(28 days)
No
The device description focuses on the mechanical components and function of a balloon catheter, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is indicated to dilate stenosis and treat obstructive lesions, directly impacting a physiological function to improve health.
No
The device is a Pheron PTA balloon catheter, which is used to dilate stenosis in arteries and treat obstructive lesions. This is a therapeutic function, not a diagnostic one.
No
The device description clearly details a physical balloon catheter with various hardware components (balloon, shaft, lumens, ports, radiopaque markers, tip, coating). There is no mention of software as the primary or sole component of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Pheron PTA balloon catheter is a medical device used directly within the body to physically dilate narrowed arteries and treat obstructive lesions. It is an interventional device, not a diagnostic one that analyzes samples outside the body.
- Intended Use: The intended use clearly describes a procedure performed in vivo (within a living organism) to treat a physical condition.
- Device Description: The description details the physical components and function of a catheter designed for insertion into blood vessels.
- Input Imaging Modality: Fluoroscopic visualization is used to guide the placement of the device within the body, not to analyze a sample.
Therefore, based on the provided information, the Pheron PTA balloon catheter is a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Pheron PTA balloon catheter is indicated to dilate stenosis in the renal, iliac, femoral, popliteal and infrapopliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Product codes
LIT, DQY
Device Description
The Pheron Percutaneous Transluminal Angioplasty (PTA) balloon catheter is indication of stendlic seqments in peripheral vessels. The dilatation balloon is designed to inflate to a known diameter at a specific inflation pressure consistent with the compliance chart on the label. Two radiopaque markers are located at either end of the ballitate fluoroscopic visualization and positioning of the balloon catheter towards and across the lesion. The balloon catheter includes a tapered soft tip to facilitate advancement of the catheter.
The balloon catheter shaft has two Luer ports at the proximal end. One port (inflation port) serves for connecting an inflation device to inflate/deflate the balloon. The other port enables insertion of the guide wire lumen. The balloon catheter is a dual lumen design, with both lumens contained within one tube. The smaller lumen is the balloon inflation lumen, as described above. The larger lumen permits the use of guide wires with a maximum diameter of 0.035" to facilitate advancement of the balloon catheter towards and through the lesion(s) to be dilated. The balloon catheter is compatible with introducer sheath (introducer) sizes according to the recommendations on the label. The balloon catheter has a BIOC (silicone) coating to improve the trackability characteristics.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopic visualization
Anatomical Site
renal, iliac, femoral, popliteal and infrapopliteal arteries; 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)
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
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OCT 3 1 2003
Ko33217
BIOTRONIK, Inc., Pheron Peripheral PTA Catheter, 510(k)
October 2, 2003
Pheron Peripheral Percutaneous Transluminal Angioplasty (PTA) Catheter 510(k) Premarket Notification
510(K) SUMMARY 1.
Name and Address of Sponsor:
BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035
Establishment Registration Number:
1028232
Device Name:
Proprietary Name: Classification: Classification Name: Product Code:
October 2, 2003
Date Prepared:
Pheron PTA Catheter Class II (21 CFR 870.1250) Percutaneous Catheter LIT; DQY
General Description:
The Pheron Percutaneous Transluminal Angioplasty (PTA) balloon catheter is indication of stendlic seqments in peripheral vessels. The dilatation balloon is designed to inflate to a known diameter at a specific inflation pressure consistent with the compliance chart on the label. Two radiopaque markers are located at either end of the ballitate fluoroscopic visualization and positioning of the balloon catheter towards and across the lesion. The balloon catheter includes a tapered soft tip to facilitate advancement of the catheter.
The balloon catheter shaft has two Luer ports at the proximal end. One port (inflation port) serves for connecting an inflation device to inflate/deflate the balloon. The other port enables insertion of the guide wire lumen. The balloon catheter is a dual lumen design, with both lumens contained within one tube. The smaller lumen is the balloon inflation lumen, as described above. The larger lumen permits the use of guide wires with a maximum diameter of 0.035" to facilitate advancement of the balloon catheter towards and through the lesion(s) to be dilated. The balloon catheter is compatible with introducer sheath (introducer) sizes according to the recommendations on the label. The balloon catheter has a BIOC (silicone) coating to improve the trackability characteristics.
BIOTRONIK proposes the following PTA catheter cleared through 510(k) notifications as a predicate device for the Pheron Peripheral PTA Catheter:
Indication for Use:
The Pheron PTA balloon catheter is indicated to dilate stenosis in the renal, iliac, femoral, popliteal and infrapopliteal arteries and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae.
Name and Address of Manufacturing Site:
BIOTRONIK GmbH & Co. (reg. no. 9610139) Woermannkehre 1, 12359 Berlin, Germany 011-49-30-689-05-304
Name and Address of Contract Manufacturing Site:
BIOTRONIK AG (reg. no. 8043892) Ackerstrasse 6 8180 Bülach, Switzerland 011-41-1-864-5247
Contact Person and Phone Number:
Jon Brumbaugh Director, Regulatory Affairs Fax (503) 635-9936 Phone (888) 345-0374
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. 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 emblem featuring three curved shapes that resemble a bird or abstract human figures. The emblem is black, and the text is also in black.
OCT 3 1 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biotronik, Inc. c/o Mr. Jon Brumbaugh Director, Regulatory Affairs 6024 Jean Road Oswego. OR 97035
Re: K033217
Pheron PTA Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: October 2, 2003 Received: October 3, 2003
Dear Mr. Brumbaugh:
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.
2
Page 2 - Mr. Jon Brumbaugh
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 (301) 594-4648. 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/dsma/dsmamain.html
Sincerely yours,
Ashley B. Braun
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page_ __of_1
510(k) Number (if known):__
Device Name: Pheron Peripheral Percutaneous Transluminal Angioplasty (PTA) Catheter
Indications For Use:
: : : : :
The Pheron PTA balloon catheter is indicated to dilate stenosis in the renal, iliac, femoral, popliteal and infrapopliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use |
|---|
| (Per 21 CFR 801.109) |
(Optional Format 3-10-98)
Division of Cardiovascular & Respiratory Devices
510(K) Number _______________________________________________________________________________________________________________
Adelle B. Evans laboz
Division of Cardiovascular Devices
510(k) Number_1(0532(7