(28 days)
The AngioSculpt PTA Scoring Balloon Catheter is intended for dilatation of lesions in the iliac, femoral, ilio-femoral, popliteal, infra popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.
The AngioSculpt catheter is a standard two-lumen catheter with a scoring balloon near the distal tip. The distal end of the catheter has a conventional nylon-blend balloon with a nitinol scoring element that wraps around the balloon. The scoring element creates focal concentrations of dilating force which minimizes balloon slippage and assists with luminal expansion of stenotic arteries. The balloon has radiopaque markers to aid in positioning the balloon in the stenosis, and is designed to provide an expandable segment of known diameter and length at a specific pressure.
The modified AngioSculpt PTA catheter has very similar technological characteristics as the cleared AngioSculpt PTA catheter. The modified AngioSculpt PTA Catheter is exactly the same device as the cleared AngioSculpt PTA catheter, except for minor differences to the distal bond and intermediate bond of the 0.018" OTW platform, 20mm balloon length catheters.
Here's the information regarding the acceptance criteria and the study for the AngioSculpt® PTA Scoring Balloon Catheter, based on the provided document:
This document is a 510(k) summary for a modification to an already cleared device, the AngioSculpt PTA Scoring Balloon Catheter. Therefore, the "study" described focuses on demonstrating that the modified aspects of the device still meet expectations, not on a full-scale clinical trial to prove initial efficacy or safety for a new device.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't provide specific numerical acceptance criteria (e.g., "Bond Tensile Strength >= X N") or precise numerical performance results (e.g., "Bond Tensile Strength = Y N"). Instead, it states that the modified design was evaluated against specifications and met them.
| Acceptance Criterion (Evaluated Product Attribute) | Reported Device Performance |
|---|---|
| Entry Profile (distal bond OD) | Met specifications |
| Profile (intermediate bond OD) | Met specifications |
| Fatigue Strength | Met specifications |
| Bond Tensile Strength | Met specifications |
| Visual inspection for distal bond imperfections | No observations of imperfections |
| Visual inspection for intermediate bond imperfections | No observations of imperfections |
2. Sample Size Used for the Test Set and Data Provenance
The document provides no explicit sample sizes for the non-clinical performance testing. It generally refers to "design verification testing" and "application of risk analysis and a change impact assessment."
The data provenance is non-clinical bench testing conducted by the manufacturer, AngioScore, Inc. Details such as country of origin for the data are not specified beyond the manufacturer's location in Fremont, CA, USA. This testing is retrospective in the sense that it's evaluating a modification to an existing design.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This was non-clinical bench testing of device attributes, not a clinical study requiring expert assessment of patient data. The "ground truth" was established by engineering specifications and testing protocols.
4. Adjudication Method for the Test Set
Not applicable. This was non-clinical bench testing. Results would typically be evaluated against pre-defined engineering specifications, not through a consensus or adjudication process involving multiple human reviewers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This document describes non-clinical engineering testing, not a clinical study involving human readers or patient cases.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not applicable. This device is a physical medical instrument (a balloon catheter), not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for this non-clinical testing was engineering specifications and established testing methodologies to measure physical properties like bond strength and profile.
8. The Sample Size for the Training Set
Not applicable. This involves non-clinical bench testing for a physical device, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. As above, this is about a physical device, not an AI/ML system.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring. MD 20993-0002
May 31, 2016
AngioScore, Inc. c/o Hogan Lovells US, LLP 555 Thirteenth Street NW Washington, District of Columbia 20004 ATTN: Jonathan S. Kahan
Re: K110767
Trade/Device Name: AngioSculpt® PTA Scoring Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PNO Dated: March 18, 2011 Received: March 18, 2011
Dear Mr. Kahan:
This letter corrects our substantially equivalent letter of April 15, 2011.
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 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
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Page 2 - Mr. Jonathan S. Kahan
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Misti L. Malone -S
for 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 Statement
510(k) Number (if known): __ K110 + 6 7
Device Name: AngioSculpt PTA Scoring Balloon Catheter
Indications for Use:
The AngioSculpt PTA Scoring Balloon Catheter is intended for dilatation of lesions in the iliac, femoral, ilio-femoral, popliteal, infra popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.
