HARBOR Occlusion Device

K250133 · Nuvascular, Inc. · KRD · Jul 9, 2025 · Cardiovascular

Device Facts

• Record ID: K250133
• Device Name: HARBOR Occlusion Device
• Applicant: Nuvascular, Inc.
• Product Code: KRD · Cardiovascular
• Decision Date: Jul 9, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The HARBOR Occlusion Device is indicated for arterial embolization in the peripheral vasculature.

Device Story

The HARBOR Occlusion Device is a self-expanding, braided nitinol mesh implant designed for arterial embolization in the peripheral vasculature. It features a platinum marker band at the proximal end for radiopacity and an uncoated nitinol ball for mechanical detachment. The device is supplied pre-loaded in an introducer sheath and attached to a 185 cm delivery system (stainless steel hypotube with nitinol wire). It is intended for use by physicians under fluoroscopic guidance. The device is delivered through compatible microcatheters (Terumo Headway 17 or 27). By occluding the target vessel, the device facilitates embolization, which can be used to manage various peripheral vascular conditions. The device is provided sterile and is for single use.

Clinical Evidence

No human clinical data provided. Evidence consists of extensive bench testing (mechanical, visual, biocompatibility per ISO 10993, shelf-life, sterilization, and packaging validation) and a GLP animal study (acute, 30-day, and 90-day). Animal study endpoints included ease of delivery, acute complications, recanalization/durability, foreign body reaction, migration, and effectiveness. All tests met acceptance criteria.

Technological Characteristics

Implant: Nitinol mesh (55-57% Ni, 43-45% Ti) with platinum marker band. Delivery system: Stainless steel hypotube with nitinol wire. Dimensions: 4.0-13.5 mm OD, 2.5-5.4 mm length. Delivery: Mechanical detachment via 0.017" or 0.027" ID microcatheters. Sterilization: E-beam. Biocompatibility: ISO 10993 compliant. Packaging: Hoop dispenser.

Indications for Use

Indicated for arterial embolization in the peripheral vasculature.

Regulatory Classification

Identification

A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.

Special Controls

*Classification.* Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 870.1(e).

Predicate Devices

• AMPLATZER® Vascular Plug 4, Arterial Embolization Device (K113658)
• AMPLATZER® Vascular Plug, Arterial Embolization Device (K031810)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

July 9, 2025

Nuvascular Inc.
Meadow Wang
Director, RA/QA
141 Innovation Drive, Suite 100
Irvine, California 92617

Re: K250133
Trade/Device Name: HARBOR Occlusion Device
Regulation Number: 21 CFR 870.3300
Regulation Name: Vascular Embolization Device
Regulatory Class: Class II
Product Code: KRD
Dated: June 9, 2025
Received: June 9, 2025

Dear Meadow Wang:

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"

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K250133 - Meadow Wang
Page 2

(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).

Your device is also subject to, among other requirements, the Quality System (QS) 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 (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-reporting-combination-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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

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K250133 - Meadow Wang
Page 3

Sincerely,

Misti L. Malone -S

Misti Malone, PhD
Assistant Director
DHT2C: Division of Coronary and Peripheral Intervention Devices
OHT2: Office of Cardiovascular Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K250133 | |
| Device Name HARBOR Occlusion Device | |
| Indications for Use (Describe) The HARBOR Occlusion Device is indicated for arterial embolization in the peripheral vasculature. | |
| 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 [e-mail] | |
| "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." | |

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K250133 Page 1 of 11

# 510(k) SUMMARY

## SUBMITTER

Nuvascular Inc.
141 Innovation Dr. Suite 100, Irvine, CA 92617
Phone: [phone]
Contact Person: Meadow
S. Wang Date Prepared: June 8, 2025

## DEVICE

Trade Name of the Device: Harbor Occlusion Device
Device Common Name: Vascular Embolization Device
Classification Name: Device, Vascular, for promoting embolization Regulatory Class: Class II, 21 CFR 870.3300
Product Code: KRD

## PREDICATE DEVICE

AGA Medical Corporation (was acquired by Abbott): AMPLATZER® Vascular Plug 4, Arterial Embolization Device (KRD) (K113658) (primary predicate)
AGA Medical Corporation (was acquired by Abbott): AMPLATZER® Vascular Plug, Arterial Embolization Device (KRD) (K031810)

## DEVICE DESCRIPTION

The HARBOR Occlusion Device is a self-expanding braided nitinol arterial embolization implant (Figure 1) supplied with components used for implantation (Figure 2). The Device has a radiopaque marker band attached to the proximal end of the implant. The implant is packaged collapsed within an Introducer sheath and attached to a Delivery System provided within a hoop dispenser.

