(184 days)
The CTS Heart-LIFT Balloon Positioner is a surgical instrument intended to lift and position the heart during cardiac surgery.
The CTS Heart-LIFT Balloon Positioner consists of a manually inflatable, latex-free balloon attached to a malleable shaft. The balloon is inflated using a hand pump, which is attached via a flexible air tube to the proximal end of the malleable shaft. A pressure release valve allows deflation of the balloon. There also is a pressure relief valve to prevent over-inflation.
Here's an analysis of the provided text regarding the 510(k) submission for the CardioThoracic Systems, Inc. Heart-LIFT Balloon Positioner, focusing on acceptance criteria and study details:
This 510(k) summary does not include the type of detailed acceptance criteria and study information typically found for devices that rely on performance metrics like sensitivity, specificity, accuracy, or reader studies. This is because the Heart-LIFT Balloon Positioner is a Class I device and its submission is based on substantial equivalence to a predicate device (Janke-Barron Heart Support manufactured by Baxter), rather than a detailed performance study with statistical endpoints.
Therefore, many of the requested categories (like sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of submission.
The "acceptance criteria" here are met by demonstrating that the new device is functionally similar and safe for its intended use compared to an already marketed equivalent.
Summary of Acceptance Criteria and Study Information from the Provided Text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Intended Use: Device is a surgical instrument intended to lift and position the heart during cardiac surgery. | The device performs as designed and is suitable for its intended use, aligning with the predicate device. |
| Patient Population: Similar to predicate device. | Not explicitly detailed, but implied to be cardiac surgery patients. |
| Anatomical Site: Similar to predicate device. | Not explicitly detailed, but implied to be the heart. |
| Functionality: Manually inflatable, latex-free balloon, malleable shaft, hand pump, flexible air tube, pressure release valve, pressure relief valve (to prevent over-inflation). | Bench testing and animal testing results verified that the Heart-LIFT Balloon Positioner performs as designed. |
| Safety: Device is safely used for its intended purpose. | Functional bench testing and animal testing were conducted to demonstrate this. |
| Substantial Equivalence: Device is substantially equivalent to the predicate device (Janke-Barron Heart Support by Baxter). | The submission claims substantial equivalence in intended use, patient population, and anatomical site. |
2. Sample size used for the test set and the data provenance:
- Not explicitly stated for a statistical "test set." The studies mentioned are "functional bench testing" and "animal testing." These are likely engineering and pre-clinical tests, not necessarily human clinical trials with defined statistical sample sizes for a diagnostic or AI device. Data provenance (country of origin, retrospective/prospective) is also not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" for this type of device, which is a surgical tool, would be its physical properties and its performance in a surgical environment (bench/animal testing), not expert interpretations of data like in an imaging study.
4. Adjudication method for the test set:
- Not applicable. This applies to expert reviews, which were not conducted for this type of device submission.
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:
- No, not done. This type of study is relevant for AI/diagnostic devices where human reader performance is a key measure. The Heart-LIFT Balloon Positioner is a surgical instrument.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, not applicable. This applies to AI algorithms.
7. The type of ground truth used:
- The "ground truth" for this device's performance is established through functional bench testing (evaluating physical properties and operational stability) and animal testing (evaluating its ability to lift and position the heart in a living system). This is more akin to engineering performance standards and pre-clinical safety/efficacy observations rather than expert consensus, pathology, or outcomes data in a clinical trial sense.
8. The sample size for the training set:
- Not applicable. This is for AI algorithms, which this device is not.
9. How the ground truth for the training set was established:
- Not applicable. This is for AI algorithms, which this device is not.
§ 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.