(115 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 AI or ML capabilities.
Yes
The device is intended to dilate stenoses in arteries and treat obstructive lesions, which are therapeutic interventions.
No
The device is a dilatation catheter intended to dilate stenoses, which is a therapeutic function, not a diagnostic one. While it uses radiopaque markers for placement, this aids in a therapeutic procedure rather than diagnosing a condition.
No
The device description clearly outlines a physical catheter with a balloon, guide wire compatibility, radiopaque markers, and a hub assembly with ports for inflation and guide wire insertion. This 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 in vivo (within the body) to dilate blood vessels and treat lesions. IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a catheter with an inflatable balloon designed for insertion into arteries and fistulae. This is consistent with an interventional medical device, not an IVD.
- Input Imaging Modality: The mention of fluoroscopy indicates the device is used in conjunction with imaging techniques to guide its placement and use within the body. IVD devices typically do not involve real-time imaging of the patient.
- Anatomical Site: The specified anatomical sites are all within the human body, further supporting its use as an interventional device.
In summary, the SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is an interventional medical device used for therapeutic procedures within the body, not an IVD used for testing specimens outside the body.
N/A
Intended Use / Indications for Use
The SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Product codes
LIT
Device Description
The SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is a catheter with a distal inflatable balloon, which shares the similar technological characteristics as the predicate, Powerflex Pro PTA Catheter. The SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is designed for use with a 0.035" guide wire and a catheter sheath introducer and is available in a variety of diameters and lengths. The radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement. The catheter tip is tapered to ease entry into peripheral arteries and to facilitate crossing of tight stenoses. The SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is compatible with standard .035" guide wires and 5Fr, 6Fr and 7Fr catheter sheath introducers (CSI).
The SABER™ .035" Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter has similar device/component constructions as the predicate. Powerflex Pro PTA Catheter. Same as the predicate, the balloon of the SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter has radiopaque markers at the distal and proximal ends of the balloon working length to aid in balloon placement, when under fluoroscopy. The SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter has a proximal hub assembly that contains a luer locking connector with a balloon inflation port and a guide wire port. The balloon is inflated by injecting diluted contrast medium through the inflation port of the hub and the inflation lumen connected to the balloon.
The SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is intended for single use only and is provided sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries, arteriovenous dialysis fistulae.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Design Verification and Validation (DV&V) testing were performed to verify that the proposed SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter meets the pre-determined design verification and validation requirements. Testing was also conducted to verify the effectiveness of the implemented risk control measures to mitigate the risks identified within the risk management process per ISO 14971: Medical Devices-Application of Risk Management to Medical Devices. The following design verification or performance testing of SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter have been completed with favorable test results, meeting the applicable ISO standards and FDA's recognized consensus standards pertaining to evaluations of PTA Catheters:
T=0 Baseline Sample Testing and T=3 Years Accelerated Aging Testing of Finished Devices of SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter.
Sterilization Adoption Validation of the SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter, Sterilization Validation Report.
Microbiology validation and verification evaluations were completed for the SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter with the bioburden and bacterial endotoxin test (BET) results: Microbiology Validation Report, Bioburden Test Method Validation, Endotoxin LAL Test Before Sterilization, Endotoxin LAL Test After Sterilization, Bioburden Test During PQ.
Packaging design validation and verification testing of the SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter have been completed with both t=0 baseline samples and t=3 Year, accelerated aging samples of the SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter: T0 Sample: Packaging Validation and Verification, T3 Year Sample: Packaging Validation and Verification.
