(19 days)
The iLab™ Ultrasound Imaging System is intended for ultrasound examinations of intravascular pathology. Intravascular ultrasound is indicated in patients who are candidates for transluminal interventional procedures such as angioplasty and atherectomy.
The iLab™ Ultrasound Imaging System is designed for real-time viewing of intravascular anatomies and is intended to be a basic diagnostic tool for imaging and evaluation of patients who are candidates for transluminal procedures. The iLab™ System consists of two compact PC units (one for Image Processing and one for Data Acquisition), up to two displays (one primary and an optional secondary). The iLab System imaging and processing PC are used during an intravascular procedure, at the end of the IVUS procedure, the processing PC supports the archiving of the images obtained during the procedure. The iLab System processing PC converts the native iLab images into DICOM format images prior to archiving to removal media such as a CD, DVD or removable hard disk cartridge. Images can also be archived to a DICOM network server. The iLab™ System is available in two configurations: a Cart-based Configuration and an Installed Configuration.
The document provided is a 510(k) Summary for the Boston Scientific iLab™ Ultrasound Imaging System. It describes the device, its intended use, and comparison to a predicate device. The document details various non-clinical testing performed, including software and hardware verification and validation efforts. However, it does not contain any information about clinical studies with human participants, expert review of data, or establishment of ground truth in the way typically expected for AI/ML device evaluations.
The testing described is primarily focused on engineering verification and validation of the system's components and software against predefined requirements, rather than a performance study involving a test set with established ground truth.
Therefore, many of the requested elements for acceptance criteria and study details cannot be extracted from this document, as they are not relevant to the type of submission provided.
Here's a breakdown of what can be inferred or explicitly stated based on the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from testing types) | Reported Device Performance |
|---|---|
| Non-clinical electrical safety met performance requirements | Met or exceeded performance requirements |
| Non-clinical acoustic output safety met performance requirements | Met or exceeded performance requirements |
| Integrated Installation Configuration Option EMC compliance | No new external testing for EMC was required |
| Software risk mitigations effective | FMEA determined risk mitigations effective |
| Software unit and system level acceptance criteria met | All requirements in Software Requirements Specifications verified |
| Hardware risk mitigations effective | FMEA determined risk mitigations effective |
| Video interface requirements for external monitors defined, verified, and validated | Supported specified imaging medical device vendors |
| Customer acceptance of image quality with external monitors | On-site validation in progress at time of submission |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable. The document describes software verification and validation, and hardware testing, not a clinical performance study with a "test set" in the context of patient data.
- Data Provenance: Not applicable for a clinical test set. The verification and validation involved "multiple configurations of PC systems" and "production equivalent" systems. On-site validation was planned for "3 or more customer sites."
3. 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)
- Number of Experts: Not applicable. No clinical expert review process is described for establishing ground truth for a test set.
- Qualifications of Experts: Not applicable. The "software validation effort will be performed by testers with iLab clinical experience," but these are testers for engineering validation, not clinical experts establishing ground truth for a performance study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. No clinical test set or adjudication process is described.
5. 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
- MRMC Study: No. This document describes a traditional 510(k) for an ultrasound imaging system update, not an AI/ML device requiring an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is an ultrasound imaging system, not an algorithm-only device. The testing focuses on the system's functional integrity.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not applicable. The "ground truth" in this context refers to the system meeting its engineering specifications and requirements, as outlined in "Software Requirements Specifications" and "Product and Marketing requirements." No clinical "ground truth" (e.g., pathology, outcomes) for diagnostic accuracy is mentioned.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This is not an AI/ML device that requires a training set in that context.
9. How the ground truth for the training set was established
- Training Set Ground Truth: Not applicable.
