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.

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.

AI/ML Overview

The Penumbra Catheter 025 is a medical device and is not an AI/ML device. Therefore, the questions related to AI/ML development (e.g., training set, ground truth experts, effect on human readers) are not applicable.

The acceptance criteria and the study proving the device meets these criteria are detailed in the "Summary of Non-clinical Data" section, which includes Biocompatibility and Design Verification (Bench-Top Testing). The studies conducted for this device were for 510(k) clearance, establishing substantial equivalence to predicate devices, rather than a clinical trial demonstrating efficacy against a specific medical condition.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of "acceptance criteria" alongside specific numerical "reported device performance." Instead, it lists the tests performed and states that "All tests performed passed successfully." For biocompatibility, specific results are given qualitative descriptions.

Test Category	Specific Test	Method	Acceptance Criteria (Implied) & Reported Device Performance
Biocompatibility	Cytotoxicity	L929 MEM Elution Test	Non-cytotoxic / Slight cell lysis or reactivity (Acceptable)
	Sensitization	Kligman Maximization	Non-sensitizing
	Intracutaneous Reactivity (Irritation)	Intracutaneous Injection Test	Non-irritant
	Systemic Toxicity (Acute)	ISO Acute Systemic Injection Test	Non-toxic
	Hemocompatibility - Complement Activation	Complement Activation Test	No greater biological response than corresponding control
	Hemocompatibility - Hemolysis	Hemolysis Test	Non-hemolytic
	Hemocompatibility - In vivo thrombogenicity	In vivo thrombogenicity Test	Non-thrombogenic
	Pyrogenicity	USP Material Mediated Rabbit Pyrogen Test	Non-pyrogenic
Design Verification	Dimensional / Visual Inspection	Not specified (Standard QC)	Passed successfully
	Trackability	Not specified (Bench-top simulation)	Passed successfully
	Friction	Not specified (Bench-top test)	Passed successfully
	Torsion	Not specified (Bench-top test)	Passed successfully
	Joint Tensile Strength	Not specified (Bench-top test)	Passed successfully
	Catheter Burst	Not specified (Bench-top test)	Passed successfully
	Catheter Flow Rate	Not specified (Bench-top test)	Passed successfully
	Catheter Elongation	Not specified (Bench-top test)	Passed successfully
	Kink Resistance	Not specified (Bench-top test)	Passed successfully
	Corrosion	Not specified (Bench-top test)	Passed successfully
	GLP Simulated Use	Not specified (Bench-top simulation)	Passed successfully

In summary, the statement "In summary, non-clinical testing found the Penumbra Catheter 025 to be non-cytotoxic, non-mutagenic, non-reactive (short and long-term implantation), non-sensitizing, a negligible irritant, non-pyrogenic, and non-toxic (acute systemic)" acts as the overarching reported performance for biocompatibility. For design verification, "All tests performed passed successfully" serves as the reported performance, implying the device met the established acceptance criteria for each test.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: The document states that "statistical sampling methods as required by the Penumbra Design Control procedures" were used, but it does not specify the exact sample sizes for each test (e.g., how many catheters were tested for burst strength or kink resistance). For biocompatibility, standard animal models or cell cultures are typically used, but specific numbers are not provided.
Data Provenance: The studies were non-clinical (bench-top and in vitro/in vivo biocompatibility tests, likely animal studies for some bio-tests). No information is provided regarding the country of origin of the data, but the manufacturer is based in Alameda, CA, USA, and the submission is to the US FDA, implying testing was conducted to US regulatory standards. These are prospective tests designed specifically for the device's 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable. The Penumbra Catheter 025 is a physical medical device, not an AI/ML diagnostic or prognostic tool. "Ground truth" in the context of expert medical interpretation or diagnosis is not relevant for this type of device. The "ground truth" for this device would be established by the objective results of the physical and chemical tests (e.g., did it burst at X pressure, did it cause a cytotoxic reaction).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable for a physical medical device. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or for establishing ground truth for AI/ML algorithms where expert consensus on interpretations is required. For this device, the tests have objective pass/fail criteria.

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

This question is not applicable. MRMC studies and the concept of "human readers improving with AI assistance" are relevant for AI/ML-driven diagnostic tools, not for a physical medical catheter.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. This refers to AI/ML algorithm performance, which is not relevant to the Penumbra Catheter 025.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device is established by objective physical, mechanical, and chemical test results. For example:

Biocompatibility: Laboratory standard assays (e.g., L929 MEM Elution for cytotoxicity, ISO Acute Systemic Injection Test for toxicity), which have defined biological responses or lack thereof as "ground truth."
Design Verification: Engineering specifications and performance metrics (e.g., a catheter burst at or above a certain pressure, trackability within defined parameters). The "ground truth" is measured and compared against established engineering and safety standards, often derived from predicate devices or industry guidelines.

8. The sample size for the training set

This question is not applicable. There is no "training set" in the context of a physical medical device. Training sets are used in AI/ML model development.

9. How the ground truth for the training set was established

This question is not applicable as there is no "training set."

Summary

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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.

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)

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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 IntracranialAccess System	Penumbra, IncAlameda, CA	K070970,K082290 &K083125
Excelsior SL-10 / 1018	Boston ScientificNeurovascularFremont, CA	K042568

1.7 Device Description:

Penu

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.

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	Excelsior SL-10 / 1018	Penumbra NeuronIntracranial AccessSystem	Penumbra Catheter025
510(k) No.	K042568	K070970, K082290 &K083125	To be determined
Classification	Class II, DQY	Class II, DQY	Class II, DQY
Indication	Boston Scientific'sExcelsior™ SL-10 Pre-Shaped microcatheterand Excelsior™ 1018™Pre-Shapedmicrocatheter areintended to assist in thedelivery of diagnosticagents, such as contrastmedia, and therapeuticagents, such as occlusioncoils to the peripheral,coronary, and neurovasculature.	The Neuron™Intracranial AccessSystem is indicated forthe introduction ofinterventional devices ·into the peripheral,coronary, and neurovasculature.	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 usedinstead 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 (<24 hours), external communicating devices, contacting circulating blood. All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices.

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Test	Method	Result
Cytotoxicity	L929 MEM ElutionTest	Slight cell lysis orreactivity
Sensitization	KligmanMaximization	Non-Sensitizing
IntracutaneousReactivity (Irritation)	IntracutaneousInjection Test	Non-Irritant
Systemic Toxicity(Acute)	ISO Acute SystemicInjection Test	Non-Toxic
Haemocompatibility	ComplementActivation	No greater biologicalresponse thancorresponding control
	Hemolysis	Non-Hemolytic
	In vivothrombogenicity	Non-Thrombogenic
Pyrogenicity	USP MaterialMediated RabbitPyrogen 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

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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.

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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.

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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

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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:

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

Regulation Number and Section

§ 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).