(519 days)
Not Found
No
The device description details a purely mechanical system for achieving hemostasis. There is no mention of any computational or data-driven components that would suggest the use of AI or ML.
Yes
The device is intended to promote hemostasis and provides site-specific compression to establish temporary hemostasis, aiding the body's natural clotting process. This falls under the definition of a therapeutic device as it treats a condition (bleeding at an arteriotomy site).
No
The device is designed to promote hemostasis at arteriotomy sites after catheterization procedures, and its description focuses on the mechanical process of achieving this, not on obtaining information about a patient's condition.
No
The device description clearly outlines physical components (Boomerang Wire, Boomerang Clip) and a mechanical mechanism for achieving hemostasis, indicating it is a hardware-based medical device. There is no mention of software as a component or function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to promote hemostasis at arteriotomy sites as an adjunct to manual compression. This is a therapeutic/mechanical function performed directly on the patient's body.
- Device Description: The description details a physical device (wire and clip) that is inserted into the artery to provide mechanical compression and support the body's natural clotting process. It does not involve the examination of specimens derived from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device operates directly on the patient's vascular system to achieve hemostasis.
N/A
Intended Use / Indications for Use
The Cardiva Medical Boomerang™ Wire System is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The Boomerang™ Wire System is indicated for use in patients undergoing diagnostic and/or interventional femoral artery catheterization procedures, using 5, 6 or 7 Fr introducer sheaths.
Product codes (comma separated list FDA assigned to the subject device)
DXC
Device Description
The Boomerang™ Wire System consists of a sterile disposable Boomerang Wire and a sterile disposable Boomerang Clip. In conjunction with manual compression, the Boomerang Wire System provides hemostasis at a femoral access site after femoral arterial catheterization while allowing continued distal perfusion. After completion of catheterization, the Boomerang Wire is inserted into the artery through the existing introducer sheath. After insertion, the distal tip of the Boomerang Wire is deployed, which open the flat, low-profile Boomerang Disc within the lumen of the femoral artery. The Boomerang Disc is then pulled back gently to the distal end of the introducer sheath. The introducer sheath is then removed from the vessel over the Boomerang Wire and the low-profile Boomerang Disc is positioned against the inside of the arteriotomy. Gentle upward tension is applied to the Boomerang Wire, which conforms the Boomerang Disc to the contours of the vessel and secures it against the intima, sealing the arteriotomy. The tension is then held in place by the external Boomerang Clip at the surface of the skin at the puncture site. The tension between the Boomerang Disc and the Boomerang Clip creates a site-specific compression of the arteriotomy and tract and establishes temporary hemostasis. This allows natural recoil of the smooth muscle of the vessel wall to occur at the arteriotomy site while the body's natural clotting process begins. Following the procedure, the Boomerang Disc is collapsed and the Boomerang Wire is completely removed for the artery. No part of the device is left behind nor is there any material introduced to alter the body's own natural clotting process. Final closure of the vessel occurs with manual compression to close the remaining needle puncture site left by removing the Boomerang Wire.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral artery, arteriotomy site
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)
Various testing which included bench, biocompatibility, and animal testing was performed on the Boomerang Wire System to ensure the product and the product materials were adequately test and evaluated to demonstrate the product meets or exceeds the performance requirements and is safe and effective for its intended use. In addition, post market clinical data have been included to further support that the product meets or exceeds the performance requirements and is safe and effective for its intended use.
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
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).
0
510(k) SUMMARY Cardiva Medical, Inc. Boomerang™ Wire System 510(k) Notification K051817
CEL - 6 2006
GENERAL INFORMATION
| Manufacturer: | Cardiva Medical, Inc.
