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.

Device Description

The Penumbra System is comprised of the following devices:

Penumbra Reperfusion Catheter
Penumbra 3D Revascularization Device
Penumbra Aspiration Pump
Penumbra Aspiration Pump Canister
Penumbra Aspiration Tubing
Penumbra Separator

The Penumbra System is designed to remove thrombus and restore blood flow in the neurovasculature using continuous aspiration. The Reperfusion Catheter targets aspiration from the pump directly to the thrombus. The 3D Revascularization Device is used with Reperfusion Catheters to facilitate aspiration and removal of the thrombus when needed. The Separator may be used to clear the lumen of the Reperfusion Catheter should it become blocked with thrombus. The use of the Separator may not be necessary when using a Reperfusion Catheter with an ID of 0.054 in. [1.37 mm] or larger. The Reperfusion Catheter is introduced through a guide catheter or long femoral sheath and into the intracranial vasculature and guided over a neurovascular guidewire to the site of the primary occlusion. The Penumbra Reperfusion Catheter is used with the Aspiration Pump to aspirate thrombus from an occluded vessel. As needed, a Penumbra Separator may be deployed from the Reperfusion Catheter to assist with thrombus removal. The Penumbra Separator is advanced and retracted through the Penumbra Reperfusion Catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the Reperfusion Catheter tip. For the aspiration source, the Penumbra Reperfusion Catheter is used in conjunction with the Aspiration Pump, which is connected using the Penumbra Aspiration Tubing and the Penumbra Aspiration Pump Canister. The Penumbra Reperfusion Catheter is provided with a steam shaping mandrel and rotating hemostasis valve, and a peelable sheath. The Penumbra 3D Revascularization Device is provided with an introducer sheath. The Penumbra Separator is provided with an introducer and torque device. The Penumbra Reperfusion Catheters, 3D Revascularization Device and Separators are visible under fluoroscopy.

AI/ML Overview

The Penumbra System (Reperfusion Catheter RED 43) is a medical device used for the revascularization of patients with acute ischemic stroke. The device's acceptance criteria and performance were evaluated through a series of design verification tests, as detailed in the FDA 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance:

Test Method Summary	Acceptance Criteria	Reported Device Performance
Confirms the units meet all dimensional and visual product specifications.	Met	Acceptance Criteria Met
Confirms units meet product specification related to friction.	Met	Acceptance Criteria Met
Confirms the markerband is fluoroscopically visible.	Met	Acceptance Criteria Met
Confirms the functionality of units using clinically relevant benchtop model.	Met	Acceptance Criteria Met
Particulates generated and coating integrity during simulated use (including multiple deployment cycling) were evaluated.	Met	Acceptance Criteria Met
Confirms units have no leaks when tested.	Met	Acceptance Criteria Met
Confirms units meet product specification related to tensile strength.	Met	Acceptance Criteria Met
Confirms units meet product specification related to pressure.	Met	Acceptance Criteria Met
Confirms units meet product specification related to elongation.	Met	Acceptance Criteria Met
Confirms there is no visible corrosion on the units when tested.	Met	Acceptance Criteria Met
Confirms units have sufficient torque strength.	Met	Acceptance Criteria Met
Confirms units can withstand sufficient pressure.	Met	Acceptance Criteria Met
Confirms units have appropriate distal tip stiffness.	Met	Acceptance Criteria Met
Confirms expiration date based on accelerated aging test studies.	Met	Acceptance Criteria Met
Confirms the packaging of the units meet all product specifications.	Met	Acceptance Criteria Met
Confirms the units are sterilized in accordance with ISO 11135+A1 and ISO 10993-7	Met	Acceptance Criteria Met

2. Sample Size for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for each specific test in the design verification. It only indicates that "the subject device met all established requirements."
The data provenance is from benchtop testing, which is a prospective method of evaluation performed in a controlled laboratory setting. There is no mention of country of origin for the data as it's not a clinical study.

