(208 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on the mechanical and material properties of a balloon catheter, with no mention of AI/ML or related concepts like image processing, training/test sets, or performance metrics typically associated with AI/ML algorithms.
No.
A therapeutic device is one that treats a disease or condition. This device is indicated for "temporary occlusion of vessels," which is a temporary action rather than a treatment of a disease or condition.
No
The device is described as a balloon catheter for temporary occlusion of vessels, which is a therapeutic rather than a diagnostic function.
No
The device description clearly details a physical catheter with balloons, lumens, and radiopaque markers, indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "temporary occlusion of vessels in the peripheral vasculature." This describes a therapeutic or interventional procedure performed directly on the patient's body.
- Device Description: The description details a physical catheter with balloons designed for inflation within a blood vessel. This is a medical device used for a physical intervention.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, health, disease, or congenital abnormality. This device does not involve the analysis of such specimens.
The Gatekeeper Balloon Catheter is a medical device used for a therapeutic purpose within the body, not an IVD used for diagnostic testing of specimens.
N/A
Intended Use / Indications for Use
The Gatekeeper Balloon Catheter is indicated for temporary occlusion of vessels in the peripheral vasculature.
Product codes
MJN
Device Description
The Gatekeeper Balloon Catheter is an over the wire (OTW) triple-lumen catheter with 2 compliant proximal and distal polyurethane balloons having a maximum diameter of 15 mm and 10 mm respectively. The 2 balloon lumens are connected to extension lines with stopcocks and are used to inflate and deflate the proximal and distal balloons. The third lumen is a guidewire lumen. The distance between the proximal and distal balloons is 2 cm. Two (2) radiopaque marker bands are located within the balloons at each end (30mm apart at the proximal balloon and 15mm apart at the distal balloon) to facilitate balloon placement prior to inflation. The catheter can accommodate a 0.014" diameter (or smaller) guidewire and is compatible with 6Fr (or larger) introducer sheath. The device is a single use, sterile device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral 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
The following benchtop performance tests were conducted to demonstrate that the Gatekeeper Balloon Catheter performance complies with the standards: Visual Inspection, Dimensional Inspection, Freedom from Leakage, Luer Syringe Compatibility, Guidewire Compatibility, Introducer Sheath Compatibility, Balloon Compliance (Volume v. Diameter), Inflation Time, Balloon Inflation Characteristics, Radiopacity, Shipping/ Distribution Testing, Vessel Occlusion, Balloon Fatigue, Burst or Leak Volume, Freedom from Fragmentation, Tensile Strength (Hub to Shaft), Tensile Strength (Tip to Shaft), Tensile Strength (Extension Tube), Shelf Life Testing, Package Integrity, Environmental Conditioning, Kink Testing, Torque Testing, Simulated Use. Biocompatibility testing was conducted in accordance with ISO 10993-1.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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April 25, 2020
Arch Catheter, LLC % Mary Vater 510(k) Consultant Medical Device Academy 345 Lincoln Hill Rd. Shrewsbury, Vermont 05738
Re: K192786
Trade/Device Name: Gatekeeper Balloon Catheter Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: MJN Dated: September 27, 2019 Received: September 30, 2019
Dear Mary Vater:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 mediation-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,
for Carmen Gacchina Johnson Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192786
Device Name Gatekeeper Balloon Catheter
Indications for Use (Describe)
The Gatekeeper Balloon Catheter is indicated for temporary occlusion of vessels in the peripheral vasculature.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Catheter
510(k) SUMMARY K192786
- SUBMITTER Arch Catheter, LLC 621 Grand Harbor Boulevard Ninety Six, SC, 29666 USA Tel: 1.864.680.2568 Fax: 1.864.725.7910
Contact Person: Michael Zhadkevich, MD, PhD Date Prepared: Sept. 27, 2019
| II. DEVICE | |
|---|---|
| Name of Device: | Gatekeeper Balloon Catheter |
| Common Name: | Occlusion balloon catheter |
| Classification Name: | Vascular Clamp |
| Regulation: | 21 CFR § 870.4450 |
| Regulatory Class: | Class II |
| Product Classification Code: | MJN |
| III. | PREDICATE DEVICE |
|---|---|
| ------ | ------------------ |
| Primary Predicate Manufacturer:
Primary Predicate Trade Name:
Primary Predicate 510(k): | CoAxia, Inc.
