K Number
K092298
Device Name
MODIFICATION TO MODIFIED HD GUIDE CATHETER
Date Cleared
2009-11-05

(99 days)

Product Code
Regulation Number
870.1250
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Modified HD Guide Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary or neuro vascular systems. It may also be used as a diagnostic angiographic catheter.
Device Description
The Modified HD Guide Catheter consists of a single lumen, braided, variable stiffness shaft with a radiopaque marker on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use. A rotating hemostatic valve with side-arm adapter is provided with each catheter.
More Information

Not Found

No
The summary describes a physical catheter and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.

No

The device is a guide catheter used to facilitate the insertion and guidance of other catheters; it is not directly delivering a therapeutic effect.

Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "It may also be used as a diagnostic angiographic catheter."

No

The device description clearly outlines a physical catheter with a shaft, radiopaque marker, luer hub, and hydrophilic coating, indicating it is 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 clearly describes the device as being used in vivo (within the body) to facilitate the insertion and guidance of other catheters into blood vessels and for diagnostic angiography. IVDs are used in vitro (outside the body) to examine specimens like blood, urine, or tissue.
  • Device Description: The description details a catheter designed for insertion into the vascular system, not for analyzing biological samples.
  • Lack of IVD Characteristics: There is no mention of reagents, assays, or any other components typically associated with IVD devices used for testing biological specimens.

Therefore, the Modified HD Guide Catheter 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 Modified HD Guide Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary or neuro vascular systems. It may also be used as a diagnostic angiographic catheter.

Product codes

DOY

Device Description

The Modified HD Guide Catheter consists of a single lumen, braided, variable stiffness shaft with a radiopaque marker on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use. A rotating hemostatic valve with side-arm adapter is provided with each catheter.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

peripheral, coronary or neuro vascular systems

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 results of verification and validation conducted on the Modified HD Guide Catheter demonstrate that it performs as designed, is suitable for its intended use and is substantially equivalent to the predicate device.

Key Metrics

Not Found

Predicate Device(s)

K080583

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).

0

K0922987

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

General Information

NOV - 5 2009

Trade NameModified HD Guide Catheter
Common NamePercutaneous Catheter
ClassificationPercutaneous Catheter, 21CFR 870.1250 – Class II
SubmitterConcentric® Medical, Inc.
301 E. Evelyn Avenue
Mountain View, CA 94041
Tel 650-938-2100
Fax 650-938-2700
ContactKirsten Valley
Senior Vice President, Technology & Regulatory Affairs

Intended Use

The Modified HD Guide Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary or neuro vascular systems. It may also be used as a diagnostic angiographic catheter.

Predicate Device

HD Guide Catheter, K080583

Device Description

The Modified HD Guide Catheter consists of a single lumen, braided, variable stiffness shaft with a radiopaque marker on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use. A rotating hemostatic valve with side-arm adapter is provided with each catheter.

Materials

1

All materials used in the manufacture of the Modified HD Guide Catheter are suitable for the intended use of the device and have been used in numerous previously cleared products.

Testing Summary

The results of verification and validation conducted on the Modified HD Guide Catheter demonstrate that it performs as designed, is suitable for its intended use and is substantially equivalent to the predicate device.

Summary of Substantial Equivalence

The Modified HD Guide Catheter is substantially equivalent to the predicate device with regard to device design, intended use, patient population and anatomical site. Any differences in technological characteristics between the Modified HD Guide Catheter and the predicate device do not raise any new issues of safety or effectiveness.

1

Image /page/1/Picture/1 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 a stylized image of an eagle or bird-like figure, with its wings spread and head turned to the side.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

NOV - 5 2009

Concentric Medical c/o Ms. Kirsten Valley 301 East Evelyn Avenue Mountain View, CA 94041

Re: K092298

Trade/Device Name: Modified HD Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: October 22, 2009 Received: October 27, 2009

Dear Ms. Valley:

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 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.

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); medical device reporting (reporting of medical

2

Page 2 - Ms. Kirsten Valley

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

uma R. bulmer

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):This application K092298
Device Name:Modified HD Guide Catheter
Indications for Use:The Modified HD Guide Catheter is indicated for use in
facilitating the insertion and guidance of an occlusion catheter
infusion catheter or other appropriate microcatheter into a
selected blood vessel in the peripheral, coronary or neuro
vascular systems. It may also be used as a diagnostic
angiographic catheter.

Prescription Use _X (Per 21 CFR 801.109) AND/OR

Over-The-Counter Use (Optional Format 1-2-96)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

D.R.V
Division Sign-Off

(Division Sign-Off) (Division Sign-Off)
(Division Sign-Off)
Division of Cardiovascular Devices (L.S.

Division of
510(k) Number K092298