(98 days)
The Vascular Clamp is indicated for use for temporary or partial occlusion of blood vessels during open surgical procedures.
SIBEL's vascular clamps are composed different styles and a wide variety of lengths, shapes and sizes. The length 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. The vascular clamps are reusable and have ring handles made of stainless steel or titanium with a ratchet closure to adjust the amount of tension applied to the vessel for occlusion or partial occlusion.
The provided text is a 510(k) Summary for a Vascular Clamp device. It highlights the device's technical characteristics and its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria or a study that proves the device meets specific performance metrics.
The document is a premarket notification for a medical device (a vascular clamp) asserting its substantial equivalence to an existing predicate device. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed device, rather than providing extensive independent performance studies with detailed acceptance criteria.
Therefore, for your request:
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A table of acceptance criteria and the reported device performance: This information is not present in the provided document. The 510(k) summary focuses on comparing technical characteristics to a predicate device, not on presenting performance data against predefined acceptance criteria from a specific study.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): This information is not present in the provided document, as no specific performance study data is included.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): This information is not present as there is no mention of a test set or ground truth establishment.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: This information is not present as there is no mention of a test set or adjudication.
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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: This information is not present. This device is a mechanical surgical clamp, not an AI-assisted diagnostic tool, so an MRMC study is not applicable.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This information is not present. This device is a mechanical surgical clamp, not an algorithm, so standalone performance is not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): This information is not present as there is no mention of a ground truth.
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The sample size for the training set: This information is not present as there is no mention of a training set.
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How the ground truth for the training set was established: This information is not present as there is no mention of a training set or ground truth.
In summary, the provided 510(k) document is a declaration of substantial equivalence based on a comparison of device features and intended use to a predicate device, not a report of a performance study with acceptance criteria.
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Page 1 of 3
Submitter:
Sibel SA
510(k) Summary
| Submitter Name:Submitter Address: | Surgical Instruments Belgium SAChaussée de Tirlemont, 755030 GemblouxBelgium |
|---|---|
| Phone Number: | 011 3281450459 |
| Fax Number: | 011 3281450488 |
| Contact Person: | Olivier Rouvez |
| Date Prepared: | 30 September 2007 |
| Device Trade Name: | Aortic Clamp |
| Common Name | Vascular Clamp |
| Classification Name, | Clamp, Vascular |
| Number & | 870.4450 |
| Product Code: | DXC |
| Predicate Devices: | Surgical Vascular Clamp, Walter Lorenz Surgical, Inc. |
| Device Descriptionand Statement ofIntended Use | Description: SIBEL's vascular clamps are composed different styles anda wide variety of lengths, shapes and sizes. The length and angles aredesign features that can be important to the surgeon to keep the handlesand shanks out of the field of vision of the operative site. The vascularclamps are reusable and have ring handles made of stainless steel ortitanium with a ratchet closure to adjust the amount of tension applied tothe vessel for occlusion or partial occlusion.Intended Use: The Vascular Clamp is indicated for use for temporary orpartial occlusion of blood vessels during open surgical procedures. |
| Summary ofTechnologicalCharacteristics | The Vascular Clamp consists of a variety of jaw styles to allow surgeonsto choose from based on the anatomy of the site and type of occlusion.The clamps are either fully or partially occluding. Full occlusion clampsstops blood entirely by covering the full vessel. Partial occlusion clampsare placed on part of the vessel to isolate the area to be worked on while |
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| Submitter:Sibel SA | Vascular ClampPremarket Notification: Traditional 510(k) |
|---|---|
| allowing blood flow to continue in the rest of the vessel. The lengths andangles are design features that can be important to the surgeon to keepthe handles and shanks out of the field of vision of the operative site. | |
| A table comparing the Vascular Clamp to the predicate devices isattached. | |
| Conclusion | The information discussed above demonstrates that the Vascular Clampis substantially equivalent to the predicate device. |
| Declarations | ο This summary includes only information that is also covered in thebody of the 510(k).ο This summary does not contain any puffery or unsubstantiatedlabeling claims.ο This summary does not contain any raw date, i.e., contains onlysummary data.ο This summary does not contain any trade secret or confidentialcommercial information.ο This summary does not contain any patient identification information. |
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K072834 Page 3
Submitter:
Sibel SA
Summary of Technical Characteristics
| Feature | Vascular Clamp | Surgical Vascular Clamp |
|---|---|---|
| 510(k) Number | K072834 | K973080 |
| Manufacturer | Surgical Instruments Belgium SA | Walter Lorenz Surgical, Inc. |
| Classification # & | 870.4450 | 870.4450 |
| Product Code | DXC | DXC |
| Intended Use | Temporary or partial occlusion of bloodvessels during open surgical procedures. | Temporary occlusion of blood vesselsduring vascular surgical procedures. |
| Mode of Action | Jaws applied around the vessel to isolatethe operative area. The lengths andangles are design features to keep thehandles and shanks out of the field ofvision of the operative site. | Jaws applied around the vessel toisolate the operative area. The lengthsand angles are design features to keepthe handles and shanks out of the fieldof vision of the operative site. |
| Reusable | Yes | Yes |
| Material ofConstruction | Stainless Steel orTitanium | Stainless Steel |
| Method ofocclusion | Clamp jaws around vessel | Clamp jaws around vessel |
| Method of ClosureAdjustment | Ratcheting handle for user control | Ratcheting handle for user control |
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Public Health Service
Image /page/3/Picture/2 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized depiction of an eagle or bird in flight. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the top half of the circle, following its curvature.
JAN - 9 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Surgical Instruments Belgium SA c/o Mr. William F. Greenrose Official Correspondent & Regulatory Consultant 220 River Road Claremont, NH 03743
Re: K072834
Vascular Clamp Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II (two) Product Code: DXC Dated: December 24, 2007 Received: January 3, 2008
Dear Mr. Greenrose:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. William F. Greenrose
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); 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. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
uma R. lohner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K072834
Device Name: Vascular Clamp
Indications For Use:
The Vascular Clamp is indicated for use for temporary or partial occlusion of blood vessels during open surgical procedures.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Duna R. Vechner
Division Sign-Off) Tivision of Cardiovascular Devices
110(K) Number_K072834
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§ 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).