(109 days)
Not Found
No
The device description focuses on mechanical components and functions (balloon inflation/deflation, pressure monitoring, catheter design) and does not mention any software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are also marked as "Not Found".
Yes
The device is described as a "large vessel occlusion catheter" intended for "temporary occlusion of large vessels and monitoring of blood pressure," which directly implies interaction with the body for a medical purpose.
No
The device is intended for temporary occlusion of large vessels and monitoring of blood pressure, which are interventional and monitoring functions, not diagnostic.
No
The device description clearly details a physical catheter with multiple hardware components (balloon, shaft, hub, extension lines, marker bands, peel-away sheath). It is a tangible medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Function: The ER-REBOA Catheter is designed for temporary occlusion of large vessels and monitoring of blood pressure within the body. It is an invasive device used directly on the patient's circulatory system.
- Intended Use: The intended use clearly states "temporary occlusion of large vessels and monitoring of blood pressure," which are procedures performed in vivo (within a living organism).
- Device Description: The description details a catheter with a balloon and lumens for inflation and pressure monitoring, all designed for insertion into blood vessels.
The device's function and intended use are entirely focused on procedures performed directly on the patient's body, not on analyzing samples taken from the body.
N/A
Intended Use / Indications for Use
The ER-REBOA Catheter is intended for temporary occlusion of large vessels and monitoring of blood pressure.
Product codes (comma separated list FDA assigned to the subject device)
DOY, DOO
Device Description
The ER-REBOA™ Catheter is a large vessel occlusion catheter with a dedicated lumen for pressure monitoring. The device consists of a compliant occlusion balloon with an atraumatic distal tip (P-tip™), a dual lumen catheter shaft and a hub with extension lines to provide access to each lumen. The balloon lumen is used to inflate and deflate the balloon. The arterial line lumen is used to monitor blood pressure. The catheter has a uni-body design and is designed to be used without a guidewire. A peel-away sheath is pre-loaded on the catheter shaft to ease insertion of the catheter's P-tip™ into an introducer sheath hemostasis valve. The device has an effective length of 72 cm and is compatible with 7 Fr or larger introducer sheaths. The device is a single use sterile device. The distal tip (P-tip™) eases advancement of the catheter in a blood vessel. The compliant occlusion balloon is capable of occluding vessels up to 32 mm in diameter. Radiopaque platinum iridium marker bands are located at the functional ends of the balloon to facilitate accurate balloon placement. A co-axial catheter shaft provides appropriate stiffness and a dedicated lumen for pressure monitoring distal to the balloon. Pad printed marks on the outer catheter shaft indicate distance to the center of the balloon to facilitate proper placement. The proximal end of the catheter has a hub and extension lines. The stopcocks provide control to each of the catheters two lumens. The peel-away sheath can be separated from the catheter shaft after insertion if needed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
large vessels, 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)
The following in vitro bench tests were performed to demonstrate that the ER-REBOA™ Catheter meets applicable design and performance requirements and is therefore equivalent to its predicate devices:
- Balloon Burst Testing
- Balloon Inflation/Deflation Testing
- Simulated Use Testing
- Torque Testing
- Fatique Testing
- Occlusion Time Testing
- Tensile Strength Testing
- Pressure Response Testing
- Dimensional Testing
- Maximum Inflation Volume Testing
- Balloon Diameter to Inflation Volume Testing
- Kink Diameter Testing
- Freedom From Leakage Testing
- Sterilization Validation
- Packaging Validation
- Shelf-Life Validation
- Biocompatibility Testing
The following in vivo tests were performed to demonstrate that the ER-REBOA™ Catheter meets applicable design and performance requirements and is therefore substantially equivalent to the predicate devices:
- Performance Evaluation of the ER-REBOA™ Catheter in the Aorta of an Acute Naïve Porcine
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.
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
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles three human profiles facing right, with flowing lines beneath them.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 23, 2015
Pryor Medical Devices, Inc % Semih Oktay, PhD President CardioMed Device Consultants, LLC 5523 Research Park Dr #205 Catonsville, MD 21228
Re: K151821
Trade/Device Name: ER-REBOA Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY, DOO Dated: September 22, 2015 Received: September 23, 2015
Dear Dr. Oktay:
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
1
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.
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.
Kenneth J. Cavanaugh -S
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) K151821
Device Name ER-REBOA Catheter
Indications for Use (Describe)
The ER-REBOA Catheter is intended for temporary occlusion of large vessels and monitoring of blood pressure.
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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Image /page/3/Picture/0 description: The image contains the logo for Pryor Medical. The logo consists of a red cross-like figure with curved gray and blue lines around it, followed by a vertical line. To the right of the vertical line, the words "PRYOR" and "MEDICAL" are stacked on top of each other, with "PRYOR" in a darker blue and "MEDICAL" in a lighter blue.
SECTION 07: 510(K) SUMMARY
Introduction ー
- The following contains the 510(k) summary for the ER-REBOA™ 1.1 Catheter. The content of this summary is based on the requirements of 21 CFR 807.92.
