(116 days)
The Pinnacle Precision Access System is used to facilitate placing a catheter through the skin into a vein or artery.
The Entry Needle is an accessory device which is used to gain access to the vein or 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.
The Pinnacle Precision Access System consists of an introducer sheath and a dilator which are packaged together with a metallic entry needle, a mini guide wire and a guide wire inserter, prior to sterilization. The Pinnacle Precision Access System is used to facilitate placing a catheter through the skin into a vein or artery. The sheath and dilator contain bismuth, making these devices visible under fluoroscopy
The entry needle (cannula) is an accessory device which is used to gain access to the vein or artery for placement of the mini guide wire.
The mini guide wire is an accessory device which is used for placement of the sheath and dilator into the vein or artery. The mini guide wire is offered in two versions, a stainless steel (spring coil) model and a Palladium tipped Nitinol model.
A guide wire inserter is also provided to assist in insertion of the mini guide wire into the cannula.
The provided text describes the Terumo Medical Corporation's Pinnacle Precision Access System and its premarket notification (510(k) summary) to the FDA. This document is for a medical device (catheter introducer) and therefore does not involve AI or machine learning. As such, many of the requested categories related to AI model evaluation are not applicable.
Here's the information that can be extracted or deduced from the provided text, along with an explanation for categories that are not applicable:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are generally implied by the successful passing of the listed performance tests. The reported device performance is that it "successfully passed all of the following performance tests." Specific quantitative thresholds for "acceptance" are not explicitly detailed in the summary but are inherent in the "pass" result for each test.
| Test Category | Specific Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Needle | Needle surface free from defects | Free from defects | Passed |
| Needle OD | Within specified range | Passed | |
| Needle length | Within specified range | Passed | |
| Needle ID | Within specified range | Passed | |
| Needle hub conical entry angle | Within specified range | Passed | |
| Bevel indicator visibility | Visible | Passed | |
| Bevel indicator position | Correct position | Passed | |
| Needle to hub joint strength | Meets strength requirements | Passed | |
| Gauge luer taper | Conforms to standard | Passed | |
| Liquid leakage from fitting assembly under pressure | No liquid leakage | Passed | |
| Air leakage into the fitting assembly during aspiration | No air leakage | Passed | |
| Separation force of fitting assembly | Meets force requirements | Passed | |
| Unscrewing torque of fitting assembly | Meets torque requirements | Passed | |
| Ease of assembly | Easy to assemble | Passed | |
| Resistance to overriding | Resistant to overriding | Passed | |
| Stress cracking | No stress cracking | Passed | |
| Tip penetration through thin film | Effective penetration | Passed | |
| Corrosion resistance | Resistant to corrosion | Passed | |
| Guidewires | Guidewire surface free from defects | Free from defects | Passed |
| Tip buckling test | No buckling | Passed | |
| Test for resistance of guidewires to damage by flexing | Resistant to damage | Passed | |
| Test for fracture of guidewires | No fracture | Passed | |
| Test for distal tip retention and proximal end retention | Tip retention maintained | Passed | |
| Guidewire OD | Within specified range | Passed | |
| Guidewire length | Within specified range | Passed | |
| Corrosion resistance | Resistant to corrosion | Passed | |
| Radiopacity | Radiopaque | Passed | |
| Dilator | Dilator surface free from defects | Free from defects | Passed |
| Dilator tip ID | Within specified range | Passed | |
| Dilator to hub joint strength | Meets strength requirements | Passed | |
| Dilator length | Within specified range | Passed | |
| Dilator OD at sheath tip interface | Within specified range | Passed | |
| Dilator hub to sheath hub snap fit strength | Meets strength requirements | Passed | |
| Hypotube length | Within specified range | Passed | |
| Hypotube to hub joint strength | Meets strength requirements | Passed | |
| Hypotube fall-out | No fall-out | Passed | |