Prescription Use X (Per 21 C.F.R. 801.109)
AND/OR
Over-The-Counter Use (Per 21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
summa R vduu
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number k11076.7
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510(k) SUMMARY
APR 1 5 2011
AngioScore AngioSculpt® PTA Scoring Balloon Catheter
1. Submitter's Name / Contact Person
| Submitter: | AngioScore, Inc.5055 Brandin CourtFremont, CA 94538 |
|---|---|
| Contact Person: | Kimberley KlineRegulatory Affairs ManagerPhone: 510.933.7989Fax: 510.933.7994 |
Summary Preparation Date: April 11, 2011
2. General Information
| Trade Name: | AngioSculpt® PTA Scoring Balloon Catheter |
|---|---|
| Common / Usual Name: | Angioplasty catheter |
| Classification Name: | Percutaneous Catheter |
| Classification Regulation: | 21 CFR § 870.1250 |
| Product Codes: | DQY and LIT |
| Predicate Devices: | AngioSculpt® Scoring Balloon Catheter (K050629,K072225, K080151, K081220, K082059, K091966,K100303) |
3. Intended Use / Indications
The AngioSculpt PTA Scoring Balloon Catheter is intended for dilatation of lesions in the illiac, femoral, ilio-femoral, popliteal, infra popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.
4. Device Description
The AngioSculpt catheter is a standard two-lumen catheter with a scoring balloon near the distal tip. The distal end of the catheter has a conventional nylon-blend balloon with a nitinol scoring element that wraps around the balloon. The scoring element creates focal concentrations of
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dilating force which minimizes balloon slippage and assists with luminal expansion of stenotic arteries. The balloon has radiopaque markers to aid in positioning the balloon in the stenosis, and is designed to provide an expandable segment of known diameter and length at a specific pressure.
The modified AngioSculpt PTA catheter has very similar technological characteristics as the cleared AngioSculpt PTA catheter. The modified AngioSculpt PTA Catheter is exactly the same device as the cleared AngioSculpt PTA catheter, except for minor differences to the distal bond and intermediate bond of the 0.018" OTW platform, 20mm balloon length catheters.
5. Summary of Non-Clinical Performance Testing
Design verification testing of the distal and intermediate bonds, manufactured using the modified design and modifications to the manufacturing process, was conducted to verify that the modified bonds meet specifications.
Based on the application of risk analysis and a change impact assessment, the device was evaluated for the following product attributes potentially affected by the design changes and the modifications to the bonding processes:
- . Entry Profile (distal bond OD)
- Profile (intermediate bond OD) .
- Fatigue Strength .
- Bond Tensile Strenath •
- Visual inspection for distal bond imperfections -
- Visual inspection for intermediate bond imperfections ・
Conclusions
The results of the testing demonstrate that the device meets the acceptance criteria and has substantially equivalent performance to the predicate.
The changes to the distal and intermediate bonds have no impact on all other previously submitted data. The previously submitted data are applicable to the modified AngioSculpt PTA catheter.
6. Substantial Equivalence Comparison
The modified AngioSculpt PTA Catheter has the same intended use and indications for use as the previously cleared AngioSculpt PTA Catheter. In addition, the modified AngioSculpt PTA Catheter has very similar technological characteristics as its predicate. The differences between the current AngioSculpt PTA Catheter and its cleared predicate include minor modifications to the design and manufacturing process of the distal and intermediate bond of the device. These differences do not raise new questions of safety or efficacy, nor substantially
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alter the fundamental scientific technology of the device. Testing demonstrates that the modified device meets its specifications with no observations of distal or intermediate bond imperfections, and is substantially equivalent to the cleared AngioSculpt PTA Catheter.
As the AngioSculpt PTA Catheter has the same intended use and indications for use as the predicate, and has substantially similar technological characteristics, and the minor technological differences do not raise new questions of safety or efficacy, the AngioSculpt PTA Catheter is substantially equivalent to the predicate device.
§ 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).