(111 days)
Not Found
No
The description focuses on the physical characteristics and mechanical performance of a catheter, with no mention of AI/ML or data processing.
Yes
The device is intended to assist in the delivery of therapeutic agents.
No
The device is intended to assist in the delivery of diagnostic and therapeutic agents, not to perform a diagnostic function itself.
No
The device description clearly details a physical catheter with specific dimensions, materials, and accessories, indicating it is a hardware medical device, not software-only.
Based on the provided information, the Penumbra Catheter 025 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for assisting in the delivery of diagnostic and therapeutic agents within the peripheral and neuro vasculature. This is an in vivo application (within a living organism), not an in vitro application (outside of a living organism, typically in a lab setting).
- Device Description: The description details a catheter designed for insertion into blood vessels, which is consistent with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples of blood, tissue, or other bodily fluids outside of the body to diagnose a condition.
IVD devices are used to perform tests on samples taken from the body to provide information for diagnosis, monitoring, or screening. The Penumbra Catheter 025 is a delivery system used directly within the body.
N/A
Intended Use / Indications for Use
The Penumbra Catheter 025 is intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils to the peripheral and neuro vasculature.
Product codes
DQY
Device Description
The Penumbra Catheter 025 is a variable stiffness, coil reinforced catheter with a maximum distal outer diameter of 0.040" and a maximum proximal outer diameter of 0.045". It is available with an inner diameter of 0.025". The Penumbra Catheter 025 has a PTFE-lined lumen, is coil re-enforced, flexible, and hydrophilically coated. The Penumbra Catheter 025 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, tip shaping mandrel and introducer sheath.
The Penumbra Catheter 025 will be available in various tip configurations including straight, 45°, 90° and J, to allow physician ease of device tracking to the target site. The Penumbra Catheter 025 is sterile, non-pyrogenic and intended for single use only.
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:
Biocompatibility tests were conducted in accordance with ISO-10993 -1 guidelines for limited duration (
§ 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
Kloozze.
Penumbra Catheter 025
510(K) SUMMARY
Penumbra
JUL 1 3 2010
(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 Penumbra Cather 025.
1.1 Sponsor/Applicant Name and Address
Penumbra Inc.
1
1351 Harbor Bay Parkway Alameda, CA 94502
1.2 Sponsor Contact Information
Seth A. Schulman Director, Regulatory Affairs Phone: 510-748-3223 FAX: 510-217-6414 email: seth.schulman@penumbrainc.com
1.3 Date of Preparation of 510(k) Summary
March 22, 2010
Device Trade or Proprietary Name 1.4
TBD
Device Common/Usual or Classification Name ાં ડ
Catheter, Percutaneous (Product Code: DQY)
1
Identification of the Legally Marketed Devices to which Equivalence 1.6 is Being Claimed:
| Name of Predicate Device | Name of Manufacturer
(Town, State) | 510(k) Number |
|-----------------------------------------------|---------------------------------------------------|----------------------------------|
| Penumbra Neuron Intracranial
Access System | Penumbra, Inc
Alameda, CA | K070970,
K082290 &
K083125 |
| Excelsior SL-10 / 1018 | Boston Scientific
Neurovascular
Fremont, CA | K042568 |
1.7 Device Description:
Penu
The Penumbra Catheter 025 is a variable stiffness, coil reinforced catheter with a maximum distal outer diameter of 0.040" and a maximum proximal outer diameter of 0.045". It is available with an inner diameter of 0.025". The Penumbra Catheter 025 has a PTFE-lined lumen, is coil re-enforced, flexible, and hydrophilically coated. The Penumbra Catheter 025 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, tip shaping mandrel and introducer sheath.
The Penumbra Catheter 025 will be available in various tip configurations including straight, 45°, 90° and J, to allow physician ease of device tracking to the target site. The Penumbra Catheter 025 is sterile, non-pyrogenic and intended for single use only.
1.8 Intended Use:
The Penumbra Catheter 025 is intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils to the peripheral and neuro vasculature.
