(97 days)
No
The device description focuses on mechanical components and aspiration technology, with no mention of AI, ML, or image processing for analysis or decision-making.
Yes
The device is used for the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease within 8 hours of symptom onset, which is a therapeutic intervention.
No
The device description clearly states its purpose is to "remove thrombus from the neurovasculature using continuous aspiration" and is indicated for "revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease." This describes a therapeutic, not a diagnostic, function.
No
The device description clearly outlines multiple hardware components including catheters, separators, tubing, and a pump. The performance studies also focus on the physical characteristics and function of these hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Penumbra System is for the revascularization of patients with acute ischemic stroke. This is a therapeutic intervention performed in vivo (within the living body) to remove a blockage in blood vessels.
- Device Description: The description details a system designed to remove thrombus (blood clots) from the neurovasculature using aspiration. This is a mechanical process performed directly on the patient's circulatory system.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of bodily specimens.
The device is a medical device used for a therapeutic procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
Penumbra Reperfusion Catheters and Separators
As part of the Penumbra System, the Reperfusion Catheters and Separators are 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.
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 Pump MAX.
Penumbra Pump MAX
The Penumbra Pump MAX 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
The Penumbra System is designed to remove thrombus from the neurovasculature using continuous aspiration. The Reperfusion Catheter targets aspiration from the pump directly to the thrombus. 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 [1.37mm] 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 Penumbra Reperfusion Catheter is used with the Penumbra Pump MAX to aspirate thrombus from an occluded vessel. As
needed, a Penumbra Separator may be deployed from the Reperfusion Catheter to assist with thrombus removal. The Penumbra Separator is advanced and retracted through the Penumbra 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 Penumbra Reperfusion Catheter is used in conjunction with the Penumbra Pump MAX, which is connected using the Penumbra Aspiration Tubing and the Penumbra Pump/Canister Tubing. The Penumbra Reperfusion Catheter is provided with a steam shaping mandrel and rotating hemostasis valve, and a peelable sheath. The Penumbra Separator is provided with an introducer and torque device. The devices are visible under fluoroscopy. The Penumbra Reperfusion Catheter, Separator, and Aspiration Tubing are provided sterile, non-pyrogenic, and intended for single use only. Additionally, a pre-packaged configuration (KIT packaging) for all Penumbra System Reperfusion Catheters with Aspiration Tubing is available.
The Penumbra Pump MAX
The Penumbra Pump MAX is designed to provide aspiration for the Penumbra System. The Penumbra Pump MAX operates using AC power. The Penumbra Pump MAX provides vacuum of up to 29 inHg and is available in both 110Vac and 230Vac versions. The Penumbra Pump MAX and Pump/Canister Tubing are provided non-sterile and is used outside the sterile field.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy
Anatomical Site
intracranial (internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries), neurovasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Non-Clinical Data - KIT Configuration:
Packaging Validation Testing: The KIT configuration met all established requirements.
Packaging Validation: The physical and mechanical properties of the KIT configuration were assessed using standard test methods and pre-determined acceptance criteria.
Tests performed:
- Visual Inspection: Results - Pass.
- Simulated Use (Intracranial Access, Vessel Access Entry Performance & Clot Removal): Simulated use testing of the Catheter and Separator was performed with accessory devices in an anatomical model which simulated the tortuosity of the neurovasculature. Devices were delivered through the tortuous anatomical model to evaluate the effectiveness of the devices to remove clots and that the Reperfusion Catheter does not collapse under vacuum. Results - 100% Pass.
- Catheter Coating: Coating has not delaminated, peeled, or flaked after simulated use. Results - 100% Pass.
- Gross Leak: Pouch seals, pouch front, and pouch back material do not leak. Results - 100% Pass.
Key results: All tests passed successfully. The physical and mechanical properties of the KIT configuration devices are acceptable for the intended use and substantially equivalent to the predicate device.
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.
K072718, K090752, K100769, K113163, K133317, K142458, K151623, K122756, K051758
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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a caduceus, a staff with two snakes entwined around it, often associated with medicine and healthcare. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 25, 2016
Penumbra, Inc. Mr. Richard Kimura Regulatory Affairs Specialist One Penumbra Place Alameda, California 94502
Re: K160449
Trade/Device Name: Penumbra System and Penumbra Pump MAX Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: April 22, 2016 Received: April 25, 2016
Dear Mr. Richard Kimura:
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 (reporting of medical devicerelated 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 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 Industry and Consumer Education 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,
Carlos L. Pena -S/A
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) K160449
Device Name Penumbra System® and Penumbra Pump MAX
Indications for Use (Describe)
Penumbra Reperfusion Catheters and Separators
As part of the Penumbra System, the Reperfusion Catheters and Separators are 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.
