(48 days)
The Galaxy Ultrasound Imaging System is intended for ultrasound examination of intravascular pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures such as angioplasty and atherectomy.
The Galaxy Imaging System applies reflected ultrasound energy through a catheter tip transducer directly into the interior vessel wall of the patient to obtain a two dimension image of the vessel structure that can be used to detect abnormalities or obstructions.
The provided text describes an Intravascular Ultrasound Imaging System (Galaxy Intravascular Ultrasound System) seeking 510(k) clearance. The document focuses on demonstrating substantial equivalence to predicate devices and provides details about non-clinical testing. However, it does not contain the information required to answer the specific questions about acceptance criteria and clinical study results.
Here's what can be inferred and what is missing:
-
A table of acceptance criteria and the reported device performance
- Inferred Acceptance Criteria: The primary acceptance criterion appears to be "substantial equivalence" to predicate devices (BSC Insight III Imaging System and EndoSonics In-Vision™) in intended use, design, and method of operation.
- Reported Device Performance: The document states that the device "is similar in design, function, and application to these ultrasound systems" and "is substantially equivalent" to the predicate devices.
- Missing: Specific quantitative performance metrics (e.g., accuracy, sensitivity, specificity, resolution) that would be typically found in a clinical study report are not provided. The document focuses on declaring equivalence rather than presenting novel performance data against defined thresholds.
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Missing: This information is not present in the provided text. The document refers only to "Bench and acoustic output testing" and "Bench testing, both hardware and software will undergo complete verification and validation testing." There is no mention of a test set with patient data.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Missing: Since no clinical test set is described, there's no mention of experts or their qualifications for establishing ground truth.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Missing: As no clinical test set is described, there's no information about an adjudication method.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Missing: No MRMC study is mentioned. This device is an imaging system, not an AI-assisted diagnostic tool, and the application predates widespread AI in medical imaging.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Missing: This information is not applicable. The device is an imaging system, not an algorithm, and its performance is inherently tied to its function in providing images for human interpretation.
-
The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Missing: No ground truth for clinical performance is mentioned, as no clinical study with a test set is detailed. The "ground truth" for the non-clinical tests would be defined specifications, industry standards, and engineering measurements.
-
The sample size for the training set
- Missing: This is not applicable as the device is not an AI/machine learning algorithm requiring a "training set."
-
How the ground truth for the training set was established
- Missing: This is not applicable as the device is not an AI/machine learning algorithm requiring a "training set."
Summary of Study (Based on Provided Text):
The submission for the Galaxy Intravascular Ultrasound System relies on non-clinical testing to demonstrate safety and effectiveness, specifically comparing it to legally marketed predicate devices.
- Non-Clinical Tests:
- Bench Testing: Both hardware and software were to undergo complete verification and validation testing.
- Acoustic Output Testing: Measurements and calculations were to be performed per the "Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment (UD-2, Revision 1, December 7, 1993)." The document notes a deviation from a later 1997 FDA guidance document regarding the NEMA standard, clarifying that the 1993 version was used due to the unavailability of the 1997 standard at the time of submission.
- Study Design: This appears to be a "Special 510(k)" submission, which typically involves demonstrating substantial equivalence through modifications to an already cleared device, often relying on non-clinical data and comparisons to predicate devices rather than new clinical trials with patient populations. The FDA's clearance letter requests a "postclearance special report" with "acoustic output measurements based on production line devices," indicating that validation would occur as part of manufacturing, not a clinical trial.
In conclusion, the document describes a regulatory submission based on substantial equivalence and non-clinical engineering and bench testing, not a clinical study with acceptance criteria related to diagnostic performance outcomes on patient data.
{0}------------------------------------------------
APR 22 1998
510(k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMD 1990 and 21 CFR 807.92.
