(265 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a balloon catheter, with no mention of AI or ML.
Yes
The device is indicated for "balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion," which is a therapeutic intervention.
No
Explanation: The SeQuent® Neo PTCA Dilatation Catheter is indicated for the balloon dilatation of stenotic portions of coronary arteries or bypass grafts. This is a therapeutic action (treatment/intervention) rather than a diagnostic one (identifying a condition or disease).
No
The device description clearly details a physical catheter with a balloon, lumina, radiopaque markers, and a hypotube, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the mechanical dilatation of coronary arteries or bypass grafts using a balloon catheter. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The description details a physical catheter with a balloon, lumens for inflation and guidewire insertion, and radiopaque markers. This is a medical device used for intervention, not for testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used for direct treatment within the body.
N/A
Intended Use / Indications for Use
The SeQuent® Neo PTCA Dilatation Catheters are indicated for the balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The balloon sizes 2.00-4.00 mm are also indicated for post-delivery expansion of balloon expandable stents.
Product codes
LOX
Device Description
The SeQuent® Neo PTCA-Catheter is a balloon-tipped, rapid exchange catheter. The distal shaft (25 cm) consists of two (2) lumina. One lumen enables inflation and deflation of the balloon, the other permits the insertion of a guidewire. Two (2) radiopaque markers indicate the length of the cylindrical portion of the balloon. The 1.5 mm diameter balloon catheter has one (1) x-ray marker only. The balloon is protected with a removable sheath which protects the initial profile. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. The two markers on the shaft of the catheter appear when the tip of the balloon-tipped catheter leaves the guiding catheter (brachial: 100 cm/femoral: 110 cm). The proximal section of the catheter is a single-lumen, stainless steel hypotube with a luer adapter connected to the balloon lumen. A needle with a luer port is included for flushing the distal guide wire lumen. SeQuent Neo has a hydrophilic coated surface at the distal catheter portion. Due to this, SeQuent Neo provides optimal gliding properties during intervention.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary artery or bypass graft
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 SeQuent Neo catheters have been evaluated through ISO 14971-compliant risk analysis and design verification and validation (DV&V) testing in accordance with the requirements of September 8, 2010 FDA guidance Class II Special Controls Guidance Document for Certain PTCA Catheters, including ISO 10993 compliant biocompatibility evaluations. Results of these evaluations demonstrate the SeQuent Neo catheter is suitable for its intended use as a PTCA balloon catheter. The below evaluations were performed.
Biocompatibility Evaluations
- Cytotoxicity
- Sensitization
- Intradermal reactivity
- Acute Systemic Toxicity
Non-clinical Evaluations (Bench)
- Dimensional verification
- Balloon Preparation, Deployment and Retraction
- Balloon Rated Burst Pressure
- Balloon Fatigue (Repeat Balloon Inflations)
- Balloon Compliance (Diameter vs. Pressure)
- Balloon Inflation and Deflation Time
- Catheter Bond Strength
- Haemocompatibility (Thrombogenicity, Complement Activation, Hemolysis)
- Pyrogenicity
- Flexibility and Kink Test
- Torque Strength
- Radiopacity
- Coating Integrity
- Particulate Evaluation
- Balloon Rated Burst Pressure (in Stent)
- Balloon Fatigue (Repeat Balloon Inflations, in Stent)
- Catheter Withdrawal Force
- Shelf Life / Packaging
Additionally, a clinical literature evaluation was performed to evaluate the benefits and risks of PTCA catheter clinical use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.5100 Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.
(a)
Standard PTCA Catheter —(1)Identification. A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end. A PTCA balloon catheter has a single or double lumen shaft. The catheter features a balloon of appropriate compliance for the clinical application, constructed from a polymer. The balloon is designed to uniformly expand to a specified diameter and length at a specific pressure as labeled, with well characterized rates of inflation and deflation and a defined burst pressure. The device generally features a type of radiographic marker to facilitate fluoroscopic visualization of the balloon during use. A PTCA catheter is intended for balloon dilatation of a hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. A PTCA catheter may also be intended for the treatment of acute myocardial infarction; treatment of in-stent restenosis (ISR) and/or post-deployment stent expansion.(2)
Classification. Class II (special controls). The special control for this device is “Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.” See § 870.1(e) for the availability of this guidance document.(b)
Cutting/scoring PTCA Catheter —(1)Identification. A cutting/scoring PTCA catheter is a balloon-tipped catheter with cutting/scoring elements attached, which is used in those circumstances where a high pressure balloon resistant lesion is encountered. A cutting/scoring PTCA catheter is intended for the treatment of hemodynamically significant coronary artery stenosis for the purpose of improving myocardial perfusion. A cutting/scoring PTCA catheter may also be indicated for use in complex type C lesions or for the treatment of in-stent restenosis.(2)
Classification. Class III (premarket approval). As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 870.3.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles a caduceus or a staff with a serpent entwined around it, but in this case, it is a more abstract design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 12, 2017
B. Braun Interventional Systems Inc. Peter Flosdorf Engineering Manager 824 Twelfth Avenue Bethlehem. Pennsylvania 18018
Re: K162625
Trade/Device Name: SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters Regulation Number: 21 CFR 870.5100 Regulation Name: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Regulatory Class: Class II Product Code: LOX Dated: May 4, 2017 Received: May 11, 2017
Dear Peter Flosdorf:
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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Fernando Aguel-S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K162625
Device Name
SeQuent® Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters
Indications for Use (Describe)
The SeQuent® Neo PTCA Dilatation Catheters are indicated for the balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The balloon sizes 2.00-4.00mm are also indicated for post-delivery expansion of balloon expandable stents.
