GLIDESHEATH SLENDER

K142183 · Terumo Medical Corporation · DYB · Nov 21, 2014 · Cardiovascular

Device Facts

• Record ID: K142183
• Device Name: GLIDESHEATH SLENDER
• Applicant: Terumo Medical Corporation
• Product Code: DYB · Cardiovascular
• Decision Date: Nov 21, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Indications for Use

The Glidesheath Slender is used to facilitate placing a catheter through the skin into the radial artery.

Device Story

The Glidesheath Slender is a manual catheter introducer kit used to facilitate radial artery access. The kit includes an introducer sheath, dilator, entry needle, mini guide wire, and guide wire inserter. The sheath features a hydrophilic coating to reduce friction during insertion and removal. Both the sheath and dilator contain bismuth for radiopacity under fluoroscopy. The device is operated manually by a clinician in a clinical setting. The entry needle or IV catheter is used to access the radial artery; the guide wire is inserted; the sheath and dilator are advanced over the wire; the wire and dilator are removed, leaving the sheath in place for subsequent catheter insertion. The device benefits the patient by providing a stable, low-friction access point for diagnostic or interventional procedures.

Clinical Evidence

No clinical data. Bench testing only, including ISO 11070 performance verification (surface, corrosion, radiodetectability, leakage, force at break, flexibility, insertion/removal resistance) and biocompatibility testing per ISO 10993-1.

Technological Characteristics

Materials: ETFE, Bismuth Trioxide, Polypropylene, Stainless Steel, Silicone Rubber, SEBS, Polybutadiene, Polycarbonate, Polyethylene, Nickel-Titanium, Tungsten. Sensing/Actuation: Manual. Connectivity: None. Sterilization: Ethylene Oxide (SAL 10^-6). Form factor: Introducer sheath and dilator kit. No software or algorithm.

Indications for Use

Indicated for patients requiring catheter placement into the radial artery via percutaneous access.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• Glidesheath Slender (6Fr) (K122980)

Reference Devices

• Surflo IV catheter (K891087)
• Glidesheath (5Fr) (K082644)
• Radiofocus Introducer II Kit (7Fr) (K954234)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular arrangement of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized image of an eagle with three human profiles incorporated into the design of the eagle's body and wings. The eagle is facing to the right.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 21, 2014

Terumo Medical Corporation Erin Doyle Regulatory Affairs Specialist 950 Elkton Blvd Elkton, Maryland 21921

Re: K142183 Trade/Device Name: Glidesheath Slender Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II Product Code: DYB Dated: October 21, 2014 Received: October 22, 2014

Dear Erin Doyle,

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Melissa A. Torres -S

For Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

Device Name Glidesheath Slender™

Indications for Use (Describe)

The Glidesheath Slender is used to facilitate placing a catheter through the skin into the radial artery.

Type of Use (Select one or both, as applicable)

ال Prescription Use (Part 21 CFR 801 Subpart D)

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

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## A. Submitter Information (807.92(a)(1))

| <b>Prepared by:</b> | Erin Michael Doyle |
|---------------------|-------------------------------|
| | Regulatory Affairs Specialist |
| | Terumo Medical Corporation |
| | Tel. [phone] |
| | Fax [phone] |

#### Prepared for: Owner/Operator Terumo Corporation 44-1, 2-Chome, Hatagaya Shibuya-Ku, Tokyo, Japan 151-0072 Registration Number: 801 002 6

Manufacturer and Sterilization Facility Ashitaka Factory of Terumo Corporation 150 Maimaigi-cho Fujinomiya Shizuoka, Japan 418-0015 Registration No: 968 183 4

- Contact Person: Erin Michael Doyle Regulatory Affairs Specialist Terumo Medical Corporation 950 Elkton Boulevard Elkton, MD 21921 Tel. [phone] Fax [phone] E-mail: [e-mail]
Date Prepared: November 19, 2014

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

| Proprietary Name: | Glidesheath Slender™ |
|----------------------|----------------------|
| Common Name: | Introducer Sheath |
| Classification Name: | Introducer, Catheter |
| Regulation Number: | 21 CFR 870.1340 |
| Regulatory Class: | Class II |
| Product Code: | 74 DYB |
| Review Panel: | Cardiovascular |

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

The legally marketed device to which substantial equivalence is claimed is the current Glidesheath Slender (6Fr) which is manufactured by Ashitaka Factory of Terumo Corporation and was cleared under K122980.

## D. Reason for 510(k) Submission

This premarket notification (Special 510(k)) is being submitted to extend the current Glidesheath Slender (6Fr) product line to include the 5Fr and 7Fr sizes. This is a modification to the Glidesheath Slender (6Fr) (K122980) introducer sheath manufactured by Ashitaka Factory of Terumo Corporation.

## E. Device Description (807.92(a)(4))

### Principle of Operation Technology

The Glidesheath Slender (GSS) (5Fr & 7Fr) submitted in this 510(k) and the GSS (6Fr) cleared under K122980 are operated manually or by a manual process.

### Design/Construction

Both the predicate Glidesheath Slender 6Fr (GSS 6Fr) and the modified Glidesheath Slender 5Fr & 7Fr (GSS 5Fr & 7Fr) consist of an introducer sheath and a dilator which are packaged together with an entry needle, mini guide wire and guide wire inserter. The GSS devices (all sheath sizes) are used to facilitate placing a catheter through the skin into the radial artery. The sheath and dilator contain bismuth, making these devices visible under fluoroscopy. The sheath is coated with hydrophilic coating to minimize frictional resistance when inserting or removing the sheath from the patient's blood vessel.

The entry needle (cannula) is used to gain access to the radial artery for placement of the mini guide wire. The entry needle is offered in two versions, either a stainless steel entry needle or a Surflo IV catheter (K891087).

The mini guide wire is used for placement of the sheath and dilator into the radial artery. The mini guide wire is offered in two versions, either a stainless steel (spring coil) model or a polyurethane (nitinol core) plastic model.

The mini guide wire is inserted through a cannula placed in the patient's blood vessel. A guide wire inserter is provided to assist in insertion of the mini guide wire into the cannula. Following guide wire insertion, the cannula is removed and the sheath and dilator are then inserted over the mini guide wire and into the blood vessel. The mini guide wire is then withdrawn from the vessel. The dilator maintains the integrity of the sheath and dilates the blood vessel during insertion. Once the sheath is situated in the vessel, the dilator is removed and an appropriate catheter can then be inserted through the sheath.

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The entry needle, the mini guide wire and the guide wire inserter are packaged with the GSS in an individual package prior to sterilization. With the exception of the Surflo IV catheter, which is cleared under K891087, accessories provided in the GSS kit are not offered for individual sale.

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#### Materials

The materials for all GSS sheath sizes including the modified GSS (5Fr & 7Fr) and predicate GSS (6Fr) are provided in Table 5.1 below.

| GSS Component | Material | |
|------------------------------|-----------------------------------------------------------------|---------------------------------------------------------------|
| Tube | Ethylene-Tetrafluoroethylene (ETFE) copolymer, Bismuth Trioxide | |
| Hydrophilic Coating | Dimethyl acrylamide-glycidyl methacrylate copolymer | |
| Housing | Polypropylene | |
| Caulking Pin | Stainless Steel | |
| Sheath | Cap | Polypropylene |
| | Valve | Silicone Rubber |
| | Sheath Support | Styrene-ethylene-butylene-styrene block copolymer |
| | Side Tube | Polybutadiene |
| | 3-Way Stopcock | Polyethylene, Polypropylene, Polycarbonate |
| Dilator | Tube | Polypropylene, Bismuth subcarbonate |
| | Hub | Polypropylene |
| | Caulking Pin | Stainless Steel |
| Guide Wire Plastic Type | Nickel-Titanium alloy, Tungsten, Polyurethane | |
| Guide Wire Spring Type | Stainless Steel | |
| Guide wire inserter | Polyethylene | |
| Stainless steel entry needle | Cannula | Stainless Steel |
| | Hub | Polycarbonate |
| | Catheter tube | Ethylene-Tetrafluoroethylene (ETFE) copolymer, Barium sulfate |
| Surflo IV Catheter | Hub | Polypropylene |
| | Caulking Pin | Stainless Steel |
| | Filter Cap | Polystyrene, Polyester-Chlorinated polyvinyl chloride |
| | Adapter | Polypropylene |
| | Needle Cannula | Stainless Steel |
| Needle Hub | Polycarbonate | |

