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510(k) Data Aggregation
(248 days)
MEDICON MOGEN CLAMP
The Medicon Mogen Circumcision Clamp is an instrument used in a medical procedure to compress the foreskin of the penis during circumcision of a male infant or child.
The Medicon Mogen Circumcision Clamp is a stainless steel, reusable circumcision clamp consisting out of multiple components, including clamp and locking bar. For safety reasons the lock screw of the clamp is fixed with a spot welding point in order not to become loose. For safety reasons the clamp opens to a maximum of 2.5 mm, in order not to trap the glans and the edges of closing area are chamfered and rounded inside and outside to avoid injuries
The provided text describes a Medical Device: Medicon Mogen Circumcision Clamp, which is a reusable stainless steel instrument used to compress the foreskin of the penis during circumcision of a male infant or child.
Here's an analysis of the acceptance criteria and supporting study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance (Medicon Mogen Circumcision Clamp) |
|---|---|---|
| Material | Stainless Steel Standards | Complies with ASTM F 899-09 and ISO 7153-1 (Standard Specification for Stainless Steels for Surgical Instruments). |
| Corrosion Resistance | Corrosion Standards | Complies with ASTM F 1089-10 and ISO 13402 (Standard Specifications for resistance against corrosion and autoclaving of Surgical Instruments). All components are corrosion resistant. |
| Sterilization | Sterilization Validation | Sterilization validation performed (though non-sterile upon supply, intended for autoclave steam sterilization by user). Demonstrated substantial equivalence in sterilization. |
| Mechanical Performance | Mechanical Performance Testing | Performance testing mechanical characteristics performed. Jaws designed to separate to a maximum of 2.5 mm in open position. Locks with a defined closing force. Lock screw fixed with a spot welding point. Demonstrated substantial equivalence in mechanical performance. |
| Design/Safety | Design Features | Opens to a maximum of 2.5 mm (to not trap glans). Edges of closing area are chamfered and rounded inside and outside (to avoid injuries). Lock screw fixed with spot welding (not to become loose). |
| Intended Use | Consistent with Predicate | Identical to predicate device: "an instrument used in a medical procedure to compress the foreskin of the penis during circumcision of a male infant or child." |
| Operating Principle | Consistent with Predicate | Identical to predicate device. |
Regarding the study that proves the device meets the acceptance criteria:
The document describes a non-clinical laboratory study comparing the Medicon Mogen Circumcision Clamp to a predicate device (T. S. Medical Circumcision Clamp, K033403) to establish substantial equivalence.
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify a "sample size" in the context of human subjects or a clinical test set. The testing performed was non-clinical laboratory testing on the device itself.
- Data Provenance: The data provenance is from non-clinical laboratory tests conducted on the Medicon Mogen Circumcision Clamp, likely at the manufacturer's facility or a contracted lab. The country of origin of the device manufacturer is Germany (MEDICON eG). This was a laboratory study, not a human study, so terms like "retrospective or prospective" are not directly applicable in the typical clinical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This was a non-clinical laboratory study involving material and mechanical performance testing, not human-centered data requiring expert ground truth for diagnostic accuracy. Standards (ASTM, ISO) served as the "ground truth" for material and performance specifications.
4. Adjudication method for the test set
- Not applicable. As this was a non-clinical laboratory study, there was no adjudication method involving expert review of results in the traditional sense of a clinical outcome. Compliance with established engineering and material standards determined acceptance.
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 is a medical instrument, not an AI-powered diagnostic or assistive technology. Therefore, no MRMC study or AI-related effectiveness analysis was performed or is relevant to this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical instrument, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the non-clinical tests was established by recognized international and national standards for surgical instruments and materials:
- ASTM F 899-09 (Standard Specification for Stainless Steels for Surgical Instruments)
- ISO 7153-1 (Surgical instruments — Metallic materials — Part 1: Stainless steel)
- ASTM F 1089-10 (Standard Specification for Wrought Stainless Steels for Surgical Instruments Used in the Body)
- ISO 13402 (Surgical instruments — General aspects including safety, marking and information provided by the manufacture)
8. The sample size for the training set
- Not applicable. This was not a machine learning or AI algorithm development; therefore, there was no "training set." The device itself was tested directly against established physical and material standards.
9. How the ground truth for the training set was established
- Not applicable. (See point 8. above). The "ground truth" for the acceptance criteria was based on compliance with industry standards, not a training set.
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