(94 days)
The Penumbra System™ is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (in the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset.
The Penumbra System consists of four 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 (K051758). 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.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific acceptance criteria or report a direct device performance metric in a quantifiable manner (e.g., a specific percentage of primary endpoint success that the device had to meet). Instead, it states that the device "met the specifications and the outcome measures of the clinical protocol."
The document focuses on demonstrating substantial equivalence to predicate devices. This means the acceptance criteria are implicitly linked to the performance and safety profile of the predicate devices. The "performance" reported is that the device was found to be substantially equivalent.
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Bench testing, in vitro testing, in vivo testing, and a clinical study have been performed..." However, it does not specify the sample size used for the clinical study (test set).
Regarding data provenance, the document does not explicitly state the country of origin or whether the study was retrospective or prospective. Given it's a 510(k) submission to the FDA, it's highly likely to be a prospective clinical study, though this is not explicitly confirmed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number of experts used to establish ground truth for the test set or their specific qualifications. It only refers to a "clinical study" without detailing its design or evaluation methodology.
4. Adjudication Method for the Test Set
The document does not provide information on any adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention or describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. Therefore, no effect size of human readers improving with or without AI assistance is reported. This is logical as the device is a medical device (catheter system) for mechanical thrombectomy, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
The document does not describe a standalone (algorithm-only) performance study. The Penumbra System is a physical medical device (catheter) used in a medical procedure, not an algorithm.
7. Type of Ground Truth Used
The document refers to a "clinical study" and "outcome measures of the clinical protocol." For a device like the Penumbra System, the ground truth for revascularization would typically be established by:
- Imaging results: Post-procedure angiographic assessments (e.g., TIMI score, mTICI score) to determine the degree of reperfusion.
- Clinical outcomes data: Such as modified Rankin Scale (mRS) scores at 90 days to assess functional independence, and potentially NIHSS scores to assess neurological deficit.
However, the document does not explicitly state the specific type of ground truth used, beyond implying it followed clinical protocol outcomes.
8. Sample Size for the Training Set
The document does not mention a "training set" as it is describing a physical medical device and its clinical evaluation, not an AI model.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned (see point 8), this information is not applicable to the provided document.
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72718
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
| Date Summary Prepared | September 20, 2007 | |
|---|---|---|
| Trade Name | Penumbra System™ | DEC 2 8 2007 |
| Common Name | Percutaneous Catheter | |
| Classification Name | Percutaneous Catheter(21 CFR Part 870.1250; Product Code NRY) | |
| Submitted By | Penumbra, Inc.2401 Merced Street, Suite 200San Leandro, CA 94577 | |
| Contact | Theresa Brander-AllenVP of Regulatory and QualityTel: 510-618-3223Fax: 510-352-1766tballen@penumbrainc.com |
Predicate Devices
Merci Retriever models X5 and X6 (K033736) and Merci Micro Catheter (K003086) Manufactured by Concentric Medical, Inc.
Device Description
The Penumbra System consists of four 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 (K051758).
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.
Intended Use
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The Penumbra System is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (in the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8
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hours of symptom onset. The indication statement of the Penumbra System is substantially equivalent to the legally marketed predicate devices.
Substantial Equivalence
The intended use, method of operation, methods of construction and materials used, are either identical or substantially equivalent to the existing, legally marketed, predicate devices. Therefore, Penumbra believes the Penumbra System is substantially equivalent to the predicate devices.
Testing
Bench testing, in vitro testing, in vivo testing, and a clinical study have been performed on the device materials, components, subassemblies, and final assemblies. The devices tested met the specifications and the outcome measures of the clinical protocol.
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DEC 2 8 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Penumbra, Inc. % Ms. Theresa Brander-Allen V. P., Regulatory and Quality 2401 Merced Street, Suite 200 San Leandro, CA 94577
Re: K072718 Trade/Device Name: Penumbra System™ Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II Product Code: NRY Dated: November 30, 2007 Received: December 3, 2007
Dear Ms. Brander-Allen:
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 such 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); good manufacturing practice requirements as set forth in the quality systems (OS) 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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Page 2 - Ms. Theresa Brander-Allen
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 yours.
Mark N Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name:
Indications 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 (in the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. 1
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)
Arlene Brown
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number K020718
§ 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).