(23 days)
Not Found
No
The device description and performance studies focus on the physical and mechanical properties of a catheter, with no mention of AI or ML capabilities.
No.
The device is a catheter used to introduce other interventional devices, and primarily aids in the delivery of a therapeutic device rather than providing therapy itself.
No
The PICA™ Catheter is indicated for the introduction of interventional devices, acting as a conduit rather than providing diagnostic information.
No
The device description clearly details a physical catheter with material specifications, dimensions, and mechanical properties, indicating it is a hardware medical device.
Based on the provided information, the PICA™ Catheter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the "introduction of interventional devices into the peripheral and neuro vasculature." This describes a device used within the body for a therapeutic or interventional procedure, not for testing samples outside the body.
- Device Description: The description details a catheter designed for insertion into blood vessels to facilitate the delivery of other devices. This is consistent with an in-vivo medical device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. The PICA Catheter's function is purely mechanical and procedural within the vascular system.
N/A
Intended Use / Indications for Use
The PICA™ Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
Product codes (comma separated list FDA assigned to the subject device)
DQY, LIT
Device Description
The PICA Catheter is a variable stiffness catheter with an outer diameter of 0.056in, has a catheter shaft reinforced with a stainless steel coil, and has a radiopaque markerband on the distal end. It is available with an inner diameter of 0.041 in and in various lengths. The PICA Catheter has a PTFE-lined lumen, which is coil re-enforced, flexible, and hydrophilically coated. The PICA Catheter is inserted through a guide catheter or vascular sheath, provides access to the target site and once in place, provides a reinforcing conduit for other intravascular devices. The device is provided sterile and includes a rotating hemostasis valve and tip shaping mandrel. The PICA Catheter will be available in various configurations to allow physician ease of device tracking to the target site
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral and neuro 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)
Biocompatibility tests conducted for the PICA Catheter were selected in accordance with ISO-10993 -1 guidelines (Biological Evaluation of Medical Devices) for external communicating devices contacting circulating blood. All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices.
Non-clinical testing found the PICA Catheter to be biocompatible and non-pyrogenic. The physical, mechanical and performance testing of the subject PICA Catheter demonstrate that the product is safe and effective for its labeled indications and is Substantially Equivalent to the currently marketed predicate devices.
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.
K072718 & K090752, K070970, K082290 & K083125
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
Image /page/0/Picture/0 description: The image contains a sequence of handwritten digits. The digits appear to be '093970'. The handwriting style is somewhat cursive, with some connections between the digits. The image is in black and white.
Image /page/0/Picture/1 description: The image shows the logo for Penumbra. The logo consists of the word "Penumbra" in a bold, sans-serif font, with the tagline "the path is clear" underneath in a smaller font. To the right of the text is a circular graphic with a stylized "P" inside. The logo is simple and modern, with a focus on clarity and readability.
JAN 1 5 2010
PICA™ Catheter
10 510(K) SUMMARY
(as required by 21 CFR 807.92)
Pursuant to Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, Penumbra Inc. is providing the summary of Substantial Equivalence for the PICA Catheter.
10.1 Sponsor/Applicant Name and Address
Penumbra Inc. 1351 Harbor Bay Parkway Alameda, CA 94502
10.2 Sponsor Contact Information
Seth A. Schulman Director, Regulatory Affairs Phone: 510-748-3223 FAX: 510-217-6414 email: seth.schulman@penumbrainc.com
. 10.3 Date of Preparation of 510(k) Summary
December 22, 2009
10.4 Device Trade or Proprietary Name
PICA™ Catheter
10.5 Device Common/Usual or Classification Name
Catheter, Percutaneous (Product Code: DQY)
1
Image /page/1/Picture/1 description: The image contains the word "Penumbra" in a bold, sans-serif font. Below the word "Penumbra" is the phrase "the path is clear" in a smaller, less bold font. To the right of the word "Penumbra" is a circular logo with a stylized letter "P" inside.
10.6 Identification of the Legally Marketed Devices to which Equivalence is Being Claimed:
| Name of Predicate Device | Name of Manufacturer
(Town, State) | 510(k) Number |
|-----------------------------------------|---------------------------------------|----------------------------------|
| Penumbra System Reperfusion
Catheter | Penumbra, Inc
Alameda, CA | K072718 &
K090752 |
| Neuron™ Intracranial Access
System | Penumbra, Inc
Alameda, CA | K070970,
K082290 &
K083125 |
10.7 Device Description:
The PICA Catheter is a variable stiffness catheter with an outer diameter of 0.056in, has a catheter shaft reinforced with a stainless steel coil, and has a radiopaque markerband on the distal end. It is available with an inner diameter of 0.041 in and in various lengths. The PICA Catheter has a PTFE-lined lumen, which is coil re-enforced, flexible, and hydrophilically coated. The PICA Catheter is inserted through a guide catheter or vascular sheath, provides access to the target site and once in place, provides a reinforcing conduit for other intravascular devices. The device is provided sterile and includes a rotating hemostasis valve and tip shaping mandrel. The PICA Catheter will be available in various configurations to allow physician ease of device tracking to the target site
10.8 Intended Use:
The PICA™ Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
10.9 Summary of Non-clinical Data:
Biocompatibility tests conducted for the PICA Catheter were selected in accordance with ISO-10993 -1 guidelines (Biological Evaluation of Medical Devices) for external communicating devices contacting circulating blood. All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices.
Non-clinical testing found the PICA Catheter to be biocompatible and non-pyrogenic. The physical, mechanical and performance testing of the subject PICA Catheter demonstrate that the product is safe and effective for its labeled indications and is Substantially Equivalent to the currently marketed predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. 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 image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Penumbra, Inc. c/o Seth A. Schulman Director, Regulatory Affairs 1351 Harbor Bay Parkway Alameda, CA 94502
'JAN 1 5 2010
Re: K093970
Trade/Device Name: PICA Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (2) Product Code: LIT, DQY Dated: December 22, 2009 Received: December 23, 2009
Dear Mr. Schulman:
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 I ou may , dierelevy manns of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability addition. Teasonote: US/122 as , that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be may of subject to additions, 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 or any I cochar battle and seeguirements, including, but not limited to: registration and listing (21
3
Page 2 - Mr. Seth A. Schulman
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Dma R. Vilmer
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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Image /page/4/Picture/0 description: The image shows the logo for Penumbra. The word "Penumbra" is written in a bold, sans-serif font. Below the word "Penumbra" is the phrase "the path is clear" in a smaller, lighter font. To the right of the word "Penumbra" is a circular logo with a stylized "P" in the center.
PICA™ Catheter
STATEMENT OF INDICATION FOR USE
Indications for Use.
510(k) Number (if known): Not Yet Assigned - K 0 9 3 9 7 0
Device Name: PICA™ Catheter
Indications for Use:
2
The PICA™ Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over The Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duna R. Vihner
(Division Sign-Off) Division of Cardiovascular Devices
EiO(k) Number_ K093970
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