The All'InCath 035M PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The All'InCath 035M is also intended to provide angiographic visualization of the vasculature when combined with the delivery of radiopaque contrast media.

This catheter is not for use in coronary arteries.

Device Description

The All'InCath 035M PTA Balloon Dilatation Catheter (All'InCath 035M) is a sterile single use dilatation balloon and contrast injection catheter.
The All'InCath 035M is an over the wire (OTW) catheter compatible with 0.035" (0.89mm) guidewire.
The proximal end of the catheter includes a three ports hub connected to the three lumens of the shaft: the port provided with a stopcock valve is used for angiographic contrast injection, the straight entry port allows access to the distal tip of the catheter for guidewire insertion, and the last port is used for balloon inflation/deflation.
Contrast is injected into the vascular system through three holes in the contrast lumen proximal to the balloon and marked by a radiopaque marker.
The balloon is mounted at the distal end of the catheter.
The balloon has two radiopaque markers indicating the dilating section of the balloon and aid positioning the balloon relative to the lesion. The tip of the catheter is made of a soft radiopaque tubing.

AI/ML Overview

This document is a 510(k) Premarket Notification for the All'InCath 035M PTA Balloon Dilatation Catheter. It is a medical device submission to the FDA, demonstrating substantial equivalence to a legally marketed predicate device. This type of document is not an AI/ML study, it's a submission for a medical device. Therefore, the questions related to AI/ML study parameters (like sample size for test/training sets, expert adjudication, MRMC studies, ground truth establishment for AI/ML) are not applicable to this document.

However, I can extract the acceptance criteria and performance data for the physical medical device based on the provided text, as well as information about the types of studies conducted for its safety and performance.

Acceptance Criteria and Reported Device Performance (Physical Device)

The document primarily focuses on demonstrating substantial equivalence based on in vitro performance tests and a pre-clinical study in an animal model. The acceptance criteria are generally implied as meeting established standards and not raising different questions of safety and effectiveness compared to predicate devices.

Acceptance Criteria Category	Reported Device Performance / Study Finding
In vitro Performance Tests
Dimensional Verification	Test results met all acceptance criteria and ensure the design and construction are suitable for its intended use as recommended by the Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (FDA; September 8, 2010).
Balloon Rated Burst Pressure	Test results met all acceptance criteria and ensure the design and construction are suitable for its intended use as recommended by the Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (FDA; September 8, 2010).
Balloon Fatigue	Test results met all acceptance criteria and ensure the design and construction are suitable for its intended use as recommended by the Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (FDA; September 8, 2010).
Balloon Compliance	Test results met all acceptance criteria and ensure the design and construction are suitable for its intended use as recommended by the Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (FDA; September 8, 2010).
Balloon Inflation Time	Test results met all acceptance criteria and ensure the design and construction are suitable for its intended use as recommended by the Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (FDA; September 8, 2010).
Catheter Bond Strength	Test results met all acceptance criteria and ensure the design and construction are suitable for its intended use as recommended by the Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (FDA; September 8, 2010).
Tip Pull Strength	Test results met all acceptance criteria and ensure the design and construction are suitable for its intended use as recommended by the Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (FDA; September 8, 2010).
Trackability	Test results met all acceptance criteria and ensure the design and construction are suitable for its intended use as recommended by the Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (FDA; September 8, 2010).
Radiopacity	Test results met all acceptance criteria and ensure the design and construction are suitable for its intended use as recommended by the Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (FDA; September 8, 2010).
Biocompatibility Tests (ISO 10993-1)
Cytotoxicity	Test results met all acceptance criteria and ensure the design and construction are suitable for its intended use. The catheter has been evaluated in accordance with ISO 10993-1.
Sensitization	Test results met all acceptance criteria and ensure the design and construction are suitable for its intended use. The catheter has been evaluated in accordance with ISO 10993-1.
Intracutaneous Reactivity	Test results met all acceptance criteria and ensure the design and construction are suitable for its intended use. The catheter has been evaluated in accordance with ISO 10993-1.
Acute Systemic Toxicity	Test results met all acceptance criteria and ensure the design and construction are suitable for its intended use. The catheter has been evaluated in accordance with ISO 10993-1.
Hemocompatibility (Hemolysis, Complement Activation,	Test results met all acceptance criteria and ensure the design and construction are suitable for its intended use. The catheter has been evaluated in accordance with ISO 10993-1.
and in vivo Thromboresistance)
Pyrogenicity	Test results met all acceptance criteria and ensure the design and construction are suitable for its intended use. The catheter has been evaluated in accordance with ISO 10993-1.
Sterilization (ISO 11135)	The catheter has been evaluated in accordance with ISO 11135.
*Pre-clinical in vivo* Safety and Performance Study**	The study evaluated the acute safety and performance of the device during angiography and angioplasty procedures compared to predicate devices (Biotronik-Passeo-35 PTA catheter and Boston Scientific Contra 4F angiography catheter). The assessment included angiographic appearance, ergonomics, total procedure time, amount of contrast, and vessel damage. The general conclusion is that the performance testing demonstrated the device performed as intended and does not raise different questions of safety and effectiveness. Specific numerical acceptance criteria or performance numbers for this in vivo study are not provided in this summary. The study was conducted in a porcine vascular model.

