(185 days)
The Ceres PTA Catheter is intended for dilatation of lesions in the femoral, renal, iliac, popliteal, peroneal, and profunda arteries and native or synthetic arteriovenous dialysis fistulae.
The Ceres PTA catheter is a single-use, sterile balloon dilation catheter for angioplasty. A double lumen coaxial shaft features an inflatable balloon at its distal end. The proximal end provides a double hub connector, whose first port allows the attachment of an inflatable device which is used to inflate and deflate the balloon through the outer lumen. A second hub port allows the advance of a guidewire throughout the entire length of the catheter using the distally open inner lumen. Platinum radiopaque bands are used to locate the balloon under fluoroscopy.
The provided text describes a 510(k) summary for a medical device called the "Ceres PTA Catheter". This document focuses on establishing substantial equivalence to a predicate device, rather than presenting a study with acceptance criteria and device performance metrics in the way one would for an AI/ML powered device or a device with new performance claims.
Therefore, the requested information, particularly regarding acceptance criteria, reported device performance in a numerical table, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment, cannot be extracted from the provided text.
The document states:
- Non-clinical Performance: "Non-clinical testing was conducted to confirm the safe and effective performance of the Ceres PTA catheter. Non-clinical testing also demonstrated the biocompatibility of the subject device." This indicates that some testing occurred, but specific acceptance criteria or performance metrics are not detailed.
- Substantial Equivalence: "The Ceres PTA catheter is substantially equivalent to the Fox Plus PTA catheter because the indications for use are identical and the function, design and performance specifications are comparable." This is the primary "proof" mentioned, relying on comparison to a cleared predicate device rather than a de novo study with explicit acceptance criteria.
In summary, the provided text does not contain the detailed study information needed to fill out the requested table and answer the specific questions about acceptance criteria, performance, sample sizes, expert ground truth, or study methodologies typically associated with software or diagnostic device evaluations.
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Appendix 2
0C1 - 6 2006
Page 15
5. 510(k) Summary (Revised)
| 510(k) Summary | This summary of 510(k) safety and effectiveness information is beingsubmitted in accordance with the requirements of 21 C.F.R 807.92. |
|---|---|
| Submitter | Ceres Medical Systems, L.L.C.4665 Sweetwater Blvd., Suite 104Sugar, Land, TX 77479 |
| Contact Person | Corrine Bonfiglio, RACTel: (858) 481-1638Fax: (858) 481-2363Mobile: (858) 342-0344E-mail: cbonfiglio@meister.net |
| Date Prepared | September 26, 2006 |
| Trade Name | Ceres PTA Catheter |
| Common Name | Percutaneous Transluminal Angioplasty (PTA) Catheter |
| Classification Name | Percutaneous Catheter (21 CFR 870.1250, Product Code DQY) |
| Predicate Device | The Ceres PTA Catheter manufactured by JOMED AG which was clearedfor market entry on April 11, 2002 under 510(k) #K020854. |
| Description | The Ceres PTA catheter is a single-use, sterile balloon dilation catheter forangioplasty. A double lumen coaxial shaft features an inflatable balloon atits distal end. The proximal end provides a double hub connector, whosefirst port allows the attachment of an inflatable device which is used toinflate and deflate the balloon through the outer lumen. A second hub portallows the advance of a guidewire throughout the entire length of thecatheter using the distally open inner lumen. Platinum radiopaque bandsare used to locate the balloon under fluoroscopy. |
| Indications for Use | The Fox Plus PTA Catheter is intended for dilatation of lesions in thefemoral, renal, iliac, popliteal, peroneal, and profunda arteries and nativeor synthetic arteriovenous dialysis fistulae. |
| Substantial Equivalence | The Ceres PTA catheter is substantially equivalent to the Fox Plus PTAcatheter because the indications for use are identical and the function,design and performance specifications are comparable. |
| Non-clinical Performance | Non-clinical testing was conducted to confirm the safe and effectiveperformance of the Ceres PTA catheter. Non-clinical testing alsodemonstrated the biocompatibility of the subject device. |
| Conclusion | The Ceres PTA catheter is substantially equivalent to the currentlymarketed predicate device. |
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
QC7 - 6 2006
Ceres Medical Systems L.L.C. c/o Ms. Corrine M. Bonfiglio 13195 Seagrove Street San Diego, CA 92130
Re: K060927
Ceres PTA Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (Two) Product Code: DQY Dated: September 26, 2006 Received: September 27, 2006
Dear Ms. Bonfiglio:
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. Corrine M. Bonfiglio
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 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 vours.
ua R. buchner
Image /page/2/Picture/5 description: The image contains a handwritten symbol or character. It appears to be a stylized or abstract representation, possibly resembling a letter or a signature. The symbol is composed of curved and angular lines, with a bold stroke at the bottom.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Premarket Notification for Ceres PTA Catheter Response to Requested Information September 26, 2006
Appendix 1
Indications for Use Statement (Revised) 4.
510(k) Number (if known): K060927
Device Name: Ceres PTA Catheter
Indications for Use:
The Ceres PTA Catheter is intended for dilatation of lesions in the femoral, renal, iliac, popliteal, peroneal, and profunda arteries and native or synthetic arteriovenous dialysis fistulae.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
and the country of the
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duana P. de lunes
ியாவி இடையி Joseph . . Carolovascular Devices
510(k) Number K060927
Page 1 of 1
(Posted November 13, 2003)
Ceres Medical Systems L.L.C. considers this application to be confidential and not subject to disclosure without the express written consent of the applicant.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).