(89 days)
The Renal Guiding Sheath is intended for the introduction of interventional and diagnostic devices into the human vasculature including but not limited to the renal arteries.
The Renal Guiding Sheath is designed to perform as a guiding catheter and an introducer sheath. The sheath is coil reinforced, has a radiopaque marker and is hydrophilically coated on the distal 5 cm. It comes packaged with a dilator, a rotating hemostatic valve (or a detachable hemostatic valve), and a dilator retaining clip.
This document describes a medical device, the "Renal Guiding Sheath," and its submission for FDA clearance. It focuses on demonstrating substantial equivalence to a predicate device, not on AI/algorithm performance. Therefore, many of the requested fields related to AI, ground truth, and expert evaluation are not applicable.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Tests) | Reported Device Performance (Reference to Predicate) |
|---|---|
| Penetration | Substantially equivalent to Super Arrow-Flex Percutaneous Sheath Introducer Set |
| Kink Resistance | Substantially equivalent to Super Arrow-Flex Percutaneous Sheath Introducer Set |
| Leakage | Substantially equivalent to Super Arrow-Flex Percutaneous Sheath Introducer Set |
| Tensile Strength | Substantially equivalent to Super Arrow-Flex Percutaneous Sheath Introducer Set |
| Tortuous Path / Durability | Substantially equivalent to Super Arrow-Flex Percutaneous Sheath Introducer Set |
| Sterility Assurance Level (SAL) | 10^-6 (validated according to ANSI / AAMI / ISO 11135-1994) |
| Biocompatibility | Blood contacting materials found to be biocompatible (tested in accordance with FDA General Program Memorandum #G95-1 / ISO 10993) |
| Expiration Dating | 30 months |
2. Sample Size Used for the Test Set and Data Provenance
This document does not specify sample sizes for each performance test. The data provenance is not mentioned beyond the fact that tests were performed to demonstrate substantial equivalence. It is likely internal testing without country-of-origin specification, and it is implied to be prospective testing (performance evaluations of the new device).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a physical medical instrument, not an AI or diagnostic algorithm that requires expert-established ground truth for its performance evaluation in this context. The performance tests are engineering and biological evaluations.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for expert review of images or clinical cases to establish ground truth for AI algorithms. For physical device performance tests, standards and objective measurements are used.
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
Not applicable. This document describes a physical medical device, not an AI system. Therefore, no MRMC study or AI assistance effect size is relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm, so standalone performance is not relevant.
7. The Type of Ground Truth Used
For the performance tests:
- Engineering Standards / Objective Measurements: For tests like Penetration, Kink Resistance, Leakage, Tensile Strength, and Tortuous Path / Durability, the "ground truth" would be the successful adherence to pre-defined engineering specifications and measurable performance within acceptable limits, often compared directly to the predicate device's measured performance.
- Validated Standards: For sterilization, the ground truth is established by validation against ANSI / AAMI / ISO 11135-1994 to achieve a specified SAL.
- Biocompatibility Standards: For biocompatibility, the ground truth is conformity with test recommendations in FDA General Program Memorandum #G95-1 (ISO 10993).
8. The Sample Size for the Training Set
Not applicable. This is a physical device, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. This is a physical device, not an AI algorithm.
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NOV 21 2001
SECTION II. SUMMARY OF SAFETY & EFFECTIVENESS
DEVICE NAME A.
Proprietary Name: Has not been established yet Classification Name: Catheter Introducer Common Name: Guiding Sheath
B. PREDICATE DEVICE
The predicate device is the Super Arrow-Flex Percutaneous Sheath Introducer Set, which is manufactured by Arrow International, Inc. The Super Arrow-flex is cleared through the premarket notification process (K924607).
C. INTENDED USE
The Renal Guiding Sheath is intended for the introduction of interventional and diagnostic devices into the human vasculature including but not limited to the renal arteries.
