(60 days)
Not Found
No
The summary describes a mechanical embolization system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended for the embolization of various vascular abnormalities, which aligns with the definition of a therapeutic intervention.
No
Explanation: The device is described as an embolization coil system used for treating conditions like aneurysms and arteriovenous malformations by physically blocking blood flow. Its function is interventional/therapeutic, not diagnostic.
No
The device description explicitly lists physical components made of platinum, Nitinol, stainless steel, and polymer, which are hardware. The performance studies also focus on the physical and mechanical properties of these components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are 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 Description and Intended Use: The Penumbra Coil System is a physical device intended for embolization within the body. It is implanted directly into blood vessels to block blood flow to treat conditions like aneurysms and malformations. This is an in vivo procedure (within the living body).
The description clearly outlines a medical device used for a therapeutic procedure performed inside the patient's body, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
The Penumbra Coil System is intended 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 (comma separated list FDA assigned to the subject device)
HCG, KRD
Device Description
The Penumbra Coil System consists of the following components, which are sold separately:
- . Standard Complex Coils attached to detachment pusher
- . Soft Complex Coils attached to detachment pusher
- J Soft Coils attached to detachment pusher
- Curve Extra Soft Coils attached to detachment pusher .
- Curve Complex Extra Soft Coils attached to detachment pusher .
- Detachment Handle .
The coils are primarily manufactured from platinum wire and Nitinol wire. The coils are attached to a stainless steel / polymer detachment pusher. The coils are available in varying secondary diameters and shapes based on coil type.
The Penumbra Coils are sterile, non-pyrogenic and intended for single use only. The Penumbra Detachment Handle is sterile, non-pyrogenic and may be used to detach multiple coils within a single patient procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracranial, Neurovascular, Arterial, Venous
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 in accordance with ISO-10993 -1 guidelines for a blood contacting permanent implant device. Studies conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices. Results: Non-Toxic, Non-Sensitizing, Non-Irritant, Non-Mutagenic, No greater biological response than corresponding control, Non-Hemolytic, Non-Thrombogenic, Non-Pyrogenic.
Design Verification (Bench-Top Testing): Evaluated physical and mechanical properties. Tests performed on units which were 2x sterilized and met finished goods release requirements. Tests included: Dimensional / Visual Inspection (all sizes), Joint Tensile Strength, Fatigue, Friction, Torsion, Stiffness, Corrosion, Handle Function, MRI Compatibility, GLP Simulated Use. All tests performed passed successfully.
Key Results: The physical, mechanical and performance testing of the subject Penumbra Coil System demonstrate that the product is safe and effective for its labeled indications and is Substantially Equivalent to the currently marketed predicate device.
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
§ 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
K (20330
APR - 2 2012
1 510(k) Summary of Safety & Effectiveness
(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 Coil System/Penumbra Coil 400TM
1.1 Sponsor/Applicant Name and Address
Penumbra, Inc. 1351 Harbor Bay Parkway Alameda, CA 94502
Sponsor Contact Information 1.2
Emilly Tojima Nurthen Penumbra, Inc. Regulatory Affairs Program Manager TEL: 510-748-3314 FAX: 510-217-6414
E-MAIL: emilly.nurthen@penumbrainc.com
1.3 Date of Preparation of 510(k) Summary
March 20, 2012
1.4 Device Trade or Proprietary Name
Penumbra Coil System/Penumbra Coil 400™
Device Classification 1.5
Device, Vascular and Neurovascular Embolization (Product Code: HCG& KRD)
1.6 Predicate Devices
| Name of Predicate Device | 510(k)
Number |
|----------------------------------------|------------------|
| Penumbra Coil System/Penumbra Coil 400 | K103305 |
Predicate Device Comparison 1.7
The Penumbra Coil System/Penumbra Coil 400, subject of this 510(k), has the same technological characteristics as the predicate device, and the change is limited to revised product labeling.
1
Device Description 1.8
The Penumbra Coil System consists of the following components, which are sold separately:
- . Standard Complex Coils attached to detachment pusher
- . Soft Complex Coils attached to detachment pusher
- J Soft Coils attached to detachment pusher �
- Curve Extra Soft Coils attached to detachment pusher .
