(63 days)
Not Found
No
The summary describes a mechanical embolization device (platinum coils) and its components. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies focus on biocompatibility, bench-top testing, MRI compatibility, and animal studies, all typical for a mechanical implantable device.
Yes
The device is used for the "embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and arterial and venous embolizations in the peripheral vasculature", which are all treatments for medical conditions.
No
The device is an embolization system designed to treat neurovascular abnormalities and other arterial/venous embolizations by packing coils to achieve occlusion, which is a therapeutic rather than diagnostic function.
No
The device description explicitly states it consists of three physical components: a Coil Implant, a Detachment Pusher, and a Detachment Handle. The performance studies also focus on biocompatibility, bench-top testing of physical and mechanical properties, and MRI compatibility, all related to hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- POD System Function: The description clearly states the POD System is used for the embolization of blood vessels within the body. This is an in vivo procedure, meaning it is performed inside a living organism.
- Lack of IVD Characteristics: The description does not mention any testing of samples, analysis of biological markers, or any other activities associated with in vitro diagnostics.
The POD System is a device used for therapeutic intervention within the body, not for diagnostic testing of samples outside the body.
N/A
Intended Use / Indications for Use
The POD System is indicated for the embolization of:
- Intracranial aneurysms .
- Other neurovascular abnormalities such as arteriovenous malformations and . arteriovenous fistulae
- . Arterial and venous embolizations in the peripheral vasculature
Product codes
HCG, KRD
Device Description
The POD System functions to selectively embolize targeted segments of the vasculature by packing a sufficient quantity of soft platinum coils to achieve occlusion in an equivalent fashion to existing bare-platinum embolization coils. The POD System consists of three components: a Coil Implant attached to a Detachment Pusher and a Detachment Handle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracranial, neurovascular (e.g., arteriovenous malformations, arteriovenous fistulae), arterial and venous (peripheral 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)
Summary of Non-Clinical Data
As required under Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, a summary of any information regarding safety and effectiveness of the device follows.
Included in this section are descriptions of the testing's, which substantiates the safe and effective performance of the POD System as well as its substantial equivalence to the predicate devices:
- Biocompatibility
- Design Verification (Bench-Top Testing) .
- MRI Compatibility .
- Design Validation (GLP Animal Testing)
The subject POD System met all established requirements.
Biocompatibility Testing
Non-clinical testing found POD to be biocompatible according to the requirements of EN ISO 10993 requirements. Biocompatibility for POD was derived from studies on the predicate device. Studies, were selected in accordance with EN ISO 10993 -1 guidelines (Biological Evaluation of Medical Devices). All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices. All tests performed passed.
Bench-top Testing
The physical, mechanical and performance testing of the POD System components demonstrate that the devices are substantially equivalent to the currently marketed predicate devices.
Design Verification testing was conducted to evaluate the physical and mechanical properties of POD System components. 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. All tests performed yielded 100% Pass results.
MRI Compatibility
Penumbra consulted with an MR scanning expert and concluded minor design changes will have no impact on RF heating, and the same MRI conditions that are safe for the Penumbra Coil System Coil Implants arrays will also be safe for the POD Coil Implants.
Design Validation (GLP Animal Testing)
The existing Penumbra Coil System GLP animal study fully characterizes the POD System's interaction with the vasculature. No additional animal testing is required for the POD System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5950 Neurovascular embolization device.
(a)
Identification. A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 882.1(e).
0
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 POD™ System.