D. DESCRIPTION
The Renal Guiding Sheath is designed to perform as a guiding catheter and an introducer sheath. The sheath is coil reinforced, has a radiopaque marker and is hydrophilically coated on the distal 5 cm. It comes packaged with a dilator, a rotating hemostatic valve (or a detachable hemostatic valve), and a dilator retaining clip.
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PRINCIPLE OF OPERATION / TECHNOLOGY E.
The Renal Guiding Sheath and the Super Arrow-Flex Percutaneous Sheath Introducer Set are operated manually or by a manual process.
DESIGN / MATERIALS F.
The Renal Guiding Sheath use similar materials as the predicate device. Differences in materials between the two devices do not raise any new issues of safety and effectiveness.
G. SPECIFICATIONS
| Sheath Size: | 6-7Fr. |
|---|---|
| Nominal ID / OD: | 6Fr.: .087" / .109" |
| 7Fr.: .100" / .122" | |
| Sheath Length: | 45-55cm |
| Hydrophilic Coating: | Distal 5 cm |
| Distal Shape Configurations: | Straight, Hockey Stick, Multipurpose |
H. PERFORMANCE
The performance of the Renal Guiding Sheath is substantially equivalent to the performance of the Super Arrow-Flex Percutaneous Sheath Introducer. The following tests were performed to demonstrate the substantial equivalence of the devices.
-
Penetration
- Kink Resistance A
-
Leakage
-
Tensile Strength
- Tortuous Path / Durability A
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ADDITIONAL SAFETY INFORMATION I.
Sterilization conditions have been validated in accordance with ANSI / AAMI / ISO 11135-1994 to provide a Sterility Assurance Level of 10-6.
Blood contacting materials were tested in accordance with the test recommendations in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO 10993, "Biological Evaluation of Medical Devices - Part I: Evaluation and Testing." The Renal Guiding Sheath is categorized as "Externally Communicating Device, Circulating Blood, Limited Contact (≤24hrs)". The blood contacting materials were found to be biocompatible.
Expiration dating for the Renal Guiding Sheath will be 30 months.
SUBSTANTIAL EQUIVALENCE J.
The Renal Guiding Sheath submitted in this 510(k) is substantially equivalent in intended use, design, principle of operation / technology, materials and performance to the Super Arrow-Flex Percutaneous Sheath Introducer Set (K924607), which is manufactured by Arrow International, Inc. Differences between the devices do not raise any issues of safety or effectiveness.
Terumo's statement of substantial equivalence is done solely to comply with the requirements of the Federal Food, Drug and Cosmetic Act and is not intended whatsoever to be the basis for a patent infringement action.
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SUBMITTER INFORMATION K.
Name and Address
Terumo Medical Corporation 125 Blue Ball Rd. Elkton, MD 21921
Contact Person
Mrs. Yuk-Ting Lewis Senior Regulatory Specialist Ph: 410-392-7213 Fax: 410-398-6079 Email: yukting.lewis@terumomedical.com
Date Prepared
August 1, 2001
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 21 2001
Ms. Yuk-Ting Lewis Senior Regulatory Specialist TERUMO Medical Corporation 125 Blue Ball Road Elkton, MD 21921
Re: K012854
Renal Guiding Sheath Regulation Number: 870.1340 Regulation Name: Catheter introducer. Regulatory Class: II (two) Product Code: 74 DYB Dated: August 23, 2001 Received: August 24, 2001
Dear Ms. Lewis:
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 such 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); 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.
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Page 2 - Ms. Yuk-Ting Lewis
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Pcoelho
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: Renal Guiding Sheath
Indications For Use:
The Renal Guiding Sheath is intended for the introduction of interventional and diagnostic devices into the human vasculature including but not limited to the renal arteries.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Prescription Use(Per 21 CFR 801.109) | ✓ |
| OR | Over-The-Counter Use ______ |
| Division of Cardiovascular & Respiratory Devices510(k) Number | K017854 |
| (Optional Format 1-2-96) |
§ 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).