(28 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and function 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" and "balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction", which are therapeutic interventions.
No
The device is described as a "balloon dilatation catheter" used for dilating stenotic portions of coronary arteries or bypass grafts. Its function is to perform a therapeutic physical action (dilatation), not to diagnose a condition.
No
The device description explicitly states it is a "sterile, flexible tube" with a "distensible Nylon balloon at its distal tip," which are physical hardware components. The performance studies also focus on bench testing of these physical attributes.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used in vivo (within the body) for a therapeutic procedure (balloon dilatation of coronary arteries). IVDs are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a catheter designed to be inserted into the body and inflated within a blood vessel. This is consistent with an in vivo medical device, not an in vitro diagnostic.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with IVD devices.
Therefore, the POT PTCA balloon dilatation catheter is a therapeutic medical device used in vivo, not an IVD.
N/A
Intended Use / Indications for Use
The POT PTCA balloon dilatation catheter is indicated for:
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 coronary artery occlusion for the treatment of acute myocardial infarction
balloon dilatation of a stent after implantation (balloon models O2.25 mm - O5.00 mm only)
Note: Bench testing was conducted with the POT PTCA Balloon Dilatation Catheter and marketed balloon expandable stents. Consideration should be taken when this device is used with different manufacturers' stents due to difference in stent design.
Product codes (comma separated list FDA assigned to the subject device)
LOX
Device Description
The POT PTCA balloon dilatation catheter is a sterile, flexible tube designed to be used in percutaneous transluminal coronary angioplasty (PTCA) to dilate a stenotic coronary artery by controlled inflation of a distensible Nylon balloon at its distal tip. It is typically a rapid exchange (Rx) type with a single-lumen catheter. It is a single-use device and available in various sizes.
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)
Additional bench testing were performed to support a determination of substantial equivalence between subject device and predicates in accordance with the FDA guidance entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" and "The Special 510(k) Program - Guidance for Industry and FDA Staff". The results of all tests provide reasonable assurance that the proposed POT PTCA catheter has been designed and tested to assure conformance to the requirements of its intended use.
All additional testing were conducted on the subject device as recommended in FDA PTCA guidance:
- Dimensional verification
- Simulated Use
- Balloon Rated Burst Pressure
- Balloon Fatigue
- Balloon Compliance
- Balloon Inflation and Deflation Time
- Balloon Burst (in stent)
- Balloon Fatigue (in stent)
In vitro bench testing met all acceptance criteria and demonstrated that the subject device 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.
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
§ 870.5100 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 the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 19, 2023
BrosMed Medical Co., Ltd. Crystal Lee Registration Affairs Manager 15th Building, SMEs Venture Park, SongShan Lake Hi-Tech Industrial Development Zone Dongguan, GD 523808 China
Re: K230705
Trade/Device Name: POT PTCA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Regulatory Class: Class II Product Code: LOX
Dear Crystal Lee:
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 April 11, 2023. Specifically, FDA is updating this SE Letter (e.g., inaccurate device description in 510(k) summary) 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,
Digitally signed by Ariel G. Ash-Digitally signed by Ash-shakoor -S shakoor -S Date: 2023.04.19 10:12:06 -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
1
Image /page/1/Picture/0 description: The image contains 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.
April 11, 2023
BrosMed Medical Co., Ltd. Crystal Lee Registration Affairs Manager 15th Building, SMEs Venture Park, SongShan Lake Hi-Tech Industrial Development Zone Dongguan, GD 523808 China
Re: K230705
Trade/Device Name: POT PTCA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Percutaneous Transluminal Coronary Angioplasty (Ptca) Catheter Regulatory Class: Class II Product Code: LOX Dated: March 14, 2023 Received: March 14, 2023
Dear Crystal Lee:
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 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 requirements,
2
including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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-devices/medical-device-safety/medical-device-reporting-mdr-howreport-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) CDRH and 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 DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorythe assistance/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,
Ariel G. Ashshakoor -S
Digitally signed by Ariel G. Ash-shakoor -S Date: 2023.04.11 10:18:58 -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) K230705
Device Name POT PTCA Balloon Dilatation Catheter
Indications for Use (Describe)
The POT PTCA balloon dilatation catheter is indicated for:
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 coronary artery occlusion for the treatment of acute myocardial infarction
· balloon dilatation of a stent after implantation (balloon models Ø2.25 mm - Ø5.00 mm only)
Note: Bench testing was conducted with the POT PTCA Balloon Dilatation Catheter and marketed balloon expandable stents. Consideration should be taken when this device is used with different manufacturers' stents due to difference in stent design.
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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4
510(k) SUMMARY
1. GENERAL INFORMATION
1.1 Submitter
BrosMed Medical Co., Ltd. 15th Building, SMEs Venture Park SongShan Lake Hi-Tech Industrial Development Zone Dongguan, Guangdong, 523808, China Office: +86 (769) 2289 2018 Fax: +86 (769) 2289 2016
1.2 Contract person
Crystal Lee, Email: crystallee@brosmed.com Office: +86 (769) 2289 2018
1.3 Date of Preparation March 03, 2023
March 03, 2023
2. NAME OF THE DEVICE
- 2.1.1 Trade/Proprietary Name POT PTCA Balloon Dilatation Catheter
2.1.2 Common/Usual Name Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter
- 2.1.3 Classification Information Classification Name: Catheters, Transluminal Coronary Angioplasty, Percutaneous Classification Regulation: 21 CFR 870.5100 Device Class: Class II (Special Controls) LOX Product Code: Review Panel: Cardiovascular
3. PREDICATE DEVICE
DESCRIPTION OF THE DEVICE 4.
