(79 days)
Not Found
No
The description focuses on the mechanical aspiration mechanism and does not mention any AI/ML components or image processing.
Yes.
The device is used to remove emboli and thrombi from blood vessels in the peripheral arterial system, directly treating a medical condition.
No
The device is described as an aspiration system for removing emboli and thrombi, which is a therapeutic intervention, not a diagnostic one.
No
The device description explicitly details physical components like Aspiration Catheters, Separators, and Aspiration Tubing, and mentions sterilization and single-use, indicating a hardware-based medical device.
Based on the provided information, the Penumbra Embolectomy Aspiration System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the removal of emboli and thrombi from vessels of the peripheral arterial system. This is a therapeutic procedure performed directly on the patient's body, not a diagnostic test performed on a sample taken from the body.
- Device Description: The device description focuses on the mechanical action of aspiration to remove material from the body. It does not mention analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health status
- Using reagents or assays
- Measuring biomarkers or other indicators
The device is clearly intended for a therapeutic intervention (removing blockages) within the patient's circulatory system.
N/A
Intended Use / Indications for Use
The Penumbra Embolectomy Aspiration System is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial system. Not for use in the coronaries, the venous system or the neurovasculature.
Product codes (comma separated list FDA assigned to the subject device)
DXE
Device Description
The Penumbra Embolectomy Aspiration System's fundamental mechanism of action is aspiration. Aspiration draws the embolus or thrombus into the Aspiration Catheter to remove the embolus or thrombus from the body. All Separators function to break up the clot inside of the catheter to make it more amenable to removal from the body via aspiration. The Aspiration Catheter, Separator and Aspiration Tubing are available in multiple configurations. The devices are provided sterile, non-pyrogenic, and intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peripheral arterial system. Not for use in the coronaries, the venous system or the 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)
Summary of Non-Clinical Data:
- Biocompatibility / Pyrogenicity: Established based on tests selected in accordance with EN ISO 10993 -1 guidelines for limited duration (
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).
0
9 510(K) SUMMARY
(as required by 21 CFR 807.92)
SEP
19 2012
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 Embolectomy Aspiration System.
Sponsor/Applicant Name and Address 9.1
Penumbra, Inc. 1351 Harbor Bay Parkway Alameda, CA 94502, USA
9.2 Sponsor Contact Information
Michaela Mahl Regulatory Affairs Program Manager Phone: (510) 748-3288 FAX: (510) 217-6414 Email: michaela.mahl@penumbrainc.com
9.3 Date of Preparation of 510(k) Summary
September 14, 2012
9.4 Device Trade or Proprietary Name
Penumbra Embolectomy Aspiration System
તે તે રે Common/Usual Name
Penumbra Embolectomy Aspiration System
9.6 Device Classification
Regulatory Class: II Classification Panel: Cardiovascular Classification Name: Embolectomy catheter Regulation Number: 21 CFR § 870.5150 Product Code: DXE
9.7 Predicate Devices
| 510(k) Number /
Clearance Date | Name of Predicate Device | Name of
Manufacturer |
|-----------------------------------|--------------------------------------------------------|--------------------------------|
| K100569 / 11Mar2011 | Merit Embolectomy Catheter | Merit Medical
Systems, Inc. |
| K072718 / 28Dec2007 | Penumbra System | Penumbra, Inc. |
| K090752 / 21Sep2009 | Penumbra System 054 | Penumbra, Inc. |
| K100769 / 21May2010 | Penumbra System Separator Flex [026, 032,
041, 054] | Penumbra, Inc. |
| K113163 / 23Nov2011 | Penumbra System MAX | Penumbra, Inc. |
1
Device Description 9.8
The Penumbra Embolectomy Aspiration System's fundamental mechanism of action is aspiration. Aspiration draws the embolus or thrombus into the Aspiration Catheter to remove the embolus or thrombus from the body. All Separators function to break up the clot inside of the catheter to make it more amenable to removal from the body via aspiration. The Aspiration Catheter, Separator and Aspiration Tubing are available in multiple configurations. The devices are provided sterile, non-pyrogenic, and intended for single use only.
و. و Intended Use
The Penumbra Embolectomy Aspiration System is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial system. Not for use in the coronaries, the venous system or the neurovasculature.
9.10 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 safety and effectiveness of the device follows.
Included in this section are descriptions of the testing, which substantiates the safe and effective performance of the Penumbra Embolectomy Aspiration System as well as its substantial equivalence to the predicate devices:
- . Biocompatibility / Pyrogenicity
- . Design Verification (Bench-Top Testing)
- . Animal Study
For the subject Penumbra Embolectomy Aspiration System all established requirements and acceptance criteria were met.
9.10.1 Biocompatibility Testing
Biocompatibility is established for the Penumbra Embolectomy Aspiration System devices based on tests selected in accordance with EN ISO 10993 -1 guidelines (Biological Evaluation of Medical Devices) for limited duration (