(88 days)
A Circumcision Clamp is an instrument used in a procedure to compress the foreskin of the penis during circumcision of male infant or child.
The Fine Surgical Gomco Circumcision Clamp is a disposable medical device that is constructed of chrome plated brass. The device will be sold non sterile for further processing (ie. Packaging and sterilization) by the final distributor. We do not intend to sell these devices directly to the end user.
Here's an analysis of the provided text regarding the Fine Surgical Circumcision Clamp's acceptance criteria and the study (or lack thereof) to prove it:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance (Implicit from Substantial Equivalence Claim) |
|---|---|
| Intended Use: Used in medical procedure to compress the foreskin of the penis during circumcision of a male infant or child. | Meets intended use, identical to predicate device, with additional size for "child." |
| Material: Chrome plated brass. | Chrome plated brass. |
| Disposable: Not intended for re-use. | Disposable. |
| Non-sterile: Sold non-sterile for further processing (packaging and sterilization) by final distributor. | Sold non-sterile for further processing. |
| Safety and Effectiveness: Implied to be safe and effective for its intended use, based on predicate. | Declared safe and effective based on substantial equivalence to predicate device. |
| Available Sizes (expanded): Extra Small: 1.1 cm, Newborn: 1.3 cm, Infant: 1.45 cm, Child: 1.6 cm. | Device is available in these sizes, including a new "Child" size. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. No test set was used because no non-clinical or clinical tests were performed.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No ground truth was established from experts for a test set, as no tests were performed.
4. Adjudication method for the test set:
- Not applicable. No test set 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 manual surgical instrument, not an AI-powered diagnostic or assistive technology. No MRMC study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a manual surgical instrument, not an algorithm.
7. The type of ground truth used:
- Implicit Ground Truth: The ground truth for the acceptability of the Fine Surgical Circumcision Clamp is based on its substantial equivalence to a legally marketed predicate device (Centurion® CirClamp™). The predicate device's prior marketing and presumed safety/effectiveness serve as the "ground truth" for the new device's acceptance.
8. The sample size for the training set:
- Not applicable. This device is a manual surgical instrument and does not involve AI or machine learning, thus no training set was used.
9. How the ground truth for the training set was established:
- Not applicable. There was no training set.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
Based on the provided 510(k) summary, "no clinical testing was performed" and "non Clinical testing was not performed."
The "study" that proves the device meets the acceptance criteria is explicitly stated as a comparison to a predicate device (the Centurion® CirClamp™). The submitter, Fine Surgical Instruments, Inc., argues that their device is "identical in materials, design, and intended use" to the predicate, with two minor differences:
- It will be offered non-sterile for further processing.
- A larger size will be available (1.6 cm, designated "Child").
The FDA's finding of substantial equivalence allows the device to be marketed. This means that the FDA determined the new device is as safe and effective as a legally marketed device that was on the market prior to May 28, 1976 (or a reclassified device that doesn't need premarket approval). The acceptance criteria are "met" by demonstrating that the new device is essentially the same as an already accepted device.
§ 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.