(33 days)
The Carevix™ Suction Cervical Stabilizer is indicated to snare, grasp, hold and manipulate cervical tissue.
Carevix™ Suction Cervical Stabilizer is a sterile, single-use, two-piece device consisting of three main parts: a reloadable vacuum reserve embedded inside the main body, including a piston to generate the vacuum, an activation/deactivation push-button, and an anatomic-shaped suction head to put in contact with the cervix. The suction head includes a rod that connects the main body.
The provided text describes a 510(k) premarket notification for the Carevix™ Suction Cervical Stabilizer. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a full study report for a novel medical device, especially an AI/ML-driven one.
Therefore, many of the requested details, particularly those pertaining to AI/ML device performance (sample size for test set, data provenance, number of experts for ground truth, adjudication, MRMC studies, standalone performance, training set details), are not present in the provided text, as this is a traditional medical device submission.
Here's what can be extracted based on the provided text:
Acceptance Criteria and Device Performance:
The document states that the device was evaluated against its design and user specifications, and that "All the results were in accordance with the test acceptance criteria." However, it does not provide a table of specific quantitative acceptance criteria or the reported device performance metrics for different parameters (e.g., specific force applied, vacuum pressure achieved, or a pass/fail rate for a clinical outcome).
Instead, it lists the types of tests performed and their general outcomes:
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Non-cytotoxic, non-sensitizing, non-irritating | "demonstrated the subject device is non-cytotoxic non-sensitizing, and non-irritating." |
| Sterilization | Meets ANSI/AAMI/ISO 11137-2:2013 standards | "Sterilization validation was performed... and was conducted following testing protocols used for the predicate device." (Implied successful validation) |
| Performance & Safety | Meets design and user specifications, no new safety/effectiveness questions raised compared to predicate. | "All tests were conducted according to the protocols used to validate the predicate device ASPIVIX v1.1. All the results were in accordance with the test acceptance criteria." |
Missing Information (as per the provided text):
- Sample size used for the test set and the data provenance: Not mentioned. The testing appears to be primarily bench testing (biocompatibility, sterilization, performance) rather than clinical studies with patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not mentioned. Ground truth as typically understood for AI/ML devices (e.g., disease presence) is not relevant to this device's testing.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/not mentioned.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is not an AI/ML device nor a diagnostic imaging device that would typically involve human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, as this is not an AI/ML algorithm.
- The type of ground truth used: For biocompatibility, the ground truth is established by standardized lab tests (e.g., cell viability, skin irritation). For performance, the ground truth is the device's design specifications. No "expert consensus" or "pathology" ground truth is mentioned.
- The sample size for the training set: Not applicable, as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.
Summary of what the document focuses on instead:
The document outlines a 510(k) submission for a modified medical device. The primary goal is to demonstrate "substantial equivalence" to a previously cleared predicate device (ASPIVIX v1.1 Cervical Suction Tenaculum, K203820). This is achieved by:
- Comparing Indications for Use: Stating they are the same ("to snare, grasp, hold and manipulate cervical tissue").
- Comparing Technological Characteristics: Identifying both similarities and differences (e.g., changes in rod length, inner diameter, trigger mechanism, vacuum generation, and two-piece vs. one-piece design).
- Providing Safety and Performance Data for the Modifications: This includes:
- Biocompatibility testing: Performed in accordance with ISO 10993-1, 10993-5, 10993-10, and ISO 14971:2019. Tests confirmed non-cytotoxic, non-sensitizing, and non-irritating results.
- Sterilization validation: Performed via e-beam in accordance with ANSI/AAMI/ISO 11137-2:2013.
- Performance and Safety testing: Conducted according to protocols used for the predicate device, with all results meeting acceptance criteria. The document states that newly identified risks (related to assembly) do not raise new questions of safety or effectiveness because they are identifiable before patient use.
- Conclusion: The testing results support the determination of substantial equivalence, meaning the modified device is considered as safe and effective as the predicate device.
In essence, this is a clearance for a physical medical instrument based on engineering and biological testing, not an AI/ML software 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.