(43 days)
IVUS Plus is a digital image processing accessory to Boston Scientific's intravascular ultrasound imaging systems, ClearView (K891386) and Insight (K921750). It adds fulllength longitudinal digital display capability, full image rotation capability, and mensuration functions. It is indicated for use in patients who are candidates for transluminal interventional procedures such as angioplasty and atherectomy
The provided document is a 510(k) summary and FDA clearance letter for a device called "IVUS Plus." This device is described as a digital image processing accessory for intravascular ultrasound imaging systems, adding features like full-length longitudinal digital display, image rotation, and mensuration functions.
However, the document does not contain any information regarding specific acceptance criteria, a study proving the device meets those criteria, or performance metrics. The FDA clearance is based on substantial equivalence to predicate devices, meaning it has a similar intended use, design, and operational characteristics to previously approved devices, not necessarily a new clinical study demonstrating specific performance metrics against pre-defined acceptance criteria.
Therefore, I cannot provide the requested information from the given text. The provided document is a regulatory approval, not a scientific study report.
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24103
510(k) Summary As required by 807.92 For CALM Patterns Prepared on December 2, 2002
Submitted by: INDEC Systems, Inc. 505 E. Evelyn Mt. View, California 94041
JAN 2 4 2003
Tel. 650-903-9755 Fax: 650-919-0150
……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
Contact Person: Carol Hubler
Device Trade Name: IVUS Plus
Common Name: digital image display system for intravascular ultrasound
Classification: Picture Archiving and Communication System, Class II Sec. 21 CFR 807.92
Predicate Device: Resolve Option for the Oracle In-Vision Intravascular Imaging System K965223 and Galaxy Intravascular Ultrasound System K980851
Manufactured by: Jomed Corporation, 2870 Kilgore Road, Rancho Cordova, CA 95670 Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537
Description of the Device: IVUS Plus will function as an accessory to ClearView and Insight (K891386 and K921750), Boston Scientific's intravascular ultrasound imaging systems. IVUS Plus adds digital image review capability and full-length longitudinal display with full image rotation and mensuration functions.
Intended Use for the Device: It is indicated for use in patients who are candidates for transluminal interventional procedures such as angioplasty and atherectomy.
Substantial Equivalence to Predicate Device: The IVUS Plus add on accessory to the ClearView ultrasound system is substantially equivalent in intended use, design and operation characteristics to the following currently marketed devices:
Endosonics In-Vision (Now called Jomed) with Resolve (K965223), Boston Scientific (formerly CVIS) Insight II (K921750) with Automatic Pullback Device (K933517) and Longview (K930311) Boston Scientific Galaxy system (K980851)
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Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of what appears to be a caduceus, a symbol often associated with healthcare, represented by a staff entwined with snakes.
JAN 2 4 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Carol Hubler General Manager and Vice President INDEC Systems, Inc. 505 East Evelyn, Suite D MOUNTAIN VIEW CA 94041
Re: K024103
Trade/Device Name: IVUS Plus Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: December 2, 2002 Received: December 12, 2002
Dear Ms. Hubler:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k)
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 the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Ver/ 3 - 4/24/96 - -
510(k) Number (if known):
Applicant: _ INDEC Systems, Inc.
Device Name: IVUS Plus
ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ Indications For Use:
IVUS Plus is a digital image processing accessory to Boston Scientific's intravascular ultrasound imaging systems, ClearView (K891386) and Insight (K921750). It adds fulllength longitudinal digital display capability, full image rotation capability, and mensuration functions. It is indicated for use in patients who are candidates for transluminal interventional procedures such as angioplasty and atherectomy
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAG IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
ાં છે.
વર્ષના પાક
h inks, tumper
Nancyc Brogdon
(Division Sign Off)
Division of Reproductive, Abdominal,
12024103
Comment Dovices
Prescription Use
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).