, ENT, | |
| and Radiological Devices | |
| 510(k) Number | K980423 |
Pg. 4Indications for Use REVISED