(189 days)
Not Found
Not Found
No
The device description details a purely mechanical surgical instrument (vascular clamps) with no mention of software, data processing, or any computational elements that would suggest the use of AI or ML.
No
The device is described as a surgical tool for temporary occlusion of blood vessels, not as providing therapy itself.
No
The devices are described as instruments for temporary occlusion of blood vessels during surgical procedures, not for diagnosing medical conditions.
No
The device description clearly describes physical vascular clamps made of materials with specific design features like handles, ratchets, and jaws, indicating a hardware device.
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 occlusion of blood vessels during vascular surgical procedures." This describes a surgical tool used in vivo (within the body) to manipulate blood vessels.
- Device Description: The description details the physical characteristics and function of surgical clamps used to physically interact with blood vessels during surgery.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any interaction with specimens or diagnostic purposes.
Therefore, this device is a surgical instrument, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
These devices are for temporary occlusion of blood vessels during vascular surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
74DXC
Device Description
Vascular clamps are made in a wide variety of lengths, shapes, and sizes. The lengths and angles are design features that can be important to the surgeon to keep the handles and shanks out of the field of vision of the operative site.
Walter Lorenz Surgical's vascular clamps often have ring handles with a ratchet closure to adjust the amount of tension applied to the vessel for occlusion. Bulldog clamps are another type of vascular cross clamp that use a spring or crossaction mechanism to apply tension to the vessel for occlusion.
The choice of jaw style depends on the surgeon's preference, based on the type and delicacv of the vessel to be occluded. Walter Lorenz vascular clamps employ one of the following jaw styles;
- · single row of teeth
- · double row of teeth (both jaws) , groove in the center
- · single row of teeth on one jaw and double row of teeth on opposite (variation of this style may have additional rows of teeth)
- · serrated: horizontal, logitudinal, or crossed
- · smooth (variation of this style may have slightly roughed finish)
The surgeon chooses the vascular clamp based on the anatomy of the site and the type of occlusion desired.
Clamps are either fully or partially occluding. Full occlusion clamps stops blood flow entirely by covering the full vessel. Partial occlusional clamps are placed on part of the vessel to isolate the area to be worked on while allowing blood flow to continue in the rest of the vessel.
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
professionals with the knowledge and technical staff trained within vascular surgical disciplines.
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.
Not Found
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
MM ISCCC
L O O O O O
FEB 2 3 1998
SUMMARY OF SAFETY AND EFFECTIVENESS
Classification Name: Vascular Clamp
Device Classification: Class II
Device Product Code: 74DXC - (CFR 870.4450)
Intended Use: These devices are for temporary occlusion of blood vessels during vascular surgical procedures.
- Device Description: Vascular clamps are made in a wide variety of lengths, shapes, and sizes. The lengths and angles are design features that can be important to the surgeon to keep the handles and shanks out of the field of vision of the operative site.
Walter Lorenz Surgical's vascular clamps often have ring handles with a ratchet closure to adjust the amount of tension applied to the vessel for occlusion. Bulldog clamps are another type of vascular cross clamp that use a spring or crossaction mechanism to apply tension to the vessel for occlusion.
The choice of jaw style depends on the surgeon's preference, based on the type and delicacv of the vessel to be occluded. Walter Lorenz vascular clamps employ one of the following jaw styles;
- · single row of teeth
- · double row of teeth (both jaws) , groove in the center
- · single row of teeth on one jaw and double row of teeth on opposite (variation of this style may have additional rows of teeth)
- · serrated: horizontal, logitudinal, or crossed
- · smooth (variation of this style may have slightly roughed finish)
The surgeon chooses the vascular clamp based on the anatomy of the site and the type of occlusion desired.
Clamps are either fully or partially occluding. Full occlusion clamps stops blood flow entirely by covering the full vessel. Partial occlusional clamps are placed on part of the vessel to isolate the area to be worked on while allowing blood flow to continue in the rest of the vessel.
1
| Sterility Information: | The cardiovascular clamps are reusable devices, sterilization of
instruments by hospitals is of great concern to Walter Lorenz as a
manufacturer and distributor of surgical instrumentation. Since
Walter Lorenz is not familiar with individual hospital handling
procedures, cleaning methods, or bioburden levels, Walter Lorenz
will not assume the responsibility for the sterilization of product by
a hospital. General hospital controls for cleaning and sterilization
must be up to the user facility. At this time, a package insert has
not been drafted for the cardiovascular instrumentation. However,
a recommendation on the label for hospitals to use the
AAMI Method, SSSA 1988 sterilization guidelines. |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial Equivalence: | The vascular clamps marketed by competitors displayed in
Attachment III, IV, and V are believed to be substantially
equivalent to Walter Lorenz vascular clamps for the following
reasons:
• The intended uses for devices are equivalent
• The devices have the same technological features
• The safety and effectiveness of the devices are equivalent |
| Potential Risks: | The devices will be sold only to professionals with the knowledge
and technical staff trained within vascular surgical disciplines.
All devices should be inspected by trained staff prior to sterilization
use of reusable surgical vascular clamps. Any risks
due to substandard hospital practices will not be listed.
• Trauma to the vessel
• Puncture, tearing of vessel
• Loss of life or limb |
. . . . . .
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2
Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name arranged in a circular fashion around a central emblem. The emblem consists of a stylized caduceus-like symbol, with a staff and a serpent intertwined, representing health and medicine. The text is in a sans-serif font and is arranged to follow the curve of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 3 1998
Ms. Diana Preston Regulatory Specialist Walter Lorenz Surgical, Inc. P.O. Box 18009 32229-8009 Jacksonville, FL
Re: K973080 Surgical Vascular Clamp Regulatory Class: II (two) Product Code: 74 DXC Dated: February 3, 1998 Received: February 4, 1998
Dear Ms. Preston:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such ` assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): unknown
Device Name: Vascular Clamps
. .
Indications For Use: These devices are for temporary occlusion of blood vessels during vascular surgical procedures.
Tuth
(on Sign-Off)
ion of Cardiovascular, Res, 1 3. . . . . . inrological Devices
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801..109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)