(129 days)
The Rinspirator is intended to infuse physician specified fluid and remove/aspirate fluid, fresh, soft emboli and thrombi from the coronary and 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 provided documents describe the "Rinspirator" device, an embolectomy catheter, and its 510(k) summary for substantial equivalence. However, the documents do not contain information regarding detailed acceptance criteria, a specific study proving the device meets those criteria, or performance metrics like sensitivity, specificity, accuracy, or effect sizes for AI assistance.
The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (The Rinspiration Catheter System K062275), primarily noting a change in the lubricious coating on the catheter shaft. It states that "The subject device was shown to have substantially equivalent performance when compared to the predicate device." This implies that the device likely met performance criteria comparable to the predicate, but the specific metrics are not detailed in these documents.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can be extracted and what is missing:
1. Table of acceptance criteria and reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided document. The document only states that "The subject device was shown to have substantially equivalent performance when compared to the predicate device." | Not specified in the provided document. No specific performance metrics (e.g., success rate of emboli removal, aspiration flow rates, etc.) or targets are provided. |
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective/prospective). The 510(k) summary mentions "Special 510(k) safety and effectiveness" but doesn't detail any specific clinical study data beyond claiming substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified, as no specific test set or ground truth establishment process is described for device performance evaluation in these documents.
4. Adjudication method for the test set:
- Not applicable/Not specified.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:
- No. The device is an embolectomy catheter, not an AI or imaging diagnostic device that would typically involve an MRMC study with human readers and AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a physical medical device (catheter), not an algorithm or AI.
7. The type of ground truth used:
- Not applicable/Not specified for performance evaluation data in these documents. The comparison is primarily based on the functional equivalence due to a coating change to a predicate device already on the market.
8. The sample size for the training set:
- Not applicable/Not specified. This is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable/Not specified.
Summary from the documents:
The documents confirm the regulatory clearance of "The Rinspirator" embolectomy catheter. The basis for clearance was a 510(k) submission demonstrating substantial equivalence to an existing predicate device (The Rinspiration Catheter System K062275). The only significant change noted was the type of lubricious coating on the catheter shaft (from silicone-based to hydrophilic). The 510(k) summary explicitly states: "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." This implies that testing (likely non-clinical, such as bench testing for lubricity, biocompatibility, and functionality) was conducted to ensure the coating change did not negatively impact performance, but the specific details of these tests, acceptance criteria, and quantitative results are not provided in the publicly available 510(k) summary.
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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
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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 Catheter21 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
§ 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).