(110 days)
Not Found
No
The device description and supporting information do not mention any AI or ML components or functionalities. The device is a mechanical catheter for temporary aortic occlusion.
Yes
The device is described as a "REBOA Balloon Occlusion Catheter" intended for "temporary occlusion of the aorta," which is a direct therapeutic action to control bleeding or facilitate other medical procedures.
No
The device is designed for temporary occlusion of the aorta, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly details a physical catheter with various material components (polymeric tubing, polyamide, stainless steel, platinum marker bands) and a balloon, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Recommended for temporary occlusion of the aorta." This describes a therapeutic or interventional procedure performed on the patient's body, not a test performed on a sample taken from the patient's body.
- Device Description: The description details a catheter designed for insertion into the aorta to inflate a balloon for occlusion. This is a medical device used for treatment or intervention, not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
- Input Imaging Modality: The use of fluoroscopy is for guiding the placement of the device within the body, which is typical for interventional procedures, not for analyzing samples.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to physically occlude the aorta, which is a therapeutic action.
N/A
Intended Use / Indications for Use
Recommended for temporary occlusion of the aorta.
Product codes (comma separated list FDA assigned to the subject device)
MJN
Device Description
The REBOA Balloon Occlusion Catheter is a coaxial catheter recommended for temporary occlusion of the aorta. The outer body is made of polymeric tubing, and the inner tubing is comprised of a multi-layer extrusion of polyamide (Vestamid PA12) that surrounds a braid of 304 LV Stainless Steel. The catheter features a proximal end bifurcate with two distinct luminal passages. The inflation lumen terminates into a distally mounted balloon. This balloon is of the non-compliant variety and is designed to insert through the smallest possible introduction sleeve. The through lumen terminates at the tip of the catheter, and will accept the passage of the appropriate guidewire. All catheter sizes will have radiopaque platinum marker band(s), centered or under the balloon shoulders, for placement using fluoroscopy. There are also markings on the catheter shaft to aid in placement. The catheter is packaged in a polyethylene loop and is double packed in two heat sealed Tyvek pouches.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopy
Anatomical Site
aorta
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 Testing
- Visual Inspection: All catheters were visually inspected without any anomalies for both REBOA and Predicate Device (PTS-X).
- Balloon Preparation Test: All catheters tested were without functional difficulties or anomalies for both REBOA and Predicate Device (PTS-X).
- Diameter and Profile Test: All catheters met the acceptance criteria for both REBOA and Predicate Device (PTS-X).
- Balloon Distensibility: All data obtained demonstrates that the balloon diameter is within +/- 10% of the labeled diameter at the rated volume and will not be significantly increased at increasingly higher pressures for both REBOA and Predicate Device (PTS-X).
- Balloon Minimum Burst Strength / Volume: All catheters met the established acceptance criteria for both REBOA and Predicate Device (PTS-X).
- Repeated Balloon Inflation (Balloon Fatigue) Test: No Breaks for both REBOA and Predicate Device (PTS-X).
- Balloon Inflation/Deflation Test: All catheters met the established acceptance criteria for both REBOA and Predicate Device (PTS-X).
- Balloon Deflatability Test: All catheters met the established acceptance criteria for both REBOA and Predicate Device (PTS-X).
- Tip Pull and Torque Test: No breaks for both REBOA and Predicate Device (PTS-X).
- Bond Strength Test: All bonds met the established acceptance criteria for both REBOA and Predicate Device (PTS-X).
- Catheter Body Maximum Pressure Test: All samples met the established acceptance criteria for both REBOA and Predicate Device (PTS-X).
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.
K041306, K110903, K131869, K152762, K093911
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.
Not Found
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
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(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" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles forming the staff and a wing-like shape above them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 20, 2016
NuMED, Inc. Nichelle LaFlesh Regulatory Affairs Manager/ Compliance Officer 2880 Main Street Hopkinton, New York 12965
Re: K160598
Trade/Device Name: REBOA Catheter Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: MJN Dated: May 17, 2016 Received: May 19, 2016
Dear Nichelle LaFlesh:
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 the quality systems (QS) 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
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 yours,
Bram D. Zuckerman -S
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) K160598
Device Name REBOA Catheter
| Indications for Use (Describe) |
|---|
| Recommended for temporary occlusion of the aorta. |
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
K160598
510(k) Summary
| Contact
Information | NuMED, Inc.
