The SURGIMEDICS®/TMP® Vision Cardioplegia Delivery System is intended to mix, cool, warm, and deliver oxygenated blood cardioplegia solution during cardiopulmonary bypass.

Device Description

The Vision Cardioplegia Delivery System is intended for mixing, cooling, warming, and delivery of oxygenated blood cardioplegia solution during cardiopulmonary bypass.

AI/ML Overview

The K964571 submission for the SURGIMEDICS®/TMP® Vision Cardioplegia Delivery System does not contain the specific details required to fully address all parts of your request regarding acceptance criteria and study particulars. This document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study results or acceptance criteria in the format you've requested for a device that might be AI-driven.

However, based on the provided text, I can extract and infer some information, particularly regarding the performance comparison to predicate devices, which serves as the basis for demonstrating substantial equivalence.

Here's an attempt to answer your questions based on the available information, with caveats for missing details:

1. A table of acceptance criteria and the reported device performance

The provided document does not explicitly state acceptance criteria in a quantitative or pass/fail format, nor does it present device performance in a structured table against such criteria. Instead, it states that the device "showed similar rates" to the predicate, implying that performance comparable to the predicate device was considered acceptable.

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance (Vision Cardioplegia Delivery System)
Hemolysis	Similar rates to Sorin BCD Vanguard Cardioplegia System	Showed similar rates to Sorin BCD Vanguard Cardioplegia System
Heat Exchange Effectiveness	Similar rates to Sorin BCD Vanguard Cardioplegia System	Showed similar rates to Sorin BCD Vanguard Cardioplegia System
Warming	Similar performance to Sorin BCD Vanguard Cardioplegia System	Showed similar performance to Sorin BCD Vanguard Cardioplegia System
Cooling	Similar performance to Sorin BCD Vanguard Cardioplegia System	Showed similar performance to Sorin BCD Vanguard Cardioplegia System
Internal Resistance to Flow	Similar performance to Sorin BCD Vanguard Cardioplegia System	Showed similar performance to Sorin BCD Vanguard Cardioplegia System
Maximum Water Side Pressure Tolerance	Similar tolerance to Sorin BCD Vanguard Cardioplegia System	Showed similar tolerance to Sorin BCD Vanguard Cardioplegia System
Maximum Blood Side Pressure Tolerance	Similar tolerance to Sorin BCD Vanguard Cardioplegia System	Showed similar tolerance to Sorin BCD Vanguard Cardioplegia System
Debubbling Capacity	Similar capacity to Sorin BCD Vanguard Cardioplegia System	Showed similar capacity to Sorin BCD Vanguard Cardioplegia System

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "comparative bench testing" but does not specify the sample size (e.g., number of devices tested, number of test runs) or the provenance (country of origin, retrospective/prospective) of the data. It appears to be bench testing rather than human subject data.

3. 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)

This is not applicable as the device is a medical device for cardioplegia delivery, not an AI-powered diagnostic or image analysis tool requiring expert ground truth for a test set in the context of typical AI/ML studies. The evaluation was based on physical performance metrics.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as this was not an expert-driven adjudication of medical cases, but rather bench testing of device performance.

5. 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 device is not an AI-assisted diagnostic tool or an imaging device involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is framed for AI algorithms. For this physical medical device, the "standalone" performance is the bench testing described, which evaluated the device's operational characteristics independently.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For this device, the "ground truth" for performance comparison was the established performance characteristics of the legally marketed predicate devices (Sorin Biomedical Buckberg BCD Vanguard, Sorin Biomedical BCD Advanced Blood Cardioplegia System, Avecor Cardiovascular MYOtherm Cardioplegia System). The performance metrics (hemolysis, heat exchange, etc.) themselves are quantifiable physical parameters, not subjective expert interpretations or pathological diagnoses.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set. The device was developed and then tested against established physical performance criteria.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device.

In summary, the provided document is a 510(k) summary demonstrating substantial equivalence for a physical medical device. The evaluation relies on comparative bench testing against predicate devices. The concepts of AI-specific acceptance criteria, test/training sets, expert ground truth, and MRMC studies are not relevant to this type of submission.

Summary

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K964571

8 1997 AUG

510(k) Summary SURGIMEDICS®/TMP® Vision Cardioplegia Delivery System (per 21 CFR 807.92)

1.	Date Prepared:	November 11, 1996
2.	Sponsor/Applicant:	SURGIMEDICS® /TMP®2828 N. Crescent Ridge DriveThe Woodlands Research ForestThe Woodlands, TX 77381
3.	Contact Name:	Russell Jones, Manager of Regulatory AffairsTelephone Number: 713-363-4949
4.	Device Name:

Proprietary Name:	Vision Cardioplegia Delivery System
Common/Usual Name:	Cardioplegia Heat Exchanger
Classification Name:	Cardiopulmonary Bypass Heat Exchanger

5. Device Classification:

Cardioplegia heat exchangers are similar to cardiopulmonary bypass heat exchangers (21 CFR 870.4240, Product Code DTR) which have been classified under Section 513 of the Act as Class II by the Cardiovascular Devices Panel.

