Intracranial aneurysms .
Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous . fistulae
Arterial and venous embolizations in the peripheral vasculature .

Device Description

The Penumbra Coil System consists of the following components, which are sold separately:

. Complex Standard Implantable Embolization Coils attached to detachment pusher
. Complex Soft Implantable Embolization Coils attached to detachment pusher
. J Soft Implantable Embolization Coils attached to detachment pusher
. Curve Extra Soft Implantable Embolization 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 Embolization 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.

AI/ML Overview

This document describes the Penumbra Coil System, which is an embolization coil system. The information provided is a 510(k) summary for premarket notification to the FDA. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than the specific performance metrics of a diagnostic AI device.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC studies, standalone performance) are not applicable to this type of device and submission. The document primarily details biocompatibility and design verification tests, which are typical for medical implants.

However, I can extract information relevant to the acceptance criteria and study proving it, as available from the provided text.

Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility
Cytotoxicity	Non-Toxic	Non-Toxic
Sensitization	Non-Sensitizing	Non-Sensitizing
Intracutaneous Reactivity (Irritation)	Non-Irritant	Non-Irritant
Systemic Toxicity* (Acute)	Non-Toxic	Non-Toxic
Subacute / Subchronic Toxicity	Non-Toxic	Non-Toxic
Genotoxicity (Ames test)	Non-Mutagenic	Non-Mutagenic
Genotoxicity (Mouse Lymphoma)	Non-Mutagenic	Non-Mutagenic
Implantation	Non-Irritant	Non-Irritant
Haemocompatibility (Complement Activation)	No greater biological response than control	No greater biological response than corresponding control
Haemocompatibility (Hemolysis)	Non-Hemolytic	Non-Hemolytic
Haemocompatibility (Thrombogenicity)	Non-Thrombogenic	Non-Thrombogenic
Pyrogenicity	Non-Pyrogenic	Non-Pyrogenic
Design Verification (Bench-Top Testing)
Dimensional / Visual Inspection	Met finished goods release requirements (Implied)	Passed successfully (all sizes)
Joint Tensile Strength	Met finished goods release requirements (Implied)	Passed successfully
Fatigue	Met finished goods release requirements (Implied)	Passed successfully
Friction	Met finished goods release requirements (Implied)	Passed successfully
Torsion	Met finished goods release requirements (Implied)	Passed successfully
Stiffness	Met finished goods release requirements (Implied)	Passed successfully
Corrosion	Met finished goods release requirements (Implied)	Passed successfully
Handle Function	Met finished goods release requirements (Implied)	Passed successfully
MRI Compatibility	Compliant with standards (Implied)	Passed successfully
GLP Simulated Use	Met finished goods release requirements (Implied)	Passed successfully

Explanation of the Study and its Findings:

The "study" presented here is a summary of non-clinical data for a 510(k) premarket notification. The primary goal is to demonstrate "Substantial Equivalence" to a legally marketed predicate device (Guglielmi Detachable Coil - GDC™). This is achieved by showing that the Penumbra Coil System has comparable indications for use, fundamental technological characteristics (materials, sterilization), and meets established safety standards through various testing.

Sample size used for the test set and the data provenance:
- Biocompatibility: The specific sample sizes for each test (e.g., number of animals for in-vivo tests, number of cells for in-vitro tests) are not provided in this summary. However, the tests were conducted "in accordance with ISO-10993 -1 guidelines (Biological Evaluation of Medical Devices)" and "pursuant to 21 CFR, Part 58, Good Laboratory Practices," implying standard and appropriate sample sizes were used for these types of studies. The provenance is internal testing conducted according to international standards for medical devices.
- Design Verification (Bench-Top Testing): The document states "All studies were conducted using good scientific practices and statistical sampling methods as required by the Penumbra Design Control procedures." Specific sample sizes for each physical/mechanical test are not provided, but it notes "all sizes" for Dimensional/Visual Inspection. The provenance is internal bench-top testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not applicable as this is a physical medical device, not a diagnostic AI system requiring expert interpretation of results. The "ground truth" for biocompatibility tests is the biological response, and for design verification, it's the physical/mechanical properties measured against engineering specifications.
Adjudication method for the test set: Not applicable for this type of device testing. Results are typically objectively measured against pre-defined performance specifications (e.g., "non-toxic," "non-irritant," "passed successfully").
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: Not applicable. This device is an embolization coil, not an AI diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a physical medical implant, not an algorithm.
The type of ground truth used:
- Biocompatibility: Biological responses (e.g., cellular toxicity, systemic effects, sensitization, pyrogenicity, hemocompatibility, tissue reaction to implantation) as defined by ISO 10993 standards and measured by laboratory tests.
- Design Verification: Established engineering specifications, physical and mechanical properties, and performance benchmarks for the device components.
The sample size for the training set: Not applicable. This is a physical medical device, not an AI algorithm requiring a training set.
How the ground truth for the training set was established: Not applicable.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the word "Penumbra" in bold, black font. To the right of the word is an equals sign, followed by a black circle with a white "P" inside. There is a small black dot to the lower right of the circle.