Device implant sizing and dimensions are specified in Table 1. Based on its size, the device is designed to be used with commercially available microcatheters (Table 2) under fluoroscopy for delivery and implantation in the peripheral vasculature.

Figure 1 Harbor Occlusion Device – Implant

Figure 2. Harbor Occlusion Device – Delivery System

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The implant comes in various diameters ranging from 4.0 to 13.5 mm Unconstrained OD and 2.0 to 5.4 mm Unconstrained Length. The Harbor Occlusion Device will be available in the following with delivery system configurations:

| Table 1: Device Size | | | | |
| --- | --- | --- | --- | --- |
| Product Model Number | Harbor Occlusion Device OD, Unconstrained, DIM A (mm) | Harbor Occlusion Device Length, Unconstrained, DIM C (mm) | Treatable Vessel Diameter Range (mm) | Compatible Microcatheter (Inch) |
| 04-OCCLUDE-020 | 4.0 | 2.5 | 2.0 – 2.5 | 0.017 |
| 04-OCCLUDE-025 | 4.0 | 2.5 | 2.0 – 2.5 | 0.017 |
| 04-OCCLUDE-030 | 4.5 | 2.8 | 2.5 – 3.0 | 0.017 |
| 04-OCCLUDE-035 | 5.0 | 3.0 | 3.0 – 3.5 | 0.017 |
| 04-OCCLUDE-040 | 5.5 | 3.2 | 3.5 – 4.0 | 0.017 |
| 04-OCCLUDE-045 | 6.0 | 3.4 | 4.0 – 4.5 | 0.017 |
| 04-OCCLUDE-050 | 6.5 | 3.6 | 4.5 – 5.0 | 0.017 |
| 04-OCCLUDE-055 | 7.0 | 3.8 | 5.0 – 5.5 | 0.017 |
| 04-OCCLUDE-060 | 7.5 | 4.0 | 5.5 – 6.0 | 0.017 |
| 04-OCCLUDE-065 | 8.0 | 4.2 | 6.0 – 6.5 | 0.017 |
| 04-OCCLUDE-070 | 8.5 | 4.4 | 6.5 – 7.0 | 0.027 |
| 04-OCCLUDE-080 | 9.5 | 4.6 | 7.0 – 8.0 | 0.027 |
| 04-OCCLUDE-090 | 10.5 | 4.8 | 8.0 – 9.0 | 0.027 |
| 04-OCCLUDE-100 | 11.5 | 5.0 | 9.0 – 10.0 | 0.027 |
| 04-OCCLUDE-110 | 12.5 | 5.2 | 10.0 – 11.0 | 0.027 |
| 04-OCCLUDE-120 | 13.5 | 5.4 | 11.0 – 12.0 | 0.027 |

The delivery system attached to the Harbor Occlusion Device implant is 185 cm in length and an outer diameter suitable for delivery through commercially available Microcatheter- Terumo Headway 17 with 0.017” ID Microcatheter or Terumo Headway 27 with 0.027” ID Microcatheter.

| Table 2 Compatible with the available Commercial Microcatheter | | | |
| --- | --- | --- | --- |
| Description | Catalog Number | Inner Diameter (In) | Usable Length (cm) |
| Terumo Headway 17 | MC172150SX | 0.017 | 150 |
| Terumo Headway 27 | MC172156S | 0.027 | 156 |

## INDICATIONS FOR USE

The Harbor Occlusion Device is indicated for arterial embolization in the peripheral vasculature.

