(247 days)
K140351 Arrow GPSCath
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a balloon catheter, with no mention of AI or ML.
Yes
The device is a "PTA Balloon Dilatation Catheter" used for "Percutaneous Transluminal Angioplasty" to treat "obstructive lesions," which are therapeutic interventions.
Yes
The device is described as being "intended to provide angiographic visualization of the vasculature when combined with the delivery of radiopaque contrast media." This function involves obtaining images to help diagnose conditions or visualize anatomical structures, qualifying it as a diagnostic capability.
No
The device description clearly outlines a physical catheter with lumens, a balloon, and ports for contrast injection and guidewire insertion. This is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for a medical procedure (Percutaneous Transluminal Angioplasty and angiographic visualization) performed on the patient's body. IVDs are used to examine specimens from the body (like blood, urine, tissue) to diagnose or monitor conditions.
- Device Description: The description details a catheter with a balloon and lumens for guidewire insertion, contrast injection, and balloon inflation/deflation. This is consistent with a device used for interventional procedures, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of reagents, assays, sample handling, or any other components or processes typically associated with in vitro diagnostics.
The device is a medical device used for therapeutic and diagnostic procedures performed directly on the patient's vascular system.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LIT, KRA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature, including iliac, femoral, popliteal and renal arteries, and ... 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)
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. The 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).
A pre-clinical study was conducted to evaluate the acute safety and performance of the device during angiography and angioplasty procedures as compared to Biotronik-Passeo-35 PTA catheter and Boston Scientific Contra 4F angiography catheter in a porcine vascular model by assessing 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.
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.
K140351 Arrow GPSCath
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.
K170635 AV Medical Technologies Ltd. Chameleon, K113468 Biotronik, Inc. Passeo-35HP
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
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) |
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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 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. The
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). |
| | A pre-clinical study was conducted to evaluate the acute safety and performance of the device
during angiography and angioplasty procedures as compared to Biotronik-Passeo-35 PTA
catheter and Boston Scientific Contra 4F angiography catheter in a porcine vascular model by
assessing 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'InCath
035M PTA Balloon Dilatation Catheter and the predicate and reference devices described above. |