K1033Q5

Penumbra Coil System

7 510(K) SUMMARY

JAN 2 6 2011

(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 Embolization Coils (Trade Name TBD).

7.1 Sponsor/Applicant Name and Address

Penumbra, Inc.

1351 Harbor Bay Parkway Alameda, CA 94502

7.2 Sponsor Contact Information

Seth A. Schulman

Director, Regulatory Affairs

Phone: 510-748-3223

FAX: 510-217-6414

email: seth.schulman@penumbrainc.com

7.3 Date of Preparation of 510(k) Summary

November 8, 2010

7.4 Device Trade or Proprietary Name

Penumbra Coil System / Penumbra Coil 400™

Device Common/Usual or Classification Name 7.5

Device, Vascular and Neurovascular Embolization (Product Code: HCG& KRD)

7.6 Identification of the Legally Marketed Devices to which Equivalence is Being Claimed:

Name of PredicateDevice	Name of Manufacturer (Town,State)	510(k) Number
Guglielmi Detachable Coil(GDCTM)	Boston Scientific NeurovascularFremont, CA	K031049&K093142

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the word "Penumbra" in bold, black font. To the right of the word is an equals sign, followed by a stylized letter "P" inside of a circle. The letter "P" and the circle are black, while the space inside the "P" and the circle are white.

7.7 Device Description:

The Penumbra Coil System consists of the following components, which are sold separately:

. Complex Standard Implantable Embolization Coils attached to detachment pusher
. Complex Soft Implantable Embolization Coils attached to detachment pusher
. J Soft Implantable Embolization Coils attached to detachment pusher
. Curve Extra Soft Implantable Embolization Coils attached to detachment pusher
. Detachment Handle

7.8 Intended Use:

The Penumbra Embolization Coils are 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}------------------------------------------------

Penu

7.9 Comparison to predicate Device

	Guglielmi Detachable Coil (GDC™)	PenumbraEmbolization Coil
510(k) No.	K031049, K093142	To be determined
Classification	Class II, HCG, KRD	Class II, HCG, KRD
Indication	Intended for the embolization of:	Same
	• Intracranial aneurysms• Other neurovascular abnormalities suchas arteriovenous malformations andarteriovenous fistulae• Arterial and venous embolizations in theperipheral vasculature
Materials	Coil:Platinum/tungsten, PolypropylenePusher: stainless steel	Coil:Platinum/tungsten,NitinolPusher: stainless steel,polymer
Sterilization	EtO	Same
Shelf-Life	36-Months	36-Months)

7.10 Summary of Non-clinical Data:

Biocompatibility 7.10.1

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}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the word "Penumbra" in a bold, sans-serif font. To the right of the word is a horizontal line that extends to a black circle. Inside the circle is a white letter "P".

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	Non-Mutagenic
	Mouse Lymphoma	Non-Mutagenic
Implantation	In vivo Implantation	Non-Irritant
Haemocompatibility	Complement Activation	No greater biological response than corresponding control
	Hemolysis	Non-Hemolytic
	In vivo thrombogenicity	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.

7.10.2 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

{4}------------------------------------------------

Penumbra Coil System

Image /page/4/Picture/1 description: The image shows the word "Penumbra" in a sans-serif font, followed by a hyphen and a stylized letter "P" inside a black circle. The letter "P" is white and has a small dot to the lower right of the circle. The word "Penumbra" is in black and appears to be the name of a company or product.

. Friction
. 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 U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wing. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper half of the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Penumbra, Inc. c/o Mr. Seth A. Schulman Director, Regulatory Affairs 1351 Harbor Bay Parkway Alameda, CA 94502

JAN 2 6 2011

Re: K103305

Trade/Device Name: Penumbra Coil System / Penumbra Coil 400™ Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG, KRD Dated: November 8, 2010 Received: November 9, 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.

2017 07:00 PM 10:00 PM 10:00 PM 10:00 PM 10:00 PM 10:00 PM 10:00 PM 10:00 PM 10:00 PM 10:00 PM 10:00 PM 1

{6}------------------------------------------------

Page 2 - Mr. Seth A. 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 (2) 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,

Melvin R. Laird

Malvina B. Eydelman, M.D. 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): K103305

Device Name: Penumbra Coil System / Penumbra Coil 400™

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 × (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kitt

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

KIO3305

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

510(k) Number.

Regulation Number and Section

§ 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).