3. Number of Experts and their Qualifications for Ground Truth:
This information is not provided in the document as the device's performance was evaluated through benchtop testing, not through expert-reviewed clinical data. Therefore, the concept of "experts establishing ground truth" in the context of clinical outcomes or imaging interpretations does not apply here.

4. Adjudication Method for the Test Set:
The concept of an adjudication method (like 2+1, 3+1) is typically relevant for studies involving human interpretation or clinical outcomes where discrepancies need to be resolved. Since the testing involved design verification and benchtop methods, such an adjudication method was not applicable and not mentioned in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No animal or clinical study was conducted as bench testing was determined sufficient for verification and validation purposes." Therefore, there is no effect size reported for human readers' improvement with AI assistance.

6. Standalone Performance:
The performance described is essentially standalone (algorithm only without human-in-the-loop performance), as it pertains to the physical and functional characteristics of the device itself as evaluated through bench testing. There is no "human-in-the-loop" component in the described verification tests.

7. Type of Ground Truth Used:
The ground truth used was based on ** predefined product specifications and established test methods** (e.g., ISO standards, internal design requirements) for each performance criterion. This is a form of technical and engineering ground truth rather than clinical, pathological, or outcomes data.

8. Sample Size for the Training Set:
A "training set" is typically associated with machine learning or AI models. Since this submission focuses on the physical device's performance through bench testing and explicitly states no animal or clinical studies were conducted, there is no mention or relevance of a training set in this context.

9. How the Ground Truth for the Training Set Was Established:
As there was no training set for an AI model, the concept of establishing ground truth for a training set is not applicable to this submission.

Summary

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December 20, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym followed by the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the rest of the name. The logo is simple and professional, reflecting the agency's role in protecting public health.

Penumbra, Inc. Micaela Victoria Regulatory Affairs Program Manager One Penumbra Place Alameda, California 94502

Re: K222808

Trade/Device Name: Penumbra System (Reperfusion Catheter RED 43) Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: November 14, 2022 Received: November 15, 2022

Dear Micaela Victoria:

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 -S

Naira Muradyan, Ph.D. Assistant Director 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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Indications for Use

510(k) Number (if known) K22808

Device Name

Penumbra System® (Reperfusion Catheter RED™ 43)

Indications for Use (Describe)

Penumbra Reperfusion Catheters and Separators

Penumbra 3D Revascularization Device

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.

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)
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Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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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 subject Penumbra System (Reperfusion Catheter RED 43).

1.1 Submitter

Penumbra, Inc. One Penumbra Place Alameda, CA 94502 USA

Contact Person: Micaela Victoria Regulatory Affairs Program Manager Tel: (510) 995-2082 Fax: (510) 217-6414 E-mail: mvictoria@penumbrainc.com

Date of Preparation:

December 19, 2022

1.2 Subject Device

Penumbra System (Reperfusion Catheter RED 43)

Regulatory Class: II Classification Panel: Neurology Classification Name: Percutaneous Catheter Regulation Number: 21 CFR 870.1250 Product Code: NRY

1.3 Predicate/References Devices

510(k) Number	Name of Device	Name ofManufacturer
Predicate Device
K203440	Penumbra System (Reperfusion Catheter RED 62)	Penumbra, Inc.
Reference Device
K072718	Penumbra System	Penumbra, Inc.

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Image /page/4/Picture/1 description: The image shows the Penumbra logo. The word "Penumbra" is written in red, with a stylized red circle containing a white "P" to the right of the word. The logo is simple and modern, with a focus on the company name and a distinctive symbol.

1.4 Device Description

The Penumbra System is comprised of the following devices:

Penumbra Reperfusion Catheter ●
Penumbra 3D Revascularization Device .
Penumbra Aspiration Pump
Penumbra Aspiration Pump Canister ●
Penumbra Aspiration Tubing
Penumbra Separator .

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Image /page/5/Picture/0 description: The image shows the word "Penumbra" in a red sans-serif font, followed by a red circle with a white "P" inside. The "P" is stylized with a horizontal line running through it. The logo is simple and modern, with a focus on the company name and a distinctive symbol.

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.

