(59 days)
Not Found
No
The device description and performance studies focus on mechanical compression and bench testing, with no mention of AI or ML.
No.
The device description and intended use indicate that it is a compression device used to assist hemostasis, which is a supportive function rather than directly treating a disease or condition. While it aids in a medical process, it does not fit the typical definition of a therapeutic device designed to cure, mitigate, treat, or prevent disease.
No
The device description and intended use clearly state that the Vasc Band hemostat is a compression device designed to assist hemostasis, meaning it helps stop bleeding. This is a therapeutic function, not a diagnostic one. Diagnostic devices are used to identify or characterize diseases or conditions.
No
The device description clearly outlines physical components like an adjustable retention strap, inflatable compression balloon, inflation tube, inflation valve, and syringe, indicating it is a hardware device.
Based on the provided information, the Vasc Band hemostat is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to assist hemostasis (stop bleeding) at vascular access sites by applying mechanical pressure. This is a direct physical intervention on the patient's body.
- Device Description: The device is a mechanical compression device with a strap, balloon, and inflation mechanism. It does not involve the analysis of biological samples (blood, urine, tissue, etc.) outside of the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Vasc Band hemostat's function is purely mechanical and therapeutic (assisting with hemostasis).
N/A
Intended Use / Indications for Use
The Vasc Band hemostat is a compression device to assist hemostasis of arterial, venous and hemodialysis percutaneous access sites.
Product codes (comma separated list FDA assigned to the subject device)
DXC
Device Description
Vasc Band hemostat (Vasc Band) is a compression device that applies mechanical pressure to achieve hemostasis of vascular access sites. Vasc Band consists of an adjustable retention strap, inflatable compression balloon, inflation tube, and an inflation valve. A 22 ml inflation syringe is also included with the device. Vasc Band is available in five band lengths: 21 cm, 27 cm, 29 cm, and 37 cm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular access sites, arterial, venous and hemodialysis percutaneous access sites.
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)
Technological differences between the subject and predicate devices have been evaluated through bench tests to provide evidence of Vasc Band substantial equivalence. Results of the verification tests met the specified acceptance criteria and did not raise new questions of safety or effectiveness.
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/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing right, stacked on top of each other, with flowing lines extending from the heads.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 23, 2014
Lepu Medical Technology (Beijing) Co., Ltd. c/o Ms. Erin Badali Sr. Regulatory Operations Associate Vascular Solutions, Inc. 6464 Sycamore Court North Minneapolis, Minnesota 55369
Re: K142359
Trade/Device Name: Vasc Band Hemostat Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: DXC Dated: August 26, 2014 Received: August 27, 2014
Dear Ms. Badali.
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 yours,
M.A. Hilleman
for
for
Bram D. Zuckerman, M.D.
Director 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): K142359
Device Name: Vasc Band hemostat
Indications for Use:
The Vasc Band hemostat is a compression device to assist hemostasis of arterial, venous and hemodialysis percutaneous access sites.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
2 510(k) Summary
[As required by 21 CFR 807.92]
Date Prepared: August 22, 2014
510(k) Number: _________
Submitter's Name / Contact Person
Manufacturer Lepu Medical Technology (Beijing) Co., Ltd. No. 37 Chaogian Road Beijing, Changping District, CH 102200 Establishment Registration # 3008002401
Regulatory Correspondent
Erin Badali Sr. Regulatory Operations Associate Vascular Solutions, Inc. 6464 Sycamore Court North Minneapolis, MN 55369 Tel: 763-656-4300 Fax: 763-656-4253
General Information
| Trade Name | Vasc Band |
|---|---|
| Common / Usual Name | hemostat |
| Classification Name | 870.4450, DXC – Clamp, vascular, Class II |
| Predicate Device(s) | K111837 - Radial Artery Compression Tourniquet, Lepu Medical |
| K081740 - HemoBand, Hemoband Corporation |
Device Description
Vasc Band hemostat (Vasc Band) is a compression device that applies mechanical pressure to achieve hemostasis of vascular access sites. Vasc Band consists of an adjustable retention strap, inflatable compression balloon, inflation tube, and an inflation valve. A 22 ml inflation syringe is also included with the device. Vasc Band is available in five band lengths: 21 cm, 27 cm, 29 cm, and 37 cm.
Intended Use / Indications
The Vasc Band hemostat is a compression device to assist hemostasis of arterial, venous and hemodialysis percutaneous access sites.
Technological Characteristics
Vasc Band has the same intended use as the predicate devices and the same indications for use statement as HemoBand. Vasc Band has the same materials of construction as the predicate Radial Artery Compression Tourniquet and is similar in design as both devices are sterile compression bands that use an inflatable balloon to apply pressure at an access site to achieve hemostasis. Vasc Band is available in a wider range of lengths than the predicate devices.
4
Substantial Equivalence and Summary of Studies
Technological differences between the subject and predicate devices have been evaluated through bench tests to provide evidence of Vasc Band substantial equivalence. Vasc Band is substantially equivalent to the specified predicate devices based on comparison of the device functionality, technological characteristics, and indications for use. The device design has been verified through balloon pressure and band size tests.
Results of the verification tests met the specified acceptance criteria and did not raise new questions of safety or effectiveness. Therefore, Vasc Band is substantially equivalent to the predicate devices.