The Oscar Peripheral Multifunctional Catheter system is indicated for percutaneous transluminal interventions in the peripheral vasculature to provide support during access in femoral, popliteal and infrapopliteal arteries.

The product is also intended for injection of radiopaque contrast media for the purpose of angiography.

Device Description

The Oscar Peripheral Multifunctional Catheter system is an intravascular balloon catheter system, supplied with a retractable sheath (Oscar Support Catheter), a flexible catheter (Oscar Dilator) and a PTA balloon (Oscar PTA balloon), allowing a variable quide wire support and injection of fluids, and adjustable length inflatable balloon up to 180 mm.

The over the wire (OTW) catheter has a retractable sheath allowing the balloon to be inflated at various lengths as determined by the physician. The balloon lengths are graduated with evenly spaced radiopaque markers.

The Oscar Peripheral Multifunctional Catheter system is a 4F and 6F catheter system with a shaft working length of 60 cm or 120 cm, compatible with 0.014" (Oscar 4F) and 0.018" (Oscar 6F) guide wires.

The device uses a semi-compliant balloon with a size dependent rated burst pressure and an indicated clinical use range of 6 atm to 16 atm. The balloon expands to a set nominal diameter (2.0, 2.5, 3.0, 4.0, 5.0, 6.0 and 7.0 mm). If required, separate PTA balloon catheters in same size range are also available separately.

AI/ML Overview

The provided text is a 510(k) summary for the Oscar Peripheral Multifunctional Catheter system. This type of regulatory document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing. It does not contain information about clinical studies involving human readers, AI assistance, or detailed ground truth establishment that would typically be found in algorithms designed for diagnostic or prognostic purposes.

Therefore, many of the requested fields are not applicable to the information provided in this document.

Here's an analysis based on the provided text:

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

The document states, "All necessary performance testing was conducted on the Oscar Peripheral Multifunctional Catheter System to ensure that the device conforms to the design specification and to support a determination of substantial equivalence to the predicate device." It lists several performance tests, indicating that the device met these specifications, but it does not explicitly state the quantitative acceptance criteria for each test or the exact reported performance values. It generally concludes that the device's performance meets specifications.

Test Type	Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Balloon compliance	Conforms to design specification	Meets design specification
Balloon nominal diameter	Conforms to design specification	Meets design specification
Balloon length	Conforms to design specification	Meets design specification
Balloon Fatigue	Conforms to design specification	Meets design specification
Marker band visibility	Conforms to design specification	Meets design specification
Inflation/deflation time	Conforms to design specification	Meets design specification
Device tracking/delivery	Conforms to design specification	Meets design specification
Torque strength	Conforms to design specification	Meets design specification
Kink resistance	Conforms to design specification	Meets design specification
Joint strength testing	Conforms to design specification	Meets design specification
Rated burst pressure	Conforms to design specification	Meets design specification
Biocompatibility	Meets biocompatibility standards	Meets biocompatibility standards
Sterilization	Validated for sterility	Validated for sterility
Shelf life	Validated shelf life	Validated shelf life
Packaging	Validated for packaging integrity and protection	Validated

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 describes non-clinical bench testing. It does not specify sample sizes for each test in the provided text, nor does it refer to "data provenance" in the context of clinical data (e.g., country of origin, retrospective/prospective). These are engineering tests performed on the device itself.

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 document describes a medical device (catheter system) and its non-clinical performance testing, not an AI/diagnostic algorithm that requires expert-established ground truth from medical images or patient data.

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

Not applicable. See point 3.

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 is a medical device, not an AI-assisted diagnostic tool. No MRMC study was conducted or is relevant for this type of submission.

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

Not applicable. This refers to an algorithm's performance. The submission is for a physical medical device.

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

For the non-clinical bench tests (e.g., balloon compliance, burst pressure), the "ground truth" would be established by engineering standards, material specifications, and validated measurement techniques. For example, a burst pressure test would compare the actual burst pressure to a pre-defined engineering specification. It is not expert consensus, pathology, or outcomes data as these are not clinical tests.

8. The sample size for the training set

Not applicable. This is a medical device, not an AI algorithm requiring a training set.

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

Not applicable. See point 8.

Summary

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Image /page/0/Picture/0 description: The image shows 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.

July 6, 2022

Biotronik, Inc. Jon Brumbaugh Vice President, Regulatory Affairs and New Product Development 6024 Jean Road Lake Oswego, Oregon 97035

Re: K214038

Trade/Device Name: Oscar Peripheral Multifunctional Catheter system Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: LIT Dated: June 23, 2022 Received: June 24, 2022

Dear Jon Brumbaugh:

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

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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 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 Ouality Center for Devices and Radiological Health

Enclosure

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Appendix 1

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K214038

Device Name

Oscar Peripheral Multifunctional Catheter system

Indications for Use (Describe)

The product is also intended for injection of radiopaque contrast media for the purpose of angiography.

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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Page 25 of 165

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Oscar Peripheral Multifunctional Catheter System (K214038) TRADITIONAL 510(K) SUMMARY

Date Prepared:	July 5, 2022
Contact:	Jon BrumbaughVice President, Regulatory Affairs & New Product DevelopmentBIOTRONIK, Inc.6024 Jean RoadLake Oswego, OR 97035 USAPhone (888) 345-0374Fax (800) 913-6993Email: jon.brumbaugh@biotronik.com
Trade Name:	Oscar Peripheral Multifunctional Catheter system
Generic/Common Name:	Percutaneous Catheter
Classification Name:	Catheter, Angioplasty, Peripheral, Transluminal
Classification & Panel:	Class II / 21 CFR § 870.1250, Cardiovascular
Product Code:	LIT
Predicate Device:	INFINITY Angioplasty Balloon Catheter (K192399, clearedMay 20, 2020)
Reference Device	CXI Triforce Peripheral Crossing Set (K170931, clearedNovember 13, 2017)

Device Description

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K214038 Oscar Peripheral Multifunctional Catheter System

Indications for Use

The product is also intended for injection of radiopaque contrast media for the purpose of angiography.

