(59 days)
The Metacross OTW PTA Balloon Dilatation Catheter is intended to dilate stenoral, ilio-femoral, popliteal, infrapopliteal and renal arteries, and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.
Metacross OTW PTA Balloon Dilatation Catheter (Metacross OTW) is an over the wire type of balloon dilation catheter, which consists of a distal tube, center tube, proximal tube, balloon, guidewire transition tube, radiopaque markers, manifold, and strain relief. A balloon is attached to the distal end of the catheter, and it can be inflated and deflated using the inflation device connected to the manifold at the proximal end. Metacross OTW has a guidewire lumen at the distal end of the catheter through which a guidewire can be inserted, and also an opening along the guidewire transition tube, center tube and proximal tube to the guidewire port of the manifold for the introduction of a guidewire.
The maximum compatible diameter of a guidewire used together with Metacross OTW in a PTA procedure is 0.035 inches; hence, sheathless guiding catheters and sheaths with a diameter of 5, 6 or 7 Fr have been deemed to be compatible with Metacross OTW. The nominal inflated balloon diameters range from 3.0 mm with balloon working lengths of 20 mm to 200 mm. Three different catheter working lengths will be provided: 650, 900 and 1350 mm.
Here's an analysis of the provided text regarding the Metacross OTW PTA Balloon Dilatation Catheter, addressing your specific questions.
It's important to note that the provided document is a 510(k) summary, which is a regulatory submission for medical devices. These submissions typically focus on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report or a multi-reader, multi-case study that would be typical for AI-powered diagnostic devices. Therefore, some of your questions may not be fully answerable from this type of document, as it pertains to a physical medical device (a balloon catheter) and its performance, rather than an AI/software device.
1. A table of acceptance criteria and the reported device performance
The document lists performance tests but does not explicitly provide a table of acceptance criteria and quantitative reported performance against those criteria. It states that the device "met all the predetermined acceptance criteria of design verification and validation" and that "The results from these tests demonstrate that the technological characteristics and performance criteria of the Metacross OTW are adequate for the intended use of the device and that the device can perform in a manner equivalent to devices currently on the market with the same intended use."
However, we can infer the types of performance criteria based on the tests conducted:
| Acceptance Criteria (Inferred from tests) | Reported Device Performance |
|---|---|
| Mechanical Performance: | Met predetermined acceptance criteria. Adequately performed for intended use |
| Dimensional Verification (e.g., balloon diameter, catheter length) | Met predetermined acceptance criteria. Adequately performed for intended use |
| Balloon Preparation, Deployment and Retraction (e.g., ease of use, smooth operation) | Met predetermined acceptance criteria. Adequately performed for intended use |
| Balloon Rated Burst Pressure (e.g., withstand specified pressure without bursting) | Met predetermined acceptance criteria. Adequately performed for intended use |
| Balloon Fatigue (Repeat Balloon Inflations) (e.g., durability over multiple cycles) | Met predetermined acceptance criteria. Adequately performed for intended use |
| Balloon Compliance (e.g., inflation characteristics, expandability) | Met predetermined acceptance criteria. Adequately performed for intended use |
| Balloon Inflation and Deflation Time (e.g., speed of inflation/deflation) | Met predetermined acceptance criteria. Adequately performed for intended use |
| Catheter Bond Strength (e.g., integrity of assembled components) | Met predetermined acceptance criteria. Adequately performed for intended use |
| Flexibility and Kink Test (e.g., ability to navigate tortuous anatomy without kinking) | Met predetermined acceptance criteria. Adequately performed for intended use |
| Torque Strength (e.g., ability to transmit rotational force) | Met predetermined acceptance criteria. Adequately performed for intended use |
| Radiopacity (e.g., visibility under fluoroscopy) | Met predetermined acceptance criteria. Adequately performed for intended use |
| Particulate Evaluation (e.g., absence of harmful particulates) | Met predetermined acceptance criteria. Adequately performed for intended use |
| Balloon Rated Burst Pressure (in Stent) | Met predetermined acceptance criteria. Adequately performed for intended use |
| Balloon Fatigue (Repeat Balloon Inflations; in Stent) | Met predetermined acceptance criteria. Adequately performed for intended use |
| Shelf Life Testing (e.g., stability over time) | Met predetermined acceptance criteria. Adequately performed for intended use |
| Biocompatibility: | Biocompatible for intended use, similar to predicate device |
| Cytotoxicity | Met acceptance criteria |
| Sensitization | Met acceptance criteria |
| Intracutaneous reactivity (irritation) | Met acceptance criteria |
| Systemic toxicity (acute) | Met acceptance criteria |
| Pyrogenicity | Met acceptance criteria |
| Hemocompatibility (thrombogenicity, hemolysis, and immunology) | Met acceptance criteria |
| Genotoxicity (bacterial gene mutation assay, in vitro mammalian genotoxicity assay, and in vivo cytogenetics assay) | Met acceptance criteria |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes bench testing (in vitro tests) and biocompatibility testing. These are not clinical studies with patient data. Therefore, the concepts of "test set" in the context of clinical data, "country of origin of the data," or "retrospective/prospective" do not apply here.