Table 5.1: GSS Materials (All Sheath Sizes)

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### Specifications

Table 5.2 below provides the device specifications for the modified GSS 5Fr & 7Fr and the predicate GSS (6Fr).

| Component | Specification | GSS (6Fr) -<br>(Predicate) | GSS (5Fr) -<br>(Modified) | GSS (7Fr) -<br>(Modified) |
|------------------------------------------------|-----------------------------|--------------------------------------------|---------------------------|---------------------------|
| Sheath | Size | 6Fr | 5Fr | 7Fr |
| | Length (cm) | 10, 16 | | |
| | Hydrophilic coating<br>(cm) | 10, 16 (entire length of sheath) | | |
| Dilator | Length (cm) | 15.5, 21.5 | | |
| Guide Wire | Outer Diameter (inch) | 0.018, 0.021, 0.025, 0.035 | | |
| Plastic Type | Length (cm) | 45, 80 | | |
| Guide Wire<br>Spring Type<br>(Stainless Steel) | Outer Diameter (inch) | 0.018, 0.021, 0.025, 0.035 | | |
| | Length (cm) | 45, 80 | | |
| Surflo IV Catheter | Size (Gauge) | 18, 20, 22 | | |
| | Length (mm) | 25, 32, 51, 64<br>(1", 1 1/4", 2", 2 1/2") | | |
| Stainless Steel<br>Entry Needle | Size (Gauge) | 20, 21 | | |
| | Length (mm) | 35<br>(1 2/5") | | |

| | | | | Table 5.2: Glidesheath Slender Device Specifications |
|--|--|--|--|------------------------------------------------------|
|--|--|--|--|------------------------------------------------------|

# F. Intended Use (807.92(a)(5))

The Glidesheath Slender is used to facilitate placing a catheter through the skin into the radial artery.

Note: This intended use is identical to the predicate device, Glidesheath Slender (K122980).

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

The Glidesheath Slender (5Fr & 7Fr), subject of this Special 510(k), is substantially equivalent in its intended use, technology/principal of operation, materials, and performance to the Glidesheath Slender (6Fr) cleared under K122980, manufactured by Ashitaka Factory of Terumo Corporation, Japan.

A comparison of the technological characteristics is summarized in Table 5.3 below.

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| Table 5.3: Summary of Comparative Information between the Modified GSS (5Fr & 7Fr) | |
|------------------------------------------------------------------------------------|--|
| and the Predicate Device GSS (6Fr) | |

| Device Characteristic | Predicate GSS (6Fr) – K122980 | Modified GSS (5Fr & 7Fr) | |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Trade Name | Glidesheath Slender™ | same | |
| Manufacturer | Ashitaka Factory of Terumo Corporation | same | |
| Intended Use | The Glidesheath Slender is used to<br>facilitate placing a catheter through the<br>skin into the radial artery. | same | |
| Principle of Operation /<br>Technology | Manual | same | |
| Device Components | 1. Sheath<br>2. Dilator<br>3. Plastic or Stainless Steel Guide Wire<br>4. Stainless Steel Entry Needle or<br>Surflo IV Catheter | same | |
| Available Sheath Sizes | 6 Fr | 5Fr & 7Fr | |
| Available Sheath Lengths | Effective Length: 100mm, 160mm | same | |
| Sheath Radiopacity | Yes | same | |
| Dilator Radiopacity | Yes | same | |
| Material | Sheath | ETFE copolymer, Bismuth Trioxide,<br>Dimethyl acrylamide-glycidyl<br>methacrylate copolymer, Polypropylene,<br>Stainless Steel, Silicone Rubber,<br>Styrene-ethylene-butylene-styrene<br>block copolymer, Polybutadiene,<br>Polycarbonate, Polyethylene | same |
| | Dilator | Polypropylene,Bismuth subcarbonate,<br>Stainless Steel | same |
| | Guide wire<br>plastic type | Nickel-Titanium alloy, Tungsten,<br>Polyurethane | same |
| | Guide wire<br>spring type | Stainless Steel | same |
| | Guide wire<br>inserter | Polyethylene | same |
| | Stainless steel<br>entry needle | Stainless Steel, Polycarbonate | same |
| | Surflo IV<br>catheter | ETFE copolymer, Barium sulfate,<br>Polypropylene, Stainless Steel,<br>Polystyrene, Polyester-Chlorinated<br>polyvinyl chloride, Polycarbonate | same |
| Device Characteristic | Predicate GSS (6Fr) – K122980 | Modified GSS (5Fr & 7Fr) | |
| Sheath Performance | Meets ISO 11070: Sterile single-use intravascular catheter introducers M Coating (Hydrophilic coating) Particulate Evaluation per FDA PTCA Guidance Test¹ / USP788 Meets following internal standards: Catheter Insertion and Removal Resistance Penetration Resistance External Surface Sliding Performance Hydrophilic coating (M Coating) Separation Resistance | same | |
| Packaging Material | Polyester-polyethylene laminated film and paper | same | |
| Sterilization Method | Ethylene Oxide | same | |
| Shelf - life | 30months | same | |

