(169 days)
No
The device description and performance studies focus on mechanical and electrical components for aspiration, with no mention of AI/ML algorithms for image analysis, decision support, or other functions.
Yes
The device, as part of the Penumbra System, is indicated for revascularization and thrombus removal in patients with acute ischemic stroke, which directly treats a medical condition.
No
The device is designed for the mechanical removal of thrombus during acute ischemic stroke, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly outlines multiple hardware components including catheters, separators, tubing, and an aspiration pump, which is described as an electromechanical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Penumbra System is a medical device designed to physically remove blood clots (thrombus) from blood vessels in the brain using aspiration. It is an interventional device used directly within the patient's body.
- Intended Use: The intended use clearly states it's for "revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease," which is a therapeutic procedure, not a diagnostic test performed on a sample.
- Device Description: The description details the mechanical components and how they are used to physically interact with and remove the thrombus from the vasculature.
The device is a therapeutic medical device used for treating acute ischemic stroke, not for diagnosing a condition using in vitro methods.
N/A
Intended Use / Indications for Use
Penumbra Reperfusion Catheters and Separators
As part of the Penumbra System, the Reperfusion Catheters and Separators are indicated 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. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
Penumbra 3D Revascularization Device
As part of the Penumbra System, the Penumbra 3D Revascularization Device is indicated 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) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
Penumbra Aspiration Tubing
As part of the Penumbra System, the Penumbra Sterile Aspiration Tubing is indicated to connect the Penumbra Reperfusion Catheters to the Penumbra Aspiration Pump.
Penumbra Aspiration Pump
The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.
Product codes (comma separated list FDA assigned to the subject device)
NRY
Device Description
The Penumbra System is designed to remove thrombus from large intracranial vessels by aspirating the proximal side of the thrombus using the Penumbra Reperfusion Catheter, Penumbra Separator, 3D Revascularization Device, Penumbra Aspiration Tubing, and Penumbra Aspiration Pump. The Penumbra System was most recently cleared under K162901.
The Penumbra System is designed to remove thrombus from the vasculature using continuous aspiration. The Reperfusion Catheter targets aspiration from the Aspiration Pump directly to the thrombus. The 3D Revascularization Device is used with the Reperfusion Catheters to facilitate aspiration and removal of the thrombus when needed. The Separator may be used to clear the lumen of the Reperfusion Catheter should it become blocked with thrombus. The use of the Separator may not be necessary when using a Reperfusion Catheter with an I.D. of 0.054in or larger. The Reperfusion Catheter is introduced through a guide catheter or long femoral sheath and into the intracranial vasculature and guided over a neurovascular guidewire to the site of the primary occlusion. The Reperfusion Catheter is used with the Aspiration Pump to aspirate thrombus from an occluded vessel. As needed, a Separator may be deployed from the Reperfusion Catheter to assist with thrombus removal. The Separator is advanced and retracted through the Reperfusion Catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the Reperfusion Catheter tip. For the aspiration source, the Reperfusion Catheter is used in conjunction with the Aspiration Pump, which is connected using the Aspiration Tubing and Canister. The Reperfusion Catheter is provided with a steam shaping mandrel and rotating hemostasis valve, and a peelable sheath. The Separator is provided with an introducer and torque device. The Reperfusion Catheters, 3D Revascularization Device and Separators are visible under fluoroscopy.
The Penumbra Engine Pump and Canister
The Penumbra Engine Pump ("Engine Pump") is an electromechanical device designed to create vacuum pressure for use with the Penumbra System. The Engine Pump maintains vacuum pressure for 3 hours of continuous use and has an operating life of ≥ 500 hours. The pump can be used in environments with 100 - 240 Vac and 50/60 Hz. The Engine Pump is intended for use in operating rooms or interventional catheterizations laboratories. The Engine Pump and Canister do not come into contact with the patient. The Engine Pump Canister is a 1000 mL minimum volume reservoir which is an accessory to the Engine Pump. The Canister has a lid with a stopflow filter to prevent excess fluid from entering the patient port on the lid is sized to accept the Suction Connector on the Penumbra Aspiration Tubing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy
Anatomical Site
Intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Operating rooms or interventional catheterizations laboratories
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)
Summary of Non-Clinical Data includes:
- Biocompatibility: No additional testing required as subject and predicate Penumbra System sterile devices are identical. The Penumbra Engine Pump and Canister are non-sterile and do not contact the patient, so biocompatibility testing is not required.