Device Attribute	Predicate Device	Reference Device	Subject Device
Trade Name	Penumbra System(Reperfusion Catheter RED 62)	Penumbra System[Reperfusion Catheter 041]	Penumbra System(Reperfusion Catheter RED 43)
FDA ProductClassification	Class II, NRY, 21 CFR 870.1250	SAME	SAME
510(k) Number	K203440	K072718	K222808
Indications forUse	Penumbra Reperfusion Cathetersand SeparatorsAs part of the Penumbra System,the Reperfusion Catheters andSeparators are indicated for use inthe revascularization of patientswith acute ischemic strokesecondary to intracranial large	The Penumbra System™ isintended for use in therevascularization of patientswith acute ischemic strokesecondary to intracraniallarge vessel occlusivedisease (in the internal	SAME as Predicate
Device Attribute	Predicate Device	Reference Device	Subject Device
Trade Name	Penumbra System(Reperfusion Catheter RED 62)	Penumbra System[Reperfusion Catheter 041]	Penumbra System(Reperfusion CatheterRED 43)
	vessel occlusive disease (withinthe internal carotid, middlecerebral - M1 and M2 segments,basilar, and vertebral arteries)within 8 hours of symptom onset.Patients who are ineligible forintravenous tissue plasminogenactivator (IV t-PA) or who fail IVt-PA therapy are candidates fortreatment.	carotid, middle cerebral -M1 and M2 segments,basilar, and vertebralarteries) within 8 hours ofsymptom onset.
	Penumbra 3D RevascularizationDeviceAs part of the Penumbra System,the Penumbra 3DRevascularization Device isindicated for use in therevascularization of patients withacute ischemic stroke secondaryto intracranial large vesselocclusive disease (within theinternal carotid, middle cerebral -M1 and M2 segments) within 8hours of symptom onset. Patientswho are ineligible for intravenoustissue plasminogen activator (IVt-PA) or who fail IV t-PA therapyare candidates for treatment.
	Penumbra Aspiration TubingAs part of the Penumbra System,the Penumbra Sterile AspirationTubing is indicated to connect thePenumbra Reperfusion Cathetersto the Penumbra AspirationPump.
	Penumbra Aspiration PumpThe Penumbra Aspiration Pumpis indicated as a vacuum sourcefor Penumbra AspirationSystems.
Principles ofOperation	See Section 1.4	SAME	SAME
Device Attribute	Predicate Device	Reference Device	Subject Device
Trade Name	Penumbra System(Reperfusion Catheter RED 62)	Penumbra System[Reperfusion Catheter 041]	Penumbra System(Reperfusion CatheterRED 43)
Device Materials	Stainless Steel, PTFE,Polyurethane, Polyether BlockAmide, Nylon 12, Nitinol,Platinum/Iridium	Stainless Steel, PTFE,Polyurethane, PolyetherBlock Amide, Nylon 12,Platinum/Iridium	SAME as Predicate
ID Band Color	Polyolefin, black [white text]	Polyolefin, PET green[white text]	SAME as Predicate
Coating	Hydrophilic coating (proprietary)	Similar to Predicate	SAME as Predicate
Dimensions
Proximal OD	0.076 in. (1.93 mm) Max	0.056 in. (1.42 mm) Max	0.060 in. (1.52 mm) Max
Proximal ID	0.062 in. (1.57 mm) Min	0.041 in. (1.04 mm) Min	0.043 in. (1.09 mm) Min
Distal OD	0.076 in. (1.93 mm) Max	0.056 in. (1.42 mm) Max	SAME as Reference
Distal ID	0.062 in. (1.57 mm) Min	0.041 in. (1.04 mm) Min	0.043 in. (1.09 mm) Min
Distal FlexLength	30 cm	SAME	SAME
Coating Length	30 cm	60 cm	SAME as Reference
Effective Lengths	115, 120, 125, 127, 132, 138,and 160 cm	137 cm	115, 120, 125, 127, 132,136, 138, 145, 150, 153,155, 160, 162, and 167 cm
Accessories	Peelable Sheath, ShapingMandrel, RHV	Shaping Mandrel, RHV	SAME as Predicate
PackagingMaterials	Polyester/Polyethylene/Tyvek,Polystyrene, SBS Paperboard	SAME	SAME
ConditionSupplied	Sterile and Single Use	SAME	SAME
SterilizationMethod	EO	SAME	SAME