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

### Performance

Performance testing was conducted to ensure safety and effectiveness of the modified GSS (5Fr & 7Fr) device throughout the shelf-life, verify conformity to applicable ISO and internal standards and acceptance criteria, and demonstrate substantial equivalence to the predicate device.

No new issues of safety and effectiveness were raised with the testing performed and results were within the predetermined acceptance criteria. The performance of the modified GSS (5Fr & 7Fr) is substantially equivalent to that of the predicate GSS (6Fr) device and is safe and effective for its intended use.

A list of the performance tests that were conducted is provided in the Table 5.4 below.

¹ Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (2010)

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| Table 5.4 GSS 5Fr & 7Fr Verification Tests | |
|--------------------------------------------------------|----------------------------------|
| | |
| Test | Standard |
| Sheath | |
| Surface | ISO 11070: Sec. 4.3 |
| Corrosion Resistance | ISO 11070: Sec. 4.4 |
| Radiodetectability | ISO 11070: Sec.4.5 |
| Size Designation (Dimensional Verification) | ISO 11070: Sec. 7.2 |
| Freedom from Leakage from Sheath Introducer | ISO 11070: Sec. 7.3 |
| Freedom from Leakage through Haemostasis Valve | ISO 11070: Sec. 7.4 |
| Force at Break (sheath) | ISO 11070: Sec. 7.6 |
| Force at Break (sheath to hub) | ISO 11070: Sec. 7.6 |
| Sheath to Dilator Fit | ISO 11070: Annex A.1 |
| Rollback Test | ISO 11070: Annex A.1 |
| Puncture model test | ISO 11070: Annex A.1 |
| Flexibility (Kink Angle) | ISO 11070: Annex A.1 |
| Flexibility (Radius of Curvature) | ISO 11070: Annex A.1 |
| Catheter Insertion and Removal Resistance | Internal Standard |
| Penetration Resistance | Internal Standard |
| External Surface Sliding Performance | Internal Standard |
| Hydrophilic coating (M Coating) Separation Resistance | Internal Standard |
| Hydrophilic coating (M Coating) Particulate Evaluation | FDA Guidance2<br>USP 788 |
| Dilator | |
| Surface | ISO 11070: Sec. 4.3 |
| Size Designation (Dimensional Verification) | ISO 11070: Sec. 9.2 |
| Conical Fitting | ISO 11070: Sec 9.3.2<br>ISO594-1 |
| Strength of Union between Hub and Dilator | ISO 11070: Sec 9.3.3 |

² Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters

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### Biocompatibility

Biocompatibility of the modified GSS (5Fr & 7Fr) was evaluated based upon ISO 10993-1: 2009. The modified GSS (5Fr & 7Fr) including Sheath, Dilator, Guidewire, and Entry needle are classified as Externally Communicating Devices. Circulating Blood, Limited Contact (<24 hrs). This is the same classification as the predicate Glidesheath Slender (6Fr) (K122980).

All of the modified GSS (5Fr & 7Fr) materials are the same as the predicate GSS (6Fr) (K122980) and/or other currently marketed Terumo devices including the Glidesheath (5Fr) (K082644) and the Radiofocus Introducer II Kit (7Fr) (K954234). These devices have the same intended use, body contact and contact duration classification based on ISO10993-1: 2009. The Glidesheath and Radiofocus Introducer product lines have a demonstrated history of safe and effective use.