{0}------------------------------------------------
K072517
SEP 26 2007
510(k) Summary of Safety and Effectiveness
Boston Scientific Corporation
iLab™ Ultrasound Imaging System
Boston Scientific Corporation Submitted By 49700 Bayside Parkway Fremont, CA 94538
Christine Dunbar Contact Person Principal Regulatory Affairs Specialist Tel: (510) 624-2461 Fax: (510) 624-2569 christine.dunbar@bsci.com
September 06, 2007 Date Prepared
Proprietary Name iLab™ Ultrasound Imaging System
Common Name(s) Ultrasound Diagnostic Imaging System Ultrasonic Pulsed Doppler Imaging System (90IYN) Ultrasonic Pulsed Echo Imaging System (90IYO)
Classification 21 CFR Part 892.1550 (90IYN) Name(s) Ultrasonic Pulsed Doppler Imaging System 21 CFR Part 892.1560 (90IYO)
Ultrasonic Pulsed Echo Imaging System
{1}------------------------------------------------
Prodicate Device The iLab™ Ultrasound Imaging System with software version 1,3 Update and the Integrated Installation Configuration Option is substantially equivalent to the following device:
| Product | 510(k) | Clearance Date |
|---|---|---|
| iLab™ Intravascular UltrasoundSystem | K051579 | July 14, 2005 |
Description of the Device
The iLab™ Ultrasound Imaging System is dcsigned for real-time viewing of intravascular anatomies and is intended to be a basic diagnostic tool for imaging and evaluation of patients who are candidates for transluminal procedures.
The iLab™ System consists of two compact PC units (one for Image Processing and one for Data Acquisition), up to two displays (one primary and an optional secondary). The il ab System imaging and processing PC are used during an intravascular procedure, at the end of the IVUS procedure, the processing PC supports the archiving of the images obtained during the procedure. The iLab System processing PC converts the native iLab images into DICOM format images prior to archiving to removal media such as a CD, DVD or removable hard disk cartridge. Images can also be archived to a DICOM network server.
The iLab™ System is available in two configurations: a Cart-based Configuration and an Installed Configuration. There is no functional or electrical difference between the Cart-Based and Installed Configurations; differences are limited to cable lengths and the location of the modules of the system. The main market features of the iLab System are as follows:
Cart System
The Cart based system contains the complete iLab System in a portable, compact cart. The Cart System supports one LCD monitor.
{2}------------------------------------------------
Installed System
Multiple monitor mounting options for installation into the Hospital's catheter lab procedure room
Tableside Controller
Provides sterile field control of IVUS measurements and playback of IVUS runs
Touch Panel
Intuitive user interface and simplified display
Upgradeable
The iLab system allows for future innovation and technological advancement
The proposed new Integrated Installation Configuration Options supports an additional installed version configuration to enable the use of a customer's existing catherization lab monitor as the second monitor.
Intended Use / Indications for Use
The iLab™ Ultrasound Imaging System is intended for ultrasound examinations of intravascular pathology. Intravascular ultrasound is indicated in patients who are candidates for transluminal interventional procedures such as angioplasty and atherectomy.
Device Technology Characteristics and Comparison to Predicate Device
The iLab™ System applies ultrasound energy through a transducer enclosed within a catheter. This ultrasound energy is directed from the catheter in the lumen of a vessel into the interior vessel wall of the patient in order to obtain a two-dimensional image of the vessel anatomy. The two-dimensional image, reconstructed from the reflected RF Ultrasound echo, can be used to evaluate the morphology of the vessel and as such potentially detect abnormalities or obstructions. Each of the technological characteristics found in the iLab™ System 1.3 Update are identical or similar to those of the predicate device, iLab Intravascular Imaging System,
{3}------------------------------------------------
Non-Clinical Testing
Bench electrical safety and acoustic output safety testing demonstrated that thecurrently marketed iLab™ System, and its accessories met or exceeded performance requirements and is safe and effective for its intended use.
The Integrated Installation Configuration Option was evaluated by an outside testing agency for the iLab System and it was determined that no new external testing for EMC was required.
All software risk mitigations determined by the FMEA have been verified to be effective and demonstrate that the iLab 1.3 Update meets all product and marketing requirements.
Software Verification Testing
Software unit and system level verification testing demonstrate that the 1.3 Update meets the acceptance criteria as noted in the iLab System Software Unit and System Test Plans, All requirements in the Software Requirements Specifications have been verified by the system level testing.
The iLab System 1.3 Update has been fully verified in accordance with applicable FDA guidance documents. This testing includes software verification testing performed on multiple configurations of PC systems. The results demonstrate that iLab System 1.3 Update satisfies all Product and Marketing requirements for its intended purpose as a safe and effective update to the predicate iLab System.