Study Information (Pertaining to the Physical Device)

Sample sizes used for the test set and data provenance:
- In vitro tests: The specific number of devices/samples tested for each in vitro performance criterion (dimensional verification, burst pressure, fatigue, etc.) is not explicitly stated in this summary. These tests are typically performed on a statistically significant sample size to ensure reproducibility and reliability, but the exact numbers are not detailed here.
- Biocompatibility tests: Similarly, specific sample sizes (e.g., number of animals for in vivo biocompatibility components or number of samples for in vitro components) are not detailed. These are typically done according to the requirements of ISO 10993.
- Pre-clinical study: The sample size (number of porcine models) for the in vivo pre-clinical study is not specified in the document.
- Data Provenance: The document states the pre-clinical study was conducted in a porcine vascular model. No country of origin for the data is explicitly mentioned for the studies, but the submitter is "NexStep Medical, 7-9 Place Saint Bernard 21000 Dijon France" and the contact person is in Minneapolis, MN, USA. The studies themselves are retrospective to the submission date.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is a medical device submission based on physical and biological performance, not an AI/ML image-based study requiring expert ground truth in the traditional sense. The "ground truth" for device performance comes from direct measurements (in vitro) and observed biological/physiological responses (in vivo animal model) against predefined engineering and biological standards.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This refers to consensus among human readers for an AI/ML study, which is not what this document describes.
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. This type of study relates to AI/ML software.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the device's performance relies on engineering specifications, physical measurements (e.g., balloon dimensions, burst pressure), biological standards (e.g., biocompatibility per ISO 10993), and direct observation/measurement of device behavior in a controlled in vitro environment and an in vivo animal model. There is no "pathology" or human "outcomes data" presented for specific patients, as this is a pre-market submission, not a clinical trial report on human subjects.
The sample size for the training set: Not applicable. This pertains to AI/ML models.
How the ground truth for the training set was established: Not applicable. This pertains to AI/ML models.

Summary

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January 15, 2020

NexStep Medical % Angela Mallery Principal Product Development Strategist, Regulatory NAMSA 400 Highway 169 South, Suite 500 Minneapolis, MN 55426

Re: K191275

Trade/Device Name: All'InCath 035M PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT, KRA Dated: December 11, 2019 Received: December 12, 2019

Dear Ms. Mallery:

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 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.

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

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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 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 (QS) 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-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,

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

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Indications for Use

510(k) Number (if known) K191275

Device Name

The All'InCath 035M PTA Balloon Dilatation Catheter

Indications for Use (Describe)

The All'InCath 035M is also intended to provide angiographic visualization of the vasculature when combined with the delivery of radiopaque contrast media.

This catheter is not for use in coronary arteries.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CER 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

