· Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in □ patients evidencing coronary ischemia for the purpose of improving myocardial perfusion.

· Balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial □ infarction.

· In-stent restenosis.

· Post-delivery expansion of balloon expandable coronary stents.

Device Description

The Sapphire NC ULTRA Coronary Dilatation Catheter is designed to allow easy exchange of the catheter using a standard length 0.014 inch guidewire. Balloon diameters range from 1.75mm to 5.0mm. The balloon material is made of a minimally compliant material, 1.75mm to 4.0mm balloons have a rated burst pressure of 20 atmospheres, and 4.5mm to 5.0mm balloons have a rated burst pressure of 18 atmospheres. The minimally compliant balloon material allows high pressure dilatation while maintaining precise control of the balloon diameter and length. The proximal shaft of the catheter is composed of a female luer connector connected to a PTFE coated stainless steel tube. The proximal shaft allows superior proximal pushability and trackability with a smooth transition to a distal shaft. Two radiopaque platinum/iridium marker bands are located within the balloon segment. The guidewire enters the catheter tip and advances coaxially out the distal Rx port, thereby allowing both coaxial guidance and rapid exchange of catheter with a single standard-length guidewire. Two marked sections of 5mm length each located on the proximal shaft indicate catheter position relative to the tip of either a brachial or femoral guiding catheter.

AI/ML Overview

The provided text is a 510(k) summary for the Sapphire NC ULTRA Coronary Dilatation Catheter. It outlines various performance tests conducted to establish substantial equivalence to a predicate device. However, it does not contain the specific level of detail required to fully answer all aspects of your request, particularly regarding clinical study design, expert qualifications, or detailed performance metrics against acceptance criteria.

Here's an attempt to answer your questions based on the available information:

1. A table of acceptance criteria and the reported device performance

The document states: "The test results met all acceptance criteria, which are the same or similar to the predicate device and ensure that the Sapphire NC ULTRA Coronary Dilatation Catheter design and construction are suitable for their intended use."

While it lists the types of tests performed, it does not provide a table with specific acceptance criteria or quantitative performance results for each test. For example, it lists "Balloon Rated Burst Pressure (in-stent)" as a test, but doesn't state what the accepted pressure was or what the device achieved.

Here's a generalized table based on the types of tests mentioned, but without specific numerical criteria or performance data:

Acceptance Criteria Category	Reported Device Performance
In vitro Performance:
Visual Inspection	Met acceptance criteria
Particulate Evaluation	Met acceptance criteria
Dimensional Verification	Met acceptance criteria
Balloon Compliance	Met acceptance criteria
Hub Leakage Test	Met acceptance criteria
Balloon Prep, Deployment, Retraction	Met acceptance criteria
Balloon Inflation/Deflation Time	Met acceptance criteria
Coating Integrity	Met acceptance criteria
Balloon Fatigue (in-stent)	Met acceptance criteria
Balloon Fatigue	Met acceptance criteria
Balloon Rated Burst Pressure (in-stent)	Met acceptance criteria
Balloon Rated Burst Pressure	Met acceptance criteria
Shaft Burst	Met acceptance criteria
Catheter Bond Strength	Met acceptance criteria
Tip Pull Strength	Met acceptance criteria
Flexibility and Kink	Met acceptance criteria
Torque Strength	Met acceptance criteria
Marker Band Radiopacity	Met acceptance criteria
Biocompatibility:
Cytotoxicity	Met acceptance criteria
Sensitization	Met acceptance criteria
Intracutaneous Reactivity	Met acceptance criteria
Acute Systemic Toxicity	Met acceptance criteria
Pyrogenicity	Met acceptance criteria
Hemolysis	Met acceptance criteria
Partial Thromboplastin Time	Met acceptance criteria
Platelet and Leukocyte Counts	Met acceptance criteria
Complement Activation	Met acceptance criteria
Toxicological Risk Assessment (TRA) of Extractable Chemicals	Met acceptance criteria
Other:
Packaging and Sterilization Validation	Met acceptance criteria
Shelf Life	Met acceptance criteria

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document describes in vitro performance tests and biocompatibility tests. This means the "test set" refers to material samples (e.g., catheter units, material extracts) used for these laboratory tests, not a clinical patient dataset.

