(252 days)
No
The device description and performance studies focus on the physical and electrical properties of a standard introducer sheath with electrodes, with no mention of AI/ML algorithms for data processing or interpretation.
No.
The device facilitates venous access for introducing other devices and sensing signals, but it does not directly treat a condition or restore function.
No
The device is an introducer sheath for facilitating venous access and introducing other devices, and may sense intravenous signals. While sensing signals could be part of a diagnostic process, the primary function described here is access and introduction, rather than standalone diagnostic interpretation.
No
The device description clearly outlines physical components such as a sheath, dilator, guidewire, electrodes, and cables, indicating it is a hardware device, not software-only.
Based on the provided information, the Acutus Medical AcQRef Introducer Sheath is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states it's for "percutaneous procedures to facilitate venous access... for introduction of catheters and other devices, and may be used to sense intravenous signals." This describes a device used within the body for access and sensing, not for testing samples outside the body.
- Device Description: The description details components like a sheath, dilator, guidewire, hemostasis valve, flush port, and electrodes. These are all components of a device used for accessing and working within the vascular system.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The sensing of intravenous signals is for procedural guidance or monitoring in vivo, not for in vitro diagnostic testing.
- Performance Studies: The performance studies focus on the physical and electrical integrity of the device for its intended use in accessing the vasculature, not on the accuracy or reliability of diagnostic results from biological samples.
- Predicate Devices: The predicate devices listed are also introducer sheaths, which are not IVD devices.
In summary, the Acutus Medical AcQRef Introducer Sheath is a medical device used for accessing the venous system and facilitating the introduction of other devices, with the added capability of sensing intravenous signals. This function is performed in vivo and does not involve the in vitro analysis of biological samples, which is the defining characteristic of an IVD.
N/A
Intended Use / Indications for Use
The Acutus Medical AcQRef Introducer Sheath is indicated for use in percutaneous procedures to facilitate venous access from the lower extremities for introduction of catheters and other devices, and may be used to sense intravenous signals.
Product codes
DYB
Device Description
The Acutus Medical AcQRef Introducer Sheath is a sterile, single use, venous access device that consists of a straight shaft with lumen, hemostasis valve, flush port, electrodes, and attached extension cable for electrode connectivity. The AcQRef Introducer Sheath consists of the following components:
- One (1) 7Fr Introducer Sheath with electrodes and connection cable ●
- One (1) 7Fr Vessel Dilator ●
- o One (1) Guide wire - 0.038 in, J-tip
The AcQRef Introducer Sheath is compatible for use with the AcQMap® High Resolution Imaging and Mapping System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peripheral (Venous)
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
All necessary testing was conducted on the AcQRef Introducer Sheath to support a determination of substantial equivalence to the predicate device.
Nonclinical Testing Summary:
Extensive performance bench testing was conducted on the AcQRef Introducer Sheath. This testing was performed to ensure that the AcQRef Introducer Sheath performs as intended. The nonclinical testing included:
- Packaging and Shelf-Life
- Sterilization
- Biocompatibility
- Surface, Dimensional, and Electrical Integrity ●
- Valve Air Leak Test
- Simulated Use Test
- Pressure Leak Test ●
- Flexion and Fatigue ●
- Electrical Safety
- Corrosion Resistance
- Pull Strength
- o Design validation testing in an animal model
The collective results of the nonclinical testing demonstrate that the materials chosen, the manufacturing processes, and design of the AcQRef Introducer Sheath meet the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that the AcQRef device does not raise different questions of safety or effectiveness for percutaneous catheter introduction into the vasculature.
Clinical Testing Summary:
No clinical testing is being submitted to support review of this 510(k) premarket notification.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is in blue and consists of the letters "FDA" and the words "U.S. Food & Drug Administration".
February 6, 2018
Acutus Medical, Inc. Brenda Clay Regulatory Affairs Manager 2210 Faraday Ave., Suite 100 Carlsbad, California 92008
Re: K171557
Trade/Device Name: AcORef Introducer Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: January 9, 2018 Received: January 10, 2018
Dear Brenda Clay:
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. 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 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn
(http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
M. A. Hillebrenner
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K171557
Device Name Acutus Medical AcQRef Introducer Sheath
Indications for Use (Describe)
The Acutus Medical AcQRef Introducer Sheath is indicated for use in percutaneous procedures to facilitate venous access from the lower extremities for introduction of catheters and other devices, and may be used to sense intravenous signals.
