(90 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 TS Medical Circumcision Clamp is a stainless steel, reusable, and "mogenstyle" circumcision clamp. The T.S. Medical Circumcision Clamps are constructed of stainless steel that meets the requirements of ASTM-F 899, Stainless Steel Bullet. Bar and Wire for Surgical Instruments. The following size will be offered: 2.5 mm.
The provided documentation for the T.S. Medical Circumcision Clamp (K033403) states that no non-clinical or clinical tests were performed to establish acceptance criteria or demonstrate device performance.
Therefore, most of the requested information cannot be provided from this document.
Here's what can be extracted based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
2. Sample size used for the test set and data provenance:
- Not applicable, as no tests were performed.
3. Number of experts used to establish the ground truth for the test set and their qualifications:
- Not applicable, as no tests were performed.
4. Adjudication method for the test set:
- Not applicable, as no tests were performed.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:
- No, an MRMC study was not done.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, this device is a physical medical instrument, not an algorithm. Therefore, standalone performance in this context is not applicable.
7. The type of ground truth used:
- Not applicable, as no tests were performed.
8. The sample size for the training set:
- Not applicable, as no tests were performed.
9. How the ground truth for the training set was established:
- Not applicable, as no tests were performed.
Summary of what the document states instead:
The submission for the T.S. Medical Circumcision Clamp (K033403) relies on substantial equivalence to predicate devices rather than new performance data.
- The device is described as identical in materials, design, and intended use to the circumcision clamps marketed by Tri-State Medical Corp. (K935491) and the "grandfathered" Mogen Circumcision Clamp marketed by Mogen Circumcision Instruments, Ltd.
- Non-clinical tests were not performed.
- Clinical tests were not performed.
- The conclusion is that the device is "safe and effective for its intended use" based on this substantial equivalence argument.
§ 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.