The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.

Device Description

The Aperta NSE™ PTA Balloon Dilatation Catheter (Aperta NSE PTA) is an over-the-wire (OTW) type catheter used for percutaneous transluminal angioplasty of lesions in peripheral arteries and obstructive lesions of arteriovenous dialysis fistula. The Aperta NSE PTA catheter is designed with protruding polymer elements parallel to the balloon to aid dilatation of stenotic lesions that are difficult to expand with a conventional balloon.

AI/ML Overview

The provided FDA 510(k) Clearance Letter for the Aperta NSE PTA Balloon Dilatation Catheter describes a device that is substantially equivalent to a predicate device. This document does not contain acceptance criteria for performance of the device in a clinical setting (e.g., success rates, complication rates) nor does it describe a study proving such performance.

Instead, the document focuses on demonstrating substantial equivalence through non-clinical testing (bench testing, biocompatibility, and packaging) in comparison to the predicate device. The acceptance criteria described are for these non-clinical tests.

Therefore, many of the requested sections (e.g., sample size for test set, data provenance, number of experts, MRMC study, ground truth type, training set size) are not applicable to this document as it does not report on clinical performance or AI algorithm development.

Here's the information that can be extracted based on the provided document:

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

The document states that non-clinical testing was performed "After meeting all acceptance criteria." However, it does not provide the specific numerical acceptance criteria for each test or the detailed numerical "performance" results. It primarily indicates that the tests passed.

Test Category	Specific Test	Acceptance Criteria	Reported Device Performance
Bench testing	Visual verification	(Not specified in document)	Met acceptance criteria
	Dimensional verification (crossing profile & other)	(Not specified in document)	Met acceptance criteria
	Balloon compliance & RBP	(Not specified in document)	Met acceptance criteria
	Balloon RBP in stent	(Not specified in document)	Met acceptance criteria
	Catheter body burst pressure	(Not specified in document)	Met acceptance criteria
	Dimensional verification (element height)	(Not specified in document)	Met acceptance criteria
	Coating integrity (Pre & Post)	(Not specified in document)	Met acceptance criteria
	Simulated use	(Not specified in document)	Met acceptance criteria
	Balloon inflation/deflation time	(Not specified in document)	Met acceptance criteria
	Balloon fatigue	(Not specified in document)	Met acceptance criteria
	Torque strength	(Not specified in document)	Met acceptance criteria
	Flexibility and kink	(Not specified in document)	Met acceptance criteria
	Dimensional verification (Balloon element working length)	(Not specified in document)	Met acceptance criteria
	Balloon fatigue in stent	(Not specified in document)	Met acceptance criteria
	Catheter bond tensile strength	(Not specified in document)	Met acceptance criteria
	Tip pull tensile	(Not specified in document)	Met acceptance criteria
	Particulate evaluation	(Not specified in document)	Met acceptance criteria
Biocompatibility	Cytotoxicity	(Not specified in document)	Met acceptance criteria
	Sensitization	(Not specified in document)	Met acceptance criteria
	Irritation	(Not specified in document)	Met acceptance criteria
	Acute systemic toxicity	(Not specified in document)	Met acceptance criteria
	Material mediated pyrogenicity	(Not specified in document)	Met acceptance criteria
	Hemocompatibility	(Not specified in document)	Met acceptance criteria
Packaging	Label, IFU, accessory integrity	(Not specified in document)	Met acceptance criteria
	Packaging integrity	(Not specified in document)	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)

This information is not applicable as the document describes non-clinical (bench and lab-based) testing, not a clinical study on a test set of patient data.

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 information is not applicable as the document describes non-clinical testing.

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

This information is not applicable as the document describes non-clinical testing.

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

A MRMC comparative effectiveness study was not reported. This document is for a medical device (a catheter), not an AI-powered diagnostic tool.

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

This information is not applicable as the document is for a medical device (a catheter), not an AI algorithm.

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

For the non-clinical tests, the "ground truth" would be established by the expected performance characteristics based on engineering specifications, regulatory standards (e.g., ISO, ASTM), and the predicate device's performance. For biocompatibility, it's based on established biological safety endpoints. The document does not specify the exact methods for establishing these "truths" for each individual test, but implies adherence to the FDA Guidance Document titled "Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters issued on April 14, 2023."

8. The sample size for the training set

This information is not applicable as the document describes non-clinical testing of a physical medical device, not an AI algorithm requiring a training set.

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

This information is not applicable as the document describes non-clinical testing of a physical medical device, not an AI algorithm.

