The MIDWAY Delivery Catheters are single lumen percutaneous catheters designed to provide a conduit for introduction of interventional devices to the peripheral, coronary, and neuro vasculature. The MIDWAY Delivery Catheter is a single lumen, coil-reinforced, variable stiffness catheter with a radiopaque marker band on the distal end and a Luer hub on the proximal end. The MIDWAY Delivery Catheter is compatible with sheaths and guide catheters appropriately sized for the outer diameter of the MIDWAY Delivery Catheter. The MIDWAY Delivery Catheter has a hydrophilic coating on the distal segment of the catheter shaft.

AI/ML Overview

The document provided is a 510(k) summary for a medical device (MIDWAY Delivery Catheter) seeking substantial equivalence to existing predicate devices. It does not contain information about a study proving the device meets acceptance criteria for a clinical or AI performance study. Instead, it outlines bench performance testing and other non-clinical data to demonstrate substantial equivalence to legally marketed predicate devices.

Therefore, many of the requested elements for describing an acceptance criteria study (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set size, ground truth for training set) are not applicable to the information provided.

However, I can extract the acceptance criteria and confirmed performance for the bench performance tests that were conducted:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Test Method Summary	Reported Device Performance
Simulated Use Test	Confirms the functionality of MIDWAY Delivery Catheters using clinically relevant benchtop model, including testing with a marketed stent-retriever.	Acceptance Criteria Met (Functionality confirmed)
Compatibility Test	Confirms compatibility of MIDWAY Delivery Catheters with a marketed introducer sheath, guidewire, microcatheter, and stent-retriever.	Acceptance Criteria Met (Compatibility confirmed)
Particulate Test	Particulates generated during simulated use were evaluated.	Acceptance Criteria Met (Acceptable particulate levels)
Coating Integrity Test	Confirms that coating of MIDWAY Delivery Catheters has not delaminated, peeled, or flaked before or after simulated use.	Acceptance Criteria Met (Coating integrity maintained)
Surface Integrity	The MIDWAY Delivery Catheter surface is inspected for defects.	Acceptance Criteria Met (Surface free of defects)
Tensile Strength Test	Confirms MIDWAY Delivery Catheters meet product specification related to tensile strength after simulated use.	Acceptance Criteria Met (Meets tensile strength specifications)
Burst Pressure Test	Confirms MIDWAY Delivery Catheters can withstand sufficient pressure after simulated use.	Acceptance Criteria Met (Withstands sufficient burst pressure)

The following information is not present in the provided document:

2. Sample size used for the test set and the data provenance: The document refers to "bench performance testing" which are laboratory-based tests of physical properties and functionality, not a clinical "test set" of patient data. The sample sizes for these bench tests are not specified, nor is data provenance (country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this was bench testing, not a study requiring expert-established ground truth on clinical data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The device is a physical delivery catheter, not an AI-powered diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the bench tests, the "ground truth" would be established engineering specifications and industry standards for mechanical performance, material integrity, and functionality.
8. The sample size for the training set: Not applicable, as this is bench testing for a physical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

Overall Study Information:

The study described is a series of bench performance tests and confirmation of existing data from reference devices (MIDWAY 43 Delivery Catheter and MIDWAY 62 Delivery Catheter were compared to Reperfusion Catheter RED 43 (K222808) and Reperfusion Catheter RED 62 (K203440), respectively). The primary purpose was to demonstrate substantial equivalence to predicate devices for a new indication (introduction of interventional devices into peripheral, coronary, and neuro vasculature).

Key Findings:

All listed bench performance tests (Simulated Use, Compatibility, Particulate, Coating Integrity, Surface Integrity, Tensile Strength, Burst Pressure) met their respective acceptance criteria.
The subject devices share the same design, materials, and manufacturing as their reference devices.
Other performance data for the reference devices (Biocompatibility, Shelf Life, Sterilization, Packaging) were also used to support the subject device.
No animal or clinical studies were deemed necessary for the 510(k) submission.
The conclusion is that the MIDWAY Delivery Catheters are substantially equivalent to the predicate devices, perform as intended, and do not raise new questions of safety or effectiveness.

Summary

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March 27, 2024

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Penumbra, Inc. Sheina Rajkumar Regulatory Affairs Specialist II One Penumbra Place Alameda. California 94502

Re: K233201

Trade/Device Name: MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter) Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY Dated: February 21, 2024 Received: February 22, 2024

Dear Sheina Rajkumar:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 2

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Indications for Use

510(k) Number (if known) K233201

Device Name

MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter)

Indications for Use (Describe)

The MIDWAY Delivery Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image shows the word "Penumbra" in red font. To the right of the word is a red circle with a white "P" inside. A white line extends from the right of the word "Penumbra" to the left side of the red circle.

