(11 days)
Not Found
No
The device description focuses on the mechanical and material properties of a steerable microcatheter and does not mention any computational or algorithmic components related to AI or ML.
No.
The device is a microcatheter intended to provide access, support, and delivery of agents (including therapeutic ones), but it does not intrinsically perform a therapeutic function itself.
No
The device is described as a microcatheter intended for the delivery of agents, not for the purpose of diagnosing a condition. While it can deliver "diagnostic agents," its function is delivery, not the diagnostic interpretation itself.
No
The device description clearly details a physical, tubular device with a lumen, radiopaque markers, and a luer adapter, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used within the body (in vivo) to access vasculature and deliver agents or support procedures. IVD devices are used to examine specimens from the body (in vitro) to provide diagnostic information.
- Device Description: The description details a physical catheter designed for insertion into blood vessels. This is consistent with an in vivo device, not an in vitro diagnostic.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with IVD testing.
The device is an interventional medical device used for diagnostic and therapeutic procedures within the patient's body.
N/A
Intended Use / Indications for Use
The "PivotTM" Steerable Microcatheter is intended to be used to access tortuous vasculature for sub-selective controlled infusion or delivery of diagnostic, embolic, and therapeutic agents into the distal, peripheral, coronary, and neurovasculature, and for guide wire exchange/support during diagnostic or interventional procedures.
Product codes
KRA
Device Description
The "PivotTM" Steerable Microcatheter is a 1.9F/2.4F (nominal distal/proximal) tubular device, ~150 cm in length, with a lumen to be used for delivery of contrast, drugs, or embolics. The lumen is constructed from a polymeric material and has an inside diameter of 0.017". The device is coated on the outer diameter with a lubricious coating over the distal segment of the device. Two radiopaque markers are positioned at the distal tip of the device to aid visualization under fluoroscopy. The proximal end of the device has a standard luer adapter for attachment of accessories and can be used to flush the lumen. The subject device has the ability to access distal, tortuous vasculature over a guide wire, deliver embolics and agents, and has the ability to be steered like a guide wire as needed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy
Anatomical Site
distal, peripheral, coronary, and neurovasculature
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
Performance testing of the "Pivot™" Steerable Microcatheter was conducted in accordance with ISO 10555-1, Sterile, Single-Use Intravascular Catheters -- Part 1. Verification testing for the subject device included dimensional inspection, hub integrity, flow rate measurements, burst strength, tensile strength, guidewire compatibility testing and performance under simulated conditions. Subject product testing has yielded acceptable results. In addition, torsional strength, torqueability, and corrosion resistance tests have also yielded acceptable results. The results of these tests, in conjunction with the substantial equivalence claims as outlined in the premarket notification, effectively demonstrate the "Pivot™" Steerable Microcatheter is substantial equivalent to the cited predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).
0
Summary of Safety and Effectiveness
Prepared 8 March 2005
| General
Provisions | Submitter of 510(k)
Premarket Notification: | Boston Scientific - Precision Vascular
2405 West Orton Circle
West Valley City, UT 84119
Phone: 801.974.1700
Fax: 801.974.1740 | |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| | Contact Person: | Rick Gaykowski
Vice President, Regulatory/Clinical
Affairs & Quality Systems | |
| | Device Trade Name: | "PivotTM" Steerable Microcatheter | |
| | Device Generic Name: | Infusion Catheter | |
| | The predicate devices are listed below. | | |
| Predicate
Devices | Device | Manufacturer | 510(k) Number/Date
Pro Code |
| | SDS 0.018" | PVS, Inc. | K020733, 21 March 2002
KRA |
| | SDS 0.010" | PVS, Inc. | K032494, 05 Sep 2003
KRA |
| | Pivot "SDS" | PVS, Inc. | K033726, 16 Jan 2004
KRA |
| Classification | Class II, 21 CFR 870.1210, Continuous Flush Catheter, KRA | | |
| Performance
Standards | Performance standards have not been established by FDA under section 514 of the
Federal Food, Drug and Cosmetic Act. | | |
| Intended Use | The "PivotTM" Steerable Microcatheter is intended to be used to access tortuous
vasculature for sub-selective controlled infusion or delivery of diagnostic, embolic, and
therapeutic agents into the distal, peripheral, coronary, and neurovasculature, and for
guide wire exchange/support during diagnostic or interventional procedures. | | |
| Device
Description | The "PivotTM" Steerable Microcatheter is a 1.9F/2.4F (nominal distal/proximal) tubular
device, ~150 cm in length, with a lumen to be used for delivery of contrast, drugs, or
embolics. The lumen is constructed from a polymeric material and has an inside
diameter of 0.017". The device is coated on the outer diameter with a lubricious
coating over the distal segment of the device. Two radiopaque markers are positioned
