SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is intended to dilate stenoses in iliac, femoral, ilio-femoral, poplited, infra poplited and renal arteries and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae. The device is also indicated for post-dilatation of balloon-expandable and selfexpanding stents in the peripheral vasculature.

Device Description

The SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is a catheter with a distal inflatable balloon, which is the same device as its predicate, SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter (K201333), with an additional indication. The device has identical technological characteristics as the predicate, SABER™ .035 PTA Dilatation Catheter (K201333). 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. 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" PTA Dilatation Catheter has identical device/component constructions as the predicate, SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter (K201333). Same as the predicate, the balloon of the SABER™ .035 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 PTA Dilatation Catheter has a proximal hub assembly that contains a luer locking connector with a balloon inflation port and a quide 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

This document describes the submission of the SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter (K210626) to the FDA for a 510(k) premarket notification. The submission aims to demonstrate substantial equivalence to its predicate device (K201333) with an additional indication for post-dilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.

Here's an analysis based on the provided text, addressing your specific points:

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

The document does not provide a formal table of explicit acceptance criteria with numerical targets. Instead, it states that "Design Verification and Validation (DV&V) testing was performed to verify that the proposed SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter meets the pre-determined safety and performance requirements." It also mentions that testing "completed with favorable test results, meeting the applicable ISO standards and FDA's recognized consensus standards pertaining to evaluations of PTA Catheters."

The reported device performance is that all listed tests had "favorable test results" and demonstrated "conformance to the FDA's recognized standards."

Here's a summary of the performance testing categories:

Acceptance Criteria Category	Reported Device Performance
Biocompatibility	Favorable results, demonstrating biological safety per ISO 10993-1: 2018.
Design Verification (T=0 & T=3 years accelerated aging)	All listed tests yielded favorable results, meeting applicable ISO standards and FDA recognized consensus standards.
Sterilization Adoption Validation	Favorable results, demonstrating appropriateness for inclusion in the validated sterilization process.
Microbiology Validation & Verification	Bioburden and bacterial endotoxin test results completed and favorable.
Packaging Design Validation & Verification	Completed with both T=0 baseline and T=3 year accelerated aging samples, demonstrating favorable results.

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

The document does not explicitly state the numerical sample size for individual tests within the "Design Verification Performance Testing" or the "Biocompatibility Assessment." It mentions "samples" for accelerated aging and packaging validation.

For Biocompatibility Assessment, it states the testing "has been conducted at a US testing laboratory."
For Sterilization Adoption Validation and Microbiology Validation, the document points to external reports ("eCopy 002") and mentions "Confluent Medical Technologies" as the physical manufacturer and "Synergy Health" (for sterilization cycle 2.0) and "Steris AST" for sterilization.

This suggests the data provenance is primarily from US testing laboratories and manufacturing/sterilization facilities. The nature of these tests (e.g., material testing, mechanical testing) implies they are prospective tests performed on newly manufactured devices.

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 information is not provided in the document. The tests performed are primarily engineering, chemical, and biological evaluations, not clinical studies requiring expert interpretation of patient data to establish ground truth.

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

This information is not applicable and therefore not provided. The tests described are objective measurements (e.g., burst pressure, material compatibility, sterility) and do not involve subjective interpretation or a need for adjudication among multiple experts to establish a "ground truth."

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study in the document. This type of study is typically conducted for diagnostic devices (especially imaging-based AI) where human interpretation is involved. The SABER™ .035 PTA Dilatation Catheter is an interventional medical device, and its safety and efficacy are evaluated through performance testing, biocompatibility, and substantial equivalence to a predicate device, not through human reader performance with or without AI assistance.

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

This information is not applicable as the device is a physical medical device (dilatation catheter), not an AI algorithm or software. Therefore, there is no "standalone" algorithm performance to assess.

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

The concept of "ground truth" as typically applied in AI/diagnostic studies (e.g., expert consensus for image interpretation, pathology for disease diagnosis) is not directly applicable to the type of device and testing described. For this device, the "ground truth" for performance is established by objective measurements against pre-defined engineering specifications, international standards (e.g., ISO), and FDA recognized consensus standards.

For example:

Biocompatibility: Conformance to ISO 10993-1 standards (e.g., passing cytotoxicity, sensitization tests).
Mechanical Properties: Achieving specific values for burst pressure, tensile strength, inflation/deflation times, kink diameter, etc., as defined by design specifications and relevant standards for PTA catheters.
Sterilization: Demonstrated sterility assurance level (SAL) according to established sterilization validation protocols.

8. The sample size for the training set

This information is not applicable as the device is a physical medical device, not an AI or machine learning model that requires a training set.

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

This information is not applicable for the same reason as point 8.

