Oscar Peripheral Multifunctional Catheter system

K241711 · Biotronik, Inc. · LIT · Jul 11, 2024 · Cardiovascular

Device Facts

• Record ID: K241711
• Device Name: Oscar Peripheral Multifunctional Catheter system
• Applicant: Biotronik, Inc.
• Product Code: LIT · Cardiovascular
• Decision Date: Jul 11, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Oscar Peripheral Multifunctional Catheter system is indicated for percutaneous transluminal interventions in the peripheral vasculature to provide support during access into and to dilate stenoses in femoral, popliteal and infrapopliteal arteries. The product is also intended for injection of radiopaque contrast media for the purpose of angiography.

Device Story

Intravascular balloon catheter system; includes retractable sheath (support catheter), flexible catheter (dilator), and semi-compliant PTA balloon. Used in peripheral vasculature interventions; operated by physicians in clinical settings. Device provides guide wire support, fluid injection, and vessel dilation. Physician advances catheter over-the-wire; retractable sheath allows adjustment of balloon inflation length (up to 180 mm). Radiopaque markers facilitate positioning under fluoroscopy. Balloon inflation (6-16 atm) dilates stenoses in femoral, popliteal, and infrapopliteal arteries. Benefits include combined support and dilation functionality, reducing need for multiple device exchanges. Output is mechanical dilation of arterial stenoses and angiographic imaging.

Clinical Evidence

Bench testing only. Performance data included removal force, lesion crossing profile, balloon compliance, burst pressure, failure mode, and longitudinal balloon compliance for both the PTA catheter and the combined support/PTA catheter system. Results demonstrate that the device meets established specifications and performs consistently with the predicate.

Technological Characteristics

Over-the-wire catheter system (4F/6F); semi-compliant balloon (2.0-7.0 mm diameter); hydrophobic coating; EO sterilization; single-use. Features retractable sheath for variable balloon length (20-180 mm). Radiopaque markers for positioning. Operates at 6-16 atm. No software or electronic components.

Indications for Use

Indicated for patients requiring percutaneous transluminal interventions in the peripheral vasculature, specifically for accessing and dilating stenoses in femoral, popliteal, and infrapopliteal arteries, and for angiography via radiopaque contrast media injection.

Regulatory Classification

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.

Predicate Devices

• Oscar Peripheral Multifunctional Catheter system (K214038)

Submission Summary (Full Text)

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July 11, 2024

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

Re: K241711

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, KRA Dated: June 13, 2024 Received: June 14, 2024

### 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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Gregory W. O'connell - S

Digitally signed by Gregory W. O'connell -S Date: 2024.07.11 09:09:02

Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and QualityCenter for Devices and Radiological Health

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## Indications for Use

Submission Number (if known)

K241711

Device Name

Oscar Peripheral Multifunctional Catheter system

Indications for Use (Describe)

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

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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# Oscar Peripheral Multifunctional Catheter System (K241711) 510(K) SUMMARY

| Date Prepared: | July 10, 2024 |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Jon Brumbaugh<br>Vice President, Regulatory Affairs & New Product Development<br>BIOTRONIK, Inc.<br>6024 Jean Road<br>Lake Oswego, OR 97035 USA<br>Phone [phone]<br>Fax [phone]<br>Email : [e-mail] |
| 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 (Primary), KRA (Secondary) |
| Predicate Device: | Oscar Peripheral Multifunctional Catheter system (K214038,<br>cleared July 6,2022) |

#### 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 guide 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) quide 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.

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#### Indications for Use

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

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 Oscar Peripheral Multifunctional Catheter system (K214038, cleared July 6, 2022). The modified Oscar Peripheral Multifunctional Catheter system after stabilizing pressure membrane elimination and the predicate device have identical technological features and indications for use 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 | | | |
|---------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|---------------------------------------------|
| Device<br>510(k) Number | Predicate Device<br>K214038 | Subject Device | Rationale for<br>Substantial<br>Equivalence |
| Classification | Class II | | Identical |
| Product Code | LIT | LIT/KRA | Comparable |
| Regulation | 21 CFR 870.1250 | | Identical |
| Indications for Use | The Oscar Peripheral Multifunctional Catheter<br>system is indicated for percutaneous<br>transluminal interventions in the peripheral<br>vasculature to provide support during access into<br>and to dilate stenoses in femoral, popliteal and<br>infrapopliteal arteries.<br>The product is also intended for injection of<br>radiopaque contrast media for the purpose of<br>angiography. | | Identical |
| Principle of operation | Inflation of semi-compliant balloon for dilation | | Identical |
| Catheter Type | Over the wire | | Identical |
| Coating | Hydrophobic | | Identical |
| Recommended guide<br>wire | 0.014″/0.018" | | Identical |
| Balloon Material | Semi- compliant | | Identical |
| Balloon Diameter (mm) | 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0 and 7.0 mm | | Identical |

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| Device<br>510(k) Number | Predicate Device<br>K214038 | Subject Device<br>TBD | Rationale for<br>Substantial<br>Equivalence |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|---------------------------------------------|
| Balloon Length (mm) | Length: 20-180 mm (Ø2.0-6.0)<br>Length: 20-100 mm (Ø7.0) | TBD | Identical |
| Balloon Marker | Distal radiopaque balloon marker (1) and<br>subsequently two radiopaque markers (2) at 60<br>mm distance each for the dimensions 2-6 mm,<br>or two radiopaque markers at 50 mm distance<br>for the 7 mm dimension of the Oscar PTA<br>balloon. | TBD | Identical |
| Balloon Length<br>Variability | Yes | TBD | Identical |
| Outer Sheath | Yes | TBD | Identical |
| Number of radiopaque<br>marker bands | 3 for diameters 2-6mm<br>2 for 7mm diameter | TBD | Identical |
| Location markers | PTA Balloon radiopaque markers:<br>Ø2.0-6.0: three markers starting distally, each<br>60 mm apart<br>Ø7.0: two markers starting distally, 50 mm apart | TBD | Identical |
| Catheter Shaft Length<br>(cm) | 4F / 6F: 120 cm (long)<br>6F: 60 cm (short) | TBD | Identical |
| Sterilization Method | EO | TBD | Identical |
| Single use | Yes | TBD | Identical |
| Supplied Sterile | Yes | TBD | Identical |

#### Performance Data

The following performance data were provided in support of the substantial equivalence.

PTA Catheter:

- Removal Force Balloon Protector .
- Lesion Crossing Profile
- o Balloon Compliance
- Balloon Compliance Burst Pressure and Failure Mode .
- Longitudinal Balloon Compliance .

Support Catheter+ PTA Catheter:

- Longitudinal Balloon Compliance at NP and RBP in Combination with Slippage ●
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

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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.