(119 days)
No
The device description focuses on physical components and materials, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device facilitates placing a catheter, which is a therapeutic device, but it is not therapeutic itself.
No
Explanation: The Glidesheath is used to facilitate the placement of a catheter into a vein or artery for interventional or therapeutic purposes, not for diagnosing a condition.
No
The device description clearly outlines physical components such as a sheath, dilator, guide wire, and needle, which are hardware. The device is used to facilitate placing a catheter through the skin, which is a physical intervention.
Based on the provided information, the Glidesheath is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "facilitate placing a catheter through the skin into a vein or artery". This is a procedural device used for accessing blood vessels, not for examining specimens derived from the human body for diagnostic purposes.
- Device Description: The description details a physical device (sheath, dilator, guide wire, needle, etc.) used for insertion into the body. It does not describe reagents, instruments, or systems intended for use in vitro.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
The Glidesheath is a medical device used for a procedural purpose (vascular access), not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Glidesheath™ is indicated to facilitate placing a catheter through the skin into a vein or artery including but not limited to the radial artery.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
The Glidesheath consists of an introducer (sheath and dilator), which are packaged together with a mini guide wire. Some product configurations also include an entry needle, guide wire inserter and a flushing syringe. The Glidesheath is used to facilitate placing a catheter through the skin into a vein or artery. The sheath is coated with hydrophilic coating to minimize frictional resistance when inserting or removing the sheath from the patient's blood vessel. In addition, the sheath and dilator contain bismuth, making these devices visible under fluoroscopy.
The entry needle (cannula) is used to gain access to the vein or artery for placement of the mini guide wire. The entry needle is offered in either stainless steel (SS) version or the Surflo (SR) IV catheter (which includes a needle) (K891087). There are two different types of stainless steel entry needles that are available in various gauges and lengths.
The mini guide wire is inserted through the cannula into the patient's blood vessel and is used for placement of the sheath and dilator into the vein or artery. A guide wire inserter is provided to assist in insertion of the mini guide wire into the cannula. The mini guide wire is offered in three versions, either a stainless steel spring coil model (stainless steel), a nitinol model with palladium tipped (nitinol) or a polyurethane plastic model with a nitinol core (plastic).
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. The flushing syringe is used to prime the dilator with heparinized saline.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vein or artery including but not limited to the radial artery
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was conducted to ensure the proposed TMC Glidesheath met the applicable design and performance requirements throughout the shelf life, verify conformity to the applicable external and internal standards, and demonstrate substantial equivalence to the predicate device. The components tested met the predetermined acceptance criteria and results support a determination of substantial equivalence.
Summary of Sheath Performance Testing Component Test Description Standard
Sheath Visual Inspection – Extraneous matter ISO 11070: 1998, Sect. 4.3; Visual Inspection - Process and surface defects ISO 11070: 1998, Sect. 4.3; Visual Inspection – Lubricant on external surfaces ISO 11070: 1998, Sect. 4.3; Corrosion Resistance ISO 11070: 1998, Sect. 4.4 & Annex B; Radiodetectability ISO 11070: 1998, Sect. 4.5 / ASTM F640-12; Liquid leakage through sheath ISO 11070:1998, Sect. 7.3 & Annex D; Liquid leakage through valve ISO 11070:1998, Sect. 7.4 & Annex E; Sheath to housing joint strength ISO 11070: 1998, Sect. 7.6; Sheath tubing tensile strength ISO 11070: 1998, Sect. 7.6; Kink resistance ISO 11070:1998, Annex A Section A.1; Sheath side tube to housing joint strength ISO 11070: 1998, Annex C *ISO 11070 does not require test on side tube Ref. for test method only; 3WSC to side tube joint strength ISO 11070: 1998, Annex C *ISO 11070 does not require test on side tube Ref. for test method only; Visual Inspection – housing color Internal; Penetration of Sheath, Dilator System in thin film, Sheath Tip Cracks Internal; Housing to cap joint strength Internal; Assembled side tube length Internal; Side tube burst Internal; Sheath housing to support joint strength Internal; Sheath Length Internal; Visual Inspection – Suture Eye Internal; Catheter insertion through valve Internal; Aspiration & injection through side tube Internal; External Lubricity Internal; Particulate & Coating Integrity Testing Note: Test conducted using whole kit FDA PTCA Guidance /USP788.