The assigned 510(k) number is:
Applicant Information:
| Date Prepared: | March 3, 1998 |
|---|---|
| Name: | Boston Scientific Corporation - San Jose2710 Orchard ParkwaySan Jose, CA 95134 |
Donna K. Templeman Contact Persons: Dennis L. Wong Manager, Regulatory Affairs Regulatory Affairs Associate
Telephone numbers: (408) 895-3526 or (408) 895-3607
Fax number: (408) 895-2202
Device Information:
| Classification: | Class II | |
|---|---|---|
| Trade Name: | Galaxy Intravascular Ultrasound System | |
| Common Name: | Intravascular Ultrasound Imaging System | |
| Product Code: | FR Number | Product Code |
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | 90-IYN |
| Ultrasonic Pulsed Echo Imaging System | 892.1560 | 90-IYO |
Equivalent Devices:
The Galaxy Imaging System is substantially equivalent in intended use, design and / or method of operation to a combination of the following predicate devices:
-
- BSC (formerly CVIS) Insight III Imaging System (K921750) with
-
- EndoSonics In-Vision™ (Clearance number: Not available)
Special 510(k)
Galaxy Intravascular Ultrasound Imaging System
{1}------------------------------------------------
Intended Use:
The Galaxy Ultrasound Imaging System is intended for ultrasound examination of intravascular pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures such as angioplasty and atherectomy.
Comparison To Predicate Devices:
The Galaxy Imaging System applies reflected ultrasound energy through a catheter tip transducer directly into the interior vessel wall of the patient to obtain a two dimension image of the vessel structure that can be used to detect abnormalities or obstructions. There are other ultrasound systems presently on the market with these intravascular imaging capabilities. The subject BSC Galaxy Imaging System is similar in design, function, and application to these ultrasound systems.
The Galaxy Imaging System is substantially equivalent in intended use, design and operation characteristics to the following devices: (1) BSC (formerly CVIS) Insight III Imaging System (K921750) (with Automatic Pullback Device (K933517) and LongView (K930311)), and (2) EndoSonics In-Vision™ (Clearance number: Not available). All predicate devices are used for ultrasound imaging of intravascular pathology in vessel anatomy.
{2}------------------------------------------------
Non-Clinical Tests:
Bench and acoustic output testing will be tested to demonstrate that the BSC Galaxy Intravascular Ultrasound Imaging System is safe and effective, while meeting the anticipated clinical requirements for its intended use.
Bench Testina:
Bench testing, both hardware and software will undergo complete verification and validation testing.
Acoustic Output Testing:
The BSC Galaxy Intravascular Ultrasound Imaging System will be measured and calculated per the Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment (UD-2, Revision 1, December 7, 1993), not 1997, as referenced in the FDA guidance Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers of September 30, 1997. This is a possible deviation of the acoustic output measurement methodology at Boston Scientific from the NEMA guidance documents referred to in the FDA's guidance document.
Rationale for Deviation
The FDA guidance document Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers of September 30, 1997 refers to the Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment (NEMA 1997), and specifically to its Section 3.3.2. However, it is our understanding that no 1997 standard has been published yet, and the most recent version of the NEMA standard that we have been able to obtain is the Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment (UD-2, Revision 1. December 7. 1993). The section 3.2.2 of this document does not reflect the wording of the 1997 FDA document and its reference to the 1997 NEMA standard regarding the low end of the frequency response of the hydrophone system (i.e., f./20). Also, the 1997 FDA quidance document states the following: "non-membrane (e.g., needle-type) hydrophones are acceptable for uses not directly affecting reporting or labeling, such as in quality control measurements" which is not reflected in the wording of the Section 3.2.2 in the Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment (UD-2, Revision 1, December 7, 1993).
Summary:
There are other ultrasound systems presently on the market with intravascular imaging capabilities. The subject BSC Galaxy Imaging System is similar in design, function, and application to these ultrasound systems and is substantially equivalent to these currently marketed predicate devices.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird in flight, composed of three curved lines that suggest movement and dynamism. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the bird image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 2 1998
Donna Templeman Boston Scientific Corporation 2710 Orchard Parkway San Jose, CA 95134
Re: K980851 Galaxy Intravascular Ultrasound Imaging System Dated: March 4, 1998 Received: March 5, 1998 Regulatory class: II 21 CFR 892.1560/Procode: 90 IYO
Dear Ms. Templeman:
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 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. You may, therefore, market the device, subject to the general controls The general controls provisions of the Act include provisions Act (Act). requirements for registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the Galaxy Intravascular Ultrasound Imaging System, as described in your premarket notification:
Transducer Model Number
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.
