(64 days)
No
The device description and performance studies focus on the material properties and mechanical performance of a physical medical device (a separator for stroke treatment). There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is intended for "revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease," which is a treatment for a medical condition.
No
The Penumbra System is intended for revascularization and treatment of acute ischemic stroke, not for diagnosing it.
No
The device description clearly describes a physical medical device (Separator Flex) made of Nitinol and intended for single use, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease". This describes a therapeutic intervention performed directly on the patient's body to restore blood flow.
- Device Description: The device is a "Separator Flex" used within the Penumbra System, which is a mechanical thrombectomy system. This is a physical device used to remove blood clots from vessels.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform such analysis on bodily specimens.
The information provided clearly indicates a device used for a therapeutic procedure within the body, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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.
Product codes
NRY
Device Description
The Penumbra System Separator Flex (026, 032, 041, and 054) is an alternative The Fenamora System Separator Pish (020) 6027 852 8826 Separators. The Separators. The Separator Flex utilizes a Nitinol core wire in place of the current stainless steel corewire. The I lex attiffees a ritmor off in all four current sizes (026, 032, 041, and 054). Both the existing Separators and the subject Separator Flex models will be available to address Physician preference of stainless steel and nitinol. The device is provided sterile, nonpyrogenic, 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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical data for biocompatibility and design verification (bench-top testing).
Biocompatibility tests were conducted in accordance with ISO-10993 - I for a limited exposure (≤ 24 hours), externally communicating device with circulating blood contact. Tests included: in vitro cytotoxicity, acute intracutaneous reactivity, acute systemic toxicity, rabbit pyrogen study, sensitization, hemo-compatibility (in vitro hemolysis, in vitro coagulation (PT, PTT), complement activation). All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices. Results indicated the device was non-cytotoxic, non-mutagenic, non-reactive, non-sensitizing, a negligible irritant, non-pyrogenic, and non-toxic (acute systemic).
Design Verification testing evaluated physical and mechanical properties. Tests included: Dimensional / Visual Inspection (all sizes), Simulated Use (all sizes): Reperfusion Catheter / Separator Flex / Aspiration Tubing Assembly Performance, Separator Flexibility Test (all sizes), Separator Flex Bond Joint Test. All tests passed successfully. The physical, mechanical and performance testing demonstrated that the product is safe and effective for its labeled indications and is Substantially Equivalent to the currently marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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).
0
Penumbra
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どこ
Penumbra System® Separator™ Flex
510(k) SUMMARY OF SAFETY & EFFECTIVENESS 10. (as required by 21 CFR § 807.92)
MAY 2 1 2010
Pursuant to Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, Penumbra, Inc.
System Santarant Casino and Final planes for the Repumbra System Separator Fle Pursuant to Section 12, Part (a)(1)(3A) of the Sale Medical Develover 100 Separator Flex.
is providing the summary of Substantial Equivalence for the Penumbra System Separato
10.1 Sponsor/Applicant Name and Address
Penumbra, Inc. 1351 Harbor Bay Parkway Alameda, CA 94502, USA
Sponsor Contact Information 10.2
Michaela Mahl Principal Regulatory Specialist Phone: (510) 748-3288 FAX: (510) 217-6414 Email: michaela.mahl@penumbrainc.com
10.3 Date of Preparation of 510(k) Summary
April 20, 2010
10.4 Device Trade or Proprietary Name
Penumbra System® Separator™ Flex
10.5 Device Classification
Regulatory Class: II Cardiovascular Classification Panel: Percutaneous Catheter Classification Name: 21 CFR § 870.1250 Regulation Number: Product Code: NRY
10.6 Predicate Devices
| 510(k) Number /
| Clearance Date | Name of Predicate Device | Name of Manufacturer |
|---|---|---|
| K090752 / 21 Sep 2009 | Penumbra Reperfusion Catheter | |
| 054, Penumbra Separator 054 | Penumbra, Inc. | |
| K072718 / 28 Dec 2007 | Penumbra System [026, 032, 041] | Penumbra, Inc. |
1
ે.
| | Penumbra System Separator
[026, 032, 041, 054] | Penumbra System Separator Flex
[026, 032, 041, 054] |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| 510(k) No. | K072718 & K090752 | To be determined |
| Classification | Class II, NRY | SAME |
| Indication | 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. | SAME |
| Materials | | |
| Core wire | Stainless Steel | Nitinol Wire |
| Coating | PTFE GREEN PC | PTFE GREEN PC
Low Cure PTFE |
| Proximal wire | | SAME |
| Outer coil | Stainless Steel | SAME |
| Core wire | Stainless Steel Core Wire | Nitinol Core Wire |
| Solder joint | Silver Solder (95% Sn / 5%Ag) | SAME |
| Distal tip | | |
| Outer coil | Stainless Steel | SAME |
| Inner coil | Platinum Alloy | SAME |
| Solder joint | Gold Solder (80% Au / 20% Sn)
Silver Solder (95% Sn / 5%Ag) | SAME |
| Separator cone
tip | Pebax 40D green (026) ,yellow
(032), blue (041), purple (054) | SAME |
| ID band | Polyolefin (PET) | SAME |
| Sterilization | EtO | SAME |
| Shelf Life | 36 Months | SAME |
10.7 Comparison to Predicate Devices
10.8 Device Description
The Penumbra System Separator Flex (026, 032, 041, and 054) is an alternative The Fenamora System Separator Pish (020) 6027 852 8826 Separators. The Separators. The Separator Flex utilizes a Nitinol core wire in place of the current stainless steel corewire. The I lex attiffees a ritmor off in all four current sizes (026, 032, 041, and 054). Both the existing Separators and the subject Separator Flex models will be available to address Physician preference of stainless steel and nitinol. The device is provided sterile, nonpyrogenic, and intended for single use only.
