(266 days)
Not Found
No
The summary describes a mechanical device (balloon catheter) and its performance testing, with no mention of AI/ML, image processing, or data-driven analysis.
Yes
The device is a "Balloon Dilatation Catheter" indicated for "percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries" and "treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae," which are therapeutic procedures.
No.
The device description and intended use clearly state that this is a therapeutic device (for angioplasty and dilatation), not a diagnostic one.
No
The device description clearly indicates it is a physical catheter with a balloon and polymer elements, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The Aperta NSE PTA Balloon Dilatation Catheter is a physical device used within the body (percutaneously) to treat blockages in blood vessels. It's a therapeutic device, not a diagnostic one that analyzes samples.
- Lack of Diagnostic Testing: The description focuses on the mechanical action of the balloon and its elements for dilating arteries and fistulae. There is no mention of analyzing biological samples or providing diagnostic information.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
PNO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
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)
The following non-clinical testing was performed in accordance with the FDA Guidance Document titled Peripheral Percutaneous Transluminal Anaioplasty (PTA) and Specialty Catheters (Draft: Jan 2020, Final: Apr 2023) to demonstrate that the subject device is substantially equivalent to the predicate device and reference devices:
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)
- Simulated use
- Balloon inflation/deflation time
- Coating integrity (Post)
- Balloon fatique
- Torque strength
- Flexibility and kink
- Dimensional verification (Balloon element working length)
- Balloon fatique in stent
- Catheter bond tensile strength
- Tip pull tensile
- Scoring performance
- Particulate evaluation
- Lubricity test
Biocompatibility
- Cytotoxicity
- Sensitization
- Irritation
- Acute systemic toxicity
- Material mediated pyrogenicity
- Hemocompatibility
Packaging
- Label, IFU, accessory integrity
- Packaging integrity
Animal Testing
- Safety evaluation in acute (Day 0) and chronic (Day 30) porcine peripheral artery model
After meeting all acceptance criteria, non-clinical testing has demonstrated that the Aperta NSE PTA is substantially equivalent to the predicate.
Clinical Testing - Not Applicable.
The non-clinical testing demonstrated that the difference between subject device, Aperta NSE PTA catheter and the legally marketed predicate device, AngioSculpt PTA Scoring Balloon Catheter (K150634) do not raise new questions of safety and effectiveness. Therefore, the subject device is substantially equivalent to the predicate 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
§ 870.1250 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).
0
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March 28, 2024
Goodman Co., Ltd. % Nozomi Yagi Senior Regulatory Affairs Manager Infraredx, Inc. 28 Crosby Drive, Suite 100 Bedford, Massachusetts 01730
Re: K232013
Trade/Device Name: Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, AW18-14550040. AW18-05060040/AA18-05060040. AW18-09060040/AA18-09060040. AW18-14560040 AW18-05070040/AA18-05070040. AW18-09070040/AA18-09070040. AW18-14570040. AW18-05080040/AA18-05080040, AW18-09080040/AA18-09080040, AW18-14580040) Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PNO Dated: January 26, 2024 Received: January 26, 2024
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
1
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).
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 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 medical devices and radiation-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.
Digitally signed by Ariel Ariel G. Ash-G. Ash-shakoor -S Date: 2024.03.28 shakoor -S 12:21:54 -04'00'
2
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
Submission Number (if known)
Device Name
Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040, AW18-09040040/ AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/ AA18-09050040, AW18-14550040, AW18-05060040/AA18-05060040, AW18-09060040/ AA18-09060040, AW18-14560040 AW18-05070040/AA18-05070040, AW18-09070040/ AA18-09070040, AW18-14570040, AW18-05080040/AA18-05080040, AW18-09080040/ AA18-09080040, AW18-14580040)
Indications for Use (Describe)
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.
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) #: K232013
510(k) Summary
Prepared on: 2024-03-28
| 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 |
| (AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, | |
| AW18-14540040, | |
| AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, | |
| AW18-14550040, | |
| AW18-05060040/AA18-05060040, AW18-09060040/AA18-09060040, | |
| AW18-14560040, | |
| AW18-05070040/AA18-05070040, AW18-09070040/AA18-09070040, | |
| AW18-14570040, | |
| AW18-05080040/AA18-05080040, AW18-09080040/AA18-09080040, | |
| AW18-14580040) | |
| Common Name: | Percutaneous catheter |
| Classification Name: | Catheter, Percutaneous, Cutting/Scoring |
| Regulation Number: | 870.1250 |
| Product Code: | PNO |
| Legally Marketed Predicate Device | 21 CFR 807.92(a)(3) | |
|---|---|---|
| Predicate # | Predicate Trade Name | Product Code |
| K150634 | AngioSculpt PTA Scoring Balloon Catheter | PNO |
Device Description Summary
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.
21 CFR 807.92(a)(4)
5
Intended Use/Indications for Use
The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, 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 selfexpanding stents in the peripheral vasculature. This device is not for use in the coronary or neurovasculature including carotid arteries.
Indications for Use Comparison
The subject device has equivalent indications for use language as the predicate device, with the exception of in-stent restenosis (ISR) indication. Non-clinical testing has demonstrated that addition of ISR indication does not raise new questions of safety or effectiveness.
Technological Comparison
The subject device has equivalent technological characteristics (i.e., design, material, chemical composition, principle of operation) as the predicate device. While there is a difference in scoring element materials between the subject (polymer) and predicate (nitinol), 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
The following non-clinical testing was performed in accordance with the FDA Guidance Document titled Peripheral Percutaneous Transluminal Anaioplasty (PTA) and Specialty Catheters (Draft: Jan 2020, Final: Apr 2023) to demonstrate that the subject device is substantially equivalent to the predicate device and reference devices:
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)
- . Simulated use
- Balloon inflation/deflation time
- . Coating integrity (Post)
- . Balloon fatique
- Torque strength •
- . Flexibility and kink
- . Dimensional verification (Balloon element working length)
- Balloon fatique in stent ●
- Catheter bond tensile strength ●
- Tip pull tensile .
- Scoring performance
- Particulate evaluation
- . Lubricity test
Biocompatibility
- Cytotoxicity •
- Sensitization •
- . Irritation
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
21 CFR 807.92(a)(5)
21 CFR 807.92(b)
6
- Acute systemic toxicity
- . Material mediated pyrogenicity
- Hemocompatibility
Packaging
- Label, IFU, accessory integrity •
- Packaging integrity
Animal Testing
- Safety evaluation in acute (Day 0) and chronic (Day 30) porcine peripheral artery model •
After meeting all acceptance criteria, non-clinical testing has demonstrated that the Aperta NSE PTA is substantially equivalent to the predicate.
Clinical Testing - Not Applicable.
The non-clinical testing demonstrated that the difference between subject device, Aperta NSE PTA catheter and the legally marketed predicate device, AngioSculpt PTA Scoring Balloon Catheter (K150634) do not raise new questions of safety and effectiveness. Therefore, the subject device is substantially equivalent to the predicate device.