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.

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.

AI/ML Overview

The provided text describes the 510(k) submission for the SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter. A 510(k) submission is for demonstrating "substantial equivalence" to a legally marketed predicate device, not for establishing novel performance criteria or conducting studies that prove efficacy or an AI's performance against human readers. Therefore, the document does not contain the information required to answer most of the questions related to acceptance criteria, AI performance, multi-reader multi-case studies, or detailed ground truth establishment.

The document focuses on showing that the new device (SABER™) is as safe and effective as a previously cleared predicate device (Powerflex™ Pro). This is primarily achieved through:

Comparison of technological characteristics: demonstrating similarity in design, materials, and operation.
Biocompatibility testing: ensuring the materials are safe for human contact.
Design Verification and Validation (DV&V) testing: confirming the device meets pre-determined engineering requirements and performance specifications (e.g., inflation/deflation, burst pressure, kink resistance).
Sterilization and packaging validation: ensuring the device is sterile and remains so until use.

Here's what can be extracted from the provided text, and where the information is not present:

1. A table of acceptance criteria and the reported device performance

The document does not present a single table of acceptance criteria with corresponding performance data. Instead, it states that "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." It also states that tests were completed "with favorable test results, meeting the applicable ISO standards and FDA's recognized consensus standards pertaining to evaluations of PTA Catheters" and that "favorable results... show that no new questions of safety or effectiveness are raised."

The specific performance tests conducted are listed under "Design Verification Performance Testing":

Acceptance Criteria (Implied: Conformance to ISO standards and pre-determined design requirements)	Reported Device Performance
CSI Withdrawal	Favorable test results
Guide Wire Compatibility	Favorable test results
Usable catheter length	Favorable test results
Kink diameter	Favorable test results
Visual coating integrity	Favorable test results
Particulate Count Testing	Favorable test results
Outer surface lubricity	Favorable test results
Marker Band Locations	Favorable test results
Inflation / Deflation	Favorable test results
No Leakage	Favorable test results
Connector compatibility	Favorable test results
Hub-Catheter tensile test	Favorable test results
Balloon proximal tensile test	Favorable test results
Balloon Distal Tip tensile test	Favorable test results
Catheter Body Burst (Inflation Lumen)	Favorable test results
Catheter Body Burst (Guide Wire Lumen)	Favorable test results
Torque-ability	Favorable test results
Balloon Working Length	Favorable test results
Balloon Diameter	Favorable test results
Balloon compliance	Favorable test results
Balloon Burst	Favorable test results
System Fatigue	Favorable test results

Note: The document confirms "favorable test results" for all listed tests, indicating they met their respective acceptance criteria. However, explicit numerical thresholds for these criteria are not provided.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not explicitly stated in terms of the number of devices tested for each performance characteristic. The document refers to "samples" being tested (e.g., "T=0 Baseline Sample Testing and T=3 Years Accelerated Aging Testing of Finished Devices").
Data Provenance: Not specified for the performance testing if it refers to patient data. This is a device performance study, not a clinical study involving patients. Biocompatibility testing was conducted at a "US testing laboratory." The physical manufacturer of the device is Confluent Medical Technologies.
Retrospective/Prospective: Not applicable in the context of device performance testing.

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)

Not applicable. This submission pertains to a medical device (catheter), not an AI algorithm or diagnostic tool that requires expert human interpretation to establish ground truth for a test set. The "ground truth" here is based on engineering specifications, physical measurements, and compliance with recognized standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This refers to a process for resolving discrepancies in expert interpretations, which is not relevant for the type of device performance testing described.

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

Not applicable. This device is a physical catheter, not an AI or imaging software. Therefore, an MRMC study related to human reader improvement with AI assistance was not conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This pertains to an AI algorithm; the device is a physical medical instrument.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is established by:

Engineering Specifications: Pre-determined design requirements and measurable performance parameters (e.g., specific dimensions, burst pressures, tensile strengths).
Recognized Consensus Standards: Compliance with relevant ISO standards (e.g., ISO 10993-1 for biocompatibility, ISO 14971 for risk management) and FDA's recognized consensus standards for PTA Catheters.
Physical Measurements and Laboratory Tests: Direct measurement of device characteristics (e.g., usable catheter length, balloon diameter) and tests under controlled conditions (e.g., inflation/deflation, burst, fatigue).

