(253 days)
The balloon dilatation catheter is intended to dilate stenoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent dilatation post-deployment in the peripheral vasculature.
The non-compliant PTA (Over-the-Wire, OTW) balloon dilatation catheter family consists of Castor NC (0.014"), Achilles NC (0.018") and Hermes NC (0.035") PTA balloon catheter. The PTA (OTW type) device is an over the wire (OTW) peripheral balloon catheter, specially designed for Percutaneous Transluminal Angioplasty (PTA). The catheter working length is 70, 90 and 150cm. Balloon diameters range from Ø2.0mm to Ø10.0mm, balloon work length range from 10mm to 150mm. The three PTA balloon dilatation catheters are filed in one 510(k) submission due to the similar/equivalent construction and identical material of the products. The comparison of them was summarized in Table 1. The differences only exist in the guide wire compatibility and the balloon configuration which have been controlled by the Design Verification. The balloon material is made of a non-compliant Nylon material for diameter 2.0mm to 10.0mm with a rated burst pressure of 18-22 atmospheres. It is a coaxial double lumen catheter with a balloon located near the distal tip. One lumen is used for inflation of the balloon and accessed via the side leg port. The second lumen, starting at the straight entry port, allows access to the distal tip of the catheter for guide wire insertion. The three products of the non-compliant PTA (OTW type) balloon catheter family have different diameter of the guide wire port from max.0.014" to 0.035". The guide wire compatibility was shown in table 1. The balloon has radiopaque markers for positioning the balloon relative to the stenosis. The radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement. The balloon is dilated using the side leg port, at which the balloon material expands to a known diameter at specific pressure. The working pressure range for the balloon is between the nominal size pressure and the rated burst pressure. All balloons distend to sizes above the nominal size at pressures greater than the nominal pressure. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.
The provided text is a 510(k) summary for the BrosMed Medical Co., Ltd.'s Castor, Achilles, and Hermes NC PTA Balloon Dilatation Catheters. This document details the regulatory approval process for a medical device by demonstrating its substantial equivalence to previously cleared predicate devices.
It is crucial to understand that this document describes the acceptance criteria and study results for a medical device (balloon dilatation catheters), NOT for an Artificial Intelligence (AI) device. The questions posed in your prompt (e.g., sample size for test/training sets, experts for ground truth, MRMC studies, standalone algorithm performance) are highly specific to AI/Machine Learning model evaluations, which are not applicable to the traditional medical device approval process described here.
Therefore, I cannot directly answer your questions as they relate to AI. However, I can extract the information relevant to the device's performance and acceptance criteria as presented in a traditional medical device context:
Here's a breakdown of the acceptance criteria and performance as described for these PTA Balloon Dilatation Catheters, framed as closely as possible to your request, while acknowledging the inherent differences:
The study conducted was a series of in-vitro performance tests and biocompatibility tests to demonstrate that the device meets predetermined acceptance criteria and is substantially equivalent to predicate devices. There is no mention of an "AI" component, data sets for training/testing AI models, or human expert consensus for "ground truth" derived from imaging.