Software Validation Testing
The iLab System 1.3 Update validation effort will be performed by testers with iLab clinical experience on PC systems that are production equivalent and meet the minimum system requirements. The validation results summary report in progress at the time of this submission. All plans, test results and summary reports will be retained in the Design History File for the iLab System 1.3 Update project.
Confidential
{4}------------------------------------------------
Hardware Verification Testing
The iLab Integrated Installation Configuration Option contains minimal hardware necessary to send the video signal to the customer's LCD Monitor. The video interface requirements have been defined, verified and validated to support specified imaging medical device vendors. An additional on-site validation on 3 or more customer sites who utilize Angiography systems from these vendors will ensure that the video interface is robust. The use of industry standard Information Technology Equipment (ITE) certified video converters (also called multimodality switches), cabling and monitors provides a broad based video interface for ease in interconnectivity.
All hardware risk mitigations determined by the FMEA have been verified to be effective and demonstrate that the iLab Integrated Installation Configuration Option meets all product and marketing requirements.
On-Site Validation Testing
The on-site validation for the video connections is intended to ensure customer acceptance of the image quality with the current iLab imaging system when using external video monitors that meet the video interface requirements. The on-site validation effort is in progress at the time of this submission.
All plans, test results and summary reports will be retained in the Design History File for the iLab System Integrated Installation Configuration Option project.
Conclusion
The iLab™ Ultrasound Imaging System with the 1.3 Update and the Integrated Installation Configuration Option, contains the same fundamental technology, has similar technical
{5}------------------------------------------------
characteristics (i.e. GUI and software functions) and has the same intended use as the predicate device, the iLab™ Ultrasound Imaging System.
Based on the non-clinical and design verification tests results, the subject device has been shown to be substantially equivalent to the currently marketed device and effective for its intended use..
{6}------------------------------------------------
Image /page/6/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem consisting of three abstract shapes resembling birds in flight, arranged in a stacked formation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Christine Dunbar Principal Regulatory Affairs Specialist Boston Scientific Corporation 47900 Bayside Parkway FREMONT CA 94538
SEP 2 6 2007
Re: K072517
Trade/Device Name: iLab™ Ultrasound Imaging System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, ITX and IYO Dated: September 6, 2006 Received: September 7, 2007
Dear Ms. Dunbar:
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, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the iLab™ Ultrasound Imaging System, as described in your premarket notification:
Transducer Model Number
Sonicath® Ultra™, 6F 20 MHz Sonicath® Ultra™, 9F 9 MHz Sonicath® Ultra™ 6F 12.5 MHz Sonicath® Ultra™, 3.2F 20 MHz Ultra ICE, 9F 9 MHz Atlanits SR, 3.2F 40 MHz
Atlantis® PV, 8F 15 MHz Atlantis® SR Pro, 3.2F 40 MHz Atlantis® ICE, 9F 9 MHz Atlantis® SR Pro2, 3.2F 40 MHz iSight, 2.4F 40 MHz
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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.
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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html
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Page 3 – Ms. Dunbar
If you have any questions regarding the content of this letter, please contact Lauren Hefner at (240) 276-3666.
Sincerely yours,
Herbert Semmer for
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
:
Enclosure(s)
: .