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
510(k) Summary
Date Prepared: June 12, 2017
| 510(k) Submitter | Contact | |
|---|---|---|
| B. Braun Interventional Systems Inc. | ||
| 824 Twelfth Avenue | ||
| Bethlehem, PA 18018 | ||
| FDA Est. Reg. #: 3006332832 | Contact: | |
| Peter Flosdorf, Engineering Manager | ||
| Tel: 610-997-4694; Fax: 610-849-5319 | ||
| Email: | ||
| Peter.Flosdorf@bbrauninterventional.com | ||
| General Information | ||
| Trade Name | SeQuent® Neo Percutaneous Transluminal Coronary Angioplasty | |
| (PTCA) Balloon Catheters | ||
| Common Name | Rapid Exchange Coronary Balloon Catheter | |
| Classification | ||
| Information | Catheters, Transluminal Coronary Angioplasty, Percutaneous | |
| (21 CFR 870.5100; Class II); Pro Code: LOX; Panel: | ||
| Cardiovascular | ||
| Predicate | ||
| Device(s) | Boston Scientific Corporation, Emerge™ Monorail® PTCA | |
| Dilatation Catheter (K113220, K121196, & K130391) |
Device Description
The SeQuent® Neo PTCA-Catheter is a balloon-tipped, rapid exchange catheter. The distal shaft (25 cm) consists of two (2) lumina. One lumen enables inflation and deflation of the balloon, the other permits the insertion of a guidewire. Two (2) radiopaque markers indicate the length of the cylindrical portion of the balloon. The 1.5 mm diameter balloon catheter has one (1) x-ray marker only. The balloon is protected with a removable sheath which protects the initial profile. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. The two markers on the shaft of the catheter appear when the tip of the balloon-tipped catheter leaves the guiding catheter (brachial: 100 cm/femoral: 110 cm). The proximal section of the catheter is a single-lumen, stainless steel hypotube with a luer adapter connected to the balloon lumen. A needle with a luer port is included for flushing the distal guide wire lumen. SeQuent Neo has a hydrophilic coated surface at the distal catheter portion. Due to this, SeQuent Neo provides optimal gliding properties during intervention.
Intended Use / Indications
The SeQuent® Neo PTCA Dilatation Catheters are indicated for the balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The balloon sizes 2.00-4.00 mm are also indicated for post-delivery expansion of balloon expandable stents.
4
B. Braun Interventional Systems Inc. Traditional 510(k) - SeQuent® Neo PTCA Balloon Catheters (K162625) Page | 2
Substantial Equivalence Comparison
The SeQuent Neo PTCA Balloon Catheters have substantially equivalent indications, principle of operation, and design to the currently marketed Emerge PTCA balloon predicate catheters. Both the subject and predicate systems are sterile, non-pyrogenic, single use catheters that are provided with accessories to facilitate the balloon dilatation procedure.
Performance Data
The SeQuent Neo catheters have been evaluated through ISO 14971-compliant risk analysis and design verification and validation (DV&V) testing in accordance with the requirements of September 8, 2010 FDA guidance Class II Special Controls Guidance Document for Certain PTCA Catheters, including ISO 10993 compliant biocompatibility evaluations. Results of these evaluations demonstrate the SeQuent Neo catheter is suitable for its intended use as a PTCA balloon catheter. The below evaluations were performed.
Biocompatibility Evaluations
- Cytotoxicity
- Sensitization ●
- Intradermal reactivity ●
- Acute Systemic Toxicity
Non-clinical Evaluations (Bench)
- Dimensional verification
- Balloon Preparation, Deployment . and Retraction
- Balloon Rated Burst Pressure ●
- Balloon Fatigue (Repeat Balloon Inflations)
- . Balloon Compliance (Diameter vs. Pressure)
- Balloon Inflation and Deflation Time
- Catheter Bond Strength
- Haemocompatibility ● (Thrombogenicity, Complement Activation, Hemolysis)
- Pyrogenicity ●
- Flexibility and Kink Test ●
- Torque Strength ●
- Radiopacity ●
- Coating Integrity ●
- Particulate Evaluation ●
- Balloon Rated Burst Pressure (in Stent)
- . Balloon Fatigue (Repeat Balloon Inflations, in Stent)
- Catheter Withdrawal Force
- Shelf Life / Packaging
Additionally, a clinical literature evaluation was performed to evaluate the benefits and risks of PTCA catheter clinical use.
5
Conclusions
The SeQuent Neo PTCA Balloon Catheters have substantially equivalent indications, principle of operation, and design to the currently marketed Emerge PTCA balloon predicate catheters. Results of performance evaluations, performed in accordance with FDA guidance and industry standards, demonstrate the SeQuent Neo catheter is suitable for its intended use as a PTCA balloon catheter. Based on the predicate comparison and performance evaluation information provided in this 510(k), the SeQuent Neo catheter has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the predicate device.
- End of 510(k) Summary -