EmeryGlide™ (EG18008901)

K253262 · Nano4imaging GmbH · DQX · Mar 6, 2026 · Cardiovascular

Device Facts

• Record ID: K253262
• Device Name: EmeryGlide™ (EG18008901)
• Applicant: Nano4imaging GmbH
• Product Code: DQX · Cardiovascular
• Decision Date: Mar 6, 2026
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

EmeryGlide is intended to direct a catheter to the desired anatomical location in the vasculatory system during diagnostic or interventional procedures.

Device Story

EmeryGlide is a sterile, disposable, manually operated guidewire; used to direct catheters to specific anatomical locations within the vasculature during diagnostic or interventional procedures. Device consists of a high-strength glass fiber and polymer core, aramid fiber mantle, and PTFE extrusion. Distal tip features passive markers for MRI and X-ray visibility. Operated by clinicians in clinical settings. Device is MR Conditional, allowing use in 1.5T or 3.0T MRI environments under specified gradient and SAR limits. Output is physical guidance of catheters; assists healthcare providers in navigating vascular anatomy. Benefits include improved procedural access and compatibility with MRI imaging.

Clinical Evidence

No clinical data. Bench testing only, including mechanical performance (flexing/bending resistance, bending modulus), packaging integrity (seal strength, dye penetration, bubble leak), transportation simulation, biocompatibility (cytotoxicity, chemical characterization, toxicological risk assessment), sterilization validation, and simulated use in vascular phantom models.

Technological Characteristics

Core: glass fibers and polymers; Mantle: aramid fiber; Outer sleeve: PTFE. Diameter: 0.035" (0.89 mm). Length: 180 cm. Passive markers for MRI/X-ray visibility. MR Conditional. Sterilization: Ethylene oxide (SAL 10^-6). Standards: ISO 11070, ISO 14125, ASTM F88, ASTM F1929, ASTM F1886, ASTM F2096, ISO 11737-1, ISO 10993 series, USP <85>, ISO 11135.

Indications for Use

Indicated for directing catheters to desired anatomical locations in the vasculature during diagnostic or interventional procedures. Contraindicated for coronary or cerebral vasculature.

Regulatory Classification

Identification

A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.

Special Controls

*Classification.* Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• MRWire Guide Wire (K173423)

Submission Summary (Full Text)

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FDA U.S. FOOD &amp; DRUG ADMINISTRATION

March 6, 2026

Nano4imaging GmbH
Natalie Theisen
Director Regulatory Affairs and Quality Management
Life Science Centre
Merowingerplatz 1
Duesseldorf, NRW 40225
Germany

Re: K253262
Trade/Device Name: EmeryGlide
Regulation Number: 21 CFR 870.1330
Regulation Name: Catheter guide wire
Regulatory Class: Class II
Product Code: DQX
Dated: September 29, 2025
Received: September 29, 2025

Dear Natalie Theisen:

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.

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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).

Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13484 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and 21 CFR 820.70) and document changes and approvals in the Medical Device File (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 Management System Regulation (QMSR) (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-

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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).

Sincerely,

Jenny R. Katsnelson -S
Digitally signed by Jenny R. Katsnelson -S
Date: 2026.03.06 23:28:07
-05'00"

for Lydia Glaw
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) K253262 | |
| Device Name EmeryGlide | |
| Indications for Use (Describe) EmeryGlide is intended to direct a catheter to the desired anatomical location in the vasculatory system during diagnostic or interventional procedures. | |
| 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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# 1. Special 510(k) Summary

## 1.1. Submitters Information (807.92(a)(1))

**Owner/Operator**

Nano4Imaging GmbH

**Prepared for:**

Life Science Center

Merowingerplatz 1

40225 Düsseldorf, Germany

[phone]

Natalie Theisen

**Contact details:**

Director Regulatory Affairs and Quality Management

Phone: [phone]

Email: [e-mail]

**Prepared by:**

Sjef Cremers, Ph.D.

Senior Special Project Manager

**Date of preparation:**

09/29/2025

## 1.2. Device Name (807.92(a)(2))

**Device Trade Name:**

EmeryGlide™

**Device Common Name:**

Guide Wire

**Classification Name:**

Wire, Guide, Catheter

**Classification Pannel:**

Cardiovascular

**Regulation:**

21 CFR 870.1330

**Product Code:**

DQX

**Classification:**

Class II

## 1.3. Predicate Device (807.92(a)(3))

The legally marketed device to which substantial equivalency is claimed is:

| Predicate device | Manufacturer | 510(k) | Date |
| --- | --- | --- | --- |
| MRWire Guide Wire | Contract Medical GmbH for Nano4Imaging GmbH | K173423 | 11/17/2017 |

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## 1.4. Reason for Special 510(k) Submission

The purpose of this Special 510(k) submission is to establish substantial equivalence of EmeryGlide™ to the predicate MRWire Guide Wire (K173423). The subject device incorporates minor technical modifications, including the use of an alternative PTFE colorant, a change in pouch material, transfer to a new FDA-registered contract sterilizer and manufacturer, and an extension of shelf life. These modifications do not alter the device's intended use or fundamental scientific technology, and verification/validation activities confirmed that the EmeryGlide™ is substantially equivalent to the predicate device.

