(133 days)
Not Found
No
The document describes a physical medical device (a catheter) and its mechanical function, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as assisting in temporary occlusion of blood flow and serving as a conduit for other devices, which are functional roles, not directly therapeutic.
No
The device is described as a guide catheter with a balloon for temporary occlusion of blood flow and a conduit for other devices; its purpose is interventional, not diagnostic.
No
The device description clearly details a physical catheter with a balloon, radiopaque markerband, and Luer hub, indicating it is a hardware device, not software only.
No, 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 Function: The Penumbra Balloon Guide Catheter is a device used inside the body (in vivo) during a medical procedure. Its purpose is to temporarily block blood flow and provide a pathway for other devices within the neurovasculature.
- Lack of Specimen Testing: The description does not mention the device being used to analyze any biological specimens.
Therefore, based on the provided information, the Penumbra Balloon Guide Catheter is a surgical or interventional device, not an IVD.
N/A
Intended Use / Indications for Use
The Penumbra Balloon Guide Catheter is indicated for temporary occlusion of blood flow and to serve as a conduit for devices used in the neurovasculature.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The Penumbra Balloon Guide Catheter is a coaxial-lumen, braid-reinforced, variable stiffness catheter with a radiopaque markerband on the distal end and bifurcated Luer hub on the proximal end. A semi-compliant balloon is flush mounted on the distal end. During use, the balloon may be inflated to temporarily occlude blood flow, and the catheter lumen may be used to provide a conduit for passage of vascular devices. The design combines the features of a guide catheter with the features of a semi-compliant balloon catheter.
Materials used in the Penumbra Balloon Guide Catheter are manufactured from medical grade materials that are commonly used in the industry, are similar or identical to the predicate device, and have historically been demonstrated to be both biocompatible and suitable for this use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neurovasculature
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, in vitro testing, and in vivo testing have been performed on the device materials, components, subassemblies, and final assemblies. The devices tested acceptably met the specifications.
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
1/2
Penumbra
510(k) Summary
77 0.7000
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(c)
| 510(k) Number | K053491 |
|---|---|
| Date Summary Prepared | April 20, 2006 |
| Trade Name | Penumbra Balloon Guide Catheter |
| Common Name | Balloon Guide Catheter |
| Classification Name | Percutaneous Catheter, Balloon Type Catheter |
| (21 CFR Part 870.1250, 21CFR 878.4200; Product | |
| Code DQY) | |
| Submitted By | Penumbra, Inc. |
| 2401 Merced Street, Suite 200 | |
| San Leandro, CA 94577 | |
| Contact | Theresa Brander-Allen |
| VP of Regulatory and Quality | |
| Tel: 510-618-3223 | |
| Fax: 510-352-1766 | |
| tballen@penumbrainc.com |
Predicate Device Concentric Balloon Guide Catheter (K021899) Manufactured by Concentric Medical, Inc.
Device Description
The Penumbra Balloon Guide Catheter is a coaxial-lumen, braid-reinforced, variable stiffness catheter with a radiopaque markerband on the distal end and bifurcated Luer hub on the proximal end. A semi-compliant balloon is flush mounted on the distal end. During use, the balloon may be inflated to temporarily occlude blood flow, and the catheter lumen may be used to provide a conduit for passage of vascular devices. The design combines the features of a guide catheter with the features of a semi-compliant balloon catheter.
Materials used in the Penumbra Balloon Guide Catheter are manufactured from medical grade materials that are commonly used in the industry, are similar or identical to the predicate device, and have historically been demonstrated to be both biocompatible and suitable for this use.
1
Image /page/1/Picture/0 description: The image shows the word "Penumbra" in a bold, sans-serif font. Above the word is a curved line, resembling an arc or a smile. The text and the line are both black, contrasting with the white background.
2/2
Intended Use
The Penumbra Balloon Guide Cathcter is indicated for temporary occlusion of blood flow and to serve as a conduit for devices used in the neurovasculature. The indication statement of the Penumbra Balloon Guide Catheter is substantially equivalent to the legally marketed predicate device.
Substantial Equivalence
The intended use, method of operation, methods of construction and materials used, are either identical or substantially equivalent to the existing, legally marketed, predicate device. Therefore, Penumbra believes the Penumbra Balloon Guide Catheter is substantially equivalent to the predicate device.
Testing
Bench testing, in vitro testing, and in vivo testing have been performed on the device materials, components, subassemblies, and final assemblies. The devices tested acceptably met the specifications.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with three intertwined strands and a bird-like figure at the top. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2 7 206
Penumbra, Inc. c/o Ms. Theresa Brandner-Allen VP of Regulatory and Quality 2401 Merced Street - Suite 200 San Leandro, California 94577
Re: K053491
Trade/Device Name: Penumbra Balloon Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II Product Code: DOY Dated: March 29, 2006 Received: March 30, 2006
Dear Ms. Brandner-Allen:
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.
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 r, good manufacturing practice requirements as set
3
Page 2 -- Ms. Theresa Brandner-Allen
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) 276-0115. 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,
Mark H. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image shows the word "Penumbra" in a bold, sans-serif font. Above the word is a curved line, resembling an arc or a stylized representation of a shadow. The text and the line are both black against a white background, creating a high-contrast image.
K053 461
4/3
Indications for Use
510(k) Number (if known): K053491
Device Name:
Penumbra Balloon Guide Catheter
Indications for Use:
The Penumbra Balloon Guide Catheter is indicated for temporary occlusion of blood flow and to serve as a conduit for devices used in the neurovasculature.
Prescription Use _X (Per 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
:11V 3
Page 1 of 1