{4}------------------------------------------------
Page 2 - Donna Templeman
This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G,
(enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
This letter will allow you to begin marketing your device as described in your premarket 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 (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 Paul Gammell, Ph.D. at (301) 594-1212.
Sincerely yours,
L. Elinard C. Heymann
llian 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
Enclosure
{5}------------------------------------------------
510(k) Number (if known):
Galaxy Intravascular Ultrasound Imaging System Device Name:
Indication For Use:
The Galaxy Intravascular Ultrasound Imaging System is intended for ultrasound examination of intravascular pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures such as angioplasty and atherectomy.
K 980851
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Thiel A. Segrom
(Division Sign-Off)
Division of Reproductive, Abdominal, B and Radiological Devi 510(k) Number
Prescription Use
(Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
March 4, 1998
0:91
BSC - San Jose
{6}------------------------------------------------
K 980851
Special 510(k)
Galaxy Intravascular Ultrasound Imaging System
Diagnostic Ultrasound Indications for Use Form For Galaxy System Imaging Console
Fill out one form for each ultrasound system and each transducer.
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 | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | N | |||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:_
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
March 4, 1998
{7}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form For Sonicath Ultra 9F/9MHz
Fill out one form for each ultrasound system and each transducer.
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 | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | E | |||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:_________________
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows a sequence of handwritten characters, which appear to be a combination of letters and numbers. The sequence reads 'K980851'. The characters are written in a simple, slightly irregular style, giving them a casual, handwritten appearance. The contrast between the characters and the background is clear, making the sequence easily readable.
Diagnostic Ultrasound Indications for Use Form For Discovery 2.6F/40MHz
Fill out one form for each ultrasound system and each transducer.
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 | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | E | |||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: _________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
{9}------------------------------------------------
Special 510(k) Galaxy Intravascular Ultrasound Imaging System
Diagnostic Ultrasound Indications for Use Form For Discovery 2.6F/30MHz
Fill out one form for each ultrasound system and each transducer.
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 | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | E | |||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: _________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
March 40199
યું ક
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image shows the text "K980851" in a handwritten style. Below this, the text "Special 510(k)" is printed in a smaller, more formal font. The text "Galaxy Intravascular Ultrasound Imaging System" is printed below the "Special 510(k)" text.
Diagnostic Ultrasound Indications for Use Form For Sonicath Ultra 3.2F/20MHz
Fill out one form for each ultrasound system and each transducer.
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 | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ﺍ | |||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | P | |||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:___
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
{11}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form For Sonicath Ultra 6F/20MHz
Fill out one form for each ultrasound system and each transducer.
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 | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | E | |||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:_
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Qra
Image /page/11/Picture/11 description: The image shows the text "March 4, 1998" on the top line and "0197" on the second line. The text is black and the background is white. The text is slightly blurry.
{12}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form For Sonicath Ultra 6F/12.5MHz
Fill out one form for each ultrasound system and each transducer.
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 | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) | |
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | E | ||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:________________
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
J
March 409989 8
{13}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form For UltraCross 2.9F/30MHz
Fill out one form for each ultrasound system and each transducer.
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 | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | E | |||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:__________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
March 4,
{14}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form For UltraCross 3.2F/30MHz
Fill out one form for each ultrasound system and each transducer.
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 | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) | |
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | E | ||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Image /page/14/Picture/10 description: The image shows a signature in black ink on a white background. The signature appears to be stylized and cursive, with the letters 'JW' or a similar combination of characters visible. The strokes are bold and fluid, suggesting a quick and confident hand movement. The signature is positioned centrally in the image.
§ 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.