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## 1.5. Device Description

### Principle of Operation Technology

EmeryGlide™ is operated by manual process.

### Design/Construction

EmeryGlide™ is a sterile, disposable guidewire for the introduction and/or placement of diagnostic or interventional devices. EmeryGlide™ is constructed from a high strength core composite of glass fibers and polymers, protected by a high-strength aramid fiber mantle and covered with a PTFE extrusion. The distal tip of EmeryGlide™ is marked with discrete ring markers for MRI and X-Ray visibility and comes in an angled configuration. EmeryGlide™ is supplied sterile and non-pyrogenic. EmeryGlide™'s diameter is 0.035" (0.89 mm).

### MRI Safety Information


Non-clinical testing has demonstrated that EMERYGLIDE™ is MR Conditional.

A patient with this device can be safely scanned in an MR system meeting the following conditions:

- Static magnetic field of 1.5 or 3.0 T
- Maximum spatial field gradient of 3600 Gauss/cm (36.0 T/m) for 1.5 T systems
- Maximum spatial field gradient of 1800 Gauss/cm (18.0 T/m) for 3.0 T systems
- Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 4.0 W/kg (First Level Operating Mode at 1.5T)
- Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 4.0 W/kg (First Level Operating Mode at 3.0 T)

Under the scan conditions defined above, EmeryGlide expected to produce a maximum temperature rise of less than 0.6 °C after 15 minutes continuous scanning.

In non-clinical testing, the image artifact caused by the device extends approximately 8 mm from EmeryGlide™ when imaged with a gradient echo pulse sequence and a 3 T MRI system.

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# Specifications

The specifications for EmeryGlide™ are provided in the table below.

Table 1.1: EmeryGlide™ Specifications

| Part | Specification |
| --- | --- |
| Model Number | EG18008901 |
| Diameter of Guide Wire | 0.035" |
| Length of Guide Wire | 180 cm |
| Distal tip shape processing | Preshaped |
| Tip Configuration | Angled |
| Tip length | 40 mm |
| Outer sleeve material | PTFE |
| MRI and X-ray visibility | Passive markers at discrete positions 0, 2, 4 cm from the tip |
| MRI Labeling | MR Conditional |
| Shelf life | 1 year |

## 1.6. Indications For Use (807.92(a)(5))

EmeryGlide™ is intended to direct a catheter to the desired anatomical location in the vasculatory system during diagnostic or interventional procedures.

### Contraindications:

EmeryGlide™ is not intended for coronary or cerebral vasculature.

## 1.7. Substantial Equivalence Comparison (807.92(a)(6))

EmeryGlide™ subject of this special 510(k) is substantially equivalent in intended/indications for use, technology /principle of operation, and performance to the MRWire Guide Wire manufactured by Nano4Imaging GmbH.

A comparison of the technological characteristics is summarized in the table below.

Table 1: Summary of Comparative Information

| Characteristics | Subject Device
EmeryGlide™
EG18008901 | Predicate
MRWire
CV18035S and CV18035A |
| --- | --- | --- |
| 510(k) number | K253262. | K173423 |
| Trade name | EMERYGLIDE™ | MRWire Guide Wire |
| Models | EG18008901 | CV18035S (FG-02175-006) and CV18035A (FG-02175-007) |
| Indications for use | EmeryGlide™ is intended to direct a catheter to the desired anatomical location in the vasculatory system during diagnostic or interventional procedures. | The MRWire Guide Wire is intended to direct a catheter to the desired anatomical location in the vasculatory system during diagnostic or interventional procedures. |
| Principle of operation | Manual operation | Manual operation |

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| Diameter | 0.035" (0.89 mm) | 0.035" (0.89 mm) |
| --- | --- | --- |
| Effective lengths | 180 cm | 180 cm |
| Distal shape configuration | Angled | Angled, Straight |
| Sterilization method / Sterilization Assurance Level (SAL) | Ethylene oxide, SAL 10-6. | Ethylene oxide, SAL 10-6. |
| Shelf Life | 1 year | 6 months |
| MRI compatibility | Yes | Yes |
| MRI visibility | Discrete markers | Discrete markers |
| X-ray visibility | Yes | Yes |
| Material | Glass fibers, aramid fibers and PTFE | Glass fibers, aramid fibers and PTFE |
| Outer sleeve material | Blue PTFE Heat Shrink Tubing | Blue PTFE Heat Shrink Tubing |
| Coating | No | No |
| Package Material | Pouch: Coated 1073B Tyvek®/ 100ga BON, 15" x 15" Packer: Carton, 15" x 15" x 0.5" Shipper: Carton, 15" x 15" x 3.25" | Pouch: Flat PET-O/PP 12/40 Paper, 500 mm x 380 mm Packer: Carton, 380 x 380 x 10 mm Shipper: Carton, 390 x 390 x 80 mm |

