(29 days)
Not Found
No
The device description and performance studies focus on the mechanical and functional aspects of the catheter for temporary vessel occlusion and blood pressure monitoring. There is no mention of AI or ML in the text.
Yes
The device is intended for "temporary occlusion of large vessels and blood pressure monitoring including patients requiring emergency control of hemorrhage," which describes a direct therapeutic intervention.
No
The primary purpose of the device is for temporary occlusion of large vessels and blood pressure monitoring, which are therapeutic and monitoring functions, not diagnostic. While it monitors blood pressure, this is for real-time physiological assessment during an intervention rather than for diagnosing a condition.
No
The device description clearly outlines physical components such as a catheter shaft, balloon, lumens, extension lines, stopcocks, and radiopaque marker bands, indicating it is a hardware device.
Based on the provided information, the ER-REBOA™ PLUS 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 intervention on the patient's body (in vivo) for therapeutic and monitoring purposes.
- Device Description: The description details a catheter with a balloon and lumens for inflation and pressure monitoring, designed for placement within blood vessels. This is a medical device used within the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The ER-REBOA™ PLUS Catheter does not perform this function. It is used to directly interact with the patient's circulatory system.
Therefore, the ER-REBOA™ PLUS Catheter is a medical device used for in vivo procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ER-REBOA™ PLUS 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™ PLUS Catheter is a large vessel occlusion catheter. The device consists of an atraumatic distal tip (P-tip®), a compliant occlusion balloon and catheter shaft with a built-in central lumen for blood pressure monitoring. The catheter has a uni-body design and is intended to be placed and advanced without a guidewire. However, the catheter is compatible with straight tipped guidewires up to 0.025″ and may be used with a guidewire if desired to facilitate subsequent vascular procedures. The catheter contains two lumens which traverse the length of the catheter and connect to extension lines with stopcocks. The balloon lumen is used to inflate and deflate the balloon. The arterial line lumen is used to monitor blood pressure. Radiopaque marker bands are located on the catheter at the balloon to assist with positioning under fluoroscopy. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
large vessels
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)
Risk assessment pursuant to ISO 14971 was performed to assess the impact of the change to enable guidewire compatibility and results of the analysis. The following bench testing was performed: tensile strength; blood pressure; and guidewire compatibility. Testing demonstrated that the changes had the desired effect, i.e., to allow passage of a 0.025″ or smaller straight-tip guidewire, but no unintended adverse effects. Accordingly, the results support substantial equivalence of the ER-REBOA™ PLUS Catheter to the 510(k) cleared predicate.
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
§ 870.4450 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/0 description: The image contains 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" in a stacked format.
January 9, 2020
Prytime Medical Devices, Inc Brian Young SVP. Ouality and Regulatory Affairs 229 North Main Street Boerne, Texas 78006
Re: K193440
Trade/Device Name: ER-REBOA PLUS Catheter Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular clamp Regulatory Class: Class II Product Code: MJN, DQY, DQO Dated: December 5, 2019 Received: December 11, 2019
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (QS) 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
2
Indications for Use
510(k) Number (if known)
Device Name ER-REBOA™ PLUS Catheter
Indications for Use (Describe)
The ER-REBOA™ PLUS 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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3
K193440 510(k) Summary
The following information is provided in accordance with 21 CFR 807.92 for the Premarket 510(k) Summary:
| Company: | Prytime Medical Devices, Inc.
229 North Main Street
Boerne, TX 78006 |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Brian Young
SVP, Quality and Regulatory
Prytime Medical Devices, Inc.
Tel: (210) 340-0116
FAX: (210) 558-1860
Email: byoung@prytimemedical.com |
| Date Summary Prepared: | October 10, 2019 |
| Name of the Device: | |
| Trade Name: | ER-REBOA™ PLUS Catheter |
| Common Name: | Occlusion balloon catheter |
| Classification Name: | Vascular clamp |
| Review Panel: | Cardiovascular (CV) |
| Regulation: | 870.4450, 870.1250, 870.1200 |
| Class: | II |
| Product Code: | MJN, DQY, DQO |
| Submission Type: | Special 510(k) |
| Predicate device: | |
The ER-REBOA™ PLUS Catheter claims substantial equivalence to the ER-REBOA™ Catheter (K172790), manufactured by Prytime Medical Devices, Inc.
4
Device Description
The ER-REBOA™ PLUS Catheter is a large vessel occlusion catheter. The device consists of an atraumatic distal tip (P-tip®), a compliant occlusion balloon and catheter shaft with a built-in central lumen for blood pressure monitoring. The catheter has a uni-body design and is intended to be placed and advanced without a guidewire. However, the catheter is compatible with straight tipped guidewires up to 0.025″ and may be used with a guidewire if desired to facilitate subsequent vascular procedures. The catheter contains two lumens which traverse the length of the catheter and connect to extension lines with stopcocks. The balloon lumen is used to inflate and deflate the balloon. The arterial line lumen is used to monitor blood pressure. Radiopaque marker bands are located on the catheter at the balloon to assist with positioning under fluoroscopy. 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.
Principle of Operation
The ER-REBOA™ PLUS Catheter is operated manually to occlude large vessels and monitor blood pressure via an arterial fluid line connection to an external blood pressure monitor.
Indications for Use
The ER-REBOA™ PLUS Catheter is intended for temporary occlusion of large vessels and blood pressure monitoring including patients requiring emergency control of hemorrhage.
Comparison of Technological Characteristics
Compared to the predicate ER-REBOA Catheter (K172790), the subject ER-REBOA PLUS Catheter is a modified device to enable the catheter to be used with a 0.025″ or smaller guidewire, whereas the predicate ER-REBOA Catheter is not guidewire compatible. This modification does not raise different questions of safety and effectiveness and can be evaluated with performance testing.
Performance Data
Risk assessment pursuant to ISO 14971 was performed to assess the impact of the change to enable guidewire compatibility and results of the analysis. The following bench testing was performed: tensile strength; blood pressure; and guidewire compatibility. Testing demonstrated that the changes had the desired effect, i.e., to allow passage of a 0.025″ or smaller straight-tip guidewire, but no unintended adverse effects. Accordingly, the results support substantial equivalence of the ER-REBOA™ PLUS Catheter to the 510(k) cleared predicate.
Conclusions
The ER-REBOA™ PLUS Catheter is substantially equivalent to the predicate device.