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 Pump MAX.
Penumbra Pump MAX The Penumbra Pump MAX is indicated as a vacuum source for Penumbra Aspiration Systems.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
1 510(k) Summary
(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®.
1.1 Sponsor/Applicant Name and Address
Penumbra, Inc. One Penumbra Place Alameda, CA 94502 USA
1.2 Sponsor Contact Information
Richard Kimura Regulatory Affairs Specialist Phone: (510) 995-2034 FAX: (510) 217-6414 Email: rkimura@penumbrainc.com
1.3 Date of Preparation of 510(k) Summary
April 22, 2016
1.4 Device Trade or Proprietary Name
Penumbra System® and Penumbra Pump MAX
1.5 Device Classification
Regulatory Class: II Classification Panel: Neurology Catheter, Thrombus Retriever Classification Name: Regulation Number: 21 CFR §870.1250 Product Code: NRY
1.6 Predicate Devices
| 510(k) Number/
Clearance Date | Name of Predicate Device | Name of
Manufacturer |
|----------------------------------|------------------------------------------------------------|-------------------------|
| Predicate Devices | | |
| K152541[13Jan2016] | Penumbra System ACE 64 and ACE
68 Reperfusion Catheters | Penumbra, Inc. |
| K122756[02Oct2012] | Penumbra Pump MAX | Penumbra, Inc. |
4
1.7 Predicate Comparison
| Predicate Device | Subject Device | |
|---|---|---|
| Trade Name | Penumbra System | Penumbra System (including |
| Penumbra Pump MAX) | ||
| Predicate 510(k) | ||
| No. | Penumbra System : K152541 | |
| Reference 510(k) | ||
| No. | Penumbra System: K072718, K090752, | |
| K100769, K113163, K133317, | ||
| K142458, K151623 | ||
| Penumbra Pump MAX:K122756 and | ||
| K051758 | K160449 | |
| Classification | Penumbra System: Class II, NRY | |
| Penumbra Pump MAX: Class II, JCX | Class II, NRY | |
| Indication for Use | Penumbra System | |
| 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. |
Penumbra Aspiration Pump
The Penumbra Pump MAX is intended
for general suction use in hospitals or
clinics. | 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.
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 Pump MAX.
Penumbra Pump MAX
The Penumbra Pump MAX is
indicated as a vacuum source for
Penumbra Aspiration Systems. |
| Reperfusion Catheter | | |
| Materials | Biocompatible, commonly utilized for
interventional devices | SAME |
| Coating | Hydrophilic | SAME |
| Markerband | Radiopaque | SAME |
| Guidewire
compatible | Yes | SAME |
| Dimensions | | |
| - OD [Maximum] | 0.051" - 0.080" [1.295mm – 2.030mm] | SAME |
| - Working Length | $125cm - 153cm$ | SAME |
| Separator | | |
| Materials | Biocompatible, commonly utilized for
interventional devices | SAME |
| | Predicate Device | Subject Device |
| Trade Name | Penumbra System | Penumbra System (including
Penumbra Pump MAX) |
| Predicate 510(k)
No. | Penumbra System : K152541 | |
| Reference 510(k)
No. | Penumbra System: K072718, K090752,
K100769, K113163, K133317,
K142458, K151623
Penumbra Pump MAX:K122756 and
K051758 | K160449 |
| Classification | Penumbra System: Class II, NRY
Penumbra Pump MAX: Class II, JCX | Class II, NRY |
| Dimensions | | |
| - Distal OD | 0.022" – 0.045" [0.56mm – 1.14mm] | SAME |
| - Working Length | 135cm – 155cm | SAME |
| Aspiration Tubing | | |
| Materials | Biocompatible, commonly utilized for
interventional devices | SAME |
| Dimensions | | |
| - ID | 0.071" – 0.110" [1.80mm – 2.80mm] | SAME |
| - Length | 112.0" [284.5cm] | SAME |
| Sterilization | EO | SAME |
| Shelf-Life | 36-Months | SAME |
| Aspiration Pump | | |
| IEC 60601-1
Compliance | Yes | SAME |
| IEC 60601-1-2
Compliance | Yes | SAME |
| Voltage | 100-115 Vac/230 Vac | SAME |
| Frequency | 50 Hz/60 Hz | SAME |
| Sterilization | Non sterile | SAME |
| Shelf Life | N/A | SAME |
5
Device Description 1.8
The Penumbra System
The Penumbra System is designed to remove thrombus from the neurovasculature using continuous aspiration. The Reperfusion Catheter targets aspiration from the pump directly to the thrombus. 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 [1.37mm] 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 Penumbra Reperfusion Catheter is used with the Penumbra Pump MAX to aspirate thrombus from an occluded vessel. As
6
needed, a Penumbra Separator may be deployed from the Reperfusion Catheter to assist with thrombus removal. The Penumbra Separator is advanced and retracted through the Penumbra 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 Penumbra Reperfusion Catheter is used in conjunction with the Penumbra Pump MAX, which is connected using the Penumbra Aspiration Tubing and the Penumbra Pump/Canister Tubing. The Penumbra Reperfusion Catheter is provided with a steam shaping mandrel and rotating hemostasis valve, and a peelable sheath. The Penumbra Separator is provided with an introducer and torque device. The devices are visible under fluoroscopy. The Penumbra Reperfusion Catheter, Separator, and Aspiration Tubing are provided sterile, non-pyrogenic, and intended for single use only. Additionally, a pre-packaged configuration (KIT packaging) for all Penumbra System Reperfusion Catheters with Aspiration Tubing is available.