| Wire passage | Smooth wire passage | Passed | |
| Sheath | Corrosion resistance (hypotube) | Resistant to corrosion | Passed |
| Sheath surface free from defects | Free from defects | Passed | |
| Sheath tip ID | Within specified range | Passed | |
| Sheath length | Within specified range | Passed | |
| Sheath tip cracks | No cracks | Passed | |
| Radiopacity | Radiopaque | Passed | |
| Simulated Use | System use in anatomical model | Successful deployment and function in model | Passed |
| Dilator and sheath tip penetration | Effective tip penetration | Passed | |
| Biocompatibility | Physicochemical profile | Meets USP requirements | Meets requirements |
| Cytotoxicity | Not considered to have cytotoxic potential | Not considered cytotoxic | |
| Hemolysis | Non-hemolytic | Non-hemolytic | |
| In vitro Hemocompatibility Assay | Pass | Pass | |
| Thrombogenicity Study in Dogs | Thrombosis not significant | Not considered significant | |
| Complement Activation | Meets requirements | Meets requirements | |
| Unactivated Partial Thromboplastin time | Meets requirements | Meets requirements | |
| Prothrombin Time | No adverse effect on prothrombin time | No adverse effect | |
| Sensitization | Meets requirements | Meets requirements | |
| Intracutaneous Reactivity | Meets requirements | Meets requirements | |
| Acute Systemic Toxicity | Negative | Negative | |
| Pyrogenicity | Meets requirements | Meets requirements | |
| Genotoxicity | Not considered mutagenic | Not considered mutagenic | |
| Other Tests | Analysis of Metals in Extract by ICP-MS (Echogenic Taper Needle) | Meets ISO 7864 requirements | Meets requirements |
| Biocompatibility (Aged Devices) - Physicochemical profile | Meets USP requirements | Meets requirements | |
| Biocompatibility (Aged Devices) - Cytotoxicity | Not considered to have cytotoxic potential | Not considered cytotoxic | |
| Biocompatibility (Aged Devices) - Hemolysis | Non-hemolytic | Non-hemolytic | |
| Sterilization | Sterility Assurance Level (SAL) | 10^-6 | Achieved SAL of 10^-6 |
| Residual EO/ECH | EO < 4mg/device, ECH < 9mg/device | Meets requirements | |
| Non-pyrogenic | Non-pyrogenic in unopened/undamaged package | Certified non-pyrogenic |
2. Sample sizes used for the test set and the data provenance
The document does not explicitly state the sample sizes for each performance test. It mentions "Testing was performed on the worse case configuration of the system" for biocompatibility. The tests are general device performance and biocompatibility tests, not clinical studies with patient data.
- Sample Size for Test Set: Not explicitly stated for each individual test. It mentions "worse case configuration" for biocompatibility testing. These are laboratory/bench tests, not studies on patient data.
- Data Provenance: Not applicable in the context of patient data for a test set. This refers to laboratory and bench testing performed by the manufacturer, Terumo Medical Corporation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable. "Ground truth" in this context typically refers to clinical diagnosis or outcomes. The performance tests are objective engineering and biological evaluations, not dependent on expert interpretation of clinical data for a test set.
4. Adjudication method for the test set
This is not applicable. The performance tests are objective measurements against predefined specifications, not subject to adjudication by multiple experts in the way clinical diagnostic interpretations would be.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. The device is a medical instrument (catheter introducer), not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical medical instrument, not an algorithm.
7. The type of ground truth used
For the performance tests, the "ground truth" refers to established engineering standards, material specifications, and biological testing protocols (e.g., ISO, USP, ASTM standards for biocompatibility and physical properties). For example, for "Needle OD," the ground truth would be the specified diameter range from the design documents. For biocompatibility tests, the ground truth is defined by the limits and criteria set forth in the referenced ISO and ASTM standards.
8. The sample size for the training set
This is not applicable. The device is a physical medical instrument, not an AI model requiring a training set.
9. How the ground truth for the training set was established
This is not applicable. The device is a physical medical instrument, not an AI model.
