(90 days)
No
The device description and performance studies focus on mechanical compression and pressure maintenance, with no mention of AI or ML technologies.
Yes
The device is described as a "compression device to assist haemostasis," which means it helps to stop bleeding, a therapeutic action.
No
Explanation: The device is described as a "compression device to assist haemostasis" and functions by applying pressure to a puncture site to stop bleeding. It does not collect or interpret any diagnostic information about the patient's condition.
No
The device description clearly outlines physical components such as a plastic belt, adjustable fastener, compression balloons, tubing, and a unilateral valve, indicating it is a hardware device, not software-only.
No, 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 information is used for diagnosis, monitoring, or screening.
- Device Function: The Radial Artery Compression Tourniquet Device is a mechanical device that applies external pressure to a blood vessel to stop bleeding (haemostasis). It does not analyze any biological samples.
- Intended Use: The intended use clearly describes a physical intervention on the patient's arm/wrist to assist with haemostasis after a procedure.
Therefore, based on the provided information, this device falls under the category of a therapeutic or surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Radial Artery Compression Tourniquet Device is a compression device to assist haemostasis following a catheterization or other puncture into a blood vessel in a patient's arm, including radial artery catheterization, arterial or venous line removal, haemodialysis, and in patients on anticoagulation therapy.
Product codes
DXC
Device Description
The Radial Artery Compression Tourniquet devices consist of a plastic belt with an adjustable fastener on each end, two compression balloons, tubing and a unilateral valve. The plastic belt has a support plate over the two compression balloons to assure that the balloons and belt conform to the contour of the wrist and are made of clear plastic which allows the physician to view the access site during the haemostasis process. The inflation device introduces air through the unilateral valve filling two compression balloons (large and small) at the same time. The top small balloon is layered and internally connected to the bottom large balloon. The result of the balloon inflation is the haemostasis of the puncture site within the patient's wrist.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's arm, wrist
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)
Biocompatibility: The Radial Artery Compression Tourniquet was assessed against the standard ISO 10993 Biological Evaluation of Medical Devices - Part 10 for Irritation and Sensitization and Part 5 Tests for Cytotoxicity, has been shown to meet the acceptance criteria, and did not raises additional safety and effectiveness concerns.
Performance: A side-by-side comparison of the predicate TR Band®, Terumo Corporation, K070423 performance of the balloon's maintenance of internal pressure was performed with the Lepu's device. The balloon profile performance characteristics of both devices are very similar when factoring the balloon size and volume inflation difference and do not impose any additional safety or performance issues.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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).
0
Section 5: 510k) Summary
The Summary of Safety and Effectiveness on the Radial Artery Compression Tourniquet reflects data available and represented at the time the submission was prepared, but caution should be exercised in interpreting the data. The results of future studies and or tequire alterations of the conclusions or recommendations set forth.
: 上
| Applicant: | Lepu Medical Technology (Beijing) Co., Ltd. |
|---|---|
| No. 37 Chaoqian Road | |
| Changping District, Beijing 102200 | |
| P.R. China | |
| SEP 27 2011 | |
| Telephone: | +86-10-80120641 |
| Date: | June 27, 2011 |
| Name: | Radial Artery Compression Tourniquet |
| Common Name: | Vascular Compression Device |
| Classification Name: | Vascular Clamp |
| Classification: | 870.4550 |
| Product Code: | DXC |
| Predicate: | TR Band®, Terumo Corporation, K070423 and RadAR™ Vascular |
| Compression Devices, Advanced Vascular Dynamics Division, K092503 | |
| with market clearance dates of March 28, 2007 and November 19, 2009 | |
| respectively. | |
| Description: | The Radial Artery Compression Tourniquet devices consist of a plastic belt |
| with an adjustable fastener on each end, two compression balloons, tubing | |
| and a unilateral valve. The plastic belt has a support plate over the two | |
| compression balloons to assure that the balloons and belt conform to the | |
| contour of the wrist and are made of clear plastic which allows the | |
| physician to view the access site during the haemostasis process. The | |
| inflation device introduces air through the unilateral valve filling two | |
| compression balloons (large and small) at the same time. The top small | |
| balloon is layered and internally connected to the bottom large balloon. | |
| The result of the balloon inflation is the haemostasis of the puncture site | |
| within the patient's wrist. | |
| Intended Use | The Radial Artery Compression Tourniquet Device is a compression device |
| to assist haemostasis following a catheterization or other puncture into a | |
| blood vessel in a patient's arm, including radial artery catheterization, | |
| arterial or venous line removal, haemodialysis, and in patients on | |
