ENGAGE JAW INSERTS

K992980 · Novare Surgical Systems, Inc. · DXC · Jun 8, 2000 · Cardiovascular

Device Facts

• Record ID: K992980
• Device Name: ENGAGE JAW INSERTS
• Applicant: Novare Surgical Systems, Inc.
• Product Code: DXC · Cardiovascular
• Decision Date: Jun 8, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

ENGAGE Jaw Inserts are used with a surgical clamp to occlude a blood vessel temporarily and may be used to clamp over indwelling catheters. ENGAGE Jaw Inserts are adaptable to Fogarty Hydragrip® Surgical Clamps.

Device Story

ENGAGE Jaw Inserts are atraumatic inserts designed for use with surgical clamps, specifically Fogarty Hydragrip® Surgical Clamps. The device functions by attaching to the jaws of a surgical clamp; when the clamp is closed, the inserts provide a surface to squeeze and temporarily occlude blood vessels or indwelling catheters. Used by surgeons in vascular procedures to control blood flow. The device is a mechanical accessory; it does not involve electronic inputs, software, or automated processing.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Atraumatic jaw inserts for surgical clamps. Mechanical device; no energy source, software, or connectivity. Designed for compatibility with Fogarty Hydragrip® Surgical Clamps.

Indications for Use

Indicated for temporary occlusion of blood vessels (veins and arteries) and clamping over indwelling catheters during vascular surgery.

Regulatory Classification

Identification

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

Predicate Devices

• Fogarty® Hydragrip® Surgical Clamp (preamendment)
• Safejaw Inserts (Baxter International)

Submission Summary (Full Text)

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K992980

JUN - 8 2000

Attachment 2

# 510(k) SUMMARY

Document Mail Center (HFZ-401) Center for Devices and Radiological Health Food and Drug Administration 1390 Piccard Drive Rockville, MD 20850

This summary of 510(k) safety and effectiveness information is being submitted in accordance with 21 CFR 8807.92.

Novare Surgical intends to introduce into commercial distribution the ENGAGE Inserts. The equivalent predicate devices are Allegiance Healthcare's Fogarty® Hydragrip® Surgical Clamp (preamendment) and Baxter International's Safejaw Inserts (see copy of Product Insert Sheet in Attachment 2).

The FDA has classified vascular clamps as Class II devices (21CFR870-4450). Novare ENGAGE Inserts are a Class II medical device. The common name for Novare's device is: Surgical Clamp / atraumatic insert.

ENGAGE Jaw Inserts are used with a surgical clamp to occlude a blood vessel temporarily and may be used to clamp over indwelling catheters. ENGAGE Jaw Inserts are adaptable to Fogarty Hydra-Grip Surgical Clamps. This surgical clamp is intended for use in vascular surgery. The ENGAGE Inserts and Safejaw Inserts are substantially equivalent in terms of intended use, principles of operation, basic technological characteristics, and target population of surgical disciplines.

The principle of operation for occlusion with these clamps is the squeezing together of the jaws to temporarily occlude vessels. The need for clamping is present in most vascular procedures. The device labeling supports the use of these devices for vascular applications in surgery.

T.R. Hoff 12/17/93

Kermit R. Pope, Jr. President/CEO

Date

Novare Surgical 10231 Bubb Road Cupertino, CA 95014 [phone]

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN = 8 2000

Mr. Terry Buelna Vice President, Chief Technical Officer Novare Surgical Systems 10231 Bubb Road Cupertino, CA 95014

K992980 Re: Engage Jaw Inserts Trade Name: Requlatory Class: II (two) Product Code: DXC Dated: May 15, 2000 Received: May 17, 2000

Dear Mr. Buelna:

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 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.

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### Page 2 - Mr. Terry Buelna

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 your 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".

Sincerely yours,

Brim E. Hawaym
James E. Dillard III
Director
for

Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment 3

510 (k) Number: K992980

Device Name: ENGAGE Jaw Inserts

## Indications For Use

### For Vascular Work

- Suitable for veins and arteries
- ENGAGE Jaw Inserts are used with a surgical clamp to occlude a blood vessel temporarily and may be used to clamp over indwelling catheters.
- ENGAGE Jaw Inserts are adaptable to Fogarty Hydragrip® Surgical Clamps. .

Sam E. Dunaway

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
✓

OR

Over-The-Counter Use