(91 days)
Not Found
No
The summary describes a mechanical vascular clamp and explicitly states "Not Found" for mentions of AI, DNN, or ML, and lacks any description of AI/ML-related components or performance studies.
No
This device is a surgical tool used for temporary occlusion of blood vessels during procedures, not a therapeutic device designed to treat a condition itself.
No
The device is used for temporary or partial occlusion of blood vessels during surgical procedures, which is a therapeutic intervention, not a diagnostic one. It does not measure, analyze, or provide information about a patient's condition for diagnosis.
No
The device description explicitly states it is a family of vascular clamps made of stainless steel and titanium alloy, which are physical hardware components.
Based on the provided information, the Wexler Vascular Clamp Series is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "temporary or partial occlusion of blood vessels during surgical procedures." This is a direct intervention on the patient's body during surgery.
- Device Description: The device is a "family of vascular clamps" used "during surgical procedures." This describes a surgical instrument.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening. The Wexler Vascular Clamp does not perform this function. It is a surgical tool used on the patient.
Therefore, the Wexler Vascular Clamp Series falls under the category of a surgical instrument, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Wexler Vascular Clamp Series is indicated for use for temporary or partial occlusion of blood vessels during surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
DXC
Device Description
The Wexler Vascular Clamp Series is a family of vascular clamps, both stainless steel and titanium alloy, used during surgical procedures. The clips are supplied nonsterile and are chosen based on the dimensions, features and technological characteristics desired.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
blood 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)
Not Found
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
APR 1 9 2011
510(k) SUMMARY
K110148
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR, Part 807.92.
Submitter's Name: Microsurgical Laboratories, dba Wexler Surgical Supplies 11333 Chimney Rock Road, Suite 110 Houston, TX 77035 Telephone: (713) 723-6900 Fax: (713) 723-6906 Contact person: Mr. Danny Fishman, COO
Date of Summary: January 13, 2011
Device Names:
Trade Name, Common Name: Vascular Clamps, various Classification Name: Vascular Clamp (21 CFR 870.4450, Product Code DXC)
Legally Marketed Device to which Equivalence is Claimed: The legally marketed predicate device is the Vascular Clamp (K072834) manufactured by Surgical Instruments Belgium (SIBEL) SA, determined to be substantially equivalent to a legally marketed (preAmendment) device on January 9, 2008.
Device Description: The Wexler Vascular Clamp Series is a family of vascular clamps, both stainless steel and titanium alloy, used during surgical procedures. The clips are supplied nonsterile and are chosen based on the dimensions, features and technological characteristics desired.
Intended Use: The Wexler Vascular Clamp Series is indicated for use for temporary or partial occlusion of blood vessels during surgical procedures.
Descriptive Summary of Technological Characteristics and Those of Predicate Device: The indications for use, principles of operation, and device design of the Wexler Vascular Clamp Series are virtually identical to those of the predicate device, the Vascular Clamp (K072834) manufactured by Surgical Instruments Belgium (SIBEL) SA. Both series of devices are made of stainless steel or titanium, and share technological characteristics common to all vascular clamps of their types. These devices function by clamping around the blood vessel, and the degree of closure is adjusted by a ratcheting handle. There are no significant differences in either technology or performance specifications. The Wexler Vascular Clamp Series devices are supplied non-sterile, and the devices are subjected by the sterilization cycle specified by the institution.
Conclusion: The information and data provided in this 510(k) Notification establish that the Wexler Vascular Clamp Series is substantially equivalent to the legally marketed predicate device.
16
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Wexler Surgical Supplies, Inc. c/o Devices for the Future 540 College St. Bellaire, TX 77401 Attn: Lisa S. Jones
APR 1 9 2011
Re: K110148
Trade/Device Name: Wexler Surgical Vascular Clamp Series Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II (two) Product Code: DXC Dated: April 5, 2011 Received: April 6, 2011
Dear Ms. Jones:
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.
2
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-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
fo Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K110148
Device Name: Wexler Vascular Clamp Series
Indications For Use: The Wexler Vascular Clamp Series is indicated for use for temporary or partial occlusion of blood vessels during surgical procedures.
Prescription Use
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
fo-(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K110448