# 1.8. Non Clinical Tests (807.92(b)(1))

# Performance

Performance testing was conducted to evaluate the mechanical and functional characteristics of the EmeryGlide™ throughout its labeled shelf life, verify conformity to applicable ISO/ASTM standards, and demonstrate substantial equivalence to the predicate device (K173423). With the exception of biocompatibility, bioburden, and bacterial endotoxin (LAL) testing, all performance tests were performed on both non-aged and accelerated-aged samples to simulate a 1-year shelf life. All samples tested met the applicable acceptance criteria, and substantial equivalence was established.

Table 2: Performance Testing per ISO Standard/ASTM

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| Test Item | Reference Standard |
| --- | --- |
| Flexing and Bending Resistance | ISO 11070:2014, Section 8.5 |
| Bending Modulus | ISO 14125:2011 |
| Packaging Seal Strength | ASTM F88/F88M-23 |
| Packaging Integrity – Dye Penetration | ASTM F1929-23 Red |
| Packaging Integrity – Visual Inspection | ASTM F1886/F1886M-16(2024) |
| Packaging Integrity – Bubble Leak Test | ASTM F2096-11 (R2019) |
| Transportation Simulation | ISTA 3A:2018 |
| Bioburden Testing | ISO 11737-1:2018 |
| Biocompatibility – Cytotoxicity | ISO 10993-5:2009 |
| Biocompatibility – Sample preparation and reference material | ISO 10993-12:2021/Amd 1:2025 |
| Biocompatibility – Toxicological risk assessment | ISO 10993-17:2023 |
| Biocompatibility – Chemical characterization | ISO 10993-18:2020 |
| LAL/Endotoxin Testing | USP <85> / AAMI ST72:2019 |
| Sterilization Adoption | ISO 11135:2014 + Amd.1:2019
TIR28:2016/(R)2020 |
| Particulate evaluation | USP <788>, AAMI TIR42:2021 |

Additionally, performance testing other than that recommended in the above ISO standard was performed on the device in accordance with FDA guidance documents and/or in-house standards. The subject device complies with the acceptance criteria established based on the predicate device and/or the FDA guidance documents, as shown in the table below.

Table 3: Performance Testing per In-house Standard

| Test Item | Reference |
| --- | --- |
| U-Turn Test (worst-case anatomical kink resistance) | In-house protocol, FDA-reviewed |
| Simulated Use Test (vascular phantom model) | In-house protocol |
| Product dimension | In-house standard |

Performance testing demonstrated that EmeryGlide™ conformed to the recognized consensus ISO standards, FDA guidance documents or in-house standards, is substantially equivalent to the predicate device.

## Biocompatibility

In accordance with ISO 10993-1:2018, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process, EmeryGlide™ is classified as an Externally Communicating Device, Circulating Blood, Limited Contact (&lt;24 hours). This is the same classification as the predicate MRWire Guide Wire (K173423) intended for vascular use.

All new blood-contacting materials of the subject device were evaluated through biocompatibility testing in accordance with FDA Guidance "Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process" (September 8, 2023) and the FDA-recognized ISO 10993-1 standard.

## Sterilization

The device was adopted into an existing sterilization cycle that was validated in accordance with ISO 11135:2014 + Amd.1:201, Sterilization of health-care products - Ethylene Oxide -

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Requirements for development, validation and routine control of a sterilization process for medical devices, to provide a Sterility Assurance Level (SAL) of 10⁻⁶.

Pyrogenicity evaluation confirmed that the device is non-pyrogenic, with no bacterial endotoxin contamination (USP &lt;85&gt;, ANSI/AAMI ST72:2019) and no evidence of material-mediated pyrogenicity.

## Risk Analysis

A Product Risk Analysis was conducted in accordance with ISO 14971: 2019, Medical devices-Application of risk management to medical devices, and no new risks were identified.

## 1.9. Clinical Tests (807.92(b)(2))

This 510(k) does not include data from clinical tests.

## 1.10. Conclusion (807.92(b)(3))

In summary, EmeryGlide™, subject of this special 510(k), is substantially equivalent in its intended use/indications for use, technology/principal of operation, and performance to the predicate device MRWire Guide Wire cleared under k173423.