(5 days)
No
The document describes a mechanical balloon catheter and does not mention any AI/ML components or related data/performance metrics.
Yes
The device is described as a "Balloon Dilatation Catheter" recommended for "Percutaneous Transluminal Angioplasty of small, narrowed or obstructed iliac, femoral, or renal vessels in the peripheral vasculature," which are therapeutic procedures.
No
Explanation: The device description states its use for "Percutaneous Transluminal Angioplasty of small, narrowed or obstructed iliac, femoral, or renal vessels in the peripheral vasculature." This describes a therapeutic, rather than a diagnostic, procedure aimed at treating a condition by dilating vessels.
No
The device description clearly describes a physical catheter with lumens, a balloon, and a shaft, 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:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The description clearly states that the Symmetry and Symmetry Stiff Shaft Balloon Dilatation Catheters are used for "Percutaneous Transluminal Angioplasty of small, narrowed or obstructed iliac, femoral, or renal vessels in the peripheral vasculature." This is a procedure performed inside the body (in vivo) to physically open up blood vessels.
- Lack of Specimen Testing: There is no mention of collecting or analyzing any biological specimens from the patient.
Therefore, the device is a therapeutic device used for a medical procedure, not an IVD used for diagnostic testing of specimens.
N/A
Intended Use / Indications for Use
Symmetry and Symmetry Stiff Shaft Balloon Dilatation Catheters are recommended for Percutaneous Transluminal Angioplasty of small, narrowed or obstructed iliac, femoral, or renal vessels in the peripheral vasculature.
Product codes
LIT
Device Description
The Symmetry Balloon Dilatation Catheter is an over-the-wire catheter offered in a three lumen catheter shaft design. One lumen, marked "distal", is the central lumen of the catheter which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire. The Symmetry device is designed to be placed over guidewires which have outer diameters of 0.018" or smaller. The lumen marked "balloon" is comprised of two smaller, separate lumens which both communicate with the balloon at one end and terminate in a single balloon hub and lead tube at the proximal end of the device. The Symmetry device is offered in both standard and stiff shaft versions.
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)
Not Found
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
APR 1 2 2006
510(k) Summary
per 21 CFR §807.92
| Submitter's Name
and Address | Boston Scientific Corporation
Two Scimed Place
Maple Grove, MN 55311 |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name and
Information | Angela Byland
Manager, Regulatory Affairs
Phone: (763) 494-2887
Fax: (763) 494-2981 |
| Date Prepared | April 6, 2006 |
| Proprietary
Name(s) | Symmetry Balloon Dilatation Catheter |
| Common Name | Balloon Dilatation Catheter |
| Product Code | LIT |
| Classification of
Device | Class II, 21 CFR Part 870.1250 |
| Predicate Device | Symmetry Balloon Dilatation Catheter K953602 October 18, 1995 |
| Device
Description | The Symmetry Balloon Dilatation Catheter is an over-the-
wire catheter offered in a three lumen catheter shaft design.
One lumen, marked "distal", is the central lumen of the
catheter which terminates at the distal tip. This lumen is
used to pass the catheter over a guidewire. The Symmetry
device is designed to be placed over guidewires which have
outer diameters of 0.018" or smaller. The lumen marked
"balloon" is comprised of two smaller, separate lumens
which both communicate with the balloon at one end and
terminate in a single balloon hub and lead tube at the
proximal end of the device.
The Symmetry device is offered in both standard and stiff
shaft versions. |
| Intended Use of
Device | Symmetry and Symmetry Stiff Shaft Balloon Dilatation
Catheters are recommended for Percutaneous Transluminal
Angioplasty of small, narrowed or obstructed iliac, femoral,
or renal vessels in the peripheral vasculature. |
| Comparison of
Technological
Characteristics | The materials and design of the Symmetry balloon dilatation
catheter are equivalent to the predicate Symmetry Balloon
dilatation catheter. |
| Support of
Substantial
Equivalence | Boston Scientific Corporation considers the proposed
Symmetry Balloon Dilatation Catheter to be substantially
equivalent to the existing Symmetry Balloon Dilatation
Catheter (K953602 cleared October 18, 1995). This
assessment is based upon identical device materials and
design characteristics and the only change being initiated is
to add a single warning to the Directions for Use. |
| Conclusion | Based on the indications for use and the technological
characteristics, the Symmetry Balloon Dilatation Catheter
has been shown to be equivalent in intended use and is
considered to be substantially equivalent to the Symmetry
Balloon Dilatation Catheter (K000798; cleared October 18,
1995). |
:
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement.
APR 1 2 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Boston Scientific Corporation c/o Ms. Angela Byland Manager, Regulatory Affairs Two Scimed Place Maple Grove, MN 55311-1566
Re: K060959
Symmetry Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, Angioplasty, Peripheral, Transluminal Regulatory Class: Class II Product Code: LIT Dated: April 6, 2006 Received: April 7, 2006
Dear Ms. Byland:
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 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.
3
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 (OS) 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 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 (240) 276-0120. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
R.Z. M.P.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number:
Symmetry Balloon Dilatation Catheter Device Name:
Indications for Use:
Symmetry and Symmetry Stiff Shaft Balloon Dilatation Catheters are recommended for Percutaneous Transluminal Angioplasty of small, narrowed or obstructed iliac, femoral, or renal vessels in the peripheral vasculature.
Prescription Use × (part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off) If Cardiovascular Devices Division o
510(k) Number K060957
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