(266 days)
Not Found
No
The 510(k) summary describes a purely mechanical balloon catheter for temporary vessel occlusion. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies are bench and in-vivo tests of the physical device's mechanical properties and function.
No
The device is used for temporary occlusion of blood vessels to control hemorrhage in emergency situations, which is a method of immediate intervention rather than a long-term treatment or rehabilitation.
No
The device is intended for temporary occlusion of large vessels to control hemorrhage, which is a therapeutic intervention, not a diagnostic one. While it uses radiological location for placement, this is for operational guidance, not to diagnose a condition.
No
The device description clearly outlines multiple hardware components including a catheter, balloon, handle, shaft, and guide wire. The performance studies also focus on bench and in-vivo testing of these physical components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- LANDMARK REBOA Catheter Function: The LANDMARK REBOA Catheter is a device that is inserted directly into a blood vessel within the body to temporarily stop bleeding. It does not perform any tests on samples taken from the body.
- Intended Use: The intended use clearly states "temporary occlusion of large vessels including patients requiring emergency control of hemorrhage." This is a therapeutic intervention, not a diagnostic test.
- Device Description: The description details a physical catheter with a balloon for occlusion, designed for insertion into the vascular system. This aligns with an in-vivo (within the living body) device, not an in-vitro device.
Therefore, based on the provided information, the LANDMARK REBOA Catheter is a medical device used for a therapeutic purpose within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The LANDMARK REBOA Catheter is intended for temporary occlusion of large vessels including patients requiring emergency control of hemorrhage.
Product codes
MJN, DQY
Device Description
The LANDMARK REBOA Catheter is a 67cm, 59cm working length, 6.5 Fr (2.2mm), single lumen balloon catheter for temporary intravascular vessel occlusion in patients requiring emergency control of hemorrhage. Radio-opaque markers are provided on the catheter shaft at the proximal and distal ends of the balloon for radiological location of the device is additionally provided with depth markings referenced from the balloon to provide positioning information similar to the predicate device prior to confirmation of placement through radiological means. The device is intended to be deployed through a 7F introducer sheath placed into the femoral artery through normal vascular access procedures.
The LANDMARK REBOA Catheter consists of five elements:
- . Occluder Balloon Inflation Lumen with female luer (DEHP free PVC)
- Catheter Handle (PA 12)
- Catheter Shaft (polyimide and stainless steel) with Marker Bands (stainless steel)
- Occluder Balloon (polyurethane)
- Guide J-tip (stainless steel, nitinol, acrylic) ●
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic location using radio-opaque markers and/or radio-opaque inflation media.
Anatomical Site
Large vessels. Insertion site: Femoral Artery.
Indicated Patient Age Range
Adult patients. Contraindication: minors (younger than 18 years old).
Intended User / Care Setting
Emergency settings, Pre-hospital, In hospital, Acute Care, Military
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)
Performance (Bench) and Comparative Testing was conducted to ensure that the LANDMARK REBOA Catheter met the applicable design and performance requirements throughout its shelf life, verify conformity to applicable standards, and demonstrate substantial equivalence to the predicate system. Types of testing included: Balloon Burst Testing, Balloon Inflation/Deflation Testing, Balloon Diameter to Inflation Volume Testing, Occlusion Time Testing, Torque Testing, Kink Diameter Testing, Fatigue Testing, Freedom From Leakage Testing, Tensile Strength Testing, Dimensional Testing, Maximum Inflation Volume Testing, Shelf-Life Testing.
Simulated use results provided by ZIEN Medical Technologies, Inc. support the conclusion that the proposed device is clinically safe for prescription use.
In Vivo Testing: Performance evaluation of the LANDMARK REBOA Catheter was performed in the aorta of an acute Porcine model to demonstrate the catheter meets applicable design and performance requirements and is substantially equivalent to the predicate device.
Conclusion of comparison: Based on the performance testing conducted and provided in this submission, it was concluded that the LANDMARK REBOA Catheter is substantially equivalent to the ER-REBOA (K172790).
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.
