(169 days)
Not Found
No
The description focuses on the mechanical aspects of a steerable sheath and dilator, with no mention of AI or ML capabilities.
No
The device is described as a steerable sheath for introducing catheters, and specifically states it is "compatible with diagnostic and therapeutic devices," implying it is not a therapeutic device itself. Its function is to facilitate the introduction and positioning of other devices.
No
The device is described as a steerable sheath for introducing catheters into the heart, compatible with diagnostic and therapeutic devices. Its function is to facilitate catheter introduction and positioning, not to perform diagnosis itself.
No
The device description explicitly details physical components like a shaft, handle, valve, and dilator, and the performance studies focus on bench testing of these physical attributes. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for percutaneous catheter introduction into the chambers of the heart." This describes a procedure performed on the patient's body, not a test performed on a sample taken from the patient.
- Device Description: The description details a physical device (sheath, handle, valve, dilator) used to facilitate the insertion and positioning of a catheter within the heart. This is a surgical/interventional tool, not a diagnostic test kit or instrument that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely procedural – facilitating access and positioning within the heart.
N/A
Intended Use / Indications for Use
The AcQGuide is intended for percutaneous catheter introduction into the chambers of the heart. The AcQGuide deflection facilitates catheter positioning.
Product codes
DRA
Device Description
The AcQGuide Steerable Sheath is a sterile, single use device consisting of a composite structured single lumen shaft, an ergonomic handle to provide torque and active deflection, and a hemostasis valve with side flush port, to allow safe introduction of a catheter while simultaneously permitting saline to be flushed via the main shaft. The AcQGuide Steerable Sheath is designed for maneuverability of standard electrophysiology catheters that are advanced through the sheath and into the right or left chambers of the sheath is compatible with diagnostic and therapeutic devices. The AcQGuide Steerable Sheath includes a dilator. The dilator is designed to introduce the Steerable Sheath into the vasculature and into chambers of the heart.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
chambers of the heart, vasculature
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
Nonclinical Testing Summary: Extensive performance bench testing was conducted on the AcOGuide Steerable Sheath. This testing was performed in order to ensure that the AcQGuide Steerable Sheath performs as intended. The nonclinical testing included: Packaging and Shelf-Life, Sterilization, Biocompatibility, Design Verification and Validation studies, including: Dimensional Inspection of Sheath and Dilator, Visual Inspection for any defects, Leak Testing, Functional and Compatibility Testing, Mechanical Testing, Handle Torque Testing. Physician simulated use in an animal model. The collective results of the nonclinical testing demonstrate that the materials chosen, the manufacturing processes, and design of the AcQGuide Steerable Sheath meet the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that the AcQGuide does not raise different questions of safety or effectiveness for percutaneous catheter introduction into the vasculature and into chambers of the heart when compared to the predicate devices.
Clinical Testing Summary: This section is not applicable. 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)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1280 Steerable catheter.
(a)
Identification. A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
April 6, 2017
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Acutus Medical, Inc. Brenda Clay Regulatory Affairs Manager 2210 Faraday Ave Suite 100 Carlsbad, California 92008
Re: K162925
Trade/Device Name: AcQGuide Steerable Sheath Regulation Number: 21 CFR 870.1280 Regulation Name: Steerable Catheter Regulatory Class: Class II Product Code: DRA Dated: March 3, 2017 Received: March 6, 2017
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Mude Jellman
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) K162925
Device Name AcQGuide Steerable Sheath
Indications for Use (Describe)
The AcQGuide is intended for percutaneous catheter introduction into the chambers of the heart. The AcQGuide deflection facilitates catheter positioning.
| 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 K162925
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: 442-232-6161 FAX: 442-232-6081 Email: Brenda.Clay@acutus.com
Date Prepared: April 3, 2017
DEVICE INFORMATION [807.92(a)(2)]
Trade Name:
AcQGuide™ Steerable Sheath
Generic/Common Name:
Steerable Catheter
Classification:
21 CFR 870.1280
Product Code: DRA
4
PREDICATE DEVICE(S) [807.92(a)(3)]
The predicate device to support substantial equivalence of the AcQGuide Steerable Sheath is the Medtronic CryoCath LP Flexcath Advance® Steerable Sheath and Dilator cleared under K123591.
DEVICE DESCRIPTION [807.92(a)(4)]
The AcQGuide Steerable Sheath is a sterile, single use device consisting of a composite structured single lumen shaft, an ergonomic handle to provide torque and active deflection, and a hemostasis valve with side flush port, to allow safe introduction of a catheter while simultaneously permitting saline to be flushed via the main shaft. The AcQGuide Steerable Sheath is designed for maneuverability of standard electrophysiology catheters that are advanced through the sheath and into the right or left chambers of the sheath is compatible with diagnostic and therapeutic devices. The AcQGuide Steerable Sheath includes a dilator. The dilator is designed to introduce the Steerable Sheath into the vasculature and into chambers of the heart.