Sample Size: The document does not specify the sample size for the in vitro or biocompatibility tests.
Data Provenance: Not applicable in the context of in vitro and biocompatibility testing. These are laboratory tests conducted on device components or finished products.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is geared towards clinical studies involving human interpretation or pathology. Since the provided text only details in vitro and biocompatibility testing, there is no information about experts or their qualifications for establishing ground truth as would be required in a clinical setting. These tests typically follow standardized protocols and are evaluated by lab personnel, not medical experts establishing clinical ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Again, this question is relevant for clinical studies with human assessors. For the in vitro and biocompatibility testing described, adjudication methods like N+1 are not applicable. The results are typically quantitative measurements or observations against predefined pass/fail criteria according to established standards (e.g., ISO, FDA guidance).

5. 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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The device is an angioplasty catheter, not an AI software or a device that assists human readers in interpreting images. Therefore, this question is not applicable to the information provided.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is also not applicable. The Sapphire NC ULTRA Coronary Dilatation Catheter is a physical medical device, not an algorithm or software requiring standalone performance testing in that context.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the in vitro performance tests, the "ground truth" is established by adherence to predefined engineering specifications, material properties, and performance benchmarks derived from industry standards (e.g., those in the "Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters").

For biocompatibility testing, the "ground truth" is established by compliance with international standards like ISO 10993-1, which define acceptable biological responses and safety profiles for medical device materials.

8. The sample size for the training set

This question is applicable to machine learning or AI models. Since the device is a physical medical catheter and the testing described is primarily in vitro and biocompatibility, there is no concept of a "training set" in this context.

9. How the ground truth for the training set was established

As there is no training set for a physical medical device, this question is not applicable.

Summary

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August 16, 2024

OrbusNeich Medical (Shenzhen) Co., Ltd. Jerry Cheung Senior Director of Regulatory Affairs No.1 Jinkui Road Futian Free Trade Zone Shenzhen, 518038 China

Re: K233499

Trade/Device Name: Sapphire NC ULTRA Coronary Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Regulatory Class: Class II Product Code: LOX Dated: July 16, 2024 Received: July 16, 2024

Dear Jerry Cheung:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Brian D. Pullin -S

for Lydia Glaw 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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Indications for Use

Submission Number (if known)

K233499

Device Name

Sapphire NC ULTRA Coronary Dilatation Catheter

Indications for Use (Describe)

The Sapphire NC ULTRA Coronary Dilatation Catheter is indicated for:

· Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in □ patients evidencing coronary ischemia for the purpose of improving myocardial perfusion.

· Balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial □ infarction.

· In-stent restenosis.

· Post-delivery expansion of balloon expandable coronary 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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510(k) Summary

This 510(k) Summary is submitted in accordance with 21 CFR 807.92.