510(k) Summary

1. Submitter

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

Contact Person: Sheina Rajkumar Regulatory Affairs Specialist II Tel: (510) 995-2426 E-mail: srajkumar(@penumbrainc.com

Date of Preparation: March 26, 2024

2. Subject Device

MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter)

Classification Name: Catheter, Percutaneous, Neurovasculature Regulation Number: 21 CFR 870.1250 - Class II Product Code: QJP, DQY

3. Predicate/Reference Devices

MIDWAY 43 Delivery Catheter
Predicate	K070970	Neuron Intracranial Access System
Reference	K222808	Penumbra System (Reperfusion Catheter RED 43)
MIDWAY 62 Delivery Catheter
Predicate	K142321	Benchmark Intracranial Access System
Reference	K203440	Penumbra System (Reperfusion Catheter RED 62)

4. Device Description

MIDWAY 43 Delivery Catheter
· MIDWAY 62 Delivery Catheter

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Image /page/4/Picture/0 description: The image shows the word "Penumbra" in red font, followed by a red circle with a white "P" inside. The "P" is connected to the word "Penumbra" by a thin white line. The logo is simple and modern, and the colors are eye-catching.

The MIDWAY Delivery Catheter is a single lumen, coil-reinforced, variable stiffness catheter with a radiopaque marker band on the distal end and a Luer hub on the proximal end. The MIDWAY Delivery Catheter is compatible with sheaths and guide catheters appropriately sized for the outer diameter of the MIDWAY Delivery Catheter. The MIDWAY Delivery Catheter has a hydrophilic coating on the distal segment of the catheter shaft.

5. Indications For Use

The MIDWAY Delivery Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

6. Comparison of Technological Characteristics with the Predicate and Reference Devices

Device Name	Neuron IntracranialAccess System[Predicate]	Penumbra System(Reperfusion CatheterRED 43)[Reference]	MIDWAY 43Delivery Catheter[Subject]	Comparison
Classification	Class II, DQY	Class II, NRY	Class II, QJP, DQY	N/A
510(k)Number	K070970	K222808	K233201	N/A
Indicationsfor Use	The Neuron™Intracranial AccessSystem is indicated forthe introduction ofinterventional devicesinto the peripheral,coronary, and neurovasculature.	Penumbra ReperfusionCatheters and SeparatorsAs part of the PenumbraSystem, the ReperfusionCatheters and Separators areindicated for use in therevascularization of patientswith acute ischemic strokesecondary to intracranial largevessel occlusive disease (withinthe internal carotid, middlecerebral - M1 and M2segments, basilar, and vertebralarteries) within 8 hours ofsymptom onset. Patients whoare ineligible for intravenoustissue plasminogen activator(IV t-PA) or who fail IV t-PAtherapy are candidates fortreatment.Penumbra 3DRevascularization DeviceAs part of the PenumbraSystem, the Penumbra 3DRevascularization Device is	The MIDWAYDelivery Catheter isindicated for theintroduction ofinterventional devicesinto the peripheral,coronary, and neurovasculature.	SAME asPredicate Device[K070970]
Device Name	Neuron IntracranialAccess System[Predicate]	Penumbra System(Reperfusion CatheterRED 43)[Reference]	MIDWAY 43Delivery Catheter[Subject]	Comparison
		indicated for use in therevascularization of patientswith acute ischemic strokesecondary to intracranial largevessel occlusive disease (withinthe internal carotid, middlecerebral – M1 and M2segments) within 8 hours ofsymptom onset. Patients whoare ineligible for intravenoustissue plasminogen activator(IV t-PA) or who fail IV t-PAtherapy are candidates fortreatment.Penumbra Aspiration TubingAs part of the PenumbraSystem, the Penumbra SterileAspiration Tubing is indicatedto connect the PenumbraReperfusion Catheters to thePenumbra Aspiration Pump.Penumbra Aspiration PumpThe Penumbra AspirationPump is indicated as a vacuumsource for PenumbraAspiration Systems.
Materials	Stainless Steel, PTFE,Polyurethane, PolyetherBlock Amide, Nylon,Platinum/Iridium	Stainless Steel, PTFE,Polyurethane, Polyether BlockAmide, Nylon 12, Nitinol,Platinum/Iridium	Stainless Steel, PTFE,Polyurethane, PolyetherBlock Amide, Nylon 12,Nitinol, Platinum/Iridium	SAME asReferenceDevice[K222808]
Coating	Hydrophilic(proprietary)	Hydrophilic(proprietary)	Hydrophilic(proprietary)	SAME asReferenceDevice[K222808]
Distal InnerDiameter (ID)	0.053 in Min	0.043 in Min	0.043 in Min	SAME asReferenceDevice[K222808]
Proximal ID	0.053 in Min	0.043 in Min	0.043 in Min	SAME asReferenceDevice[K222808]
Distal OuterDiameter (OD)	0.072 in Max	0.056 in Max	0.056 in Max	SAME asReferenceDevice[K222808]
Proximal OD	0.083 in Max	0.060 in Max	0.060 in Max	SAME asReferenceDevice[K222808]
Device Name	Neuron IntracranialAccess System[Predicate]	Penumbra System(Reperfusion CatheterRED 43)[Reference]	MIDWAY 43Delivery Catheter[Subject]	Comparison
EffectiveLengths	105, 115 cm	115, 120, 125, 127, 132, 136, 138,145, 150, 153, 155, 160, 162, 167 cm	115, 120, 125, 127, 136,138, 160, 162, 167 cm	SAME
PackagingMaterials	Polyester/Polyethylene/Tyvek, Polyethylene,SBS Paperboard.	Polyester/Polyethylene/Tyvek,Polystyrene, SBS Paperboard	Polyester/Polyethylene/Tyvek,SBS Paperboard	SAME
Sterilization	Ethylene Oxide (EO)	EO	EO	SAME
Shelf-Life	36 Months	36 Months	36 Months	SAME
Single Use	Single use	Single use	Single use	SAME