Sponsor/Applicant Name and Address
Penumbra, Inc. 1351 Harbor Bay Parkway Alameda, CA 94502, USA
Sponsor Contact Information
Charles DeNault Regulatory Affairs Specialist . Phone: (510) 748-3302 Fax: (510) 217-6414 Email: cdenault@penumbrainc.com
Date of Preparation of 510(k) Summary
April 30, 2014
Device Trade or Proprietary Name
POD™ System
Device Classification
II Regulatory Class: Classification Panel: Neurology Neurovascular/vascular embolization device Classification Name: 21 CFR 882.5950, 21 CFR 870.3300 Regulation Number: Product Code: HCG, KRD
Predicate Devices
| 510(k) Number /
Clearance Date | Name of Predicate Device | Name of
Manufacturer |
|-----------------------------------|--------------------------|-------------------------|
| K103305 / 26-Jan-2011 | Penumbra Coil System | Penumbra, Inc. |
| K120330 / 02-Apr-2012 | Penumbra Coil System | Penumbra, Inc. |
1
Predicate Comparison
| Penumbra Coil System | POD System | |
|---|---|---|
| 510(k) No. | K103305 & K120330 | To be determined |
| Classification | Class II, HCG, KRD | Same |
| Indication | Indicated for the endovascular | |
| embolization of: | ||
| • Intracranial aneurysms | ||
| • Other neurovascular abnormalities such | ||
| as arteriovenous malformations and | ||
| arteriovenous fistulae | ||
| •Arterial and venous embolizations in the | ||
| peripheral vasculature | Same | |
| Materials | ||
| Coil | Platinum/Tungsten, Nitinol | Same |
| Detachment Pusher | Stainless steel, Polymer, | |
| Platinum/Iridium, Nitinol | Same | |
| Detachment Handle Shell/Funnel | Plastic | |
| Dimensions/Shape | ||
| Coil Secondary Length | 1-60 cm | Same |
| Coil Secondary Diameter | 2-32 mm | 4-8 mm* |
| Coil Secondary Shape | Complex (Standard, Soft, Extra Soft), | |
| Helical (Curve), J | Complex | |
| Accessories | ||
| Introducer Sheath | Polypropylene (color: orange) | Same |
| Packaging Materials | ||
| Coil Hoop | Polyethylene | Same |
| Pouch | Polyester/Polyethylene/Tyvek | Same |
| Display Carton | SBS Paperboard | Same |
| Sterilization/Shelf Life | ||
| Sterilization Method | EtO | Same |
| Shelf Life | 8 years | Same |
*The proximal segment of the coil will have a reduced secondary diameter
Device Description
ﮨ
The POD System functions to selectively embolize targeted segments of the vasculature by packing a sufficient quantity of soft platinum coils to achieve occlusion in an equivalent fashion to existing bare-platinum embolization coils. The POD System
2
consists of three components: a Coil Implant attached to a Detachment Pusher and a Detachment Handle.
Intended Use
The POD System is indicated for the embolization of:
- Intracranial aneurysms .
- Other neurovascular abnormalities such as arteriovenous malformations and . arteriovenous fistulae
- . Arterial and venous embolizations in the peripheral vasculature
Summary of Non-Clinical Data
As required under Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, a summary of any information regarding safety and effectiveness of the device follows.
Included in this section are descriptions of the testing's, which substantiates the safe and effective performance of the POD System as well as its substantial equivalence to the predicate devices:
- . Biocompatibility
- Design Verification (Bench-Top Testing) .
- MRI Compatibility .
- . Design Validation (GLP Animal Testing)
The subject POD System met all established requirements.