2
| | Excelsior SL-10 / 1018 | Penumbra Neuron
Intracranial Access
System | Penumbra Catheter
025 |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| 510(k) No. | K042568 | K070970, K082290 &
K083125 | To be determined |
| Classification | Class II, DQY | Class II, DQY | Class II, DQY |
| Indication | Boston Scientific's
Excelsior™ SL-10 Pre-
Shaped microcatheter
and Excelsior™ 1018™
Pre-Shaped
microcatheter are
intended to assist in the
delivery of diagnostic
agents, such as contrast
media, and therapeutic
agents, such as occlusion
coils to the peripheral,
coronary, and neuro
vasculature. | The Neuron™
Intracranial Access
System is indicated for
the introduction of
interventional devices ·
into the peripheral,
coronary, and neuro
vasculature. | Same as Excelsior SL-
10 / 1018 |
| Materials | | | |
| - Catheter Shaft/Hub | Thermoplastic,
hydrophilic coating | Nylon, PTFE,
Polyurethane,
hydrophilic coating | SAME |
| - Catheter shaft support | Metal | Stainless Steel | Nitinol |
| - Catheter Markerband | Platinum / Iridium | Platinum / Iridium | SAME |
| - Packaging | PET/PE/Tyvek pouch,
polyethylene hoop,
SBS carton | PET/PE/Tyvek pouch,
polyethylene hoop,
SBS carton | SAME
(A PET Tray is used
instead of the PE Hoop) |
| Sterilization | EtO | EtO | SAME |
| Shelf Life | 36 Months | 36 Months | SAME |
1.9 Comparison to Predicate Devices
1.10 Summary of Non-clinical Data
1.10.1 Biocompatibility
Biocompatibility tests conducted with the Penumbra Catheter 025 were selected in accordance with ISO-10993 -1 guidelines (Biological Evaluation of Medical Devices) for limited duration (In vivo
thrombogenicity | Non-Thrombogenic |
| Pyrogenicity | USP Material
Mediated Rabbit
Pyrogen Test | Non-Pyrogenic |
ISO-10993 GLP Testing Summary for Penumbra Catheter 025
In summary, non-clinical testing found the Penumbra Catheter 025 to be non-cytotoxic, non-mutagenic, non-reactive (short and long-term implantation), nonsensitizing, a negligible irritant, non-pyrogenic, and non-toxic (acute systemic).
1.10.2 Design Verification (Bench-Top Testing)
The physical, mechanical and performance testing of the Penumbra Catheter 025 demonstrates that the product is substantially equivalent to the currently marketed predicate devices:
Design Verification testing was conducted to evaluate the physical and mechanical properties of the Penumbra Catheter 025. All studies were conducted using good scientific practices and statistical sampling methods as required by the Penumbra Design Control procedures. All testing was performed using units which were 2x sterilized and met finished goods release requirements. The tests performed on the Penumbra Catheter 025 included:
- . Dimensional / Visual Inspection
4
Penumbra Catheter 025
-
Trackability .
Penumbra -
Friction .
-
Torsion .
-
Joint Tensile Strength .
-
Catheter Burst .
-
Catheter Flow Rate .
-
Catheter Elongation .
-
Kink Resistance .
-
Corrosion .
-
GLP Simulated Use .
All tests performed passed successfully.
The physical, mechanical and performance testing of the subject Penumbra Catheter 025 demonstrate that the product is safe and effective for its labeled indications and is Substantially Equivalent to the currently marketed predicate devices.
5
Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL 1 3 2010
Penumbra, Inc. c/o Seth A. Schulman Director, Regulatory Affairs 1351 Harbor Bay Parkway Alameda, CA 94502
Re: K100826
Trade/Device Name: Penumbra Catheter 025 Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: March 22, 2010 Received: March 24, 2010
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 general controls provisions 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 warranties. We remind you, however, 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 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.
6
Page 2 - Mr. Seth Schulman
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); 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 yours,
via R. Vorher
Image /page/6/Picture/8 description: The image contains a close-up of a handwritten letter 'B' next to a symbol that looks like a cursive letter 'C'. The letter 'B' is in uppercase and appears to be written in a simple, clear font. The cursive 'C' is slightly more stylized and is positioned to the left of the 'B'.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Image /page/7/Picture/1 description: The image shows the word "Penumbra" in a simple, sans-serif font. To the right of the word, there is a horizontal line that connects to a circular logo. The logo contains a stylized letter "P" inside the circle.
STATEMENT OF INDICATION FOR USE
Indications for Use
510(k) Number (if known): Not Yet Assigned K100826
Device Name: Penumbra Catheter 025 (Trade Name TBD)
Indications for Use:
2
The Penumbra Catheter 025 is intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils to 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)
p. ladner
sion Sign-Off Division Sign-On)
Sign-Only
510(k) Number K700826
Page | of |
Proprietary and Confidential DOCUMENT INFO: Penumbra Catheter 025 510K FINAL.DOC