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Indications for Use Statement
510(k) Number:
iLab™ Ultrasound Imaging System Device Name:
The iLab™ Ultrasound Imaging System is intended for ultrasound Indications for Use: examinations of intravascular pathology. Intravascular ultrasound is indicated in patients who are candidates for transluminal interventional procedures such as angioplasty and atherectomy.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
Page 1 of
Hateen
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
Confidential
0877
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Hoflemn
(Division Sign-Off) Division of Reproductive, Abdominal and Diagnostic Indications for Use Form Radiological Devices for the 111795 510(k) Number ________________________________________________________________________________________________________________________________________________________________ iLab™ Ultrasound Imaging System
Intended Use: Diagnostic ultrasound imaging of 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 | ||||||||||||
| Intraoperative (specify) | ||||||||||||
| Intraoperative Neurological | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ (specify) | ||||||||||||
| 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: Cleared July 14, 2005, K051679
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Confidential
{11}------------------------------------------------
Table 5-2: Track 1 Summary Table for the iLab™ Ultrasound Imaging System
| ClinicalApplication | A | B | M | PWD | CWD | CD | Combined(specify) | Other †(specify) |
|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||
| Fetal Imaging& Other* | X | |||||||
| Cardiac, Adult& Pediatric | ||||||||
| PeripheralVessel |
*Abdominal, Intraoperative, Pediatric, Small Organ (breast, thyroid, testes, etc.), Neonatal Cephalic, Adult Cephalic, Musculo-skeletal (conventional), Musculo-skeletal (superficial)
1 Examples may include: Amplitude Doppler, 3-D Imaging, Tissue Motion Doppler, Color Velocity Imaging
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices K072517 510(k) Number _
Confidential
{12}------------------------------------------------
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
Diagnostic Indications for Use Form for the Sonicath® Ultra™, 6F 20 MHz
Intended Use: Diagnostic ultrasound imaging of fluid flow analysis of the human body as follows:
| ClinicalApplication | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative(specify) | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ(specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | P | |||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Other (specify) |
N = New indication; P = Previously cleared by FDA; E = Added under Appendix E
Additional Comments: Cleared under K890772, May 10, 1989 and K060947 (cleared April 19, 2006)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
{13}------------------------------------------------
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices
| 510(k) Number | K072517 |
|---|---|
| --------------- | --------- |
Table 5-2: Track 1 Summary Table for the Sonicath® UltraTM, 6F 20 MHz
| Clinical Application | A | B | M | PWD | CWD | CD | Combined (specify) | Other † (specify) |
|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||
| Fetal Imaging & Other* | X | |||||||
| Cardiac, Adult & Pediatric |
Peripheral Vessel
*Abdominal, Intraoperative, Pediatric, Small Organ (breast, thyroid, testes, etc.), Neonatal Cephalic, Adult Cephalic, Musculo-skeletal (conventional), Musculo-skeletal (superficial)
1 Examples may include: Amplitude Doppler, 3-D Imaging, Tissue Motion Doppler, Color Velocity Imaging 100 million and the controlled to the control controlled of the comments of the comments of the comments of the comments of the comments of the comments of the comments of th
{14}------------------------------------------------
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number __
Diagnostic Indications for Use Form for the Sonicath® Ultra™, 9F 9 MHz
Intended Use: Diagnostic ultrasound imaging of fluid flow analysis of the human body as follows:
| ClinicalApplication | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Color VelocityImaging | Combined(specify) | Other(specify) |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative(specify) | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ(specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | E | |||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Other (specify) |
N = New indication; P = Previously cleared by FDA; E = Added under Appendix E Additional Comments: Released to market February 28, 1996 via Letter-To-File against K902245 (cleared October 9, 1996).
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Confidential
{15}------------------------------------------------
Division Sign Off
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices Table 5-2: Track 1 Summary Table 510(k) Number ______________________________________________________________________________________________________________________________________________________________ for the Sonicath® Ultra™, 9F 9 MHz
| ClinicalApplication | A | B | M | PWD | CWD | CD | Combined(specify) | Other †(specify) |
|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||
| Fetal Imaging& Other* | X | |||||||
| Cardiac, Adult& Pediatric | ||||||||
| PeripheralVessel |
*Abdominal, Intraoperative, Pediatric, Small Organ (breast, thyroid, testes, etc.), Neonatal Cephalic, Adult Cephalic, Musculo-skeletal (conventional), Musculo-skeletal (superficial)
1 Examples may include: Amplitude Doppler, 3-D Imaging, Tissue Motion Doppler, Color Velocity Imaging
{16}------------------------------------------------
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number __
Diagnostic Indications for Use Form for the Sonicath® Ultra™, 6F 12.5 MHz
Intended Use: Diagnostic ultrasound imaging of fluid flow analysis of the human body as follows:
| ClinicalApplication | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative(specify) | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ(specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | E | |||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Other (specify) |
N = New indication; P = Previously cleared by FDA; E = Added under Appendix E Additional Comments: Released to market February 28, 1997 via Letter-To-File against K902245 (Cleared October 9, 1996).
