(186 days)
No
The device description and performance studies focus on the mechanical and material properties of a standard balloon catheter, with no mention of AI or ML.
Yes
The device is indicated for balloon dilatation of stenotic coronary arteries or bypass grafts to improve myocardial perfusion, which is a therapeutic purpose.
No
Explanation: The device, a PTCA RX Dilatation Catheter, is used for balloon dilatation to improve myocardial perfusion, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly details a physical catheter with lumens, a balloon, a tip, a hub, and radiopaque markers. It also describes bench testing related to physical properties like coating, balloon performance, and particulate matter. This is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The Tamarin Blue PTCA RX Dilatation Catheter is a device used directly within the body (in vivo) to physically dilate a narrowed coronary artery or bypass graft. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly states "for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion." This is a treatment, not a diagnostic test.
- Device Description: The description details the physical components and function of a catheter used for angioplasty, not for analyzing biological samples.
The information provided describes a medical device used for a therapeutic procedure, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Tamarin Blue PTCA RX Dilatation Catheters are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion.
Product codes (comma separated list FDA assigned to the subject device)
LOX
Device Description
The Tamarin Blue PTCA RX Dilatation Catheter is a standard Rapid Exchange (RX) PTCA catheter with a single lumen proximally, a dual lumen distally, a semi-compliant inflatable balloon and a soft, tapered distal tip to aid in crossing tight stenoses. One lumen of the catheter's dual lumen is used for inflation and deflation of the balloon, and the other lumen allows guide wire access through the distal part of the catheter. The maximum recommended guide wire diameter is 0.014". A luer lock fitting (hub) allows connection with an inflation device. Two radiopaque markers on the guide wire lumen tubing provide visual reference points for balloon positioning across the stenosis. A hydrophilic coating has been applied on the distal portion of catheter i.e., up to the RX port, to improve catheter pushability. The balloon material expands to a known diameter at a specific pressure as defined in the compliance table supplied with the catheter.
The device is supplied sterile and intended for one-time use.
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)
Non-clinical bench testing was performed on the subject device to determine substantial equivalence. The testing performed is as follows:
- Coating Inspection
- Coating Integrity (Performance and Durability)
- Balloon preparation, deployment and retraction
- Balloon Rated Burst
- Balloon Fatigue
- Balloon compliance
- Balloon inflation/deflation
- Particulate
In vitro bench testing demonstrated that the hydrophilic coating performed as intended and did not impact the functionality of the 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
§ 870.5100 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/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
July 20, 2021
Natec Medical Ltd. % Candace Cederman Principal Consultant CardioMed Device Consultants LLC 1783 Forest Drive, Suite 254 Annapolis, Maryland 21401
Re: K210012
Trade/Device Name: Tamarin Blue PTCA RX Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Regulatory Class: Class II Product Code: LOX
Dear Candace Cederman:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated July 9, 2021. Specifically, FDA is updating this SE Letter typo in the Company name as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Gregory O'Connell, OHT2: Office of Cardiovascular Devices, 301-796-6075, Gregory.Oconnell@fda.hhs.gov.
Sincerely,
For
Digitally signed by Sara M. Sara M. Royce -S · Date: 2021.07.20 ROYCE -S Date: 2021.07.2
Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Image /page/1/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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below that.
July 9, 2021
Nantec Medical Ltd. c/o Candace Cederman Principal Consultant CardioMed Device Consultants LLC 1783 Forest Drive, Suite 254 Annapolis, Maryland 21401
Re: K210012
Trade/Device Name: Tamarin Blue PTCA RX Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Regulatory Class: Class II Product Code: LOX Dated: June 9, 2021 Received: June 10, 2021
Dear Candace Cederman:
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 mav, 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
2
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 (OS) 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,
Sara M. Digitally signed by
Sara M. Royce -S
Date: 2021.07.09
Royce -S 16:46:28 -04'00'
For
Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K210012
Device Name Tamarin Blue PTCA RX Dilatation Catheter
Indications for Use (Describe)
The Tamarin Blue PTCA RX Dilatation Catheters are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion.
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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510(k) Summa [as required by 21 CFR 807.92(c)]
Tamarin Blue PTCA RX Dilatation Catheter 510(k) K210012
| DATE PREPARED: | July 9, 2021 |
|---|---|
| APPLICANT: | Natec Medical Ltd. |
| Maeva Centre Building – Ebene Business Park | |
| Reduit 72201, Mauritius | |
| CONTACT: | Roy Devassy Pallippatt, Regulatory Affairs Manager |
| TRADE NAME: | Tamarin Blue PTCA RX Dilatation Catheter |
| COMMON NAME: | PTCA RX Catheter |
| CLASSIFICATION | Catheters, transluminal coronary angioplasty, percutaneous |
| REGULATION: | (21 CFR §870.5100, Product Code LOX) |
| DEVICE CLASS: | Class II |
| PANEL CODE: | Cardiovascular |
| PREDICATE DEVICE: | Tamarin Blue PTCA RX Dilatation Catheter, K112735 |
| REFERENCE DEVICES: | Filao NC RX PTCA Dilatation Catheter, K141933 |
INTENDED USE/INDICATIONS FOR USE:
The Tamarin Blue PTCA RX Dilatation Catheters are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion.