{0}------------------------------------------------
OCT - 3 2011
K1116.06
Terumo Medical Corporation Premarket Notification - Pinnacle Precision Access System™ Section II. 510(k) Summary
SECTION II. 510(K) SUMMARY
A. Device Name
| Proprietary Name | Pinnacle Precision Access System |
|---|---|
| Classification Name | Catheter Introducer (as per 870.1340) |
| Common Name | Introducer Sheath |
| Product Code | DYB |
B. Intended Use
The Pinnacle Precision Access System is used to facilitate placing a catheter through the skin into a vein or artery.
The Entry Needle is an accessory device which is used to gain access to the vein or 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.
C. Device Description
The Pinnacle Precision Access System consists of an introducer sheath and a dilator which are packaged together with a metallic entry needle, a mini guide wire and a guide wire inserter, prior to sterilization. The Pinnacle Precision Access System is used to facilitate placing a catheter through the skin into a vein or artery. The sheath and dilator contain bismuth, making these devices visible under fluoroscopy
The entry needle (cannula) is an accessory device which is used to gain access to the vein or artery for placement of the mini guide wire.
The mini guide wire is an accessory device which is used for placement of the sheath and dilator into the vein or artery. The mini guide wire is offered in two versions, a stainless steel (spring coil) model and a Palladium tipped Nitinol model.
A guide wire inserter is also provided to assist in insertion of the mini guide wire into the cannula.
{1}------------------------------------------------
Terumo Medical Corporation Premarket Notification - Pinnacle Precision Access System™ Section II. 510(k) Summary
D. Principle of Operation / Technology
The Pinnacle Precision Access System and its accessories are operated manually or by a manual process.
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.
E. Design / Materials and Comparison to Predicate Devices
The primary components of the Pinnacle Precision Access System in this submission (the Sheath and Dilator) are unchanged from those of the Radifocus Introducer II predicate device (K954234). The Pinnacle Precision Access System differs from the Radifocus Introducer II predicate device in the addition of the metallic entry needle and the optional Nitinol Mini Guide Wire. A metallic entry needle and Nitinol Mini Guide Wire are included in the Glidesheath predicate device (K102008).
The Pinnacle Precision Access System submitted in this 510(k), the Radifocus Introducer II (K954234) and the Glidesheath (K102008) have similar components which function in the same manner. Material differences between the devices, as shown in the following table, do not raise any new issues of safety and effectiveness.
| Component | Radifocus Introducer II (K954234) | Glidesheath (K102008) | Pinnacle Precision Access System |
|---|---|---|---|
| Wire | Stainless Steel | Nitinol w/Palladiumdistal coil | Stainless Steel or Nitinolw/Palladium distal coil |
| Needle | N/A | Stainless Steel | Stainless Steel |
| Needle Hub | N/A | Styrene-Butadienecopolymer | Styrene-Butadienecopolymer |
| Protective Sleeve | N/A | Polypropylene | Polypropylene |
| Dilator Tubing | Polypropylenew/Bismuthsubcarbonate | Polypropylenew/Bismuthsubcarbonate | Polypropylenew/Bismuth subcarbonate |
| Dilator Stiffener | N/A | N/A | Stainless Steel (optionalon 4Fr and 5Fr) |
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Terumo Medical Corporation Premarket Notification - Pinnacle Precision Access System™ Section II. 510(k) Summary
| Dilator CaulkingPin | Stainless Steel | Stainless Steel | Stainless Steel |
|---|---|---|---|
| Dilator Hub | Polypropylene | Polypropylene | Polypropylene |
| Sheath Tubing | ETFE w/15% BiO3,w/2% TiO2 | ETFE w/15% BiO3,w/2% TiO2 | ETFE w/15% BiO3,w/2% TiO2 |
| Sheath CaulkingPin | Stainless Steel | Stainless Steel | Stainless Steel |
| Sheath Housing | Polypropylene | Polypropylene | Polypropylene |
| Sheath Support | Styrene elastomer | Styrene elastomer | Styrene elastomer |
| Valve | Silicone rubber | Silicone rubber | Silicone rubber |
| Cap | Polypropylene | Polypropylene | Polypropylene |
| Sidetube | Polybutadiene | Polybutadiene | Polybutadiene |
| 3 WSC | Polycarbonate,Polyethylene,Polypropylene | Polycarbonate,Polyethylene,Polypropylene | Polycarbonate,Polyethylene,Polypropylene |
| Guide wireinserter | Polypropylene | Polypropylene | Polypropylene |
F. Specifications and Comparison to Predicate Devices
The Pinnacle Precision Access System submitted in this 510(k), the Radifocus Introducer II (K954234) and the Glidesheath (K102008) have similar device specifications. Differences in specifications between the devices do not raise any new issues of safety and effectiveness.