K1912752
--------------	--

Submitter	NexStep Medical7-9 Place Saint Bernard21000 Dijon France
Contact Person	Angela Mallery400 Highway 169 SouthMinneapolis, MN 55426Phone: (763) 287-3830amallery@namsa.com
Date Prepared	January 14, 2020
Trade Name	All'InCath 035M PTA Balloon Dilatation Catheter
Classification	Regulation Number: 21 CFR 870.1250Regulation Name: Catheter, Angioplasty, Peripheral, TransluminalCommon Name: PTA Balloon Dilatation CatheterRegulatory Class: Class IIProduct Code: LIT, KRAProduct Panel: Cardiovascular
DeviceDescription	The All'InCath 035M PTA Balloon Dilatation Catheter (All'InCath 035M) is a sterile single usedilatation balloon and contrast injection catheter.The All'InCath 035M is an over the wire (OTW) catheter compatible with 0.035" (0.89mm)guidewire.The proximal end of the catheter includes a three ports hub connected to the three lumens of theshaft: the port provided with a stopcock valve is used for angiographic contrast injection, thestraight entry port allows access to the distal tip of the catheter for guidewire insertion, and thelast port is used for balloon inflation/deflation.Contrast is injected into the vascular system through three holes in the contrast lumen proximalto the balloon and marked by a radiopaque marker.The balloon is mounted at the distal end of the catheter.The balloon has two radiopaque markers indicating the dilating section of the balloon and aidpositioning the balloon relative to the lesion. The tip of the catheter is made of a soft radiopaquetubing.
Indication forUse	The All'InCath 035M PTA Balloon Dilatation Catheter is indicated for PercutaneousTransluminal Angioplasty in the peripheral vasculature, including iliac, femoral, popliteal andrenal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenousdialysis fistulae.

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	The All'InCath 035M is also intended to provide angiographic visualization of the vasculaturewhen combined with the delivery of radiopaque contrast media.This catheter is not for use in coronary arteries.
TechnologicalCharacteristics	Comparisons of the new and predicate devices show the technological characteristics such asproduct performance, design, and intended use are substantially equivalent to the currentlymarketed predicate devices.
PrimaryPredicate Device	K140351 Arrow GPSCath
ReferenceDevice	K170635 AV Medical Technologies Ltd. ChameleonK113468 Biotronik, Inc. Passeo-35HP
Summary ofTechnologicalCharacteristicsof the NewDevice inComparison tothose of thePredicate evice	The information provided in this section demonstrates the All'InCath 035M is substantiallyequivalent to the Primary Predicate in terms of performance characteristics and materials.The All'InCath 035M is considered equivalent to the primary predicate.The All'InCath 035M has an equivalent indication for use statement The All'InCath 035M has the equivalent technological characteristics The testing has demonstrated the differences between the All'InCath 035M and thepredicate/reference devices do not raise different questions of safety and effectiveness The table shows the analysis that establishes how the All'InCath 035M is substantiallyequivalent.
	Substantial Equivalence Executive Summary
	ComparisonItems	All'InCath 035M	Primary Predicate	Reference Devices
			K140351GPSCath	K170635Chameleon	K1134681Passeo-35 HP
	Intended Use	A percutaneouscatheter is a devicethat is introducedinto a vein or arterythrough the skinusing a dilator and asheath (introducer)or guide wire forPercutaneousTransluminalAngioplasty in theperipheralvasculature and forthe treatment of	A percutaneouscatheter is a devicethat is introducedinto a vein or arterythrough the skinusing a dilator and asheath (introducer)or guide wire forPercutaneousTransluminalAngioplasty in theperipheralvasculature and forthe treatment of	A percutaneouscatheter is a devicethat is introducedinto a vein or arterythrough the skinusing a dilator and asheath (introducer)or guide wire forPercutaneousTransluminalAngioplasty in theperipheralvasculature and forthe treatment of	A percutaneouscatheter is a devicethat is introduced intoa vein or arterythrough the skinusing a dilator and asheath (introducer) orguide wire forPercutaneousTransluminalAngioplasty in theperipheralvasculature and forthe treatment of
	obstructive lesionsof native orsyntheticarteriovenousdialysis fistulae	obstructive lesionsof native orsyntheticarteriovenousdialysis fistulae	obstructive lesionsof native or syntheticarteriovenousdialysis fistulae	obstructive lesions ofnative or syntheticarteriovenous dialysisfistulae
Indicationsfor Use	The All'InCath035M PTA BalloonDilatation Catheteris indicated forPercutaneousTransluminalAngioplasty in theperipheralvasculature,including iliac,femoral, popliteal,and renal arteries,and for thetreatment ofobstructive lesionsof native orsyntheticarteriovenousdialysis fistulae.The All'InCath isalso intended toprovideangiographicvisualization of thevasculature whencombined with thedelivery ofradiopaque contrastmedia.This catheter is notfor use in coronaryarteries	The ArrowGPSCath™ BalloonDilatation Catheter(150cm) is indicatedfor PercutaneousTransluminalAngioplasty (PTA)in the peripheralvasculature,including iliac,femoral, popliteal,infra-popliteal andrenal arteries, andfor the treatment ofobstructive lesionsof native orsyntheticarteriovenousdialysis fistulae.This catheter is notfor use in coronaryarteries.	The Chameleon PTABalloon Catheter isindicated for use inPercutaneousTransluminalAngioplasty ofthe femoral, iliac,and renal arteriesand for the treatmentof obstructivelesions of native orsyntheticarteriovenousdialysis fistulae. TheChameleon enablesthe infusion ofdiagnostic ortherapeutic fluids.This catheter is notfor use in coronaryarteries orcerebral vasculature.	The ELM PTABalloon DilatationCatheter is indicatedfor use inPercutaneousTransluminalAngioplasty ofthe femoral, iliac, andthe renal arteries andfor the treatment ofobstructive lesions ofnative or syntheticarteriovenous dialysisfistulae.This catheter isnot for use incoronary arteries.
PrimaryProduct Code	LIT	LIT	LIT	LIT
CatheterType	OTW	OTW	OTW	OTW
BalloonMaterial	Vestamid	Unknown	Unknown	Nylon/Pebax,controlledcompliance
DeviceCoating(s)	No coating.	No coating	No coating	No coating
UseableCatheterLength	80-120cm	80-150cm	75 cm	40-752 cm
BalloonDiameter	4.0-10.0 mm	3.0-12 mm	5.0-12 mm	3.0-12.0 mm
BalloonLength	20-80 mm	20-100 mm	40 mm	20-100 mm
GuidewireCompatibility	0.035''	0.035"	0.035"	0.035"
NominalPressure(atm)	6	8	12-14	12-14
RBP (atm)	14-18	16-24	14-25	18-27
MarkerBandsPresent	Yes	Yes	Yes	Yes
Can InfuseContrast	Yes	Yes	Yes	No
Packaging	Pouch in Pressboardcarton	Pouch in Pressboardcarton	Pouch inPressboard carton	Pouch inPressboard carton
Sterilization	EO	EO	EO	EO

