(105 days)
No
The device description and performance summary focus on the physical components and mechanical function of the introducer sheath and associated accessories. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is used to facilitate placing a catheter, which is a procedural step rather than a direct therapeutic intervention.
No
The device is an introducer sheath and dilator system used to facilitate placing a catheter into the radial artery for therapeutic or interventional procedures, not for diagnostic purposes.
No
The device description clearly outlines multiple physical components including an introducer sheath, dilator, entry needle, mini guide wire, and guide wire inserter. It also mentions materials like bismuth and hydrophilic coating. This is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The Glidesheath Slender is a device used to facilitate the physical placement of a catheter into a blood vessel (the radial artery). It is a tool used during a medical procedure, not a device that analyzes biological samples.
- Intended Use: The intended use clearly states it's for "facilitating placing a catheter through the skin into the radial artery." This is a procedural function, not a diagnostic one based on sample analysis.
- Device Description: The description details the physical components (sheath, dilator, needle, guide wire) and how they are used to access a blood vessel. There is no mention of collecting or analyzing biological samples.
Therefore, the Glidesheath Slender is a procedural medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Glidesheath Slender is used to facilitate placing a catheter through the skin into the radial artery.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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 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.
Non-clinical tests included:
Sheath tests: Surface, Corrosion Resistance, Radiodetectability, Size Designation (Dimensional Verification), Freedom from Leakage from Sheath Introducer, Freedom from Leakage through Haemostasis Valve, Force at Break (sheath), Force at Break (sheath to hub), Sheath to Dilator Fit, Rollback Test, Puncture model test, Flexibility (Kink Angle), Flexibility (Radius of Curvature), Catheter Insertion and Removal Resistance, Penetration Resistance, External Surface Sliding Performance, Hydrophilic coating (M Coating) Separation Resistance, Hydrophilic coating (M Coating) Particulate Evaluation.
Dilator tests: Surface, Size Designation (Dimensional Verification), Conical Fitting, Strength of Union between Hub and Dilator.
Biocompatibility tests: Cytotoxicity (L929 MEM Elution Test), Sensitization (Kligman Maximization Test), Irritation/ Intracutaneous Reactivity (Intracutaneous Injection Test), Acute Systemic Toxicity (Systemic Injection Test), Pyrogenicity (Rabbit Pyrogen Test (Material Mediated)), Hemocompatibility (Hemolysis, Complement Activity, Thrombosis), Physiochemical Profile (Physicochemical and FT-IR Analysis).
Sterilization validation according to ANSI / AAMI / ISO 11135-1.
Pyrogen Testing (Limulus Amebocyte Lysate (LAL) (Photometric Quantitative Method) testing).
Risk Analysis in accordance with ISO 14971: 2007.
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).
0
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
1
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 (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,
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
2
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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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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3
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 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. (410) 392-7243 Fax (410) 398-6079 E-mail: erin.doyle@terumomedical.com
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 |
4
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.
5
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.
の 2007年の1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には1000年に100000000000000000000000000000000000000000000000000000000000000
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)
6
Specifications
Table 5.2 below provides the device specifications for the modified GSS 5Fr & 7Fr and the predicate GSS (6Fr).
| Component | Specification | GSS (6Fr) -
(Predicate) | GSS (5Fr) -
(Modified) | GSS (7Fr) -
(Modified) |
|------------------------------------------------|-----------------------------|--------------------------------------------|---------------------------|---------------------------|
| Sheath | Size | 6Fr | 5Fr | 7Fr |
| | Length (cm) | 10, 16 | | |
| | Hydrophilic coating
(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
Spring Type
(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
(1", 1 1/4", 2", 2 1/2") | | |
| Stainless Steel
Entry Needle | Size (Gauge) | 20, 21 | | |
| | Length (mm) | 35
(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.
7
| 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 | ||
| facilitate placing a catheter through the | |||
| skin into the radial artery. | same | ||
| Principle of Operation / | |||
| Technology | Manual | same | |
| Device Components | 1. Sheath |
- Dilator
- Plastic or Stainless Steel Guide Wire
- Stainless Steel Entry Needle or
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,
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 | same |
| | Guide wire
plastic type | Nickel-Titanium alloy, Tungsten,
Polyurethane | same |
| | Guide wire
spring type | Stainless Steel | same |
| | Guide wire
inserter | Polyethylene | same |
| | Stainless steel
entry needle | Stainless Steel, Polycarbonate | same |
| | Surflo IV
catheter | ETFE copolymer, Barium sulfate,
Polypropylene, Stainless Steel,
Polystyrene, Polyester-Chlorinated
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 | |
8
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)
9
| 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 |
| 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 |
| 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
10
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 ( 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.
11
| 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: | |
| Complement Activation Assay Direct Contact - ISO 10993-4: 2002/A1:2006 | |
| Thrombosis: | |
| Thrombogenicity Study in Dogs- ISO 10993-4: 2002/A1:2006 | |
| Physiochemical | |
| Profile | Physicochemical |
| USP | |
| FT-IR | |
| USP |
| 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.
12
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) 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.