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
{17}------------------------------------------------
(Division Sign-Off)
Division of Reproductive, Abdominal and
| Radiological Devices | |
|---|---|
| 510(k) Number | K072517 |
Table 5-2: Track 1 Summary Table
for the
Sonicath
®
Ultra
TM
, 6F 12.5 MHz
| Clinical Application | A | B | M | PWD | CWD | CD | Combined (specify) | Other † (specify) |
|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||
| Fetal Imaging & Other* | X |
Abdominal, Intraoperative, Pediatric, Small Organ (breast, thyroid, testes, etc.), Neonatal Cephalic, Adult
1 Examples may include: Amplitude Doppler, 3-D Imaging, Tissue Motion Doppler, Color
Cephalic, Musculo-skeletal (conventional), Musculo-skeletal (superficial)
Cardiac, Adult & Pediatric
Velocity Imaging
Peripheral Vessel
Boston Scientific Corporation Special 510(k) iLab™ Ultrasound Imaging System, 1.3 Update and Integrated Installation Option
{18}------------------------------------------------
H.D. Lewis
(Division Division of Reproductive, Abdominal and Radiological Devices Diagnostic Indications for Use Form 510(k) Number ________________________________________________________________________________________________________________________________________________________________ for the Sonicath® Ultra™, 3.2F 20 MHz
Intended Use: Diagnostic ultrasound imaging of fluid flow analysis of the human body as follows:
| ClinicalApplication | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Color VelocityImaging | Combined(specify) | Other(specify) |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative(specify) | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ(specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | P | |||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Other (specify) |
N = New indication; P = Previously cleared by FDA; E = Added under Appendix E
Additional Comments: Cleared under K970049, June 20, 1997.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
{19}------------------------------------------------
Het lemu
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K072517
Table 5-2: Track 1 Summary Table
for the
Sonicath® Ultra
TM, 3.2F 20 MHz
| Clinical Application | A | B | M | PWD | CWD | CD | Combined (specify) | Other † (specify) |
|---|---|---|---|---|---|---|---|---|
| Ophthalmic | — | — | — | — | — | — | — | — |
| Fetal Imaging & Other* | — | X | — | — | — | — | — | — |
| Cardiac, Adult & Pediatric | — | — | — | — | — | — | — | — |
| Peripheral Vessel | — | — | — | — | — | — | — | — |
Abdominal, Intraoperative, Pediatric, Small Organ (breast, thyroid, testes, etc.), Neonatal Cephalic, Adult Cephalic, Musculo-skeletal (conventional), Musculo-skeletal (superficial)
† Examples may include: Amplitude Doppler, 3-D Imaging, Tissue Motion Doppler, Color Velocity Imaging
{20}------------------------------------------------
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _
Diagnostic Indications for Use Form for the Ultra ICE, 9F 9 MHz
Intended Use: Diagnostic ultrasound imaging of fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Color VelocityImaging | Combined(specify) | Other(specify) | |
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify | |||||||||||
| IntraoperativeNeurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | E | ||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletalSuperficial | |||||||||||
| Other (specify) |
N = New indication; P = Previously cleared by FDA; E = Added under Appendix E
Additional Comments: Released to market December 10, 1997 via Letter-To-File against K902245 (Cleared October 9, 1996).
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Boston Scientific Corporation Special 510(k) iLab™ Ultrasound Imaging System, 1.3 Update and Integrated Installation Option
{21}------------------------------------------------
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices
| 510(k) Number | K072317 |
|---|---|
| --------------- | --------- |
Table 5-2: Track 1 Summary Table for the Ultra ICE, 9F 9 MHz
| Clinical Application | A | B | M | PWD | CWD | CD | Combined (specify) | Other † (specify) |
|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||
| Fetal Imaging & Other* | X | |||||||
| Cardiac, Adult & Pediatric | ||||||||
| Peripheral Vessel |
Abdominal, Intraoperative, Pediatric, Small Organ (breast, thyroid, testes, etc.), Neonatal Cephalic, Adult Cephalic, Musculo-skeletal (conventional), Musculo-skeletal (superficial)
1 Examples may include: Amplitude Doppler, 3-D Imaging, Tissue Motion Doppler, Color Velocity Imaging______________________________________________________________________________________________________________________________________________________________
{22}------------------------------------------------
(Division Sign-U)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K072517 Diagnostic Indications for Use Form
for the
Atlantis® SR, 3.2F 40 MHz
Intended Use: Diagnostic ultrasound imaging of fluid flow analysis of the human body as follows:
| ClinicalApplication | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative(specify) | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ(specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | P | |||||||||
| PeripheralVascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Other (specify) |
N = New indication; P = Previously cleared by FDA; E = Added under Appendix E Additional Comments: Cleared under K000743, September 7, 2000.
