(53 days)
No
The device description and performance studies focus on the mechanical function and clinical outcomes of a physical catheter, with no mention of AI or ML components.
Yes
The device is intended for "temporary occlusion of large vessels and blood pressure monitoring including patients requiring emergency control of hemorrhage," which are therapeutic interventions.
Yes
The device is described as having a "dedicated lumen for pressure monitoring" and the "arterial line lumen is used to monitor blood pressure," which are diagnostic functions.
No
The device description clearly outlines a physical catheter with a balloon, lumens, hub, and other hardware components. It is not solely software.
Based on the provided information, the ER-REBOA™ Catheter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "temporary occlusion of large vessels and blood pressure monitoring including patients requiring emergency control of hemorrhage." This describes a direct medical intervention within the body (in vivo), not a test performed on samples taken from the body (in vitro).
- Device Description: The description details a catheter with a balloon for occlusion and a lumen for pressure monitoring, designed to be inserted into blood vessels. This is consistent with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is mechanical (occlusion) and physiological monitoring (pressure).
Therefore, the ER-REBOA™ Catheter is a medical device used for therapeutic and monitoring purposes within the body, not an IVD.
N/A
Intended Use / Indications for Use
The ER-REBOA™ Catheter is intended for temporary occlusion of large vessels and blood pressure monitoring including patients requiring emergency control of hemorrhage.
Product codes (comma separated list FDA assigned to the subject device)
MJN, DQY, DQO
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 quidewire. 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 coaxial 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 catheter's two lumens. The peelaway 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
plain x-ray
Anatomical Site
large vessels, aortic occlusion
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)
Real world clinical data was available for the ER-REBOA™ Catheter and it was derived from: 1) the American Association for the Surgery of Trauma Aortic Occlusion for Resuscitation in Trauma and Acute Care Surgery (AORTA) registry that prospectively identified trauma patients requiring aortic occlusion (AO) from eight ACS Level 1 centers; and 2) a case series report of ER-REBOA™ Catheter use in an austere military environment. All patients were critically injured and required emergency management of hemorrhaqe. 27.7% of the placements in the registry were without medical imaging and 68.1% of placements in the registry were with plain x-ray. All of the device placements in the case series were performed without medical imaging. Successful aortic occlusion with use of the device was achieved in 95.7% of cases in the registry and with all of the patients in the case series. There were no instances of extremity ischemia, distal embolism or retroperitoneal hemorrhage as complications of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Successful aortic occlusion with use of the device was achieved in 95.7% of cases in the registry and with all of the patients in the case series.
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
§ 870.4450 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
Public Health Service
Image /page/0/Picture/2 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 emblem featuring three stylized human profiles facing to the right, arranged in a way that they appear to be interconnected.
April 4, 2017
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Prytime Medical Devices, Inc. Brian Young SVP. Ouality and Regulatory 229 North Main Street Boerne, Texas 78006
Re: K170411
Trade/Device Name: ER-REBOA 110 Catheter Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: MJN, DQY, DQO Dated: February 8, 2017 Received: February 10, 2017
Dear Brian Young:
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 device
1
related 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,
Fernando
Aguel-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) K170411
Device Name ER-REBOA™ Catheter
Indications for Use (Describe)
The ER-REBOA™ Catheter is intended for temporary occlusion of large vessels and blood pressure monitoring including patients requiring emergency control of hemorrhage
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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5. 510(k) Summary
The following information is provided in accordance with 21 CFR 807.92 for the Premarket 510(k) Summary:
5.1 Submitter Information
| Company: | |
|---|---|
| Prytime Medical Devices, Inc. | |
| 229 North Main Street | |
| Boerne, Texas 78006 USA | |
| Telephone: 210-340-0116 | |
| Fax: 210-558-1860 | |
| Contact: | Brian Young |
| SVP, Quality and Regulatory | |
| 229 North Main Street | |
| Boerne, Texas | |
| Telephone: 210-216-3020 | |
| Fax: 210-558-1860 | |
| byoung@prytimemedical.com | |
| Date Summary Prepared: | March 28, 2017 |
| 5.2 Name of the Device | |
| Trade Name: | ER-REBOA™ Catheter |
| Common Name: | Percutaneous balloon catheter |
| Classification Name: | Catheter, Percutaneous |
| Review Panel: | Cardiovascular (CV) |
| Regulation: | 870.4450, 870.1250, 870.1200 |
| Class: | Class II |
| Product Code: | MJN, DQY, DQO |
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5.3 Equivalence Claimed to Predicate Device
The ER-REBOA™ Catheter is equivalent to the ER-REBOA™ Catheter (K151821), manufactured by Pryor Medical Devices, Inc. and the Equalizer Occlusion Balloon Catheter (K140273), manufactured by Boston Scientific Corp.
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 quidewire. 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 coaxial 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 catheter's two lumens. The peelaway sheath can be separated from the catheter shaft after insertion if needed.
Principle of Operation
The ER-REBOA™ Catheter is operated manually to occlude large vessels and monitor blood pressure.
Intended Use / Indications for Use
Indications for Use: The ER-REBOA™ Catheter is intended for temporary
5
occlusion of large vessels and blood pressure monitoring including patients requiring emergency control of hemorrhage.
Comparison of Technological Characteristics
The ER-REBOA™ Catheter is identical to the predicate device in terms of technological characteristics. The expiration date is being changed from 1 to 3 years. The labeling changes include minor administrative changes, updated sheath compatibility information, additional options for medical imaging, a clinical data summary, and an update to the indication for use.
The addition of "including patients requiring emergency control of hemorrhaqe" to the indication for use adds an additional specific indication to the existing general indications for use. The device was designed and intended for situations where emergency hemorrhage is ongoing or expected and this is the most common use of the predicate. Accordingly, the indication change does not alter the intended therapeutic, diagnostic, or surqical use of the device and clinical performance data has demonstrated substantially equivalent safety and effectiveness compared to the predicate device when used as labeled.
Performance Data
Nonclinical Testing
The shelf life extension is supported by test data demonstrating that the device and packaging adhere to the same acceptance criteria used in the original 510(k) after aqing equivalent to 3 years.
Clinical Data
Real world clinical data was available for the ER-REBOA™ Catheter and it was derived from: 1) the American Association for the Surgery of Trauma Aortic Occlusion for Resuscitation in Trauma and Acute Care Surgery (AORTA) registry that prospectively identified trauma patients requiring aortic occlusion (AO) from eight ACS Level 1 centers; and 2) a case series report of ER-REBOA™ Catheter use in an austere military environment. All patients were critically injured and required emergency management of hemorrhaqe. 27.7% of the placements in the registry were without medical imaging and 68.1% of placements in the registry were with plain x-ray. All of the device placements in the case series were performed without medical imaging. Successful aortic occlusion with use of the device was achieved in 95.7% of cases in the registry and with all of the patients in the case series. There were
6
no instances of extremity ischemia, distal embolism or retroperitoneal hemorrhage as complications of the device.
Conclusions
The ER-REBOA™ Catheter is substantially equivalent to the identified predicate devices.