(28 days)
Not Found
Not Found
No
The provided text does not mention AI, ML, or any related concepts like deep learning, neural networks, or image processing that would typically indicate the use of AI/ML in this context.
No
The catheter is for "ultrasound examination of peripheral pathology only," indicating a diagnostic rather than therapeutic purpose.
Yes
The device is intended for "ultrasound examination of peripheral pathology," which implies diagnosing conditions or diseases in the periphery.
No
The device is described as an "Imaging Catheter," which is a hardware component used for ultrasound examination. The summary does not mention any software-only aspects.
Based on the provided information, the Atlantis™ PV Imaging Catheter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "ultrasound examination of peripheral pathology only" and "intravascular ultrasound imaging". This describes a device used in vivo (within the living body) for imaging, not a device used in vitro (outside the body) to examine specimens like blood, tissue, or urine.
- Device Description (Not Found): While the description is missing, the intended use is the primary indicator of whether a device is an IVD.
- Mentions image processing, AI, DNN, or ML (Not Found): These are often associated with IVDs that analyze images of specimens, but their absence doesn't definitively rule out an IVD. However, combined with the intended use, it further supports the conclusion.
- Input Imaging Modality: Ultrasound is an in vivo imaging modality.
- Anatomical Site: "Peripheral" refers to a location within the body.
IVDs are devices used to examine specimens obtained from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Atlantis™ PV Imaging Catheter is used to image structures within the body.
N/A
Intended Use / Indications for Use
The Atlantis™ PV Imaging Catheter is intended for ultrasound examination of peripheral pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.
Product codes
OBJ
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
peripheral pathology
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
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
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/2 description: The image shows the logo for the Department of Health and Human Services (HHS) in the United States. The logo features a stylized depiction of a human figure, with three overlapping profiles suggesting a sense of community and support. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the figure. The logo is simple, clean, and uses a monochromatic color scheme.
MAY 2 4 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Boston Scientific/Scimed c/o Mr. Robert Z. Phillips Manager, Regulatory Affairs IVUS Technology Center 47900 Bayside Parkway Fremont, CA 94539-6515
Re: K041727
Trade/Device Name: Atlantic PV Imaging Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: II Product Code: OBJ Dated: June 24, 2004 Received: June 25, 2004
Dear Mr. Phillips:
This letter corrects our substantially equivalent letter of July 23, 2004.
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 (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.
1
Page 2 - Mr. Phillips
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.
This letter will allow you to continue 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 (240) 276-4008. 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/cdrh/dsma/dsmamain.html
Sincerely yours,
Bram D. Zuckerman, M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use Statement
K041727 510(k) Number: Atlantis™ PV Imaging Catheter Device Name: The Atlantis™ PV Imaging Catheter is intended for Indications for Use: ultrasound examination of peripheral pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates transluminal for interventional procedures.
PLEASE DO NOJ WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nith.P.Ogden
vision Signvision of Cardiovascular Devices
602
510(k) Number K041727
Prescription Use
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Per 21 CFR 801. 109)
Confidential
Page