Summary

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April 23, 2021

Cordis Corporation Wai Morgan Regulatory Affairs Principal Specialist 14201 N.W. 60th Avenue Miami Lakes, Florida 33014

Re: K210626

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: February 26, 2021 Received: March 2, 2021

Dear Wai Morgan:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 (QS) 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,

For

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) K210626

Device Name

SABERTM .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter

Indications for Use (Describe)

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 for SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter

l. Applicant/Manufacturer Information

Company: Cordis Corporation

Type of 510(k) Submission: Traditional 510(k) Premarket Notification 510(k) Correspondent: Ms. Wai Morgan(wai.morgan@cardinalhealth.com) Submission date: February 26, 2021

II. Requlatorv Information

Proposed Device:

Trade/Proprietary Name: SABER™ .035 Percutaneous Transluminal ● Angioplasty (PTA) Dilatation Catheter
Regulation Name: Percutaneous Catheter ●
Classification Panel: Cardiovascular o
Device Class: II o
o Regulation Number: 21 CFR 870.1250
Product Code: LIT ●
. 510k Submitter: Cordis Corporation, (a Cardinal Health Company) 14201 N.W. 60th AVE. Miami Lakes, FL 33014 Tel: 305-528-6181 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. The device is also indicated for post-dilatation of balloonexpandable and self-expanding stents in the peripheral vasculature.

Predicate Device:

Trade/Proprietary Name: SABER™.035 Percutaneous Transluminal 0 Angioplasty (PTA) Dilatation Catheter
Regulation Name: Percutaneous Catheter ●
Product Code: LIT
510k number: K201333
510k Submitter: Cordis Corporation, (a Cardinal Health Company) o 14201 N.W. 60th AVE. Miami Lakes, FL33014
o Indications for Use: 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

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for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

III. Device Description of the SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter:

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 and raw material construction of the SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter are identical to the predicate device, SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter (K201333). . 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. Both the SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter and the predicate device (K201333) are indicated for use to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. In addition, the subject SABER™.035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is also indicated for post-dilatation of balloon-expandable and self-expanding stents in

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the peripheral vasculature. Both the proposed and predicate devices are provided sterile with ethylene oxide sterilization and intended for single use only.

The proposed and predicate devices share the identical patient contacting materials, and the biocompatibility testing of the SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter which was performed to verify conformance to the same requirements of the ISO 10993-1 (2018) standard for biological safety evaluation. Given all the critical technological characteristics as well as indications for use/intended use are similar, the proposed SABER™ .035 PTA Dilatation Catheter is assessed as substantially equivalent to the predicate device, SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter (K201333).

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, SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter (K201333).

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 biological safety evaluations are met for the proposed device. The favorable biocompatibility test results provide assurance of the biologically safety profile of the SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter.

GLP Biocompatibility Testing Performed:

Extractables of SABER™ .035 Percutaneous Transluminal Angjoplasty ● (PTA) Dilatation Catheter
Cytotoxicity-ISO MEM Elution Using L-929 Mouse Fibroblast Cell ●
ISO Guinea Piq Maximization Sensitization 0
ISO Intracutaneous Irritation ●
ISO Acute Systemic Toxicity
ISO Materials Mediated Rabbit Pyrogen o
Hemocompatibility-ASTM Hemolysis o
Hemocompatibility-Complement Activation o
o Hemocompatibility Thromboresistance Evaluation
Chemical Characterization o
Toxicology Risk Assessment Report o

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VI. Design Verification and Validation Testing

Design Verification and Validation (DV&V) testing was performed to verify that the proposed SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter meets the pre-determined safety and performance 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 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 0
Usable catheter length ●
Kink diameter o
Visual coating integrity ●
Particulate Count Testing o
o 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-ability ●
Balloon Working Length
Balloon Diameter
Balloon compliance ●
Balloon Burst ●
System Fatique o

VII. Sterilization, Microbiology and Packaging Validation and Verification

The EO sterilization process for the SABER .035 PTA Dilatation Catheter and the predicate, SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter (K201333) fall under the same sterilization product family category set up by

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Confluent Medical Technologies, which is the physical manufacturer of both the SABER .035 PTA Dilatation Catheter and the predicate. SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter (K201333).

The product family under which both the SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter and the predicate under K201333 have been previously validated using the overkill approach for EO sterilization. The predicate and proposed device share identical technological characteristics, which have been considered and assessed 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 sterilization cycle 2.0 at Synergy Health. For a complete listing of the sterilization adoption report and sterilization report (cycle 2.0- Synergy Health), please refer to Section 18.1, Ethylene Oxide Sterilization of the SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter in eCopy 002.

Sterilization Adoption Validation of the SABER™ .035 Percutaneous ● Transluminal Angioplasty (PTA) Dilatation Catheter
2020 Sterilization Validation Report for Cycle 2 at Steris AST

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:

o Microbiology Validation Report
o Bioburden Test Method Validation
o 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 has 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:

o T0 Sample: Packaging Validation and Verification
T3 Year Sample: Packaging Validation and Verification o

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VIII. Substantial Equivalence Assessment

From the standpoint of safety and performance evaluation, the proposed SABER™ .035 PTA Dilatation Catheter demonstrated conformance to the FDA's recognized standards. The favorable test results of the proposed device which confirmed to meet the FDA's recognized standards as well as the manufacturer's design verification requirements further demonstrated an equivalent profile of the SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter in safety and essential performance as the predicate device, SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter (K201333).

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, fundamental technological characteristics are identical to the predicate device, SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter (K201333). The favorable results of the aforementioned safety and performance testing demonstrate conformance to the FDA's recognized standards and further demonstrate that no different questions in safety and effectiveness assessment are being 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).