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.

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.

AI/ML Overview

Based on the provided text, the document is a 510(k) summary for the "POT PTCA Balloon Dilatation Catheter." This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed clinical study report with specific acceptance criteria, sample sizes, and expert adjudication for a novel AI/software device. As such, most of the requested information regarding an AI/ML device's acceptance criteria and study proving its performance is not present in this document.

However, I can extract the information related to performance testing for this physical medical device (a balloon catheter) and note the absence of data pertinent to AI/ML device evaluations.

Here's a breakdown based on the provided text:

Acceptance Criteria and Device Performance (for the physical device, not AI/ML):

The document mentions that bench testing was performed and met all acceptance criteria. However, it does not explicitly list the specific numerical acceptance criteria for each test. It only states that the tests demonstrated the device performed as intended and did not impact functionality.

Acceptance Criteria (Description)	Reported Device Performance
Dimensional verification	Met all acceptance criteria (specific values not provided in document)
Simulated Use	Met all acceptance criteria (specific outcomes not provided in document)
Balloon Rated Burst Pressure	20-22 atm (Identical to predicate)
Balloon Fatigue	Met all acceptance criteria (specific outcomes not provided in document)
Balloon Compliance	Met all acceptance criteria (specific outcomes not provided in document)
Balloon Inflation and Deflation Time	Met all acceptance criteria (specific outcomes not provided in document)
Balloon Burst (in stent)	Met all acceptance criteria (specific outcomes not provided in document)
Balloon Fatigue (in stent)	Met all acceptance criteria (specific outcomes not provided in document)

Information NOT available in the document, as it pertains to AI/ML device studies, not physical medical devices like this one:

Sample sizes used for the test set and the data provenance: Not applicable to this type of device submission. The "test set" here refers to physical bench tests, not a dataset for an algorithm.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's performance is typically established through engineering specifications and standardized testing, not expert consensus as in image interpretation.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For a physical device, ground truth relates to its physical properties and mechanical performance, established by engineering standards and measurements.
The sample size for the training set: Not applicable (no AI/ML training involved).
How the ground truth for the training set was established: Not applicable.

Summary of Relevant Information from the Document (for a physical medical device):

Device Name: POT PTCA Balloon Dilatation Catheter
Purpose: To demonstrate substantial equivalence to a predicate device (Apollo Balloon Dilatation Catheter K133852 & K153742). This is a 510(k) submission for a physical medical device, not an AI/ML software.
Study Type: Bench testing (in vitro) to assess physical characteristics and performance.
Tests Performed:
- 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)
Result of Tests: "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."
Ground Truth (for this device): The ground truth for performance of this physical device is based on engineering specifications, recognized standards, and comparison to the predicate device's established performance.

Summary

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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

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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,

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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

Enclosure

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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)

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) 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

Apollo Balloon Dilatation Catheter (K133852 and K153742). ●

DESCRIPTION OF THE DEVICE 4.

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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) .

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.

TechnologicalCharacteristic	Subject DevicePOT	Predicate DeviceApollo (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

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TechnologicalCharacteristic	Subject DevicePOT	Predicate DeviceApollo (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.

Regulation Number and Section

§ 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.