KSEA DEPLOYABLE CARDIOVASCULAR CLAMP

K014277 · KARL STORZ Endoscopy-America, Inc. · DXC · Dec 11, 2002 · Cardiovascular

Device Facts

• Record ID: K014277
• Device Name: KSEA DEPLOYABLE CARDIOVASCULAR CLAMP
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: DXC · Cardiovascular
• Decision Date: Dec 11, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The KSEA Deployable Vascular Clamp is intended for use by qualified surgeons for temporary cross-occlusion of arteries and veins ranging between 0.3 -1.6 cm in diameter during endoscopic surgery.

Device Story

KSEA Deployable Vascular Clamp is a manual surgical instrument designed for temporary cross-occlusion of blood vessels during endoscopic procedures. Operated by qualified surgeons, the device provides mechanical clamping of arteries and veins ranging from 0.3 to 1.6 cm in diameter. The device is constructed from surgical grade stainless steel. It functions as a manual tool to assist in vessel management during surgery, aiding the surgeon in maintaining a bloodless field or controlling flow during endoscopic interventions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual surgical instrument; material: surgical grade stainless steel; dimensions: designed for vessels 0.3-1.6 cm in diameter; form factor: deployable clamp for endoscopic use.

Indications for Use

Indicated for qualified surgeons performing endoscopic surgery requiring temporary cross-occlusion of arteries and veins with diameters between 0.3 and 1.6 cm.

Regulatory Classification

Identification

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

Submission Summary (Full Text)

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## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge.

| Applicant: | Karl Storz Endoscopy - America, Inc.<br>600 Corporate Pointe Drive<br>Culver City, CA 90230<br>[phone] |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | James A. Lee, Ph.D.<br>Senior Regulatory Affairs Specialist |
| Device Identification: | Common Name:<br>Vascular Clamp Forceps, and Endoscopic Instrument<br><br>Trade Name: (optional)<br>The KSEA Deployable Vascular Clamp |

Indication: The KSEA Deployable Vascular Clamp is intended for use by qualified surgeons for temporary cross-occlusion of arteries and veins ranging between 0.3 -1.6 cm in diameter during endoscopic surgery.

Device Description: The KSEA Deployable Clamp is a manual surgical instrument for temporary cross occlusion of blood vessels. The body contact materials are surgical grade stainless steel.

Substantial Equivalence: The KSEA Deployable Vascular Clamp is substantially equivalent to the predicate device since dimensions, performance, stainless steel, and intended uses are similar. The minor differences between the Deployable Vascular Clamp and the predicate device raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices.

Signed:

Signature

James A. Lee, Ph.D. Senior Regulatory Affairs Specialist

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 11 2002

Karl Storz Endoscopy America c/o James A. Lee, Ph.D. Senior Regulatory Affairs Specialist 600 Corporate Pointe 5th Floor Culver City, CA 90230

Re: K014277

Trade Name: KSEA Deployable Vascular Clamp Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II (two) Product Code: DXC Dated: September 11, 2002 Received: September 12, 2002

Dear Dr. Lee:

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 -- James A. Lee, Ph.D.

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 Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

O'Malley

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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510(k) Number (if known): K014277

.

Device Name: KSEA Deployable Vascular Clamp

Indications for Use: The KSEA Deployable Vascular Clamp is intended for use by qualified surgeons for temporary cross-occlusion of arteries and veins ranging between 0.3 -1.6 cm in diameter during endoscopic surgery.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use:

X

OR Over-The-Counter Use:

(Per 21 CFR 801.109)

E'Mallis
Division of Cardiovascular & Respiratory Devices
510(k) Number K014277

(Optional Format 1-2-96)