2 Applicant Name and Address
| Name: | Pryor Medical Devices, Inc. |
|---|---|
| Address: | 229 North Main Street |
| Boerne, TX 78006 | |
| Official Contact: | Chris Banas, Chairman |
| Contact Telephone: | (210) 340-0116 |
- 3 Summary Preparation Date: 07/02/2015
4 Device Name and Classification
| Trade Name: | ER-REBOA™ Catheter |
|---|---|
| Common Name: | Percutaneous balloon catheter |
| Classification Name: | Percutaneous catheter |
| Device Classification: | Class II, 21 CFR 870.1250 |
| Product Code: | DQY, DQO |
5 Predicate Devices
- 5.1 The ER-REBOA™ Catheter is claimed to be substantially equivalent to the following devices:
6 Device Description
- The ER-REBOA™ Catheter is a large vessel occlusion catheter with a 6.1 dedicated lumen for pressure monitoring.
- 6.2 The device consists of a compliant occlusion balloon with an atraumatic distal tip (P-tip™), a dual lumen catheter shaft and a hub with extension lines to provide access to each lumen. The balloon lumen is used to inflate and deflate the balloon. The arterial line lumen is used to monitor blood pressure. The catheter has a uni-body design and is designed to be used without a guidewire. A peel-away sheath is pre-loaded on the
4
Image /page/4/Picture/1 description: The image is a logo for Pryor Medical. The logo consists of a red cross on top of a red figure that looks like a person with arms raised. There is a gray arc behind the figure. To the right of the figure is the text "PRYOR MEDICAL" in blue. The word "PRYOR" is in a darker blue than the word "MEDICAL".
Section 07: 510(k) Summary
catheter shaft to ease insertion of the catheter's P-tip™ into an introducer sheath hemostasis valve. The device has an effective length of 72 cm and is compatible with 7 Fr or larger introducer sheaths. The device is a single use sterile device.
- 6.3 The distal tip (P-tip™) eases advancement of the catheter in a blood vessel. The compliant occlusion balloon is capable of occluding vessels up to 32 mm in diameter. Radiopaque platinum iridium marker bands are located at the functional ends of the balloon to facilitate accurate balloon placement. A co-axial catheter shaft provides appropriate stiffness and a dedicated lumen for pressure monitoring distal to the balloon. Pad printed marks on the outer catheter shaft indicate distance to the center of the balloon to facilitate proper placement. The proximal end of the catheter has a hub and extension lines. The stopcocks provide control to each of the catheters two lumens. The peel-away sheath can be separated from the catheter shaft after insertion if needed.
Principle of Operation 7
- The ER-REBOA™ Catheter is operated manually to occlude large 7.1 vessels and monitor blood pressure.
ထ Intended Use
- 8 1 The ER-REBOA™ Catheter is intended for temporary occlusion of large vessels and monitoring of blood pressure.
9 Comparison of Technological Characteristics
- 9.1 The ER-REBOA™ Catheter is identical in terms of intended use and basic technologic characteristics to the predicate devices. The ER-REBOA™ Catheter employs the same technologies as the identified predicates including:
- Large vessel occlusion with inflatable/deflatable compliant 9.1.1 occlusion balloon
- Fluid column pressure monitoring 9.1.2
- 9.2 The ER-REBOA™ Catheter has the following differences from the predicate devices:
- Use without a guidewire 9.2.1
- 6 Fr profile (compatibility with a 7 Fr introducer sheath) 9.2.2
- 9.2.3 72 cm effective length
- 9.3 Performance bench and in vivo (animal) testing were performed to support the safety and effectiveness of these modifications. The results of these tests demonstrate that the ER-REBOA™ Catheter has been designed and tested to conform to its intended use and comparably to the predicate devices. Technological differences of the ER-REBOA™ Catheter do not present any new safety or effectiveness concerns. As
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Image /page/5/Picture/1 description: The image is a logo for Pryor Medical. The logo consists of a red cross on top of a red figure that looks like a person with arms raised. There are two curved lines around the figure, one gray and one blue. To the right of the figure is the text "PRYOR MEDICAL" in blue.
Section 07: 510(k) Summary
such, it can be considered substantially equivalent to the predicate devices.
10 Performance Testing (non-clinical)
- 10.1 The following in vitro bench tests were performed to demonstrate that the ER-REBOA™ Catheter meets applicable design and performance requirements and is therefore equivalent to its predicate devices:
- 10.1.1 Balloon Burst Testing
- 10.1.2 Balloon Inflation/Deflation Testing
- 10.1.3 Simulated Use Testing
- 10.1.4 Torque Testing
- 10.1.5 Fatique Testing
- 10.1.6 Occlusion Time Testing
- 10.1.7 Tensile Strength Testing
- 10.1.8 Pressure Response Testing
- 10.1.9 Dimensional Testing
- 10.1.10 Maximum Inflation Volume Testing
- 10.1.11 Balloon Diameter to Inflation Volume Testing
- 10.1.12 Kink Diameter Testing
- 10.1.13 Freedom From Leakage Testing
- 10.1.14 Sterilization Validation
- 10.1.15 Packaging Validation
- 10.1.16 Shelf-Life Validation
- 10.1.17 Biocompatibility Testing
- 10.2 The following in vivo tests were performed to demonstrate that the ER-REBOA™ Catheter meets applicable design and performance requirements and is therefore substantially equivalent to the predicate devices:
10.2.1 Performance Evaluation of the ER-REBOA™ Catheter in the Aorta of an Acute Naïve Porcine
11 Conclusions
- 11.1 Based on a comparison of intended use, the ER-REBOA™ Catheter is substantially equivalent to the identified predicate devices.