Key results: Favorable test results for all performance tests.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 11, 2020
Cordis Corporation Kyungyoon Kang Regulatory Affairs Manager 14201 N.W. 60th Ave. Miami Lakes, Florida 33014
Re: K201333
Trade/Device Name: SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: July 28, 2020 Received: July 31, 2020
Dear Kyungyoon Kang:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201333
Device Name
SABERTM .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter
Indications for Use (Describe)
The SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
| 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) |
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510(k) Summarv: SABER™.035 Percutaneous Transluminal Angioplastv (PTA) Dilatation Catheter
l. Applicant/Manufacturer Information
Company: Cordis Corporation Type of 510(k) Submission: Traditional 510(k) Premarket Notification 510(k) Correspondent: Mr. Kyungyoon Kang (Kyungyoon.kang@cardinalhealth.com) Submission date: May 8th, 2020
II. Requlatory Information-Assigned 510(k) Number: K201333
Proposed Device:
- Trade/Proprietary Name: SABER™ .035 Percutaneous Transluminal ● Angioplasty (PTA) Dilatation Catheter
- Regulation Name: Percutaneous Catheter ●
- Classification Panel: Cardiovascular ●
- . Device Class: II
- Regulation Number: 21 CFR 870.1250 ●
- . Product Code: LIT
- 510k Submitter: Cordis Corporation, (a Cardinal Health Company) 14201 N.W. 60th AVE. Miami Lakes, FL33014 Tel: 408-273-3121 Fax: 408-955-0704 Establishment registration number: 1016427
- Indications for Use: The SABER™.035 Percutaneous Transluminal . Angioplasty (PTA) Dilatation Catheter is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Predicate Device:
- Trade/Proprietary Name: Powerflex™ Pro Percutaneous Transluminal . Angioplasty Catheter
- Regulation Name: Percutaneous Catheter ●
- . Product Code: LIT
- 510k number: K121442 ●
- 510k Submitter: Cordis Corporation, (a Johnson & Johnson Company) . 430 Route 22 East, Bridgewater, NJ 08807
- Indications for Use: The Powerflex™ Pro Percutaneous Transluminal . Angioplasty Catheter is intended to dilate stenoses in iliac, femoral, illiofemoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
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The device is also indicated for post-dilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.
III. Device Descriptions of the SABER™ .035 Percutaneous Transluminal Anqioplasty (PTA) Dilatation Catheter:
The SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is a catheter with a distal inflatable balloon, which shares the similar technological characteristics as the predicate, Powerflex Pro PTA Catheter. The SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is designed for use with a 0.035" guide wire and a catheter sheath introducer and is available in a variety of diameters and lengths. The radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement. The catheter tip is tapered to ease entry into peripheral arteries and to facilitate crossing of tight stenoses. The SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is compatible with standard .035" guide wires and 5Fr, 6Fr and 7Fr catheter sheath introducers (CSI).
The SABER™ .035" Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter has similar device/component constructions as the predicate. Powerflex Pro PTA Catheter. Same as the predicate, the balloon of the SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter has radiopaque markers at the distal and proximal ends of the balloon working length to aid in balloon placement, when under fluoroscopy. The SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter has a proximal hub assembly that contains a luer locking connector with a balloon inflation port and a guide wire port. The balloon is inflated by injecting diluted contrast medium through the inflation port of the hub and the inflation lumen connected to the balloon.
The SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is intended for single use only and is provided sterile.
IV. Substantial Equivalence Assessments of Technological Characteristics:
Fundamental technological characteristics of the SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter are similar to the predicate device, Powerflex™ Pro Percutaneous Transluminal Angioplasty Catheter. The overall raw material construction of the SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is similar to the predicate device. The operation principle, clinical applications, and instructions for use of the SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter are similar to the predicate device, as both devices are used to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Both the proposed and predicate devices are provided sterile with ethylene oxide sterilization and intended for single use only.
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The proposed and predicate devices share the similar patient contacting materials, and the biocompatibility testing of the SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter was performed to verify conformance to the same requirements of the ISO 10993-1 (2018) standard for biocompatibility evaluation. Given all the critical technological characteristics as well as indications for use/intended use are similar, the proposed SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is assessed as substantially equivalent to the predicate device, Powerflex Pro PTA Catheter.
V. Biocompatibility Assessment
In accordance with ISO 10993-1: 2018. Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process, the SABER™ ,035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is classified as "Externally Communicating Devices, Circulating blood, Limited Contact (