The Penumbra Pump MAX™ is designed to provide general suction for use in hospitals or clinics. The Aspiration Pump operates using AC power and is designed to be portable if needed. The Aspiration Pump provides vacuum of up to 29 inHg. The pump is available in both 110Vac and 230Vac versions.

The front face of the Aspiration Pump has a display panel with a vacuum gauge, suction regulating valve, and power switch. The pump is used with the available 1000 ml canister / tubing set.

The Aspiration Pump connects to the canister reservoir with a tubing assembly (Penumbra Pump/Canister Tubing), which is provided as an accessory. The Penumbra Pump/Canister Tubing consists of a short tubing segment with an inline filter with connectors on each end to facilitate attachment to the Pump's vacuum port. The tubing is supplied pre-attached to the canister reservoir lid. The Penumbra Pump/Canister Tubing is provided non-sterile and is used outside the sterile field.

AI/ML Overview

This document (K122756) describes the 510(k) summary for the Penumbra Pump MAX™, a general suction apparatus for hospitals or clinics. The submission focuses on demonstrating substantial equivalence to a predicate device, the Penumbra Aspiration Pump (K051758), through non-clinical performance testing.

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

1. Table of Acceptance Criteria and Reported Device Performance

Attribute	Acceptance Criteria	Reported Device Performance
The Pump shall be compliant with IEC 60601-1 requirements.	100% Pass	Pass: 100%
The Pump shall be compliant with IEC 60601-1-2 requirements.	100% Pass	Pass: 100%
The Pump shall be compliant with ISO 10079-1 requirements.	100% Pass	Pass: 100%
The Pump controls shall be easily identifiable by the User.	100% Pass	Pass: 100%
The pump controls shall be validated for Usability.	100% Pass	Pass: 100%
Pump MAX™ should supply uniform vacuum level for an entire case.	100% Pass	Pass: 100%
Pump MAX™ will be a durable piece of capital equipment.	100% Pass	Pass: 100%
Pump MAX™ should be quiet.	100% Pass	Pass: 100%
After use, any blood or clot collected in the canister should be able to be removed for analysis.	100% Pass	Pass: 100%
The Canister should have volume reference markings.	100% Pass	Pass: 100%
The Canister lid should be backward compatible with the current Aspiration Tubing.	100% Pass	Pass: 100%
Canister should be able to withstand maximum pressure delivered by the Pump.	100% Pass	Pass: 100%
Canister lid should include a feature to prevent excess fluid from entering the pump.	100% Pass	Pass: 100%

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

The document describes "Pump Design Verification Testing Summary" through non-clinical data. It does not specify a "test set" in the context of clinical studies with human subjects. The testing described appears to be engineering verification and validation, likely conducted in a laboratory setting by the manufacturer (Penumbra, Inc. in Alameda, CA, USA). There is no information provided on sample sizes for these engineering tests in terms of the number of devices or components tested, nor does it specify if the data is retrospective or prospective in a clinical sense. The provenance of the data is implicitly from Penumbra, Inc.

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 information is not applicable to the type of non-clinical testing described. The "ground truth" for compliance with standards (IEC 60601-1, IEC 60601-1-2, ISO 10079-1) or performance attributes (e.g., uniform vacuum level, durability, quiet operation) would be established by relevant engineering standards, internal specifications, and measurement protocols, not by expert medical consensus.

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

This information is not applicable as the document describes non-clinical engineering and performance testing, not a clinical study involving human interpretation or adjudication.

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 information is not applicable. The device is a medical suction pump, not an AI-powered diagnostic or assistive technology. No MRMC study was conducted or is relevant for this type of device.

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

This information is not applicable. The Penumbra Pump MAX™ is a mechanical medical device, not an algorithm.

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

For the non-clinical testing, the "ground truth" is based on:

Compliance with international standards (IEC 60601-1, IEC 60601-1-2, ISO 10079-1).
Adherence to design specifications and functional requirements (e.g., uniform vacuum level, durability, quiet operation, identifiable controls, usability, canister features).
These are objective, measurable criteria established through engineering principles and regulatory requirements.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is not a machine learning or AI device. The development of the pump would involve engineering design, prototyping, and iterative testing.

