(30 days)
No
The device description and intended use focus on the mechanical function of a balloon catheter for angioplasty. There is no mention of software, algorithms, or data processing that would suggest the use of AI or ML.
Yes
The device is indicated for medical purposes such as pre-dilatation and dilatation of stenotic portions of coronary arteries or bypass grafts to improve myocardial perfusion, which are therapeutic interventions.
No
Explanation: The device is a PTCA Dilatation Catheter used for the balloon catheter dilatation of stenotic coronary arteries or bypass grafts. Its purpose is to physically improve myocardial perfusion or expand stents, which are therapeutic actions, not diagnostic ones.
No
The device description clearly outlines a physical medical device (catheter with balloon, shaft, marker bands, coatings) used in a physical procedure (coronary angioplasty). There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Emerge PTCA Dilatation Catheter is a medical device used within the body (in vivo) to physically dilate narrowed coronary arteries or bypass grafts. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly describes a procedure performed directly on the patient's anatomy to improve blood flow, not to analyze a sample outside the body.
- Device Description: The description details a catheter with a balloon for inflation, designed for insertion into blood vessels. This is consistent with an in vivo therapeutic device.
The information provided clearly indicates this is a device used for a medical procedure performed directly on the patient, not for testing samples in a laboratory setting.
N/A
Intended Use / Indications for Use
The Emerge Over-The-Wire and Emerge Monorail PTCA Dilatation Catheters (1.20 mm balloon models) are indicated as pre-dilatation catheters in the stenotic portion of a coronary artery or bypass graft stenosis (>=70% stenosis).
The Emerge Over-The-Wire and Emerge Monorail PTCA Dilatation Catheters (balloon models 1.50-4.00 mm) are indicated for the balloon catheter dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
The Emerge Over-The-Wire and Emerge Monorail PTCA Dilatation Catheters (balloon models 2.00-4.00 mm) are also indicated for the post-delivery expansion of balloon expandable stents (bare metal and drug-eluting).
Product codes (comma separated list FDA assigned to the subject device)
LOX
Device Description
The Boston Scientific Emerge™ PTCA Dilatation Catheter is a sterile (EO), single-use, intravascular medical device for use in coronary angioplasty procedures. The catheter consists of a dual-lumen polymeric shaft with a balloon near the distal tip. The outer lumen is used for inflation of the balloon, and the inner lumen permits the use of a guidewire to facilitate advancement of the catheter to the appropriate location. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. The Emerge™ PTCA Dilatation Catheter is offered in both Monorail (MR) and Over-The-Wire (OTW) platforms. Marks on the proximal portion of the catheter shaft (at 90 cm and 100 cm) indicate the exit of the balloon catheter tip out of the guide catheter. Radiopaque marker bands located under the balloon aid in positioning the system during the procedure. Hydrophilic and hydrophobic coatings are applied to the balloon and catheter to enhance insertion and withdrawal performance. The Emerge™ PTCA Dilatation Catheters (1.20 mm and 1.50 mm balloon models) are available in balloon lengths from 8 mm to 20 mm. The Emerge™ PTCA Dilatation Catheters (2.00 - 4.00 mm balloon models) are available in balloon lengths from 8 mm to 30 mm.
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
Prescription Use
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)
Bench testing was performed to support a determination of substantial equivalence. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the device testing. The following performance tests were completed on the Emerge™ PTCA Dilatation Catheter: Corrosion Resistance, Proximal Mark Abrasion Resistance, Proximal Shaft Marks, Repeat Inflation, Midshaft Bond Tensile, Shaft and Bond Burst Pressure. The following biocompatibility and chemical characterization tests were completed on the Emerge™ PTCA Dilatation Catheter: Cytotoxicity, Partial Thromboplastin Time, Sensitization, In Vitro Hemocompatibility, Intracutaneous Reactivity, Complement Activation, Acute Systemic Injection, USP Physicochemical, Materials Mediated Pyrogenicity, Latex Assay, Mutagenicity, Nonvolatile Residue, Hemolysis, SEM.
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
§ 870.5100 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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 14, 2016
Boston Scientific Corporation Jane Horan Senior Regulatory Affairs Specialist Three Scimed Place Maple Grove, Minnesota 55311
Re: K163174
Trade/Device Name: Emerge PTCA Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Regulatory Class: Class II Product Code: LOX Dated: November 10, 2016 Received: November 14, 2016
Dear Jane Horan:
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 the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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,
Brian D. Pullin -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) K163174
Device Name Emerge PTCA Dilatation Catheter
Indications for Use (Describe)
The Emerge Over-The-Wire and Emerge Monorail PTCA Dilatation Catheters (1.20 mm balloon models) are indicated as pre-dilatation catheters in the stenotic portion of a coronary artery or bypass graft stenosis (≥70% stenosis).