- Design Verification (Bench-Top Testing and Electrical Safety/EMC Testing): No additional bench-top testing required for sterile devices as they are identical to predicate. Bench-top testing was conducted for the Penumbra Engine Pump and Canister to evaluate physical and mechanical properties, with all studies conducted using good scientific practices and statistical sampling methods. Electrical safety and EMC testing were performed in accordance with IEC 60601-1 and IEC 60601-1-2 by Intertek. The Engine Pump and Canister passed all tests and met all acceptance criteria.
- Shelf Life: No additional shelf life testing required for sterile devices as they are identical to predicate. Shelf life testing is not applicable to the non-sterile, reusable Penumbra Engine Pump, which has an established operating life of 500 hours based on reliability testing. The Penumbra Engine Pump Canister does not have an established shelf life.
- Sterilization: No additional sterilization testing required for sterile devices as they are identical to predicate. Sterilization testing is not applicable to the non-sterile Penumbra Engine Pump and Canister.
- Packaging: No additional packaging testing required for sterile devices as they are identical to predicate. Packaging materials and processes for the Engine Pump and Canister are similar to the predicate; packaging validation was performed by transportation conditioning per ASTM D4169.
Results of Design Verification (Bench-top Testing and Electrical Safety/EMC Testing):
- Pump - Electrical Safety: N=1, 100% Pass for IEC 60601-1 and IEC 60601-1-2 requirements, and EN ISO 10079-1 compliance.
- Pump - Environmental Testing: N=5, 100% Pass for pump performance specifications under environmental conditions.
- Pump - Dimensional Inspection: N=5, 100% Pass for dimensional specifications per Product Specification.
- Pump - Inspection of Design Features: N=5, 100% Pass for design specifications per Product Specification.
- Pump - Performance: N=5, 100% Pass for performance specifications per Product Specification.
- Pump - Performance at variable voltage and frequency: N=5, 100% Pass for performance specifications per Product Specification.
- Pump and Canister - 500 hour Use Testing: N=5, 100% Pass for performance specifications after 500 hour use.
- Pump Canister - Inspection of Design Features: N=5, 100% Pass for design specifications per Product Specification.
- Pump Canister - Performance: N=5, 100% Pass for performance specifications per Product Specification.
- Pump and Canister - Simulated Use: N=5, 100% Pass for pump and canister use specifications.
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.
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
§ 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).
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
June 20, 2018
Penumbra, Inc. Michaela Mahl, MSBE Senior Manager Regulatory Affairs One Penumbra Place Alameda, California 94502
Re: K180008
Trade/Device Name: Penumbra System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: May 17, 2018 Received: May 21, 2018
Dear Michaela Mahl, MSBE:
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Xiaolin Zheng -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K180008
Device Name Penumbra System
Indications for Use (Describe)
Penumbra Reperfusion Catheters and Separators
As part of the Penumbra System, the Reperfusion Catheters and Separators are indicated 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. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
Penumbra 3D Revascularization Device
As part of the Penumbra System, the Penumbra 3D Revascularization Device is indicated 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) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
Penumbra Aspiration Tubing
As part of the Penumbra System, the Penumbra Sterile Aspiration Tubing is indicated to connect the Penumbra Reperfusion Catheters to the Penumbra Aspiration Pump.
Penumbra Aspiration Pump The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| × Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary [K180008] 1
(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 System® Penumbra Engine™ Pump and Canister.
