(49 days)
Not Found
No
The document describes a physical guiding sheath and its components, with no mention of software, algorithms, or AI/ML capabilities.
No
The device is described as an introducer sheath and guiding catheter for introducing other interventional and diagnostic devices, rather than performing a therapeutic function itself.
No
This device is a guiding sheath designed to introduce other diagnostic or interventional devices into the vasculature. Its function is to facilitate the placement of other devices, not to perform diagnostics itself.
No
The device description explicitly lists physical components (Sheath, Dilator, Hemostatic Valve, Dilator Retaining Clip) and describes bench and cadaver testing, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "introduction of interventional and diagnostic devices into the human vasculature." This describes a device used within the body for procedures, not a device used to test samples outside the body (which is the definition of an IVD).
- Device Description: The description details components like a sheath, dilator, and hemostatic valve, all consistent with a device used for vascular access and guidance during procedures.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
Therefore, the Pinnacle® Destination® Peripheral Guiding Sheath is a medical device used for interventional and diagnostic procedures within the body, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device 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.
The Pinnacle® Destination® Peripheral Guiding Sheath and the Carotid Guiding Sheath are operated manually or by a manual process.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human vasculature, including but not limited to lower extremity access via a contralateral approach.
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)
The performance of the Pinnacle® Destination® Peripheral Guiding Sheath is substantially equivalent to the performance of the Carotid Guiding Sheath. The equivalence was shown through bench and cadaver testing.
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.
Not Found
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/0 description: The image shows handwritten text on a white background. The text at the top reads "K051601", and the text below reads "p. 4 of 5". The handwriting is in black ink and appears to be somewhat bold.
and the same of the same of the same of the same of the same of the same of the same of the seat the seat the seat the seat of the seat of the seat of the seat the seat the s
SECTION II. 510(k) SUMMARY
| A. | Device Name | 11 |
|---|---|---|
| B. | Predicate Device | 11 |
| C. | Intended Use | 11 |
| D. | Description | 11 |
| E. | Principle of Operation / Technology | 12 |
| F. | Design / Materials | 12 |
| G. | Specifications | 12 |
| H. | Performance | 12 |
| I. | Additional Safety Information | 13 |
| J. | Substantial Equivalence | 13 |
| K. | Submitter Information | 14 |
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SECTION II. 510(k) SUMMARY
DEVICE NAME A.
- Pinnacle® Destination® Peripheral Guiding Sheath Proprietary Name: Classification Name: Catheter Introducer Common Name: Guiding Sheath
PREDICATE DEVICE B.
The predicate device is the Carotid Guiding Sheath, which is manufactured by Terumo Medical Corporation. The Carotid Guiding Sheath is cleared through the premarket notification process (K012812).
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.
2
The Pinnacle® Destination® Peripheral Guiding Sheath and the Carotid Guiding Sheath are 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.
్ర SPECIFICATIONS
| Sheath Size: | 6-7Fr. |
|---|---|
| Nominal ID / OD: | 6Fr.: 0.087" / 0.112" |
| 7Fr.: 0.100" / 0.122" | |
| Sheath Length: | 55-75 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 Carotid Guiding Sheath. The equivalence was shown through bench and cadaver testing.
KOSIGOI
3
ADDITIONAL SAFETY INFORMATION I.
Sterilization conditions have been validated in accordance with ANSI / AAMI / ISO 11135-1994 to provide a Sterility Assurance Level of 106
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 Carotid Guiding Sheath (K012812), which is manufactured by Terumo Medical Corporation. 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.
KOS1601
p. 4 of S
4
SUBMITTER INFORMATION K.
and the same of the same of the same of the same of the same of the same of
Name and Address
Terumo Medical Corporation 950 Elkton Blvd. Elkton, MD 21921
Contact Person
Mr. Mark Unterreiner Regulatory Affairs Specialist Ph: 410-392-7213 Fax: 410-398-6079 Email: mark.unterreiner@terumomedical.com
Date Prepared
June 15, 2005
KOSI601 p. Soft
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/5/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
AUG 4 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Terumo Medical Corporation c/o Mr. Mark Unterreiner Regulatory Affairs Specialist 950 Elkon Blvd. Elkton, MD 21921
Re: K051601
Pinnacle Destination Peripheral Guiding Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II (Two) Product Code: DYB Dated: June 15, 2005 Received: June 16, 2005
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.
6
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 (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. 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Dmna R. Lochner
1Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use
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 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)
Duna R. bochner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_¥05|60 |
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