(30 days)
Not Found
No
The device description details a mechanical system for achieving hemostasis and does not mention any computational or data-driven components indicative of AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No
A therapeutic device is typically one that treats or cures a disease or condition. This device promotes hemostasis as an adjunct and provides temporary hemostasis, allowing the body's natural clotting process to begin. It does not treat a medical condition on its own but rather assists in the body's natural healing process.
No
Explanation: The device is intended to promote hemostasis at arteriotomy sites, which is a therapeutic function, not a diagnostic one. It is used as an adjunct to manual compression after catheterization procedures.
No
The device description clearly details physical components (Boomerang Plus Wire, Boomerang Clip, Boomerang Disc, introducer sheath) and a mechanical mechanism of action for achieving hemostasis. There is no mention of software as a component or function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Boomerang™ Wire/PlusWire System is a medical device used in vivo (within the body) to physically promote hemostasis (stop bleeding) at an arteriotomy site after a catheterization procedure. It works by applying mechanical pressure and facilitating the body's natural clotting process.
- Lack of Sample Analysis: The device does not analyze any biological samples taken from the patient. It is a physical tool used during a medical procedure.
Therefore, the function and intended use of the Boomerang™ Wire/PlusWire System clearly fall outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Boomerang™ Wire/PlusWire System is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The Boomerang™ Wire/PlusWire System is indicated for use in patients undergoing diagnostic and/or interventional femoral artery catheterization procedures using 5F, 6F or 7F introducer sheaths.
Product codes (comma separated list FDA assigned to the subject device)
DXC
Device Description
The Boomerang™ Plus Wire System is an extension of the Boomerang Wire System family of devices. The Boomerang Plus Wire System is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The Boomerang™ Plus Wire System includes design modifications to enhance ease of device removal and to minimize ooze from the tissue tract. The Boomerang Plus Wire System maintains the same indication for use as the Boomerang Wire System family of devices.
The Boomerang Plus Wire System consists of a sterile disposable Boomerang Plus Wire and a sterile disposable Boomerang Clip. In conjunction with manual compression, the Boomerang PlusWire System provides temporary hemostasis at a femoral access site after femoral arterial catheterization while allowing continued distal perfusion. After completion of catheterization, the Boomerang Plus Wire is inserted into the artery through the existing introducer sheath. After insertion, the distal tip of the Boomerang Plus Wire is deployed, which opens 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 Plus Wire and the low-profile Boomerang Disc conforms to the contours of the vessel and secures it against the intima, sealing the arteriotomy. As gentle tension is applied to the Boomerang Plus Wire, the sleeve covering the tensioning coil is gently retracted until the distal tip appears at the skin surface to expose the coated tensioning coil to the tissue tract. The applied tension is maintained 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 Plus Wire is completely removed from the artery. No part of the device is left behind. Final closure of the arteriotomy occurs by applying gentle manual or mechanical compression after removal of the Boomerang Plus Wire System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
arteriotomy sites, femoral artery, femoral access 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, animal and clinical testing was performed on the Boomerang Plus Wire System to insure the product and the product materials were adequately tested and evaluated to demonstrate 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
MAR 2 2 2007
Section II. 510(k) Summary
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 (Glenn Foy, President)
- Contact Person: Michael J. Billig Regulatory Consultant Experien Group Phone: 408-400-0856 Facsimile: 408-400-0865
- Date Prepared: February 16, 2007
DEVICE INFORMATION
| Trade Name: | Cardiva Medical Boomerang™ Plus Wire System |
|---|---|
| Classification Names: | Vascular Clamp (21 CFR §870.4450) |
| Classification: | Class II |
PREDICATE DEVICES
Cardiva Medical Boomerang™ Wire System (K051817)
INTENDED USE/INDICATIONS FOR USE
The Boomerang™ Wire/PlusWire System is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The Boomerang™ Wire/PlusWire System is indicated for use in patients undergoing diagnostic and/or interventional femoral artery catheterization procedures using 5F, 6F or 7F introducer sheaths.
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DEVICE DESCRIPTION
The Boomerang™ Plus Wire System is an extension of the Boomerang Wire System family of devices. The Boomerang Plus Wire System is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The Boomerang™ Plus Wire System includes design modifications to enhance ease of device removal and to minimize ooze from the tissue tract. The Boomerang Plus Wire System maintains the same indication for use as the Boomerang Wire System family of devices.
The Boomerang Plus Wire System consists of a sterile disposable Boomerang Plus Wire and a sterile disposable Boomerang Clip. In conjunction with manual compression, the Boomerang PlusWire System provides temporary hemostasis at a femoral access site after femoral arterial catheterization while allowing continued distal perfusion. After completion of catheterization, the Boomerang Plus Wire is inserted into the artery through the existing introducer sheath. After insertion, the distal tip of the Boomerang Plus Wire is deployed, which opens 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 Plus Wire and the low-profile Boomerang Disc conforms to the contours of the vessel and secures it against the intima, sealing the arteriotomy. As gentle tension is applied to the Boomerang Plus Wire, the sleeve covering the tensioning coil is gently retracted until the distal tip appears at the skin surface to expose the coated tensioning coil to the tissue tract. The applied tension is maintained 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 Plus Wire is completely removed from the artery. No part of the device is left behind. Final closure of the arteriotomy occurs by applying gentle manual or mechanical compression after removal of the Boomerang Plus Wire System.
SUBSTANTIAL EQUIVALENCE
The Boomerang PlusWire System is substantially equivalent to the predicate device with regard to function, intended use, physical characteristics and performance testing.
PERFORMANCE TESTING
Various testing which included bench, biocompatibility, animal and clinical testing was performed on the Boomerang Plus Wire System to insure the product and the product materials were adequately tested and evaluated to demonstrate the product meets or exceeds the performance requirements and is safe and effective for its intended use.
2
CONCLUSION
The Boomerang PlusWire System was properly designed, tested and shown to be substantially equivalent to the identified predicate device.
3
Image /page/3/Picture/2 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
MAR 2 7 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Michael J. Billig Regulatory Consultant for Cardiva Medical Experien Group, LLC 155-A Moffett Park Drive Suite A-101 Sunnyvale, CA 94098
Re: K070485
Trade/Device Name: Cardiva Medical Boomerang PlusWire System Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: II (two) Product Code: DXC Dated: February 16, 2007 Received: February 20, 2007
Dear Mr. Billig:
This letter corrects our substantially equivalent letter of March 22, 2007. 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 (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
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Page 2 - Mr. Billig
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); 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 continue 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/dsma/dsmamain.html
Sincerely yours,
B. Bernimor for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
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Section I. Statement of Indications for Use
Statement of Indications for Use
510(k) Number (if known):_ K 070年85
Device Name: Cardiva Medical Boomerang™ PlusWire System
Indications for Use:
The Boomerang™ Wire/Plus Wire System is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The Boomerang™ Wire/Plus Wire System is indicated for use in patients undergoing diagnostic and/or interventional femoral artery catheterization procedures using 5F, 6F or 7F introducer sheaths.
Please Do Not Write Below This Line – Continue On Another Page If Needed
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
| Prescription Use | X | Division of Cardiovascular Devices | Over-the-counter Use | |
|---|---|---|---|---|
| Confidential | 510(k) Number | K070485 |
Danna R. Vachney
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