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Image /page/5/Picture/0 description: The image shows the Penumbra company logo. The word "Penumbra" is written in red, with a stylized "P" in a red circle to the right of the word. A thin white line runs horizontally through the "P" in the circle.

K233201

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Image /page/6/Picture/0 description: The image shows the word "Penumbra" in a red, sans-serif font. To the right of the word is a red circle with a white "P" inside. The "P" is stylized with a horizontal line extending from the top of the "P" to the edge of the circle.

Device Name	BenchmarkIntracranial AccessSystem [Predicate]	Penumbra System(Reperfusion Catheter RED62)[Reference]	MIDWAY 62Delivery Catheter[Subject]	Comparison
Classification	Class II, DQY	Class II, NRY	Class II, QJP, DQY	N/A
510(k)Number	K142321	K203440	K233201	N/A
Indications forUse	The Benchmark™Intracranial AccessSystem is indicated forthe introduction ofinterventional devicesinto the peripheral,coronary, and neurovasculature.	Penumbra ReperfusionCatheters and SeparatorsAs part of the PenumbraSystem, the ReperfusionCatheters and Separatorsare indicated for use in therevascularization ofpatients with acuteischemic stroke secondaryto intracranial large vesselocclusive disease (withinthe internal carotid,middle cerebral - M1 andM2 segments, basilar, andvertebral arteries) within 8hours of symptom onset.Patients who are ineligiblefor intravenous tissueplasminogen activator (IVt-PA) or who fail IV t-PAtherapy are candidates fortreatment.Penumbra 3DRevascularization DeviceAs part of the PenumbraSystem, the Penumbra 3DRevascularization Device isindicated for use in therevascularization of patientswith acute ischemic strokesecondary to intracranial largevessel occlusive disease(within the internal carotid,	The MIDWAYDelivery Catheter isindicated for theintroduction ofinterventional devicesinto the peripheral,coronary, and neurovasculature.	SAME asPredicateDevice[K142321]
Device Name	BenchmarkIntracranial AccessSystem [Predicate]	Penumbra System(Reperfusion Catheter RED62)[Reference]	MIDWAY 62Delivery Catheter[Subject]	Comparison
		middle cerebral – M1 and M2segments) within 8 hours ofsymptom onset. Patients whoare ineligible for intravenoustissue plasminogen activator(IV t- PA) or who fail IV t-PAtherapy are candidates fortreatment.Penumbra Aspiration TubingAs part of the PenumbraSystem, the Penumbra SterileAspiration Tubing isindicated to connect thePenumbra ReperfusionCatheters to the PenumbraAspiration Pump.Penumbra Aspiration PumpThe Penumbra Aspiration Pumpis indicated as a vacuum sourcefor Penumbra AspirationSystems.
Materials	Stainless Steel, PTFE,Polyurethane,Polyether BlockAmide, Nylon,Platinum/Tungsten	Stainless Steel, PTFE,Polyurethane, Polyether BlockAmide, Nylon 12, Nitinol,Platinum/Iridium	Stainless Steel, PTFE,Polyurethane, PolyetherBlock Amide, Nylon12, Nitinol,Platinum/Iridium	SAME asReferenceDevice[K203440]
Coating	Hydrophilic(proprietary)	Hydrophilic(proprietary)	Hydrophilic(proprietary)	SAME asReferenceDevice[K203440]
Distal ID	0.070 in Min	0.062 in Min	0.062 in Min	SAME asReferenceDevice[K203440]
Proximal ID	0.070 in Min	0.062 in Min	0.062 in Min	SAME asReferenceDevice[K203440]
Distal OD	0.083 in Max	0.076 in Max	0.076 in Max	SAME asReferenceDevice[K203440]
Proximal OD	0.083 in Max	0.076 in Max	0.076 in Max	SAME asReferenceDevice[K203440]
EffectiveLengths	95, 105, 115 cm	115, 120, 125, 127, 132, 138,160 cm	115, 120, 125, 132, 138,160 cm	SAME
PackagingMaterials	Polyester/Polyethylene	Polyester/Polyethylene/	Polyester/Polyethylene/Tyvek, SBS Paperboard	SAME
Device Name	BenchmarkIntracranial AccessSystem [Predicate]	Penumbra System(Reperfusion Catheter RED62)[Reference]	MIDWAY 62Delivery Catheter[Subject]	Comparison
	SBS Paperboard	Tyvek, Polystyrene, SBSPaperboard
Sterilization	EO	EO	EO	SAME
Shelf-Life	36 Months	36 Months	36 Months	SAME
Single Use	Single use	Single use	Single use	SAME

