(22 days)
Not Found
Not Found
No
The 510(k) summary describes a mechanical catheter for guidewire support and fluid delivery, with no mention of AI, ML, image processing, or any other computational analysis of data that would suggest the use of AI/ML.
No
The device is described as a "Crossing Support Catheter" intended to support a guidewire, allow for guidewire exchanges, and provide a passage for delivery of saline solutions and/or diagnostic contrast agents in the peripheral vascular system. While it enables procedures, it does not directly treat a disease or condition itself.
Yes
Explanation: The device description states it can "provide a passage for delivery of saline solutions and/or diagnostic contrast agents," indicating its role in diagnostic procedures by facilitating the delivery of diagnostic agents.
No
The device is described as a "Crossing Support Catheter," which is a physical medical device used in the peripheral vascular system. The description focuses on its physical functions (guidewire exchange, infusion, support, passage for delivery) and does not mention any software component as the primary or sole function.
Based on the provided information, the Seeker™ Crossing Support Catheters are not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a device used within the body (in the peripheral vascular system) to support guidewires, facilitate exchanges, and deliver substances. This is an in vivo application.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to examine specimens (like blood, urine, or tissue) taken from the body to provide information about a person's health. This is an in vitro application (meaning "in glass" or "outside the body").
The description of the Seeker™ Crossing Support Catheters aligns with a device used for interventional procedures within the vascular system, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
The Seeker™ Crossing Support Catheters are recommended for guidewire exchange and infusion devices designed for use in the peripheral vascular system. The catheters are intended to support a guidewire during access into the vasculature, allow for guidewire exchanges, and provide a passage for delivery of saline solutions and/or diagnostic contrast agents.
Product codes
DQY
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vascular system
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Bard Peripheral Vascular, Inc. c/o Mark Job Responsible Third Party Official Regulatory Technical Services LLC 1394 25th Street NW Buffalo, MN 55313
DEC - 8 2010
Re: K103367
K103367
Trade/Device Name: Seeker Crossing Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (Two) Product Code: DQY Dated: November 15, 2010 Received: November 16, 2010
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section > IV(K) prematics in envir lent (for the indications
referenced above and have determined the device is substantialy equivalent (for the indicat referenced above and have determined the usedicate devices marketed in interstate
for use stated in the enclosure) to legally marketed predicate devices mendments. for use stated in the enclosure) to the enactment date of the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food, Drug, commerce prior to May 28, 1976, the enactinent and of the Federal Food, Drug, Drug,
devices that have been reclassified in accordance with the provisions of the Federal Food, devices that have been reclassified in accordance whil the provisions of the Art (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act. The and Cosmetic Act (Act) that do not require approval or a prevalons of the Act. The Act. The Act. The Act. The Act. The Act. The Act. The You may, therefore, market the device, subject to the general connol registration, listing of
general controls provisions of the Act include requirements misuranding and general controls provisions of the Act include requirents its amans st
devices, good manufacturing practice, labeling, and prohibitions against fiabili devices, good manufacturing practice, labeling, and promonton related to contract liability.
adulteration. Please note: CDRH does not evaluate information related to adulteration. Please note: CDRH does not evaluate information reason of the most misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it
in be If your device is classified (see above) into eliment class if (discuss affecting your device can be
may be subject to additional controls. Existing major regulations affect may be subject to additional controls. Existing more regalations on of on found in the Code of Federal Regulations, This 21, I and 11
publish further announcements concerning your device in the Federal Register.
1
Page 2 - Mr. Mark Job
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA's issuance of a substantial equires with other requirements of the Act
that FDA has made a determination that your device addess Edgerales You m that FDA has made a determination in an your devices on other Federal agencies. You must or any Federal statutes and regulations and limited to: registration and listing (21
comply with all the Act's requirements, including, but newsting of medical comply with all the Act's requirements, they and reporting (teporting of medical
CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical CFR Part 807); labeling (21 CFR Parl 601); pood manufacturing practice requirements as set
device-related adverse events) (21 CFR 803); good manufacturing practice requiremen device-related adverse events) (21 CFR 803), good manatalonal passage and if annoplicable, the electronic
forth in the quality systems (QS) regulation (2) CFR Path At): 21 forth in the quality systems (QS) regulation (21 CFR PCF CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
r (1580), please on and CD (100 - 100 (CDRH/CDPH/CDPH/CDPH/CDPH/CDPH/CD If you desire specific advice for your devices offices/CDRHOffices/ucm 115809.htm for for for for for for for for for go to http://www.fda.gov/AbourLD/cellers/inconers/inces/f-compliance. Also, please
the Center for Devices and Radiological Health's (CDBH's) Offication" (21CFR Part the Center for Devices and Radiological Treams 3 (1) Office of Confessor (2) (2) CFR Part
note the regulation entitled, "Misbranding by reference to premarke more the MDR reg note the regulation entitled, "Misbranding by reference to promation in the MDR regulation (21 CFR Part 803), please go to
CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of http://www.ida.gov/MedicanDevices/Darof Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the You may obtain other general intormational on Consumer Assistance at its toll-free number
Division of Small Manufacturers, International and Consumer Assistance at its toll-f Division of Sman Manafacturer, 100 or at its Internet address (800) 638-2041 of (501) 790-7100 of ut its internet for You/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Dina R. Richter
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page 2
Indications for Use
DEC - 8 2010
510(k) Number (if known):
Device Name: Seeker™ Crossing Support Catheter
Indications for Use: The Seeker™ Crossing Support Catheters are recommended for guidewire exchange and infusion devices designed for use in the peripheral vascular system. The catheters are intended to support a guidewire during access into the vasculature, allow for guidewire exchanges, and provide a passage for delivery of saline solutions and/or diagnostic contrast agents.
Prescription Use X CFR 801 Subpart D)
AND/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)
una R.V. Ames
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_K10 536 +
Page 1 of 1
Bard Peripheral Vascular, Inc.