Summary of Dilator Performance Testing Component Test Description Standard
Dilator Visual Inspection – Extraneous matter ISO 11070: 1998, Sect. 4.3; Visual Inspection – Process and surface defects ISO 11070: 1998, Sect. 4.3; Visual Inspection – Lubricant on external surfaces ISO 11070: 1998, Sect. 4.3; Corrosion Resistance ISO 11070: 1998, Sect. 4.4 & Annex B; Radiodetectability ISO 11070: 1998, Sect. 4.5; Dilator tubing to hub joint strength ASTM F640-12; Gauge Luer Taper ISO 11070: 1998, Sect. 9.3.3 & Annex C; Liquid Leakage from fitting assembly under pressure ISO 594-1:1986, Sect. 5.1; Air leakage into the fitting assembly during aspiration ISO 594-2: 1998, Sect. 5.2; Separation force of fitting assembly ISO 594-2: 1998, Sect. 5.3; Unscrewing torque of fitting assembly ISO 594-2:1998,Sect. 5.4; Ease of assembly ISO 594-2:1998, Sect. 5.5; Resistance to overriding ISO 594-2:1998, Sect. 5.6; Stress cracking ISO 594-2: 1998, Sect. 5.7; Visual Inspection – hub color ISO 594-2: 1998, Sect. 5.8; Dilator hub to sheath housing fitting strength Internal; Dilator OD at Sheath Tip interface & shaft OD; Sheath tip ID Internal; Dilator Length Internal; Dilator tip ID Internal; Penetration of Dilator System in thin film Internal; Pass wire through dilator to check for blockage Internal.
Summary of Guide Wire Performance Testing Component Test Description Standard
Guide Wires Visual Inspection – Extraneous matter ISO 11070: 1998, Sect. 4.3;Visual Inspection – Process and surface defects ISO 11070: 1998, Sec. 4.3; Visual Inspection – Lubricant on external surfaces ISO 11070: 1998, Sec. 4.3; Corrosion Resistance ISO 11070: 1998, Sect. 4.4 & Annex B; Radiodetectability ISO 11070: 1998, Sec. 4.5, ASTM F640-12; Test for fracture of guide wires ISO 11070: 1998, Annex F; Test for resistance of guide wires to damage by flexing ISO 11070: 1998, Annex G; Guide Wire Tensile ISO 11070: 1998, Annex H; Guide Wire OD Internal; Guide Wire length Internal; Tip buckling (Tip butt resistance) test Internal; Insertion against flashback Internal; Removal through standard 21G needle (Nitinol Wire only) Internal.
Summary of Entry Needles Performance Testing Component Test Description Standard
Entry Needles (including Surflo (SR) I.V. Catheter) Visual Inspection – Extraneous matter ISO 11070: 1998, Sect. 4.3; Visual Inspection – Process and surface defects ISO 11070: 1998, Sec. 4.3; Visual Inspection – Lubricant on external surfaces ISO 11070: 1998, Sec. 4.3; Corrosion Resistance ISO 11070: 1998, Sect. 4.4 & Annex B; Radiodetectability ISO 11070: 1998, Sec. 4.5, ASTM F640-12; Visual Inspection – Needle Point ISO 11070:1998, Section 5.3; Distance from heel of needle to catheter tip (Surflo Needle test only) ISO11070:1998, Section 5.3; Catheter to hub joint strength (Surflo Catheter test only) ISO 11070: 1998, section 6.2; Needle to hub joint strength ISO 11070:1998, Annex C; Gauge Luer Taper ISO/ FDIS 11070: 2014, Annex I; Liquid Leakage from fitting assembly under pressure ISO 594-1:1998, Sect. 5.1; Air leakage into the fitting assembly during aspiration ISO 594-2: 1998, Sect. 5.2; Separation force of fitting assembly ISO 594-1: 1986, Sect. 5.2 for SR Needles only; Unscrewing torque of fitting assembly (SR needles not included) ISO 594-2: 1998, Sect. 5.3; Ease of assembly (SR needles not included) ISO 594-1: 1986, Sect. 5.3 for SR Needles only; Resistance to overriding (SR needles not included) ISO 594-2: 1998, Sect. 5.4; Stress cracking ISO 594-1: 1986, Sect. 5.4 for SR Needles only; Visual Inspection – hub color ISO 594-2:1998, Sect. 5.5; Visual Inspection – SR Catheter hub ISO 594-2:1998, Sect. 5.6; Needle Length ISO 594-2: 1998, Sect. 5.7; Needle bevel indicator position ISO 594-2: 1998, Sect. 5.8; Needle bevel indicator Visibility ISO 594-1: 1986, Sect. 5.5 for SR Needles only; Wire can pass through insertion device provided in kit (needles only) ISO 6009:1992, Sect. 2; Needle I.D. Internal; Needle Flashback Internal; Surflo I.V. Catheter Penetration Internal; Needle Penetration Internal.