1 K113468 was initially cleared as the Creagh Medical ELM PTA Catheter, it is a non-coated PTA device. Access GUIDID database lists this as being marketed under the Brand name Passeo-35

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² https://biotronik.cdn.mediamid.com/cdn_bio_doc/bio24718/20818/bio24718.pdf

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Intended Use

The general purpose and function of the devices are equivalent.

The devices are all intended to be introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire for Percutaneous Transluminal Angioplasty in the peripheral vasculature and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Indication for use

The subject device has an equivalent indication for use to that of the GPSCath and a similar indication to the reference devices.

Substantial Equivalence Conclusion

The All'InCath 035M is substantially equivalent to the predicate device and reference devices.

The devices have similar designs, however the exact specifications between the subject and primary predicate/reference devices differ in certain aspects. In each case where there was a difference, design verification testing was performed to demonstrate substantial equivalence.

In all cases, performance testing demonstrated the device performed as intended.

The devices are considered equivalent for the following reasons:

The All'InCath 035M does not raise different questions of safety and effectiveness
The All'InCath 035M has the equivalent indication for use statement as the predicate and reference devices
The design of the All'InCath 035M and the predicate and reference devices are substantially equivalent with minor differences to the device dimensions, materials types, and performance

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	The testing has demonstrated the differences between the All' InCath 035M and thepredicate/reference devices do not raise different questions of safety and effectiveness
PerformanceData	In vitro performance tests, including dimensional verification, balloon rated burst pressure,balloon fatigue, balloon compliance, balloon inflation time, catheter bond strength,tip pull strength, trackability, and radiopacity and biocompatibility tests, such as cytotoxicity,sensitization, intracutaneous reactivity, acute systemic toxicity, hemocompatibility (hemolysis,complement activation, and in vivo thromboresistance), and pyrogenicity were conducted. Thetest results met all acceptance criteria and ensure the design and construction are suitable for itsintended use as recommended by the Class II Special Controls Guidance Document for CertainPercutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (FDA; September 8, 2010).
	A pre-clinical study was conducted to evaluate the acute safety and performance of the deviceduring angiography and angioplasty procedures as compared to Biotronik-Passeo-35 PTAcatheter and Boston Scientific Contra 4F angiography catheter in a porcine vascular model byassessing the angiographic appearance, ergonomics, total procedure time, amount of contrast,and vessel damage.
	The catheter has been evaluated in accordance with ISO 10993-1 and ISO 11135.
Conclusion	This information supports a determination of substantial equivalence between the All'InCath035M PTA Balloon Dilatation Catheter and the predicate and reference devices described above.

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).