The Penumbra Pump MAX
The Penumbra Pump MAX is designed to provide aspiration for the Penumbra System. The Penumbra Pump MAX operates using AC power. The Penumbra Pump MAX provides vacuum of up to 29 inHg and is available in both 110Vac and 230Vac versions. The Penumbra Pump MAX and Pump/Canister Tubing are provided non-sterile and is used outside the sterile field.
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.
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 Pump MAX.
Penumbra Pump MAX
The Penumbra Pump MAX is indicated as a vacuum source for Penumbra Aspiration Systems.
7
1.10 Leveraged Non-Clinical Data - Individual Packaged Devices
The subject and predicate devices are identical. There are no changes in the device design, materials, manufacturing, packaging and sterilization methods. Therefore, biocompatibility data, bench top data, sterilization data, and stability data from previous pre-market notifications listed in Section 1.6 are directly applicable and no additional testing was required or was performed to support the consolidation of the Penumbra System and Penumbra Pump MAX under the same product code (NRY), clarifications of the Indications for Use statements, and Instructions for Use (IFU) and Operation, Maintenance, and Service Manual revisions.
1.11 Non-Clinical Data - KIT Configuration
Included in this section is a brief summary of additional testing performed for the KIT configuration packaging:
- Packaging Validation Testing .
The KIT configuration met all established requirements.
1.11.1 Packaging Validation
The physical and mechanical properties of the KIT configuration were assessed using standard test methods and pre-determined acceptance criteria. The following tests were performed and all tests passed successfully:
| Attribute | Specification | Acceptance
Criteria | Results |
|----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|-----------|
| Visual Inspection | These evaluations confirm that the units used in this
Design Verification testing meet all inspection
criteria for release of finished goods (clinically
acceptable) product. | | Pass |
| Simulated Use
(Intracranial
Access, Vessel
Access Entry
Performance &
Clot Removal) | Simulated use testing of the Catheter and Separator
was performed with accessory devices in an
anatomical model which simulated the tortuosity of
the neurovasculature. Devices were delivered
through the tortuous anatomical model to
evaluate the effectiveness of the devices to remove
clots and that the Reperfusion Catheter does not
collapse under vacuum. | | 100% Pass |
| Catheter Coating | Coating has not delaminated, peeled, or flaked after
simulated use. | | 100% Pass |
| Gross Leak | Pouch seals, pouch front, and pouch back material
do not leak. | | 100% Pass |
The results of the tests appropriately address the physical and mechanical performance expectations of the KIT configuration. Based on these overall results, the physical and mechanical properties of the KIT configuration devices are acceptable for the intended use and substantially equivalent to the predicate device.
8
1.12 Leveraged Animal Study - Individual Packaged Devices and KIT Configuration
The subject and predicate devices are identical. Therefore, Animal Testing data from previous pre-market notifications listed in Section 1.6 are directly applicable and no further Animal Testing was required or was performed to support the consolidation of the Penumbra System and Penumbra Pump MAX under the same product code (NRY), clarifications in the Indications for Use statements, and IFU and Operation, Maintenance, and Service Manual revisions.
1.13 Summary of Substantial Equivalence
The subject Penumbra System is substantially equivalent to the predicate devices with regard to intended use, operating principle, design concept, materials, shelf-life, packaging and sterilization processes.