Summary of Syringe Performance Testing Component Test Description Standard
Syringe Gauge Luer Taper ISO 594-1:1986, Sect. 5.1; Liquid Leakage from fitting assembly under pressure ISO 594-1:1986, Sect. 5.2; Air leakage into the fitting assembly during aspiration ISO 594-1:1986, Sect. 5.3; Separation force of fitting assembly ISO 594-1:1986, Sect. 5.4; Stress Cracking ISO 594-1:1986, Sect. 5.5; Barrel finger grips – Flash and Sharp edges ISO 7886-1: 1993, Sect. 11.2; Barrel finger grips - Rolling ISO 7886-1: 1993, Sect. 11.2; Plunger length past finger grips ISO 7886-1: 1993, Sect. 12.1; Fit of the piston in the barrel ISO 7886-1: 1993, Sect. 12.2; Piston/Plunger Assembly – One-Handed Design ISO 7886-1: 1993, Sect. 12.1; Separation force of fitting assembly ISO 7886-1: 1993, Sect. 12.1; Visual Inspection - lubricant inside of syringe barrel ISO 7886-1: 1993, Sect. 8; Visual Inspection - Glidesheath Access Kit w/ SR and Syringe Internal.
Summary of 3-Way Stopcock Performance Testing Component Test Description Standard
3-Way Stopcock Gauge Luer Taper ISO 594-1:1986, Sect. 5.1; Liquid Leakage from fitting assembly under pressure ISO 594-2:1998 Sec. 5.2; Air leakage into the fitting assembly during aspiration ISO 594-2:1998 Sec. 5.3; Separation force of fitting assembly ISO 594-2:1998 Sec. 5.4; Unscrewing torque of fitting assembly ISO 594-2:1998 Sec. 5.5; Ease of assembly ISO 594-2:1998 Sec. 5.6; Resistance to overriding ISO 594-2:1998 Sec. 5.7; Stress cracking ISO 594-2:1998 Sec. 5.8.
Biocompatibility testing was conducted: Cytotoxicity, Hemocompatibility (Hemolysis and Thrombogenicity), Sensitization, Intracutaneous reactivity (acute), Systemic toxicity (acute), Pyrogenicity, Physicochemical for non-aged and accelerated-aged (12m) whole devices. Extractables and Acidity/Alkalinity testing were performed on the needles. All test results met requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 01, 2015
Terumo Medical Corporation Erin Doyle Regulatory Affairs Specialist 950 Elkton Blvd. Elkton, MD 21921
Re: K152173
Trade/Device Name: Glidesheath™ Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: October 29, 2015 Received: October 30, 2015
Dear Mr. 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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
M.A. Hillebrand
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Glidesheath™
Indications for Use (Describe)
The Glidesheath™ is indicated to facilitate placing a catheter through the skin into a vein or artery including but not limited to the radial artery.
Type of Use (Select one or both, as applicable)
X | Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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SECTION 5 – 510(K) SUMMARY
A summary of 510(k) information in accordance with the requirements of 21 CFR 807.92.
Section Contents
| A. SUBMITTER INFORMATION (807.92(a)(1)) | 41 |
|---|---|
| B. DEVICE NAME (807.92(a)(2)) | 42 |
| C. PREDICATE DEVICE (807.92(a)(3)) | 42 |
| D. REASON FOR 510(k) SUBMISSION | 42 |
| E. DEVICE DESCRIPTION (807.92(a)(4)) | 43 |
| F. INDICATIONS FOR USE (807.92(a)(5)) | 46 |
| G. SUBSTANTIAL EQUIVALENCE COMPARISON (807.92(a)(6)) | 46 |
| H. NON CLINICAL TESTS (807.92(b)(1)) | 48 |
| I. CLINICAL TESTS (807.92(b)(2)) | 56 |
| J. CONCLUSION (807.92(b)(3)) | 56 |
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510(K) SUMMARY
A. SUBMITTER INFORMATION (807.92(a)(1))
Prepared by: Erin Michael Doyle Regulatory Affairs Specialist Terumo Medical Corporation Tel. (410) 392-7243 Fax (410) 398-6079
Prepared for: Owner/Operator
Terumo Medical Corporation 2101 Cottontail Lane Somerset, NJ 08873, USA Registration Number: 2243441
Manufacturer (Applicant)
Terumo Medical Corporation 950 Elkton Blvd. Elkton, MD 21921 Registration Number: 2246552
Sterilization Facility
Steris Isomedix Services Inc. 3459 South Clinton Ave South Plainfield, NJ 07080 Registration Number: 2246552
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Image /page/5/Picture/1 description: The image shows the logo for Terumo. The logo consists of a red arc above the word "TERUMO" in green. The arc is positioned above and to the left of the word "TERUMO". The font of the word "TERUMO" is bold and sans-serif.