1.1 Sponsor/Applicant Name and Address
Penumbra, Inc. One Penumbra Place Alameda, CA 94502 USA Phone: (510) 748-3200
1.2 Sponsor Contact Information
Michaela Mahl Senior Manager Regulatory Affairs Phone: (510) 748-3288 FAX: (510) 217-6414 Email: mmahl@penumbrainc.com
1.3 Date of Preparation of 510(k) Summary
May 17, 2018
1.4 Device Trade or Proprietary Name
Penumbra System®
1.5 Device Classification
| Regulatory Class: | II |
|---|---|
| Classification Panel: | Neurology |
| Classification Name: | Percutaneous Catheter |
| Regulation Number: | 21 CFR §870.1250 |
| Product Code: | NRY (Catheter, Thrombus Removal) |
1.6 Predicate and Reference Devices
| 510(k) Number / Clearance Date | Name of Device | Name of Manufacturer |
|---|---|---|
| Predicate Device | ||
| K162901 cleared on April 20, 2017 | Penumbra System | Penumbra, Inc. |
| One Penumbra Place | ||
| Alameda, CA 94502 USA | ||
| Reference Device | ||
| K122756 cleared on October 2, 2012 | Penumbra Pump MAX | Penumbra, Inc. |
| One Penumbra Place | ||
| Alameda, CA 94502 USA |
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Image /page/4/Picture/0 description: The image shows the word "Penumbra" in a red sans-serif font. To the right of the word is a red circle with a white "P" inside. The "P" is stylized with a horizontal line extending from the left side of the "P" to the edge of the circle. The logo is simple and modern.
1.7 Predicate Comparison
| Predicate Device | Subject Device | |
|---|---|---|
| Trade Name | Penumbra System (with Penumbra Pump | |
| MAX and Canister) | Penumbra System (with Penumbra Engine | |
| Pump and Canister) | ||
| 510(k) No. | K162901 | K180008 |
| Classification | Class II, NRY | SAME |
| Indication for Use | Penumbra Reperfusion Catheters and | |
| Separators | ||
| As part of the Penumbra System, the | ||
| Reperfusion Catheters and Separators are | ||
| indicated 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. Patients | ||
| who are ineligible for intravenous tissue | ||
| plasminogen activator (IV t-PA) or who fail | ||
| IV t-PA therapy are candidates for | ||
| treatment. | SAME | |
| Penumbra 3D Revascularization Device¹ | ||
| As part of the Penumbra System, the | ||
| Penumbra 3D Revascularization Device is | ||
| indicated 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) within 8 hours of symptom onset. | ||
| Patients who are ineligible for intravenous | ||
| tissue plasminogen activator (IV t-PA) or | ||
| who fail IV t-PA therapy are candidates for | ||
| treatment. | ||
| Penumbra Aspiration Tubing | ||
| As part of the Penumbra System, the | ||
| Penumbra Sterile Aspiration Tubing is | ||
| indicated to connect the Penumbra | ||
| Reperfusion Catheters to the Penumbra | ||
| Aspiration Pump. |
Penumbra Aspiration Pump
The Penumbra Aspiration Pump is indicated
as a vacuum source for Penumbra
Aspiration Systems | |
| | Predicate Device | Subject Device |
| Trade Name | Penumbra System (with Penumbra Pump MAX and Canister) | Penumbra System (with Penumbra Engine Pump and Canister) |
| 510(k) No. | K162901 | K180008 |
| Classification | Class II, NRY | SAME |
| Aspiration Pump | | |
| Trade Name | Penumbra Pump MAX and Canister | Penumbra Engine Pump and Canister |
| IEC 60601-1
Compliance | Yes | SAME |
| IEC 60601-1-2
Compliance | Yes | SAME |
| Voltage | 100-115 Vac/230 Vac | 100-240 Vac |
| Frequency | 50 Hz/60 Hz | SAME |
| Sterilization | Non sterile | SAME |
¹ This statement is only present in the Instructions for Use contained in the Penumbra 3D Revascularization Device product box.
