The Entry Needle is an accessory device which is used to gain access to the vein or artery including but not limited to the radial artery, for placement of the Mini Guide Wire.

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.

Device Description

The Glidesheath is comprised of an introducer sheath and a dilator. The Glidesheath is coated with a hydrophilic coating to reduce the frictional resistance of the sheath when inserting or removing the sheath from the patient's blood vessel. The Sheath and Dilator contain bismuth, making these devices visible under fluoroscopy. 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 Entry Needle is an accessory device which is used to gain access to the vein or artery including but not limited to the radial artery, for placement of the Mini Guide Wire.

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 Guide Inserter which is attached to the Mini Guide Wire holder is used to straighten out the wire.

Accessories to the Glidesheath are the metal entry needle and the mini guide wire. Both the metal entry needle and the mini guide wire are packaged with the Glidesheath in a pouch prior to sterilization.

AI/ML Overview

The provided text describes the 510(k) summary for the Glidesheath introducer sheath, comparing it to a predicate device (K082644) to demonstrate substantial equivalence. The information focuses on the device's design, materials, specifications, and performance testing, which is largely bench testing and biocompatibility studies.

Here's an analysis of the requested information based on the provided document:

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail threshold manner for each performance test. Instead, it lists the performance tests that were successfully passed. The implication is that passing these tests constitutes meeting the acceptance criteria for a medical device of this type.

Table of Acceptance Criteria and Reported Device Performance:

Performance Test Category	Specific Test	Reported Device Performance
Needle	Needle surface free from defects	Successfully passed (implied: surface was free from defects)
	Needle OD	Successfully passed (implied: met specified OD)
	Needle length	Successfully passed (implied: met specified length)
	Needle ID	Successfully passed (implied: met specified ID)
	Needle hub conical entry angle	Successfully passed (implied: met specified angle)
	Bevel indicator visibility	Successfully passed (implied: indicator was visible)
	Bevel indicator position	Successfully passed (implied: met specified position)
	Needle to hub joint strength	Successfully passed (implied: met strength requirements)
	Gauge Luer taper	Successfully passed (implied: conformed to Luer taper standards)
	Liquid leakage from fitting assembly under pressure	Successfully passed (implied: no liquid leakage)
	Air leakage into the fitting assembly during aspiration	Successfully passed (implied: no air leakage)
	Separation force of fitting assembly	Successfully passed (implied: met separation force requirements)
	Unscrewing torque of fitting assembly	Successfully passed (implied: met unscrewing torque requirements)
	Ease of assembly	Successfully passed (implied: easy to assemble)
	Resistance to overriding	Successfully passed (implied: resisted overriding)
	Stress cracking	Successfully passed (implied: no stress cracking)
	Corrosion resistance	Successfully passed (implied: resistant to corrosion)
Guide Wire	Guidewire surface free from defects	Successfully passed (implied: surface was free from defects)
	Tip buckling test	Successfully passed (implied: tip resisted buckling)
	Test for resistance of guidewires to damage by flexing	Successfully passed (implied: guidewire resisted damage from flexing)
	Test for fracture of guidewires	Successfully passed (implied: no fracture)
	Test for distal tip retention	Successfully passed (implied: distal tip was retained)
	Guidewire OD	Successfully passed (implied: met specified OD)
	Guidewire length	Successfully passed (implied: met specified length)
	Test for corrosion resistance	Successfully passed (implied: resistant to corrosion)
Dilator	Dilator surface free from defects	Successfully passed (implied: surface was free from defects)
	Dilator tip ID	Successfully passed (implied: met specified tip ID)
	Dilator to hub joint strength	Successfully passed (implied: met strength requirements)
Sheath	Sheath surface free from defects	Successfully passed (implied: surface was free from defects)
	Sheath tip ID	Successfully passed (implied: met specified tip ID)
	Sheath to housing joint strength	Successfully passed (implied: met strength requirements)
	Housing to cap joint strength	Successfully passed (implied: met strength requirements)
Inserter	Guidewire inserter surface free from defects	Successfully passed (implied: surface was free from defects)
System	System use in model	Successfully passed (implied: system functioned correctly in a model)
Biocompatibility	Physicochemical Profile	Successfully passed (implied: met profile requirements)
	Cytotoxicity	Successfully passed (implied: no cytotoxic effects)
	Sensitization	Successfully passed (implied: no sensitization)
	Acute Intracutaneous Reactivity	Successfully passed (implied: no intracutaneous reactivity)
	Acute Systemic Toxicity	Successfully passed (implied: no systemic toxicity)
	Hemolysis	Successfully passed (implied: no hemolysis)
	Thromobogenicity	Successfully passed (implied: not thrombogenic)
	Complement Activation Assay	Successfully passed (implied: no complement activation)
	Unactivated Partial Thromboplastin Time Assay	Successfully passed (implied: appropriate coagulation response)
	In Vitro Hemolysis	Successfully passed (implied: no in vitro hemolysis)
	Genotoxicity	Successfully passed (implied: no genotoxic effects)
	Pyrogen Study	Successfully passed (implied: non-pyrogenic)
	Extractable Metals and Acidity/Alkalinity	Successfully passed (implied: met requirements for extractables)
Sterilization	ANSI / AAMI / ISO 11135 validation	Successfully validated to SAL of 10^-6