The Emerge Over-The-Wire and Emerge Monorail PTCA Dilatation Catheters (balloon models 1.50-4.00 mm) are indicated for the balloon catheter dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
The Emerge Over-The-Wire and Emerge Monorail PTCA Dilatation Catheters (balloon models 2.00-4.00 mm) are also indicated for the post-delivery expansion of balloon expandable stents (bare metal and drug-eluting).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510k Summary
Per 21 CFR §807.92
| Common or
| Usual Name | PTCA Dilatation Catheter |
|---|---|
| Trade Name(s) | Emerge™ Monorail PTCA Dilatation Catheter |
| Emerge™ Push Monorail PTCA Dilatation Catheter | |
| Emerge™ Over-The-Wire Monorail PTCA Dilatation Catheter | |
| Emerge™ Push Over-The-Wire Monorail PTCA Dilatation Catheter | |
| Product Code | LOX - Percutaneous Transluminal Coronary Angioplasty |
| (PTCA) Catheter | |
| Classification of | |
| Device | Class II, 21 CFR 870.5100 |
| Submitter's Name | |
| and Address | Boston Scientific Corporation |
| Three Scimed Place | |
| Maple Grove, MN 55311-1566 | |
| Contact Name | |
| and Information | Jane Horan |
| Senior Regulatory Affairs Specialist | |
| Phone: 763-494-2572 | |
| Fax: 763-494-2222 | |
| Email: Jane.Horan@bsci.com | |
| Date Prepared | 7 Dec. 2016 |
| Section 514 of the | |
| Act Performance | |
| Standards | No performance standards have been established under |
| Section 514 of the Food, Drug and Cosmetic Act for | |
| percutaneous catheters. |
4
| Establishment
Registration
Numbers | Owner
/Operator: | Boston Scientific Corporation
300 Boston Scientific Way
Marlborough, MA 01752
ERN: 9912058 |
|------------------------------------------|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| | Manufacturing
Facility: | Boston Scientific Corporation
Two Scimed Place
Maple Grove, MN 55311
ERN: 2134265 |
| | Sterilization
Facilities: | Boston Scientific Corporation –
Coventry
8 Industrial Drive
Coventry, RI 02816
ERN: 1000121056 |
| | | STERIS Isomedix Services
3459 South Clinton Avenue
South Plainfield, NJ 07080
ERN: 2246552 |
| | | Synergy Health Ireland Ltd.
(Tullamore)
IDA Business & Technology Park
Tullamore, County Offaly
Ireland
ERN: 3002807314 |
| | | Synergy Health AST, SRL
B13. 1 Street 4, Avenue 1
El Coyol Free Zone
El Coyol, Alajeula 20102
Costa Rica
ERN: 3010273872 |
| | | Synergy Health Venlo
Faunalaan 38
Venlo Limburg, Netherlands
5928 RZ
ERN: 3009337401 |
5
| Predicate Devices | Emerge™ PTCA Dilatation Catheter, K113220, cleared 22
March 2012. |
|---------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Emerge™ PTCA Dilatation Catheter, K121196, cleared 31
August 2012. |
| | Emerge™ PTCA Dilatation Catheter, K130391, cleared 10
July 2013. |
| Reference
Device | NC Emerge™ PTCA Dilatation Catheter, K141236,
cleared 7 August 2014 |
| Device
Description | The Boston Scientific Emerge™ PTCA Dilatation Catheter is a sterile (EO), single-use, intravascular medical device for use in coronary angioplasty procedures. The catheter consists of a dual-lumen polymeric shaft with a balloon near the distal tip. The outer lumen is used for inflation of the balloon, and the inner lumen permits the use of a guidewire to facilitate advancement of the catheter to the appropriate location. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. The Emerge™ PTCA Dilatation Catheter is offered in both Monorail (MR) and Over-The- Wire (OTW) platforms. Marks on the proximal portion of the catheter shaft (at 90 cm and 100 cm) indicate the exit of the balloon catheter tip out of the guide catheter. Radiopaque marker bands located under the balloon aid in positioning the system during the procedure. Hydrophilic and hydrophobic coatings are applied to the balloon and catheter to enhance insertion and withdrawal performance. The Emerge™ PTCA Dilatation Catheters (1.20 mm and 1.50 mm balloon models) are available in balloon lengths from 8 mm to 20 mm. The Emerge™ PTCA Dilatation Catheters (2.00 - 4.00 mm balloon models) are available in balloon lengths from 8 mm to 30 mm. |
| Intended Use/
