Who is the manufacturer of SIBEL SA VASCULAR CLAMP?

Surgical Instruments Belgium SA filed the 510(k) submission for SIBEL SA VASCULAR CLAMP (K072834).

What is the FDA product code for SIBEL SA VASCULAR CLAMP?

DXC. It is classified under 21 CFR 870.4450 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for SIBEL SA VASCULAR CLAMP?

510(k) clearance (submission type: Traditional).

What are the predicate devices for SIBEL SA VASCULAR CLAMP?

Surgical Vascular Clamp, Walter Lorenz Surgical, Inc. (K973080).

Who can help prepare an FDA 510(k) submission like SIBEL SA VASCULAR CLAMP?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SIBEL SA VASCULAR CLAMP

K072834 · Surgical Instruments Belgium SA · DXC · Jan 9, 2008 · Cardiovascular

Device Facts

Record ID	K072834
Device Name	SIBEL SA VASCULAR CLAMP
Applicant	Surgical Instruments Belgium SA
Product Code	DXC · Cardiovascular
Decision Date	Jan 9, 2008
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.4450
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Vascular Clamp is indicated for use for temporary or partial occlusion of blood vessels during open surgical procedures.

Device Story

Vascular clamp used for temporary or partial occlusion of blood vessels during open surgery. Device consists of reusable stainless steel or titanium jaws with ring handles and a ratchet closure mechanism to adjust occlusion tension. Available in various lengths, shapes, and sizes to accommodate different anatomical sites and occlusion requirements. Operated by surgeons in an OR setting; design features (lengths/angles) keep handles and shanks out of the surgeon's field of vision. Provides mechanical vessel isolation to allow surgical work on specific areas while maintaining blood flow in the remainder of the vessel.

Clinical Evidence

No clinical data. Substantial equivalence is based on design, intended use, and technological characteristics compared to the predicate device.

Technological Characteristics

Reusable vascular clamp; materials: stainless steel or titanium; mechanism: ratcheting handle for adjustable occlusion tension; jaw styles: full or partial occlusion; design: various lengths and angles for ergonomic access.

Indications for Use

Indicated for temporary or partial occlusion of blood vessels during open surgical procedures in patients requiring vascular isolation.

Regulatory Classification

Identification

A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.

Predicate Devices

Surgical Vascular Clamp, Walter Lorenz Surgical, Inc. (K973080)

Related Devices

K123077 — VASCULAR CLAMPS · Hebumedical GmbH · May 14, 2013
K102048 — ATRAUMATIC VASCULAR CLAMPS · Geomed Medizin-Technik GmbH & Co. KG · Nov 9, 2010
K991589 — FLEXIBLE VASCULAR CLAMP, VERSION 2 · Allegiance Healthcare Corp. · May 18, 1999
K092544 — INSTRUMED VASCULAR CLAMPS · Instrumed International, Inc. · Oct 26, 2009
K973080 — SURGICAL VASCULAR CLAMP · Walter Lorenz Surgical, Inc. · Feb 23, 1998

Submission Summary (Full Text)

{0}------------------------------------------------ K072834 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}------------------------------------------------ K072934. 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 Page 1 of