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Confidential
{23}------------------------------------------------
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
| 510(k) Number | 2072517 |
|---|---|
| --------------- | --------- |
Table 5-2: Track 1 Summary Table
for the
Atlantis® SR, 3.2F 40 MHz
| Clinical Application | A | B | M | PWD | CWD | CD | Combined (specify) | Other (specify) | |
|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | |||||||||
| Fetal Imaging & Other* | X | ||||||||
| Cardiac, Adult & Pediatric | |||||||||
| Peripheral Vessel |
Abdominal, Intraoperative, Pediatric, Small Organ (breast, thyroid, testes, etc.), Neonatal Cephalic, Adult Cephalic, Musculo-skeletal (conventional), Musculo-skeletal (superficial)
† Examples may include: Amplitude Doppler, 3-D Imaging, Tissue Motion Doppler, Color Velocity Imaging ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
{24}------------------------------------------------
(Division Sign-Off)
Division of Reproductive, Abdominal and Diagnostic Indications for Use Form Radiological Devices for the 510(k) Number Atlantis® PV, 8F 15 MIz
Intended Use: Diagnostic ultrasound imaging of 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 | ||||||||||
| Intraoperative(specify) | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ(specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | P | |||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Other (specify) |
N = New indication; P = Previously cleared by FDA; E = Added under Appendix E
Additional Comments: Cleared under K022860, November 21, 2002 and K041727 ( cleared July 23, 2004) and K050684 (cleared May 20, 2005)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
{25}------------------------------------------------
HubRemm
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices Table 5-2: Track 1 Summary Table 510(k) Number for the Atlantis® PV, 8F 15 MHz
| ClinicalApplication | A | B | M | PWD | CWD | CD | Combined(specify) | Other†(specify) |
|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||
| Fetal Imaging& Other* | X | |||||||
| Cardiac, Adult& Pediatric | ||||||||
| PeripheralVessel |
Abdominal, Intraoperative, Pediatric, Small Organ (breast, thyroid, testes, etc.), Neonatal Cephalic, Adult Cephalic, Musculo-skeletal (conventional), Musculo-skeletal (superficial)
1 Examples may include: Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, Color Velocity Imaging
{26}------------------------------------------------
Hulbum
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number -
Diagnostic Indications for Use Form for the Atlantis® SR Pro, 3.2F 40 MHz
Intended Use: Diagnostic ultrasound imaging of fluid flow analysis of the human body as follows:
| ClinicalApplication | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative(specify) | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ(specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | E | |||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Other (specify) | ||||||||||
| N = New indication; P = Previously cleared by FDA; E = Added under Appendix E |
Additional Comments: Released to market February 14, 2003 via Letter-To-File against K000743 (Cleared September 7, 2000) and K010707 (Cleared March 28, 2001) and K063312 (cleared November 30, 2006)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
{27}------------------------------------------------
Hesleem
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
Table 5-2: Track 1 Summary Table for the Atlantis® SR Pro, 3.2F 40 MHz
| Clinical Application | A | B | M | PWD | CWD | CD | Combined (specify) | Other † (specify) |
|---|---|---|---|---|---|---|---|---|
| Ophthalmic | — | — | — | — | — | — | — | — |
| Fetal Imaging & Other* | — | X | — | — | — | — | — | — |
| Cardiac, Adult & Pediatric | — | — | — | — | — | — | — | — |
| Peripheral Vessel | — | — | — | — | — | — | — | — |
Abdominal, Intraoperative, Pediatric, Small Organ (breast, thyroid, testes, etc.), Neonatal Cephalic, Adult Cephalic, Musculo-skeletal (conventional), Musculo-skeletal (superficial)
† Examples may include: Amplitude Doppler, 3-D Imaging, Tissue Motion Doppler, Color Velocity Imaging
{28}------------------------------------------------
Hew Keun
ision Sign-Off
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices Diagnostic Indications for Use Form 510(k) Number
for the Atlantis® ICE, 9F 9 MHz
Intended Use: Diagnostic ultrasound imaging of fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Color VelocityImaging | Combined(specify) | Other(specify) | |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | E | |||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Other (specify) |
N = New indication; P = Previously cleared by FDA; E = Added under Appendix E
Additional Comments: Released to market August 8, 2003 via Letter-To-File against K902245 (Cleared October 9,1996).
