KOALA VASCULAR CLAMPS AND INSERTS

K980002 · Boss Instruments, Ltd. · DXC · Jun 18, 1998 · Cardiovascular

Device Facts

• Record ID: K980002
• Device Name: KOALA VASCULAR CLAMPS AND INSERTS
• Applicant: Boss Instruments, Ltd.
• Product Code: DXC · Cardiovascular
• Decision Date: Jun 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Koala Vascular Clamps and Inserts are reusable, ring-handled stainless steel clamps for clamping delicate vessels during surgery. They are radiopaque, visualized under fluoroscopy. Designed for tip-first closure to prevent vessel roll-out. Applications include pulmonary, gastrointestinal procedures, peripheral clamping, thoracic procedures such as occlusion of the aorta and vena cave, cross-clamping of the aorta and aortic aneurysms, etc.

Device Story

Reusable, ring-handled stainless steel vascular clamps with polyurethane inserts; designed for tip-first closure to prevent vessel roll-out; radiopaque for visualization under fluoroscopy. Used in hospital operating rooms by surgeons for clamping delicate vessels during pulmonary, gastrointestinal, and thoracic procedures. Inserts reduce tissue trauma. Clamps provided clean, non-sterile; inserts provided sterile.

Clinical Evidence

No clinical data. Substantial equivalence based on design, material, and intended use comparison to predicate device. Biocompatibility testing performed for insert material.

Technological Characteristics

Stainless steel clamps; polyurethane inserts; radiopaque; ring-handled design; tip-first closure mechanism. Biocompatibility tested to Class VI standards. No energy source. Manual operation.

Indications for Use

Indicated for clamping delicate vessels during surgery, including pulmonary, gastrointestinal, and thoracic procedures (e.g., aortic/vena cava occlusion, aortic aneurysm cross-clamping) and peripheral clamping.

Regulatory Classification

Identification

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

Predicate Devices

• Baxter V. Mueller - Fogarty Hydragrip Clamps and Inserts (K951413)

Submission Summary (Full Text)

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K980002

## 1 8 1898

For the Art of Surgery

### Non-Confidential Summary of Safety and Effectiveness

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December 29, 1997

Boss Instruments. Ltd. 1310 Central Ct. Hermitage, TN 37076

Tel - [phone] Fax - [phone]

| Official Contact: | Burns Phillips. President |
|----------------------------|------------------------------------------------------------|
| Proprietary or Trade Name: | Koala Vascular Clamps and Inserts |
| Common/Usual Name: | Vascular Clamps and Accessories |
| Classification Name: | Vascular clamps |
| Device: | Koala Vascular Clamps and Inserts |
| Predicate Devices: | Baxter V. Mueller - Fogarty Hydragrip Clamps and Inserts - |
| | K951413 |

#### Device Description:

The Boss Instrument Koala Vascular Clamps and inserts are reusable, ring-handled stainless steel instruments which have inserts which reduce trauma to the tissue being clamped.

Indicated Use --

The Koala Vascular Clamps and Inserts are reusable, ring-handled stainless steel clamps for clamping delicate vessels during surgery. They are radiopaque. visualized under fluoroscopy. Designed for tip-first closure to prevent vessel roll-out. Applications include pulmonary, gastrointestinal procedures, peripheral clamping, thoracic procedures such as occlusion of the aorta and vena cave, cross-clamping of the aorta and aortic aneurysms, etc.

Environment of Use --

Hospital and operating room (OR)

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P.O. BOX 293180 NASHVILLE, TN 37229-3180 U.S.A.
TELEPHONE [phone] FAX [phone]

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# Non-Confidential Summary of Safety and Effectiveness

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December 29, 1997

## Comparison to Predicate Devices:

| Attribute | Koala Clamps<br>and Inserts | Baxter -V. Mueller<br>Fogarty K951413 |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|---------------------------------------|
| Use | | |
| Indicated for clamping vessels<br>and total occlusion | Yes | Yes |
| Used in pulmonary, gastrointestinal,<br>peripheral clamping, thoracic<br>procedures - occlusion of aorta,<br>vena cava, cross clamping of aorta<br>and aortic aneurysms, etc. | Yes | Yes |
| Intended to be reused | Yes | Yes |
| Design | | |
| Instruments manufactured by the<br>same company | Yes | Yes |
| Various sizes and configurations<br>offered | Yes | Yes |
| Incorporate inserts to reduce trauma<br>available in 33, 61 and 86 mm sizes | Yes | Yes |
| Packaging | | |
| Inserts provided sterile in<br>Tyvek pouches | Yes | Yes |
| Clamps provided clean,<br>non-sterile | Yes | Yes |
| Materials | | |
| Clamps - Stainless Steel | Yes | Yes |
| Comparison to Predicate Devices: | | |
| Attribute | Koala Clamps<br>and Inserts | Baxter -V. Mueller<br>Fogarty K951413 |
| Materials | | |
| Inserts - polyurethane | Yes | Yes |
| Performance Standards / Specifications | | |
| Required under Section 514 | None | None |
| Biocompatability tests for Class VI<br>for the insert material | Yes | Yes |

.

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### Non-Confidential Summary of Safety and Effectiveness

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December 29. 1997

#### Differences between Other Legally Marketed Predicate Devices

The clamps are manufactured and supplied by the same manufacturer. The inserts are manufactured by different companies, but the base material is exactly the same. Therefore there are no significant differences between the intended device and the predicate - Baxter - V. Mueller - Fogarty -Hydragrip Vascular Clamps and inserts approved under K951413.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### JUN 1 8 1998

Mr. Burns Phillips President Boss Instruments, Ltd. 1310 Central Ct. Hermitage, TN 37076

Re: K980002 Koala Vascular Clamps and Inserts Trade Name: Regulatory Class: II Product Code: DXC Dated: April 17, 1998 Received: April 21, 1998

Dear Mr. Phillips:

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 A substantially equivalent determination assumes compliance to 895. 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 Failure to comply with the GMP regulation may result in assumptions. regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this

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#### Page 2 - Mr. Burns Phillips

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.

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,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDIGATIONS FOREUSE

Page 1 of 1

K 980002 (To be assigned)

510(k) Number:

Device Name:

Koala Vascular Clamps and Inserts

The Koala Vascular Clamps and Inserts are reusable, ring-handled Intended Use : I ne Roule Vassena vassens for clamping delicate vessels during surgery. Statiness 1000 comments wisualized under fluoroscopy. Designed for tip-first closure to prevent vessel roll-out. Applications include pulmonary, gastrointestinal procedures, peripheral clamping, purinemaly, grocedures such as occlusion of the aorta and vena cave, cross-clamping of the aorta and aortic aneurysms, etc.

Concurrence of CDRH, Office of Device Evaluation (ODE)

or

Tia H

(Division Sign-Off) (Division of Cardiovascular, Respiratory, and Neurological Devices x990002 510(k) Number_

**Prescription Use**
(Per CFR 801.109) ✓

Over-the-counter use

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