Acceptance Criteria and Reported Device Performance (Table)
For a medical device like a balloon dilatation catheter, acceptance criteria are typically engineering specifications, material properties, and functional performance benchmarks. The document states that "The test results met all acceptance criteria, were similar to predicate devices, and ensure that the PTA balloon catheter design and construction are suitable for its intended use." Specific numerical acceptance criteria are not detailed in this public summary, but the types of tests conducted demonstrate the areas where performance was evaluated.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| In-vitro Performance | "The test results met all acceptance criteria, were similar to predicate devices, and ensure that the PTA balloon catheter design and construction are suitable for its intended use." This general statement is provided for all in-vitro tests. Specific quantitative performance values against acceptance criteria are not published in this 510(k) summary. Specific parameters evaluated include: |
| Dimensional Verification | Met acceptance criteria. |
| Balloon Preparation | Met acceptance criteria. |
| Deployment & Retraction | Met acceptance criteria. |
| Balloon Rated Burst Pressure | Met acceptance criteria. (Rated Burst Pressure (RBP) stated as 18, 20, 22 atm for all models). The actual test result met or exceeded this. |
| Balloon Fatigue | Met acceptance criteria. |
| Balloon Compliance | Met acceptance criteria. |
| Balloon Inflation/Deflation | Met acceptance criteria. |
| Catheter Bond Strength | Met acceptance criteria. |
| Tip Pull Strength | Met acceptance criteria. |
| Flexibility & Kinking | Met acceptance criteria. |
| Torque Strength | Met acceptance criteria. |
| Radiopacity | Met acceptance criteria. |
| Coating Integrity | Met acceptance criteria. |
| Particulate Evaluation | Met acceptance criteria. |
| Balloon Burst (in stents) | Met acceptance criteria. |
| Balloon Fatigue (in stents) | Met acceptance criteria. |
| Biocompatibility | "The test results met all acceptance criteria..." Again, specific quantitative details are not provided, but the umbrella statement indicates successful performance. Specific tests include: |
| Cytotoxicity | Met acceptance criteria. |
| Sensitization | Met acceptance criteria. |
| Hemocompatibility | Met acceptance criteria. |
| Pyrogenicity | Met acceptance criteria. |
| Acute Systemic Toxicity | Met acceptance criteria. |
| Intracutaneous Reactivity | Met acceptance criteria. |
| Genotoxicity | Met acceptance criteria (bacterial mutagenicity and in vitro mouse lymphoma). |
Since the device is a physical medical instrument and not an AI algorithm, most of your specific AI-related questions (2-9) are not directly applicable. However, I can provide the closest equivalent information from the document:
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify exact sample sizes for each in-vitro or biocompatibility test. It generally states that "tests were conducted on the PTA balloon catheter." For physical device testing, sample sizes are typically determined by engineering and statistical principles to ensure sufficient data for reliability and statistical significance, but these are not disclosed in this summary.
- Data Provenance: The tests are performed by the manufacturer, BrosMed Medical Co., Ltd., based in Dongguan, China. The data originates from these internal, pre-market validation studies. All tests are inherently "prospective" in the sense that they are designed and executed to specifically test the device's performance against predefined criteria.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This question is not applicable. "Ground truth" in the context of this device refers to objective measurements and adherence to engineering specifications and biological safety standards (e.g., a balloon bursting at or above its rated pressure, or a material not causing a cytotoxic reaction). There is no "expert consensus" in the sense of human interpretation of complex medical data for performance claims, as would be the case for an AI diagnostic tool.
4. Adjudication Method for the Test Set:
- This question is not applicable. Performance is based on objective measurements against engineering specifications and validated test methods, not on human interpretation or adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC study was NOT done. This type of study is specific to evaluating diagnostic tools (often imaging-based AI) where human readers (e.g., radiologists) interpret cases with and without AI assistance to measure improvement in diagnostic accuracy. This is not relevant for a balloon dilatation catheter.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This question is not applicable as there is no algorithm or AI component to this device. Its performance is inherent to its physical design, materials, and manufacturing.
7. The Type of Ground Truth Used:
- The "ground truth" for this device's performance validation is established through:
- Engineering Specifications: Predefined performance metrics (e.g., burst pressure, dimensions, flexibility) that the device must meet.
- Validated Test Methods: Adherence to recognized national and international standards for medical device testing.
- Biocompatibility Standards: Compliance with established biological safety requirements for materials in contact with the human body.
- Comparison to Predicate Devices: Demonstrating "substantial equivalence" means showing that the device performs similarly to or better than existing, legally marketed devices.
8. The Sample Size for the Training Set:
- This question is not applicable. There is no "training set" in the context of a physical medical device. The device is designed, manufactured, and then validated through testing.
9. How the Ground Truth for the Training Set Was Established:
- This question is not applicable for the reasons stated above.
In summary, the provided document is a regulatory submission for a conventional medical device, not an AI/ML algorithm. The acceptance criteria revolve around the physical and biological performance of the catheter, and the "study" consists of a battery of engineering and biocompatibility tests designed to prove its safety and effectiveness relative to existing predicate devices.