Summary

FDA 510(k) Clearance Letter - Aperta NSE PTA Balloon Dilatation Catheter

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

April 22, 2025

Goodman Co., Ltd.
℅ Nozomi Yagi
Senior Regulatory Affairs Manager
Infraredx
28 Crosby Drive
Suite 100
Bedford, Massachusetts 01730

Re: K243944
Trade/Device Name: Aperta NSE PTA Balloon Dilatation Catheter
Regulation Number: 21 CFR 870.1250
Regulation Name: Percutaneous Catheter
Regulatory Class: Class II
Product Code: PNO
Dated: December 20, 2024
Received: April 7, 2025

Dear Nozomi Yagi:

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.

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K243944 - Nozomi Yagi Page 2

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).

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 QS 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 (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-reporting-combination-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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K243944 - Nozomi Yagi Page 3

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. ASH-SHAKOOR -S
Digitally signed by ARIEL G. ASH-SHAKOOR -S
Date: 2025.04.22 09:27:51 -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

Page 4

FORM FDA 3881 (8/23) Page 1 of 1

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known): K243944

Device Name: Aperta NSE PTA Balloon Dilatation Catheter

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Page 5

510(k) Summary

510(k) #: K243944
Prepared on: 2025-04-22

Contact Details 21 CFR 807.92(a)(1)

Applicant Name: Goodman Co., Ltd.
Applicant Address: 5F KDX Nagoya Sakae Building, 4-5-3 Sakae, Naka-Ku, Nagoya, Aichi 460-0008, Japan
Applicant Contact Telephone: +81 52 269 5309
Applicant Contact: Kanechika Aida
Applicant Contact Email: Kanechika.Aida@goodmankk.com

Correspondent Name: Infraredx, Inc.
Correspondent Address: 28 Crosby Drive Suite 100, Bedford MA 01730 USA
Correspondent Contact Telephone: (781) 221-0053
Primary Correspondent Contact: Nozomi Yagi
Primary Correspondent Contact Email: nyagi@infraredx.com
Secondary Correspondent Contact: Stephen Sum, Ph.D.
Secondary Correspondent Contact Email: ssum@infraredx.com

Device Name 21 CFR 807.92(a)(2)

Device Trade Name: Aperta NSE™ PTA Balloon Dilatation Catheter
Common Name: Percutaneous catheter
Classification Name: Catheter, Percutaneous, Cutting/Scoring
Regulation Number: 870.1250
Product Codes: PNO

Legally Marketed Predicate Device 21 CFR 807.92(a)(3)

Predicate #	Predicate Trade Name	Product Code
K232013	Aperta NSE™ PTA Balloon Dilatation Catheter	PNO

Device Description Summary 21 CFR 807.92(a)(4)

Intended Use/Indications for Use 21 CFR 807.92(a)(5)

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Indications for Use Comparison 21 CFR 807.92(a)(5)

The subject device shares identical indications for use language with the predicate device.

Technological Comparison 21 CFR 807.92(a)(6)

Compared to the predicate device, the subject device contains the following key modifications:

Balloon length: The subject device includes balloon lengths of 100 and 150 mm, compared to the predicate device's 40 mm length, and
Radiopaque (RO) markers: The longer balloon models of the subject device has two (2) RO markers at the distal end of the balloon and one (1) at the proximal end, reversing the configuration of the predicate device, which has one (1) at the distal end and two (2) at the proximal end.

The subject device has equivalent technological characteristics (i.e., design, material, chemical composition, principle of operation) as the predicate device. While there are technological differences, the non-clinical testing results have demonstrated that the technological differences do not raise new questions of safety and effectiveness.

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

The following non-clinical testing was performed in accordance with the FDA Guidance Document titled Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters issued on April 14, 2023 to demonstrate that the subject device is substantially equivalent to the predicate device:

Bench testing

Visual verification
Dimensional verification (crossing profile and other)
Balloon compliance & RBP
Balloon RBP in stent
Catheter body burst pressure
Dimensional verification (element height)
Coating integrity (Pre & Post)
Simulated use
Balloon inflation/deflation time
Balloon fatigue
Torque strength
Flexibility and kink
Dimensional verification (Balloon element working length)
Balloon fatigue in stent
Catheter bond tensile strength
Tip pull tensile
Particulate evaluation

Biocompatibility

Cytotoxicity
Sensitization
Irritation
Acute systemic toxicity
Material mediated pyrogenicity
Hemocompatibility

Packaging

Label, IFU, accessory integrity
Packaging integrity

Page 7

Animal Testing & Clinical Testing - Not Applicable.

After meeting all acceptance criteria, non-clinical testing has demonstrated that the Aperta NSE PTA is substantially equivalent to the predicate device. The non-clinical testing demonstrated that the difference between subject and predicate devices do not raise new questions of safety and effectiveness.

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).