Biocompatibility Testing
Non-clinical testing found POD to be biocompatible according to the requirements of EN ISO 10993 requirements. Biocompatibility for POD was derived from studies on the predicate device. Studies, were selected in accordance with EN ISO 10993 -1 guidelines (Biological Evaluation of Medical Devices). All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices. The following tests were performed:
3
| Test | Pass/Fail |
|---|---|
| In Vitro Cytotoxicity (MEM Elution) | Pass |
| Sensitization (Kligman Maximization) | Pass |
| Irritation (Intracutaneous Reactivity) | Pass |
| Systemic Toxicity | |
| Acute Toxicity (ISO Systemic Injection) | Pass |
| In Vivo Sub-acute / Sub-chronic Toxicity | Pass |
| Sub-chronic Toxicity Subchronic (30-Day) | Pass |
| Intravenous Toxicity Study - Mice | Pass |
| Materials Mediated Pyrogen - Rabbit | Pass |
| Genotoxicity | |
| Mouse Lymphoma | Pass |
| Ames Mutagenicity | Pass |
| In Vivo Mouse Micronucleus | Pass |
| Implantation GLP Study - Penumbra Coil | |
| System in Swine Venous Pouch Aneurysm | |
| Model | Pass |
| Intramuscular Implant Test 13 Week Duration | Pass |
| Hemocompatibility | |
| Hemolysis | Pass |
| Complement Activation | Pass |
| Dog Thrombogenicity | Pass |
Bench-top Testing
The physical, mechanical and performance testing of the POD System components demonstrate that the devices are substantially equivalent to the currently marketed predicate devices.
Design Verification testing was conducted to evaluate the physical and mechanical properties of POD System components. 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 POD System components included:
| Attribute | Specification | Results |
|---|---|---|
| Dimensional / Visual | ||
| Inspection | These evaluations confirm that the units used in this Design | |
| Verification testing meet all inspection criteria for release of | ||
| finished goods (clinically acceptable) product. | 100% Pass | |
| Fatigue Testing | The Coil Implant shall retain its secondary shape after being | |
| cycled into/out of introducer sheath 5 times | 100% Pass | |
| Friction Testing | Push/pull friction acceptable through an 0.025in ID | |
| microcatheter | 100% Pass | |
| Stiffness Testing | Appropriate stiffness per coil specifications | 100% Pass |
| Simulated Use Flow Model | ||
| Testing | These evaluations confirm that the units used in this Design | |
| Verification testing meet all inspection criteria for release of | 100% Pass |
4
| Attribute | Specification | Results |
|---|---|---|
| finished goods (clinically acceptable) product. | ||
| Coil Dimensional Inspection | ||
| (after simulated use testing) | These evaluations confirm that the units used in this Design | |
| Verification testing withstood the simulated use testing | 100% Pass | |
| Distal System Tensile Test | Coil Implant and Detachment Pusher joints has sufficient | |
| tensile strength' | 100% Pass |
All testing met specification. The results of the tests appropriately address the physical and mechanical performance expectations of the device. Based on these overall results, the physical and mechanical properties of the POD System are acceptable for the intended use and substantially equivalent to the predicate devices.
MRI Compatibility
Penumbra consulted with an MR scanning expert and concluded minor design changes will have no impact on RF heating, and the same MRI conditions that are safe for the Penumbra Coil System Coil Implants arrays will also be safe for the POD Coil Implants.
Design Validation (GLP Animal Testing)
The existing Penumbra Coil System GLP animal study fully characterizes the POD System's interaction with the vasculature. No additional animal testing is required for the POD System.
Summary of Substantial Equivalence
The POD System is substantially equivalent to the predicate devices with regard to intended use, operating principle, design concept, materials, shelf-life, packaging and sterilization processes.
5
Image /page/5/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with outstretched arms, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 3, 2014
Penumbra, Inc. Mr. Charles Denault Regulatory Affairs Specialist 1351 Harbor Bay Parkway Alameda, California 94502
Re: K141134
Trade/Device Name: POD system Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG and KRD Dated: June 4, 2014 Received: June 6, 2014
Dear Mr. Denault:
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.
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 devicerelated adverse events) {21 CFR 803); good manufacturing practice requirements as set forth in
6
Page 2 - Mr. Charles Denault
the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Felipe Aquel -S
Carlos L. Peña, PhD, MS for Director Division of Neurological
and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K141134
Device Name POD (Penumbra Occlusion Device) System
Indications for Use (Describe) The POD System is indicated for the embolization of:
Intracranial aneurysms
Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae
Arterial and venous embolizations in the peripheral vasculature
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
pe Aguel -S Date: 2014.07.03 12:31:39
04'00'
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