- Curve Complex Extra Soft Coils attached to detachment pusher .
- Detachment Handle .
The coils are primarily manufactured from platinum wire and Nitinol wire. The coils are attached to a stainless steel / polymer detachment pusher. The coils are available in varying secondary diameters and shapes based on coil type.
The Penumbra Coils are sterile, non-pyrogenic and intended for single use only. The Penumbra Detachment Handle is sterile, non-pyrogenic and may be used to detach multiple coils within a single patient procedure.
1.9 Intended Use
The Penumbra Coil System is intended for the embolization of:
- · · Intracranial aneurysms
- · Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae
- · Arterial and venous embolizations in the peripheral vasculature
2
| | Penumbra Embolization Coil | Penumbra
Embolization Coil |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| 510(k) No. | K103305 | To be K120330 |
| Classification | Class II, HCG, KRD | Class II, HCG, KRD |
| Indication | Intended for the 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
Pusher: stainless steel, polymer | Same |
| Sterilization | EtO | Same |
| Shelf-Life | 36-Months | Same |
1.10 Comparison to predicate Device
1.11 Summary of Non-clinical Data:
Biocompatibility 1.11.1
Biocompatibility tests conducted with Penumbra Coil System were selected in accordance with ISO-10993 -1 guidelines (Biological Evaluation of Medical Devices) for a blood contacting permanent implant device. All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices.
3
| Test | Method | Result |
|---|---|---|
| Cytotoxicity | L929 MEM Elution Test | Non-Toxic |
| Sensitization | Kligman Maximization | Non-Sensitizing |
| Intracutaneous | ||
| Reactivity (Irritation) | Intracutaneous Injection | |
| Test | Non-Irritant | |
| Systemic Toxicity* | ||
| (Acute) | ISO Acute Systemic | |
| Injection Test | Non-Toxic | |
| Subacute / Subchronic | ||
| Toxicity | In vivo Subacute Toxicity | Non-Toxic |
| Genotoxicity | Ames test | |
| Mouse Lymphoma | Non-Mutagenic | |
| Implantation | In vivo Implantation | Non-Irritant |
| Haemocompatibility | Complement Activation | No greater biological |
| response than | ||
| corresponding control | ||
| Hemolysis | ||
| In vivo thrombogenicity | Non-Hemolytic | |
| Non-Thrombogenic | ||
| Pyrogenicity | USP Material Mediated | |
| Rabbit Pyrogen Test | Non-Pyrogenic |
ISO-10993 GLP Testing Summary for the Penumbra Coil System
In summary, non-clinical testing found the Penumbra Coil System to be biocompatible according to the requirements of ISO 10993-1. Additionally, the product was found to be non-pyrogenic.
1.11.2 Design Verification (Bench-Top Testing)
Design Verification testing was conducted to evaluate the physical and mechanical properties of the Penumbra Coil System. 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 Coil System included:
- Dimensional / Visual Inspection (all sizes) .
- Joint Tensile Strength ●
- Fatigue .
- Friction .
4
- Torsion .
- Stiffness .
- Corrosion .
- Handle Function .
- MRI Compatibility .
- GLP Simulated Use .
All tests performed passed successfully.
The physical, mechanical and performance testing of the subject Penumbra Coil System demonstrate that the product is safe and effective for its labeled indications and is Substantially Equivalent to the currently marketed predicate device.
5
Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) of the United States. The logo consists of a stylized depiction of an eagle or bird-like figure, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Penumbra, Inc. c/o Mr. Seth Schulman Director, Regulatory Affairs 1351 Harbor Bay Parkway Alameda, CA 94502
Re: K120330
Trade/Device Name: Penumbra Coil System Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG, KRD Dated: February 1, 2012 Received: February 2, 2012
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.
APR - 2 2012
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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Qurle. A. Rimmer mo for
Malvina B. Evdelman, MD. Director Division of Ophthalmic. Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known): K120330
Device Name: Penumbra Coil System
Indications For Use:
The Penumbra Coil 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
Prescription Use . X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
JOE HUTTER
. ( Page 1 of
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices .
KI20330 510(k) Number.