(6 days)
The Radifocus Optitorque Angiographic Catheter is intended for cardiac and vascular procedures. It is designed to deliver radiopaque media, guide wires, catheters, and therapeutic agents to selected sites in the vascular system. The different shapes are designed to selectively engage arteries from access sites such as the femoral, radial, and brachial artery.
The Radifocus Optitorque Angiographic Catheter is a two-layer construction comprised of a stainless steel mesh sandwiched between layers of polyurethane polyamide elastomer. The polyurethane polyamide elastomer contains barium sulfate for visibility and contrast under fluoroscopy. The Catheter has a "soft-tip" whose purpose is to minimize trauma to the vessel wall. The soft-tip is a flexible, supple polyurethane tip that is permanently welded to the catheter shaft.
The provided text is a 510(k) summary for the Radifocus® Optitorque™ Angiographic Catheter. It states that the device is substantially equivalent to a previously cleared device (K992051) and thus does not contain a typical study with acceptance criteria and performance metrics for a new device. Instead, the justification for substantial equivalence relies on the fact that the device is identical in design, materials, and principle of operation to the predicate device, and a risk/hazard analysis was conducted.
Therefore, many of the requested details about acceptance criteria, performance, sample sizes, expert involvement, and ground truth establishment are not applicable or cannot be extracted from this document, as a new clinical performance study was not required or submitted for this specific 510(k).
Here's an attempt to address the points based on the provided text, indicating where information is not available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical/Physical Specifications | |
| Available Sizes | 4 - 6 Fr. |
| Catheter Length | 650 – 1200 mm |
| Maximum Injection Pressure | 4 Fr.: 750 psi 5, 6 Fr.: 1000 psi |
| Material Biocompatibility | Blood contacting materials are biocompatible (tested in accordance with ISO-10993). |
| Sterilization Efficacy | Sterilized to a SAL of 10^-6 (validated in accordance with EN ISO 11135-1). |
| Overall Performance for New Indication | Justified that the performance is substantially equivalent to the predicate device (K992051). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided as a formal performance study on a test set (clinical or otherwise with specific sample sizes) for this new 510(k) was not conducted. The submission relies on substantial equivalence to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided as a specific clinical performance study requiring expert ground truth establishment for this 510(k) was not conducted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as a specific clinical performance study requiring adjudication for this 510(k) was not conducted.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC study was not conducted, as this is a medical device (angiographic catheter), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is an angiographic catheter and does not involve an algorithm. The "Principle of Operation / Technology" states it "is operated manually or by a manual process."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable to this type of device submission. The performance justification relies on compliance with standards for material safety, sterility, and mechanical/physical specifications rather than a comparative ground truth for diagnostic accuracy.
8. The sample size for the training set
This information is not applicable as this is a medical device (angiographic catheter) and does not involve a "training set" in the context of an algorithm or AI model development.
9. How the ground truth for the training set was established
This information is not applicable for the same reasons as point 8.
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Image /page/0/Picture/0 description: The image shows a sequence of handwritten digits and letters. The sequence is "K082736". The characters are written in black ink on a white background.
SEP 2 4 2008 Terumo Corporation Premarket Notification - Radifocus® Optitorque™ Angiographic Catheter Section II. 510(k) Summary
SECTION II. 510(K) SUMMARY
A. Device Name
| Proprietary Name: | Radifocus® Optitorque™ Angiographic Catheter |
|---|---|
| Classification Name: | Angiographic Catheter |
| Common Name: | Angiographic Catheter |
B. Intended Use
The Radifocus Optitorque Angiographic Catheter is intended for cardiac and vascular procedures. It is designed to dcliver radiopaque media, guide wires, catheters, and therapeutic agents to sclected sites in the vascular system. The different shapes are designed to selectively engage arteries from access sites such as the femoral, radial, and brachial artery.
C. Device Description
The Radifocus Optitorque Angiographic Catheter is a two-layer construction comprised of a stainless steel mesh sandwiched between layers of polyurethane polyamide elastomer. The polyurethane polyamide elastomer contains barium sulfate for visibility and contrast under fluoroscopy. The Catheter has a "soft-tip" whose purpose is to minimize trauma to the vessel wall. The soft-tip is a flexible, supple polyurethane tip that is permanently welded to the catheter shaft.
D. Principle Of Operation / Technology
The Radifocus Optitorque Angiographic Catheter is operated manually or by a manual process.
E. Design / Materials
The Radifocus Optitorque Angiographic Catheter in this submission is the same device that was cleared under K992051. There are no changes in the design or materials.
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F. Specifications
| Available Sizes | 4 - 6 Fr. |
|---|---|
| Catheter Length | 650 – 1200 mm |
| Maximum InjectionPressure | 4 Fr.: 750 psi5, 6 Fr.: 1000 psi |
G. Performance
A risk/hazard analysis was conducted according to EN ISO 14971 Medical Devices -Application of risk management to medical devices. Performance characteristics for this new indication for use were determined. Then it was justified that the performance of the Radifocus Optitorque Angiographic Catheter is substantially equivalent to the performance of the Radifocus Optitorque Angiographic Catheter cleared under K992051.
H. Additional Safety Information
Manufacturing controls include visual, functional, dimensional and sterility tests.
Blood contacting materials were tested in accordance with the tests recommended in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing".
The catheter is classified as Externally Communicating Devices, Circulating Blood, limited Contact (<24 hrs). Results of the testing demonstrate that the blood contacting materials are biocompatible.
Sterilization conditions have been validated in accordance with EN ISO 11135-1, Sterilization of health care products - Ethylene Oxide - Part 1: Requirements for development, validation and routine control of sterilization process for medical devices. The device is sterilized to a SAL of 10 .
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Terumo Corporation Premarket Notification - Radifocus® Optitorque™ Angiographic Catheter Section II. 510(k) Summary
H. Substantial Equivalence
The Radifocus Optitorque Angiographic Catheter is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the predicate device the Radifocus Optitorque Angiographic Catheter, cleared under K992051. Differences between the devices do not raise any significant issues of safety or effectiveness.
I. Submitter Information
.
| Prepared By: | Mr. Mark Unterreiner |
|---|---|
| Sr. Regulatory Affairs Specialist | |
| Prepared For: | Terumo Medical Corporation |
| 950 Elkton Blvd. | |
| Elkton, MD 21921 | |
| Phone: (410) 392-7213 | |
| Fax: (410) 398-6079 | |
| Email: mark.unterreiner@terumomedical.com | |
| Date Prepared: | August 29, 2008 |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a person embracing another, representing health and human services.
SEP 2 4 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Terumo Corporation c/o Mr. Mark Job Reviewer Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 55313
Re: K082736
Radifocus Optitorque Angiographic Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: Class II Product Code: DQO Dated: September 17, 2008 Received: September 18, 2008
Dear Mr. Job:
We have reviewed your Section 510(k) promarket 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 gencral 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 - Mr. Mark Job
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 cntitled, "Misbranding by reference to premarket notification" (21CFR 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 vours.
Bram D. Zuckerman, M.D.
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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Indications for Use
510(k) Number (if known):
Radifocus® Optitorque™ Angiographic Catheter Device Name:
Indications For Use:
The Radifocus Optitorque Angiographic Catheter is intended for cardiac and vascular procedures. It is designed to deliver radiopaque media, guide wires, catheters, and therapeutic agents to selected sites in the vascular system. The different shapes are designed to selectively engage arteries from access sites such as the femoral, radial, and brachial artery,
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
ion Silan-Off) Division of Cardiovascular Devices 510(k) Number_ Kos
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).