Study Details for Acceptance Criteria Proof:

Sample size used for the test set and data provenance:
- The document does not specify sample sizes for individual performance tests (e.g., how many needles were tested for joint strength).
- It also does not indicate the data provenance (e.g., country of origin, retrospective or prospective). Given the nature of bench testing, it's typically performed in a laboratory setting by the manufacturer.
Number of experts used to establish the ground truth for the test set and their qualifications:
- This information is not provided. For mechanical and biocompatibility testing, ground truth is typically established by adhering to recognized international standards and internal quality control specifications, rather than relying on expert consensus in the way clinical studies do. The "experts" would be the engineers and scientists performing and interpreting the standardized tests.
Adjudication method for the test set:
- This information is not applicable or not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving subjective interpretations (e.g., image reading). The listed performance tests are primarily objective, quantitative, or qualitative assessments against defined standards.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:
- No, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for diagnostic imaging devices or devices where human interpretation is a key component, often comparing human performance with and without AI assistance. This document describes a physical medical device (introducer sheath) that does not involve diagnostic interpretation or AI.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not done. This device is a physical mechanical instrument and does not incorporate an AI algorithm.
The type of ground truth used:
- The ground truth for most performance tests (Needle, Guide Wire, Dilator, Sheath, Inserter, System) would be based on engineering specifications, material science standards, and functional requirements for similar medical devices.
- For Biocompatibility, the ground truth is established by international biological evaluation standards (ISO 10993), which define acceptable thresholds for biological responses (e.g., absence of cytotoxicity, genotoxicity, etc.).
- For Sterilization, the ground truth is based on sterilization validation standards (ANSI/AAMI/ISO 11135) to achieve a defined Sterility Assurance Level (SAL) of 10^-6.
The sample size for the training set:
- This is not applicable. The Glidesheath is a physical medical device, not an AI or machine learning model that requires a "training set."
How the ground truth for the training set was established:
- This is not applicable for the same reason as point 7.

Summary

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510(k) Summary

FDA CDRH DMC

A. Device Name		JUL 21 2010
Proprietary Name	Glidesheath	Received
Classification Name	Catheter Introducer (as per 870.1340)
Common Name	Introducer Sheath
Product Code	DYB

B. Intended Use

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 Entry Needle is an accessory device which is used to gain access to the vein or artery including but not limited to the radial artery, for placement of the Mini Guide Wire.

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.

C. Device Description

The Entry Needle is an accessory device which is used to gain access to the vein or artery including but not limited to the radial artery, for placement of the Mini Guide Wire.

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D. Principle of Operation / Technology

The Glidesheath and its accessories are operated manually or by a manual process.

Using the Guide Inserter to straighten the Mini Guide Wire, the Mini Guide Wire is inserted through a cannula placed in the patient's blood vessel. The Glidesheath is 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 while the Glidesheath is being placed into the vessel. The Dilator can be removed and an appropriate catheter can then be inserted.

E. Design / Materials

	Current Glidesheath	Predicate Glidesheath (K082644)
Sheath
Tubing	Ethylene-Tetrafluoroethylene (ETFE) copolymer containingbismuth trioxide	Ethylene-Tetrafluoroethylene (ETFE) copolymer containingbismuth trioxide
HydrophilicCoating	Dimethyl acrylamide-glycidyl methacrylatecopolymer	Dimethyl acrylamide-glycidylmethacrylate copolymer
Housing	Polypropylene	Polypropylene
Valve	Silicone Rubber	Silicone Rubber
Cap	Polypropylene	Polypropylene
Caulking Pin	Stainless Steel	Stainless Steel
Sheath Support	Styrene elastomer	Styrene elastomer
Side Tube	Polybutadiene	Polybutadiene
Three-way stopcock
Holder	Polycarbonate	Polycarbonate
Cock	Polyethylene	Polyethylene
Luer Cap	Polypropylene	Polypropylene
Dilator
Tube	Polypropylene containingbismuth subcarbonate	Polypropylene containing bismuthsubcarbonate
Hub	Polypropylene	Polypropylene

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	Current Glidesheath	Predicate Glidesheath (K082644)
Caulking Pin	Stainless Steel	Stainless Steel
Mini Guide Wire		Plastic Option	Metallic Option
Spring	Palladium	Polyurethane/tungsten with silicon coating	Stainless Steel
Core	Nickel-Titanium alloy	Nickel-Titanium alloy	Stainless Steel
Inserter	Polyethylene	Polyethylene
Needle Hub	Polycarbonate	Polycarbonate
Cannula	Stainless Steel	Stainless Steel
Cap	Polypropylene	Polycarbonate

Both devices have similar parts which function in the same manner. Differences in materials between the Glidesheath device covered in this submission and the predicate device, cleared under K082644, raise no new issues of safety or effectiveness.