Contact Person: Erin Michael Doyle Regulatory Affairs Specialist Terumo Medical Corporation 950 Elkton Blvd. Elkton, MD 21921 Tel. (410) 392-7243 Fax (410) 398-6079 E-mail: erin.doyle@terumomedical.com
Date prepared: July 31, 2015
B. DEVICE NAME (807.92(a)(2))
| Proprietary Name: | Glidesheath™ |
|---|---|
| Common Name: | Introducer Sheath |
| Classification Name: | Introducer, Catheter |
| Classification Panel: | Cardiovascular |
| Regulation: | 21 CFR 870.1340 |
| Product Code: | DYB |
| Classification: | Class II |
C. PREDICATE DEVICE (807.92(a)(3))
The legally marketed device(s) to which substantial equivalence is/are claimed is/are:
- K082644, Glidesheath™ manufactured by manufactured by Terumo ● Corporation, Japan.
D. REASON FOR 510(k) SUBMISSION
This premarket notification (510(k)) is being submitted due to the addition of a new manufacturing site for the Glidesheath™ (K082644) currently manufactured by Terumo Corporation (Ashitaka, Japan facility). The GlidesheathTM design, technology, and manufacturing is being transferred from its current manufacturing site, Terumo Corporation (Ashitaka, Japan facility) to Terumo Medical Corporation (Elkton, Maryland facility). The Ashitaka facility of Terumo Corporation will continue to manufacture the Glidesheath.
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Image /page/6/Picture/1 description: The image shows the logo for Terumo. The logo consists of the word "TERUMO" in green, with a red curved line above the letters "TE". The font is bold and sans-serif. The red curved line is positioned above the left side of the word.
E. DEVICE DESCRIPTION (807.92(a)(4))
Principle of Operation Technology
The proposed Glidesheath™ manufactured by Terumo Medical Corporation (TMC) and the predicate Glidesheath (K082644) manufactured by Terumo Corporation (TC) are operated manually or by a manual process.
Design/Construction
The Glidesheath consists of an introducer (sheath and dilator), which are packaged together with a mini guide wire. Some product configurations also include an entry needle, guide wire inserter and a flushing syringe. The Glidesheath is used to facilitate placing a catheter through the skin into a vein or artery. The sheath is coated with hydrophilic coating to minimize frictional resistance when inserting or removing the sheath from the patient's blood vessel. In addition, the sheath and dilator contain bismuth, making these devices visible under fluoroscopy.
The entry needle (cannula) is used to gain access to the vein or artery for placement of the mini guide wire. The entry needle is offered in either stainless steel (SS) version or the Surflo (SR) IV catheter (which includes a needle) (K891087). There are two different types of stainless steel entry needles that are available in various gauges and lengths.
The mini guide wire is inserted through the cannula into the patient's blood vessel and is used for placement of the sheath and dilator into the vein or artery. A guide wire inserter is provided to assist in insertion of the mini guide wire into the cannula. The mini guide wire is offered in three versions, either a stainless steel spring coil model (stainless steel), a nitinol model with palladium tipped (nitinol) or a polyurethane plastic model with a nitinol core (plastic).
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. The flushing syringe is used to prime the dilator with heparinized saline.
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Image /page/7/Picture/1 description: The image shows the logo for Terumo. The logo consists of a red swoosh above the word "TERUMO" in green. The swoosh is curved and points to the right. The word "TERUMO" is in a bold, sans-serif font.
The entry needle, the mini guide wire, the guide wire inserter and flushing syringe, are all accessories to the Glidesheath. Depending on the product code, certain accessories may or may not be contained within the kit. All of the accessories for a given product code are provided in an individual package with the Glidesheath and sterilized together.
Materials
Table 5.1 below provides an overview of the materials of the proposed TMC Glidesheath.
| Glidesheath 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 | |
| Tube | Polypropylene, | |
| Bismuth subcarbonate | ||
| Dilator | Hub | Polypropylene |
| Caulking Pin | Stainless Steel | |
| Plastic Jacketed Guide Wires | Nickel-Titanium alloy, | |
| Tungsten, Polyurethane | ||
| Stainless Steel Straight and J- | ||
| Tip Guide Wires | Stainless Steel | |
| Nitinol Guide Wire | Nickel-Titanium alloy, Palladium | |
| Guide Wire Inserter | Polyethylene | |
| TPC | ||
| Stainless | ||
| Steel Entry | ||
| Needle | Cannula | Stainless Steel |
| Hub | Polycarbonate |
Table 5.1: Proposed TMC Glidesheath Materials
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| Glidesheath Component | Material | |
|---|---|---|
| TRI | ||
| Stainless | ||
| Steel Entry | ||
| Needle | Cannula | Stainless Steel |
| Hub | Styrene-butadiene | |
| Surflo IV | ||
| Catheter | Catheter tube | Ethylene-Tetrafluoroethylene (ETFE) copolymer, Barium sulfate |
| Hub | Polypropylene | |
| Caulking Pin | Stainless Steel | |
| Filter Cap | Polystyrene, Polyester-Chlorinated polyvinyl chloride | |
| Adapter | Polypropylene | |
| Needle | ||
| Cannula | Stainless Steel | |
| Needle Hub | Polycarbonate | |
| Flushing | ||
| Syringe | Barrel | Polypropylene |
| Plunger | Polypropylene | |
| Gasket | Rabalon |
Specifications
Table 5.2 below provides an overview of the device specifications for the proposed TMC Glidesheath.
