(85 days)
There are no predicate devices mentioned in the document. The text "Not Found" appears under the "Predicate Device(s)" heading, indicating that no predicate devices were identified within the provided input.
Not Found
No
The description focuses on mechanical stabilization and vacuum technology, with no mention of AI, ML, or related concepts.
Yes
The device is intended for use during coronary artery bypass grafting to isolate a diseased artery and minimize motion of the beating heart to facilitate the grafting procedure, which is a therapeutic intervention.
No
The device is a tissue stabilizer used to facilitate surgical procedures by minimizing motion of the heart; it does not diagnose medical conditions.
No
The device description explicitly mentions physical components like a plastic handle, vacuum tubing connection, malleable stainless steel arm, suction tip, and "feet" design, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "coronary artery bypass grafting to isolate diseased artery and minimize motion of the beating heart to facilitate the grafting procedure." This is a surgical procedure performed directly on the patient's heart.
- Device Description: The description details a physical device with a handle, arm, suction tip, and "feet" designed for physical manipulation and stabilization during surgery.
- Lack of IVD characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) in vitro (outside the body) to provide diagnostic information.
IVD devices are used to perform tests on samples taken from the body to diagnose diseases or conditions. This device is a surgical tool used in vivo (within the body) during a surgical procedure.
N/A
Intended Use / Indications for Use
The indications or intended use for the DLP Octopus™ Tissue Stabilizer and the predicate product, Cardiothoracic Systems, Inc. (CTS) Thoracic Access Platform and Stabilizer are the same. Both are intended for use du ring coronary artery bypass grafting to isolate diseased artery and minimize motion of the beating heart to facilitate the grafting procedure.
Product codes
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Device Description
The design of the Octopus"" is similar to both predicate products referenced in the Comparison Information Section. It features plastic handle with vacuum tubing connection, malleable stainless steel arm and suction tip similar to the DLP Cardiac Suction Tube product. The "feet" design of the Octopus" is intended to position the anastomosis site between two "feet" for isolation and stabilization control which is the same as the CTS Thoracic Access Platform and Stabilizer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4500 Cardiovascular surgical instruments.
(a)
Identification. Cardiovascular surgical instruments are surgical instruments that have special features for use in cardiovascular surgery. These devices include, e.g., forceps, retractors, and scissors.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
JAN 30 1997
SUMMARY OF SAFETY AND EFFECTIVENESS CFR 807.92(c)
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- INDICATIONS: The indications or intended use for the DLP Octopus™ Tissue Stabilizer and the predicate product, Cardiothoracic Systems, Inc. (CTS) Thoracic Access Platform and Stabilizer are the same. Both are intended for use du ring coronary artery bypass grafting to isolate diseased artery and minimize motion of the beating heart to facilitate the grafting procedure.
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- DESIGN: The design of the Octopus"" is similar to both predicate products referenced in the Comparison Information Section. It features plastic handle with vacuum tubing connection, malleable stainless steel arm and suction tip similar to the DLP Cardiac Suction Tube product. The "feet" design of the Octopus" is intended to position the anastomosis site between two "feet" for isolation and stabilization control which is the same as the CTS Thoracic Access Platform and Stabilizer.
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- MATERIALS: The contact surface of the Octopus™ feet or tentacles on the heart is a plastic material that has been biocompatibility tested.
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- SAFETY AND EFFICACY: No differences in safety and efficacy. Materials have undergone acceptable biocompatibility testing. Intended use is same as CTS Stabilizer predicate product. Design characteristics are similar to both DLP Cardiac Suction and CTS Stabilizer predicate products.
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- DIFFERENCES: Primary differences between Octopus™ and CTS Stabilizer is the Octopus " functions by applying controlled suction to the myocardium whereas the CTS Stabilizer applies random amount of pressure.
Roger W. Brink
Roger W. Brink Director of Regulatory Affairs DLP, Div. of Medtronic, Inc.
(616) 732-7337 Telephone (616) 242-5214 Fax