1.6 Comparison of Technological Characteristics with the Predicate and Reference Devices

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Image /page/6/Picture/1 description: The image shows the word "Penumbra" in red font, followed by a red circle with a white "P" inside. The font is sans-serif and the word is written in a simple, clean style. The logo is simple and modern, and the colors are bold and eye-catching. The logo is likely for a company or organization called Penumbra.

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Image /page/7/Picture/0 description: The image shows the word "Penumbra" in a red font, followed by a red circle with a white "P" inside. The word "Penumbra" is written in a sans-serif font. The "P" in the circle is also in a sans-serif font. The circle is slightly offset to the right of the word "Penumbra".

1.7 Performance Data

The following performance data were provided in support of the substantial equivalence determination:

. Design Verification
. Shelf-Life
Packaging Validation .
Sterilization .

The subject device met all established requirements.

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Image /page/8/Picture/1 description: The image contains the word "Penumbra" in red font. To the right of the word is a red circle with a white "P" inside. The logo is simple and modern. The word "Penumbra" is written in a sans-serif font.

Design Verification Testing 1.7.1

The following design verification tests were performed on the subject device:

Test	Test Method Summary	Conclusion
Dimensional/VisualInspection Test	Confirms the units meet all dimensional and visual productspecifications.	Acceptance Criteria Met
Friction Test	Confirms units meet product specification related tofriction.	Acceptance Criteria Met
Fluoroscopy Test	Confirms the markerband is fluoroscopically visible.	Acceptance Criteria Met
Simulated Use Test	Confirms the functionality of units using clinicallyrelevant benchtop model.	Acceptance Criteria Met
Particulate Test	Particulates generated and coating integrity during simulateduse (including multiple deployment cycling) were evaluated.	Acceptance Criteria Met
Hub/Air Test	Confirms units have no leaks when tested.	Acceptance Criteria Met
Tensile Test	Confirms units meet product specification related to tensilestrength.	Acceptance Criteria Met
Pressure Test	Confirms units meet product specification related topressure.	Acceptance Criteria Met
Elongation Test	Confirms units meet product specification related toelongation.	Acceptance Criteria Met
Corrosion ResistanceTest	Confirms there is no visible corrosion on the units whentested.	Acceptance Criteria Met
Torque Strength Test	Confirms units have sufficient torque strength.	Acceptance Criteria Met
Burst Pressure Test	Confirms units can withstand sufficient pressure.	Acceptance Criteria Met
Distal Tip Stiffness Test	Confirms units have appropriate distal tip stiffness.	Acceptance Criteria Met
Shelf-Life	Confirms expiration date based on accelerated aging teststudies.	Acceptance Criteria Met
Packaging Validation	Confirms the packaging of the units meet all productspecifications.	Acceptance Criteria Met
Sterilization Test	Confirms the units are sterilized in accordance with ISO11135+A1 and ISO 10993-7	Acceptance Criteria Met

Biocompatibility 1.7.2

There are no changes to materials compared to the predicate device. Therefore, testing in support of the predicate device applies to the subject device and additional biocompatibility testing was not required.

1.7.3 Performance Data – Animal, Clinical

No animal or clinical study was conducted as bench testing was determined sufficient for verification and validation purposes.

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Conclusions 1.8

The subject Penumbra System (Reperfusion Catheter RED 43) is substantially equivalent to the predicate Penumbra System (Reperfusion Catheter RED 62) and reference Penumbra System. The subject device has the identical intended use as the predicate device. The device testing described in the 510(k) Summary demonstrates the subject device is substantially equivalent to the predicate and reference devices in regard to intended use, operating principle, design concept, fundamental technology and device performance.

Regulation Number and Section

§ 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).