(114 days)
This device is labeled for Percutaneous Transluminal Angioplasty (PTA) if the femoral, iliac and renal arteries. These catheters are not designed to be used in the coronary arteries.
The BIB PTA Catheter has a tri-axial shaft design which allows for inflation of two balloons, one contained inside the other, and a guidewire lumen for placement inside the vasculature. Both balloons are identical to those currently marketed by NuMed on the Tyshak PTA and Z-Med PTA catheters. The balloons are non-compliant and include radiopaque platinum marker bands on the catheter shaft to facilitate placement of the device under fluoroscopy. The BIB catheter will be available in standard diameters from 8 mm to 24 mm for the outer balloon and 4 mm to 12 mm for the inner balloon. Balloon lengths of 1.5 cm to 5.5 cm will available. The device has an overall shaft length of 110 cm.
The provided text describes a 510(k) summary for the BIB PTA Balloon Catheter. This document is a regulatory submission for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results as typically found in clinical trials for novel devices or AI algorithms.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, as they relate to proving a device meets specific acceptance criteria through a study, is not present in the provided text.
The document states: "The BIB PTA Balloon Catheter have been tested and compared to the Summary of predicate devices listed herein. All data gathered demonstrate the BIB PTA Safety and Effectiveness Catheter is substantially equivalent. No new issues of safety or efficacy have been raised." This indicates that verification and validation activities were performed to support substantial equivalence, but the specifics of those tests and their acceptance criteria are not detailed.
Here's an assessment based on the provided text, indicating where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
Not available. The document does not provide a table of acceptance criteria or specific performance metrics. It generally states that the device has been "tested and compared" to predicate devices and deemed "substantially equivalent" with "no new issues of safety or efficacy."
2. Sample size used for the test set and the data provenance
Not available. The document does not specify a test set sample size or data provenance (e.g., country of origin, retrospective/prospective). It refers to "all data gathered" for demonstrating 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 available. This device is a PTA Balloon Catheter, not an AI diagnostic device. The concept of "ground truth" and "experts to establish ground truth" as typically applied to image analysis or diagnostic AI algorithms does not directly apply here. For a physical medical device, "ground truth" would be related to its physical properties, biocompatibility, and functional performance, which are evaluated through engineering tests, material analysis, and potentially animal or human clinical data (though no specific clinical study details are provided here beyond reference to predicate devices).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not available. As explained above, an adjudication method for a test set, pertaining to expert consensus on diagnostic outcomes, is not relevant to this type of device and its regulatory submission.
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
Not applicable. This specific type of study (MRMC for AI assistance) is not relevant for a physical medical device like a balloon catheter.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This concept pertains to AI algorithms, not a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not available. While the document states "biocompatibility tests" were passed and the device was "tested and compared" to predicate devices, it does not specify the type of ground truth used for these tests. For a physical device, ground truth would typically refer to validated measurement techniques for physical properties (e.g., burst pressure, inflation/deflation times), material science standards, and potentially in vivo or in vitro models for biocompatibility and performance.
8. The sample size for the training set
Not applicable/Not available. The concept of a "training set" applies to machine learning algorithms, which is not the subject of this 510(k) submission.
9. How the ground truth for the training set was established
Not applicable/Not available. As above, this concept pertains to machine learning algorithms.
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Appendix D
510(k) Summary
| GeneralProvisions | Trade Name: BIB PTA Balloon Catheter |
|---|---|
| Classification Name: Percutaneous Transluminal Angioplasty Catheter | |
| Name ofPredicateDevice | Tyshak PTA Balloon Catheter (K931009)Z-Med PTA Balloon Catheter (K931009) |
| Classification | Class II |
| PerformanceStandards | Performance Standards have not been established by FDA under Section 514of the Food, Drug and Cosmetic Act. |
| Intended Use | This device is recommended for Percutaneous Transluminal Angioplasty(PTA) of the femoral, iliac and renal arteries. These catheters are notdesigned to be used in the coronary arteries.Continued on next page |
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510(k) 510(k) Summary, Continued
The BIB PTA Catheter is This device is recommended for Percutaneous Device Transluminal Angioplasty (PTA) of the femoral, iliac and renal arteries. Description These catheters are not designed to be used in the coronary arteries. The BIB PTA Catheter has a tri-axial shaft design which allows for inflation of two balloons, one contained inside the other, and a guidewire lumen for placement inside the vasculature. Both balloons are identical to those currently marketed by NuMed on the Tyshak PTA and Z-Med PTA catheters. The balloons are non-compliant and include radiopaque platinum marker bands on the catheter shaft to facilitate placement of the device under fluoroscopy. The BIB catheter will be available in standard diameters from 8 mm to 24 mm for the outer balloon and 4 mm to 12 mm for the inner balloon. Balloon lengths of 1.5 cm to 5.5 cm will available. The device has an overall shaft length of 110 cm. All materials used to manufacture the BIB PTA Balloon Catheter are Biocompatibility available on other commercially available NuMed, Inc. devices (K931009) and have passed all relevant biocompatibility tests. No additional biocompatibility testing was conducted for the BIB PTA Balloon Catheter. The BIB PTA Balloon Catheter have been tested and compared to the Summary of predicate devices listed herein. All data gathered demonstrate the BIB PTA Safety and Effectiveness Catheter is substantially equivalent. No new issues of safety or efficacy have been raised.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, a staff with two snakes entwined around it, representing medicine and health, along with the letters "USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 3 2005
NuMED, Inc. c/o Ms. Nichelle R. LaFlesh Regulatory Affairs Manager 2880 Main St Hopkinton, NY 12965
Re: K050857
BIB PTA Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: NVM Dated: July 1, 2005 Received: July 5, 2005
Dear Ms. LaFlesh:
This letter corrects our substantially equivalent letter of July 28, 2005.
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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear prominently as a boxed warning in the device's labeling immediately following the statement of the Indications for Use:
The safety and effectiveness of this device for use as a stent delivery system in the placement of intravascular stents has not been established.
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Page 2 - Ms. Nichelle R. LaFlesh
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 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.
If you desire specific information about the application of other labeling requirements to your device (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" (21 CFR 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Tillman, Ph.D. nna-Bea Director Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known): K050857
Device Name: BIB PTA Balloon Catheter
Indications For Use: This device is labeled for Percutaneous Transluminal Angioplasty (PTA) if the femoral, iliac and renal arteries. These catheters are not designed to be used in the coronary arteries.
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)
R. Vachner
(Division Sign-Off) (Division Sign-On)
Division of Cardiovascular Devices
510(k) Number K050857
§ 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).