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 Description

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.

AI/ML Overview

The provided 510(k) notification for the Baladi Inverter™ with Coaxial Aortic Punch is for a mechanical surgical device, not a diagnostic or AI-powered device. Therefore, many of the requested categories related to algorithm performance, training sets, ground truth establishment, and expert involvement for AI/diagnostic studies are not applicable to this submission.

However, I can extract information related to the device's performance, testing, and acceptance criteria as described in the document.

Acceptance Criteria and Device Performance

The acceptance criteria for this type of mechanical device are primarily focused on safety, effectiveness in performing its intended function, and substantial equivalence to predicate devices. The "reported device performance" is essentially a statement that the device met these criteria based on the non-clinical and clinical studies conducted.

Acceptance Criteria Category	Reported Device Performance
Safety	No adverse effects (Animal Clinical Study). No new issues of Safety (Cadaver Study). No complications or adverse events (Human Clinical Studies). Hazard Analysis resulted in a "Very Low (VL)" rating, presenting "no new issues of safety." Device is considered safe.
Effectiveness (Hemostasis)	Successfully maintained hemostasis (Animal Clinical Study). Performed clinically as expected (Human Clinical Studies). Substantially equivalent to predicate vascular clamps.
Effectiveness (Aortic Punch)	Successfully punched the aorta facilitating anastomosis (Animal Clinical Study). Performed clinically as expected (Human Clinical Studies). Substantially equivalent to predicate aortic punches.
Biocompatibility	Met qualifications (Non-Clinical Testing). Histopathology revealed no device-related issues (Animal Clinical Study).
Sterilization	Met qualifications (Non-Clinical Testing).
Design Verification	Met qualifications (Non-Clinical Testing).
Substantial Equivalence	Considered substantially equivalent to legally marketed predicate devices (FDA Conclusion).

Study Details (Applicable to a Mechanical Device)

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Animal Clinical Study: Sample size not specified.
- Cadaver Study: Sample size not specified.
- Human Clinical Studies: Sample size not specified.
- Data Provenance: Not specified, but generally, 510(k) studies for devices intended for the US market would involve data generated under US regulatory guidelines, though the specific location of study conduct is not stated. The studies are prospective in nature, as they assess the device's function and safety during use.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- For a mechanical device, "ground truth" is typically established through direct observation of the device's mechanical function, surgical outcomes, and histopathological analysis. The document doesn't specify the exact number or qualifications of experts for defining "ground truth" in the way it would for a diagnostic AI. However, implicit "experts" involved would include:
  - Veterinary staff/surgeons: For the animal study.
  - Anatomists/Pathologists: For the cadaver study.
  - Cardiac surgeons: For the human clinical studies, who would assess the device's performance, ease of use, and any complications.
  - Pathologists: For histopathology results.
- No specific years of experience are detailed for these experts.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable in the context of this mechanical device study. Adjudication methods like 2+1 or 3+1 are typically used for interpreting ambiguous diagnostic findings or images, which is not the primary focus here. Assessment of device function and safety would be direct observation and outcome measurement.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is a mechanical surgical device and not a diagnostic device requiring human reader interpretation or AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a mechanical surgical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For this mechanical device, the "ground truth" was established using a combination of:
  - Direct observation of mechanical function: In animal, cadaver, and human studies (e.g., successful hemostasis, successful aortic punch).
  - Pathology/Histopathology: To assess tissue response and rule out device-related issues.
  - Surgical Outcomes Data: Absence of complications, adverse events, and expected clinical performance in human studies.
The sample size for the training set
- Not applicable. This is a mechanical device, not an AI/machine learning algorithm that requires a training set.
How the ground truth for the training set was established
- Not applicable. There is no training set for this type of device.

Summary

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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
1. Common or Usual
  Vascular Clamp and Aortic Punch
1. 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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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 (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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:

Tant

(Division Sign Off)

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

ological i

510(k) Number

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The Counter _____________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 870.4450 Vascular clamp.

(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).