8. The sample size for the training set

Not applicable. There is no "training set" in the context of a 510(k) submission for a physical medical device. This term is relevant for machine learning models.

9. How the ground truth for the training set was established

Not applicable. As there is no training set for a machine learning model, this question is not relevant.

Summary

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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

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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)

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 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 (<24 hrs). This is the same classification of the biocompatibility evaluation as the predicate, Powerflex Pro PTA Catheter (K152740).

The biocompatibility testing of the SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter listed below has been conducted at a US testing laboratory, in order to ensure that FDA's latest consensus standards with respect to biocompatibility evaluations are met for the proposed device. The favorable biocompatibility test results provide assurance of the biologically safe profile of the SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter.

GLP Biocompatibility Testing Performed:

Extractables of SABER™ .035 PTA Dilatation Catheter .
Cytotoxicity-ISO MEM Elution Using L-929 Mouse Fibroblast Cell .
ISO Guinea Pig Maximization Sensitization ●
ISO Intracutaneous Irritation .
ISO Acute Systemic Toxicity
ISO Materials Mediated Rabbit Pyrogen .
Hemocompatibilitv-ASTM Hemolysis ●
Hemocompatibility-Complement Activation
Hemocompatibility Thromboresistance Evaluation ●
Chemical Characterization .
Toxicology Risk Assessment Report .

VI. Design Verification and Validation Testing

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

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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.

Design Verification Performance Testing:

T=0 Baseline Sample Testing and T=3 Years Accelerated Aging Testing of Finished Devices of SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter:

CSI Withdrawal
Guide Wire Compatibility ●
Usable catheter length
Kink diameter
Visual coating integrity
Particulate Count Testing
Outer surface lubricity
Marker Band Locations ●
Inflation / Deflation
No Leakage
Connector compatibility
Hub-Catheter tensile test
Balloon proximal tensile test
. Balloon Distal Tip tensile test
Catheter Body Burst (Inflation Lumen) ●
Catheter Body Burst (Guide Wire Lumen)
Torque-abilitv ●
Balloon Working Length ●
. Balloon Diameter
. Balloon compliance
Balloon Burst
. System Fatique

VII. Sterilization, Microbiology and Packaging Validation and Verification

The EO sterilization process for the SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter and the predicate, Powerflex Pro PTA Catheter (K121442) fall under the same sterilization product family category set up by Confluent Medical Technologies, which is the physical manufacturer of both the SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter and the predicate, Powerflex Pro PTA Catheter.

The product family under which both the SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter and the predicate, Powerflex Pro PTA Catheter

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(K121442) fall, has been previously validated using the overkill approach for EO sterilization. The predicate, Powerflex Pro PTA Catheter and the SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter share highly similar technological characteristics, which have been considered in reaching the decision to have the SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter be included into the validated sterilization process used at the Confluent Medical Technologies facility.

The favorable results of the sterilization adoption assessments demonstrate it is appropriate to include and adopt the SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter into the EO processing product family using the validated sterilization cycle.

Sterilization Adoption Validation of the SABER™ .035 Percutaneous . Transluminal Angioplasty (PTA) Dilatation Catheter
Sterilization Validation Report .

The 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

The 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 ●

VIII. Substantial Equivalence Assessment

The proposed SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is assessed substantially equivalent to the predicate device, given the fact that its indications for use/intended use are identical, and its fundamental technological characteristics are similar to the predicate device, Powerflex Pro PTA Catheter.

The proposed SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter demonstrate conformance to the FDA's recognized standards. The favorable test results of the proposed device have further demonstrated to fulfill the design

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verification requirements and support the substantially equivalent profile of the SABER™ .035 Percutaneous Transluminal Angioplsty (PTA) Dilatation Catheter to the predicate device, Powerflex Pro PTA Catheter. The favorable results of the design verification and validation testing show that no new questions of safety or effectiveness are raised compared to the predicate device.

Regulation Number and Section

§ 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).