(62 days)
Not Found
No
The summary describes a mechanical dilatation system and does not mention any AI or ML components or functionalities.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated to dilate stenoses in the peripheral vasculature" and "for the treatment of obstructive lesions," which are therapeutic actions.
No
The device is used to dilate stenoses and obstructive lesions, which is a treatment, not a diagnostic function.
No
The device description explicitly lists hardware components such as a Catheter, Inflation Unit, connecting cable, battery pack, recharging unit, battery receptacle, and a disposable cartridge. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, the PolarCath™ Peripheral Dilatation System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- PolarCath™ Function: The PolarCath™ Peripheral Dilatation System is a medical device used within the body (in vivo) to physically dilate blood vessels and grafts. It is a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Elements: The description focuses on the mechanical components and the inflation medium used for dilation. There is no mention of analyzing biological samples or providing diagnostic information.
Therefore, the PolarCath™ Peripheral Dilatation System falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PolarCath™ Peripheral Dilatation System is indicated to dilate stenoses in the peripheral vasculature (iliac, femoral, popliteal, infrapopliteal, renal and subclavian arteries) and for the treatment of obstructive lesions of polytetrafluoroethylene (PTFE) access grafts or arteriovenous dialysis fistulae. The PolarCath™ Peripheral Dilatation System is also indicated for post-deployed stent expansion of self-expanding peripheral vascular stents.
Product codes (comma separated list FDA assigned to the subject device)
LIT/DQY
Device Description
The PolarCath™ Peripheral Dilatation System consists of a Catheter, Inflation Unit, connecting cable and a rechargeable battery pack with recharging unit and battery receptacle. The inflation medium (liquid nitrous oxide) is provided in a disposable 14 gram cartridge.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature (iliac, femoral, popliteal, infrapopliteal, renal and subclavian arteries), polytetrafluoroethylene (PTFE) access grafts or arteriovenous dialysis fistulae.
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.
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
§ 870.1250 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
ATTACHMENT 4
JUN 1 3 2007
510(k) Summary
per 21 CFR §807.92
| Submitter's Name and Address | Boston Scientific Corporation
One Scimed Place
Maple Grove, MN 55311 |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name and Information | Monica Morrison
Regulatory Affairs
Phone: (763) 494-2676
Fax: (763) 494-2981
Email: morrisom@bsci.com |
| Date Prepared | April 11, 2007 |
| Proprietary Name(s) | PolarCath™ Peripheral Dilatation System |
| Common Name | Percutaneous Transluminal Angioplasty Catheter |
| Product Code | LIT/DQY |
| Classification of Device | Class II, 21 CFR Part 870.1250 |
| Predicate Device | PolarCath™ Peripheral Dilatation System K062594 September 28, 2006 |
| Device Description | The PolarCath™ Peripheral Dilatation System consists of a Catheter, Inflation Unit, connecting cable and a rechargeable battery pack with recharging unit and battery receptacle. The inflation medium (liquid nitrous oxide) is provided in a disposable 14 gram cartridge. |
| Intended Use of Device | The PolarCath™ Peripheral Dilatation System is indicated to dilate stenoses in the peripheral vasculature (iliac, femoral, popliteal, infrapopliteal, renal and subclavian arteries) and for the treatment of obstructive lesions of polytetrafluoroethylene (PTFE) access grafts or arteriovenous dialysis fistulae. The PolarCath™ Peripheral Dilatation System is also indicated for post-deployed stent expansion of self-expanding peripheral vascular stents. |
:
CONFIDENTIAL
1
| Comparison of
Technological
Characteristics | The proposed changes to the PolarCath™ Peripheral Dilatation
System apply only to the circuit board within the Inflation Unit.
These changes include the addition of resistors, fuses, capacitors,
a voltage suppressor and an update to the circuit board layout.
There are no changes to the other materials or design elements of
this product as compared to the currently cleared PolarCath™
Peripheral Dilatation System. |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Support of
Substantial
Equivalence | Boston Scientific Corporation considers the proposed PolarCath™
Peripheral Dilatation System to be substantially equivalent to the
existing PolarCath™ Peripheral Dilatation System (K062594,
Cleared September 28, 2006). This assessment is based upon the
successful completion of verification testing (refer to Section 5.2
and Attachment 3) which assessed the function of inflation units
and their circuitry through 12 sequential runs, or inflations, of the
balloon. In addition, there have been no changes to the overall
design, function, material, intended use, labeling, or directions for
use of the PolarCath™ Peripheral Dilatation System. The changes
only affect the Inflation Unit circuit board and have been proven
not to adversely affect the function of the device. |
. .
.
.
.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three heads, representing the three branches of government. The eagle is surrounded by a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 3 2007
Boston Scientific Corp. c/o Ms. Monica Morrison Regulatory Affiars One Scimed Place Maple Grove, MN 55311
Re: K071042
PolarCath™ Peripheral Dilation System Regulation Number: 21 CFR 870.1250 Regulation Name: Peripheral Dilation Catheter Regulatory Class: Class II Product Code: LIT/DQY Dated: April 16, 2007 Received: May 29, 2007
Dear Ms. Morrison:
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
Page 2 - Ms. Monica Morrison
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 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerety Jours,
R
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
ATTACHMENT 2
Indications for Use Statement
K071042 510(k) Number:
PolarCath™ Peripheral Dilatation System Device Name:
Indications for Use:
The PolarCath™ Peripheral Dilatation System is indicated to dilate stenoses in the peripheral vasculature (iliac, femoral, popliteal, infrapopliteal, renal and subclavian arteries) and for the treatment of obstructive lesions of polytetrafluoroethylene (PTFE) access grafts or arteriovenous dialysis fistulae. The PolarCath™ Peripheral Dilatation System is also indicated for post-deployed stent expansion of self-expanding peripheral vascular stents.
Prescription Use X (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)
Divisio S/C
Division S/m-On)
Division of Cardiovascular Devices
510(k) Number K071042
Boston Scientific Corporation
CONFIDENTIAL
PolarCath™ Peripheral Dilatation System Page 11 of 14