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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3
510(k) Notification K_K171557
GENERAL INFORMATION [807.92(a)(1)]
Applicant:
Acutus Medical, Inc. 2210 Faraday Ave., Suite 100 Carlsbad, CA 92008 USA Phone: 1-442-232-6080 Fax: 1-442-232-6081
Contact Person:
Brenda Clay Regulatory Affairs Manager Acutus Medical, Inc. 2210 Faraday Ave., Suite 100 Carlsbad, CA 92008 USA Phone: 1-442-232-6161 FAX: 1-442-232-6081 Email: Brenda.Clay@acutus.com
Date Prepared: May 26, 2017
DEVICE INFORMATION [807.92(a)(2)]
Trade Name:
AcQRef Introducer Sheath
Generic/Common Name:
Catheter introducer
Classification:
21 CFR 870.1340
Product Code:
DYB
4
PREDICATE DEVICE(S) [807.92(a)(3)]
The predicate device to support substantial equivalence of the AcQRef Introducer Sheath is the Galt Medical Corp. Catheter Introducer, marketed as the Hemostasis Valve Catheter Introducer Set, cleared under K043525. This 510(k) is also citing the St. Jude Agilis ES Steerable Introducer cleared under K103083 as a secondary predicate (reference device).
DEVICE DESCRIPTION [807.92(a)(4)]
The Acutus Medical AcQRef Introducer Sheath is a sterile, single use, venous access device that consists of a straight shaft with lumen, hemostasis valve, flush port, electrodes, and attached extension cable for electrode connectivity. The AcQRef Introducer Sheath consists of the following components:
- One (1) 7Fr Introducer Sheath with electrodes and connection cable ●
- One (1) 7Fr Vessel Dilator ●
- o One (1) Guide wire - 0.038 in, J-tip
The AcQRef Introducer Sheath is compatible for use with the AcQMap® High Resolution Imaging and Mapping System.
INDICATIONS FOR USE [807.92(a)(5)]
The Acutus Medical AcQRef Introducer Sheath is indicated for use in percutaneous procedures to facilitate venous access from the lower extremities for introduction of catheters and other devices, and may be used to sense intravenous signals.
5
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES [807.92(a)(6)]
| Feature | Proposed Device
AcQRef Introducer
Sheath
(K____) | Predicate Device
Galt Medical Corp.
Catheter Introducer
K043525 | Reference Device
Agilis™ ES
Steerable
Introducer
K103083 | Analysis of
Differences |
|----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | 21 CFR § 870.1340 | 21 CFR § 870.1340 | 21 CFR § 870.1340 | All devices have the
same classification
number |
| Product Code | DYB | DYB | DYB | All devices have the
same product code |
| Indications for
Use | The Acutus Medical
AcQRef Introducer
Sheath is indicated
for use in
percutaneous
procedures to
facilitate venous
access from the lower
extremities for
introduction of
catheters and other
devices, and may be
used to sense
intravenous signals. | The Sheath
Introducer System is
indicated for use in
percutaneous
procedures to
introduce catheters
and other
intravascular devices
into the vasculature. | The Agilis ES
Steerable Introducer
is indicated when
introducing various
cardiovascular
catheters into the
heart, including the
left side of the heart
through the
interatrial septum.
The Introducer may
be used for
recording
intracardiac signals
and for cardiac
stimulation during
electrophysiology
studies. | Similar indication
for use language
compared to the
predicate. Proposed
indications for use
fall within the
intended use for the
predicate device and
also includes
language similar to
the reference device
related to sensing
electrical signals.
The differences in
Indications for Use
do not raise
different questions
of safety or
effectiveness. |
| Intended Use | Catheter delivery
system
including electrodes
for intravenous signal
sensing when used
with compatible
mapping system. | Catheter Delivery
System | Mapping/Pacing/
Catheter Delivery
System
(The steerable
introducer,
constructed of a
polymer shaft that
incorporates three
platinum-iridium
electrodes, the
primary use of
which is
visualization on the
EnSite™ System) | Same intended use
as the predicate
device with regard
to catheter delivery.
Same intended use
as the reference
device with respect
sensing electrical
signals for use with
an
electrophysiology
system. |
| Device Inner
Diameter (ID)
(French) | 7F | 4F to 9F | 8.5F | Proposed device
French size is
within the range of
the predicate device |
| Device Length | 30 cm | 5 cm to 110 cm | 71cm | Proposed device
length is within the
range of the
predicate device |
| Feature | Proposed Device
AcQRef Introducer
Sheath
(K | Predicate Device
Galt Medical Corp.
