(388 days)
No
The device description and intended use focus on mechanical components and visualization techniques, with no mention of AI or ML.
No.
The device is used for temporary occlusion of vessels for diagnostic or procedural purposes (e.g., arteriography, blocking blood flow), not for directly treating a disease or condition.
No
The device is used for temporary occlusion of large vessels and not for diagnosing a condition. Its uses include arteriography, preoperative occlusion, and emergency controlled hemorrhage procedures. While it aids in visualization, its primary function is therapeutic or procedural, not diagnostic.
No
The device description clearly outlines physical components like a catheter shaft, lumens, balloon material, radiopaque markers, and a 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 is for "temporary occlusion of large vessels in applications such as arteriography, preoperative occlusion, and emergency controlled hemorrhage procedures." This describes a therapeutic or interventional procedure performed directly on a patient's body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a catheter with a balloon designed to be inserted into blood vessels for physical manipulation (occlusion). This is consistent with an interventional device, not a diagnostic test kit or instrument used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to physically interact with the patient's vascular system for therapeutic or procedural purposes.
N/A
Intended Use / Indications for Use
The SentreHeart Occlusion Balloon Catheter is intended for temporary occlusion of large vessels in applications such as arteriography, preoperative occlusion, and emergency controlled hemorrhage procedures.
Product codes
DQY
Device Description
The Occlusion Balloon Catheter consists of a catheter shaft with two independent lumens upon which an expandable balloon material is bonded. The "Guide Wire" lumen extends the length of the catheter and is used for placement of guide wires and injection of contrast for angiographic visualization. The "Balloon" lumen is used to inflate and deflate the balloon. Radiopaque markers at the location of the balloon provide fluoroscopic visualization of balloon placement. The outer diameter of the catheter shaft is coated with a hydrophilic polymer that reduces friction during manipulation in the vessel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
large vessels
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)
Functional testing was conducted to support the claim of substantial equivalence and to demonstrate the Occlusion Balloon Catheter is safe and effective for its intended use.
The materials used in the Occlusion Balloon Catheter are commonly used materials in other medical devices. Results of testing demonstrate the Occlusion Balloon Catheter is biocompatible.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
CODA Balloon Catheter, Cook Corp (K032869), Equalizer Balloon Catheter, Boston Scientific (K021721), Sentry Balloon Catheter, Boston Scientific (993292)
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
SECTION 4 - 510(K) SUMMARY
This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
510(k) number: K070126
8 % .
Date Prepared: January 10, 2007 Revised February 5, 2008
Applicant Information: SentreHeart 2468 Embarcadero Way Palo Alto, CA 94303
Contact Person: Linda Guthrie, Manager Regulatory Affairs Phone Number: (650) 354-1200 (650) 354-1204 Fax Number:
Device Information:
| Trade Name: | Occlusion Balloon Catheter |
|---|---|
| Classification: | Class II per 21CFR 870.1250 |
| Classification Name: | Catheter, Percutaneous |
| Product Code: | DQY |
Physical Description:
The Occlusion Balloon Catheter consists of a catheter shaft with two independent lumens upon which an expandable balloon material is bonded. The "Guide Wire" lumen extends the length of the catheter and is used for placement of guide wires and injection of contrast for angiographic visualization. The "Balloon" lumen is used to inflate and deflate the balloon. Radiopaque markers at the location of the balloon provide fluoroscopic visualization of balloon placement. The outer diameter of the catheter shaft is coated with a hydrophilic polymer that reduces friction during manipulation in the vessel.
Intended Use:
The SentreHeart Occlusion Balloon Catheter is intended for temporary occlusion of large vessels in applications such as arteriography, preoperative occlusion, and emergency controlled hemorrhage procedures.
1
SECTION 4 - 510(K) SUMMARY
Predicate Devices: CODA Balloon Catheter, Cook Corp (K032869) Equalizer Balloon Catheter, Boston Scientific (K021721) Sentry Balloon Catheter, Boston Scientific (993292)
Safety and Performance:
Performance
Functional testing was conducted to support the claim of substantial equivalence and to demonstrate the Occlusion Balloon Catheter is safe and effective for its intended use.
Biocompatibility
The materials used in the Occlusion Balloon Catheter are commonly used materials in other medical devices. Results of testing demonstrate the Occlusion Balloon Catheter is biocompatible.
Summary:
Based on the intended use, product testing, and information provided in this notification, the subject device has been shown to be safe and effective for its intended use and substantially equivalent to the predicate devices.
2
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized depiction of an eagle or bird-like figure. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the emblem. The emblem itself is composed of three curved lines that form the shape of a bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FFB -8 908
SentreHeart Inc. c/o Ms. Linda Guthrie Manager, Regulatory Affairs 2468 Embarcadero Way Palo Alto, CA 94303
Re: K070126
Occlusion Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: February 1, 2008 Received: February 4, 2008
Dear Ms. Guthrie:
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.
3
Page 2 - Ms. Linda Guthrie
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,
Duna R. Vochner
A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
and the state of the same of the same of the many of the same of the same of the same of
SECTION 3 - INDICATIONS FOR USE STATEMENT
510(k) Number (if known): ______ K070126
Device Name: Occlusion Balloon Catheter
Indications for Use: The SentreHeart Occlusion Balloon Catheter is intended for temporary occlusion of large vessels in applications such as arteriography, preoperative occlusion, and emergency controlled hemorrhage procedures.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)
Duna R. h. Lunes
ivision of Cardiovascular Devices
510(k) Number_k o
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