(98 days)
Not Found
No
The summary describes a purely mechanical surgical instrument with no mention of software, data processing, or any terms related to AI/ML.
No.
Explanation: A therapeutic device is used to treat a disease or condition. This device is indicated for temporary or partial occlusion of blood vessels during open surgical procedures, serving as a surgical tool rather than a therapeutic treatment itself.
No
Explanation: The device is described as a vascular clamp used for temporary or partial occlusion of blood vessels during surgical procedures, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is composed of physical components like stainless steel or titanium, ring handles, and a ratchet closure, indicating it is a hardware device.
No, 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 open surgical procedures." This is a direct surgical intervention on the patient's body.
- Device Description: The description details a physical surgical instrument used to manipulate blood vessels.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health. This device does not interact with specimens in this way.
The device described is a surgical instrument used in vivo (within the living body) during a surgical procedure.
N/A
Intended Use / Indications for Use
The Vascular Clamp is indicated for use for temporary or partial occlusion of blood vessels during open surgical procedures.
Product codes
DXC
Device Description
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.
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
surgeons / open 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
Page 1 of 3
Submitter:
Sibel SA
510(k) Summary
| Submitter Name:
Submitter Address: | Surgical Instruments Belgium SA
Chaussée de Tirlemont, 75
5030 Gembloux
Belgium |
|--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 Description
and Statement of
Intended Use | Description: 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.
Intended Use: The Vascular Clamp is indicated for use for temporary or
partial occlusion of blood vessels during open surgical procedures. |
| Summary of
Technological
Characteristics | The Vascular Clamp consists of a variety of jaw styles to allow surgeons
to choose from based on the anatomy of the site and type of occlusion.
The clamps are either fully or partially occluding. Full occlusion clamps
stops blood entirely by covering the full vessel. Partial occlusion clamps
are placed on part of the vessel to isolate the area to be worked on while |
1
3
Fare 2 ot
| Submitter:
Sibel SA | Vascular Clamp
Premarket Notification: Traditional 510(k) |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | allowing blood flow to continue in the rest of the vessel. 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. |
| | A table comparing the Vascular Clamp to the predicate devices is
attached. |
| Conclusion | The information discussed above demonstrates that the Vascular Clamp
is substantially equivalent to the predicate device. |
| Declarations | ο This summary includes only information that is also covered in the
body of the 510(k).
ο This summary does not contain any puffery or unsubstantiated
labeling claims.
ο This summary does not contain any raw date, i.e., contains only
summary data.
ο This summary does not contain any trade secret or confidential
commercial information.
ο This summary does not contain any patient identification information. |
2
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 blood | |
| vessels during open surgical procedures. | Temporary occlusion of blood vessels | |
| during vascular surgical procedures. | ||
| Mode of Action | Jaws applied around the vessel to isolate | |
| the operative area. The lengths and | ||
| angles are design features to keep the | ||
| handles and shanks out of the field of | ||
| vision of the operative site. | Jaws applied around the vessel to | |
| isolate the operative area. The lengths | ||
| and angles are design features to keep | ||
| the handles and shanks out of the field | ||
| of vision of the operative site. | ||
| Reusable | Yes | Yes |
| Material of | ||
| Construction | Stainless Steel or | |
| Titanium | Stainless Steel | |
| Method of | ||
| occlusion | Clamp jaws around vessel | Clamp jaws around vessel |
| Method of Closure | ||
| Adjustment | Ratcheting handle for user control | Ratcheting handle for user control |
3
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.
4
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
5
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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