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# DEVICE Attributes

Table 3 list the attributes of HARBOR Occlusion Device.

| Table 3 HARBOR Occlusion Device Attributes | |
| --- | --- |
| Device Attributes | Nuvascular Harbor Occlusion Device (Subject Device) |
| Device Classification | Class II, KRD, 21 CFR 870.3300 |
| Intended Use/Indications for Use Statement | Indicated for arterial embolization in the peripheral vasculature |
| Device Function | Embolization in the arterial peripheral vasculature |
| Anatomical Location | Peripheral Arterial Vasculature |
| Harbor (Implant) | Self-expanding, Nitinol mesh occlusion device with non-blood contact platinum core to improve radiopacity. The device has a radiopaque marker band at the proximal end and an uncoated Nitinol ball at one end for attaching to the delivery system. |
| Implant Material | Nitinol |
| Implant Shape | Single Layer Braid Device
Single Lobe with Cylindrical shape |
| Delivery System Material | Stainless Steel Hypotube with Nitinol Wire |
| Introducer Sheath | HDPE, High Density Polyethylene |
| Radiopaque Marker | Platinum Marker Band at the proximal end of the Harbor Occlusion Device |
| Delivery Method | Delivered and compatible with Terumo Headway 17, 0.017” or Headway 27, 0.027” microcatheter
Terumo Headway 17
MC172150SX:
Inner Diameter (in): 0.017
Usable Length (cm)
150
Terumo Headway 27
MC272156S:
Inner Diameter (in): 0.027
Usable Length (cm): 156 |
| Delivery system Length | 185 cm |
| Detachment System | Mechanical Detachment |
| Materials of Construction for Implant | Nitinol Wire (Main Substances: Nickel: 55-57%, Titanium: 43-45%) |
| Materials of Construction for Delivery system | Stainless Steel Hypotube with inner Nitinol wire |

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# COMPARISON OF TECHNOLOGICAL CHARACTERISTICS OF THE HARBOR OCCLUSION DEVICE WITH THE PREDICATE DEVICE

The method of application of the Harbor Occlusion Device is the same as the predicate device, AMPLATZER Vascular Plug 4, Arterial Embolization Device (KRD) (K113658) and AMPLATZER Vascular Plug, Arterial Embolization Device (KRD) (K031810). They both utilize the same principle of operation to be delivered to a select target site for the vessel and embolic used. They are both available in a range of diameters to permit the selection of appropriate sizes for target vessel embolization. Accurate placement of the Harbor Occlusion Device is conducted with visualization using radiographic (fluoroscopy) imaging.

Table 4 compares the subject device, HARBOR Occlusion Device, and the predicate.

| Table 4: Comparison of Technological Characteristics with the Predicate Device | | | | |
| --- | --- | --- | --- | --- |
| Device Attributes | Nuvascular HARBOR Occlusion Device (Subject Device) | Abbott AMPLATZER® Vascular Plug 4 (Primary Predicate Device) (K113658) | Abbott AMPLATZER® Vascular Plug (Predicate Device) (K031810) | Justification for Difference (If Present) |
| Device Classification | Class II, KRD, 21 CFR 870.3300 | Class II, KRD, 21 CFR 870.3300 | Class II, KRD, 21 CFR 870.3300 | Same, Identical device classification |
| Intended Use/Indications for Use Statement | Indicated for arterial embolization in the peripheral vasculature | Indicated for arterial and venous embolization in the peripheral vasculature | Indicated for arterial and venous embolization in the peripheral vasculature | Same Intended Use/Indication for Use Statement, the intended use of the subject device is narrower than the predicate device |
| | Principle of Operation/Fundamental Scientific Technology | | | |
| Device Function | Arterial embolization in the peripheral vasculature | Embolization in the peripheral vasculature | Embolization in the peripheral vasculature | Same function, subject device function is narrower than the predicate device |
| Anatomical Location | Peripheral Arterial Vasculature | Peripheral Vasculature including arterial and venous | Peripheral Vasculature including arterial and venous | Same, the anatomical location of subject device is narrower than the predicate device |
| | Device Design | | | |