| Component | Parameter | Specification | ||
|---|---|---|---|---|
| Sheath | Size | 4Fr | 5Fr | 6Fr |
| Sheath | Length | 10,16, 25 (cm) | ||
| Sheath | Hydrophilic coating | 10,16, 25 (cm) - entire length of sheath | ||
| Dilator | Applicable to GW | 0.021, 0.025 (inch) | 0.021,0.025 | |
| 0.035 (inch) | ||||
| Dilator | Length | 15.7, 21.7, 30.7cm | ||
| Guide Wire (Stainless | ||||
| Steel) | Outer Diameter | 0.021 (inch) | 0.021, 0.025 | |
| (inch) | 0.021,0.025 | |||
| 0.035(inch) | ||||
| Length | 45, 80 (cm) | |||
| Guide Wire (Nitinol) | Outer Diameter | n/a | 0.021 (inch) | |
| Guide Wire (Nitinol) | Length | n/a | 45 (cm) | |
| Guide Wire (Plastic) | Outer Diameter | 0.021, 0.025 (inch) | ||
| Guide Wire (Plastic) | Length | 45 (cm) | 45, 80 (cm) | |
| Surflo IV Catheter | Type | 20, 22 (G) | ||
| Surflo IV Catheter | Length | 25,32 (mm) – 1, 11/4 (inch) | ||
| Surflo IV Catheter | (20G x 32mm, 22G x 25mm) | |||
| Surflo IV Catheter | Type | n/a | 20, 21 (G) |
Table 5.2: Proposed TMC Glidesheath Specifications
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| TPC Stainless Steel
Entry Needle | Length | n/a | 35 (mm)
(1 2/5") |
|-------------------------------------|--------|-------|---------------------|
| TRI Stainless Steel
Entry Needle | Type | n/a | 21 (G) |
| TRI Stainless Steel
Entry Needle | Length | n/a | 38 (mm)
(1 1/2") |
| Flushing Syringe | Volume | 2.5mL | |
F. INDICATIONS FOR USE (807.92(a)(5))
The Glidesheath is indicated to facilitate placing a catheter through the skin into a vein or artery including but not limited to the radial artery.
G. SUBSTANTIAL EQUIVALENCE COMPARISON (807.92(a)(6))
The proposed Glidesheath manufactured by Terumo Medical Corporations, subject of this 510(k), is substantially equivalent in its intended use/indications for use, technology/principal of operation, materials, and performance to the predicate Glidesheath, manufactured by Terumo Corporation.
Table 5.3 below provides a summary comparison of the proposed TMC Glidesheath and the predicate TC Glidesheath (K082644).
| Device
Characteristic | Proposed TMC Glidesheath | Predicate TC Glidesheath
(K082644) |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Terumo Medical Corporation (Elkton,
MD) | Terumo Corporation
(Ashitaka, Japan) |
| Intended Use /
Indications for
Use | The Glidesheath is indicated to
facilitate placing a catheter through the
skin into a vein or artery including but
not limited to the radial artery. | The Glidesheath is used to
facilitate placing a catheter
through the skin into a vein or
artery including but not limited to
the radial artery.
The Mini Guide Wire is an
accessory device which is used
for placement of the sheath into
the vein or artery including but
not limited to the radial artery.