DEVICE DESCRIPTION:
The Tamarin Blue PTCA RX Dilatation Catheter is a standard Rapid Exchange (RX) PTCA catheter with a single lumen proximally, a dual lumen distally, a semi-compliant inflatable balloon and a soft, tapered distal tip to aid in crossing tight stenoses. One lumen of the catheter's dual lumen is used for inflation and deflation of the balloon, and the other lumen allows guide wire access through the distal part of the catheter. The maximum recommended guide wire diameter is 0.014". A luer lock fitting (hub) allows connection with an inflation device. Two radiopaque markers on the guide wire lumen tubing provide visual reference points for balloon positioning across the stenosis. A hydrophilic coating has been applied on the distal portion of catheter i.e., up to the RX port, to improve catheter pushability. The balloon material expands to a known diameter at a specific pressure as defined in the compliance table supplied with the catheter.
The device is supplied sterile and intended for one-time use.
5
COMPARISON WITH PREDICATE DEVICE:
Comparisons of the Tamarin Blue PTCA RX Dilatation Catheter and the predicate device shows that the technological characteristics of the subject device such as components, design, sterilization method, shelf life and operating principle are identical to the currently marketed predicate device. Comparison of the subject device to the reference device show that the material, specifically the hydrophilic coating, are identical. Therefore, the addition of a hydrophilic coating to the subject device does not raise any new questions of safety or effectiveness.
The intended use/indications for use between the subject device and the predicate device are identical.
6
becial 510(k) Premarket Notification – Tamarin Blue PTCA RX Dilatation Cathet
| Device Name | Subject | Predicate | Reference |
|---|---|---|---|
| Manufacturer | Natec Medical Ltd | Natec Medical Ltd | Natec Medical Ltd |
| 510(k) | K112735 | K141933 | |
| Intended Use/Indication | |||
| For Use | • balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion | • balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion | • balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion |
| • balloon dilatation of a stent after implantation (balloon models 2.00mm – 4.50mm) | |||
| Regulation | 21 CFR 870.5100 | 21 CFR 870.5100 | 21 CFR 870.5100 |
| Regulation Name | Catheters, transluminal coronary angioplasty, percutaneous | Catheters, transluminal coronary angioplasty, percutaneous | Catheters, transluminal coronary angioplasty, percutaneous |
| Regulation Class | Class II | Class II | Class II |
| Product Code | LOX | LOX | LOX |
| Prescription/OTC | Prescription | Prescription | Prescription |
| Device Design/Processing | |||
| Catheter Design | Rapid Exchange | Rapid Exchange | Rapid Exchange |
| Balloon diameter (mm) | 1.5-4.0 | 1.5-4.0 | 2.0-4.5 |
| Balloon length (mm) | 8 to 30 | 8 to 30 | 8 to 30 |
| Effective Length (mm) | 1400 | 1400 | 1400 |
| Balloon Compliance | Semi-compliant | Semi-compliant | Non-compliant |
| Coating | Hydrophilic | None | Hydrophilic |
| Sterilization Method | EO | EO | EO |
| Performance Specifications | |||
| Nominal Pressure | 8 atm | 8 atm | 12 atm |
| Rated Burst Pressure | 16 atm | 16 atm | 20 atm |
COMPARISON WITH PREDICATE AND REFERENCE DEVICES:
7
NON-CLINICAL TESTING/PERFORMANCE DATA:
Non-clinical bench testing was performed on the subject device to determine substantial equivalence. The testing performed is as follows:
- Coating Inspection
- Coating Integrity (Performance and Durability)
- Balloon preparation, deployment and retraction
- Balloon Rated Burst
- Balloon Fatigue ●
- Balloon compliance
- Balloon inflation/deflation
- Particulate ●
In vitro bench testing demonstrated that the hydrophilic coating performed as intended and did not impact the functionality of the device.
BIOCOMPATIBILITY:
The Tamarin Blue PTCA RX Dilatation Catheter was compared to the predicate and reference devices, Based on similarities of the materials used in the subject device to its predicates / reference devices, the biocompatibility of the Tamarin Blue PTCA RX Dilatation Catheter was verified to be the same as those of the predicates / reference devices.
The results are being leveraged due to the similarities in the underlying materials to which the hydrophilic coating is applied.
The results of the testing show that the subject device in this submission met all acceptance criteria and the subject device is biocompatible.
CONCLUSION:
The Tamarin Blue PTCA RX Dilatation Catheter included in this notification is identical to the previously cleared predicate device in terms of intended use and technological characteristics. Any differences that exist between the Tamarin Blue PTCA RX Dilatation Catheter and the predicate did not raise any new questions of safety or effectiveness,
The Tamarin Blue PTCA RX Dilatation Catheter is substantially equivalent to the reference product cleared in the US in terms of biocompatibility.