(131 days)
Not Found
No
The summary describes a mechanical aspiration system for removing blood clots and does not mention any AI/ML components or functions.
Yes
The device is intended for the revascularization of patients with acute ischemic stroke, which directly treats a medical condition.
No
The device is described as a "Reperfusion Catheter" used to "aspirate thrombus from an occluded vessel," indicating a treatment or therapeutic function rather than a diagnostic one.
No
The device description explicitly states that the device is a "Reperfusion Catheter" and is used with an "Aspiration Pump" to aspirate thrombus. These are physical hardware components, not software.
Based on the provided information, 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. They are used outside of the body.
- Device Description: The Penumbra System ACE 64 and ACE 68 Reperfusion Catheters are described as devices used within the neurovasculature to aspirate thrombus from an occluded vessel. This is an in vivo procedure (performed inside the body).
- Intended Use: The intended use is for revascularization of patients with acute ischemic stroke, which is a therapeutic intervention performed directly on the patient's circulatory system.
Therefore, the Penumbra System, as described, is a medical device used for treatment within the body, not an in vitro diagnostic test.
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 (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset.
Product codes (comma separated list FDA assigned to the subject device)
NRY
Device Description
The Penumbra System ACE 64 and ACE 68 Reperfusion Catheters are components to the currently available Penumbra System. The Penumbra System ACE AC 64 and ACE 68 Reperfusion Catheters are used with the Aspiration Pump to aspirate thrombus from an occluded vessel in the neurovasculature. 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
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)
Design Validation (GLP Animal Testing): The subject Penumbra System ACE 64 and ACE 68 Reperfusion Catheters met all established requirements.
Animal Study: The safety and performance of the ACE 64 and ACE 68 Reperfusion Catheters, when "wedged" in a vessel and using maximum aspiration, was evaluated in the accepted porcine vascular model. The purpose of this study was to evaluate the Reperfusion Catheter ACE aspiration vascular response when "wedged" within a swine artery. Safety of the test articles was assessed by consideration of the acute and chronic vascular response. Vascular response was assessed by contrast angiography and by gross necropsy and histopathology of associated vasculature performed by the Sponsor Pathologist.
The study concluded that:
- No significant vessel response was noted on the contrast angiograms following the aspiration treatment with the test article in a wedged position.
- No significant pathological findings were identified during the gross or histopathological evaluation.
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.
Not Found
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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 13, 2016
Penumbra, Inc. Ms. Michaela Mahl, MSBE Senior Manager Regulatory Affairs One Penumbra Place Alameda, California 94502
Re: K152541
Trade/Device Name: Penumbra System ACE 64 and ACE 68 Reperfusion Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: December 11, 2015 Received: December 14, 2015
Dear Ms. Michaela 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.
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,
Michael J. Hoffmann -A
for 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) K152541
Device Name
Penumbra System® ACE 64 and ACE 68 Reperfusion Catheters
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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 ACE 64 and ACE 68 Reperfusion Catheters .
1.1 Sponsor/Applicant Name and Address
Penumbra, Inc. One Penumbra Place Alameda, CA 94502 USA
1.2 Sponsor Contact Information
Michaela Mahl Senior Manager, Regulatory Affairs Phone: (510) 748-3288 FAX: (510) 217-6414 Email: michaela.mahl@penumbrainc.com
Date of Preparation of 510(k) Summary 1.3
December 11, 2015
1.4 Device Trade or Proprietary Name
Penumbra System® ACE 64 and ACE 68 Reperfusion Catheters
Device Classification 1.5
| Regulatory Class: | II |
|---|---|
| Classification Panel: | Neurology |
| Classification Name: | Percutaneous Catheter |
| Regulation Number: | 21 CFR §870.1250 |
| Product Code: | NRY (Catheter, Thrombus Removal) |
1.6 Predicate Devices
| 510(k) Number / Clearance
| Date | Name of Predicate Device | Name of Manufacturer |
|---|---|---|
| K142458 / 22May2015 | Penumbra System® ACE 64 and | |
| ACE 68 Reperfusion Catheters | Penumbra, Inc. | |
| One Penumbra Place | ||
| Alameda, CA 94502 USA |
4