For the bench tests, the sample sizes for each specific test (e.g., number of balloons tested for burst pressure) are not provided in this summary. Similarly, for biocompatibility, the number of samples or animal subjects (if applicable) is not specified.
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 question is not applicable. The product is a physical medical device (balloon catheter), and the "ground truth" for its performance is established through objective engineering and biological tests, not through expert interpretation of clinical images or data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the same reasons as in question 3. No clinical adjudication method is mentioned as these are bench and biocompatibility tests.
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
This is not applicable. The device is a balloon catheter, not an AI-powered diagnostic system or an assistive AI for human readers. No MRMC study was conducted or would be relevant for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical catheter, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is based on:
- Engineering specifications and standards: For mechanical performance tests (e.g., burst pressure is compared against a specified pressure, dimensions against design drawings).
- Established biological safety standards: For biocompatibility tests (e.g., cytotoxicity is measured against established limits for cellular response).
- Predicate device characteristics: The ultimate goal is to demonstrate equivalence to the predicate device's established performance.
8. The sample size for the training set
This is not applicable. No "training set" in the context of machine learning or AI is involved. The device's design and manufacturing processes are developed based on engineering principles and existing knowledge.
9. How the ground truth for the training set was established
This is not applicable as there is no training set in the AI/ML sense. The "ground truth" for the various performance tests (dimensional, mechanical, biocompatibility) is established through standardized methodologies, calibrated equipment, and predefined acceptance criteria based on regulatory guidance and engineering principles.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 24, 2015
Kaneka Corporation % Christopher M. Sloan Principal Consultant Quintiles Consulting 1801 Rockville Pike, Suite 300 Rockville, MD 20852
Re: K152080
Trade/Device Name: Metacross OTW PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: July 24, 2015 Received: July 27, 2015
Dear Mr. Sloan:
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,
Kenneth J. Cavanaugh -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) K152080
Device Name
Metacross OTW PTA Balloon Dilatation Catheter
Indications for Use (Describe)
The Metacross OTW PTA Balloon Dilatation Catheter is intended to dilate stenoral, ilio-femoral, popliteal, infrapopliteal and renal arteries, and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) SUMMARY
Metacross OTW PTA Balloon Dilatation Catheter
510(k) Submitter
Kaneka Corporation Medical Device Division 1-12-32, Akasaka, Minato-ku Tokyo, Japan Contact Person: Toshihiko Motomine Telephone: +81-3-5574-8023 Email: Toshihiko.Motomine@kaneka.co.jp
Official Correspondent
Christopher M. Sloan Principal Consultant Quintiles Consulting 1801 Rockville Pike, Suite 300 Rockville, MD 20852 Phone: (301) 272-3114 Facsimile: (301) 272-0004 Email: chris.sloan@quintiles.com
Date Prepared: July 24, 2015
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Subject Device Name:
| Trade Name | Metacross OTW PTA Balloon Dilatation Catheter |
|---|---|
| Common or usual name | Percutaneous (peripheral) transluminalangioplasty catheter |
| Classification name | Percutaneous catheter [21 CFR 870.1250;Product code LIT |
| Class | II |
| Classification Panel | Cardiovascular (74) |
Predicate Device:
- EverCross™ .035" OTW PTA Dilatation Catheter or "EverCross" [K082579 (ev3, ● Inc.)]