2880 Main Street
Hopkinton, NY 12965
Telephone - (315) 328-4491
Contact Person: Nichelle LaFlesh, RAC
Date summary was prepared – 29 April 2016 | |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| General
Provisions | Trade Name: REBOA Catheter | |
| | Common Name: Catheter, Intravascular Occluding, Temporary | |
| | Classification Name: Catheter, Intravascular Occluding, Temporary | |
| Name of
Predicate
Devices | PTS-X PTV Catheter – K041306, K110903, and K131869
Class II, 21 CFR 870.4450 - Product Code MJN | |
| | Fogarty Occlusion Catheter – K152762 and K093911
Class II, 21 CFR 870.4450 – Product Code MJN | |
| Classification | Class II, 21 CFR 870.4450 - Product Code MJN | |
| Performance
Standards | Performance Standards have not been established by FDA under Section 514
of the Food, Drug and Cosmetic Act. | |
| Intended Use | Recommended for temporary occlusion of the aorta. | |
| | Continued on next page | |
4
510(k) Summary, Continued
| Device Description | The REBOA Balloon Occlusion Catheter is a coaxial catheter recommended for temporary occlusion of the aorta. The outer body is made of polymeric tubing, and the inner tubing is comprised of a multi-layer extrusion of polyamide (Vestamid PA12) that surrounds a braid of 304 LV Stainless Steel. The catheter features a proximal end bifurcate with two distinct luminal passages. The inflation lumen terminates into a distally mounted balloon. This balloon is of the non-compliant variety and is designed to insert through the smallest possible introduction sleeve. The through lumen terminates at the tip of the catheter, and will accept the passage of the appropriate guidewire. All catheter sizes will have radiopaque platinum marker band(s), centered or under the balloon shoulders, for placement using fluoroscopy. There are also markings on the catheter shaft to aid in placement. The catheter is packaged in a polyethylene loop and is double packed in two heat sealed Tyvek pouches. |
|---|---|
| Biocompatibility | All materials used to manufacture the REBOA Catheter are available on other commercially available NuMED, Inc. devices (K041360, K022722, K081680, and K014124) and have passed all relevant biocompatibility tests. No additional biocompatibility testing was conducted for the REBOA Catheter. |
| In-Vitro Testing | A complete list of tests performed and the results are provided in the table below. |
Continued on next page
5
| Test
Performed | Acceptance
Criteria | REBOA
Results | Predicate
Device -
PTS-X Results |
|---------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Visual
Inspection | The catheters
shall be free from
contamination,
discoloration, and
any form of
damage that could
impact the proper
functioning of the
device. | All catheters
were visually
inspected without
any anomalies. | All catheters were
visually inspected
without any
anomalies. |
| Balloon
Preparation Test | Each catheter
shall be prepped
per the procedure
without functional
difficulties or
anomalies. | All catheters
tested were
without
functional
difficulties or
anomalies. | All catheters
tested were
without functional
difficulties or
anomalies. |
| Diameter and
Profile Test | The balloon
diameter at rated
burst pressure /
volume shall be
within +/- 10% of
the labeled
balloon diameter
and the samples
should fit through
the selected
introducer with
no problems. | All catheters met
the acceptance
criteria. | All catheters met
the acceptance
criteria. |
| Balloon
Distensibility | The results must
demonstrate that
the balloon
diameter are
within +/- 10% of
the labeled
diameter at the
RBP / rated
volume and will
not be
significantly
increased at
increasingly
higher pressures | All data obtained
demonstrates that the
balloon diameter is
within +/- 10% of the
labeled diameter at
the rated volume. All
data obtained
demonstrates that the
diameter of the
balloons will not be
significantly
increased at
increasingly higher
pressures. | All data obtained
demonstrates that the
balloon diameter is
within +/- 10% of the
labeled diameter at the
RBP. All data
obtained demonstrates
that the diameter of
the balloons will not
be significantly
increased at
increasingly higher
pressures. |
| Test
Performed | Acceptance
Criteria | REBOA
Results | Predicate
Device -
PTS-X Results |
| Balloon Minimum
Burst Strength /
Volume | The results must
show statistically
that with at least
95% confidence,
99.9% of the
balloons will not
burst at or below
the maximum
recommended
rated burst
pressure / volume. | All catheters met
the established
acceptance
criteria. | All catheters met
the established
acceptance
criteria. |
| Repeated Balloon
Inflation (Balloon
Fatigue) Test | No breaks
allowed | No Breaks. | No breaks. |
| Balloon
Inflation/Deflation
Test | Inflation achieved
in less than 12
seconds and
deflation achieved
in less than 59
seconds | All catheters met
the established
acceptance
criteria. | All catheters met
the established
acceptance
criteria. |
| Balloon
Deflatability Test | There should be
no interference
with balloon
deflation | All catheters met
the established
acceptance
criteria. | All catheters met
the established
acceptance
criteria. |
| Tip Pull and
Torque Test | Must withstand at
least 8 turns
without breaking | No breaks | No breaks |
| Bond Strength
Test | All bonds must
withstand at least
8.9 Newtons / 2
lbs. of pull
strength. | All bonds met the
established
acceptance
criteria. | All bonds met the
established
acceptance
criteria. |
| Catheter Body
Maximum
Pressure Test | All samples must
withstand 700 psi. | All samples met
the established
acceptance
criteria. | All samples met
the established
acceptance
criteria. |
6
7
Comparison of The technological characteristics of the REBOA balloon are identical to those Technological in the predicate (PTS-X) in terms of the following: Characteristics with the Mode of Operation; ● predicate Materials: ● Device
- Design;
- Performance testing;
- Method of delivery; ●
- . Sterilization Method;
- Packaging Method. ●
The technological characteristics of the REBOA balloon is substantially equivalent in intended use, indications for use, sterilization, and size range to those in the predicate device (Fogarty).
Both devices are for temporary vessel occlusion. The REBOA is specific to the aorta, whereas, the larger Fogarty balloon catheters are for the aorta. The Fogarty balloon catheter has a broader indications for use than the REBOA.
Both devices are provided sterilized via EtO sterilization and are for single use only.
Both devices are catheters with distal end balloons that are inserted percutaneously.
Both devices are similar in the size ranges being offered. The REBOA catheter is available in balloon diameters of 15mm - 40mm, and the Fogarty larger balloon catheters are available in sizes of 11mm - 45mm.
- Conclusions The REBOA Catheter has been tested and/or compared to the predicate devices listed herein. All data gathered demonstrate the REBOA Catheter is substantially equivalent. No new issues of safety or efficacy have been raised.