FloControl Catheter
K090970 |
|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| Secondary Predicate Manufacturer:
Secondary Predicate Trade Name:
Secondary Predicate 510(k): | Via Biomedical, Inc.
Stent Graft Balloon Catheter
K091624 |
| Secondary Predicate Manufacturer:
Secondary Predicate Trade Name:
Secondary Predicate 510(k): | QXMedical, LLC
Q50 PLUS Stent Graft Balloon
K120381 |
No reference devices were used in this submission.
IV. DEVICE DESCRIPTION
The Gatekeeper Balloon Catheter is an over the wire (OTW) triple-lumen catheter with 2 compliant proximal and distal polyurethane balloons having a maximum diameter of 15 mm and 10 mm respectively. The 2 balloon lumens are connected to extension lines with stopcocks and are used to inflate and deflate the proximal and distal balloons. The third lumen is a guidewire lumen. The distance between the proximal and distal balloons is 2 cm. Two (2) radiopaque marker bands are located within the balloons at each end (30mm apart at the proximal balloon and 15mm apart at the distal balloon) to facilitate balloon placement prior to inflation. The catheter can accommodate a 0.014" diameter (or smaller) guidewire and is compatible with 6Fr (or larger) introducer sheath. The device is a single use, sterile device.
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V. INDICATIONS FOR USE
The Gatekeeper Balloon Catheter is indicated for temporary occlusion of vessels in the peripheral vasculature.
VI. SUMMARY OF SUBSTANTIAL EQUIVALENCE
Compared to the predicate devices of the CoAxia FloControl Catheter (K090970), Via Biomedical Stent Graft Balloon Catheter (K091624), and QXMEDICAL Q50 PLUS Stent Graft Balloon Catheter (K120381). the subject Gatekeeper Balloon Catheter has the same intended use and mechanism of action for temporary occlusion of vessels. The indication statements for the predicate devices describe additional functions for expanding vascular prostheses, controlling blood flow, or occlusion of large vessels; but all devices are intended for temporary occlusion of vessels. The subject device has different technological characteristics of catheter design and materials that do not raise different questions of safety and effectiveness and were evaluated with non-clinical testing.
The subject device is designed to fulfill the requirements of the following recognized standards:
- 6-301 ISO 10555-1 Second edition 2013-06-15 Intravascular catheters Sterile and single-use intravascular catheters - Part 1: General requirements
- 6-322 ISO 10555-4 Second edition 2013-06-15 Intravascular catheters -- Sterile and single-use catheters -- | Part 4: Balloon dilatation catheters
- 6-408 ISO 10555-1 Second edition 2013-06-15 Intravascular catheters - Sterile and single-use intravascular catheters - Part 1: General requirements [Including AMENDMENT 1 (2017)]
The following benchtop performance tests were conducted to demonstrate that the Gatekeeper Balloon Catheter performance complies with the standards.
- Visual Inspection
- -Dimensional Inspection
- Freedom from Leakage ー
- Luer Syringe Compatibility —
- Guidewire Compatibility
- Introducer Sheath Compatibility ー
- Balloon Compliance (Volume v. Diameter)
- -Inflation Time
- Balloon Inflation Characteristics —
- -Radiopacity
- -Shipping/ Distribution Testing
- -Vessel Occlusion
- Balloon Fatigue
- -Burst or Leak Volume
- Freedom from Fragmentation
- -Tensile Strength (Hub to Shaft)
- -Tensile Strength (Tip to Shaft)
- -Tensile Strength (Extension Tube)
- Shelf Life Testing ー
- Package Integrity
- -Environmental Conditioning
- Kink Testing —
- -Torque Testing
- -Simulated Use
Biocompatibility testing was conducted in accordance with ISO 10993-1.
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VII. CONCLUSIONS
The Gatekeeper Balloon Catheter has the same intended use as the predicate devices. The technological differences do not raise different questions of safety and effectiveness. Based on the results of non-clinical testing, the data supports the Gatekeeper Balloon Catheter is substantially equivalent to the predicate devices.