(27 days)
Not Found
No
The summary describes a mechanical catheter system with a balloon and sheath, and mentions standard performance testing for such devices. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
Yes
The device is used to dilate stenoses in arteries, which is a direct therapeutic action to treat a medical condition.
Yes
The device is intended for "injection of radiopaque contrast media for the purpose of angiography," which is a diagnostic procedure used to visualize blood vessels. While it also performs therapeutic interventions (dilating stenoses), the angiography aspect is diagnostic.
No
The device description clearly outlines physical components such as catheters, balloons, and sheaths, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Oscar Peripheral Multifunctional Catheter system is an intravascular balloon catheter system used for percutaneous transluminal interventions in the peripheral vasculature. This involves physically interacting with blood vessels within the body.
- No Mention of Samples: There is no mention of the device being used to test samples taken from the body. Its function is to access, support, dilate, and inject contrast media within the body.
Therefore, the Oscar Peripheral Multifunctional Catheter system is a medical device used for therapeutic and diagnostic procedures performed in vivo (within the living body), not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LIT, KRA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral, popliteal and infrapopliteal arteries.
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)
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out next to it.
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).
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
Indications for Use
Submission Number (if known)
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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3
Oscar Peripheral Multifunctional Catheter System (K241711) 510(K) SUMMARY
| Date Prepared: | July 10, 2024 |
|---|---|
| Contact: | Jon Brumbaugh |
| Vice President, Regulatory Affairs & New Product Development | |
| BIOTRONIK, Inc. | |
| 6024 Jean Road | |
| Lake Oswego, OR 97035 USA | |
| Phone (888) 345-0374 | |
| Fax (800) 913-6993 | |
| Email : 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 (Primary), KRA (Secondary) |
| Predicate Device: | Oscar Peripheral Multifunctional Catheter system (K214038, |
| 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.
4
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 | |||
| 510(k) Number | Predicate Device | ||
| K214038 | Subject Device | Rationale for | |
| Substantial | |||
| 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 | ||
| 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. | Identical | ||
| Principle of operation | Inflation of semi-compliant balloon for dilation | Identical | |
| Catheter Type | Over the wire | Identical | |
| Coating | Hydrophobic | Identical | |
| Recommended guide | |||
| 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 |
5
| Device
510(k) Number | Predicate Device
K214038 | Subject Device
TBD | Rationale for
Substantial
Equivalence |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|---------------------------------------------|
| Balloon Length (mm) | Length: 20-180 mm (Ø2.0-6.0)
Length: 20-100 mm (Ø7.0) | TBD | Identical |
| Balloon Marker | Distal radiopaque balloon marker (1) and
subsequently two radiopaque markers (2) at 60
mm distance each for the dimensions 2-6 mm,
or two radiopaque markers at 50 mm distance
for the 7 mm dimension of the Oscar PTA
balloon. | TBD | Identical |
| Balloon Length
Variability | Yes | TBD | Identical |
| Outer Sheath | Yes | TBD | Identical |
| Number of radiopaque
marker bands | 3 for diameters 2-6mm
2 for 7mm diameter | TBD | Identical |
| Location markers | PTA Balloon radiopaque markers:
Ø2.0-6.0: three markers starting distally, each
60 mm apart
Ø7.0: two markers starting distally, 50 mm apart | TBD | Identical |
| Catheter Shaft Length
(cm) | 4F / 6F: 120 cm (long)
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
6
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.