(74 days)
Not Found
No
The device description and performance studies focus on the mechanical aspects of fluid infusion and dispersion, with no mention of AI or ML technologies.
No
The device is used for the "infusion of physician-specified fluids, including thrombolytics," which are therapeutic substances, but the device itself is for "controlled and selective infusion" and fluid dispersal, making it a delivery system rather than a therapeutic device that directly treats a condition.
No
The device is described as an infusion system used to deliver physician-specified fluids into the peripheral vasculature, which is a therapeutic function, not a diagnostic one.
No
The device description clearly describes a physical catheter with multiple lumens and a guidewire, indicating it is a hardware device, not software-only.
Based on the provided information, the SpiralFuse Peripheral Infusion System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "controlled and selective infusion of physician-specified fluids... into the peripheral vasculature." This describes a therapeutic intervention performed within the patient's body (in vivo).
- Device Description: The description details a catheter designed for delivering fluids directly into blood vessels. This is a medical device used for treatment, not for testing samples outside the body (in vitro).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The SpiralFuse Peripheral Infusion System's function is to deliver substances into the body, which is a therapeutic or interventional use, not a diagnostic one.
N/A
Intended Use / Indications for Use
The SpiralFuse Peripheral Infusion System is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
QEY, KRA
Device Description
The SpiralFuse Peripheral Infusion System is a simpler version of the Trellis catheter that enables the physician to infuse fluids to a treatment region and disperse the fluid through a treatment region. The SpiralFuse is a multi-lumen catheter with an infusion lumen with holes located along the treatment zone to disperse the infused fluid. The other lumen is a through-lumen that is compatible with a 0.035" guidewire. The shaped infusion lumen is deployed once catheter position is achieved. The device is introduced through a standard 6F introducer sheath and passed over a 0.035" guidewire to the treatment site. Then, physicians will infuse fluid and allow it to disperse. Device removal is the same as the predicates.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature
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)
The SpiralFuse Peripheral Infusion System was tested in the same manner as the Trellis-6. All components, subassemblies, and/or full devices met the required specifications for the completed tests.
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
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the agency's name, "U.S. Food & Drug Administration."
November 22, 2021
Bacchus Vascular, Inc. Bob McRae VP. Research & Business Development 3110 Coronado Dr. Santa Clara, California 95054
Re: K082199
Trade/Device Name: SpiralFuse Peripheral Infusion System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEY, KRA
Dear Bob McRae:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated October 17, 2008. Specifically, FDA is updating this SE Letter as an administrative correction because FDA has created a new product code to better categorize your device technology.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Gregory O'Connell, OHT2: Office of Cardiovascular Devices, (301) 796-6075, Gregory.Oconnell(@FDA.HHS.gov.
Sincerely,
Digitally signed by Gregory W. Gregory W. O'connell -S O'connell -S Date: 2021.11.22 13:38:29 -05'00'
Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is simple and monochromatic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 7 7 2008
Bacchus Vascular, Inc. c/o Mr. Bob McRac 3110 Coronado Drive Santa Clara, CA 95054
Re: K082199
SpiralFuse Infusion System Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: August 1, 2008 Received: August 4, 2008
Dear Mr. McRae:
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.
2
Page 2 - Mr. Bob McRae
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" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (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,
R. Lohner
Bra
Dir
A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Attachment E: Indications for Use
510(k) Number (if known):
Device Name:
Indications for Use:
SpiralFuse™ Peripheral Infusion System
SpiralFuse Peripheral Infusion System is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
Prescription Use X
Over-The-Counter Use
(Optional Format 1-2-96) ·
(Per 21 CFR 801.109)
PLEASE DO NOT WRITE BELOW THIS LINE -(CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duma R. de Aume
(Division Sign-Off) (Division Orginial Cardiovascular Devices
510(k) Number K082199
Confidential
4
Attachment F: 510(k) Summary
(OC 1 7 2008
let 1
Date Prepared:
June 20, 2008
General Information
| Class | Class II |
|---|---|
| Trade Name | The SpiralFuse Peripheral Infusion System |
| Submitter | Bacchus Vascular, Inc |
| 3110 Coronado Drive | |
| Santa Clara, CA 95054 | |
| Tel: 408-980-8300 | |
| Fax: 408-980-8383 | |
| Contact | Bob McRae |
| VP, Research & Business Development |
Intended Use: The SpiralFuse Peripheral Infusion System is intended for controlled and selective infusion of physician specified fluids, including thrombolytics, into the peripheral vasculature.
Trellis-6 Infusion System K071664 Bacchus Vascular, Inc Predicate Device:
- Device Description: The SpiralFuse Peripheral Infusion System is a simpler version of the Trellis catheter that enables the physician to infuse fluids to a treatment region and disperse the fluid through a treatment region. The SpiralFuse is a multi-lumen catheter with an infusion lumen with holes located along the treatment zone to disperse the infused fluid. The other lumen is a through-lumen that is compatible with a 0.035" guidewire. The shaped infusion lumen is deployed once catheter position is achieved. The device is introduced through a standard 6F introducer sheath and passed over a 0.035" guidewire to the treatment site. Then, physicians will infuse fluid and allow it to disperse. Device removal is the same as the predicates.
- Materials: All materials used in the manufacture of the SpiralFuse Peripheral Infusion System are suitable for this use. The materials have been used in numerous previously cleared products and confirmed biocompatible.
- Testing Summary: The SpiralFuse Peripheral Infusion System was tested in the same manner as the Trellis-6. All components, subassemblies, and/or full devices met the required specifications for the completed tests.
- Summary of Substantial Equivalence: The SpiralFuse Peripheral Infusion System is equivalent to the predicate product, the Trellis-6 Infusion System. The indications for use, function, methods of manufacturing, and materials used are substantially equivalent.
Confidential