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| Harbor (Implant) | Self-expanding, Nitinol mesh occlusion device with non-blood contact platinum core to improve radiopacity. The device has a radiopaque marker band at the proximal end and an uncoated Nitinol ball at one end for attaching to the delivery system. | Self-expanding, Nitinol mesh occlusion device. The device has a radiopaque marker band at each end and a coated stainless steel micro screw attachment at one end for attaching to the delivery system. | Self-expanding, Nitinol mesh occlusion device. The device has a radiopaque marker band at each end and a micro screw attachment at one end for attaching to the delivery system. | Similar device design. The results of comparative bench testing, physician usability study, histopathology, biocompatibility testing, and animal study establish the substantial equivalency of the subject device with the predicate device. |
| --- | --- | --- | --- | --- |
| Harbor OD, Unconstrained | 4.0 mm
4.5 mm
5.0 mm
5.5 mm
6.0 mm
6.5 mm
7.0 mm
7.5 mm
8.0 mm
8.5 mm
9.5 mm
10.5 mm
11.5 mm
12.5 mm
13.5 mm | 4.0 mm
5.0 mm
6.0 mm
7.0 mm
8.0 mm | 4.0 mm
6.0 mm
8.0 mm
10.0 mm
12.0 mm
14.0 mm
16.0 mm | Same, the OD range of the subject device is narrower than the predicate device. |
| Harbor Unconstrained Length | 2.5 mm
2.8 mm
3.0 mm
3.2 mm
3.4 mm
3.6 mm
3.8 mm
4.0 mm
4.2 mm
4.4 mm
4.6 mm
4.8 mm
5.0 mm
5.2 mm
5.4 mm | 10.0 mm
10.5 mm
11.0 mm | 7.0 mm
8.0 mm | The range of Unconstrained Length for the subject device is similar to the predicated device
The subject device has a smaller unconstrained length compared to the predicate device.
Test data show the radial force met the radial force acceptance criteria, the simulated use test shows the subject device functions are the same as the predicate device, and the animal test met acceptance criteria.
The subject device is |

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| | | 12.5 mm
13.5 mm | | substantially equivalent to the predicate device. |
| --- | --- | --- | --- | --- |
| Target Vessel Diameter | 2.0 mm-2.5 mm
2.5 mm-3.0 mm
3.0 mm-3.5 mm
3.5 mm-4.0 mm
4.0 mm-4.5 mm
4.5 mm-5.0 mm
5.0 mm-5.5 mm
5.5 mm-6.0 mm
6.0 mm-6.5 mm
6.5 mm-7.0 mm
7.0 mm-8.0 mm
8.0 mm-9.0 mm
9.0 mm-10.0 mm
10.0 mm-11.0 mm
11.0 mm-12.0 mm | 2.5 mm-3.0 mm
3.5 mm-4.0 mm
4.0 mm-4.5 mm
4.5 mm-5.5 mm
5.5 mm-6.0 mm | 2.5 mm-3.0 mm
4.0 mm-4.5 mm
5.5 mm-6.0 mm
6.5 mm-7.5 mm
8.0 mm-9.0 mm
9.5 mm-11.0 mm
10.5 mm-12.5 mm | The range of the treated target vessel diameter for the subject device is similar to the predicate device.
The subject device treats vessels 2.0 mm to 12.0 mm compared to 2.5 mm to 12.5 mm for the predicate device.
90-day GLP animal data, histopathology, and bench testing show that the subject device can treat 2.0 mm vessels.
Test data show the radial force met the radial force acceptance criteria, the simulated use test shows the subject device functions are the same as the predicate device, and the animal test met acceptance criteria.
The subject device is substantially equivalent to the predicate device. |
| Implant Shape | Single Layer Braid Device
Single Lobe with Cylindrical shape | Single Layer Braid Device
Double-Lobed with low-profile embolization | Single Layer Braid Device
Single Lobe with Cylindrical shape | Same single layer braid device with similar shape |
| Delivery System Material | Stainless Steel Hypotube with Nitinol Wire | PTFE-coated Stainless Steel Wire Coil with Nitinol Core | Nitinol | Similar, the biocompatibility test results of the delivery system show the subject device met the acceptance criteria of ISO 10993. |