F. Specifications

	Current Glidesheath	Predicate Glidesheath(K082644)
Sheath Size	5 & 6 French	4, 5 & 6 French
Sheath Length	10 cm	10 - 25 cm
Sheath Hydrophilic Coating	10 cm(entire length of shaft)	10 - 25cm(entire length of shaft)
Dilator Length	15.5 cm	15.5 - 30.5 cm
Guide Wire OD	0.021"	0.021" - 0.038"
Guide Wire Length	45 cm	10 - 180 cm
Entry Needle: Size	21G	20 G - 21 G
Entry Needle Length	1.5"	1.5"
IV Catheter	Not Available	16 G - 22 G
IV Catheter Length	Not Available	1" - 2.5"
Scalpel	Not Available	Available
Syringe	Not Available	Available
Obturator	Not Available	Available

All specifications of the Glidesheath included in this submission are within the specification ranges of the predicate device. The comparison of specifications raises no new issues of safety or effectiveness.

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G. Performance

The Glidesheath successfully passed all of the following performance tests:

Needle

Needle surface free from defects .
◆ Needle OD
Needle length .
. Needle ID
. Needle hub conical entry angle
Bevel indicator visibility .
. Bevel indicator position
. Needle to hub joint strength
Gauge Luer taper .
Liquid leakage from fitting assembly under pressure .
. Air leakage into the fitting assembly during aspiration
. Separation force of fitting assembly
Unscrewing torque of fitting assembly ●
Ease of assembly .
Resistance to overriding .
Stress cracking .
. Corrosion resistance

Guide Wire

Guidewire surface free from defects
Tip buckling test .
Test for resistance of guidewires to damage by flexing .
Test for fracture of guidewires
. Test for distal tip retention
Guidewire OD .
Guidewire length .
Test for corrosion resistance .

Dilator

. Dilator surface free from defects
. Dilator tip ID
. Dilator to hub joint strength

Sheath

Sheath surface free from defects 0
. Sheath tip ID
. Sheath to housing joint strength

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Housing to cap joint strength .

Inserter

Guidewire inserter surface free from defects .
System
System use in model ●

H. Biocompatibility and Sterilization

The Glidesheath is classified as Externally Communicating Devices, Circulating Blood, Limited Contact (≤ 24h). Results of the testing demonstrate that the blood contacting materials are biocompatible.

Blood contacting materials were tested in accordance with the tests recommended in 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". The Glidesheath successfully passed all of the following biocompatibility tests:

Physicochemical Profile .
Cytotoxicity
Sensitization .
� Acute Intracutaneous Reactivity
Acute Systemic Toxicity .
Hemolysis .
Thromobogenicity t
Complement Activation Assay .
Unactivated Partial Thromboplastin Time Assay .
In Vitro Hemolysis .
Genotoxicity .
Pyrogen Study t
Extractable Metals and Acidity/Alkalinity (needle assembly) .

Sterilization conditions have been validated according to ANSI / AAMI / ISO 11135. Sterilization of Health Care Products-Part I: Requirements for development, validation and routine control of a sterilization process for medical devices to provide a Sterility Assurance Level (SAL) of 10-6.

I. Substantial Equivalence

The performance of the Glidesheath in this submission is substantially equivalent to the performance of the predicate device. The equivalence was shown through

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comparison of component materials and specifications, performance and biocompatibility testing and sterilization validation.

The Glidesheath is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the predicate device the Glidesheath, cleared under K082644. Differences between the devices do not raise any significant issues of safety or effectiveness.

J. Submitter Information

Prepared By:	Mr. Daniel R. PlonskiRegulatory Affairs Specialist
Prepared For:	Terumo Medical Corporation950 Elkton Blvd.Elkton, MD 21921Phone: (410) 392-7213Fax: (410) 398-7395Email: daniel.plonski@terumomedical.com
Date Prepared:	July 2, 2010

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Contro! Room -WO66-G609 Silver Spring, MD 20993-0002

Terumo Medical Corporation c/o Mark Job Reviewer Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 55313

Re: K102008 ·

Trade/Device Name: Glidesheath Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, Introducer Regulatory Class: Class II (Two) Product Code: DYB Dated: July 15, 2010 Received: July 16, 2010

Dear Mr. Job:

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.

UNI 2 1 2010

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Page 2 - Mr. Mark Job

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.

R. Vahner

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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K102008

Indications for Use

Comments of the comments of the comments of the comments of the comments of the contribution of the contribution of the contribution of the contribution of the contribution o

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Glidesheath™

Indications For Use:

UUU. 21 2010

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 Entry Needle is an accessory device which is used to gain access to the vein or artery including but not limited to the radial artery, for placement of the Mini Guide Wire.

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.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

bma R. hichner

Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K102008

Regulation Number and Section

§ 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).