| anticoagulation therapy. | |
| Contraindications | • Patients hypersensitive to the materials of compression device. |
| • Patients with infection or other serious skin diseases at the site of | |
| puncture. | |
| • Patients with an abnormal Allen test or radial pulse, or insufficient dual | |
| arterial supply. | |
| • Not intended for femoral artery compression. | |
| Warning | • Patients should not be left unattended while the Radial Artery |
| Compression Tourniquet is in use. | |
| • Ensure correct alignment of the Radial Artery Compression Tourniquet | |
| prior to use. | |
| • Do not inject air into any port other than the air injection port of this | |
| device. | |
| • Do not leave Radial Artery Compression Tourniquet on for | |
| inappropriately long periods of time as tissue damage may occur. | |
| • Arterial pulse distal to the compression site should be monitored to | |
| ensure the artery is not completely occluded as arterial damage and/or | |
| thrombosis could occur. | |
| Caution | • Ensure correct placement of Radial Artery Compression Tourniquet. |
| • Federal (USA) law restricts this device to sale by or on the order of a | |
| physician. | |
| • The product is intended for single use only. | |
| • Do not reuse or re-sterilize. | |
| • Do not use if package opened or damaged. | |
| • Over inflation of balloon > 20 ml as balloon damage could occur | |
| compromising the performance of the Radial Artery Compression | |
| Tourniquet. | |
| • The diameter of the wrist at the site of puncture is too large or too | |
| small, which exceeds the allowable range of compression device. | |
| Substantial | |
| Equivalency | |
| Information | The information provided in this submission, comparing intended use, |
| principle of operation and overall technological characteristics, the Radial | |
| Artery Compression Tourniquet Devices is substantially equivalent to | |
| existing legally marketed devices and the operational differences between | |
| the predicate device RadAR™ Vascular Compression Devices and the | |
| Radial Artery Compression Tourniquet Devices does not present a | |
| significant effect in the therapeutic outcome. | |
| Tests Conducted | Biocompatibility: The Radial Artery Compression Tourniquet was assessed |
| against the standard ISO 10993 Biological Evaluation of Medical Devices |
- Part 10 for Irritation and Sensitization and Part 5 Tests for Cytotoxicity,
has been shown to meet the acceptance criteria, and did not raises
additional safety and effectiveness concerns.
Performance: A side-by-side comparison of the predicate TR Band®,
Terumo Corporation, K070423 performance of the balloon's maintenance
of internal pressure was performed with the Lepu's device. The balloon
profile performance characteristics of both devices are very similar when
factoring the balloon size and volume inflation difference and do not
impose any additional safety or performance issues. |
| Technological
Characteristics | The device features of the Lepu LPY20 models Radial Artery Compression
Tourniquet and the predicate devices are very similar. All three products
have an adjustable strap and apply pressure to the puncture site in the
patient's arm. There are some design variations, but these do not affect the
substantial equivalence of the Lepu LPY20 Radial Artery Compression
Tourniquet Devices. |
1
Section 5: 510k) Summary
The Summary of Safety and Effectiveness on the Radial Artery Compression Tourniquet reflects data available and represented at the time the submission was prepared, but caution should be execised in interpreting the data. The results of future studies and or tests may require alterations of the conclusions or recommendations set forth.
2
Image /page/2/Picture/1 description: The image shows a logo with a circular border containing text, surrounding a stylized graphic. The graphic consists of three curved lines that appear to be flowing or waving. The overall design is simple and monochromatic, with a focus on the abstract representation of movement or flow.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
2011 SEP 27
Lepu Medical Technology (Beijing) Co., Ltd. c/o Mr. Arthur S. Goddard FDA Regulatory and Quality Systems Consultant 1531 Felton Road South Euclid. OH 44121-2722
Re: K111837
Trade/Device Name: Radial Artery Compression Tourniquet Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: DXC Dated: June 27, 2017 Received: June 29, 2011
Dear Mr. Goddard:
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. Ifsting 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
3
Page 2 - Mr. Arthur S. Goddard
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 dotermination 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-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 électronic 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm135809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,
Dr. D. Zukerman, M.D.
Žuckerman, M.D. Bram D! Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
(11/837 510(k) Number (if known): _
Device Name: Radial Artery Compression Tourniquet
Indications for Use:
The Radial Artery Compression Tourniquet is a compression device to assist haemostasis following a catheterization or other puncture into a blood vessel in a patient's arm, including radial artery catheterization, arterial or venous line removal, hemodialysis, and in patients on anticoagulation therapy.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use X (Per 21 CFR 801.109)
510(k) Number
Over-The-Counter Use (Optional Format 1-2-96)
(Division Sign-Off)
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