Additionally, biocompatibility testing was conducted in accordance with the FDA General Program memorandum #G95-1(5/1/95): Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing". Samples tested were final, sterilized, whole finished good devices (including Sheath, Dilator, Guidewire, Guidewire Inserter, and Entry needle). Testing was conducted in accordance with 21 CFR Part 58 (Good Laboratory Practice for Nonclinical Laboratory Studies).

Physiochemical Profile (Physicochemical and FT-IR Analysis) testing was also conducted by Terumo Corporation per USP <661> Containers-Plastics: Physiochemical Tests. Testing demonstrated that the physiochemical properties of the subject GSS device do not change throughout its shelf life, and, therefore, remain biocompatible.

All test results met the requirements of applicable standards. A list of biocompatibility tests conducted are summarized Table 5.5 on the following page.

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| Table 5.5: Glidesheath Slender – Biocompatibility Testing Summary | |
|-------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| | Test / Method / Standard |
| Cytotoxicity: | L929 MEM Elution Test - ISO 10993-5: 2009 |
| Sensitization: | Kligman Maximization Test - ISO 10993-10: 2010 |
| Irritation/ Intracutaneous Reactivity: | Intracutaneous Injection Test - ISO 10993-10: 2010 |
| Acute Systemic Toxicity: | Systemic Injection Test - ISO 10993-11: 2006 |
| Pyrogenicity: | Rabbit Pyrogen Test (Material Mediated) - ISO 10993-11: 2006 |
| Hemocompatibility | Hemolysis: Hemolysis Complete (Direct and Indirect) - ASTM F 756: 2008 |
| | Complement Activity:<br>Complement Activation Assay Direct Contact - ISO 10993-4: 2002/A1:2006 |
| | Thrombosis:<br>Thrombogenicity Study in Dogs- ISO 10993-4: 2002/A1:2006 |
| Physiochemical<br>Profile | Physicochemical<br>USP <661> |
| | FT-IR<br>USP <661> |

| | | Table 5.5: Glidesheath Slender - Biocompatibility Testing Summary | | | | |
|--|--|-------------------------------------------------------------------|--|--|--|--|
|--|--|-------------------------------------------------------------------|--|--|--|--|

We conclude therefore that the modified GSS (5Fr & 7Fr) is biocompatible for its intended use.

#### Sterilization

The sterilization conditions have been validated according to ANSI / AAMI / ISO 11135-1, Sterilization of Health Care Products– Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices, to provide a Sterility Assurance Level (SAL) of 10 °. The validation is on file and available upon request.

Residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) will meet requirements for limited exposure devices (contact up to 24 hours) prior to use based on ISO 10993-7, Biological Evaluation of medical devices- Part 7: Ethylene Oxide Sterilization residuals. Residual EO will not exceed 4 mg per device and residual ECH will not exceed 9 mg per device.

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### Pyrogen Testing

The Glidesheath Slender is certified to be non-pyrogenic in the unopened and undamaged package. Limulus Amebocyte Lysate (LAL) (Photometric Quantitative Method) testing is performed on each lot of product in accordance to the United States Pharmacopoeia (USP) <85> Bacterial Endotoxins Test. Validation was performed in accordance with FDA published "Guidance for Industry Pyrogen and Endotoxins Testing: Questions and Answers; June 2012".

### Risk Analysis

A Product Risk Analysis was conducted in accordance with ISO 14971: 2007, taking into account the modifications to the previous device, and it was determined that there were no new issues of safety or effectiveness.

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

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

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

The proposed GSS (5Fr & 7Fr) is substantially equivalent in intended use, principles of operation, design features, materials, performance and fundamental scientific technology when compared to the predicate GSS (6Fr) (K122980). Verification testing was conducted and demonstrated that the modified device meets the design inputs and meets the same or equivalent requirements as the predicate GSS (6Fr) for both ISO 11070 and internal standards. The differences between the predicate and proposed devices do not raise any new issues regarding safety and effectiveness. Therefore, the GSS (5Fr & 7Fr) is considered substantially equivalent to the predicate device.