(267 days)
Not Found
No
The summary describes a system for mixing, cooling, warming, and delivering cardioplegia solution, with performance studies focused on physical characteristics and comparisons to predicate devices. There is no mention of AI, ML, image processing, or data-driven decision making.
No
The device is intended to prepare and deliver a solution, not to directly treat a medical condition or disease itself. It supports a medical procedure (cardiopulmonary bypass) but is not a therapeutic device in its own right.
No
The device is described as a delivery system for cardioplegia solution, which involves mixing, cooling, warming, and delivering the solution. Its function is to prepare and deliver a substance to the patient, not to diagnose a condition or disease. The performance studies also focus on physical characteristics and delivery effectiveness rather than diagnostic capabilities.
No
The device description explicitly states it is a "Cardioplegia Delivery System" intended for mixing, cooling, warming, and delivery, which are hardware-based functions. The performance studies also describe bench testing of physical characteristics like hemolysis, heat exchange, and pressure tolerance, further indicating a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states the device is intended to "mix, cool, warm, and deliver oxygenated blood cardioplegia solution during cardiopulmonary bypass." This is a therapeutic and procedural function performed on the patient during surgery, not a diagnostic test performed on a sample taken from the patient.
- Device Description: The description reiterates the same functions, focusing on the preparation and delivery of a solution used in a medical procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) to diagnose a condition, monitor a disease, or determine a patient's health status.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnostic purposes. This device's function is entirely focused on preparing and delivering a solution used during a surgical procedure.
N/A
Intended Use / Indications for Use
The Vision Cardioplegia Delivery System is intended for mixing, cooling, warming, and delivery of oxygenated blood cardioplegia solution during cardiopulmonary bypass. The SURGIMEDICS®/TMP® Vision Cardioplegia Delivery System is intended to mix, cool, warm, and deliver oxygenated blood cardioplegia solution during cardiopulmonary bypass.
Product codes (comma separated list FDA assigned to the subject device)
DTR, 74 DTR
Device Description
The Vision Cardioplegia Delivery System is intended for mixing, cooling, warming, and delivery of oxygenated blood cardioplegia solution during cardiopulmonary bypass. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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 Drive | ||
| The Woodlands Research Forest | ||
| The Woodlands, TX 77381 | ||
| 3. | Contact Name: | Russell Jones, Manager of Regulatory Affairs |
| Telephone 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)
1
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.
2
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.
3
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
4
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)