2
Penumbra
i
10.9 Intended Use
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.
10.10 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's, which substantiates the safe and effective performance of the Penumbra System Separator Flex as well as its substantial equivalence to the predicate devices:
- Biocompatibility ●
- Design Verification (Bench-Top Testing) .
The subject Penumbra System Separator Flex met all established requirements.
10.10.1 Biocompatibility
Biocompatibility tests conducted for the Penumbra System Separator Flex were selected in accordance with ISO-10993 - I (Biological Evaluation of Medical Devices) guidelines for a limited exposure (≤ 24 hours), externally communicating device with circulating blood contact. All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices.
| Test | Method | Results |
|---|---|---|
| In Vitro | ||
| Cytotoxicity | ISO Elution Test (MEM | |
| Extract) | No evidence of cell lysis | |
| or toxicity | ||
| Acute | ||
| Intracutaneous | ||
| Reactivity | ||
| (Irritation) | ISO Intracutaneous | |
| (Intradermal) Injection | ||
| Test | No evidence of irritation | |
| Acute | ||
| Systemic | ||
| Toxicity | ISO Acute Systemic | |
| Injection Test | No evidence of systemic | |
| toxicity | ||
| Rabbit | ||
| Pyrogen Study | USP Material-Mediated | |
| Rabbit Pyrogen Test | No evidence of material- | |
| mediated pyrogenicity |
ISO, 10003 CI P Testing Summary for Separator Flex
3
Penumbra
ir
Penumbra System® Separator™ Flex
| Test | Method | Results |
|---|---|---|
| Sensitization | ISO Maximization Test | |
| for Delayed | ||
| Hypersensitivity | Non-Sensitizing | |
| Hemo-compatibility | ||
| -In Vitro | ||
| Hemolysis | ASTM Methode | |
| (Extraction & Direct | ||
| Contact) | Non-hemolytic | |
| -In Vitro | ||
| Coagulation | ||
| (PT, PTT) | Prothrombin Time (PT) | |
| Assay | ||
| Partial Thromboplastin | ||
| Time (PTT) Assay | Coagulation times are | |
| within the normal range | ||
| Non-Thrombogenic | ||
| -Complement | ||
| Activation | C3a and SC5b-9 through | |
| Enzyme Assay | No greater biological | |
| response than | ||
| corresponding control |
In summary, non-clinical testing found the Penumbra System Separator Flex to be non-cytotoxic, non-mutagenic, non-reactive (short and long-term implantation), nonsensitizing, a negligible irritant, non-pyrogenic, and non-toxic (acute systemic).
Design Verification (Bench-Top Testing) 10.10.2
Design Verification testing was conducted to evaluate the physical and mechanical properties of the Penumbra System Separator Flex. All studies were conducted using properties of the renament of yourselves sampling methods as required by the good scientifie procedures. All testing was performed using units which r chantolu Design Control processed goods release requirements. The packaging used were 2x stermbed and enarator Flex is identical to the predicate Penumbra for the Fenanora oferaging. Therefore, no packaging testing was conducted. The tests performed on the Penumbra System Separator Flex included:
- Dimensional / Visual Inspection (all sizes) .
- Simulated Use (all sizes): Reperfusion Catheter / Separator Flex / Aspiration . Tubing Assembly Performance
- Separator Flexibility Test (all sizes) .
- Separator Flex Bond Joint Test .
All performed tests passed successfully.
The physical, mechanical and performance testing of the subject Penumbra The problem, moonstrate that the product is safe and effective for its labeled indications and is Substantially Equivalent to the currently marketed predicate devices.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines extending from its head, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 ] 2010
Penumbra, Inc. c/o Ms. Michaela Mahl, MSBE Principal Regulatory Specialist 1351 Harbor Bay Pkwy. Alameda, CA 94502
Re: K100769
13100707
Trade/Device Name: Penumbra System® Separator™ Flex (026, 032, 041, 054) Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: April 20, 2010 Received: April 21, 2010
Dear Ms. Mahl:
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.
5
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 device-related 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDeyices/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 Small Manufacturers, International and Consumer Assistance 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.
Eile. Hemm of
Malvina B. Eydelman, M. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
510(k) Number (if known): K | 00 769
Device Name: Penumbra System® Separator™ Flex
Indications for Use:
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.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part)21 CFR 801 Subpart D)
AND/OR
Over The Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kristen Bowsher
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, .Nose and Throat Devices'
510(k) Number_K100 369