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Image /page/5/Picture/0 description: The image shows the word "Penumbra" in a red sans-serif font, followed by a red circle with a white "P" inside. The word "Penumbra" is written in a clean, modern typeface. The red circle with the "P" is a stylized logo, possibly representing the company or brand associated with the name "Penumbra."
Device Description 1.8
The Penumbra System is designed to remove thrombus from large intracranial vessels by aspirating the proximal side of the thrombus using the Penumbra Reperfusion Catheter, Penumbra Separator, 3D Revascularization Device, Penumbra Aspiration Tubing, and Penumbra Aspiration Pump. The Penumbra System was most recently cleared under K162901.
The Penumbra System is designed to remove thrombus from the vasculature using continuous aspiration. The Reperfusion Catheter targets aspiration from the Aspiration Pump directly to the thrombus. The 3D Revascularization Device is used with the Reperfusion Catheters to facilitate aspiration and removal of the thrombus when needed. The Separator may be used to clear the lumen of the Reperfusion Catheter should it become blocked with thrombus. The use of the Separator may not be necessary when using a Reperfusion Catheter with an I.D. of 0.054in or larger. The Reperfusion Catheter is introduced through a guide catheter or long femoral sheath and into the intracranial vasculature and guided over a neurovascular guidewire to the site of the primary occlusion. The Reperfusion Catheter is used with the Aspiration Pump to aspirate thrombus from an occluded vessel. As needed, a Separator may be deployed from the Reperfusion Catheter to assist with thrombus removal. The Separator is advanced and retracted through the Reperfusion Catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the Reperfusion Catheter tip. For the aspiration source, the
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Image /page/6/Picture/0 description: The image shows the logo for Penumbra, Inc., a global healthcare company focused on innovative therapies. The word "Penumbra" is written in a red sans-serif font. To the right of the word is a circular logo, also in red, with a white "P" inside.
Reperfusion Catheter is used in conjunction with the Aspiration Pump, which is connected using the Aspiration Tubing and Canister. The Reperfusion Catheter is provided with a steam shaping mandrel and rotating hemostasis valve, and a peelable sheath. The Separator is provided with an introducer and torque device. The Reperfusion Catheters, 3D Revascularization Device and Separators are visible under fluoroscopy.
The Penumbra Engine Pump and Canister
The Penumbra Engine Pump ("Engine Pump") is an electromechanical device designed to create vacuum pressure for use with the Penumbra System. The Engine Pump maintains vacuum pressure for 3 hours of continuous use and has an operating life of ≥ 500 hours. The pump can be used in environments with 100 - 240 Vac and 50/60 Hz. The Engine Pump is intended for use in operating rooms or interventional catheterizations laboratories. The Engine Pump and Canister do not come into contact with the patient. The Engine Pump Canister is a 1000 mL minimum volume reservoir which is an accessory to the Engine Pump. The Canister has a lid with a stopflow filter to prevent excess fluid from entering the patient port on the lid is sized to accept the Suction Connector on the Penumbra Aspiration Tubing.
1.9 Indications for Use
Penumbra Reperfusion Catheters and Separators
As part of the Penumbra System, the Reperfusion Catheters and Separators are indicated 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. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
Penumbra 3D Revascularization Device2
As part of the Penumbra System, the Penumbra 3D Revascularization Device is indicated 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) within 8 hours of symptom onset. Patients who are ineligible for
2 This statement is only present in the Instructions for Use contained in the Penumbra 3D Revascularization Device product box.
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Image /page/7/Picture/0 description: The image shows the word "Penumbra" in a red, sans-serif font. To the right of the word is a red circle with a white "P" inside. The "P" is stylized with a horizontal line extending from the left side of the "P" to the edge of the circle. The overall design is clean and modern.
intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
Penumbra Aspiration Tubing
As part of the Penumbra System, the Penumbra Sterile Aspiration Tubing is indicated to connect the Penumbra Reperfusion Catheters to the Penumbra Aspiration Pump.
