(248 days)
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.
§ 884.4530 Obstetric-gynecologic specialized manual instrument.
(a)
Identification. An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:(1) An amniotome is an instrument used to rupture the fetal membranes.
(2) A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant.
(3) An umbilical clamp is an instrument used to compress the umbilical cord.
(4) A uterine curette is an instrument used to scrape and remove material from the uterus.
(5) A fixed-size cervical dilator is any of a series of bougies of various sizes used to dilate the cervical os by stretching the cervix.
(6) A uterine elevator is an instrument inserted into the uterus used to lift and manipulate the uterus.
(7) A gynecological surgical forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynecological examination.
(8) A cervical cone knife is a cutting instrument used to excise and remove tissue from the cervix.
(9) A gynecological cerclage needle is a looplike instrument used to suture the cervix.
(10) A hook-type contraceptive intrauterine device (IUD) remover is an instrument used to remove an IUD from the uterus.
(11) A gynecological fibroid screw is an instrument used to hold onto a fibroid.
(12) A uterine sound is an instrument used to determine the depth of the uterus by inserting it into the uterine cavity.
(13) A cytological cervical spatula is a blunt instrument used to scrape and remove cytological material from the surface of the cervix or vagina.
(14) A gynecological biopsy forceps is an instrument with two blades and handles used for gynecological biopsy procedures.
(15) A uterine tenaculum is a hooklike instrument used to seize and hold the cervix or fundus.
(16) An internal pelvimeter is an instrument used within the vagina to measure the diameter and capacity of the pelvis.
(17) A nonmetal vaginal speculum is a nonmetal instrument used to expose the interior of the vagina.
(18) A fiberoptic nonmetal vaginal speculum is a nonmetal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.
(b)
Classification. (1) Class II (special controls). The device, when it is an umbilical clamp with or without a cutter, a uterine tenaculum which is sterile and does not use suction and is intended for single use, a nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.(2) Class I for the amniotome, uterine curette, cervical dilator (fixed-size bougies), cerclage needle, IUD remover, uterine sound, and gynecological biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.