AESCULAP VASCULAR INSTRUMENTS

K992053 · Aesculap, Inc. · DXC · Jan 13, 2000 · Cardiovascular

Device Facts

• Record ID: K992053
• Device Name: AESCULAP VASCULAR INSTRUMENTS
• Applicant: Aesculap, Inc.
• Product Code: DXC · Cardiovascular
• Decision Date: Jan 13, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Aesculap's Vascular Clamps and Instruments are indicated for use in vascular surgery. Alfa and Alfa-mini vascular clamps are designed for temporary occlusion of blood vessels during open surgical procedures. Atraumatic vascular clamps and clamp appliers/removers are designed for temporary occlusion of blood vessels during either an open or endoscopic surgical approach. Laparoscopic vascular scissors, forceps, clamps, dissecting spatulas and needleholder are use for cutting, dissecting, clamping, fixation and suturing vessels and tubular structures. Flexible trocars provide access to the surgical site for use in laparoscopic vascular surgery.

Device Story

Aesculap Vascular Instruments comprise vascular clamps, flexible trocars, and endoscopic instruments (scissors, forceps, clamps, dissecting spatulas, needleholders). Devices used by surgeons in OR settings during open or laparoscopic vascular procedures. Clamps provide temporary vessel occlusion; endoscopic instruments facilitate cutting, dissecting, clamping, fixation, and suturing. Flexible trocars provide surgical site access. No automated processing or electronic output; purely mechanical surgical instrumentation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical surgical instruments including vascular clamps, trocars, scissors, forceps, and needleholders. No energy source, software, or electronic components. Materials and design consistent with existing marketed vascular and endoscopic product lines.

Indications for Use

Indicated for patients undergoing vascular surgery, including open and endoscopic procedures, requiring temporary vessel occlusion, cutting, dissecting, clamping, fixation, or suturing of vessels and tubular structures.

Regulatory Classification

Identification

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

Reference Devices

• Aesculap vascular and endoscopic devices
• Codman vascular and endoscopic devices
• Heartport vascular and endoscopic devices
• Mueller vascular and endoscopic devices
• Walter Lorenz vascular and endoscopic devices

Submission Summary (Full Text)

{0}------------------------------------------------

K992053

510(k) Premarket Notification

## Aesculap Vascular Instruments

Page 1 of 2

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS in Accordance with SMDA of 1990

# AESCULAP VASCULAR INSTRUMENTS

June 17. 1999

Contact

#### Company

Aesculap®, Inc.

1000 Gateway Blvd.

So. San Francisco, CA 94080

Mary Ellen Holden, Senior Requlatory Associate 650-624-5072 Phone: FAX: [phone]

#### Trade Name

Aesculap Vascular Instruments

#### Common Name

Vascular Clamps, Endoscopic instruments, trocars

#### Classification Name and Product Code

Vascular Clamps Endoscope and Accessories 74DXC 78 KOG

## Product Classification

Class II

#### Requiatory Classification

21 CFR Section 876.1500 21 CFR Section 870.4450

Endoscope and Accessories Vascular Clamp

#### Intended Use

Aescular's Vascular Clamps and Instruments are indicated for use in vascular surgery. Alfa and Alfa-mini vascular clamps are designed for temporary occlusion of blood vessels during open surgical procedures. Atraumatic vascular clamps and clamp appliers/removers are designed for temporary occlusion of blood vessels during either an open or endoscopic surgical approach.

Laparoscopic vascular scissors, forceps, clamps, dissecting spatulas and needleholder are use for cutting, dissecting, clamping, fixation and suturing vessels and tubular structures. Flexible trocars provide access to the surqical site for use in laparoscopic vascular surgery.

(. (' 0 4

{1}------------------------------------------------

Page 2 of 2

005

#### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS in Accordance with SMDA of 1990

## AESCULAP VASCULAR INSTRUMENTS

#### Device Description

The Vascular Instruments consist of vascular clamps, flexible trocars, and various endoscopic vascular instruments (scissors, forceps, clamps).

#### Summary of Technological Characteristics

Aesculap currently markets a complete vascular product line, which includes vascular clamps and instruments. In addition, Aesculap markets a complete endoscopic product line that includes endoscopes, flexible and rigid trocars, endoscopic clip appliers and endoscopic instruments such as forceps and scissors. The expanded line of Vascular Clamps and Endoscopic Vascular Instruments included in this submission do not impart any new technological characteristics. They use the same technology as current vascular and laparoscopic product lines - the only difference is the surgical application.

#### Performance Data

No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices.

#### Substantial Equivalence

Aesculap believes that the Vascular Instruments presented in this submission are substantially equivalent in design, function, and intended use to currently marketed vascular and endoscopic devices from companies such as:

- Aesculap .
- Codman .
- Heartport .
- Mueller .
- Walter Lorenz ●

{2}------------------------------------------------

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The logo is in black and white and appears to be of moderate resolution.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 3 2000

Ms. Mary Ellen Holden Senior Regulatory Associate Aesculap®, Inc. 1000 Gateway Blvd. So. San Francisco, CA 94080

K992053 Re : Aesculap Vascular Instruments Trade Name: Requlatory Class: II Product Code: DXC and GCJ October 14, 1999 Dated: October 15, 1999 Received:

Dear Ms. Holden:

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 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). 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 Regulation (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 regulatory 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 .

{3}------------------------------------------------

Page 2 - Ms. Mary Ellen Holden

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.

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 [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 807.97). Other general information on vour responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

.gov, CA.IT, GO.MA, GO.MA.IT, IT.CM

Sincerely yours,
Chitopher for.

Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

510(k) Premarket Notification

Aesculap Vascular Instruments

Page 1 of 1

## INDICATION FOR USE STATEMENT

-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------第一次 - 1998年

510(k) Number (if known):

K992c53

Device Name:

Aesculap Vascular Instruments

### Indication for Use:

Aesculap's Vascular Clamps and Instruments are indicated for use in vascular surgery. Alfa and Alfa-mini vascular clamps are designed for temporary occlusion of blood vessels during open surgical procedures. Atraumatic vascular clamps and clamp appliers/removers are designed for temporary occlusion of blood vessels during either an open or endoscopic surqical approach.

Laparoscopic vascular scissors, forceps, clamps, dissecting spatulas and needleholder are use for cutting, dissecting, clamping, fixation and suturing vessels and tubular structures. Flexible trocars provide access to the surgical site for use in laparoscopic vascular surgery.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
*Chit for Witten*
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices

| 510(k) Number | K992053 |
|---------------|---------|
|---------------|---------|

| Prescription Use<br>(per 21 CFR 801.109) | X |
|------------------------------------------|---|
|------------------------------------------|---|

or

| Over-the-Counter Use | |
|----------------------|--|
|----------------------|--|