(260 days)
Not Found
No
The 510(k) summary explicitly states that the device has the same scientific technology as the predicate device and the only change is a material change in the shaft. There is no mention of AI or ML.
Yes
The device is used for Percutaneous Transluminal Angioplasty to treat narrowed or obstructed vessels, which is a therapeutic intervention.
No
The device is a balloon dilatation catheter used for angioplasty, which is a therapeutic procedure to open narrowed or obstructed vessels, not to diagnose a condition.
No
The device description clearly identifies it as a "Balloon Dilatation Catheter," which is a physical medical device used for angioplasty. The submission focuses on changes to the material of the catheter's shaft, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Percutaneous Transluminal Angioplasty of narrowed or obstructed iliac, femoral, or renal vessels in the peripheral vasculature." This describes a procedure performed on the patient's body to treat a condition, not a test performed on a sample taken from the patient to diagnose a condition.
- Device Description: The device is a "Balloon Dilatation Catheter," which is a physical instrument used in a medical procedure.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in vitro diagnostics.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used directly within the body for a therapeutic procedure.
N/A
Intended Use / Indications for Use
Symmetry™ and Symmetry Stiff Shaft Balloon Dilatation Catheters are indicated for Percutaneous Transluminal Angioplasty of narrowed or obstructed iliac, femoral, or renal vessels in the peripheral vasculature.
Product codes
LIT
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
iliac, femoral, or renal vessels in the peripheral vasculature
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 and biocompatibility testing were performed to support a determination of substantial equivalence. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the device testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Image /page/0/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" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol often associated with healthcare and medicine.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 24, 2015
Boston Scientific Ms. Anna Deraney Regulatory Affairs Specialist One Scimed Place Maple Grove, Minnesota 55311
Re: K143193
Trade/Device Name: Symmetry and Symmetry Stiff Shaft Balloon Dilatation Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: June 5, 2015 Received: June 8, 2015
Dear Ms. Deraney:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 801and Part 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part
1
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
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3
510k Summary
Per 21 CFR §807.92
| Common or Usual
| Name | Balloon Dilatation Catheter | |
|---|---|---|
| Trade Name(s) | Boston Scientific Symmetry™ and Symmetry Stiff Shaft Balloon | |
| Dilatation Catheter | ||
| Product Code | LIT - Catheter, Angioplasty, Peripheral, Transluminal | |
| Classification of | ||
| Device | Symmetry Balloon Dilatation catheters and accessories have been | |
| classified as Class II devices according to 21 CFR 870.1250 - | ||
| Percutaneous Catheter. | ||
| Submitter's Name | ||
| and Address | Boston Scientific Corporation | |
| One Scimed Place | ||
| Maple Grove, MN 55311-1566 | ||
| Contact Name and | ||
| Information | Anna Deraney | |
| Regulatory Affairs Specialist | ||
| Phone: 763-494-1683 | ||
| Fax: 763-494-2222 | ||
| Email: anna.deraney@bsci.com | ||
| Section 514 of the | ||
| Act Performance | ||
| Standards | Currently no FDA mandated or voluntary performance standards exist | |
| for this device. | ||
| Establishment | ||
| Registration | ||
| Numbers | Owner /Operator: | Boston Scientific Corporation |
| 300 Boston Scientific Way | ||
| Marlborough, MA 01752 | ||
| Manufacturing | ||
| Facility: | Boston Scientific Ireland Ltd. (BSIL) | |
| Ballybrit Business Park | ||
| Galway, Ireland | ||
| ERN: 9681260 | ||
| Sterilization | ||
| Facilities: | Synergy Health Ireland Limited | |
| IDA Business & Technology Park | ||
| Tullamore, County Offaly, Ireland | ||
| Predicate Devices | Symmetry Balloon Dilatation Catheter K060959 cleared April 12, |
-
| |
| Intended Use/
Indications for Use | Symmetry™ and Symmetry Stiff Shaft Balloon Dilatation Catheters
are indicated for Percutaneous Transluminal Angioplasty of narrowed
or obstructed iliac, femoral, or renal vessels in the peripheral
vasculature. | |
| Comparison of
Required
Technological
Characteristics | The proposed Symmetry Balloon Dilatation Catheter is substantially
equivalent to the existing Symmetry Balloon Dilatation Catheter
cleared by FDA under premarket notification K060959 (April 12,
2006). Symmetry has the same intended use, scientific technology,
design, materials (with the exception of the Pebax resin used in the
shaft), sterilization method, and packaging materials as the applicable
predicate device.
The vendor is discontinuing the supply of the current Pebax resin,
which is used in the shaft of the device; therefore a new resin is being
supplied. | |
| Summary of Non-
Clinical Test
Summary | Bench testing and biocompatibility testing were performed to support a
determination of substantial equivalence. The results of these tests
provide reasonable assurance that the proposed device has been
designed and tested to assure conformance to the requirements for its
intended use. No new safety or performance issues were raised
during the device testing. | |
| Conclusion | Based on the indications for use, technological characteristics, and
safety and performance testing, the proposed Symmetry Balloon
Dilatation Catheter has been shown to be appropriate for its intended
use and is considered to be substantially equivalent to the Symmetry
Balloon Dilatation Catheter (K060959). | |
4