The Radifocus Obturator is also
an accessory device which is used |
| Device
Characteristic | Proposed TMC Glidesheath | Predicate TC Glidesheath
(K082644) |
| | | by placing it into the sheath to
create an occlusion and further
provide support to the wall of the
indwelling sheath while it remains
in place within the vein or artery,
including but not limited to the
radial artery, after removal of a
catheter. |
| Operation
Principle | Manual | same |
| Design /
Specifications | Introducer (4,5,6 Fr):
• Hydrophilic Sheath
• Dilator
Accessories:
• Guide Wires - 0.021,0.025
0.035 (inch)
• Needles – 20G, 21G, 22G
• Flushing Syringe – 2.5mL
• Guide Wire Inserter | same |
| Performance | The proposed TMC Glidesheath
design and performance specifications
are based off of the same internal and
external standards as the predicate TC
Glidesheath (K082644) | same |
| Materials | Sheath
ETFE copolymer, Bismuth
Trioxide,
Dimethyl acrylamide-
glycidyl methacrylate
copolymer, Polypropylene,
Stainless Steel, Silicone
Rubber, Styrene-ethylene-
butylene-styrene block
copolymer, Polybutadiene,
Polycarbonate,
Polyethylene | same |
| | Dilator
Polypropylene, Bismuth
subcarbonate, Stainless
Steel | |
| | Plastic
Jacket
Guide
Wire
Nickel-Titanium alloy,
Polyurethane, Tungsten | |
| | SS
Stainless Steel | |
| Device
Characteristic | Proposed TMC Glidesheath | Predicate TC Glidesheath
(K082644) |
| Wire | | |
| Nitinol
Guide
Wire | Nitinol, Palladium, Epoxy | Wire not available in kits for
predicate TC Glidesheath
(K082644). Identical wire
included in kit for reference
Glidesheath (K102008). |
| Guide
Wire
Inserter | High Density Polyethylene | same |
| SR
Catheter | ETFE copolymer, Barium
sulfate, Polypropylene,
Stainless Steel, Polystyrene,
Polyester-Chlorinated
polyvinyl chloride,
Polycarbonate | same |
| SS
Needle | Stainless Steel,
Polycarbonate | same |
| Silicon-
zed SS
Needle | Stainless Steel, styrene-
butadiene | Needle not available in kits for
predicate Glidesheath (K082644).
Identical needle included kit for
reference Glidesheath (K102008) |
| Syringe | Polypropylene, Resin:
Rabalon | same |
| Packaging | Tyvek, Polyester-polyethylene
laminated film, High Impact
Polystyrene | same |
| Sterilization
Method | Ethylene oxide sterilization (validated
in accordance with ISO 11137-1 to
achieve SAL 10-6) | same |
Table 5.3: Summary of Substantial Equivalence
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Image /page/11/Picture/1 description: The image shows the Terumo company logo. The logo consists of a red swoosh above the company name, which is written in green, block letters. The font is sans-serif and the letters are bolded.
H. NON CLINICAL TESTS (807.92(b)(1))
Performance
Performance testing was conducted to ensure the proposed TMC Glidesheath met the applicable design and performance requirements throughout the shelf life, verify conformity to the applicable external and internal standards, and demonstrate substantial equivalence to the predicate device. Tables 5.4 – 5.9 below provide a list of the performance tests that were performed on the proposed TMC Glidesheath.
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Table 5.4: Summary of Sheath Performance Testing
| Component | Test
Description | Standard |
|---------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Sheath | Visual Inspection – Extraneous
matter | ISO 11070: 1998, Sect. 4.3 |
| | Visual Inspection - Process and
surface defects | ISO 11070: 1998, Sect. 4.3 |
| | Visual Inspection – Lubricant on
external surfaces | ISO 11070: 1998, Sect. 4.3 |
| | Corrosion Resistance | ISO 11070: 1998, Sect. 4.4 & Annex B |
| | Radiodetectability | ISO 11070: 1998, Sect. 4.5 /
ASTM F640-12 |
| | Liquid leakage through sheath | ISO 11070:1998, Sect. 7.3 & Annex D |
| | Liquid leakage through valve | ISO 11070:1998, Sect. 7.4 & Annex E |
| | Sheath to housing joint strength | ISO 11070: 1998, Sect. 7.6 |
| | Sheath tubing tensile strength | ISO 11070: 1998, Sect. 7.6 |
| | Kink resistance | ISO 11070:1998, Annex A Section A.1 |
| | Sheath side tube to housing joint
strength | ISO 11070: 1998, Annex C
*ISO 11070 does not require test on
side tube Ref. for test method only |
| | 3WSC to side tube joint strength | ISO 11070: 1998, Annex C
*ISO 11070 does not require test on
side tube Ref. for test method only |
| | Visual Inspection – housing color | Internal |
| | Penetration of Sheath, Dilator
System in thin film, Sheath Tip
Cracks | Internal |
| | Housing to cap joint strength | Internal |
| | Assembled side tube length | Internal |
| | Side tube burst | Internal |
| | Sheath housing to support joint
strength | Internal |
| | Sheath Length | Internal |
| Visual Inspection – Suture Eye | Internal | |
| Catheter insertion through valve | Internal | |
| Aspiration & injection through
side tube | Internal | |
| External Lubricity | Internal | |
| Particulate & Coating Integrity
Testing
Note: Test conducted using whole
kit | FDA PTCA
Guidance /USP788 | |
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Image /page/13/Picture/1 description: The image shows the Terumo company logo. The logo consists of a red swoosh above the word "TERUMO" in green, block letters. The swoosh is positioned above and to the left of the word.
