(13 days)
Not Found
No
The summary describes a standard intravascular ultrasound imaging catheter and system. There is no mention of AI, ML, or advanced image processing beyond the basic conversion of ultrasonic energy to electrical signals for display. The performance studies focus on physical integrity, functionality, and biocompatibility, not algorithmic performance.
No
The device is described as an "Imaging Catheter" intended for "ultrasound examination of peripheral intravascular pathology only," which indicates a diagnostic rather than therapeutic purpose.
Yes
The device is intended for "ultrasound examination of peripheral intravascular pathology" and forms an "imaging system that is intended for the ultrasonic examination of peripheral intravascular pathology only," which clearly indicates its use for diagnosis.
No
The device description clearly details a physical catheter with a transducer and other hardware components, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Sonicath Ultra™ 3.2F 20MHz Imaging Catheter is an intravascular ultrasound imaging catheter. It is used inside the body to visualize peripheral intravascular pathology. It does not perform tests on samples taken from the body.
- Intended Use: The intended use clearly states "ultrasound examination of peripheral intravascular pathology only." This is an imaging function, not a diagnostic test performed on a sample.
Therefore, this device falls under the category of an imaging device used for diagnostic purposes in vivo (within the living body), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Sonicath Ultra™ 3.2F 20MHz Imaging Catheter is intended for ultrasound examination of peripheral intravascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.
Product codes (comma separated list FDA assigned to the subject device)
74DQO, 90ITX
Device Description
The Sonicath Ultra™ 3.2F 20MHz Imaging Catheter is a sterile, single-use, short rail (SR), 20 MHz imaging catheter with a 3.2F distal crossing profile. The catheter is intended to operate with the BSC ClearView Ultra™, Galaxy®, Galaxy2™, or iLab® intravascular ultrasound imaging instruments. The catheter and instrument form an imaging system that is intended for the ultrasonic examination of peripheral intravascular pathology only.
The catheter consists of two (2) main assemblies: a sheath assembly and an imaging core assembly. The sheath assembly is the outer part of the catheter that comprises much of the working length of the device. The imaging core is internal to the sheath assembly and rotates independently of the sheath. The imaging core contains the piezoelectric transducer that converts electrical energy from the instrument to ultrasonic energy that is in turn transmitted. The transducer converts the returned ultrasonic energy into electrical energy for display on the instrument. The rotating imaging core drive shaft directs the path of the ultrasonic energy (beam) from the transducer. A proximal telescoping section allows the imaging core to be retracted and advanced, across an anatomical region of interest, without requiring movement of the sheath within the anatomy.
The modified Sonicath Ultra™ 3.2F 20MHz Imaging Catheter is identical in all aspects to the current Sonicath Ultra™ 3.2F 20MHz Imaging Catheter except for the following change:
- Changed catheter sheath support material from one Low Density Polyethylene (LDPE) resin formulation to another.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
peripheral intravascular
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)
Bench testing was performed to evaluate the physical integrity and functionality of the modified Sonicath Ultra™ 3.2F 20MHz Imaging Catheter. This testing included dimensional and functional (e.g., tensile, pressure) testing of the catheter sheath support and the full, sterile device. The results demonstrated that the device satisfies all performance, physical and functional requirements.
The Sonicath Ultra™ 3.2F 20MHz Imaging Catheter was subjected to a series of biocompatibility tests per USP and EN ISO 10993 standards. The results of the biocompatibility testing demonstrate that the modified Sonicath Ultra™ 3.2F 20MHz Imaging Catheter is acceptable for it intended use.
Acoustic Output testing was not required for the modified Sonicath Ultra™ 3.2F 20MHz Imaging Catheter as the formulation change to the sheath support has no effect on acoustic output. Per the FDA Guidance, Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (September 30, 1997), acoustic output measurements for the modified Sonicath Ultra™ 3.2F 20MHz Imaging Catheter remain unchanged from its predicate device, the Sonicath Ultra™ 3.2F 20MHz Imaging Catheter.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.
0
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APR 1 9 2006
510(k) Summary of Safety and Effectiveness
Boston Scientific Corporation Sonicath Ultra™ 3.2F 20MHz Imaging Catheter
| Submitted By: | Boston Scientific Corporation
IVUS Technology Center
47900 Bayside Parkway
Fremont, CA 94538 |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Robert Z. Phillips
Manager, Regulatory Affairs
Tel: (510) 624-2307
Fax: (510) 624-1449
phillipr1@bsci.com |
| Date Prepared: | April 5, 2006 |
| Proprietary Name: | Sonicath Ultra™ 3.2F 20MHz Imaging Catheter |
| Common Name(s): | Ultrasound Diagnostic Imaging Catheter
Diagnostic Intravascular Catheter (74DQO)
Diagnostic Ultrasonic Transducer (90ITX) |
| Classification Name(s): | Diagnostic Intravascular Catheters, 21 CFR 870.1200
(74DQO)
Diagnostic Ultrasonic Transducers, 21 CFR 892.1570
(90ITX) |
| Predicate Device(s): | Sonicath Ultra™ 3.2F 20MHz Imaging Catheter is
substantially equivalent to the following device: |
| Predicate | 510(k) | Clearance Date |
|---|---|---|
| Sonicath Ultra™ 3.2F | ||
| 20MHz Imaging | ||
| Catheter | K970049 | June 20, 1997 |
1
Image /page/1/Picture/0 description: The image shows the words "Boston Scientific" stacked on top of each other. The word "Boston" is on the top line, and the word "Scientific" is on the second line. The text is in a serif font and is black in color.
