(21 days)
Not Found
No
The document describes a mechanical aspiration system for removing blood clots and does not mention any AI or ML components.
Yes
The device is indicated for "revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease," which is a therapeutic intervention.
No
The devices described are part of the Penumbra System, which is indicated for the revascularization of patients with acute ischemic stroke by assisting in the removal of thrombus, not for diagnosing conditions.
No
The device description clearly outlines physical components like catheters, separators, tubing, and a pump, indicating it is a hardware-based system. There is no mention of software as the primary or sole component.
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 Description and Intended Use: The description and intended use clearly state that this device is a system of catheters, tubing, and a pump used for the revascularization of patients with acute ischemic stroke. This involves physically removing thrombus (blood clots) from blood vessels within the brain. This is an in vivo procedure (performed within the living body), not an in vitro test.
- Lack of Mention of Samples: There is no mention of collecting or analyzing samples from the patient.
- Focus on Mechanical Action: The device's function is described as delivering aspiration to remove thrombus, which is a mechanical action performed directly on the patient's anatomy.
Therefore, this device falls under the category of a medical device used for treatment, not an in vitro diagnostic device used for diagnosis based on sample analysis.
N/A
Intended Use / Indications for Use
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.
Product codes
NRY
Device Description
The Penumbra System Reperfusion Catheter Penumbra JET 7 with Xtra Flex technology (JET 7 Xtra Flex) is a component to the currently available Penumbra System. The JET 7 Xtra Flex delivers aspiration from the Aspiration Pump directly to the site of occlusion to assist in the removal of thrombus from the neurovasculature. The devices are provided sterile, non-pyrogenic, and intended for single use only.
The Penumbra System Penumbra JET 7MAX is an additional configuration to the currently available Penumbra System. The MAX Delivery Device is an optional accessory for use with the JET 7 Xtra Flex and is removed prior to aspiration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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
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
There are no differences in technological characteristics between the subject and predicate devices and therefore no verification and validation studies were required.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
August 31, 2020
Penumbra, Inc. Anush Puvvada Regulatory Affairs Specialist III One Penumbra Place Alameda, California 94502
Re: K202251
Trade/Device Name: Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX) Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: August 7, 2020 Received: August 10, 2020
Dear Anush Puvvada:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Naira Muradyan, Ph.D. Assistant Director (Acting) DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Image /page/3/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. A white line extends from the right side of the word "Penumbra" to the left side of the "P".
1. 510(k) Summary
K202251
(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 subject Penumbra System® (Penumbra JET™ 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET™ 7MAX).
1.1. Sponsor/Applicant Name and Address
Penumbra, Inc. One Penumbra Place Alameda, CA 94502 USA
Contact Person: Anush Puvvada Regulatory Specialist III Tel: (510) 440-5568 Fax: (510) 217-6414 E-mail: ypuvvada@penumbrainc.com
Date of Preparation: August 31, 2020
1.2. Subject Device
Penumbra System® (Penumbra JETTM 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JETTM 7MAX)
Regulatory Class: II Classification Panel: Neurology Classification Name: Percutaneous Catheter Regulation Number: 21 CFR 870.1250 Product Code: NRY (Catheter, Thrombus Removal)
Predicate Device Information 1.3.
Penumbra System® Reperfusion Catheter JET™ 7 (K190010)
Penumbra System® [JET™ 7 Reperfusion Catheter with MAX Delivery Device (JET™ 7MAX)] (K191946).
1.4. Device Description
The Penumbra System Reperfusion Catheter Penumbra JET 7 with Xtra Flex technology (JET 7 Xtra Flex) is a component to the currently available Penumbra System. The JET 7
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Penumbra
Xtra Flex delivers aspiration from the Aspiration Pump directly to the site of occlusion to assist in the removal of thrombus from the neurovasculature. The devices are provided sterile, non-pyrogenic, and intended for single use only.
The Penumbra System Penumbra JET 7MAX is an additional configuration to the currently available Penumbra System. The MAX Delivery Device is an optional accessory for use with the JET 7 Xtra Flex and is removed prior to aspiration.
1.5. 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.
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Image /page/5/Picture/0 description: The image shows the word "Penumbra" in a bold, red font. To the right of the word is a red circle with a white "P" inside. The logo is simple and modern, and the colors are eye-catching.
1.6. Comparison of Technological Characteristics with the Predicate Device
There are no differences in the technological characteristics between the subject device and predicate device. The changes made to the subject device are solely labeling changes for more clarity to include additional warnings, precautions, and instructions to enhance the safety of device use.
1.7. Performance Data
There are no differences in technological characteristics between the subject and predicate devices and therefore no verification and validation studies were required.
1.8. Conclusions
The subject Penumbra System® (Penumbra JET™ 7 Reperfusion Catheter with Xtra Flex Technology: Penumbra JET™ 7MAX) are substantially equivalent to the predicate devices, the Penumbra System (Reperfusion Catheter JET 7) (K190010) and the Penumbra System [JET 7 Reperfusion Catheter with MAX Delivery Device (JET 7MAX)] (K191946). The subject devices have identical intended use and technological characteristics as their corresponding predicate devices. Also, there are no changes in terms of device performance, safety, operating principle, design concept, fundamental technology manufacturing, and packaging between the subject and predicate devices. Therefore, the subject devices are substantially equivalent to their respective predicates.