BALADI INVERTER WITH COAXIAL AORTIC PUNCH

K980128 · Cardio Medical Solutions, Inc. · DXC · Jul 24, 1998 · Cardiovascular

Device Facts

• Record ID: K980128
• Device Name: BALADI INVERTER WITH COAXIAL AORTIC PUNCH
• Applicant: Cardio Medical Solutions, Inc.
• Product Code: DXC · Cardiovascular
• Decision Date: Jul 24, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Baladi Inverter™ with Coaxial Aortic Punch is intended for use by cardiac surgeons during Coronary Artery Bypass Grafting procedures to maintain hemostasis and punch a hole in the aorta to facilitate the completion of the proximal anastomosis.

Device Story

The Baladi Inverter™ with Coaxial Aortic Punch is a surgical instrument used by cardiac surgeons during coronary artery bypass grafting (CABG). The device functions as a vascular clamp to provide partial occlusion of the aorta while simultaneously acting as an aortic punch to create an opening for the proximal anastomosis. By combining these two functions into a single device, it facilitates the surgical procedure. It is used in the operating room environment. The device benefits the patient by streamlining the surgical process and maintaining hemostasis during the creation of the graft connection.

Clinical Evidence

Evidence includes an animal study confirming device effectiveness, hemostasis maintenance, and successful aortic punching with no adverse histopathology findings. A cadaver study supported safety and efficacy. Human clinical studies reported the device performed as expected with no complications or adverse events.

Technological Characteristics

Mechanical surgical instrument combining a vascular clamp and aortic punch. Materials and specifications are not detailed beyond general surgical instrument classification. Device is intended for manual operation by surgeons. Sterilization and biocompatibility testing were performed.

Indications for Use

Indicated for cardiac surgeons performing Coronary Artery Bypass Grafting (CABG) procedures to maintain hemostasis and create an aortic opening for proximal anastomosis.

Regulatory Classification

Identification

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

Predicate Devices

• Debakey Vascular Clamp
• Coolev Vascular Clamp
• Medtronic Punch
• Hancock Aortic Punch (K800122)
• Davis + Geck CardioPunch

Submission Summary (Full Text)

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Cardio Medical Solutions, Inc. Baladi Inverter™ with Coaxial Aortic Punch 510(k) Notification K980128

# Jul 24 1998

# 510(k) SUMMARY

## A. Name and Address

Cardio Medical Solutions, Inc. 17080 Newhope Street Fountain Valley, CA. 92708

# B. Telephone and Fax Number of Contact

(714) 427 - 6350 Phone: (714) 427 - 6354 Fax:

### C. Contact Person

Anthony Nobles Chief Scientific Officer & Vice President, R&D

### D. Date of Summary Preparation

January 9, 1998

# E. Name of the Device

- 1. Trade or Proprietary
Baladi Inverter™ with Coaxial Aortic Punch

- 2. Common or Usual
Vascular Clamp and Aortic Punch

- 3. Classification Name
Vascular Clamp and Aortic Punch

#### Description of the Device F.

The Baladi Inverter™ with Coaxial Aortic Punch is used to create hemostasis and punch a hole in the aorta to facilitate the anastomosis during coronary arterial bypass grafting (CABG) procedures.

### G. Summary of Substantial Equivalence

The predicate devices are standard:

Vascular clamps for total and partial occlusion. These devices are distributed by various manufacturers in various sizes and configurations.

Aortic punches for punching holes in the aorta facilitating the completion of the anastomosis during CABG procedures. These devices are distributed by Medtronic, Davis + Geck, and various other manufacturers in various sizes.

# CARDIO MEDICAL SOLUTIONS, INC. CONFIDENTIAL

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The Baladi Inverter™ with Coaxial Aortic Punch provides partial occlusion and punches a hole in the aorta facilitating the completion of the anastomosis during CABG procedures.

### H. Predicate Devices

Debakey Vascular Clamp Coolev Vascular Clamp Medtronic Punch Hancock Aortic Punch (K800122) Davis + Geck CardioPunch

#### Summary of Non-Clinical Testing I.

The Baladi Inverter™ with Coaxial Aortic Punch has undergone all of the following tests:

Sterilization Qualification Biocompatibility Design Verification

#### J. Summary of Clinical Testing

The Baladi Inverter™ with Coaxial Aortic Punch has undergone the following studies:

An Animal Clinical Study of device effectiveness concluded that the device had no adverse effects. The Baladi inverter™ successfully maintained hemostasis and successfully punched the aorta facilitating the anastomosis and completion of the CABG procedure. Histopathology results revealed no device-related issues.

A Cadaver Study was performed and the study supports the conclusion that the Baladi Inverter™ with Coaxial Aortic Punch does not represent any new issues of Safety or Efficacy.

Human Clinical Studies were performed and the device performed clinically as expected. There were no complications or adverse events reported. The device is considered safe and effective when used according to the device labeling.

## K. HAZARD ANALYSIS

The data supports the conclusion that the Baladi Inverter™ with Coaxial Aortic Punch has a Very Low (VL) rating and presents no new issues of safety during the CABG procedure.

# L. CONCLUSION

The sponsor believes that the data submitted for the Baladi Inverter™ with Coaxial Aortic Punch constitutes valid scientific evidence. The expected results with respect to procedural success and complications are well defined.

The sponsor believes that the Baladi Inverter™ is safe and effective when used for CABG procedures according to the device labeling.

The sponsor believes that the Baladi Inverter™ with Coaxial Aortic Punch presents no new issues of safety or efficacy during the CABG procedure.

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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 image of an eagle or bird with three lines forming its body and head. The logo is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 24 1998

Mr. Thomas P. Schroeder VP, Regulatory Affairs & Quality Assurance Cardio Medical Solutions, Inc. 17080 Newhope Street Fountain Valley, CA 92708

Re : K980128 Baladi Inverter™ with Attached Aortic Punch Trade Name: Requlatory Class: II Product Code: DXC Dated: July 17, 1998 Received: July 20, 1998

Dear Mr. Schroeder:

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, labelinq, 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 Requlations, 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 requlation may result in requlatory 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

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Page 2 - Mr. Thomas P. Schroeder

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 requlations.

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 requlation 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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Page __ 1 __ of ______________________________________________________________________________________________________________________________________________________________

# 510(k) Number (if known): K980128

Device Name: Baladi Inverter™ with Attached Aortic Punch

Indications For Use:

The Baladi Inverter™ with Coaxial Aortic Punch is intended for use by cardiac surgeons during Coronary Artery Bypass Grafting procedures to maintain hemostasis and punch a hole in the aorta to facilitate the completion of the proximal anastomosis.

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ological i

510(k) Number

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The Counter _____________________________________________________________________________________________________________________________________________________________

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