| Radifocus IntroducerII (K954234) | Glidesheath(K102008) | Pinnacle PrecisionAccess System | |
|---|---|---|---|
| Sheath Sizes | 4Fr - 11Fr | 5Fr and 6Fr | 4Fr through 8Fr |
| Sheath Length | 5cm - 100cm | 10 cm | 10 cm |
| Sheath Coating | Silicone | Hydrophilic | Silicone |
| Dilator Length | 6cm - 110cm | 15.5 cm | 15.5cm or 16.0cm |
| Guide Wire OD | .021" - .038" | .021" | .021" |
| Guide WireLength | 40cm - 100cm | 45cm | 45cm |
| Entry Needle:Size | N/A | 21G1.5" | 21G/19G2.75" |
{3}------------------------------------------------
Terumo Medical Corporation Premarket Notification - Pinnacle Precision Access System™ Section II. 510(k) Summary
G. Performance
.
The Pinnacle Precision Access System successfully passed all of the following performance tests: .
| Pinnacle Precision Access System Performance Testing | |
|---|---|
| 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 | |
| Tip penetration through thin film | |
| Corrosion resistance | |
| Guidewires: | 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 and proximal end retention | |
| Guidewire OD | |
| Guidewire length | |
| Corrosion resistance | |
| Radiopacity | |
| Dilator: | Dilator surface free from defects |
| Dilator tip ID | |
| Dilator to hub joint strength | |
| Dilator length | |
| Dilator OD at sheath tip interface | |
| Dilator hub to sheath hub snap fit strength | |
| Hypotube length | |
| Hypotube to hub joint strength | |
| Hypotube fall-out | |
| Wire passage | |
| Sheath: | Corrosion resistance (hypotube) |
| Sheath surface free from defects | |
| Sheath tip ID | |
| Sheath length | |
| Sheath tip cracks | |
| Radiopacity | |
| Simulated Use: | System use in anatomical model |
| Dilator and sheath tip penetration |
{4}------------------------------------------------
Terumo Medical Corporation Premarket Notification - Pinnacle Precision Access System™ Section II. 510(k) Summary
H. Biocompatibility and Sterilization
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''.
The Pinnacle Precision Access System is classified as an Externally Communicating Device, Circulating Blood, Prolonged Contact (up to 30 days), the same as the Radifocus Introducer II Sheath predicate device. Biocompatibility of the Radifocus Introducer II Sheath, classified as Externally Communicating Device, Circulating Blood, Prolonged Contact (24 hours - 30 days) has been established under K954234. Differences in materials between the Pinnacle Precision Access System and the Radifocus Introducer II Sheath affect only those portions of the system that contact the patient for a short period of time (less than 24 hours). Therefore, the full battery of biocompatibility tests was performed on the whole device for Externally Communicating Devices, Circulating Blood, Limited Contact (up to 24 hours).
Testing was performed on the worse case configuration of the system: Introducer sheath with stiffener, stainless steel guide wire and echogenic step needle. Results are presented in the following table.
