(195 days)
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a balloon catheter system, with no mention of AI or ML capabilities.
Yes.
The device is an intravascular balloon catheter system indicated for percutaneous transluminal interventions in the peripheral vasculature. The "PTA balloon" component strongly suggests its therapeutic function in dilating vessels.
No
Explanation: The device is indicated for percutaneous transluminal interventions and for the injection of radiopaque contrast media for angiography. While angiography is a diagnostic technique, the device's primary function is described as providing support during access for interventions and enabling the injection, not performing the diagnosis itself. The intervention aspect suggests a therapeutic purpose.
No
The device description clearly outlines physical components such as catheters, balloons, sheaths, and guide wires, 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:
- Intended Use: The intended use clearly states that the device is for percutaneous transluminal interventions in the peripheral vasculature and for the injection of radiopaque contrast media for angiography. These are procedures performed within the body for diagnosis and treatment.
- Device Description: The description details a catheter system with a balloon for angioplasty and features for guide wire support and fluid injection. This is consistent with an interventional medical device used directly on the patient.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze samples. This device is used inside the body for interventional procedures.
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 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
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.
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)
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.
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.
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 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
1
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
2
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 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.
| 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
3
Oscar Peripheral Multifunctional Catheter System (K214038) TRADITIONAL 510(K) SUMMARY
| Date Prepared: | July 5, 2022 |
|---|---|
| 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 |
| Predicate Device: | INFINITY Angioplasty Balloon Catheter (K192399, cleared |
| May 20, 2020) | |
| Reference Device | CXI Triforce Peripheral Crossing Set (K170931, cleared |
| November 13, 2017) |
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.
4
K214038 Oscar Peripheral Multifunctional Catheter System
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 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 Oscar | |||
| Peripheral | ||||
| Multifunctional | ||||
| Catheter system | ||||
| (Subject Device) | INFINITY | |||
| Angioplasty Balloon | ||||
| CatheterTM | ||||
| (Predicate Device) | Rationale for | |||
| Substantial | ||||
| Equivalence | ||||
| 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 Oscar | |||
| Peripheral | ||||
| Multifunctional | ||||
| Catheter system | ||||
| (Subject Device) | INFINITY | |||
| Angioplasty Balloon | ||||
| Catheter™ | ||||
| (Predicate Device) | Rationale for | |||
| Substantial | ||||
| Equivalence | ||||
| 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. | The INFINITY | |||
| Angioplasty Balloon | ||||
| Catheter is indicated | ||||
| for Percutaneous | ||||
| Transluminal | ||||
| Angioplasty (PTA) in | ||||
| the peripheral | ||||
| vasculature, including | ||||
| iliac, femoral, | ||||
| popliteal, infra- | ||||
| popliteal arteries, and | ||||
| for the treatment of | ||||
| obstructive lesions of | ||||
| native or synthetic | ||||
| arteriovenous dialysis | ||||
| fistulae. This catheter | ||||
| is not for use in | ||||
| coronary or | ||||
| cerebrovascular | ||||
| arteries. | Comparable | |||
| Principle of operation | Inflation of semi- | |||
| compliant balloon for | ||||
| dilation | Inflation of semi- | |||
| compliant balloon for | ||||
| dilation | Identical | |||
| Catheter Type | Over the wire | Over the wire | Identical | |
| Coating | Hydrophobic | Hydrophilic | Comparable | |
| Recommended quide | ||||
| wire | 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. | |||
| Variable | ||||
| Marker bands located | ||||
| at 100 mm, 200 mm, | ||||
| and 250 mm on | ||||
| balloon length | Comparable | |||
| Comparison of Characteristics between Proposed and Predicate Device | ||||
| Description | BIOTRONIK Oscar | |||
| Peripheral | ||||
| Multifunctional | ||||
| Catheter system | ||||
| (Subject Device) | INFINITY | |||
| Angioplasty Balloon | ||||
| Catheter™ | ||||
| (Predicate Device) | Rationale for | |||
| Substantial | ||||
| Equivalence | ||||
| 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. | Marker bands located | |||
| at 100 mm, 200 mm, | ||||
| and 250 mm on | ||||
| balloon length | Comparable | |||
| Balloon Length | ||||
| Variability | Yes | Yes | ||
| Balloon length | ||||
| controlled by outer | ||||
| sheath placement | ||||
| relative distal tip of the | ||||
| balloon. | Identical | |||
| Outer Sheath | Yes | Yes | Identical | |
| Number of radiopaque | ||||
| marker bands | 3 for diameters 2-6mm | |||
| 2 for 7mm diameter | 5 | |||
| Proximal and distal | ||||
| ends of balloon, 100 | ||||
| mm and 200 mm | ||||
| balloon length, and | ||||
| distal tip of outer | ||||
| sheath | Comparable | |||
| Location markers | PTA Balloon radiopaque | |||
| markers: | ||||
| Ø2.0-6.0: three | ||||
| markers starting | ||||
| distally, each 60 mm | ||||
| apartØ7.0: two markers | ||||
| starting distally, 50 | ||||
| mm apart | Yes | |||
| Markers designate | ||||
| location of the sheath | ||||
| relative to the catheter | ||||
| shaft | 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 |
5
6
7
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.