ER-REBOA™ Catheter (K172790)
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
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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
September 19, 2022
Zien Medical Technologies, Inc. Tim Nieman CEO 2757 South 300 West Suite F Salt Lake City, Utah 84115
Re: K214060
Trade/Device Name: LANDMARK REBOA Catheter Regulation Number: 21 CFR 870.4450, 21 CFR 870.1250 Regulation Name: Vascular clamp, percutaneous catheter Regulatory Class: Class II Product Code: MJN, DQY Dated: August 8, 2022 Received: August 10, 2022
Dear Tim Nieman:
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,
- Carmen Gacchina Johnson, PhD for 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) K214060
Device Name LANDMARK REBOA Catheter
Indications for Use (Describe)
The LANDMARK REBOA Catheter is intended for temporary occlusion of large vessels including patients requiring emergency control of hemorrhage.
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the logo for ZIEN Medical Technologies. The logo consists of an orange circle with a white "Z" inside, and the text "ZIEN Medical Technologies" to the right of the circle. The text is in a sans-serif font and is gray in color. The logo is simple and modern.
510(k) SUMMARY (21 CFR 807.92)
GENERAL INFORMATION
Submitted by:
| Owner's Name: | ZIEN Medical Technologies, Inc. |
|---|---|
| Address: | 2757 South 300 West Suite F |
| Salt Lake City, UT 84115 | |
| Contact Person: | |
| Name: | Tim Nieman |
| Title: | Chief Executive Officer |
| Tel: | +1 (801) 891-8610 |
| Email: | tim.nieman@zienmedical.com |
| FDA Registration Number: | 3009756153 |
| Date Prepared: | September 15, 2022 |
| Trade Name: | LANDMARK REBOA Catheter |
| Regulation Name: | Vascular Clamp and Percutaneous Catheter |
| Classification Name: | • 21 CFR §870.4450, Product Code: MJN |
| Catheter, Intravascular Occluding, Temporary | |
| • 21 CFR §870.1250, Product Code: DQY | |
| Percutaneous Catheter | |
| Classification Panel: | Cardiovascular |
| Regulatory Class | Class II |
| Predicate Device: | ER-REBOA™ Catheter (K172790), Manufactured by |
| Prytime Medical Devices, Inc. (Boerne TX) |
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DEVICE DESCRIPTION:
The LANDMARK REBOA Catheter is a 67cm, 59cm working length, 6.5 Fr (2.2mm), single lumen balloon catheter for temporary intravascular vessel occlusion in patients requiring emergency control of hemorrhage. Radio-opaque markers are provided on the catheter shaft at the proximal and distal ends of the balloon for radiological location of the device is additionally provided with depth markings referenced from the balloon to provide positioning information similar to the predicate device prior to confirmation of placement through radiological means. The device is intended to be deployed through a 7F introducer sheath placed into the femoral artery through normal vascular access procedures.
The LANDMARK REBOA Catheter consists of five elements:
- . Occluder Balloon Inflation Lumen with female luer (DEHP free PVC)
- Catheter Handle (PA 12)
- Catheter Shaft (polyimide and stainless steel) with Marker Bands (stainless steel)
- Occluder Balloon (polyurethane)
- Guide J-tip (stainless steel, nitinol, acrylic) ●
INDICATIONS FOR USE:
The LANDMARK REBOA Catheter is intended for temporary occlusion of large vessels including patients requiring emergency control of hemorrhage.
LABELING AND TECHNOLOGICAL CHARACTERISTICS COMPARISON:
As shown in Table 1, the proposed LANDMARK REBOA Catheter has equivalent intended use and similar technology characteristics to the currently marketed ER-REBOA (K172790). Technological and Intended use differences include the lack of a secondary lumen in the subject device to monitor the patient's blood pressure, which can be monitored through more common means.