{5}------------------------------------------------
Terumo Medical Corporation Premarket Notification -- Pinnacle Precision Access System™ Section II. 510(k) Summary
: :
| Biocompatibility Testing on non aged, 2x EO sterile Pinnacle Precision Access System | ||
|---|---|---|
| Test | Standard | Result |
| Physicochemical profile | USP | Meets requirements |
| Cytotoxicity | ISO 10993-5 | Not considered to have cytotoxic potential |
| Hemolysis | ASTM F756 | Non-hemolytic |
| In vitroHemocompatibility Assay | ISO 10993-4 | Pass |
| Thrombogenicity Study inDogs | ISO 10993-4 | Thrombosis was not considered significant |
| Complement Activation | ISO 10993-4 | Meets requirements |
| Unactivated PartialThromboplastin time | ISO 10993-4 | Meets requirements |
| Prothrombin Time | ISO 10993-4 | No adverse effect on the prothrombin time ofhuman plasma |
| Sensitization | ISO 10993-10 | Meets requirements |
| Intracutaneous Reactivity | ISO 10993-10 | Meets requirements |
| Acute Systemic Toxicity | ISO 10993-11 | Negative |
| Pyrogenicity | ISO 10993-11 | Meets requirements |
| Genotoxicity | ISO 10993-3 | Not considered to be mutagenic |
Alkalinity/acidity and extractables testing was performed per ISO 7864: Sterile Hypodermic Needles for Single Use on 2x EO sterile, non-aged needles.
| Pinnacle Precision Access System Echogenic Taper Needle (non-aged, 2xEO sterile) | ||
|---|---|---|
| Test | Standard | Results |
| Analysis of Metals inExtract by InductivelyCoupled Plasma MassSpectrometry | (ICP-MS) PerISO 7864 | Meets requirements |
{6}------------------------------------------------
Limited screening tests were conducted on accelerated aged, 2x EO sterile devices to demonstrate that aging does not affect the device's biocompatibility.
| Test | Standard | Results |
|---|---|---|
| Physicochemical profile | USP | Meets requirements |
| Cytotoxicity | ISO 10993-5 | Not considered to have cytotoxic potential |
| Hemolysis | ASTM F756 | Non-hemolytic |
Sterilization conditions have been validated according to ANSI / AAMI / ISO 11135, 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 10-6.
Residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) residuals 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.
The Pinnacle Precision Access System is certified to be non-pyrogenic in the unopened and undamaged package. Kinetic Turbidimetric Limulus Amebocyte Lysate (LAL) test is performed on each lot of production accordance to the United States Pharmacopoeia (USP) <85> Bacterial Endotoxins Test. Validation was performed in accordance with FDA published "Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices"; 1987.
{7}------------------------------------------------
Terumo Medical Corporation Premarket Notification – Pinnacle Precision Access System™ Section II. 510(k) Summary
I. Substantial Equivalence
The performance of the Pinnacle Precision Access System in this submission is substantially equivalent to the performance of the predicate devices. The equivalence was shown through comparison of component materials and specifications, performance and biocompatibility testing and sterilization validation.
The Pinnacle Precision Access System is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the predicate devices the Radifocus Introducer II (K954234) and the Glidesheath (K102008). 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) 392-7395Fax: (410) 398-6079Email: daniel.plonski@terumomedical.com |
| Date Prepared: | June 8, 2011 |
{8}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/8/Picture/1 description: The image shows the logo for the Department of Health and Human Services. The logo is a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the edge. Inside the circle is a symbol that looks like a stylized human figure with three lines representing the arms and legs. The figure is facing to the right.
Food and Drug Administration 10903 New Flampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Terumo Medical Corporation c/o Mr. Daniel R. Plonski, RAČ Regulatory Affairs Specialist 950 Elkton Blvd. Elkton. MD 21921
OCT - 3 2011
Re: K111606
Trade/Device Name: Pinnacle Precision Access System™ Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: September 23, 2011 Received: September 26, 2011
Dear Mr. Plonski:
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.
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
{9}------------------------------------------------
Page 2 – Mr. Daniel R. Plonski, RAC
(21 CFR Part 807); labeling (21 CFR Part 801); medical device 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/CDRH/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.him 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 (240) 276-3150 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
sincerely yours,
Bram D. Zuckerman. M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{10}------------------------------------------------
Indications for Use
510(k) Number (if known): _
Pinnacle Precision Access System™ Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Pinnacle Precision Access System is used to facilitate placing a catheter through the skin into a vein or artery.
The Entry Needle is an accessory device which is used to gain access to the vein or 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.
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)
(Division Sian-Off) Division of Cardiovascular Devices
510(k) Number K111606
:
§ 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).