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| Loading Device Method | Introducer Sheath, HDPE | Loader, PTFE | Loader, PTFE | Similar, the biocompatibility test results of the delivery system show the subject device met the acceptance criteria of ISO 10993 |
| --- | --- | --- | --- | --- |
| Radiopaque Marker | Platinum Marker Band at the proximal end of the Harbor Occlusion Device | Platinum Marker Bands at each end of the plug | Platinum Marker Bands at each end of the plug | Same material with the same principle |
| Delivery Method | Delivered and compatible with Terumo Headway 17, 0.017” or Headway 27, 0.027” Microcatheter Terumo Headway 17 MC172150SX: Inner Diameter (in): 0.017 Usable Length (cm): 150 Terumo Headway 27 MC272156S: Inner Diameter (in): 0.027 Usable Length (cm): 156 | Delivered utilizing a Diagnostic Catheter 0.038” meeting the minimum internal diameter Catheter Size: 5F with length ≤125cm 4F with length ≤100cm | Delivered utilizing a Diagnostic Catheter 0.056”, 0.066”, and 0.087” meeting the minimum internal diameter Compatible with Guide Catheter size: Vessel size vs Minimum Guide Catheter Size 2.5mm-6.0mm, ≥0.066” 6.5 mm-9.0mm, ≥0.087” 9.5 mm-12.5mm, ≥0.11” Catheter Length: ≤100cm | Similar delivery method. The Harbor Occlusion Device is designed to be delivered through a smaller ID (0.017” or 0.027” inner diameter) microcatheter. The results of bench testing and physician usability study establish the substantial equivalence of the subject device has substantially equivalent function as the predicate device |
| Delivery system Length | 185 cm | 155 cm | 135 cm | The Harbor Occlusion Device is designed to be delivered through a longer-length delivery system The results of bench testing and physician usability study establish the substantial equivalence of subject device to the predicate device |
| Detachment System | Mechanical Detachment | Mechanical Detachment | Mechanical Detachment | Same principle |

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| Device Material | | | | |
| --- | --- | --- | --- | --- |
| Materials of Construction for Implant | Nitinol Wire (Main Substances: Nickel: 55-57%, Titanium: 43-45%) | Nitinol Wire (Main Substances: Nickel: 55-57%, Titanium: 43-45%) | Nitinol Wire (Main Substances: Nickel: 55-57%, Titanium: 43-45%) | Same |
| Materials of Construction for Delivery system | Stainless Steel Hypotube with inner Nitinol Delivery wire | PTFE-coated Stainless Steel wire coil with inner Nitinol wire | Nitinol wire | Similar device material construction. The subject device has stainless steel Hypotube with inner Nitinol Delivery wire without PTFE- Coating
The materials used for the Harbor Vessel Occlusion Device met the acceptance criteria of ISO 10993 for delivery system. |
| Marker Bands | Platinum | Platinum | Platinum | Same |
| Micro Screw | N/A | Stainless Steel | Stainless Steel | The subject device has no micro screw |
| Other Attributes | | | | |
| Packaging | Harbor Occlusion Device includes implant attached to 185 cm long delivery system, loaded in a hoop dispenser | The device is shipped attached to a 155 cm delivery system in a hoop dispenser and is preloaded in a loader. A plastic vise is also included and may be attached to the delivery system to facilitate device detachment | The device is shipped attached to a 135 cm. delivery system in a hoop dispenser and is preloaded in a loader. A plastic vise is also included and may be attached to the delivery system to facilitate device detachment | Similar
The packaging validation result for the subject device shows the packaging integrity can meet the requirements per ASTM D4169, ASTM D4332, ASTM F88/F88M, ASTM F2096. |
| Sterilization Process | Ebeam | EtO (Ethylene Oxide) | EtO (Ethylene Oxide) | The sterilization validation result shows Harbor Occlusion Device met SAL of 10^{-6} |
| Method of Supply | Sterile, single use | Sterile, single use | Sterile, single use | Same |