2585 Leghorn Street
Mountain View, CA 94043
Phone: (650) 964-8900
Facsimile: (650) 964-8911
Establishment Registration Number: 3004182619 |
| --------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
- Contact Person: Glenn Foy President
- Date Prepared: 11/21/2006
DEVICE INFORMATION
| Trade Name: | Boomerang™ Wire System |
|---|---|
| Classification Names: | Vascular Clamp (21 CFR §870.4450) |
| Catheter, Intravascular, Diagnostic (21 CFR §870.1200) | |
| Surgical Vessel Dialator (21 CFR §870.4475) | |
| Blood Access Device and Accessories (21 CFR §870.5540) | |
| Classification: | Class II |
PREDICATE DEVICES
Cardiva Medical VasoStasis Vascular Closure System (K041486) Radi Medical Systems AB, FemoStop™ System (K915280) CardioThoracic Systems, Inc., CTS FloCoil™ Shunt (K970638)
INTENDED USE/INDICATIONS FOR USE
The Cardiva Medical Boomerang™ Wire System is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The Boomerang™ Wire System is indicated for use in patients undergoing diagnostic and/or interventional femoral artery catheterization procedures, using 5, 6 or 7 Fr introducer sheaths.
1
DEVICE DESCRIPTION
The Boomerang™ Wire System consists of a sterile disposable Boomerang Wire and a sterile disposable Boomerang Clip. In conjunction with manual compression, the Boomerang Wire System provides hemostasis at a femoral access site after femoral arterial catheterization while allowing continued distal perfusion. After completion of catheterization, the Boomerang Wire is inserted into the artery through the existing introducer sheath. After insertion, the distal tip of the Boomerang Wire is deployed, which open the flat, low-profile Boomerang Disc within the lumen of the femoral artery. The Boomerang Disc is then pulled back gently to the distal end of the introducer sheath. The introducer sheath is then removed from the vessel over the Boomerang Wire and the low-profile Boomerang Disc is positioned against the inside of the arteriotomy. Gentle upward tension is applied to the Boomerang Wire, which conforms the Boomerang Disc to the contours of the vessel and secures it against the intima, sealing the arteriotomy. The tension is then held in place by the external Boomerang Clip at the surface of the skin at the puncture site. The tension between the Boomerang Disc and the Boomerang Clip creates a site-specific compression of the arteriotomy and tract and establishes temporary hemostasis. This allows natural recoil of the smooth muscle of the vessel wall to occur at the arteriotomy site while the body's natural clotting process begins. Following the procedure, the Boomerang Disc is collapsed and the Boomerang Wire is completely removed for the artery. No part of the device is left behind nor is there any material introduced to alter the body's own natural clotting process. Final closure of the vessel occurs with manual compression to close the remaining needle puncture site left by removing the Boomerang Wire.
SUBSTANTIAL EQUIVALENCE
The Boomerang Wire System is substantially equivalent to predicate devices currently being marketed. The marketed predicates are identified above. The Boomerang Wire System is substantially equivalent to the predicate devise with regard to function, intended use, physical characteristics, materials and performance testing.
All necessary testing was performed on the Boomerang Wire System to ensure the product is substantially equivalent to the predicates and that any differences do not have a significant effect on safety and effectiveness.
PERFORMANCE TESTING
Various testing which included bench, biocompatibility, and animal testing was performed on the Boomerang Wire System to ensure the product and the product materials were adequately test and evaluated to demonstrate the product meets or exceeds the performance requirements and is safe and effective for its intended use. In addition, post market clinical data have been included to further support that the product meets or exceeds the performance requirements and is safe and effective for its intended use.
CONCLUSION
The Boomerang Wire System was properly designed, tested and shown to be substantially equivalent to the identified predicate devices.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 6 2006
Cardiva Medical, Inc. c/o Mr. Glenn Foy President 2585 Leghorn Street Mountain View, CA 94043
Re: K051817
Boomerang™ Wire System Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: DXC Dated: September 15, 2006 Received: September 18, 2006
Dear Mr. Foy:
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 cither 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 - Mr. Glenn Foy
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 (OS) 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,
Bram D. Zackerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K051817
Device Name: Boomerang™ Wire System
Indications for Use:
The Boomerang™ Wire System is intended to promote hemostasis at an arteriotomy site as an adjunct to manual compression. The Boomerang™ Wire System is indicated for use in patients undergoing diagnostic and/or interventional femoral artery catheterization procedures using 5, 6 or 7 Fr introducer sheaths.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular Devices | |
| 510(k) Number | K051617 |