The Penumbra System™ is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral -- M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset.

Device Description

The Penumbra System™ consists of three devices that work as a system to remove thrombus including the Penumbra Reperfusion Catheter, Penumbra Separator and Aspiration Tubing. The Penumbra System is used with the Penumbra Aspiration Pump.

Materials used in the Penumbra System devices are manufactured from medical grade materials that are commonly used in the industry, are similar or identical to the predicate devices, and have historically been demonstrated to be both biocompatible and suitable for this use.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and studies for the Penumbra Reperfusion Catheter 054 and Penumbra Separator 054:

The provided 510(k) summary (K090752) for the Penumbra Reperfusion Catheter 054 and Penumbra Separator 054 does not include detailed acceptance criteria or the specifics of a study proving device performance against such criteria in the way typically expected for an AI/ML device.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through various forms of testing, implying that if these tests are passed, the device is considered acceptable. The information provided is characteristic of a medical device submission that relies on engineering and material performance rather than diagnostic or prognostic accuracy as would be the case for AI.

Therefore, many of the requested fields regarding acceptance criteria, sample sizes for test/training sets, ground truth establishment, expert adjudication, and MRMC studies are not applicable or not detailed in this document.

Here's a breakdown of what can be extracted and what cannot:

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

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility: Materials are common, similar to predicate, and historically safe.	Materials are manufactured from medical grade materials commonly used, similar or identical to predicate devices, and have historically been demonstrated to be biocompatible and suitable for this use.
Functionality/Performance: Device materials, design, and final assemblies meet specifications.	Bench testing, in vitro testing, and in vivo testing have been performed on the device materials and final assemblies. The devices tested acceptably met the specifications.
Substantial Equivalence: Intended use, methods of operation, construction, and materials are identical or substantially equivalent to predicate devices.	The Penumbra Reperfusion Catheter 054 and Penumbra Separator 054 are substantially equivalent to the predicate devices.

2. Sample sized used for the test set and the data provenance

Not explicitly stated. The document mentions "bench testing, in vitro testing, and in vivo testing" but does not specify sample sizes or data provenance for these tests. Given the nature of a catheter, "in vivo" testing could refer to animal studies or potentially human clinical data from the predicate devices if used for equivalence, but this is not detailed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable / Not stated. This device is a mechanical thrombectomy device, not a diagnostic AI/ML system that requires expert interpretation for a "gold standard" ground truth. The "ground truth" here would relate to engineering specifications and performance metrics rather than medical diagnosis.

4. Adjudication method for the test set

Not applicable / Not stated. No mention of adjudication, as it's not a diagnostic system requiring expert consensus on findings.

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

No. This is a medical device, not an AI assistance system, so MRMC studies for human reader improvement are not relevant.

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

Not applicable. This is a standalone medical device (catheter system), but it's not an algorithm being tested for performance. Its performance is inherent to its design and mechanical function, used by a human clinician.

7. The type of ground truth used

Implied Engineering/Performance Specifications: The "ground truth" for this device would be established engineering specifications, material properties, and mechanical performance targets. For example, catheter dimensions, tensile strength, flow rates, and thrombus removal efficacy in an in-vitro model. The clinical efficacy, while an outcome from use, is primarily demonstrated through substantial equivalence to existing devices that have established clinical utility.

8. The sample size for the training set

Not applicable / Not stated. As this is not an AI/ML device, there is no "training set" in the computational sense. The design and manufacturing process would involve extensive iteration and testing, but these are not referred to as training sets.

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

Not applicable. See point 8.

Summary

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SEP 2 1 2009

Penumbra

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(c)

510(k) Number

K090752

March 19, 2009

Date Summary Prepared

Trade Name 054

Common Name

Classification Name

Submitted By

Contact

Percutaneous Catheter

Percutaneous Catheter (21 CFR Part 870, 1250; Product Code NRY)

Penumbra Reperfusion Catheter 054 and Penumbra

Separator

Penumbra, Inc. 1351 Harbor Bay Parkway Alameda, CA 94502

Louise Musante Regulatory Specialist Tel: 510-748-3247 louise.musante@penumbrainc.com

(Alternate Contact)

Theresa Brandner-Allen VP of Regulatory Tel: 510-748-3223 Fax: 510-814-8310 theresa.brandnerallen@penumbrainc.com

Predicate Devices

Penumbra System™ and Neuron™ Intracranial Access System, manufactured by Penumbra, Inc.

Device Description

Dovice Doceription
The Penumbra System™ consists of three devices that work as a system to remove thrombus including the Penumbra Reperfusion Catheter, Penumbra Separator and Aspiration Tubing. The Penumbra System is used with the Penumbra Aspiration Pump.

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Image /page/1/Picture/0 description: The image contains the word "Penumbra" in a simple, sans-serif font. To the right of the word is a circular logo. The logo appears to contain the letter "P" inside of the circle.

Intended Use

The Penumbra System is intended for use in the revascularization of patients with acute ischemic 1116 I chumora Dyoren is moial large vessel occlusive disease (in the internal carotid, middle stroke secondary to miractural large ar, and vertebral arteries) within 8 hours of symptom onset.

Substantial Equivalence

Substantial Equivations
The intended use, methods of operation, methods of construction, and materials used are either identical or substantially equivalent to the existing, legally marketed, predicate devices. IChical of Substantially equires that the Penumbra Reperfusion Catheter 054 and Penumbra Separator 054 are substantially equivalent to the predicate devices.

Testing

I esting, in vitro testing, and in vivo testing have been performed on the device materials, Denen resting, in Thi b teenig af tinal assemblies. The devices tested acceptably met the specifications.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes on its wing, representing the three levels of government: federal, state, and local. The seal is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

SEP 2 1 2009

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

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

Re: K090752

· Trade/Device Name: Penumbra Reperfusion Catheter 054, Penumbra Separator 054 Regulation Number: 21 CFR 870.1250

Regulation Name: Percutaneous Catheter

Regulatory Class: II

Product Code: NRY

Dated: September 1, 2009

Received: September 2, 2009

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.

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 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.

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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/CDRH0ffices/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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Emile Thormer Jr.

Malvina B. Eydelman, M.L Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K090752

Device Name:

Indications for Use:

Penumbra Reperfusion Catheter 054, Penumbra Separator 054

Prescription Use _ X (Per 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (Per 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)
Kristen Bowsher

(Division Sign-Off)

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

K090752 510(k) Number_

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).