(129 days)
Not Found
No
The device description and performance studies focus on mechanical function and do not mention any AI/ML components or capabilities.
No.
The device is used to temporarily occlude blood vessels during surgical procedures, which is an interventional/surgical tool rather than a therapeutic device that treats a disease or condition.
No
The device is a surgical clamp used for temporary occlusion of blood vessels during procedures, which is a therapeutic function, not diagnostic.
No
The device description clearly states it is a stainless steel clamp with a ratcheting handle, indicating it is a physical hardware device, not software.
Based on the provided information, this device 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 describes a surgical instrument used directly on the patient's body during a procedure.
- Device Description: The description details a physical clamp used to manipulate blood vessels. It does not mention any components or processes related to testing samples of human origin in vitro (outside the body).
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical tool used for physical manipulation during a procedure.
N/A
Intended Use / Indications for Use
MicroFrance® Wormald Vascular Clamps are indicated for use for temporary or partial occlusion of blood vessels during surgical procedures.
Product codes
DXC
Device Description
MicroFrance® Wormald Vascular Clamps enable a surgeon to suture the vessel defect, allowing the clamps to be released and therefore flow to be maintained. The stainless steel clamps are rotatable, allowing for proper orientation of the jaw tip as well as the handle. The device functions by clamping the jaw around the vessel to isolate the operative area. The degree of closure is adjusted by a ratcheting handle.
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
surgeon, surgical procedures
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
Bench testing provided evidence that the proposed MicroFrance® Wormald Vascular Clamps performs according to specifications. The ratchet mechanism on each device allows the surgeon to apply varying degrees of pressure on the vessel. The nature of the tests comprised of three sections for each instrument type. It tested rotation, opening and closure of the jaws as well as testing of the clamps and jaw plating to ensure consistency.
Key Metrics
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
K112662 page 1 of 2
JAN 2 0 2012
510(k) SUMMARY SUMMARY OF SAFETY AND EFFECTIVENESS FOR MicroFrance® Wormald Vascular Clamps
| 510(k) Owner: | Medtronic Xomed, Inc
6743 Southpoint Drive North
Jacksonville, Florida 32216-0980 USA
904-296-9600
904-296-2386 (FAX) |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Marsha Seetaram
Regulatory Affairs Specialist
Medtronic Xomed, Inc |
| Date Prepared: | September 9, 2011 |
| Trade Name: | MicroFrance® Wormald Vascular Clamp |
| Common Name: | Vascular clamp |
| Classification Name: | Vascular clamp
21CFR 870.4450, Pro Code DXC, Class II |
| Predicate Device: | Wexler Vascular Clamp Series
K110148 (Cleared 04/19/2011) |
| Device Description: | MicroFrance® Wormald Vascular Clamps enable a surgeon to
suture the vessel defect, allowing the clamps to be released
and therefore flow to be maintained. The stainless steel
clamps are rotatable, allowing for proper orientation of the
jaw tip as well as the handle. The device functions by
clamping the jaw around the vessel to isolate the operative
area. The degree of closure is adjusted by a ratcheting handle. |
| Statement of Intended Use: | MicroFrance® Wormald Vascular Clamps are indicated for
use for temporary or partial occlusion of blood vessels during
surgical procedures. |
| Conclusion from Data: | The data provided in this 510(k) Notification demonstrates
that the proposed MicroFrance® Wormald Vascular Clamps
are substantially equivalent to the predicate device since it has
similar indications for use, principles of operation, materials
and device design. The MicroFrance® Wormald Vascular
Clamps are as safe, as effective, and performs as well as the |
predicate device.
Page 5-1
1
K112662 page 2 of 2
Substantial Equivalence
The MicroFrance® Wormald Vascular Clamps have similar indications for use, principles of operation, materials and device design as the predicate device; Wexler Vascular Clamp Series [Table 1]. FDA originally cleared the predicate device under K110148 on April 19, 2011. K110148 510(k) summary is included in Appendix I.
| Feature | MicroFrance® Wormald
Vascular Clamps | Wexler Vascular Clamp
Series |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Medtronic Xomed
Instrumentation | Wexler Surgical Supplies,
Inc. |
| 510k Clearance | Subject of submission | K110148 |
| Procode & Class | DXC and Class II | DXC and Class II |
| Intended Use | MicroFrance® Wormald
Vascular Clamps are indicated
for use for temporary or partial
occlusion of blood vessels
during surgical procedures. | The Wexler Vascular Clamp
Series is indicated for use for
temporary or partial occlusion
of blood vessels during
surgical procedures. |
| Various sizes,
configurations | Yes | Yes |
| Principle of
Operation | Clamp jaw applied around the
vessel to isolate the operative
area. The degree of closure is
adjusted by a ratcheting
handle. | Clamp jaw applied around the
vessel to isolate the operative
area. The degree of closure is
adjusted by a ratcheting
handle. |
| Design | Variety of jaw tips and
orientations, ratchet lock on
handle, ring handle, integrated
flush port, rotatable shaft | Variety of jaw tips and
orientations, ratchet lock on
handle, ring handle |
| Material | Stainless Steel | Stainless Steel or
Titanium |
| Sterility | Non-sterile | Non-sterile |
| Reusable | Yes | Yes |
Table 1: Comparison to Legally Marketed Device
Summary of Non-Clinical Testing
Bench testing provided evidence that the proposed MicroFrance® Wormald Vascular Clamps performs according to specifications. The ratchet mechanism on each device allows the surgeon to apply varying degrees of pressure on the vessel. The nature of the tests comprised of three sections for each instrument type. It tested rotation, opening and closure of the jaws as well as testing of the clamps and jaw plating to ensure consistency.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird symbol, with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JAN 2 0 2012
Medtronic USA, Inc. c/o Marsha Seetaram 6743 Southpoint Dr. N. Jacksonville, FL 32216-0980
Re: K112662
Trade Name: MicroFrance Wormald Vascular Clamp Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular clamp Regulatory Class: Class II (two) Product Code: DXC Dated: December 15, 2011 Received: December 16, 2011
Dear Ms. Seetaram:
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.
3
Page 2 - Ms. Marsha Seetaram
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 (OS) 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/CDRH0ffices/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,
M.A. Willoham.
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: MicroFrance® Wormald Vascular Clamps
Indications for Use: MicroFrance® Wormald Vascular Clamps are indicated for use for temporary or partial occlusion of blood vessels during surgical procedures.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Val. A. Kllolien
(Division Sign-Off) Division of Čardiovascular Devices
510(k) Number_ K /12662
Medtronic Xomed, Inc. MicroFrance® Wormald Vascular Clamps Traditional 510(k), September 9, 2011
Page 4-1
K12662