Penumbra Aspiration Pump
The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.
1.10 Summary of Non-Clinical Data
As required under Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, a summary of any information regarding substantial equivalence of the device follows.
Included in this section are summary descriptions of the testing (or rationale for not testing if not applicable to the Engine Pump and Canister) which substantiates the performance of the subject Penumbra System with Engine Pump and Canister as well as its substantial equivalence to the predicate device:
- Biocompatibility ●
- Design Verification (Bench-Top Testing and Electrical Safety/EMC Testing) ●
- Shelf Life
- Sterilization ●
- Packaging
The subject Penumbra System with Engine Pump and Canister met all established requirements.
1.10.1 Biocompatibility
The subject and predicate Penumbra System sterile devices are identical. There are no changes to the previously provided biocompatibility data of the Penumbra System materials sterile devices, which were reviewed and cleared under K162901. No additional biocompatibility testing is required or was performed for the Penumbra System sterile devices.
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Image /page/8/Picture/0 description: The image shows the Penumbra logo. The word "Penumbra" is written in a red, sans-serif font. To the right of the word is a red circle with a white "P" inside. The "P" is stylized with a horizontal line running through it.
The Penumbra Engine Pump is a non-sterile reusable piece of capital equipment. The pump does not contact the patient, nor is it introduced into the sterile field. As such, biocompatibility testing is not required and was not performed for the pump. The Penumbra Engine Pump Canister also does not contact the patient, nor is it introduced into the sterile field. Furthermore, blood or body fluids collected in the canister are not re-introduced to the patient. As such, biocompatibility testing is not required and was not performed for the Canister.
1.10.2 Design Verification (Bench-top Testing and Electrical Safety/EMC Testing)
The subject and predicate Penumbra System sterile devices are identical. There are no changes to the design specifications and performance characteristics of the Penumbra System sterile devices. Therefore, all previous bench-top testing data which were reviewed and cleared under K162901 continue to support the subject Penumbra System sterile devices. No additional benchtop testing is required or was performed for the Penumbra System sterile devices.
Bench-top testing was conducted to evaluate the physical and mechanical properties of the subject Penumbra Engine Pump and Canister. All bench-top studies were conducted using good scientific practices and statistical sampling methods as required by the Penumbra Design Control procedures. Performance testing was based on the design specifications, risk analysis, performance standards, and guidance documents.
The Penumbra Engine Pump and Canister also underwent electrical safety and EMC testing in accordance with the requirements of IEC 60601-1 and IEC 60601-1-2. Testing was performed by Intertek, a nationally recognized test laboratory. The Engine Pump and Canister passed all tests and met all acceptance criteria.
| Attribute | Sample
Size | Specification | Acceptance Criteria | Results |
|---------------------------------|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|-----------|
| Pump - Electrical
Safety | N=1 | The Pump conforms to IEC 60601-1
and IEC 60601-1-2 requirements
including international worldwide
variants (CB Scheme). The Pump is
compliant with EN ISO 10079-1. | 100% Pass | 100% Pass |
| Pump - Environmental
Testing | N=5 | Pump performance specifications
under environmental conditions | 100% Pass | 100% Pass |
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Image /page/9/Picture/0 description: The image shows the Penumbra company logo. The logo consists of the word "Penumbra" in a red, sans-serif font, followed by a red circle with a white "P" inside. The "P" is formed by a white line that extends beyond the circle.