at the distal tip of the device to aid visualization under fluoroscopy. The proximal end of
the device has a standard luer adapter for attachment of accessories and can be used
to flush the lumen. The subject device has the ability to access distal, tortuous
vasculature over a guide wire, deliver embolics and agents, and has the ability to be
steered like a guide wire as needed. | | |
1
| Technological
| Characteristics | Technological similarities between the "Pivot™" Steerable Microcatheter and predicate devices include the basal tubular design and dimensions, polymeric materials and construction, and hydrophilic coating. In instances where the technological characteristics may differ slightly, it has been demonstrated that there are no new questions raised regarding safety and efficacy of the "Pivot™" Steerable Microcatheter. |
|---|---|
| Safety and | |
| Performance | |
| Tests | Performance testing of the "Pivot™" Steerable Microcatheter was conducted in accordance with ISO 10555-1, Sterile, Single-Use Intravascular Catheters -- Part 1. Verification testing for the subject device included dimensional inspection, hub integrity, flow rate measurements, burst strength, tensile strength, guidewire compatibility testing and performance under simulated conditions. Subject product testing has yielded acceptable results. |
| In addition, torsional strength, torqueability, and corrosion resistance tests have also yielded acceptable results. The results of these tests, in conjunction with the substantial equivalence claims as outlined in the premarket notification, effectively demonstrate the "Pivot™" Steerable Microcatheter is substantial equivalent to the cited predicate devices. | |
| Summary of | |
| Substantial | |
| Equivalence | Based on the indications for use, technological characteristics, and safety and performance testing, the subject "Pivot™" Steerable Microcatheter meets the minimum requirements that are considered adequate for its intended use and is substantially equivalent in design, materials, sterilization, principles of operation and indications for use to current commercially available catheters/cited predicates. |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three horizontal lines curving upwards, resembling a human figure with outstretched arms.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 2 2005
Mr. Rick Gaykowski Mice President, Regulatory/Clinical Affairs & Quality Systems Boston Scientific - Precision Vascular 2405 West Orton Circle West Valley City, UT 84119
K050630 Re:
Trade/Device Name: Pivor™ Steerable Microcatheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous flush catheter Regulatory Class: II Product Code: KRA Dated: March 10, 2005 Received: March 11, 2005
Dear Mr. Gaykowski:
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 for assessment 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 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
3
Page 2 – Mr. Rick Gaykowski
Fage 2 - "htt read as a proposion (21 CFR Part 820); and if applicable, the electronic
forth in the quality systems in and inco (Sections 531-542 of the Act); 21 CFR 1000-105 forth in the quality systems (QS) regulation (2) CFR Pat 620); and 11 CFF
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 101 - 12 - 12 - 12 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -This letter will allow you to begin marketing your device of your device to a legally
premarket notification. The FDA finding of subscification for your device to a legally remarket notification. The FDA finding of substantial on 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
s and the results of the support (240) 276.0120 . Also, please note the r If you desire specific advice for your device on our labeling nease not the regulation entitled,
contact the Office of Compliance at (240) 276-0120. Also, please not 97). contact the Office of Compliance at (240) 270-01-20. Proxet 807.97). You may obtain
"Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obta "Misbranding by reference to premarket notification "(21 cf 1 cr from the Division of Small
other general information on your responsibilities under the Act from the Division other general information on your responsibilities under (800) 638-204) or 2001)
Manufacturers, International and Consumer Assistance at its todalfred wordindex.html. Manufacturers, International and Consumer Assistance at les to restor in over index.html.
(301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/i
Sincerely yours,
Durna R. Kirchner
Bram D. Zuckerman, M.D.
Director
Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1
510(k) Number (if known): ¥650630_
Device Name: "Pivot™" Steerable Microcatheter
Indications for Use:
The "Pivot™" Steerable Microcatheter is intended to be used to access tortuous vasculature for sub-The "Pivot™" Steerable Microcather is intended to activer and therapeutic agents into the distal,
selective controlled infusion of diagnosic, emblic, and therapeupport during selective controlled infusion or delivery of diagnostic, endonic, and therebels agence of the counter of the county, or interventional procedures.
:
. . .
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ | OR | Over-the-Counter Use | |
|---|---|---|---|---|
| (Per 21 CFR 801.109) |
| Donna P. Vechinel (Division Sign-Off) Division of Cardiovascular Devices | |
|---|---|
| 510(k) Number | K050630 |