The POT PTCA balloon dilatation catheter is a sterile, flexible tube designed to be used in percutaneous transluminal coronary angioplasty (PTCA) to dilate a stenotic coronary artery by controlled inflation of a distensible Nylon balloon at its distal tip. It is typically a rapid exchange (Rx) type with a single-lumen catheter. It is a single-use device and available in various sizes.
5
న్. INDICATION FOR USE
The indication for use / intended use statement for the Subject device is as follows:
The POT PTCA Balloon Dilatation Catheter is indicated for:
- . 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 coronary artery occlusion for the treatment of acute myocardial infarction;
- balloon dilatation of a stent after implantation (balloon models Ø2.25 mm 5.00 mm only) .
Note: Bench testing was conducted with the POT PTCA Balloon Dilatation Catheter and marketed balloon expandable stents. Consideration should be taken when this device is used with different manufacturers' stents due to difference in stent design.
SUBSTANTIAL EQUIVALENCE COMPARISON 6.
Comparison of the POT PTCA Balloon Dilatation Catheter and Apollo Balloon Dilatation Catheter cleared in K133852 and K153742 shows that the subject device incorporates substantial equivalence general design components, material and performance specifications, manufacturing processes, sterilization process, packaging materials and design, and the same indications for use and principles of operation as predicates.
Please see Table 1 below for the comparison between Subject device and Predicate devices.
| Technological
Characteristic | Subject Device
POT | Predicate Device
Apollo (K133852 & K153742) | Comparison |
|---------------------------------|----------------------------------|------------------------------------------------|------------|
| Indications for Use | The POT PTCA balloon | The Apollo balloon dilatation | Identical |
| | dilatation catheter is indicated | catheter is indicated for: | |
| | for: ·balloon dilatation of the | ·balloon dilatation of the | |
| | | | |
| | stenotic portion of a coronary | stenotic portion of a coronary | |
| | artery or bypass graft stenosis | artery or bypass graft stenosis | |
| | for the purpose of improving | for the purpose of improving | |
| | myocardial perfusion | myocardial perfusion | |
| | ·balloon dilatation of a | ·balloon dilatation of a | |
| | coronary artery occlusion for | coronary artery occlusion for | |
| | the treatment of acute | the treatment of acute | |
| | myocardial infarction | myocardial infarction | |
| | ·balloon dilatation of a stent | ·balloon dilatation of a stent | |
| | after implantation (balloon | after implantation (balloon | |
| | models Ø2.25 mm - Ø5.00 mm | models Ø2.0 mm - Ø5.00 mm | |
| | only) | only) | |
| | Note: Bench testing was | Note: Bench testing was | |
| | conducted with the POT PTCA | conducted with the Apollo | |
| | Balloon Dilatation Catheter | Balloon Dilatation Catheter | |
| | and marketed balloon | and marketed balloon | |
| | expandable stents. | expandable stents. | |
| | Consideration should be taken | Consideration should be taken | |
| | when this device is used with | when this device is used with | |
| | | | |
| | different manufacturers'stents | different manufacturers'stents | |
| | due to difference in stent | due to difference in stent | |
| | design. | design. | |
| Fundamental device | Rx type sterilized PTCA | Rx type sterilized PTCA | Identical |
| design | catheter | catheter | |
Table 1. Substantial Equivalence Comparison of Subject Device and Predicate Device
6
| Technological
Characteristic | Subject Device
POT | Predicate Device
Apollo (K133852 & K153742) | Comparison |
|---------------------------------|---------------------------------------------------------|---------------------------------------------------------|-------------|
| General catheter design | Tip, balloon, body tubing, hub,
2 radiopaque markers | Tip, balloon, body tubing, hub,
2 radiopaque markers | Identical |
| Compatible guidewire (in) | 0.014 | 0.014 | Identical |
| Catheter working length
(cm) | 140 | 140 | Identical |
| Balloon diameter range
(mm) | 2.25-5.0 | 2.0-5.0 | Equivalence |
| Balloon length range
(mm) | 6-15 | 6-30 | Equivalence |
| Balloon cone length | Shorter | Longer | Equivalence |
| Nominal Pressure (atm) | 14 | 14 | Identical |
| Rated Burst Pressure
(atm) | 20-22 | 20-22 | Identical |
7. PERFORMANCE TESTING SUMMARY
Additional bench testing were performed to support a determination of substantial equivalence between subject device and predicates in accordance with the FDA guidance entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" and "The Special 510(k) Program - Guidance for Industry and FDA Staff". The results of all tests provide reasonable assurance that the proposed POT PTCA catheter has been designed and tested to assure conformance to the requirements of its intended use.
All additional testing were conducted on the subject device as recommended in FDA PTCA guidance:
- . Dimensional verification
- Simulated Use
- Balloon Rated Burst Pressure
- Balloon Fatigue
- Balloon Compliance ●
- Balloon Inflation and Deflation Time ●
- Balloon Burst (in stent) ●
- Balloon Fatigue (in stent) ●
In vitro bench testing met all acceptance criteria and demonstrated that the subject device performed as intended and did not impact the functionality of the device.
8. CONCLUSION
The information presented in this special 510(k) submission demonstrates that the proposed modifications on the subject device do not raise new/different questions of safety and effectiveness as compared to the predicate device. Therefore, the POT PTCA Balloon Dilatation Catheter is substantially equivalent to the Apollo Balloon Dilatation Catheter cleared in K133852 and K153742.