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
{29}------------------------------------------------
Hew Lewn
(Division Sign-Off) Division of Reproductive, Abdominal and Table 5-2: Track 1 Summary Table Radiological Devices for the 510(k) Number _ Atlantis® ICE, 9F 9 MHz
Combined Other Clinical Application B M PWD CWD CD (specify) (specify) A Ophthalmic X Fetal Imaging & Other* Cardiac, Adult & Pediatric Peripheral Vessel
Abdominal, Intraoperative, Pediatric, Small Organ (breast, thyroid, testes, etc.), Neonatal Cephalic, Adult Cephalic, Musculo-skeletal (conventional), Musculo-skeletal (superficial)
† Examples may include: Amplitude Doppler, 3-D Imaging, Tissue Motion Doppler, Color Velocity Imaging
{30}------------------------------------------------
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K072517 Diagnostic Indications for Use Form
for the
Atlantis® SR Pro2, 3.2F 40 MHz
Intended Use: Diagnostic ultrasound imaging of fluid flow analysis of the human body as follows:
| ClinicalApplication | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Color VelocityImaging | Combined(specify) | Other(specify) |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative(specify | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ(specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | P | |||||||||
| PeripheralVascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Other (specify) |
N = New indication; P = Previously cleared by FDA; E = Added under Appendix E
Additional Comments: Cleared under K050577, March 30, 2005 and K063312 (cleared November 30, 2006)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
{31}------------------------------------------------
(Divisioh Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
| 510(k) Number | K072517 |
|---|---|
| --------------- | --------- |
Table 5-2: Track 1 Summary Table
for the
Atlantis® SR Pro², 3.2F 40 MHz
| Clinical Application | A | B | M | PWD | CWD | CD | Combined (specify) | Other † (specify) |
|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||
| Fetal Imaging & Other* | X | |||||||
| Cardiac, Adult & Pediatric | ||||||||
| Peripheral Vessel |
Abdominal, Intraoperative, Pediatric, Small Organ (breast, thyroid, testes, etc.), Neonatal Cephalic, Adult Cephalic, Musculo-skeletal (conventional), Musculo-skeletal (superficial)
1 Examples may include: Amplitude Doppler, 3-D Imaging, Tissue Motion Doppler, Color Velocity Imaging
{32}------------------------------------------------
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
Diagnostic Indications for Use Form for the iSight, 2.4F 40 MHz
Intended Use: Diagnostic ultrasound imaging of fluid flow analysis of the human body as follows:
| ClinicalApplication | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(specify) |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative(specify) | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ(specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | P | |||||||||
| PeripheralVascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Other (specify) | ||||||||||
| N = New indication; P = Previously cleared by FDA; E = Added under Appendix E | ||||||||||
| Additional Comments: Cleared under K060175, March 24, 2006. |
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
{33}------------------------------------------------
Hestlewer
(Division Sign-Off) Division of Reproductive, Abdominal and Table 5-2: Track 1 Summary Table Radiological Devices for the 510(k) Number __ Atlantis® SR Pro2, 3.2F 40 MHz
| Clinical Application | |
|---|---|
| A | |
| B | |
| M | |
| PWD | |
| CWD | |
| CD | |
| Combined (specify) | |
| Other † (specify) | |
| Ophthalmic | |
| Fetal Imaging & Other* | X |
| Cardiac, Adult & Pediatric | |
| Peripheral Vessel |
Abdominal, Intraoperative, Pediatric, Small Organ (breast, thyroid, testes, etc.), Neonatal Cephalic, Adult Cephalic, Musculo-skeletal (conventional), Musculo-skeletal (superficial)
1 Examples may include: Amplitude Doppler, 3-D Imaging, Tissue Motion Doppler, Color Velocity Imaging
Page
.
§ 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.