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Image /page/7/Picture/0 description: The image shows the word "Penumbra" in a red, sans-serif font. To the right of the word is a red circle with a white "P" inside. A thin white line extends from the right side of the word "Penumbra" to the left side of the "P".

K233201

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Image /page/8/Picture/0 description: The image shows the logo for Penumbra, a healthcare company. The word "Penumbra" is written in a red, sans-serif font. To the right of the word is a red circle with a white "P" inside. A white line extends from the right side of the word "Penumbra" to the left side of the "P" in the circle.

7. Bench Performance Testing

The subject MIDWAY 43 Delivery Catheter and MIDWAY 62 Delivery Catheter have the same design, materials, and manufacturing as the respective reference devices: Reperfusion Catheter RED 43 (K222808) and Reperfusion Catheter RED 62 (K203440). Bench performance testing of the reference devices was used in support of the subject device. The following additional bench performance testing was conducted to support the new indication of the subject catheters:

Test	Test Method Summary	Conclusion
Simulated Use Test	Confirms the functionality of MIDWAY DeliveryCatheters using clinically relevant benchtop model,including testing with a marketed stent-retriever.	Acceptance Criteria Met
Compatibility Test	Confirms compatibility of MIDWAY Delivery Catheterswith a marketed introducer sheath, guidewire,microcatheter, and stent-retriever.	Acceptance Criteria Met
Particulate Test	Particulates generated during simulated use wereevaluated.	Acceptance Criteria Met
Coating Integrity Test	Confirms that coating of MIDWAY Delivery Cathetershas not delaminated, peeled, or flaked before or aftersimulated use.	Acceptance Criteria Met
Surface Integrity	The MIDWAY Delivery Catheter surface is inspected fordefects.	Acceptance Criteria Met
Tensile Strength Test	Confirms MIDWAY Delivery Catheters meet productspecification related to tensile strength after simulated use.	Acceptance Criteria Met
Burst Pressure Test	Confirms MIDWAY Delivery Catheters can withstandsufficient pressure after simulated use.	Acceptance Criteria Met

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Image /page/9/Picture/0 description: The image shows the word "Penumbra" in red font. To the right of the word is a red circle with a white "P" inside of it. The "P" is connected to the word "Penumbra" by a thin white line.

8. Other Performance Data

The subject MIDWAY 43 Delivery Catheter and MIDWAY 62 Delivery Catheter have the same design, materials, and manufacturing as the respective reference devices: Reperfusion Catheter RED 43 (K222808) and Reperfusion Catheter RED 62 (K203440). The following testing of the reference devices was used in support of the subject device:

Biocompatibility ●
Shelf Life .
Sterilization ●
Packaging ●

9. Animal and Clinical Data

No animal or clinical studies were deemed necessary to support the substantial equivalence of the MIDWAY Delivery Catheters.

10. Conclusions

The subject MIDWAY Delivery Catheters are substantially equivalent to the respective predicate devices (K070970 and K142321). The subject device has the same intended use as the predicate devices. The non-clinical testing demonstrates that the subject device performs as intended and is substantially equivalent to the predicate devices. The differences in technological characteristics of the subject and predicate devices do not raise new questions of safety or effectiveness.

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).