(42 days)
The ThoraTrakTM minimally invasive cardiac surgery (MICS) retractor system is intended to provide surgical access for minimally invasive cardiothoracic procedures, including minimally invasive coronary artery bypass grafting (CABG) surgery and LIMA harvest, by retraction of soft and bony tissue.
The ThoraTrak™ minimally invasive cardiac surgery (MICS) retractor system is designed for use with a minimally invasive thoracotomy, an incision in the chest wall into the pleural space, for procedures that include Coronary Artery Bypass Grafting (CABG) and Left Internal Mammary Artery (LIMA) harvesting. It consists of a retractor rack, 2 sets of LIMA blades, 4 sets of thoracotomy blades, and 2 extended mount blades. The retractor rack and blades are chromecoated stainless steel. They are non-sterile, nonpyrogenic, and reusable.
This document K132645 is a 510(k) summary for a Class I manual surgical instrument (ThoraTrak™ MICS Retractor System). Class I devices generally have the lowest risk and typically do not require extensive clinical studies or performance data to demonstrate substantial equivalence to a predicate device.
The provided text does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria in the way typically expected for devices requiring performance testing (e.g., diagnostic devices, software devices).
Here's why and what can be inferred:
- Device Type: The ThoraTrak™ MICS Retractor System is a manual surgical instrument, specifically a retractor. For such devices, the primary considerations for substantial equivalence often revolve around material safety, mechanical integrity, and equivalence in design and intended use to existing predicate devices.
- Regulatory Class: It is classified as Class I (21 CFR 878.4800, Product Code: GAD). Class I devices are subject to general controls, which generally focus on aspects like good manufacturing practices, labeling, and adverse event reporting, rather than extensive clinical performance studies.
- 510(k) Summary Content: The summary focuses on comparing the modified device to a legally marketed predicate device, highlighting similarities in intended use, technological characteristics, operating principle, design features, base materials, and shelf life. This is the typical approach for demonstrating substantial equivalence for Class I devices where fundamental safety and effectiveness are established by the predicate.
Therefore, for this specific device and submission, the following points would apply if we were to try and complete the requested table and information, recognizing that the supplied text does not detail all items:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied for Class I Manual Surgical Instruments) | Reported Device Performance (Summary of K132645) |
|---|---|
| Mechanical Integrity/Durability: Device maintains its structural integrity and functionality during intended use. | Not explicitly stated as a numerical criterion or test result, but implied by "Same operating principle" and "Same base materials" as the predicate device. The device is reusable, suggesting durable materials and construction. |
| Biocompatibility: Materials are safe for patient contact. | Not explicitly stated as a separate criterion, but implied by "Same base materials" as the predicate device, which would have established biocompatibility. The device is non-sterile and non-pyrogenic. |
| Dimensional & Design Equivalence: Device dimensions and design features are equivalent to the predicate, allowing for comparable performance. | "Same design features" and "Same technological characteristics" as the predicate device are stated, indicating this criterion is met. |
| Functional Equivalence: Device performs its intended function (tissue retraction) as effectively as the predicate. | "Same intended use," "Same operating principle," and "Same design features" are stated, implying functional equivalence to the predicate. |
| No New Safety or Effectiveness Concerns: The modifications do not introduce new risks or reduce effectiveness compared to the predicate. | The conclusion states "the indications for use modification... results in a substantially equivalent device because the fundamental scientific principle, operating principle, design features, and overall intended use are unchanged from the predicate device." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable/Not provided. The submission focuses on substantial equivalence based on design and material comparison to a predicate, not on a clinical or performance test set with a sample size as typically understood for diagnostic or interventional devices.
- Data Provenance: Not applicable/Not provided. There is no "data" in the sense of patient or test results presented in this 510(k) summary. The comparison is based on device specifications and regulatory assessment.
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)
- Not applicable/Not provided. There was no "test set" requiring expert-established ground truth for a device like this.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided.
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/Not provided. This device is a manual surgical retractor, not an AI-assisted diagnostic or interventional system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. This device is a manual surgical retractor, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided. The "ground truth" for this filing is the established safety and effectiveness of the legally marketed predicate device, as demonstrated through its history of use and prior regulatory clearance.
8. The sample size for the training set
- Not applicable/Not provided. There is no "training set" for a device of this type.
9. How the ground truth for the training set was established
- Not applicable/Not provided.
§ 878.4800 Manual surgical instrument for general use.
(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(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 § 878.9.