(15 days)
The Burbank Tenaculum is an accessory used in conjunction with the Vascular Control Systems Transvaginal Doppler Probe. The device is intended to seize and hold the cervix and to hold and secure the Transvaginal Doppler Probe in place, while performing audible Doppler procedures.
The Burbank Tenaculum is a stainless steel, ring-handled instrument with a hook at the distal end of one arm and a guide rod attached to the distal end of the other arm. The proximal end of the guide rod is threaded to guide insertion of the Vascular Control Systems Transvaginal Doppler Probe (TDP) into the vagina and secure the TDP in place. A uterine sound is brazed at the distal end of the guide rod intended to be inserted through the cervical opening into the uterine cavity.
The provided text describes a medical device, the Burbank Tenaculum, seeking 510(k) clearance. This means it is claiming substantial equivalence to legally marketed predicate devices, rather than establishing entirely new performance criteria through extensive clinical trials. Therefore, the information typically associated with acceptance criteria and a study to prove they are met (like a multi-reader multi-case study, detailed ground truth establishment, or specific performance metrics with statistical analysis) is not present in this document.
Instead, the document focuses on demonstrating that the Burbank Tenaculum is as safe and effective as its predicate devices based on design similarities and intended use.
Here's an analysis based on the information provided, specifically addressing your points where possible:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of explicit, quantifiable acceptance criteria or reported device performance in the manner one might expect for a new, higher-risk device. The clearance is based on substantial equivalence to predicate devices. The "reported device performance" is essentially the qualitative claim that it meets its product specifications and does not raise new safety or effectiveness issues, similar to already marketed devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functions as an accessory for Transvaginal Doppler Probe | Intended to seize/hold cervix and secure TDP in place for Doppler procedures |
| Similar design/materials to predicate devices | Stainless steel, ring-handled, hook, guide rod, uterine sound. Materials similar to predicates. |
| Does not raise new safety/effectiveness issues | "Found to meet its product specifications." "Does not raise new issues of safety, effectiveness, or performance." |
| Capable of seizing and holding the cervix | Designed with a hook for seizing and holding the cervix, ratchet closure |
| Capable of securing an ultrasound device | Equipped with a mechanism to hold an ultrasound device |
| Uterine sound component is substantially equivalent in design and materials | Uterine sound is substantially equivalent in design and materials as the Sims Uterine Sound. |
| Provided non-sterile and reusable | Provided non-sterile, and reusable |
2. Sample size used for the test set and the data provenance
No test set sample size or data provenance is mentioned. The clearance is based on design and material comparisons to predicate devices, and internal design control procedures.
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 by experts for a test set in the context of this 510(k) submission.
4. Adjudication method for the test set
Not applicable. No test set requiring adjudication 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 is a medical instrument (tenaculum), not an AI device or imaging analysis tool. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a manual surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as it applies to diagnostic or AI devices is not relevant here. The ground for substantial equivalence is the design, materials, intended use, and functioning characteristics comparison to existing, legally marketed predicate devices, and the claim that it meets its own product specifications.
8. The sample size for the training set
Not applicable. As a physical instrument, there is no "training set" in the machine learning sense. The "training" essentially comes from engineering design, material selection, and manufacturing processes, guided by existing device standards and performance of predicates.
9. How the ground truth for the training set was established
Not applicable. There is no training set mentioned. The "ground truth" for its design and manufacturing would be established through engineering specifications, material properties, and adherence to quality systems and design controls (as mentioned: "The Burbank Tenaculum has been designed and tested per design control procedures and was found to meet its product specifications and does not raise new issues of safety, effectiveness, or performance of the product.").
§ 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.