INDICATIONS FOR USE [807.92(a)(5)]
The AcQGuide is intended for percutaneous catheter introduction into the vasculature and into chambers of the heart. The AcQGuide deflection facilitates catheter positioning.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES [807.92(a)(6)]
| Feature | Proposed Device
AcQGuide ™ Steerable Sheath
(K162925) | Predicate Device
FlexCath Advance® Steerable
Sheath
K123591 | Analysis of
Differences |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | 21 CFR § 870.1280 | 21 CFR § 870.1280 | Same
classification |
| Product Code | DRA | DRA | Same product
code |
| Indications
for Use | The AcQGuide Steerable Sheath is
intended for percutaneous catheter
introduction into the vasculature
and into the chambers of the heart.
The Sheath deflection facilitates
catheter positioning. | The FlexCath Steerable Sheath is
intended for percutaneous catheter
introduction into the vasculature
and into the chambers of the heart.
The Sheath deflection facilitates
catheter positioning. | Same intended use |
| Key
Components | Employs single deflection curve
with atraumatic tip. Sheath
deflection facilitates accurate
catheter positioning. Facilitates use
with catheters up to 10.5F in
diameter. Hemostasis valve to
prevent air incursion and minimizes
blood loss. Flush port provides
ability to administer saline flush | Ergonomic handle with
unidirectional deflection.
Hemostasis valve allows for
introduction, withdrawal, and
exchanging of catheters and guide
wires, while preventing air ingress
and minimizing blood loss.
Facilitates use with catheters up to | Similar design
features. Minor
differences do not
raise different
questions of safety
or effectiveness. |
| Feature | Proposed Device
AcQGuide™ Steerable Sheath
(K162925) | Predicate Device
FlexCath Advance® Steerable
Sheath
K123591 | Analysis of
Differences |
| | throughout procedure. Usable
length of up to 75 cm. | 10.5F in diameter. Usable length of
up to 65 cm. | |
| Method of
Use | Percutaneous catheter introduction
into the vasculature and into the
chambers of the heart. The sheath
deflection facilitates catheter
positioning. | Percutaneous catheter introduction
into the vasculature and into the
chambers of the heart. The sheath
deflection facilitates catheter
positioning. | Same method of
use |
| Sheath Size | Inner diameter: 12.8Fr
Outer Diameter: 16Fr
Usable length: 75cm
Total length: 92cm
Radiopaque marker: distal sections
are visible when using standard or
low level fluoroscopy | Inner diameter: 12Fr
Outer Diameter: 15Fr
Usable length: 65cm
Total length: 81cm
Radiopaque marker: 5mm
proximal to sheath tip | Products have
similar inner and
outer diameter and
similar lengths.
Both devices
include
radiopaque
components for
visualization. The
minor differences
do not raise
different questions
of safety or
effectiveness. |
| Compatibility | Guidewire compatibility: .035" | Guidewire compatibility: .032" to
.035" | The guidewire
compatibility of
AcQGuide falls
within the range
of the predicate. |
| Deflection
and reach | Maximum deflection: 180 degrees
(with catheter inserted)
Reach: 5.0cm at 90 degrees | Maximum deflection: 135 degrees
(with catheter inserted)
Reach: 5.5cm at 90 degrees | Both devices
allow deflection
and have a similar
reach. |
| Sheath
Material | Shaft: Biocompatible copolymer
(Pebax®) with stainless steel,
platinum/10% Iridium, PTFE | Shaft: Biocompatible copolymer
(Pebax®) with barium sulfate
blend | Both devices are
constructed of
biocompatible
materials |
| Dilator | Total length:95.5cm
Outer diameter: 4.1mm | Total length: 87cm | The dilators of
AcQGuide and the
predicate are of
similar length |
Table 5.1: Substantial Equivalence Table - Regulatory Information
5
510(k) SUMMARY K162925
SUBSTANTIAL EQUIVALENCE
The proposed AcQGuide Steerable 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. Thus, the AcQGuide is substantially equivalent to the predicate device.
6
PERFORMANCE DATA [807.92(B)]
All necessary testing was conducted on the AcQGuide Steerable 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 AcOGuide Steerable Sheath. This testing was performed in order to ensure that the AcQGuide Steerable Sheath performs as intended. The nonclinical testing included:
- Packaging and Shelf-Life ●
- Sterilization
- Biocompatibility ●
- Design Verification and Validation studies, including: ●
- Dimensional Inspection of Sheath and Dilator o
- Visual Inspection for any defects O
- Leak Testing O
- Functional and Compatibility Testing O
- Mechanical Testing O
- Handle Torque Testing O
- Physician simulated use in an animal model
The collective results of the nonclinical testing demonstrate that the materials chosen, the manufacturing processes, and design of the AcQGuide Steerable Sheath meet the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that the AcQGuide does not raise different questions of safety or effectiveness for percutaneous catheter introduction into the vasculature and into chambers of the heart when compared to the predicate devices.
[807.92(b)(2)] Clinical Testing Summary:
This section is not applicable. 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 AcQGuide Steerable Sheath to evaluate the overall performance of the device. The collective results confirm that the AcOGuide Steerable Sheath is safe and effective, meets its specifications, is biocompatible, and exhibits the required mechanical and functional characteristics for its intended use.
SUMMARY
The AcQGuide Steerable Sheath is substantially equivalent to the predicate device