Description of the Device:
The Sonicath Ultra™ 3.2F 20MHz Imaging Catheter is a sterile, single-use, short rail (SR), 20 MHz imaging catheter with a 3.2F distal crossing profile. The catheter is intended to operate with the BSC ClearView Ultra™, Galaxy®, Galaxy2™, or iLab® intravascular ultrasound imaging instruments. The catheter and instrument form an imaging system that is intended for the ultrasonic examination of peripheral intravascular pathology only.
The catheter consists of two (2) main assemblies: a sheath assembly and an imaging core assembly. The sheath assembly is the outer part of the catheter that comprises much of the working length of the device. The imaging core is internal to the sheath assembly and rotates independently of the sheath. The imaging core contains the piezoelectric transducer that converts electrical energy from the instrument to ultrasonic energy that is in turn transmitted. The transducer converts the returned ultrasonic energy into electrical energy for display on the instrument. The rotating imaging core drive shaft directs the path of the ultrasonic energy (beam) from the transducer. A proximal telescoping section allows the imaging core to be retracted and advanced, across an anatomical region of interest, without requiring movement of the sheath within the anatomy.
Sonicath Ultra™ 3.2F 20MHz Imaqing Catheter:
The modified Sonicath Ultra™ 3.2F 20MHz Imaging Catheter is identical in all aspects to the current Sonicath Ultra™ 3.2F 20MHz Imaging Catheter except for the following change:
- Changed catheter sheath support material from one Low Density Polyethylene . (LDPE) resin formulation to another.
2
Design verification testing confirms that predetermined acceptance criteria were met and no new issues of safety or efficacy have been raised with the use of this new catheter sheath support material.
Intended Use/Indications:
The Sonicath Ultra™ 3.2F 20MHz Imaging Catheter is intended for ultrasound examination of peripheral intravascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.
Device Technology Characteristics and Comparison to Predicate Device:
The modified Sonicath Ultra™ 3.2F 20MHz Imaging Catheter is the same as the predicate device, the Sonicath Ultra™ 3.2F 20MHz Imaging Catheter cleared June 20, 1997, in all aspects except one -- change in sheath support resin formulation.
Non-clinical Test Results:
Bench and biological safety testing demonstrate that the modified Sonicath Ultra™ 3.2F 20MHz Imaging Catheter meets performance requirements and is safe and effective for its intended use.
Bench Testing:
Bench testing was performed to evaluate the physical integrity and functionality of the modified Sonicath Ultra™ 3.2F 20MHz Imaging Catheter. This testing included dimensional and functional (e.g., tensile, pressure) testing of the catheter sheath support and the full, sterile device. The results demonstrated that the device satisfies all performance, physical and functional requirements.
3
Image /page/3/Picture/1 description: The image shows the words "Boston Scientific" stacked on top of each other. The word "Boston" is on the top line, and the word "Scientific" is on the bottom line. The font is a serif font, and the text is black. The background is white.
APF 1 9 2005
Biological Safety Testing:
The Sonicath Ultra™ 3.2F 20MHz Imaging Catheter was subjected to a series of biocompatibility tests per USP and EN ISO 10993 standards. The results of the biocompatibility testing demonstrate that the modified Sonicath Ultra™ 3.2F 20MHz Imaging Catheter is acceptable for it intended use.
Acoustic Output Testing:
Acoustic Output testing was not required for the modified Sonicath Ultra™ 3.2F 20MHz Imaging Catheter as the formulation change to the sheath support has no effect on acoustic output.
Per the FDA Guidance, Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (September 30 1997), acoustic output measurements for the modified Sonicath Ultra™ 3.2F 20MHz Imaging Catheter remain unchanged from its predicate device, the Sonicath Ultra™ 3.2F 20MHz Imaging Catheter.
Conclusion:
The modified Sonicath Ultra™ 3.2F 20MHz Imaging Catheter utilizes the same design features and has the same intended use as the predicate device, the Sonicath Ultra™ 3.2F 20MHz Imaging Catheter. The tests conducted support a determination of substantial equivalence of the modified device to the predicate device.
Image /page/3/Picture/11 description: The image shows the word "Confidential" on the top left, followed by the word "Page" on the bottom left. To the right of the word "Page" is the number 78. The text is in a simple, sans-serif font and is likely part of a document or report cover page.
4
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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
APR 1 2 2006
Mr. Robert Z. Phillips Manager, Regulatory Affairs Boston Scientific Corporation IVUS Technology Center 47900 Bayside Parkway FREMONT CA 94538-6515
Re: K060947
Trade Name: Sonicath Ultra™ Imaging Catheter Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: ITX Dated: April 5. 2006 Received: April 6, 2006
Dear Mr. Phillips:
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 Sonicath Ultra™ Imaging Catheter, as described in your premarket notification:
Transducer Model Number
3.2F 20MHz
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA). it may be subject to such additional controls. Existing major regulations affecting your device can
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ling Public - Health
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Page 2 - Mr. Phillips
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 r reade of a , made a determination that your device complies with other requirements of the Act that + D. Has Internations and regulations administered by other Federal agencies. You must or uny 1 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 Of It in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic rordly to and ation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 predicated wice 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 rryou desire 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 other generalional and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
If you have any questions regarding the content of this letter, please contact Ewa Czerska at (301) 594-1212.
Sincerely yours.
David A. Ingram
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
6
Indications for Use Statement K 060947 510(k) Number: Sonicath Ultra™ 3.2F 20MHz Imaging Catheter Device Name: The Sonicath Ultra™ 3.2F 20MHz Imaging Catheter is Indications for Use: intended for ultrasound examination of peripheral intravascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.
Prescription Use_ × (Part 21 CFR 801 Subpart D) OR
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
David H. Lynn
(Division Sign-Off) (Division Sign-On)
Division of Reproductive, Abde Division of neproof and Radiological Devices and Radiological Devices and Radiological Proper and (k) Number -
Confidential
Page