(231 days)
The ASPIVIX v1.1 Cervical Suction Tenaculum is indicated to snare, grasp, hold and manipulate cervical tissue.
ASPIVIX v1.1 is a sterile, single-use, one-piece device that consists of four non-removable parts: a reloadable vacuum reserve embedded inside the main body, an activation / deactivation slider ring, a sliding tube to generate vacuum in the main body and an anatomic suction pad to put in contact with the cervix.
This document describes a 510(k) premarket notification for the ASPIVIX v1.1 Cervical Suction Tenaculum. It details the device's indications for use, comparison to a predicate device, and performance data provided to support substantial equivalence.
Based on the provided text, the device itself is a manual instrument, not an AI device. Therefore, many of the requested elements pertaining to AI device validation (e.g., sample size for test/training sets, data provenance, expert ground truth establishment, MRMC studies, standalone performance, etc.) are not applicable to this submission. The 510(k) summary focuses on demonstrating that the new manual device is as safe and effective as a legally marketed predicate device.
However, I can extract the information relevant to the performance data and acceptance criteria as described for this manual device.
1. Table of Acceptance Criteria and Reported Device Performance
The document broadly states that "All test results were in accordance with the test acceptance criteria." However, it does not explicitly list the specific numerical acceptance criteria for each test. Instead, it lists the types of performance tests conducted and the general conclusion.
| Performance Test Category | Specific Tests Conducted | Reported Device Performance and Acceptance Criteria |
|---|---|---|
| Biocompatibility | Cytotoxicity (ISO 10993-5:2009) | Non-cytotoxic |
| Sensitization (ISO 10993-10:2010) | Non-sensitizing | |
| Vaginal Irritation (ISO 10993-10:2010) | Non-irritating | |
| Sterilization | Sterilization validation (e-beam irradiation) | Performed in accordance with ANSI/AAMI/ISO 11137-2: 2013 |
| Performance Testing | Release traction force | In accordance with test acceptance criteria (specific values not provided in this summary) |
| Mechanical traction (pull) | In accordance with test acceptance criteria (specific values not provided in this summary) | |
| Bend strength | In accordance with test acceptance criteria (specific values not provided in this summary) | |
| Tissue safety | In accordance with test acceptance criteria (specific values not provided in this summary) |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the given text. The document refers to "testing" but does not specify the number of units or samples used for each test, nor the provenance (country of origin, retrospective/prospective) of any clinical data, as this is a physical medical device clearance, not an AI/software as a medical device (SaMD) submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable and not provided. As this is a manual medical device, there is no "ground truth" to be established by experts in the context of image interpretation or diagnostic accuracy. The testing involves physical and biological properties.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typical for human reader studies with AI, which are not relevant for this manual device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable and not provided. MRMC studies are used to evaluate diagnostic performance of AI or human readers, which is not the type of claim being made or evaluated for this manual device.
6. Standalone Performance (Algorithm Only)
This information is not applicable and not provided. This is a manual physical device, not an algorithm or software.
7. Type of Ground Truth Used
This information is not applicable in the AI/diagnostic sense. For this manual device, the "ground truth" or reference standards are the established performance metrics and biocompatibility standards (e.g., ISO standards for cytotoxicity, sensitization, irritation; mechanical testing standards for traction and bend strength).
8. Sample Size for the Training Set
This information is not applicable and not provided. This device does not involve machine learning or AI models with training sets.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided. As above, there is no training set as this is not an AI 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.