(23 days)
The PICA™ Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
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
Here's an analysis of the provided text regarding the PICA™ Catheter, focusing on acceptance criteria and the study that proves the device meets those criteria:
Important Note: The provided document is a 510(k) summary for a medical device (PICA™ Catheter) intended for market clearance, not an in-depth clinical study report. Therefore, it does not contain the detailed clinical study results, statistical analyses, or specific acceptance criteria (e.g., sensitivity, specificity, accuracy targets) that would typically be found in a performance study for an AI/ML device.
This document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing. It does not describe a study involving an AI model or human readers.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) summary for a catheter, the "acceptance criteria" are not framed in terms of AI model performance metrics like sensitivity, specificity, or AUC. Instead, for this type of device, acceptance criteria relate to its physical, mechanical, and biological properties to ensure safety and effectiveness.
| Acceptance Criteria Category | Reported Device Performance (PICA™ Catheter) |
|---|---|
| Biocompatibility | Found to be biocompatible. |
| Non-pyrogenicity | Found to be non-pyrogenic. |
| Physical Performance | Demonstrated to be safe and effective for labeled indications. (Details on specific physical tests like burst pressure, tensile strength, etc., are not provided in this summary but would have been performed). |
| Mechanical Performance | Demonstrated to be safe and effective for labeled indications. (Details on specific mechanical tests like flexibility, torqueability, trackability, etc., are not provided in this summary). |
| Substantial Equivalence | Found to be substantially equivalent to currently marketed predicate devices (Penumbra System Reperfusion Catheter and Neuron™ Intracranial Access System). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: This document does not describe a "test set" in the context of an AI/ML model where a dataset is used to evaluate algorithmic performance. The testing described is non-clinical performance testing of the device itself (e.g., mechanical, physical, biocompatibility). The sample sizes for these engineering and lab tests are not specified in this summary.
- Data Provenance: Not applicable in the context of clinical data provenance for an AI/ML model. The tests are described as "non-clinical data," conducted in accordance with ISO-10993-1 guidelines and 21 CFR, Part 58 (Good Laboratory Practices). This implies laboratory testing of the device components/assembly, not clinical patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not applicable as the document describes non-clinical laboratory testing of a mechanical device, not the evaluation of an AI algorithm against expert-established ground truth from clinical images/data. Ground truth in this context would be physical measurements and chemical analyses performed by trained technicians/scientists.
4. Adjudication Method for the Test Set
- Not applicable. There is no "adjudication method" in the context of consensus among experts for clinical data, as this document describes non-clinical testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- No. An MRMC study was not done. This device is a catheter, not an AI diagnostic or assistive tool. The document does not discuss AI assistance or human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No. This document describes a physical medical device (catheter), not an algorithm. Therefore, no standalone algorithm performance study was conducted or is relevant.
7. The Type of Ground Truth Used
- For the non-clinical testing: The "ground truth" would be established by validated laboratory methods and engineering specifications. For example, a successful biocompatibility test would mean the materials did not elicit a toxic response based on established biological assays. A mechanical test might verify that burst pressure exceeds a certain threshold. These are objective measurements against predefined engineering and biological standards.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" as this device is a physical catheter, not an AI/ML model that requires training.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set for an AI/ML model, the concept of establishing ground truth for it does not apply.
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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)
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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 ReperfusionCatheter | Penumbra, IncAlameda, CA | K072718 &K090752 |
| Neuron™ Intracranial AccessSystem | Penumbra, IncAlameda, 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.
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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
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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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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
Page 1 of 1
§ 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).