Comparison of Technological Characteristics with the Predicate Devices

The BIOTRONIK Oscar Peripheral Multifunctional Catheter system is substantially equivalent to the predicate for this submission, the INFINITY Angioplasty Balloon Catheter (K192399, cleared May 20, 2020). The indications for use are similar, with only minor differences. The Oscar Peripheral Multifunctional Catheter system and the predicate device have comparable safety and technological features as mentioned below.

The minor device differences do not introduce new issues of safety or effectiveness as demonstrated by the Oscar Peripheral Multifunctional Catheter system performance testing.

Comparison of Characteristics between Proposed and Predicate Device
Description	BIOTRONIK OscarPeripheralMultifunctionalCatheter system(Subject Device)	INFINITYAngioplasty BalloonCatheterTM(Predicate Device)	Rationale forSubstantialEquivalence
510(k) Number	TBD	K192399	N/A
Classification	Class II	Class II	Same
Product Code	LIT	LIT	Same
Regulation	21 CFR 870.1250	21 CFR 870.1250	Same
Comparison of Characteristics between Proposed and Predicate Device
Description	BIOTRONIK OscarPeripheralMultifunctionalCatheter system(Subject Device)	INFINITYAngioplasty BalloonCatheter™(Predicate Device)	Rationale forSubstantialEquivalence
Indications for Use	The Oscar PeripheralMultifunctionalCatheter system isindicated forpercutaneoustransluminalinterventions in theperipheral vasculatureto provide supportduring access into andto dilate stenoses infemoral, popliteal andinfrapopliteal arteries.The product is alsointended for injectionof radiopaque contrastmedia for the purposeof angiography.	The INFINITYAngioplasty BalloonCatheter is indicatedfor PercutaneousTransluminalAngioplasty (PTA) inthe peripheralvasculature, includingiliac, femoral,popliteal, infra-popliteal arteries, andfor the treatment ofobstructive lesions ofnative or syntheticarteriovenous dialysisfistulae. This catheteris not for use incoronary orcerebrovasculararteries.	Comparable
Principle of operation	Inflation of semi-compliant balloon fordilation	Inflation of semi-compliant balloon fordilation	Identical
Catheter Type	Over the wire	Over the wire	Identical
Coating	Hydrophobic	Hydrophilic	Comparable
Recommended quidewire	0.014″/0.018″	0.018"	Comparable
Balloon Material	Semi- compliant	'Semi-compliant'	Identical
Balloon Diameter (mm)	2.0, 2.5, 3.0, 3.5, 4.0,5.0, 6.0 and 7.0 mm	5.0	Comparable
Balloon Length (mm)	Length: 20-180 mm(Ø2.0-6.0)Length: 20-100 mm(Ø7.0)	Length: 40-250 mm.VariableMarker bands locatedat 100 mm, 200 mm,and 250 mm onballoon length	Comparable
Comparison of Characteristics between Proposed and Predicate Device
Description	BIOTRONIK OscarPeripheralMultifunctionalCatheter system(Subject Device)	INFINITYAngioplasty BalloonCatheter™(Predicate Device)	Rationale forSubstantialEquivalence
Balloon Marker	Distal radiopaqueballoon marker (1) andsubsequently tworadiopaque markers(2) at 60 mm distanceeach for thedimensions 2-6 mm, ortwo radiopaquemarkers at 50 mmdistance for the 7 mmdimension of the OscarPTA balloon.	Marker bands locatedat 100 mm, 200 mm,and 250 mm onballoon length	Comparable
Balloon LengthVariability	Yes	YesBalloon lengthcontrolled by outersheath placementrelative distal tip of theballoon.	Identical
Outer Sheath	Yes	Yes	Identical
Number of radiopaquemarker bands	3 for diameters 2-6mm2 for 7mm diameter	5Proximal and distalends of balloon, 100mm and 200 mmballoon length, anddistal tip of outersheath	Comparable
Location markers	PTA Balloon radiopaquemarkers:Ø2.0-6.0: threemarkers startingdistally, each 60 mmapartØ7.0: two markersstarting distally, 50mm apart	YesMarkers designatelocation of the sheathrelative to the cathetershaft	Comparable
Catheter Shaft Length(cm)	4F / 6F: 120 cm (long)6F: 60 cm (short)	150	Comparable
Sterilization Method	EO	EO	Identical
Single use	Yes	Yes	Identical
Supplied Sterile	Yes	Yes	Identical

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Performance Data

All necessary performance testing was conducted on the Oscar Peripheral Multifunctional Catheter System to ensure that the device conforms to the design specification and to support a determination of substantial equivalence to the predicate device. The non-clinical bench testing included:

Design Verification O
- . Balloon compliance
- . Balloon nominal diameter
- Balloon length ●
- Balloon Fatigue ●
- . Marker band visibility
- Inflation and deflation time
- Device tracking, delivery, and retrieval ●
- . Torque strength
- Kink resistance ●
- Joint strength testing
- . Rated burst pressure
O Design Validation
Biocompatibility Testing O

In addition, BIOTRONIK has performed sterilization, shelf life and packaging validations. The collective results of the non-clinical testing demonstrate that the materials chosen, the manufacturing processes, and design of the Oscar components meet the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that the Oscar do not introduce new issues of safety or effectiveness when compared to the predicate device.

Conclusions

Based on the performance testing and the technological characteristics, it can be concluded that the Oscar Peripheral Multifunctional Catheter System meets its established performance for its intended use and is substantially equivalent 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).