1.7 Predicate Comparison
| System Name | Predicate
Reperfusion Catheters | | Subject
Reperfusion Catheters | |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| | ACE 64 | ACE 68 | ACE 64 | ACE 68 |
| Device Name | ACE 64 | | ACE 68 | |
| 510(k) No. | K142458 | | SAME | |
| 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. The Reperfusion Catheters ACE
64 and ACE 68 are intended for use in
revascularization within the Internal
Carotid Artery (ICA) within 8 hours of
symptom onset. | | 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. | |
| Materials | | | | |
| Proximal hub | Grilamid (TR55-LX) | SAME | SAME | SAME |
| Strain Relief [Hub Sleeve] | Grilamid (TR55) | SAME | SAME | |
| Strain Relief | Stainless Steel, 304 | SAME | SAME | |
| ID Band | Polyolefin, PET yellow [black ink] | SAME | SAME | |
| Catheter Shaft | | | | |
| Distal Extrusions | Pellethane 80A, Tecoflex 80A,
Tecoflex 80A/Pebax 35D, Pebax 35D,
Pebax 35D/40D Blend, Pebax 40D,
Pebax 40D/55D Blend, Pebax 55D,
Pebax 63D | | SAME | |
| Proximal Extrusions | Pebax 55D, Pebax
72D, Vestamid | Pebax 55D/72D
Blend, Pebax
72D, Vestamid | SAME | SAME |
| Proximal Coil
Reinforcement | SS flat (0.0015 in x
0.006 in) and SS
round (0.0025 in) | SS flat (0.0015
in x 0.006 in)
and NiTi round
(0.0025 in) | SAME | SAME |
| Extrusion Colorants | Clear/ Natural or Purple | SAME | SAME | |
| Tip Shape | Straight | | SAME | |
| Markerband | C-cut Pt/Ir band | | SAME | |
| Coating | SRDX Harmony (proprietary) | | SAME | |
| Dimensions | | | | |
| Proximal OD | 0.084 in Max | 0.084 in Max | SAME | SAME |
| Proximal ID | 0.068 in Min | 0.068 in Min | SAME | SAME |
| Distal OD | 0.080 in Max | 0.084 in Max | SAME | SAME |
| Distal ID | 0.064 in Min | 0.068 in Min | SAME | SAME |
| Effective Length | 115, 120, 125, 127, 132 cm | | SAME | |
| Coating Length | 30 cm | | SAME | |
| Accessories | | | | |
| System Name | Predicate
Reperfusion Catheters | | Subject
Reperfusion Catheters | |
| Device Name | ACE 64 | ACE 68 | ACE 64 | ACE 68 |
| Rotating Hemostasis Valve | Polycarbonate, silicone o-ring | | SAME | |
| Shaping Mandrel | 0.038in OD | | SAME | |
| Packaging Materials | | | | |
| Pouch | Polyester/Polyethylene/
Tyvek® | | SAME | |
| Packaging Hoop | Polyethylene | | SAME | |
| Packaging Card | Polyethylene | | SAME | |
| Display Carton | SBS Paperboard | | SAME | |
| Packaging Configuration | Individual | | SAME | |
| Sterilization | EO | | SAME | |
| Shelf-Life | 36 Months | | SAME | |
5
Device Description 1.8
The Penumbra System ACE 64 and ACE 68 Reperfusion Catheters are components to the currently available Penumbra System. The Penumbra System ACE AC 64 and ACE 68 Reperfusion Catheters are used with the Aspiration Pump to aspirate thrombus from an occluded vessel in the neurovasculature. The devices are provided sterile, non-pyrogenic, and intended for single use only.
1.9 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 (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset.
1.10 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 substantial equivalence of the devices follows.
Included in this section is a summary description of the testing, which substantiates the performance of the subject Penumbra System ACE 64 and ACE 68 Reperfusion Catheters as well as its substantial equivalence to the predicate devices:
- · Design Validation (GLP Animal Testing)
The subject Penumbra System ACE 64 and ACE 68 Reperfusion Catheters met all established requirements.
6
1.10.1 Animal Study
The safety and performance of the ACE 64 and ACE 68 Reperfusion Catheters, when "wedged" in a vessel and using maximum aspiration, was evaluated in the accepted porcine vascular model. The purpose of this study was to evaluate the Reperfusion Catheter ACE aspiration vascular response when "wedged" within a swine artery. Safety of the test articles was assessed by consideration of the acute and chronic vascular response. Vascular response was assessed by contrast angiography and by gross necropsy and histopathology of associated vasculature performed by the Sponsor Pathologist.
The study concluded that:
- . No significant vessel response was noted on the contrast angiograms following the aspiration treatment with the test article in a wedged position.
- No significant pathological findings were identified during the gross or . histopathological evaluation.
1.10.2 Leveraged Non-Clinical Data
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 the predicate devices (K142458) are directly applicable and no additional testing is required or was performed.
1.11 Summary of Substantial Equivalence
The subject Penumbra System ACE 64 and ACE 68 Reperfusion Catheters are substantially equivalent to the predicate device with regard to intended use, operating principle, design concept, materials, shelf-life, packaging and sterilization processes.