(62 days)
Not Found
No
The description focuses on the physical components and mechanical function of an introducer sheath and its accessories. There is no mention of software, algorithms, or any capabilities that would suggest the use of AI or ML.
No.
The device facilitates the placement of other catheters and provides support, but it does not directly treat a disease or condition itself.
No
Explanation: The device is an introducer sheath used to facilitate the placement of a catheter into a vein or artery. Its function is to gain access and maintain a pathway, not to diagnose a condition or disease. While it is visible under fluoroscopy (an imaging modality), this visibility is for placement guidance, not for diagnostic imaging itself.
No
The device description clearly details physical components made of ETFE tubing, a band, and mentions the use of RF welding. It also describes a Mini Guide Wire, Inserter, Dilator, and Obturator, all of which are physical medical devices. The summary focuses on the physical characteristics and use of these hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Pinnacle® RO11 HiFlow Introducer Sheath and its accessories are used to facilitate the placement of catheters directly into a vein or artery within the patient's body. This is an invasive procedure performed in vivo.
- Intended Use: The intended use clearly describes a procedure for accessing blood vessels for catheter placement, not for analyzing biological samples.
- Device Description: The description focuses on the physical components and how they are used to access and maintain access to blood vessels.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other elements typically associated with IVD devices.
Therefore, the Pinnacle® RO11 HiFlow Introducer Sheath is a medical device used for a surgical/interventional procedure, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Pinnacle® RO11 HiFlow Introducer Sheath is used to facilitate placing a catheter through the skin into a vein or artery. The Mini Guide Wire is an accessory device which is used for placement of the sheath into the vein or artery. The RADIFOCUS Obturator is also an accessory device which is used by placing it into the sheath to create an occlusion and further provide support to the wall of the indwelling sheath while it remains in place within the vein or artery after removal of a catheter.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
The introducer sheath consists of 2 pieces of ETFE tubing - a long segment and a short tip segment. The band is sandwiched between the two segments and radiofrequency (RF) welding is used to fuse the two segments together. The band is completely encapsulated within the tubing wall.
The PINNACLE R/O II HiFlow Introducer Sheath is used to facilitate placement of a catheter through the skin into a vein or artery. A Mini Guide Wire (with Inserter) may be included with the device. The Inserter does not contact blood and is used strictly for guiding the Guide Wire into a cannula or Introducer.
The Mini Guide Wire is inserted through a cannula placed in the patient's blood vessel. The PINNACLE R/O II HiFlow Introducer Sheath is 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 while the Introducer Sheath is being placed into the vessel. The Dilator can be removed and an appropriate catheter can then be inserted. The RADIFOCUS Obturator is an accessory device which creates an occlusion when inserted into the Sheath. The Obturator also provides support to the indwelling Sheath after the catheter is removed.
The Sheath, Dilator and Obturator contain bismuth, making these devices slightly visible under fluoroscopy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy
Anatomical Site
Vein or artery
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® ROII HiFlow Introducer Sheath is substantially equivalent to the performance of the predicate device K003424. The equivalence was shown through bench 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
The introducer sheath consists of 2 pieces of ETFE tubing - a long segment and a short tip segment. The band is sandwiched between the two segments and radiofrequency (RF) welding is used to fuse the two segments together. The band is completely encapsulated within the tubing wall.
The PINNACLE R/O II HiFlow Introducer Sheath is used to facilitate placement of a catheter through the skin into a vein or artery. A Mini Guide Wire (with Inserter) may be included with the device. The Inserter does not contact blood and is used strictly for guiding the Guide Wire into a cannula or Introducer.
The Mini Guide Wire is inserted through a cannula placed in the patient's blood vessel. The PINNACLE R/O II HiFlow Introducer Sheath is 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 while the Introducer Sheath is being placed into the vessel. The Dilator can be removed and an appropriate catheter can then be inserted. The RADIFOCUS Obturator is an accessory device which creates an occlusion when inserted into the Sheath. The Obturator also provides support to the indwelling Sheath after the catheter is removed.
The Sheath, Dilator and Obturator contain bismuth, making these devices slightly visible under fluoroscopy.
E. PRINCIPLE OF OPERATION / TECHNOLOGY
The Pinnacle® ROII HiFlow Introducer Sheaths operated manually or by a manual process.
F. DESIGN / MATERIALS
The Pinnacle® ROH Hill low Introducer 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.
1
Terumo Medical Corporation Special 510(k) – Pinnacle® ROII HiFlow Introducer Sheath Section II. 510(k) Summary
ਾਂ SPECIFICATIONS
| Sheath Sizes: | 6Fr. (0.087" nominal lumen size)
7Fr. (0.100" nominal lumen size)
8Fr. (0.115" nominal lumen size) |
|-----------------|----------------------------------------------------------------------------------------------------------|
| Sheath Length: | 4-110 cm |
| Dilator Length: | 5-110 cm |
| Guide Wire OD: | 0.021" - 0.038" |
H. PERFORMANCE
The performance of the Pinnacle® ROII HiFlow Introducer Sheath is substantially equivalent to the performance of the predicate device K003424. The equivalence was shown through bench testing.
2
Terumo Medical Corporation Special 510(k) – Pinnacle® ROII HiFlow Introducer Sheath Section II. 510(k) Summary
I. ADDITIONAL SAFETY INFORMATION
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 Pinnacle® ROII HiFlow Introducer Sheath is categorized as "Externally Communicating Device, Circulating Blood, Prolonged Contact (24hrs to 30 days)". The blood contacting materials were found to be biocompatible.
Expiration dating for the Pinnacle® ROII HiFlow Introducer Sheath will be 30 months.
J. SUBSTANTIAL EQUIVALENCE
The Pinnacle® ROII HiFlow Introducer Sheath submitted in this 510(k) is substantially equivalent in intended use, design, principle of operation / technology, materials and performance to the Pinnacle® ROII (K003424), which is also manufactured by Terumo Medical Corporation. Differences between the devices do not raise any issues of safety or effectiveness.
3
Terumo Medical Corporation Special 510(k) – Pinnacle® ROII HiFlow Introducer Sheath Section II. 510(k) Summary
SUBMITTER INFORMATION K.
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
August18, 2006
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle faces to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 3 2006
Terumo Medical Corporation c/o Mr. Mark Unterreiner Sr. Regulatory Affairs Specialist 125 Blue Ball Road Elkton, MD 21921
Re: K062446
Pinnacle® RO11 HiFlow Introducer Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: II Product Code: DYB Dated: September 25, 2006 Received: September 26, 2006
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 (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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Dina R. Lochner
Image /page/5/Picture/5 description: The image shows a black and white drawing of a symbol or abstract shape. The shape is composed of curved lines and appears to be a stylized representation of something, though its exact meaning is unclear. The lines are thick and bold, creating a strong contrast against the white background.
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 510(k) Number (if known): _
Pinnacle® ROII HiFlow Introducer Sheath Device Name:
Indications For Use:
The Pinnacle® RO11 HiFlow Introducer Sheath is used to facilitate placing a catheter through the skin into a vein or artery. The Mini Guide Wire is an accessory device which is used for placement of the sheath into the vein or artery. The RADIFOCUS Obturator is also an accessory device which is used by placing it into the sheath to create an occlusion and further provide support to the wall of the indwelling sheath while it remains in place within the vein or artery after removal of a catheter.
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. lahner
Division of Cardiovascular Devices
510(k) Number K 062