(44 days)
Not Found
No
The summary describes a physical medical device (guiding sheath) and its components, with no mention of software, algorithms, or AI/ML capabilities. The performance studies focus on physical equivalence.
No.
The device is described as a guiding sheath intended for introducing other interventional and diagnostic devices, not for directly treating a condition itself.
Yes
The "Intended Use / Indications for Use" states that the device is intended for the introduction of "interventional and diagnostic devices" into human vasculature. While the device itself is an introducer, its function is directly related to enabling the use of diagnostic devices.
No
The device description explicitly lists physical components (Sheath, Dilator, Hemostatic Valve, Dilator Retaining Clip) and the performance studies involve bench and vessel model testing, indicating a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the introduction of interventional and diagnostic devices into the human vasculature. This describes a device used in vivo (within the living body) for procedures, not a device used in vitro (outside the living body) to examine specimens like blood or tissue.
- Device Description: The description of the components (sheath, dilator, valve) aligns with a device used for accessing and navigating blood vessels during medical procedures.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to facilitate access and delivery of other devices within the body.
N/A
Intended Use / Indications for Use
The Destination® 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.
Product codes
DYB
Device Description
The Destination® Renal Guiding Sheath is designed to perform as a guiding catheter and an introducer sheath. The Guiding Sheath is packaged with the following components: a Sheath, a Dilator, a Hemostatic Valve, and a Dilator Retaining Clip.
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 the Renal Arteries.
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
The performance of the Destination® Renal Guiding Sheath is substantially equivalent to the performance of the unmodified Renal Guiding Sheath. The equivalence was shown through bench and vessel model testing.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K08/045 100% Lot 4
Terumo Medical Corporation Special 510(k)- Destination® Renal Guiding Sheath Section II. 510(k) Summary
MAY 2 8 2008
SECTION II. 510(k) SUMMARY
A. DEVICE NAME
Proprietary Name: Destination® Renal Guiding Sheath Classification Name: Catheter Introducer Common Name: Guiding Sheath
B. PREDICATE DEVICE
The predicate device is the Renal Guiding Sheath, which is manufactured by Terumo Medical Corporation. The Renal Guiding Sheath is cleared through the premarket notification process (K012854).
C. INTENDED USE
The Destination® 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 Destination® Renal Guiding Sheath is designed to perform as a guiding catheter and an introducer sheath. The Guiding Sheath is packaged with the following components: a Sheath, a Dilator, a Hemostatic Valve, and a Dilator Retaining Clip.
1
E. PRINCIPLE OF OPERATION / TECHNOLOGY
The Destination® Renal Guiding Sheath is operated manually or by a manual process.
F. DESIGN / MATERIALS
The Destination® Renal 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.
G. SPECIFICATIONS
| Sheath Size: | 5Fr. |
|---|---|
| Sheath Length: | 45-55 cm |
| Hydrophilic Coating: | Distal 5 cm |
| Distal Shape Configurations: | Straight, HS, RDC, LIMA, MP |
H. PERFORMANCE
The performance of the Destination® Renal Guiding Sheath is substantially equivalent to the performance of the unmodified Renal Guiding Sheath. The equivalence was shown through bench and vessel model testing.
2
Terumo Medical Corporation Special 510(k)- Destination® Renal Guiding Sheath Section II. 510(k) Summary
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 Destination® 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 Destination® Renal Guiding Sheath will be 30 months.
J. SUBSTANTIAL EQUIVALENCE
The Destination® Renal Guiding Sheath submitted in this 510(k) is substantially equivalent in intended use, design, principle of operation / technology, materials and performance to the Renal Guiding Sheath (K012854), which is manufactured by Terumo Medical Corporation. Differences between the devices do not raise any issues of safety or effectiveness.
3
KOE 1045 page let y
Terumo Medical Corporation Special 510(k)- Destination® Renal Guiding Sheath Section II. 510(k) Summary
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
. "A
. . .
Date Prepared
April 11, 2008
.
4
Public Health Service
Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure, with its wings forming a flowing, abstract shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 8 2008
Terumo Medical Corporation c/o Mr. Mark Unterreiner Sr. Regulatory Affairs Specialist 950 Elkton Blvd. Elkton, MD 21921
Re: K081045
Trade/Device Name: Destination Renal Guiding Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class; Class II (two) Product Code: DYB Dated: May 19, 2008 Received: May 20, 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.
5
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 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,
uma R.v.luhner
A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
6
Indications for Use
| 510(k) Number (if known): | K081045 |
|---|---|
| --------------------------- | --------- |
Destination® Renal Guiding Sheath Device Name:
Indications For Use:
The Destination® 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.
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)
Anna R. Kirchner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_ Ko81045