(114 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a balloon catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended to dilate stenosis in arteries and treat obstructive or synthetic arteriovenous dialysis fistulae, which are therapeutic interventions.
No
The device is a balloon dilatation catheter intended to dilate stenosis and for stent post-dilatation; it does not perform any diagnostic function.
No
The device description clearly outlines physical components such as a catheter, balloon, guidewire transition tube, radiopaque markers, hub, and strain relief, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used within the body to physically dilate blood vessels and treat fistulae. This is an interventional procedure, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a physical catheter with a balloon for mechanical action. It doesn't mention any components or processes related to analyzing biological samples (like blood, urine, tissue, etc.).
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device performs a therapeutic action directly on the patient's anatomy.
N/A
Intended Use / Indications for Use
The Crosperio RX PTA Balloon Dilatation Catheter is intended to dilate stenosis in the iliac, femoral, popliteal, infra-popliteal 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.
Product codes
LIT
Device Description
Crosperio RX PTA Balloon Dilatation Catheter (Crosperio RX) is a rapid exchange balloon dilation catheter, which consists of a distal tube, proximal tube, balloon, guidewire transition tube, radiopaque markers, hub, 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 hub at the proximal end. Crosperio RX has a lumen (guidewire transition tube) at the distal end of the catheter through which a guidewire can be inserted, and also an opening along the balloon and distal tube to the guidewire port for the introduction of a guidewire.
The maximum compatible diameter of a guidewire used together with Crosperio RX in a PTA procedure is 0.014 inches; hence, sheath introducers with a minimum diameter of 4 Fr have been deemed to be compatible with Crosperio RX. The nominal inflated balloon diameters range from 1.5 mm to 4.0 mm with balloon working lengths of 20 mm to 200 mm. Two different catheter working lengths will be provided: 900 and 1500 mm.
The Crosperio RX is provided with the following accessory device:
- Flushing Needle: provided per one catheter device for the purpose of flushing and filling . of the guidewire lumen with heparinized saline before use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
iliac, femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae. peripheral vasculature.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Bench testing was performed on the subject device, consisting of: 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, Coating Integrity, Particulate Evaluation, Balloon Rated Burst Pressure (in Stent), and Balloon Fatigue (Repeat Balloon Inflations; in Stent), and Shelf Life Testing.
Biocompatibility testing was performed in accordance with ISO 10993-1, including 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 technological characteristics and performance criteria of the Crosperio RX 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. The results from these tests demonstrate that the Crosperio RX is biocompatible for its intended use similar to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
K150865 (Kaneka Corporation), K131199 (Bard ● Peripheral Vascular Inc.)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The seal is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 22, 2016
Kaneka Corporation % Mr. Christopher Sloan Principal Consultant Ouintiles Consulting 1801 Rockville Pike, Suite 300 Rockville, Maryland 20852
Re: K152887
Trade/Device Name: Crosperio RX PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: December 18, 2015 Received: December 21, 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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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" (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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K152887
Device Name
Crosperio RX PTA Balloon Dilatation Catheter
Indications for Use (Describe)
The Crosperio RX PTA Balloon Dilatation Catheter is intended to dilate stenosis in the iliac, femoral, popliteal, infra-popliteal 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)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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510(K) SUMMARY
Crosperio RX 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: September 10, 2015
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Subject Device Name:
| Trade Name | Crosperio RX PTA Balloon Dilatation Catheter |
|---|---|
| Common or usual name | Percutaneous (peripheral) transluminal |
| angioplasty catheter | |
| Classification name | Percutaneous catheter [21 CFR 870.1250; |
| product code (LIT)] | |
| Class | II |
| Classification Panel | Cardiovascular (74) |
Predicate Devices:
- Metacross RX PTA Balloon Dilatation Catheter [K150865 (Kaneka Corporation)]
- Ultraverse® RX PTA Dilatation Catheter or "Ultraverse RX" [K131199 (Bard ● Peripheral Vascular Inc.)]
Device Description:
Crosperio RX PTA Balloon Dilatation Catheter (Crosperio RX) is a rapid exchange balloon dilation catheter, which consists of a distal tube, proximal tube, balloon, guidewire transition tube, radiopaque markers, hub, 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 hub at the proximal end. Crosperio RX has a lumen (guidewire transition tube) at the distal end of the catheter through which a guidewire can be inserted, and also an opening along the balloon and distal tube to the guidewire port for the introduction of a guidewire.
The maximum compatible diameter of a guidewire used together with Crosperio RX in a PTA procedure is 0.014 inches; hence, sheath introducers with a minimum diameter of 4 Fr have been deemed to be compatible with Crosperio RX. The nominal inflated balloon diameters range from 1.5 mm to 4.0 mm with balloon working lengths of 20 mm to 200 mm. Two different catheter working lengths will be provided: 900 and 1500 mm.
The Crosperio RX is provided with the following accessory device:
- Flushing Needle: provided per one catheter device for the purpose of flushing and filling . of the guidewire lumen with heparinized saline before use.
Indications for Use
The Crosperio RX 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
6
synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.
Comparison of Indications for Use to Predicate Devices
The indications for use of the Crosperio RX is identical to that of the Metacross RX. The Crosperio RX has the same intended use (percutaneous transluminal angioplasty) and similar indications for use as the Ultraverse RX. Therefore, the subject device, Crosperio RX, may be considered substantially equivalent to predicate devices.
Comparison of Technological Characteristics to Predicate Devices
Technological Comparison to Predicate Devices
The Metacross RX has the following similarities to the predicate devices:
- . Same intended use (same as Metacross RX and Ultraverse RX)
- . Same indications for use (same as Metacross RX and similar to Ultraverse RX)
- Same target population (same as Metacross RX and Ultraverse RX)
- . Same operating principle (same as Metacross RX and Ultraverse RX)
- Similar materials (similar to Metacross RX and Ultraverse RX)
- . Same fundamental scientific technology (same as Metacross RX and Ultraverse RX)
- . Same sterility assurance level and method of sterilization (same as Metacross RX and Ultraverse RX)
Performance Testing
To demonstrate substantial equivalence of Crosperio RX to the predicate devices, 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:
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, Coating Integrity, Particulate Evaluation, Balloon Rated Burst Pressure (in Stent), and Balloon Fatigue (Repeat Balloon Inflations; in Stent), and Shelf Life Testing.
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The results from these tests demonstrate that the technological characteristics and performance criteria of the Crosperio RX 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 Crosperio RX to the predicate devices, the following biocompatibility testing was performed in accordance with ISO 10993-1:
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 Crosperio RX is biocompatible for its intended use similar to the predicate devices.
Conclusions:
The Crosperio RX met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs. The Crosperio RX PTA Balloon Dilatation Catheter is substantially equivalent to legally marketed predicate devices.