| Table 5.5: Summary of Dilator Performance Testing | ||||
|---|---|---|---|---|
| -- | -- | -- | --------------------------------------------------- | -- |
| Component | Test # /
Description | Standard |
|----------------------------------------------------|-----------------------------------------------------------------|-------------------------------------------|
| Dilator | Visual Inspection – Extraneous matter | ISO 11070: 1998, Sect. 4.3 |
| | Visual Inspection – Process and surface
defects | ISO 11070: 1998, Sect. 4.3 |
| | Visual Inspection – Lubricant on
external surfaces | ISO 11070: 1998, Sect. 4.3 |
| | Corrosion Resistance | ISO 11070: 1998, Sect. 4.4 &
Annex B |
| | Radiodetectability | ISO 11070: 1998, Sect. 4.5 |
| | Dilator tubing to hub joint strength | ASTM F640-12 |
| | Gauge Luer Taper | ISO 11070: 1998, Sect. 9.3.3 &
Annex C |
| | Liquid Leakage from fitting assembly
under pressure | ISO 594-1:1986, Sect. 5.1 |
| | Air leakage into the fitting assembly
during aspiration | ISO 594-2: 1998, Sect. 5.2 |
| | Separation force of fitting assembly | ISO 594-2: 1998, Sect. 5.3 |
| | Unscrewing torque of fitting assembly | ISO 594-2:1998,Sect. 5.4 |
| | Ease of assembly | ISO 594-2:1998, Sect. 5.5 |
| | Resistance to overriding | ISO 594-2:1998, Sect. 5.6 |
| | Stress cracking | ISO 594-2: 1998, Sect. 5.7 |
| | Visual Inspection – hub color | ISO 594-2: 1998, Sect. 5.8 |
| | Dilator hub to sheath housing fitting
strength | Internal |
| | Dilator OD at Sheath Tip interface &
shaft OD; Sheath tip ID | Internal |
| | Dilator Length | Internal |
| Dilator tip ID | Internal | |
| Penetration of Dilator System in thin
film | Internal | |
| Pass wire through dilator to check for
blockage | Internal | |
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| Guide
| Wires | Visual Inspection – Extraneous matter | ISO 11070: 1998, Sect. 4.3 |
|---|---|---|
| Visual Inspection – Process and surface defects | ISO 11070: 1998, Sec. 4.3 | |
| Visual Inspection – Lubricant on external surfaces | ISO 11070: 1998, Sec. 4.3 | |
| Corrosion Resistance | ISO 11070: 1998, Sect. 4.4 & Annex B | |
| Radiodetectability | ISO 11070: 1998, Sec. 4.5 | |
| ASTM F640-12 | ||
| Test for fracture of guide wires | ISO 11070: 1998, Annex F | |
| Test for resistance of guide wires to damage by flexing | ISO 11070: 1998, Annex G | |
| Guide Wire Tensile | ISO 11070: 1998, Annex H | |
| Guide Wire OD | Internal | |
| Guide Wire length | Internal | |
| Tip buckling (Tip butt resistance) test | Internal | |
| Insertion against flashback | Internal | |
| Removal through standard 21G needle (Nitinol Wire only) | Internal | |
| Entry Needles (including Surflo (SR) I.V. Catheter) | Visual Inspection – Extraneous matter | ISO 11070: 1998, Sect. 4.3 |
| Visual Inspection – Process and surface defects | ISO 11070: 1998, Sec. 4.3 | |
| Visual Inspection – Lubricant on external surfaces | ISO 11070: 1998, Sec. 4.3 | |
| Corrosion Resistance | ISO 11070: 1998, Sect. 4.4 & Annex B | |
| Radiodetectability | ISO 11070: 1998, Sec. 4.5 | |
| Visual Inspection – Needle Point | ASTM F640-12 | |
| Distance from heel of needle to catheter tip (Surflo Needle test only) | ISO11070:1998, Section 5.3 | |
| Catheter to hub joint strength (Surflo Catheter test only) | ISO 11070: 1998, section 6.2 | |
| Needle to hub joint strength | ISO 11070:1998, Annex C | |
| Gauge Luer Taper | ISO/ FDIS 11070: 2014, Annex I | |
| Liquid Leakage from fitting assembly under pressure | ISO 594-1:1998, Sect. 5.1 | |
| Air leakage into the fitting assembly during aspiration | ISO 594-2: 1998, Sect. 5.2 | |
| Separation force of fitting assembly | ISO 594-1: 1986, Sect. 5.2 for SR Needles only | |
| Unscrewing torque of fitting assembly (SR needles not included) | ISO 594-2: 1998, Sect. 5.3 | |
