(80 days)
Not Found
Not Found
No
The description focuses on the mechanical components and intended use of a balloon catheter, with no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No
The device is used for temporary vessel occlusion, chemotherapeutic drug infusion, and renal opacification procedures, which are not therapeutic in nature. While it facilitates chemotherapy, it is not directly delivering the therapy itself.
No
The device is used for temporary vessel occlusion, contrast medium infusion, or delivery of other agents, which are therapeutic or procedural support functions, not diagnostic ones.
No
The device description clearly outlines physical components such as a catheter shaft, luer fittings, a balloon, and a syringe, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used in vivo (within the body) for temporary vessel occlusion during various medical procedures like arteriography, hemorrhage control, and drug infusion.
- Device Description: The description details a catheter with a balloon designed to be inserted into a vessel.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests outside the body on biological samples. This device is clearly designed for direct intervention inside the body.
N/A
Intended Use / Indications for Use
Occlusion Balloon Catheters are indicated for use for temporary vessel occlusion in applications including arteriography, preoperative occlusion, emergency control of hemorrhage, chemotherapeutic drug infusion and renal opacification procedures.
The Occlusion Balloon Catheter product line consists of two specific designs – Standard Occlusion Balloons and Berenstein™ Occlusion Balloon Catheters.
Only the Berenstein Occlusion Balloon Catheter has been designed for coaxial delivery of small catheters or embolic agents.
Product codes
DQY
Device Description
The proposed devices are constructed of a dual lumen catheter shaft to which two luer fittings are attached proximately and a soft compliant balloon is mounted on the distal end of the shaft. The tubing marked BALLOON is the balloon inflation lumen. The tubing marked DISTAL is the central lumen. The central lumen is used to pass the catheter over a guidewire. This lumen can also be used for infusion of contrast medium or, in the case of the Berenstein Occlusion Balloon Catheter, coaxial delivery of small catheters or embolic agents.
As are the predicated devices, the proposed devices are provided with 1.25ml syringe. There are no changes to this accessory proposed in this submission
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessel
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)
Occlusion Balloon Catheters have been tested and compared to the predicate devices. All data gathered demonstrate this device as substantially equivalent. No new issues of safety or efficacy have been raised.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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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Special 510(k) Premarket Notification Occlusion Balloon Catheter
| 510(k) Summary OCT 20 2006 | |
|---|---|
| General | |
| Provisions | Trade Name: To be determined |
| Classification Name: Percutaneous Catheter | |
| Name of | |
| Predicate Devices | Occlusion Balloon Catheter, Van-Tec Occlusion Balloon Catheter |
| Classification | Class II |
| Performance | |
| Standards | Performance Standards have not been established by FDA under Section 514 of the |
| Food, Drug and Cosmetic Act. | |
| Intended Use | Occlusion Balloon Catheters are indicated for use for temporary vessel occlusion |
| in applications including arteriography, preoperative occlusion, emergency control | |
| of hemorrhage, chemotherapeutic drug infusion and renal opacification procedures. |
The Occlusion Balloon Catheter product line consists of two specific designs –
Standard Occlusion Balloons and Berenstein™ Occlusion Balloon Catheters.
Only the Berenstein Occlusion Balloon Catheter has been designed for coaxial
delivery of small catheters or embolic agents. |
| Device
Description | The proposed devices are constructed of a dual lumen catheter shaft to which two
luer fittings are attached proximately and a soft compliant balloon is mounted on
the distal end of the shaft. The tubing marked BALLOON is the balloon inflation
lumen. The tubing marked DISTAL is the central lumen. The central lumen is used
to pass the catheter over a guidewire. This lumen can also be used for infusion of
contrast medium or, in the case of the Berenstein Occlusion Balloon Catheter,
coaxial delivery of small catheters or embolic agents.
As are the predicated devices, the proposed devices are provided with 1.25ml
syringe. There are no changes to this accessory proposed in this submission |
| Biocompatibility | Occlusion Balloon Catheters have been tested for biocompatibility per ISO 10993.
All data demonstrate this device is biocompatible for its intended use. |
| Summary of
Substantial
Equivalence | Occlusion Balloon Catheters have been tested and compared to the predicate
devices. All data gathered demonstrate this device as substantially equivalent. No
new issues of safety or efficacy have been raised. |
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 0 2006
Boston Scientific Corporation c/o Mr. Nicholas Condakes 100 Boston Scientific Way Marlborough, MA 01752
Re: K062202
Occlusion Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (Two) Product Code: DQY Dated: September 26, 2006 Received: September 27, 2006
Dear Mr. Condakes:
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.
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Page 2 - Mr. Condakes
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 nf 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Duna R. lochner
Image /page/2/Picture/5 description: The image shows a handwritten signature. The signature is composed of a series of curved lines and loops, forming an abstract shape. The signature is written in black ink on a white background.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Special 510(k) Premarket Notification Occlusion Balloon Catheter
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Indications For Use
| 510(k) Number (if known) | Unknown K062202 |
|---|---|
| Device Name: | Occlusion Balloon Catheter |
| Indications for Use | Occlusion Balloon Catheters are indicated for use for temporary vessel occlusion in applications including arteriography, preoperative occlusion, emergency control of hemorrhage, chemotherapeutic drug infusion and renal opacification procedures. |
| The Occlusion Balloon Catheter product line consists of two specific designs – Standard Occlusion Balloons and Berenstein™ Occlusion Balloon Catheters. | |
| Only the Berenstein Occlusion Balloon Catheter has been designed for coaxial delivery of small catheters or embolic agents. | |
| Prescription Use (Part 21 CFR 801 Subpart D) | X |
| 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)
duma R. whney
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K062202
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