(129 days)
Not Found
No
The summary describes a mechanical device for fluid infusion and aspiration, with no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes
The device is intended to infuse and remove fluids, emboli, and thrombi from the vasculature, which are actions to treat a medical condition.
No
The device is described as an infusion and aspiration device for removing emboli and thrombi, which are therapeutic functions. It does not mention detection, diagnosis, or assessment of a medical condition.
No
The device description explicitly states it consists of a catheter and a hand-held unit with accessories, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device that is used within the body (coronary and peripheral vasculature) to infuse and aspirate fluids and materials. This is an in vivo procedure.
- Device Description: The description details a catheter and hand-held unit designed for direct interaction with the patient's circulatory system.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide diagnostic information. IVDs are typically used in laboratories or point-of-care settings to analyze samples.
Therefore, the Rinspirator is a medical device used for therapeutic and interventional purposes within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Rinspirator is intended to infuse physician specified fluid and remove/aspirate fluid, fresh, soft emboli and thrombi from the coronary and peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
QEZ, KRA, DXE
Device Description
The Rinspirator consists of a catheter and a hand-held unit with accessories. The Rinspirator Catheter is a multi-lumen, rail configuration catheter to dispense an infusible fluid. The central lumen of the catheter is used for aspiration. The Rinspirator is provided sterile for single-use. The system is sterilized by Ethylene Oxide (ANSI/AAMI/ISO 11135), including limits for Ethylene Oxide residuals and validated to a sterility assurance level (SAL) of 106. The device is biocompatible per ISO-10993-1. The only difference between the cleared Rinspiration Catheter System and The Rinspirator is the lubricious coating on the external surface of the catheter shaft. The previously cleared device is coated using a silicone based material, which is being replaced with a hydrophilic coating, consisting of a primer and topcoat in an ethanol solvent base, and is cured using UV light.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and 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 subject device was shown to have substantially equivalent performance when compared to the predicate device. The Rinspirator with coating modifications is considered substantially equivalent to the Rinspiration Catheter System (K062275).
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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services - USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in a way that "FDA" is in a blue square, followed by "U.S. FOOD & DRUG" on the first line and "ADMINISTRATION" on the second line.
September 15, 2021
Fox Hollow Technologies Melissa Murphy 740 Bay Road Redwood City, California 94063
Re: K071826 Trade/Device Name: The Rinspirator Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ, KRA
Dear Melissa Murphy:
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 November 9, 2007. Specifically, FDA is updating this SE Letter 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,
Gregory W - Digitally signed by Gregory W. O'connell -S O'connell -S Date: 2021.09.15
Gregory O'Connell Assistant Director Plaque Modification Devices Team 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/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines extending from its body, representing the department's commitment to health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - (USA)" is arranged in a circular fashion around the eagle symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 0 9 2007
FoxHollow Technologies, Inc. c/o Ms. Melissa S. Murphy Regulatory Affairs Manager 740 Bay Road Redwood City, CA 94063
Re: K071826
Trade/Device Name: The Rinspirator Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: DXE Dated: October 17, 2007 Received: October 19, 2007
Dear Ms. Murphy:
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.
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Page 2 - Ms. Melissa S. Murphy
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,
er R. Vachner
NBram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. INDICATIONS FOR USE STATEMENT
510(k) Number if known: Kグアルマイ・
Device Name: The Rinspirator
The Rinspirator is intended to infuse physician specified fluid and remove/aspirate fluid, fresh, soft emboli and thrombi from the coronary and peripheral vasculature.
Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (Per 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
sumai R. lochner
(Division Sign-Off) (Division Cardiovascular Devices
510(k) wumber_6071826
. ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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5. 510(K) SUMMARY
510(K) SUMMARY
| Device Name | The Rinspirator® | |
|---|---|---|
| Classification Name: | Embolectomy Catheter | |
| 21 CFR §870.5150, Class II | NOV 09 2007 | |
| Product Code: | DXE | |
| Common and Usual Name: | Embolectomy Catheter | |
| Proprietary Name: | The Rinspirator® |
Predicate Device
The Rinspiration Catheter System (K062275), currently marketed by FoxHollow Technologies, Inc. (Redwood City, CA).
Summary
This summary of Special 510(k) safety and effectiveness is being submitted in accordance with requirements of SMDA 1990.
The Rinspirator is intended to infuse physician specified fluid and remove/aspirate fluid, fresh, soft emboli and thrombi from the coronary peripheral vasculature. The Rinspirator consists of a catheter and a hand-held unit with accessories. The Rinspirator Catheter is a multi-lumen, rail configuration catheter to dispense an infusible fluid. The central lumen of the catheter is used for aspiration. The Rinspirator is provided sterile for single-use. The system is sterilized by Ethylene Oxide (ANSI/AAMI/ISO 11135), including limits for Ethylene Oxide residuals and validated to a sterility assurance level (SAL) of 106. The device is biocompatible per ISO-10993-1.
The only difference between the cleared Rinspiration Catheter System and The Rinspirator is the lubricious coating on the external surface of the catheter shaft. The previously cleared device is coated using a silicone based material, which is being replaced with a hydrophilic coating, consisting of a primer and topcoat in an ethanol solvent base, and is cured using UV light.
With the exception of the coating, The Rinspirator is substantially equivalent in materials of construction, design, intended use, and safety and efficacy to the predicate device. The subject device was shown to have substantially equivalent performance when compared to the predicate device. The Rinspirator with coating modifications is considered substantially equivalent to the Rinspiration Catheter System (K062275).
Contact
Sridevi Sheshadri Clinical Research Associate FoxHollow Technologies, Inc. 740 Bay Road Redwood City, CA 94063 Main Tel (650) 421-8400
Date June 26, 2007