(189 days)
These devices are for temporary occlusion of blood vessels during vascular surgical procedures.
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.
The provided document describes a 510(k) premarket notification for a surgical vascular clamp. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria and performance studies in the way an AI/ML device would.
Therefore, the document does not contain the requested information regarding acceptance criteria and a study proving the device meets them, because a traditional clinical study with defined performance metrics, sample sizes, expert ground truth, adjudication methods, or MRMC studies for AI/ML devices, was not required for this type of medical device submission.
Instead, the submission for the Walter Lorenz Surgical Vascular Clamps relies on demonstrating substantial equivalence to existing, legally marketed predicate devices. The arguments for substantial equivalence are provided rather than specific performance data against pre-defined acceptance criteria.
Here's how the provided information relates to your requested points, highlighting why much of it is not applicable in this context:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Not applicable - Substantial Equivalence Basis) | Reported Device Performance (Not applicable - Substantial Equivalence Basis) |
|---|---|
| N/A - The device's acceptance is based on demonstrating substantial equivalence to predicate devices, not on meeting specific, quantitative performance criteria from a clinical study. | N/A - The document outlines the device's design features and intended use, but does not provide quantitative performance metrics from a dedicated study against predefined acceptance criteria. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. No test set (in the context of evaluating performance against specific metrics) was used for this 510(k) submission. The submission is a comparison to predicate devices, not a study involving a test dataset of patient cases.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. As there was no test set in the traditional sense, no experts were used to establish ground truth for such a set. The "experts" involved are presumably the clinicians who would use such a device, and the regulatory body (FDA) reviewers who assess the equivalence claim.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No test set or corresponding adjudication was performed within this submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a physical surgical tool (vascular clamp), not an AI/ML diagnostic or assistive device. Therefore, no MRMC study or assessment of AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical surgical tool, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. For a 510(k) for a physical surgical instrument, "ground truth" as conceptualized for AI/ML or diagnostic studies is not directly relevant. The "truth" being established is that the device is as safe and effective as its predicate devices, based on design, materials, and intended use.
8. The sample size for the training set:
- Not applicable. There is no "training set" for a physical device like a vascular clamp in the context of an algorithm or AI.
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set.
Summary of Substantial Equivalence Claim (as provided in the document):
The manufacturer claims substantial equivalence to predicate devices based on:
- Equivalent intended uses: "These devices are for temporary occlusion of blood vessels during vascular surgical procedures."
- Same technological features: The document describes various design features (lengths, shapes, sizes, handle types, jaw styles), implying these are comparable to predicate devices.
- Equivalent safety and effectiveness: This is the core claim of substantial equivalence, asserted without specific new performance data but based on the similarity to legally marketed devices.
Potential Risks (identified in the document):
- Trauma to the vessel
- Puncture, tearing of vessel
- Loss of life or limb
These are generally recognized risks associated with the use of such devices, and the assumption is that the new device presents no new or different risks compared to its predicates.
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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.
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| Sterility Information: | The cardiovascular clamps are reusable devices, sterilization ofinstruments by hospitals is of great concern to Walter Lorenz as amanufacturer and distributor of surgical instrumentation. SinceWalter Lorenz is not familiar with individual hospital handlingprocedures, cleaning methods, or bioburden levels, Walter Lorenzwill not assume the responsibility for the sterilization of product bya hospital. General hospital controls for cleaning and sterilizationmust be up to the user facility. At this time, a package insert hasnot been drafted for the cardiovascular instrumentation. However,a recommendation on the label for hospitals to use theAAMI Method, SSSA 1988 sterilization guidelines. |
|---|---|
| Substantial Equivalence: | The vascular clamps marketed by competitors displayed inAttachment III, IV, and V are believed to be substantiallyequivalent to Walter Lorenz vascular clamps for the followingreasons:• 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 knowledgeand technical staff trained within vascular surgical disciplines.All devices should be inspected by trained staff prior to sterilizationuse of reusable surgical vascular clamps. Any risksdue 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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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.
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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)
§ 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).