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Image /page/0/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 13, 2016
BrosMed Medical Co., Ltd. Ms. Tina Yin Regulatory Affairs Manager 15th Bldg., SMEs Venture Park Songshan Lake Hi-Tech Industrial Development Zone Dongguan 523808, China
Re: K160941
Trade/Device Name: Castor, Achilles, and Hermes NC PTA Balloon Dilatation Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: October 31, 2016 Received: November 3, 2016
Dear Ms. Yin:
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. 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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) 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" (21 CFR 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,
Brian D. Pullin -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
510(k) Number (if known) K160941
Device Name Castor NC PTA Balloon Dilatation Catheter Achilles NC PTA Balloon Dilatation Catheter Hermes NC PTA Balloon Dilatation Catheter
Indications for Use (Describe)
The balloon dilatation catheter is intended to dilate stenoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent dilatation post-deployment in the peripheral vasculature.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
This 510(k) Summary is submitted in accordance with 21 CFR 807.92(c).
| Submitter: | BrosMed Medical Co., Ltd15th Building, SMEs Venture ParkSongShan Lake Hi-Tech Industrial Development ZoneDongguan 523808, ChinaOffice: +86 (769) 2289 2018Fax: +86 (769) 2289 2016 |
|---|---|
| Contact Person: | Tina Yin |
| Date Prepared | December 2, 2016 |
| Trade Name: | Castor NC PTA Balloon Dilatation CatheterAchilles NC PTA Balloon Dilatation CatheterHermes NC PTA Balloon Dilatation Catheter |
| Common Name: | PTA Balloon Dilatation Catheter |
| Classification Name: | Percutaneous catheter (21 CFR 870.1250, Product Code LIT) |
| Predicate Devices: | NanoCross™ Elite 0.014" Over-the-Wire PTA Balloon Dilatation Catheter(K141118; cleared July 18, 2014)Sterling Over-the-Wire (OTW) PTA Balloon Dilatation Catheter(K132430; cleared October 17, 2013)Mustang TM Balloon Dilatation Catheter (K103751; cleared March 22, 2011) |
| Device Description: | The non-compliant PTA (Over-the-Wire, OTW) balloon dilatation catheterfamily consists of Castor NC (0.014"), Achilles NC (0.018") and Hermes NC(0.035") PTA balloon catheter. The PTA (OTW type) device is an over thewire (OTW) peripheral balloon catheter, specially designed for PercutaneousTransluminal Angioplasty (PTA). The catheter working length is 70, 90 and150cm. Balloon diameters range from Ø2.0mm to Ø10.0mm, balloon worklength range from 10mm to 150mm. The three PTA balloon dilatationcatheters are filed in one 510(k) submission due to the similar/equivalentconstruction and identical material of the products. The comparison of themwas summarized in Table 1. The differences only exist in the guide wirecompatibility and the balloon configuration which have been controlled by theDesign Verification. The balloon material is made of a non-compliant Nylonmaterial for diameter 2.0mm to 10.0mm with a rated burst pressure of 18-22atmospheres. It is a coaxial double lumen catheter with a balloon located nearthe distal tip. One lumen is used for inflation of the balloon and accessed viathe side leg port. The second lumen, starting at the straight entry port, allowsaccess to the distal tip of the catheter for guide wire insertion. The threeproducts of the non-compliant PTA (OTW type) balloon catheter family havedifferent diameter of the guide wire port from max.0.014" to 0.035". Theguide wire compatibility was shown in table 1. The balloon has radiopaquemarkers for positioning the balloon relative to the stenosis. The radiopaquemarker bands indicate the dilating section of the balloon and aid in balloonplacement. The balloon is dilated using the side leg port, at which the balloonmaterial expands to a known diameter at specific pressure. The workingpressure range for the balloon is between the nominal size pressure and therated burst pressure. All balloons distend to sizes above the nominal size atpressures greater than the nominal pressure. The design of this dilatation |
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| catheter does not incorporate a lumen for distal dye injections or distal | ||||||
|---|---|---|---|---|---|---|
| pressure measurements. |
- Intended Use: The balloon dilatation catheter is intended to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent dilatation post-deployment in the peripheral vasculature.
- Comparisons of the new and predicate devices show that the technological Technological Characteristics: characteristics such as product performance, design, and intended use are substantially equivalent to the currently marketed predicate devices.