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# SUMMARY OF HARBOR OCCLUSION DEVICE PERFORMANCE TESTING:

1. Bench Test

| Table 5: Verification and Test Summary | |
| --- | --- |
| Pre-clinical Testing | Result |
| Implant, Biocompatibility Testing (ISO 10993-1)
- Medical Device Chemical Characterization and Extractables and Leachable for Compatibility of Materials (ISO 10993-18)
- Implant Hemolysis Test
- Implant Complement Activation Test
- Toxicological Risk Assessment (ISO 10993-17)
- Cytotoxicity (ISO 10993-5)
➤ L929 MEM Elution Cytotoxicity Assay
- Sensitization (ISO 10993-10)
➤ Kligman Maximization Sensitization in Guinea pigs with two extracts
- Irritation (ISO 10993-23)
➤ Irritation/Intracutaneous Injection Reactivity
- Pyrogenicity (ISO 10993-11)
➤ Material Mediated Rabbit Pyrogen
- Biocompatibility Evaluation Report (ISO10993-1) | In accordance with ISO 10993 |
| Delivery system with Introducer Sheath, Biocompatibility testing (ISO 10993-1)
- Cytotoxicity (ISO 10993-5)
➤ L929 MEM Elution Cytotoxicity Assay
- Sensitization (ISO 10993-10)
➤ Kligman Maximization Sensitization in Guinea pigs with two extracts
- Irritation (ISO 10993-23)
➤ Irritation/Intracutaneous Injection Reactivity
- Systemic Toxicity (ISO 10993-11)
➤ Acute Systemic Injection with two extracts
- Pyrogenicity (ISO 10993-11)
➤ Material Mediated Rabbit Pyrogen
- Hemocompatibility (ISO 10993-4)
➤ ASTM Hemolysis Complete, Indirect Contact | In accordance with ISO 10993 |

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| Preclinical Testing including Mechanical, Visual, and Bench Testing - Visual/Dimension Inspection - Simulated Use ➢ Preparation/Flush ➢ Introduction ➢ Tracking ➢ Advancement ➢ Kink Resistance ➢ Flexibility ➢ Microcatheter Compatibility ➢ Deployment ➢ Retraction ➢ Detachment ➢ Migration Resistance ➢ Overall Performance - Radial Force - Implant Tensile Strength - Joint Tensile Strength - Nickel Ion Release - Corrosion Resistance - Magnetic Resonance (MR) Testing - Radiopacity - Occlusion Time - Shelf-Life Study (Products/Packaging) - Pyrogenicity ➢ Sterility | Pass |
| --- | --- |
| Packaging validation (Products/Packaging) | Pass |
| Sterilization validation (Sterilization) | Pass |
| Shelf-Life Study (Products/Packaging) | Pass |

2. GLP Animal Study

| Table 6: GLP Animal Study Summary | |
| --- | --- |
| Pre-clinical Testing | Result |
| Animal testing – device compared to predicate device (Acute, 30 days and 90 days) - Ease of delivery (friction and tortuosity) - Acute Complications - Recanalization of the vessels/durability of occlusion - Local and systemic foreign body reactions - Device migration - Effectiveness | Pass |

{14}

K250133 Page 11 of 11

# SUMMARY OF SUBSTANTIAL EQUIVALENCE:

The data presented in this submission demonstrates the technological similarity and equivalency of the Harbor Occlusion Device when compared with the predicate device, AMPLATZER® Vascular Plug 4, Arterial Embolization Device (KRD) (K113658) and AMPLATZER® Vascular Plug, Arterial Embolization Device (KRD) (K031810).

The Subject device,
- has the same intended use to the predicate devices,
- has the intended use is narrower than the predicate devices,
- uses same operating principle as the predicate devices,
- uses similar materials, the types of material in subject device are less than the predicate devices,
- incorporates similar basic design and construction to the predicate devices,
- uses a similar packaging method to the predicate devices,
- has similar unconstrained OD range to the predicate devices,
- has similar unconstrained Length ranges to the predicate devices

In summary, the Harbor Occlusion Device described in this submission is substantially equivalent to the predicate devices.