Reference Device:
- Metacross RX PTA Balloon Dilatation Catheter [K150865 (Kaneka Corporation)]
Device Description:
Metacross OTW PTA Balloon Dilatation Catheter (Metacross OTW) is an over the wire type of balloon dilation catheter, which consists of a distal tube, center tube, proximal tube, balloon, guidewire transition tube, radiopaque markers, manifold, and strain relief. A balloon is attached to the distal end of the catheter, and it can be inflated and deflated using the inflation device connected to the manifold at the proximal end. Metacross OTW has a guidewire lumen at the distal end of the catheter through which a guidewire can be inserted, and also an opening along the guidewire transition tube, center tube and proximal tube to the guidewire port of the manifold for the introduction of a guidewire.
The maximum compatible diameter of a guidewire used together with Metacross OTW in a PTA procedure is 0.035 inches; hence, sheathless guiding catheters and sheaths with a diameter of 5, 6 or 7 Fr have been deemed to be compatible with Metacross OTW. The nominal inflated balloon diameters range from 3.0 mm with balloon working lengths of 20 mm to 200 mm. Three different catheter working lengths will be provided: 650, 900 and 1350 mm.
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Indications for Use
The Metacross OTW PTA Balloon Dilatation Catheter is intended to dilate stenosis 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. This device is also indicated for stent post- dilatation in the peripheral vasculature.
Comparison of Indications for Use to Predicate Device
The Metacross OTW has the same intended use (percutaneous transluminal angioplasty) as the EverCross. The indications for use of the Metacross OTW is identical to that of the EverCross. Therefore, the subject device, Metacross OTW, may be considered substantially equivalent to the predicate device.
Comparison of Technological Characteristics to Predicate Device
Technological Comparison to Predicate Device
The Metacross OTW has the following similarities to the predicate EverCross device:
- Same intended use ●
- . Same indications for use
- Same target population ●
- . Same operating principle
- Similar materials
- Same fundamental scientific technology
- Same sterility assurance level and method of sterilization
Performance Testing
To demonstrate substantial equivalence of Metacross OTW to the predicate device, the technological characteristics and performance criteria were evaluated using the bench testing recommendations outlined in the FDA Guidance Document "Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters'' dated September 8, 2010. The following in vitro tests were performed on the subject device:
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Dimensional Verification, Balloon Preparation, Deployment and Retraction, Balloon Rated Burst Pressure, Balloon Fatigue (Repeat Balloon Inflations), Balloon Compliance, Balloon Inflation and Deflation Time, Catheter Bond Strength, Flexibility and Kink Test. Torque Strength. Radiopacity. Particulate Evaluation. Balloon Rated Burst Pressure (in Stent), and Balloon Fatigue (Repeat Balloon Inflations; in Stent), and Shelf Life Testing.
The results from these tests demonstrate that the technological characteristics and performance criteria of the Metacross OTW are adequate for the intended use of the device and that the device can perform in a manner equivalent to devices currently on the market with the same intended use.
Biocompatibility:
To demonstrate the biological safety of the body-contacting materials and substantial equivalence of the Metacross OTW to the predicate device, the following biocompatibility testing was leveraged from the Metacross RX reference device in accordance with "Draft Guidance for Industry and Food and Drug Administration Staff; Use of International Standard ISO 10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing'" (dated April 23, 2013):
Cytotoxicity, Sensitization, Intracutaneous reactivity (irritation), Systemic toxicity (acute), Pyrogenicity, Hemocompatibility (thrombogenicity, hemolysis, and immunology), and Genotoxicity (bacterial gene mutation assay, in vitro mammalian genotoxicity assay, and in vivo cytogenetics assay)
The results from these tests demonstrate that the Metacross OTW is biocompatible for its intended use similar to the predicate device.
Conclusions:
The Metacross OTW met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs. The Metacross OTW PTA Balloon Dilatation Catheter is substantially equivalent to legally marketed 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).