- Performance Data: Both in vitro performance tests, such as dimensional verification, balloon preparation, deployment, and retraction, balloon rated burst pressure, balloon fatigue, balloon compliance, balloon inflation and deflation time, catheter bond strength, tip pull strength, flexibility and kinking, torque strength, radiopacity, coating integrity, particulate evaluation, balloon burst (in stents), balloon fatigue (in stents) and also biocompatibility tests, such as cytotoxicity, sensitization, hemocompatibility, pyrogenicity, acute systemic toxicity, intracutaneous reactivity and genototocity (bacterial mutagenicity and in vitro mouse lymphoma) were conducted on the PTA balloon catheter. The test results met all acceptance criteria, were similar to predicate devices, and ensure that the PTA balloon catheter design and construction are suitable for its intended use.
- Conclusion: This information supports a determination of substantial equivalence between the PTA balloon dilatation catheter and the predicate devices described above.
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| Castor NC 0.014 | Achilles NC 0.018 | Hermes NC 0.035 | Difference | ControlMethod | |
|---|---|---|---|---|---|
| Device | catheter, angioplasty,peripheral, transluminal | catheter, angioplasty,peripheral, transluminal | catheter, angioplasty,peripheral, transluminal | Identical | |
| RegulationDescription | Percutaneous catheter. | Percutaneous catheter. | Percutaneous catheter. | Identical | |
| Regulation MedicalSpecialty | Cardiovascular | Cardiovascular | Cardiovascular | Identical | |
| Review Panel | Cardiovascular | Cardiovascular | Cardiovascular | Identical | |
| Product Code | LIT | LIT | LIT | Identical | |
| Office of Device Evaluation6(ODE) | Office of Device Evaluation6(ODE) | Office of Device Evaluation6(ODE) | Identical | n/a | |
| Premarket Review | Division of CardiovascularDevices (DCD) | Division of CardiovascularDevices (DCD) | Division of CardiovascularDevices (DCD) | Identical | |
| Peripheral InterventionalDevices Branch (PIDB) | Peripheral InterventionalDevices Branch (PIDB) | Peripheral InterventionalDevices Branch (PIDB) | Identical | ||
| Submission Type | 510(k) | 510(k) | 510(k) | Identical | |
| Regulation Number | 21 CFR 870.1250 | 21 CFR 870.1250 | 21 CFR 870.1250 | Identical | |
| Device Class | 2 | 2 | 2 | Identical | |
| Indications for Use | The PTA balloon dilatationcatheter is indicated for:• dilating stenoses in theiliac, femoral, iliofemoral,popliteal, infrapopliteal, andrenal arteries, and for thetreatment of obstructivelesions of native or syntheticarteriovenous dialysisfistulae.• stent dilatationpost-deployment in theperipheral vasculature. | The PTA balloon dilatationcatheter is indicated for:• dilating stenoses in theiliac, femoral, iliofemoral,popliteal, infrapopliteal, andrenal arteries, and for thetreatment of obstructivelesions of native or syntheticarteriovenous dialysisfistulae.• stent dilatationpost-deployment in theperipheral vasculature. | The PTA balloon dilatationcatheter is indicated for:• dilating stenoses in theiliac, femoral, iliofemoral,popliteal, infrapopliteal, andrenal arteries, and for thetreatment of obstructivelesions of native or syntheticarteriovenous dialysisfistulae.• stent dilatationpost-deployment in theperipheral vasculature. | Identical | IFU |
| BalloonCharacteristic | non-compliant | non-compliant | non-compliant | Identical | DesignVerification;labeling |
| NominalPressure (Nom) | 12atm | 12atm | 12atm | Identical | DesignVerification;labeling |
| Rated BurstPressure (RBP) | 18, 20, 22atm | 18, 20, 22atm | 18, 20, 22atm | Identical | DesignVerification;labeling |
| Guide wireCompatibility | Max. 0.014"(0.36mm) | Max. 0.018" (0.46mm) | Max. 0.035"(0.89mm) | Different | DesignVerification;labeling |
| BalloonDiameter | 2.0-8.0mm | 2.0-8.0mm | 3.0-10.0mm | Different | DesignVerification:labeling |
| Balloon Length | 10-150mm | 10-150mm | 20-150mm | Different | DesignVerification:labeling |
| Shaft Length | 70, 90, 150 | 70, 90, 150 | 70, 90, 150 | Identical | DesignVerification:labeling |
Table 1, BrosMed PTA Balloon Dilatation Catheter Comparison Table
§ 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).