Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical characteristics and mechanical performance of a delivery catheter, with no mention of AI or ML capabilities.

Therapeutic

No
The device is a delivery catheter, which provides a conduit for introducing other interventional (therapeutic) devices. It does not perform a therapeutic function itself.

Diagnostic

No

The device is described as a delivery catheter for introducing interventional devices, not for diagnosing conditions. Its purpose is to facilitate access for other tools.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical catheter with hardware components (single lumen, coil-reinforced, radiopaque marker band, Luer hub, hydrophilic coating).

IVD (In Vitro Diagnostic)

Based on the provided information, the MIDWAY Delivery Catheter is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use clearly states the device is for the "introduction of interventional devices into the peripheral, coronary, and neuro vasculature." This describes a device used within the body for a therapeutic or interventional procedure, not for testing samples outside the body.
Device Description: The description details a physical catheter designed to be inserted into blood vessels. This aligns with an interventional medical device, not an IVD.
Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or provide diagnostic information based on such analysis.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The MIDWAY Delivery Catheter's function is to facilitate the delivery of other devices during a procedure, which is a different category of medical device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes

QJP, DQY

Device Description

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 Catheters include the following:

MIDWAY 43 Delivery Catheter
MIDWAY 62 Delivery Catheter

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

peripheral, coronary, and neuro vasculature

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

Bench performance testing was conducted.
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:

Simulated Use Test: Confirms the functionality of MIDWAY Delivery Catheters using clinically relevant benchtop model, including testing with a marketed stent-retriever. Result: Acceptance Criteria Met
Compatibility Test: Confirms compatibility of MIDWAY Delivery Catheters with a marketed introducer sheath, guidewire, microcatheter, and stent-retriever. Result: Acceptance Criteria Met
Particulate Test: Particulates generated during simulated use were evaluated. Result: Acceptance Criteria Met
Coating Integrity Test: Confirms that coating of MIDWAY Delivery Catheters has not delaminated, peeled, or flaked before or after simulated use. Result: Acceptance Criteria Met
Surface Integrity: The MIDWAY Delivery Catheter surface is inspected for defects. Result: Acceptance Criteria Met
Tensile Strength Test: Confirms MIDWAY Delivery Catheters meet product specification related to tensile strength after simulated use. Result: Acceptance Criteria Met
Burst Pressure Test: Confirms MIDWAY Delivery Catheters can withstand sufficient pressure after simulated use. Result: Acceptance Criteria Met

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 .

Key Metrics

Not Found

Predicate Device(s)

K070970, K142321

Reference Device(s)

K222808, K203440

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

0

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).

1

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

2

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)

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

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

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 Catheters include the following:

MIDWAY 43 Delivery Catheter
· MIDWAY 62 Delivery Catheter

4

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 Intracranial
Access System
[Predicate] | Penumbra System
(Reperfusion Catheter
RED 43)
[Reference] | MIDWAY 43
Delivery Catheter
[Subject] | Comparison |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| Classification | Class II, DQY | Class II, NRY | Class II, QJP, DQY | N/A |
| 510(k)
Number | K070970 | K222808 | K233201 | N/A |
| Indications
for Use | The Neuron™
Intracranial Access
System is indicated for
the introduction of
interventional devices
into the peripheral,
coronary, and neuro
vasculature. | 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 | The MIDWAY
Delivery Catheter is
indicated for the
introduction of
interventional devices
into the peripheral,
coronary, and neuro
vasculature. | SAME as
Predicate Device
[K070970] |
| Device Name | Neuron Intracranial
Access System
[Predicate] | Penumbra System
(Reperfusion Catheter
RED 43)
[Reference] | MIDWAY 43
Delivery Catheter
[Subject] | Comparison |
| | | 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.

5

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

6

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 | Benchmark
Intracranial Access
System [Predicate] | Penumbra System
(Reperfusion Catheter RED
62)
[Reference] | MIDWAY 62
Delivery 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 for
Use | The Benchmark™
Intracranial Access
System is indicated for
the introduction of
interventional devices
into the peripheral,
coronary, and neuro
vasculature. | 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, | The MIDWAY
Delivery Catheter is
indicated for the
introduction of
interventional devices
into the peripheral,
coronary, and neuro
vasculature. | SAME as
Predicate
Device
[K142321] |
| Device Name | Benchmark
Intracranial Access
System [Predicate] | Penumbra System
(Reperfusion Catheter RED
62)
[Reference] | MIDWAY 62
Delivery Catheter
[Subject] | Comparison |
| | | 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.

7

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

8

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 Delivery
Catheters using clinically relevant benchtop model,
including testing with a marketed stent-retriever.	Acceptance Criteria Met
Compatibility Test	Confirms compatibility of MIDWAY Delivery Catheters
with a marketed introducer sheath, guidewire,
microcatheter, and stent-retriever.	Acceptance Criteria Met
Particulate Test	Particulates generated during simulated use were
evaluated.	Acceptance Criteria Met
Coating Integrity Test	Confirms that coating of MIDWAY Delivery Catheters
has not delaminated, peeled, or flaked before or after
simulated use.	Acceptance Criteria Met
Surface Integrity	The MIDWAY Delivery Catheter surface is inspected for
defects.	Acceptance Criteria Met
Tensile Strength Test	Confirms MIDWAY Delivery Catheters meet product
specification related to tensile strength after simulated use.	Acceptance Criteria Met
Burst Pressure Test	Confirms MIDWAY Delivery Catheters can withstand
sufficient pressure after simulated use.	Acceptance Criteria Met

9

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.