Catheter Introducer
K043525 | Reference Device
AgilisTM ES
Steerable
Introducer
K103083 | Analysis of
Differences |
| Shaft Material | Pebax 72D SA01,
BaSO4 Loaded | unknown polymer | unknown polymer | All devices use
biocompatible
polymer material. |
| Deflection
(Y/N) | No | No | Yes - Bidirectional
(180/90) | Same as the
predicate device |
| Side Port for
Flush | Yes | Yes | Yes | All devices have a
side port |
| Guide wire
Compatibility | 0.038 in. | 0.018, 0.021, 0.035,
and 0.038 in. per
Dilator ID | 0.032 in. | Comparable to
guidewire
compatibility for the
predicate |
| Dilator | Yes | Yes | Yes | All devices have a
dilator |
| Electrodes | Yes (4x 90/10 Pt-Ir)
Sensing Only | No | Yes (3) | Proposed device
includes electrodes
similar to the
reference device |
| Electrode
Material | Platinum / iridium | N/A | Platinum / iridium | Same as reference
device |
| Connection to
Recording
System or
Mapping
System | Yes | No | Yes | Same as reference
device |
| Radiopaque
Elements | Yes | Yes | Yes | All devices have
radiopaque elements |
| Anatomical
location | Peripheral (Venous) | Peripheral (Vascular) | Peripheral
(Vascular) | All devices have the
same anatomical use
location |
| Package
Contents | Introducer sheath.
Guidewire, Dilator | Introducer sheath,
Guidewire, Dilator | Introducer sheath,
Guidewire, Dilator | All devices have
same main
components |
| Sterilization
Method | EtO | EtO | EtO | All devices have
same sterilization
method |
| Sheath
Hemostasis
Control | Yes | Yes | Yes | All devices provide
for hemostasis
control |
| Biocompatible
Blood, Body
and Fluid
Contacting
Materials | Yes | Yes | Yes | All devices employ
biocompatible
components for
patient contacting
components. |
Substantial Equivalence Table – Regulatory Information
6
7
SUBSTANTIAL EQUIVALENCE
The proposed AcQRef Introducer Sheath was compared to the predicate device with respect to product labeling, intended use, anatomical sites, patient population, performance testing, technological characteristics and safety characteristics. Based on this comparison, there were only minor differences in the technological characteristics between the devices which do not raise any different questions of safety or effectiveness. In addition, AcQRef was compared to a reference device as both devices provide a venous conduit and electrical reference within one product. Thus, AcQRef is substantially equivalent to the predicate device with regard to vascular access and is comparable to the reference device with respect to the sensing of electrical signals.
PERFORMANCE DATA [807.92(B)]
All necessary testing was conducted on the AcQRef Introducer Sheath to support a determination of substantial equivalence to the predicate device.
[807.92(b)(1)| Nonclinical Testing Summary:
Extensive performance bench testing was conducted on the AcQRef Introducer Sheath. This testing was performed to ensure that the AcQRef Introducer Sheath performs as intended. The nonclinical testing included:
- Packaging and Shelf-Life
- Sterilization
- Biocompatibility
- Surface, Dimensional, and Electrical Integrity ●
- Valve Air Leak Test
- Simulated Use Test
- Pressure Leak Test ●
- Flexion and Fatigue ●
- Electrical Safety
- Corrosion Resistance
- Pull Strength
- o Design validation testing in an animal model
The collective results of the nonclinical testing demonstrate that the materials chosen, the manufacturing processes, and design of the AcQRef Introducer Sheath meet the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that the AcQRef device does not raise different questions of safety or effectiveness for percutaneous catheter introduction into the vasculature.
8
[807.92(b)(2)] Clinical Testing Summary:
No clinical testing is being submitted to support review of this 510(k) premarket notification.
CONCLUSIONS [807.92(b)(3)]
Extensive nonclinical testing has been performed on the AcQRef Introducer Sheath to evaluate the overall performance of the device. The collective results confirm that the AcQRef Introducer Sheath is safe meets its specifications, is biocompatible, and exhibits the required mechanical and functional characteristics to perform per its intended use.
SUMMARY
The AcQRef Introducer Sheath is substantially equivalent to the predicate device.