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

This information is not applicable as there is no training set mentioned or relevant for this type of device.

Summary

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K122756

q. 1 of 3

OCT

2 2012

ﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ

510(k) SUMMARY 9

(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.

9.1 Sponsor/Applicant Name and Address

Penumbra Inc.

1351 Harbor Bay Parkway Alameda, CA 94502

9.2 Sponsor Contact Information

Seth A. Schulman Director, Regulatory Affairs Phone: 510-748-3223 FAX: 510-217-6414 email: seth.schulman@penumbrainc.com

Date of Preparation of 510(k) Summary 9.3

September 6, 2012

9.4 Device Trade or Proprietary Name

Penumbra Pump MAX™M

તે જે રે Device Common/Usual or Classification Name

Apparatus, Suction, Ward Use, Portable, AC-Powered (Product Code: JCX)

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

Name of Predicate Device	Name of Manufacturer (Town,State)	510(k) Number
Penumbra Aspiration Pump	Penumbra, IncAlameda, CA	K051758

9.7 Device Description:

The Penumbra Pump MAX™ is designed to provide general suction for use in hospitals or clinics. The Aspiration Pump operates using AC power and is designed to be portable

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122756

if needed. The Aspiration Pump provides vacuum of up to 29 inHg. The pump is available in both 110Vac and 230Vac versions.

The front face of the Aspiration Pump has a display panel with a vacuum gauge, suction regulating valve, and power switch. The pump is used with the available 1000 ml canister / tubing set.

9.8 Intended Use:

The Penumbra Pump MAX™ is intended for general suction use in hospitals or clinics.

9.9 Summary of Non-clinical Data:

The physical, mechanical and performance testing of the Penumbra Pump MAX™ demonstrates that the product is substantially equivalent to the currently marketed predicate device.

Attribute	AcceptanceCriteria	Results
The Pump shall be compliant with IEC60601-1 requirements.	100% Pass	Pass: 100%
The Pump shall be compliant with IEC60601-1-2 requirements.	100% Pass	Pass: 100%
The Pump shall be compliant with ISO10079-1 requirements.	100% Pass	Pass: 100%
The Pump controls shall be easilyidentifiable by the User.	100% Pass	Pass: 100%
The pump controls shall be validated forUsability	100% Pass	Pass: 100%
Pump MAX™ should supply uniformvacuum level for an entire case	100% Pass	Pass: 100%
Pump MAX™ will be a durable piece ofcapital equipment	100% Pass	Pass: 100%
Pump MAX™ should be quiet	100% Pass	Pass: 100%

Pump Design Verification Testing Summary

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KI22756 pg 3 df 3

Attribute	AcceptanceCriteria	Results
After use, any blood or clot collected inthe canister should be able to be removedfor analysis	100% Pass	Pass: 100%
The Canister should have volumereference markings	100% Pass	Pass: 100%
The Canister lid should be backwardcompatible with the current AspirationTubing	100% Pass '	Pass: 100%
Canister should be able to withstandmaximum pressure delivered by thePump	100% Pass	Pass: 100%
Canister lid should include a feature toprevent excess fluid from entering thepump.	100% Pass	Pass: 100%

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure.

Public Health Service

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

ОСТ

2 2012

Penumbra, Incorporated
% Mr. Seth Schulman
Director, Regulatory Affairs
1351 Harbor Bay Parkway
Alameda, California 94502

Re: K122756

Trade/Device Name: Penumbra Pump MAX™ Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: II Product Code: JCX Dated: September 06, 2012 Received: September 07, 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.

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

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Page 2 – Mr. Seth Schulman

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,

for

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K122756

pg. 1 of 1

Statement of Indication for Use 2

Indications for Use

510(k) Number (if known): Not Yet Assigned

Device Name: Penumbra Pump MAX™

Indications for Use:

The Penumbra Pump MAX™ is intended for general suction use in hospitals or clinics.

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)

Neil K. Deker for mxm
(Director, Sirdom

Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

122756 510(k) Number

Page

Regulation Number and Section

§ 878.4780 Powered suction pump.

(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.