(22 days)
The Pinnacle® Destination® Peripheral Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to lower extremity access via a contralateral approach.
The Pinnacle® Destination® Peripheral Guiding Sheath is designed to perform as a guiding catheter and an introducer sheath. The Peripheral Guiding Sheath is packaged with the following components: a Sheath, a Dilator, a Hemostatic Valve, and a Dilator Retaining Clip.
The provided text describes a 510(k) premarket notification for a medical device, specifically the Pinnacle® Destination® Peripheral Guiding Sheath. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through extensive clinical trials.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria in the context of an AI/algorithm-driven device. The details requested are typically associated with performance evaluations of AI algorithms, particularly those seeking de novo clearance or 510(k) clearance for AI-based functions.
Here's why the requested information is absent and what the document does provide:
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Acceptance criteria and reported device performance (Table 1): The document outlines specifications for the device (Sheath Size, Nominal ID/OD, Length, Hydrophilic Coating, Distal Shape), which are analogous to acceptance criteria in terms of physical attributes. However, it does not present a table of performance acceptance criteria (e.g., sensitivity, specificity, or specific functional benchmarks in a clinical context) with corresponding reported performance for a new AI function. It states, "The performance of the Pinnacle® Destination® Peripheral Guiding Sheath is substantially equivalent to the performance of the unmodified Peripheral Guiding Sheath. The equivalence was shown through bench and vessel model testing." This indicates the performance was compared to the predicate, not measured against novel, AI-specific acceptance criteria.
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Sample size for the test set and data provenance: Not applicable. This device is a manual medical instrument, not an AI/algorithm. Performance was assessed through bench and vessel model testing, not clinical data sets with "test sets" in the AI sense.
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Number of experts used to establish ground truth for the test set and their qualifications: Not applicable. Ground truth as typically defined for AI models (e.g., expert consensus on image labels) is not relevant for this physical device's evaluation.
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Adjudication method for the test set: Not applicable.
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Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This study design is used for evaluating human reader performance with and without AI assistance. This device is a physical guiding sheath; it doesn't "assist" human readers with interpretation.
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Standalone (algorithm-only) performance: Not applicable. There is no algorithm.
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Type of ground truth used: For the physical characteristics, the ground truth would be engineering specifications and measurements. For the "performance" described as "substantially equivalent," the ground truth is the established performance of the predicate device.
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Sample size for the training set: Not applicable. This is not an AI/ML device that requires training data.
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How the ground truth for the training set was established: Not applicable.
In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence of a physical medical device (a guiding sheath) to an existing predicate device, primarily through bench and vessel model testing. It does not involve any artificial intelligence or machine learning component, and thus, the specific questions related to AI algorithm performance evaluation are not addressed in this document.
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K080415 Page 1 of
SECTION II. 510(k) SUMMARY
A. DEVICE NAME
| Proprietary Name: | Pinnacle® Destination® Peripheral Guiding Sheath |
|---|---|
| Classification Name: | Catheter Introducer |
| Common Name: | Guiding Sheath |
B. PREDICATE DEVICE
The predicate device is the Pinnacle® Destination® Peripheral Guiding Sheath, which is manufactured by Terumo Medical Corporation. The Pinnacle® Destination® Peripheral Guiding Sheath is cleared through the premarket notification process (K051601).
C. INTENDED USE
The Pinnacle® Destination® Peripheral Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to lower extremity access via a contralateral approach.
D. DESCRIPTION
The Pinnacle® Destination® Peripheral Guiding Sheath is designed to perform as a guiding catheter and an introducer sheath. The Peripheral Guiding Sheath is packaged with the following components: a Sheath, a Dilator, a Hemostatic Valve, and a Dilator Retaining Clip.
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E. PRINCIPLE OF OPERATION / TECHNOLOGY
The Pinnacle® Destination® Peripheral Guiding Sheath is operated manually or by a manual process.
F. DESIGN / MATERIALS
The Pinnacle® Destination® Peripheral Guiding Sheath uses similar materials as the predicate device. Differences in materials between the two devices do not raise any new issues of safety and effectiveness.
(उ. SPECIFICATIONS
| Sheath Size: | 6-7Fr. |
|---|---|
| Nominal ID / OD: | 6Fr.: 0.087" / 0.109" |
| 7Fr.: 0.100" / 0.122" | |
| Sheath Length: | 45-55 cm |
| Hydrophilic Coating: | Distal 15-55 cm |
| Distal Shape Configurations: | Straight |
H. PERFORMANCE
The performance of the Pinnacle® Destination® Peripheral Guiding Sheath is substantially equivalent to the performance of the unmodified Peripheral Guiding Sheath. The equivalence was shown through bench and vessel model testing.
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I. ADDITIONAL SAFETY INFORMATION
Sterilization conditions have been validated in accordance with EN ISO 11135-1 "Sterilization of health care products - Ethylene Oxide - Part 1 : requirements for development, validation and routine control of sterilization process for medical devices." 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 Pinnacle® Destination® Peripheral 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 Pinnacle® Destination® Peripheral Guiding Sheath will be 30 months.
J. SUBSTANTIAL EQUIVALENCE
The Pinnacle® Destination® Peripheral Guiding Sheath submitted in this 510(k) is substantially equivalent in intended use, design, principle of operation / technology, materials and performance to the Pinnacle® Destination® Peripheral Guiding Sheath (K051601), which is manufactured by Terumo Medical Corporation. Differences between the devices do not raise any issues of safety or effectiveness.
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K. SUBMITTER INFORMATION
Name and Address
Terumo Medical Corporation 950 Elkton Blvd. Elkton, MD 21921
Contact Person
Mr. Mark Unterreiner Sr. Regulatory Affairs Specialist Ph: 410-392-7213 Fax: 410-398-6079 Email: mark.unterreiner@terumomedical.com
Date Prepared
February 13, 2008
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 7 2008
Terumo Medical Corporation c/o Mr. Mark Unterreiner Sr. Regulatory Affairs Specialist 125 Blue Ball Road Elkton, MD 21921
Re: K080415
Pinnacle® Destination® Peripheral Guiding Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II (two) Product Code: DYB Dated: February 13, 2008 Received: February 14, 2008
Dear Mr. Unterreiner:
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.
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Page 2 - Mr. Mark Unterreiner
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 (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. 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.
Sincerely yours,
R. bochner
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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Indications for Use
6080415 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Pinnacle® Destination® Peripheral Guiding Sheath Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Pinnacle® Destination® Peripheral Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to lower extremity access via a contralateral approach.
Prescription Use (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)
Muna R. de Mines
Division Sign-Off) Division of Cardiovascular Devices
510(k) number K080415
00005
§ 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).