Indications for
Use | The Emerge Over-The-Wire and Emerge Monorail PTCA
Dilatation Catheters (1.20 mm balloon models) are
indicated as pre-dilatation catheters in the stenotic portion
of a coronary artery or bypass graft stenosis (≥ 70%
stenosis). |
| | The Emerge Over-The-Wire and Emerge Monorail PTCA
Dilatation Catheters (balloon models 1.50-4.00 mm) are
indicated for the balloon catheter dilatation of the stenotic
portion of a coronary artery or bypass graft stenosis for
the purpose of improving myocardial perfusion. |
| | The Emerge Over-The-Wire and Emerge Monorail PTCA
Dilatation Catheters (balloon models 2.00 - 4.00 mm) are
also indicated for the post-delivery expansion of balloon
expandable stents (bare metal and drug-eluting). |
| Comparison of
Required
Technological
Characteristics | The proposed Emerge™ PTCA Dilatation Catheter
incorporates substantially equivalent device materials and
design, packaging materials and design, fundamental
technology, manufacturing processes, sterilization
process and intended use as those featured in the Boston
Scientific predicate devices, Emerge™ PTCA Dilatation
Catheter K113220 (cleared March 22, 2012); Emerge™
PTCA Dilatation Catheter K121196 (cleared August 31,
2012); and Emerge™ PTCA Dilatation Catheter K130391
(cleared July 10, 2013). |
| | The proposed and predicate devices share the following
technological characteristics: |
| | Fundamental catheter design and intended use Shaft, balloon, marker band, and coating materials Packaging materials and design Sterilization method Fundamental manufacturing processes |
| | The proposed and predicate devices differ in the following
technological characteristic: |
| | Method of making proximal marks on the shaft |
6
7
| Summary of Non-Clinical Test Summary | Bench testing was performed to support a determination of substantial equivalence. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the device testing. | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| The following performance tests were completed on the Emerge™ PTCA Dilatation Catheter: | |||||||||||||||
| Corrosion ResistanceProximal Mark Abrasion ResistanceProximal Shaft MarksRepeat InflationMidshaft Bond TensileShaft and Bond Burst Pressure | Corrosion Resistance | Proximal Mark Abrasion Resistance | Proximal Shaft Marks | Repeat Inflation | Midshaft Bond Tensile | Shaft and Bond Burst Pressure | |||||||||
| Corrosion Resistance | Proximal Mark Abrasion Resistance | ||||||||||||||
| Proximal Shaft Marks | Repeat Inflation | ||||||||||||||
| Midshaft Bond Tensile | Shaft and Bond Burst Pressure | ||||||||||||||
| The following biocompatibility and chemical characterization tests were completed on the Emerge™ PTCA Dilatation Catheter: | |||||||||||||||
| CytotoxicityPartial Thromboplastin TimeSensitizationIn Vitro HemocompatibilityIntracutaneous ReactivityComplement ActivationAcute Systemic InjectionUSP PhysicochemicalMaterials Mediated PyrogenicityLatex AssayMutagenicityNonvolatile ResidueHemolysisSEM | Cytotoxicity | Partial Thromboplastin Time | Sensitization | In Vitro Hemocompatibility | Intracutaneous Reactivity | Complement Activation | Acute Systemic Injection | USP Physicochemical | Materials Mediated Pyrogenicity | Latex Assay | Mutagenicity | Nonvolatile Residue | Hemolysis | SEM | |
| Cytotoxicity | Partial Thromboplastin Time | ||||||||||||||
| Sensitization | In Vitro Hemocompatibility | ||||||||||||||
| Intracutaneous Reactivity | Complement Activation | ||||||||||||||
| Acute Systemic Injection | USP Physicochemical | ||||||||||||||
| Materials Mediated Pyrogenicity | Latex Assay | ||||||||||||||
| Mutagenicity | Nonvolatile Residue | ||||||||||||||
| Hemolysis | SEM | ||||||||||||||
| Conclusion | Based on the indications for use, technological characteristics, and safety and performance testing, the proposed Emerge™ PTCA Dilatation Catheter has been shown to be appropriate for its intended use and is considered to be substantially equivalent to Emerge™ PTCA Dilatation Catheter (K113220), (K121196) and (K130391). |