Predicate Devices: Q.

ﺴﻌﺔ ﺍﻟﻤﺴﺘﻌﻤﻠﻬﺎ ﺍﻟﻤﺴﺘﻌﻤﻠﻬﺎ ﺍﻟﻤﺴﺘﻌﻤﻠﻬﺎ ﺍﻟﻤﺴﺘﻌﻤﻠﻬﺎ ﺍﻟﻤﺴﺘﻌﻤﻠﻬﺎ ﺍﻟﻤﺴﺘﻌﻤﻠﻬﺎ ﺍﻟﻤﺴﺘﻌﻤﻠﻬﺎ ﺍﻟﻤﺴﺘﻌﻤﻠﻬﺎ ﺍﻟﻤﺴﺘﻌﻤﻠﻬﺎ ﺍﻟﻤﺴﺘﻌﻤﻠﻬﺎ ﺍﻟﻤﺴﺘﻌﻤﻠﻬﺎ ﺍﻟﻤﺴﺘﻌﻤﻠﻬﺎ ﺍﻟﻤﺴﺘﻌﻤﻠﻬﺎ ﺍﻟﻤﺴﺘﻌﻤﻠﻬﺎ ﺍﻟﻤﺴﺘﻌﻤﻠﻬﺎ ﺍﻟﻤﺴ

The SURGIMEDICS® TMP® Vision Cardioplegia Delivery System is substantially equivalent to the following legally marketed cardioplegia heat exchangers:

Sorin Biomedical Buckberg BCD Vanguard (No K number identified)
Sorin Biomedical BCD Advanced Blood Cardioplegia System (K925369)
Avecor Cardiovascular MYOtherm Cardioplegia System (K904171)

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Device Description and Substantial Equivalence: 7.

Intended Use: The Vision Cardioplegia Delivery System is intended for mixing, cooling, warming, and delivery of oxygenated blood cardioplegia solution during cardiopulmonary bypass.

Substantial Equivalence: The Vision Cardioplegia Delivery System is substantially equivalent to the above listed cardioplegia heat exchangers based on their intended use, design, materials, and principles of operation.

Operational and Technological Characteristics: Information provided in this Premarket Notification to support the determination of substantial equivalence for the Vision Cardioplegia Delivery System includes descriptive information about the intended use, operation, and technological characteristics, as well as comparative bench testing which characterizes device performance.

When the performance of the Vision Cardioplegia Delivery System is compared to the Sorin BCD Vanguard Cardioplegia System, the SURGIMEDICS®/TMP®, both devices showed similar rates of hemolysis, heat exchange effectiveness, warming, cooling, internal resistance to flow, maximum water and blood side pressure tolerance, and debubbling capacity.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The eagle is positioned diagonally, with its head pointing towards the upper left and its tail towards the lower right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

AUG 8 1997

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

Surgimedics, Inc. c/o Ms. Rosina Robinson Staff Consultant Medical Device Consultants, Inc. 49°Plain Street North Attleboro, Massachusetts 02760

K964571 Re : Surqimedics®/TMP® Vision Cardioplegia Delivery System (BCD) Requlatory Class: II (Two) Product Code: 74 DTR Dated: June 5, 1997 Received: June 6, 1997

Dear Ms. Robison:

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 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 requlations 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation 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 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 - Ms. Rosina Robinson

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) 594-4648. 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 regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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"dsmo@fdadr.cdrh.fda.gov."

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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Image /page/4/Picture/0 description: The image shows the text "870.4246 - DTRII - CPB Heat Exchanger/Delivery Syste". The text appears to be handwritten. The text is black and the background is white.

510(k) Number (if known):	K964571
Device Name:	Vision Cardioplegia Delivery System

Indications For Use:

The SURGIMEDICS®/TMP® Vision Cardioplegia Delivery System is intended to mix, cool, warm, and deliver oxygenated blood cardioplegia solution during cardiopulmonary bypass.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Roa L. Rempaule

vision Sign-Off vision of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number K96457

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 870.4240 Cardiopulmonary bypass heat exchanger.

(a)
Identification. A cardiopulmonary bypass heat exchanger is a device, consisting of a heat exchange system used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device.(b)
Classification. Class II (performance standards).