(235 days)
This device is a protective finger guard accessory to the surgeon's glove. (a) intended to provide needlestick and suture/scalpel protection during a variety of surgical procedures. It is a protective finger guard accessory to the surgeon's glove. It is used on the finger or thumb of the non-dominant hand usually used to retract, stabilize, compress, and position tissue during surgical procedures. (b) Facilitate suture handling and placement.
This device is a sterile single use protective finger guard worn in conjunction with surgeon's glove.
The provided 510(k) summary for the MARINA MEDICAL FINGER PROTECTOR (K042534) does not describe a clinical study or performance tests with specific acceptance criteria and reported device performance in the way a typical diagnostic device submission would. Instead, this submission relies on demonstrating substantial equivalence to a predicate device (DIGICAP, K012199) primarily through comparison of technological characteristics.
Therefore, the acceptance criteria and study information will be presented reflecting this approach.
Acceptance Criteria and Study Proving Device Meets Criteria
The Marina Medical Finger Protector (K042534) sought clearance by demonstrating substantial equivalence to a predicate device (DIGICAP, K012199). The "acceptance criteria" in this context are the demonstrated identical technological characteristics to the predicate device, which inherently implies identical performance, safety, and effectiveness. The "study" proving this largely involves a comparative analysis against the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstrated Substantial Equivalence to Predicate K012199) | Reported Device Performance (as demonstrated by comparison) |
|---|---|
| Indications for use are identical | Identical |
| Target population is identical | Identical |
| Design is identical | Identical |
| Materials are identical | Identical |
| Performance is identical | Identical |
| Sterility is identical | Identical |
| Biocompatibility is identical | Identical |
| Mechanical safety is identical | Identical |
| Chemical safety is identical | Identical |
| Anatomical sites are identical | Identical |
| Human factors are identical | Identical |
| Compatibility with environment and other devices is identical | Identical |
| Where used is identical | Identical |
| Standards met are identical | Identical |
Note: "Energy used and/or delivered", "Electrical safety", "Thermal safety", and "Radiation safety" were deemed "Not applicable" for this device and thus were not criteria for comparison.
2. Sample size used for the test set and the data provenance
There was no "test set" in the traditional sense of clinical data or performance measurements on a specific sample size of the device. The comparison was based on the technological characteristics and established performance of the legally marketed predicate device (DIGICAP, K012199). Data provenance for such comparison would be the established regulatory clearances and documentation of the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth was not established by experts for a specific test set, as no clinical or performance study with a test set was conducted for this submission. The ground truth for device safety and effectiveness was established through the prior clearance of the predicate device and the comprehensive comparison of characteristics.
4. Adjudication method for the test set
Not applicable. No test set requiring adjudication was used.
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 a sterile single-use protective finger guard, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, not an algorithm.
7. The type of ground truth used
The "ground truth" for the clearance of the Marina Medical Finger Protector was the demonstrated substantial equivalence to a predicate device (DIGICAP, K012199) that had already been deemed safe and effective. The premise is that if the new device is technologically identical to a legally marketed device, it shares the same safety and effectiveness profile.
8. The sample size for the training set
Not applicable. No training set was used for an algorithm.
9. How the ground truth for the training set was established
Not applicable. No training set for an algorithm was used or required.
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls).