Who is the manufacturer of All’InCath 035M PTA Balloon Dilatation Catheter?

Nexstep Medical filed the 510(k) submission for All’InCath 035M PTA Balloon Dilatation Catheter (K191275).

What is the FDA product code for All’InCath 035M PTA Balloon Dilatation Catheter?

LIT. It is classified under 21 CFR 870.1250 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for All’InCath 035M PTA Balloon Dilatation Catheter?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like All’InCath 035M PTA Balloon Dilatation Catheter?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

All’InCath 035M PTA Balloon Dilatation Catheter

K191275 · Nexstep Medical · LIT · Jan 15, 2020 · Cardiovascular

Device Facts

Record ID	K191275
Device Name	All’InCath 035M PTA Balloon Dilatation Catheter
Applicant	Nexstep Medical
Product Code	LIT · Cardiovascular
Decision Date	Jan 15, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1250
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

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 Story

All'InCath 035M is a sterile, single-use, over-the-wire (OTW) PTA balloon dilatation catheter compatible with 0.035" guidewires. Device features a three-port proximal hub: one for contrast injection, one for guidewire access, and one for balloon inflation/deflation. Contrast is delivered via three holes proximal to the balloon. Distal end includes a balloon with two radiopaque markers for positioning and a soft radiopaque tip. Used in clinical settings by physicians for peripheral angioplasty and angiographic visualization. Device enables mechanical dilation of vascular lesions and simultaneous contrast delivery to aid visualization, potentially improving procedural efficiency and patient outcomes in peripheral vascular interventions.

Clinical Evidence

Bench testing included dimensional verification, rated burst pressure, fatigue, compliance, inflation time, bond strength, tip pull strength, trackability, radiopacity, and biocompatibility (ISO 10993-1). Pre-clinical porcine vascular study compared device to Biotronik Passeo-35 and Boston Scientific Contra 4F, assessing angiographic appearance, ergonomics, procedure time, contrast volume, and vessel damage. Results met all acceptance criteria.

Technological Characteristics

OTW catheter; Vestamid balloon material; 0.035" guidewire compatibility; 80-120cm length; 4.0-10.0mm diameter; 20-80mm balloon length; 6 atm nominal pressure; 14-18 atm RBP; radiopaque marker bands; contrast infusion capability; EO sterilization. No coating.

Indications for Use

Indicated for patients requiring Percutaneous Transluminal Angioplasty (PTA) in peripheral vasculature (iliac, femoral, popliteal, renal arteries) and treatment of obstructive lesions in native or synthetic arteriovenous dialysis fistulae. Contraindicated for use in coronary arteries.

Regulatory Classification

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.

Predicate Devices

Arrow GPSCath (K140351)

Reference Devices

Chameleon (K170635)
Passeo-35HP (K113468)

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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 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. | 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) | ### 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." {3}------------------------------------------------ # 510(k) Summary | K191275 2 | | |--------------|--| |--------------|--| | Submitter | NexStep Medical 7-9 Place Saint Bernard 21000 Dijon France | |-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person | Angela Mallery 400 Highway 169 South Minneapolis, MN 55426 Phone: (763) 287-3830 amallery@namsa.com | | Date Prepared | January 14, 2020 | | Trade Name | All'InCath 035M PTA Balloon Dilatation Catheter | | Classification | Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, Angioplasty, Peripheral, Transluminal Common Name: PTA Balloon Dilatation Catheter Regulatory Class: Class II Product Code: LIT, KRA Product Panel: Cardiovascular | | 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. | | Indication for Use | 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. | {4}------------------------------------------------ | | 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. | | | | | |-------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Technological Characteristics | Comparisons of the new and predicate devices show the technological characteristics such as product performance, design, and intended use are substantially equivalent to the currently marketed predicate devices. | | | | | | Primary Predicate Device | K140351 Arrow GPSCath | | | | | | Reference Device | K170635 AV Medical Technologies Ltd. Chameleon K113468 Biotronik, Inc. Passeo-35HP | | | | | | Summary of Technological Characteristics of the New Device in Comparison to those of the Predicate evice | The information provided in this section demonstrates the All'InCath 035M is substantially equivalent 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 the predicate/reference devices do not raise different questions of safety and effectiveness The table shows the analysis that establishes how the All'InCath 035M is substantially equivalent. | | | | | | | Substantial Equivalence Executive Summary | | | | | | | Comparison Items | All'InCath 035M | Primary Predicate | Reference Devices | | | | | | K140351 GPSCath | K170635 Chameleon | K1134681 Passeo-35 HP | | | Intended Use | 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 for Percutaneous Transluminal Angioplasty in the peripheral vasculature and for the treatment of | 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 for Percutaneous Transluminal Angioplasty in the peripheral vasculature and for the treatment of | 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 for Percutaneous Transluminal Angioplasty in the peripheral vasculature and for the treatment of | 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 for Percutaneous Transluminal Angioplasty in the peripheral vasculature and for the treatment of | | | obstructive lesions of native or synthetic arteriovenous dialysis fistulae | obstructive lesions of native or synthetic arteriovenous dialysis fistulae | obstructive lesions of native or synthetic arteriovenous dialysis fistulae | obstructive lesions of native or synthetic arteriovenous dialysis fistulae | | | Indications for Use | 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 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 | The Arrow GPSCath™ Balloon Dilatation Catheter (150cm) is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries. | The Chameleon PTA Balloon Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The Chameleon enables the infusion of diagnostic or therapeutic fluids. This catheter is not for use in coronary arteries or cerebral vasculature. | The ELM PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and the renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries. | | | Primary Product Code | LIT | LIT | LIT | LIT | | | Catheter Type | OTW | OTW | OTW | OTW | | | Balloon Material | Vestamid | Unknown | Unknown | Nylon/Pebax, controlled compliance | | | Device Coating(s) | No coating. | No coating | No coating | No coating | | | Useable Catheter Length | 80-120cm | 80-150cm | 75 cm | 40-752 cm | | | Balloon Diameter | 4.0-10.0 mm | 3.0-12 mm | 5.0-12 mm | 3.0-12.0 mm | | | Balloon Length | 20-80 mm | 20-100 mm | 40 mm | 20-100 mm | | | Guidewire Compatibility | 0.035'' | 0.035" | 0.035" | 0.035" | | | Nominal Pressure (atm) | 6 | 8 | 12-14 | 12-14 | | | RBP (atm) | 14-18 | 16-24 | 14-25 | 18-27 | | | Marker Bands Present | Yes | Yes | Yes | Yes | | | Can Infuse Contrast | Yes | Yes | Yes | No | | | Packaging | Pouch in Pressboard carton | Pouch in Pressboard carton | Pouch in Pressboard carton | Pouch in Pressboard 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 {5}------------------------------------------------ ² https://biotronik.cdn.mediamid.com/cdn_bio_doc/bio24718/20818/bio24718.pdf {6}------------------------------------------------ ## 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 {7}------------------------------------------------ | | The testing has demonstrated the differences between the All' InCath 035M and the predicate/reference devices do not raise different questions of safety and effectiveness | |---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Performance Data | In vitro performanc…

All’InCath 035M PTA Balloon Dilatation Catheter

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Submission Summary (Full Text)

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All’InCath 035M PTA Balloon Dilatation Catheter

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Submission Summary (Full Text)

Panel 1

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Special Control Matches

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