(87 days)
The UroMed Sling Kit is intended to be used in a suburethral sling procedure for the alleviation of involuntary leakage of urine due to urinary incontinence in adult women.
The UroMed Sling Kit is indicated for use by the surgeon for placing a urethral sling. The kit provides instruments to help the surgeon place the sling beneath the urethra. The kit will be used in suburethral sling procedures for female urinary incontinence due to urethral hypermobility and/or intrinsic sphincter deficiency.
The UroMed Sling Kit is a single use, manual surgical kit for use during suburethral sling procedures. The kit will be used to place a sling (autograph, allograph, or synthetic) beneath the urethra in suburethral sling procedures.
The kit is comprised of two needles, two sheaths and two loops.
The kit components are constructed out of the following materials:
Needle: Surgical Stainless Steel, meeting ASTM Specification F899-84, with a handle constructed of Polyethylene Terephthalate (PET-P).
Sheath: Polyethylene
Loop: Surgical Stainless Steel, meeting ASTM Specification F899-84, with Polyethylene shaft
The provided text describes a 510(k) submission for the UroMed Sling Kit, a surgical instrument kit. It explicitly states that the device is determined to be substantially equivalent to legally marketed predicate devices, rather than establishing acceptance criteria through a specific study with defined performance metrics and a test set.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, expert involvement, and comparative effectiveness studies is not applicable in this context. The basis for clearance is demonstrating substantial equivalence to existing devices, not meeting novel performance criteria through a dedicated study.
Here's a breakdown of why each point is not applicable based on the provided text:
- A table of acceptance criteria and the reported device performance: Not applicable. The submission focuses on substantial equivalence to predicate devices, not on setting new performance acceptance criteria for the UroMed Sling Kit itself.
- Sample sized used for the test set and the data provenance: Not applicable. No specific test set or clinical study data is presented to demonstrate performance against acceptance criteria. The clearance is based on comparison to predicate devices.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment for a test set is part of a performance study, which is not described.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set requiring adjudication is described.
- 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 surgical instrument kit, not an AI-assisted diagnostic or therapeutic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a manual surgical instrument kit.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No performance study is detailed that would require ground truth establishment.
- The sample size for the training set: Not applicable. No training set for an algorithm is relevant for this medical device submission.
- How the ground truth for the training set was established: Not applicable. No training set for an algorithm is relevant for this medical device submission.
Summary based on the provided text:
The UroMed Sling Kit's acceptance was based on demonstrating substantial equivalence to existing, legally marketed predicate devices (Cook Loop Retriever, Cook Stamey Needle, Cook Fascial Dilator, Acufex Suture Retriever). This equivalence was established by comparing the device's intended use, indications for use, and materials to those of the predicate devices. The submission also cited compliance with relevant standards such as ASTM F899-84 for surgical stainless steel and ISO 10993-1 for biological evaluation of medical devices. No new clinical performance data or studies defining specific acceptance criteria for the UroMed Sling Kit were presented or required for its 510(k) clearance.
§ 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.