(27 days)
The Fox 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 JOSTENT® Fox PTA Catheter consists of a double lumen catheter with a balloon located at the distal tip. The catheter will be available with balloon diameters of 3.0 - 12.0 mm and balloon lengths of 20 - 80 mm. The catheter will be available in lengths of 75 and 135 cm. The catheter is compatible with 0.035" diameter guidewires.
The provided document describes a JOMED Fox PTA Catheter, a Peripheral Transluminal Angioplasty Catheter. The submission is a 510(k) premarket notification, which means the device claims substantial equivalence to legally marketed predicate devices, rather than seeking approval through a Premarket Approval (PMA) application that would typically require extensive clinical trials.
Therefore, the information you're requesting regarding acceptance criteria and performance studies, particularly in the context of AI and human readers, is not present in this document. This document focuses on demonstrating substantial equivalence through bench, biocompatibility, and design control activities, which are typical for Class II medical devices like a PTA catheter.
Here's why the document doesn't contain the requested information:
- Type of Device: A Peripheral Transluminal Angioplasty Catheter is a physical medical device used for dilatation. It is not an AI/ML-driven diagnostic or assistive tool.
- Regulatory Pathway (510(k)): The 510(k) pathway for medical devices emphasizes substantial equivalence to existing devices. This usually involves demonstrating that the new device has the same intended use, technological characteristics, and performs as safely and effectively as a predicate device, often through non-clinical testing (bench, biocompatibility, design control). Extensive clinical studies, especially those involving AI performance comparisons with human readers, are not typically required for a 510(k) submission unless there are significant technological differences or new indications for use that raise new questions of safety or effectiveness.
- Date: The document is dated 2002, long before the widespread development and regulatory considerations for AI/ML in medical devices.
Based on the provided text, I cannot extract the information required for your questions about acceptance criteria and study details related to AI performance. The document states:
- Acceptance Criteria/Performance Data: "Bench, biocompatibility, and design control activities demonstrate the safety and effectiveness of the Fox PTA Catheter."
- Study Details: There are no details on sample size, data provenance, expert panels, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment because these types of studies are not relevant to demonstrating substantial equivalence for this type of physical device under the 510(k) pathway as described.
To directly answer your request based on the lack of this information in the provided text:
- A table of acceptance criteria and the reported device performance: Not explicitly provided in a quantifiable table as requested for AI performance. The general acceptance criteria are that the device demonstrates safety and effectiveness through bench, biocompatibility, and design control activities, and is substantially equivalent to predicate devices.
- Sample size used for the test set and the data provenance: Not applicable or provided as no clinical trial data of this nature were presented.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or provided.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable or provided.
- 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: No, an MRMC study was not done as this is not an AI-driven device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is not an AI-driven device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable or provided for an AI study.
- The sample size for the training set: Not applicable or provided as this is not an AI-driven device.
- How the ground truth for the training set was established: Not applicable or provided as this is not an AI-driven device.
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APR 1 1 2002
Sponsor:
JOMED
510(k) SUMMARY -- Fox PTA Catheter
| Submitter Name: | Jomed AG | ||
|---|---|---|---|
| Submitter Address: | Ampthauptstrasse, PostfachCH-8222 Beringen, Switzerland | ||
| Contact Person: | Rudi Ott | ||
| Phone Number: | + 41 52 674 8505 | ||
| Fax Number: | +41 52 674 8540 | ||
| Date Prepared: | 15 March 2002 | ||
| Device Trade Name: | Fox PTA Catheter | ||
| Device Common Name: | Peripheral Transluminal Angioplasty Catheter | ||
| Classification Name: | 21 CFR 870.1250 Percutaneous Catheter | ||
| Predicate Devices: | • Jomed Fox PTA Catheter, K010838• Guidant VIATRAC PTA Catheter, K000101• NuMED Ghost II PTA Catheter, K003972 | ||
| Device Description: | The JOSTENT® Fox PTA Catheter consists of a doublelumen catheter with a balloon located at the distal tip.The catheter will be available with balloon diameters of3.0 - 12.0 mm and balloon lengths of 20 - 80 mm. Thecatheter will be available in lengths of 75 and 135 cm.The catheter is compatible with 0.035" diameterguidewires. | ||
| Intended Use: | The Fox PTA Catheter is intended for dilatation oflesions in the femoral, renal, iliac, popliteal, peroneal,and profunda arteries and native or syntheticarteriovenous dialysis fistulae. | ||
| Device Technological | The Fox PTA Catheter is made of similar materials, is |
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.
| Characteristics andComparison toPredicate Device(s): | available in similar diameters and lengths, has a similardesign, and the same indications for use as the predicatedevices and other currently marketed PTA Catheters. |
|---|---|
| Performance Data: | Bench, biocompatibility, and design control activitiesdemonstrate the safety and effectiveness of the Fox PTACatheter. |
| Conclusion: | The Fox PTA Catheter is substantially equivalent to theclaimed predicate devices and other currently marketedPTA Catheters. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is written around the upper portion of the circle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 1 2002
Mr. Glenn N. Byrd, MBA, RAC Director, Regulatory Affairs Eminent Research Systems, Inc 1700 Rockville Pike, Suite 400 Rockville, MD 20852
Re: K020854
JoMed Fox PTA Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (two) Product Code: 74 LIT Dated: April 2, 2002 Received: April 2, 2002
Dear Mr. Byrd:
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. Iisting 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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that vour device complies with other requirements of the Act
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Page 2 - Mr. Glenn N. Byrd, MBA, RAC
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
AedacMoyn
for
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 510(k) Number (if known): | j020854 |
|---|---|
| --------------------------- | --------- |
Device Name:
Fox PTA Catheter
Indications for Use:
The Fox 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.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of Device Evaluation (ODE)
Division Sign-Off for Donna. Bee Tillman
Division of Cardiovascular, Respiratory, and Neurological Devices
| 510(k) Number | K020554 |
|---|---|
| --------------- | --------- |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| --------------------------------------- | --------------- | ---------------------- |
(Optional Format 1-2-96)
§ 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).