| Attribute | Sample
Size | Specification | Acceptance Criteria | Results |
|------------------------------------------------------------|----------------|---------------------------------------------------------|---------------------|-----------|
| Pump - Dimensional
Inspection | N=5 | Dimensional specifications per
Product Specification | 100% Pass | 100% Pass |
| Pump - Inspection of
Design Features | N=5 | Design specifications per Product
Specification | 100% Pass | 100% Pass |
| Pump - Performance | N=5 | Performance specifications per
Product Specification | 100% Pass | 100% Pass |
| Pump - Performance at
variable voltage and
frequency | N=5 | Performance specifications per
Product Specification | 100% Pass | 100% Pass |
| Pump and Canister -
500 hour Use Testing | N=5 | Performance specifications after 500
hour use | 100% Pass | 100% Pass |
| Pump Canister -
Inspection of Design
Features | N=5 | Design specifications per Product
Specification | 100% Pass | 100% Pass |
| Pump Canister -
Performance | N=5 | Performance specifications per
Product Specification | 100% Pass | 100% Pass |
| Pump and Canister -
Simulated Use | N=5 | Pump and Canister use
specifications | 100% Pass | 100% Pass |
1.10.3 Shelf Life
The subject and predicate Penumbra System sterile devices are identical. There are no changes to the previously provided shelf life data for the sterile devices which were reviewed and cleared under K162901. No additional shelf life testing is required or was performed for the Penumbra System sterile devices.
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Image /page/10/Picture/0 description: The image contains the word "Penumbra" in a red, sans-serif font. To the right of the word is a red circle with a white "P" inside. The "P" is stylized with a horizontal line extending from the right side of the "P" to the edge of the circle. The overall design appears to be a logo.
The proposed Penumbra Engine Pump is a reusable piece of capital equipment that is provided non-sterile. Therefore, shelf life testing is not applicable to the Engine Pump and shelf life testing was not performed. The Engine Pump is established for 500 hours of use based on completed life (reliability) testing. The Engine Pump Canister does not have an established shelf life.
1.10.4 Sterilization
The subject and predicate Penumbra System sterile devices are identical. There are no changes to the previously provided sterilization data of the devices, which were reviewed and cleared under K162901. No additional sterilization testing is required or was performed for these devices.
Sterilization testing is not applicable to the proposed Penumbra Engine Pump and Canister. Both are supplied non-sterile and are not intended to be sterilized.
1.10.5 Packaging
The packaging materials and process of the subject and predicate Penumbra System sterile devices are identical. There are no changes to the previously provided packaging material listing or the packaging process for these devices, which were reviewed and cleared under K162901. No additional packaging testing is required or was performed for the Penumbra System sterile devices.
The packaging materials for the proposed Engine Pump and Canister are similar to those used for the predicate Penumbra System Penumbra Pump MAX and Canister. The Engine Pump and Canister are packaged to ensure that damage does not occur during shipping. The Engine Pump is packaged in a protective, corrugated, cardboard 275 B/C Flute Double Wall RSC shipping container with custom shaped foam inserts. Pumps used for Design Verification and Packaging Validation testing first underwent transportation conditioning per ASTM D4169, Distribution Cycle 3, Assurance Level 3 to ensure packaging integrity. Canisters used for Design Verification and Packaging Validation testing first underwent transportation conditioning per ASTM D4169, Distribution Cycle 3, Assurance Level 2 to ensure packaging integrity. The Canister is packaged individual in 200 pound E-Flute container product boxes. The Canister box is then packaged in protective, corrugated, cardboard 275 B/C Flute Double Wall RSC shipping containers (8 canister boxes per shipper).
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Image /page/11/Picture/0 description: The image shows the word "Penumbra" in a red serif font, followed by a red circle with a white "P" inside. The "P" is stylized with a line extending from the top right corner of the "P" to the edge of the circle. The logo is simple and modern, and the red color gives it a sense of energy and excitement.
1.11 Summary of Substantial Equivalence
The subject Penumbra System disposable devices are unchanged and remain identical to those of the predicate Penumbra System with regard to indications, function, design, materials, biocompatibility, packaging, and sterilization. The subject Penumbra System Engine Pump and Canister are substantially equivalent to the predicate device with regard to intended use, operating principle, design concept, materials, and packaging processes.