| Table 1: Comparison Table | ||
|---|---|---|
| SUBJECT DEVICE | PREDICATE DEVICE | |
| 1. LABELING | ||
| Intended use | The LANDMARK REBOA | |
| Catheter is intended for | ||
| temporary occlusion of large | ||
| vessels including patients | ||
| requiring emergency control of | ||
| hemorrhage | The ER-REBOA Catheter is | |
| intended for temporary occlusion of | ||
| large vessels and blood pressure | ||
| monitoring including patients | ||
| requiring emergency control of | ||
| hemorrhage | ||
| Rx or OTC | Rx | Same |
| Target population | Adult patients in need of large | |
| vessel occlusion | Same | |
| Contraindications | Known allergic reactions to | |
| contrast media | Same | |
| Table 1: Comparison Table | ||
| SUBJECT DEVICE | PREDICATE DEVICE | |
| Do not have a femoral access | ||
| site that can accommodate a 7Fr | ||
| (minimum) introducer sheath | ||
| Have an aortic diameter larger | ||
| than 30mm | Similar | |
| Are minors (younger than 18 | ||
| years old) | Same | |
| 2. TECHNOLOGY | ||
| Use Environment | ||
| (Where used) | Emergency settings, Pre- | |
| hospital, In hospital, Acute Care, | ||
| Military | Same | |
| Insertion site | Femoral Artery | Same |
| Insertion depth | ||
| assessment | Radiographic location using | |
| radio-opaque markers and/or | ||
| radio-opaque inflation media | Similar; predicate permits | |
| fluoroscopy as optional | ||
| Mode of action | The user inserts the catheter | |
| through femoral access using | ||
| depth marks and/or radiological | ||
| confirmation of location wherein | ||
| the balloon can be inflated using | ||
| volume as indicator to provide | ||
| occlusion of the vessel. | Same | |
| 3. CHARACTERISTICS | ||
| Sterile single use | ||
| components and | ||
| accessories | A pre-loaded peel-away sheath | |
| is provided to aid introduction of | ||
| the catheter tip into the | ||
| introducer sheath. | A peel-away sheath is preloaded on | |
| the catheter shaft to ease insertion | ||
| of the catheters P-tip into an | ||
| introducer sheath hemostasis valve | ||
| Lengths offered | 59 cm working length | 64 cm working length (Similar) |
| Depth indicator | ||
| markings on | ||
| cannula | White indicator lines are located | |
| at 1 cm increments from the | ||
| center of the balloon for | ||
| assessing insertion depth. | Same | |
| Maximum Balloon | ||
| Diameter | 30mm | 32mm (Similar) |
| Introducer Sheath | ||
| Compatibility | 7Fr | Same |
| Shelf life | 12 months (1 year) | 3 years |
| Sterility | Ethylene Oxide (EO), SAL 10-6 | Same |
| Biocompatibility | ||
| Per ISO 10993 | • External Communicating | |
| device | ||
| • Contacting Circulating Blood | ||
| • Limited Duration (≤ 24h) | Same |
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NON-CLINICAL TESTING
Performance (Bench) and Comparative Testing: Performance bench testing was conducted to ensure that the LANDMARK REBOA Catheter met the applicable design and performance requirements throughout its shelf life, verify conformity to applicable standards, and demonstrate substantial equivalence to the predicate system. The following performance testing listed below was performed or fulfilled with the LANDMARK REBOA Catheter:
- . Balloon Burst Testing
- Balloon Inflation/Deflation Testing ●
- . Balloon Diameter to Inflation Volume Testing
- Occlusion Time Testing
- Torque Testina ●
- Kink Diameter Testing
- Fatigue Testing ●
- Freedom From Leakage Testing
- Tensile Strength Testing
- Dimensional Testing
- Maximum Inflation Volume Testing
- Shelf-Life Testing
Simulated use: Simulated use results provided by ZIEN Medical Technologies, Inc. support the conclusion that the proposed device is clinically safe for prescription use. Furthermore, ZIEN Medical Technologies, Inc. conducted a risk analysis on the proposed system in accordance with ISO 14971:2019. All identified risks have been addressed through device design, verification/validation or through documentation (labeling and Instructions for Use) provided to the user.
Biocompatibility: The patient-contacting (directlindirect fluid path) components of the LANDMARK REBOA Catheter, fulfil the requirements as set forth in:
- . ISO 10993: Biological evaluation of medical devices – Part 1: Guidance on selection of tests for and External Communicating Device, Circulating Blood, A-Limited (