Submitter:	OrbusNeich Medical (Shenzhen) Co., Ltd.No.1 Jinkui RoadFutian Free Trade ZoneShenzhen 518038, ChinaPhone: +86-755-83580181Fax: +86-755-83580169
Contact Person:	Name: Jerry CheungJob Title: Senior Director of Regulatory AffairsEmail: jcheung@orbusneich.com
Date Prepared:	October 30, 2023
Device:	Device Name: Sapphire NC ULTRA Coronary DilatationCatheterRegulation Name: Percutaneous Transluminal CoronaryAngioplasty (PTCA) CatheterTrade Name: Sapphire NC ULTRARegulation Number: 21 CFR 870.5100(a)Regulatory Class: IIProduct Code: LOX
Predicate Device:	Sapphire NC 24 Coronary Dilatation Catheter(K211807, LOX; cleared Oct.14, 2021)This predicate has not been subject to a design-related recall.
Reference Devices:	Sapphire NC Plus Coronary Dilatation Catheter(K162209; cleared Oct.06, 2016)(K192344; cleared Sep.19, 2019)Sapphire II Pro Coronary Dilatation Catheter(K163114; cleared Jan.05, 2017)(K173680; cleared Mar.1, 2018)
Device Description:	The Sapphire NC ULTRA Coronary Dilatation Catheter isdesigned to allow easy exchange of the catheter using astandard length 0.014 inch guidewire. Balloon diametersrange from 1.75mm to 5.0mm. The balloon material is madeof a minimally compliant material, 1.75mm to 4.0mmballoons have a rated burst pressure of 20 atmospheres, and4.5mm to 5.0mm balloons have a rated burst pressure of 18

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atmospheres. The minimally compliant balloon material allows high pressure dilatation while maintaining precise control of the balloon diameter and length. The proximal shaft of the catheter is composed of a female luer connector connected to a PTFE coated stainless steel tube. The proximal shaft allows superior proximal pushability and trackability with a smooth transition to a distal shaft. Two radiopaque platinum/iridium marker bands are located within the balloon segment. The guidewire enters the catheter tip and advances coaxially out the distal Rx port, thereby allowing both coaxial guidance and rapid exchange of catheter with a single standard-length guidewire. Two marked sections of 5mm length each located on the proximal shaft indicate catheter position relative to the tip of either a brachial or femoral guiding catheter.

Indications for Use: The indications for use for Sapphire NC ULTRA Coronary Dilatation Catheter remain the same as the predicate device (Sapphire NC 24):

The Sapphire NC ULTRA Coronary Dilatation Catheter is indicated for:

Balloon dilatation of the stenotic portion of a coronary ● artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion
Balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction
In-stent restenosis
Post-delivery expansion of balloon expandable coronary stents

The subject device has the following similarities to the Technological Characteristics: predicate devices:

· Same indications for use
· Same catheter design
· Same sterilization method

The following technological differences exist between the subject and predicate device:

Materials of construction
· Performance specifications
· Shelf life

Performance Data: The following performance data were provided in support

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of the substantial equivalence determination.

In vitro performance tests were conducted on subject A device in accordance with FDA guidance "Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters" issued on September 8, 2010, including:
- · Visual Inspection
- Particulate Evaluation
- · Dimensional Verification
- Balloon Compliance
- · Hub leakage test
- Balloon Preparation, Deployment, and Retraction .
- Balloon Inflation and Deflation Time .
- · Coating Integrity
- . Balloon Fatigue (in-stent)
- . Balloon Fatigue
- Balloon Rated Burst Pressure (in-stent) .
- Balloon Rated Burst Pressure .
- . Shaft burst
- Catheter Bond Strength
- · Tip Pull Strength
- Flexibility and Kink
- · Torque Strength
- · Marker Band Radiopacity
A Biocompatibility testing, conducted in accordance with the FDA guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices -Part 1: Evaluation and testing within a Risk Management Process" issued on June 16, 2016, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA, included:
- Cytotoxicity
- . Sensitization
- Intracutaneous reactivity
- Acute systemic toxicity
- Pyrogenicity
- Hemocompatibility
  - Hemolysis ●
  - . Partial thromboplastin time
  - . Platelet and leukocyte counts

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Complement activation Toxicological Risk Assessment (TRA) of Extractable Chemicals
Packaging and sterilization validation Shelf life
The test results met all acceptance criteria, which are the same or similar to the predicate device and ensure that the Sapphire NC ULTRA Coronary Dilatation Catheter design and construction are suitable for their intended use.
Conclusion:	This information supports a determination of substantial equivalence between the subject device and the predicate device described above.

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.