| Ease of assembly (SR needles not included) | ISO 594-1: 1986, Sect. 5.3 for SR Needles only | |
| Resistance to overriding (SR needles not included) | ISO 594-2: 1998, Sect. 5.4 | |
| Stress cracking | ISO 594-1: 1986, Sect. 5.4 for SR Needles only | |
| Visual Inspection – hub color | ISO 594-2:1998, Sect. 5.5 | |
| Visual Inspection – SR Catheter hub | ISO 594-2:1998, Sect. 5.6 | |
| Needle Length | ISO 594-2: 1998, Sect. 5.7 | |
| Needle bevel indicator position | ISO 594-2: 1998, Sect. 5.8 | |
| Needle bevel indicator Visibility | ISO 594-1: 1986, Sect. 5.5 for SR Needles only | |
| Wire can pass through insertion device provided in kit (needles only) | ISO 6009:1992, Sect. 2 | |
| Needle I.D. | Internal | |
| Needle Flashback | Internal | |
| Surflo I.V. Catheter Penetration | Internal | |
| Needle Penetration | Internal | |
| Gauge Luer Taper | ISO 594-1:1986, Sect. 5.1 | |
| Liquid Leakage from fitting assembly | ||
| under pressure | ISO 594-1:1986, Sect. 5.2 | |
| Air leakage into the fitting assembly | ||
| during aspiration | ISO 594-1:1986, Sect. 5.3 | |
| Separation force of fitting assembly | ISO 594-1:1986, Sect. 5.4 | |
| Stress Cracking | ISO 594-1:1986, Sect. 5.5 | |
| Barrel finger grips – Flash and Sharp | ||
| edges | ISO 7886-1: 1993, Sect. 11.2 | |
| Syringe | Barrel finger grips - Rolling | ISO 7886-1: 1993, Sect. 11.2 |
| Plunger length past finger grips | ISO 7886-1: 1993, Sect. 12.1 | |
| Fit of the piston in the barrel | ISO 7886-1: 1993, Sect. 12.2 | |
| Piston/Plunger Assembly – One- | ||
| Handed Design | ISO 7886-1: 1993, Sect. 12.1 | |
| Separation force of fitting assembly | ISO 7886-1: 1993, Sect. 12.1 | |
| Visual Inspection - lubricant inside of | ||
| syringe barrel | ISO 7886-1: 1993, Sect. 8 | |
| Visual Inspection - Glidesheath Access | ||
| Kit w/ SR and Syringe | Internal |
Table 5.6: Summary of Guide Wire Performance Testing
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Table 5.7: Summary of Entry Needles Performance Testing
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Table 5.8: Summary of Syringe Performance Testing
Table 5.9: Summary of 3-Way Stopcock Performance Testing
| 3-Way
| Stopcock | Gauge Luer Taper | ISO 594-1:1986, Sect. 5.1 |
|---|---|---|
| Liquid Leakage from fitting assembly | ||
| under pressure | ISO 594-2:1998 Sec. 5.2 | |
| Air leakage into the fitting assembly | ||
| during aspiration | ISO 594-2:1998 Sec. 5.3 | |
| Separation force of fitting assembly | ISO 594-2:1998 Sec. 5.4 | |
| Unscrewing torque of fitting assembly | ISO 594-2:1998 Sec. 5.5 | |
| Ease of assembly | ISO 594-2:1998 Sec. 5.6 | |
| Resistance to overriding | ISO 594-2:1998 Sec. 5.7 | |
| Stress cracking | ISO 594-2:1998 Sec. 5.8 |
The components tested met the predetermined acceptance criteria and results support a determination of substantial equivalence
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Image /page/17/Picture/1 description: The image shows the Terumo logo. The logo consists of a red curved line above the word "TERUMO" in green. The red curved line is positioned above and to the left of the word "TERUMO". The word "TERUMO" is written in a bold, sans-serif font.
Biocompatibility
The individual components of the Glidesheath were categorized according to the following:
- FDA General Program Memorandum #G95-1 (5/1/95): Use of . International Standard ISO 10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing"
- EN ISO 10993-1. .
Table 5.10 below provides the categorization of each of the Glidesheath components. Tests were then selected based upon these categorizations.
| Device | Body Contact | Contact Duration |
|---|---|---|
| Introducer Sheath | ||
| (Sheath and Dilator) | Externally communicating, | |
| Circulating Blood | Limited ( |