(177 days)
Terumo Pinnacle Destination, Cook Shuttle/Flexor
Not Found
No
The summary describes a mechanical guiding sheath and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is described as guiding sheaths "intended for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices." This indicates it's an accessory to facilitate other procedures, not a device that directly treats a condition.
No
This device is described as a "Peripheral Guiding Sheath" intended for percutaneous introduction of intravascular devices in arterial and venous procedures. Its function is to facilitate the insertion of other tools, not to diagnose a condition or disease. The description focuses on its physical characteristics (materials, dimensions, kinking reduction) and mechanical testing, without any mention of analyzing physiological data, providing medical information, or aiding in diagnosis.
No
The device description clearly describes a physical catheter with material components (Pebax, stainless steel wire coil) and physical dimensions (Fr sizes, lengths), indicating it is a hardware 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 "percutaneous introduction of intravascular devices" in arterial and venous procedures. This describes a device used within the body for delivering other devices, not for testing samples outside the body to diagnose conditions.
- Device Description: The description details a catheter with a reinforced body and specific dimensions and shapes. This aligns with a physical device used for access and guidance within blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.), detect biomarkers, or provide diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely procedural and interventional.
N/A
Intended Use / Indications for Use
Micrus Design Technology Peripheral Guiding Sheaths are intended for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
The Micrus Design Technology Peripheral Guiding Sheaths are single lumen catheters, incorporating a Pebax® body reinforced with a stainless steel wire coil. The intermediate segment is also Pebax® with a stainless steel coil to reduce kinking and to promote improved torque response. They are available in 5 Fr, 6Fr, 7Fr, and 8 Fr and 45 cm, 55 cm and 90 cm in length, and in a variety of shapes. The technological characteristics are equivalent to the predicate device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Mechanical laboratory testing has been performed on the Micrus Design Technology Peripheral Guiding Sheaths to assure compliance to the specifications. In addition, testing has been performed on the materials to assure biocompatibility.
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.
Terumo Pinnacle Destination, Cook Shuttle/Flexor
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
Kono816 P. Loff
Section 5: 510(k) Summary
SEP 1 9 2007
| Submitter's
Information | Micrus Design Technology
9344 NW 13 Street
Miami, Florida 33172 USA
Telephone: 1-305-477-2406
Contact: Marianne Grunwaldt, MS, CQE |
|--------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Preparation Date | 19 March 2007 |
| Name of Device | Common/Classification Name: Catheter Introducer
Trade Name: Micrus Design Technology Peripheral Guiding Sheath |
| Predicate Devices | Terumo Pinnacle Destination
Cook Shuttle/Flexor |
| Intended Use | Micrus Design Technology Peripheral Guiding Sheaths are intended for
use in arterial and venous procedures requiring percutaneous introduction
of intravascular devices. |
| Device Description
and Summary of
Technological
Characteristics | The Micrus Design Technology Peripheral Guiding Sheaths are single
lumen catheters, incorporating a Pebax® body reinforced with a stainless
steel wire coil. The intermediate segment is also Pebax® with a stainless
steel coil to reduce kinking and to promote improved torque response.
They are available in 5 Fr, 6Fr, 7Fr, and 8 Fr and 45 cm, 55 cm and 90
cm in length, and in a variety of shapes. The technological characteristics
are equivalent to the predicate device. |
| Testing Summary | Mechanical laboratory testing has been performed on the Micrus Design
Technology Peripheral Guiding Sheaths to assure compliance to the
specifications. In addition, testing has been performed on the materials to
assure biocompatibility. |
| Conclusions | The non-clinical tests as discussed above demonstrate that, like the
predicate devices, the Micrus Design Technology Peripheral Guiding
Sheath is safe and effective for its intended use. |
.
:
1
Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 9 2007
Micrus Design Technology, Inc. c/o Ms. Marianne Grunwaldt, MS, CQE Product Assurance Engineer 9344 NW 13 Street Miami, FL 33172
Re: K070816
Trade/Device Name: Peripheral Guiding Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II Product Code: DYB Dated: July 25, 2007 Received: July 27, 2007
Dear Ms. Grunwaldt:
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 devire can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, TDA max publish further announcements concerning your device in the Federal Register.
2
Page 2 - Ms. Marianne Grunwaldt
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.
Dana R. Rohner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): Ko 40816
Device Name: Micrus Design Technology Peripheral Guiding Sheath
Indications for Use:
Micrus Design Technology Peripheral Guiding Sheaths are indicated for arterial and venous procedures requiring percutaneous introduction of intravascular devices.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duna R. Varliner
(Division Si Off) Division In Cardiovascular Devices
510(k) Number Ko 70816
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