(112 days)
The Optical Aspirating Curette is indicated for use in visualizing the interior of the uterus and obtaining an endometrial tissue sample adequate for histological evaluation.
Imagyn's Optical Aspirating Curette consists of a disposable aspirating curette intended to remove tissue from the uterus and from the mucosal lining of the uterus by scraping and aspirating. The curette has a multi-lumen design that accommodates the introduction of Imagyn's reusable fiberoptic hysteroscope, which allows for visualization of the uterine cavity during the curettage procedure.
This K980096 510(k) summary for the Imagyn Medical Technologies, Inc. Optical Aspirating Curette (OAC) does not contain the detailed acceptance criteria or the study data that "proves" the device meets these criteria in the way a modern AI/ML device submission would.
Instead, this is a traditional medical device submission based on substantial equivalence to predicate devices. The "study" here is essentially the argument for functional and technological equivalence, rather than a performance study with acceptance criteria and statistical analysis as is common for AI/ML.
Let's break down why this information is missing based on the provided text, and what can be inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance (Inferred) |
|---|---|
| Visualization of uterine interior: OAC should provide similar visualization capabilities to the predicate hysteroscope. | The OAC accommodates the introduction of Imagyn's reusable fiberoptic hysteroscope, enabling visualization of the uterine cavity. This function is stated as similar to the MicroSpan Hysteroscope (K961688). |
| Obtaining endometrial tissue sample adequate for histological evaluation: OAC should be able to collect tissue samples of sufficient quality and quantity for pathology, similar to predicate curettes. | The OAC is a disposable aspirating curette intended to remove tissue from the uterus by scraping and aspirating. It is stated to be similar to the Milex "Tis-U-Trap" Uterine Suction Curette (K760264) and the Pipelle "Endometrial Suction Curette" (K881456). The intended use explicitly states "obtaining an endometrial tissue sample adequate for histological evaluation." |
| Safety and Biocompatibility: The materials and design should be safe for uterine use and biocompatible. | Not explicitly detailed, but assumed to be equivalent to predicate devices based on the 510(k) clearance process. The general controls provisions of the Act (including good manufacturing practice) apply. |
Explanation: In a traditional 510(k), particularly one from 1998, the "acceptance criteria" are implied by the performance of the predicate devices. The manufacturer's burden is to demonstrate that their new device performs as well as or in a similar manner to the legally marketed predicate devices for its intended use. There isn't a quantitative "performance" metric in the sense of accuracy, sensitivity, or specificity presented, because it's not a diagnostic AI/ML device.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable in the context of a performance study for this type of device. There isn't a "test set" of patient data in the way you'd consider for an AI model. The "test" here is the comparison of technological characteristics and intended use to existing devices.
- Data Provenance: Not applicable. The "data" considered is the design, materials, and intended use of the OAC and its predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- Number of Experts & Qualifications: Not applicable. There was no "ground truth" to establish for a test set of patient data. The regulatory body (FDA) reviews the technical specifications and comparisons provided by the manufacturer.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. No test set of patient data requiring adjudication was performed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- MRMC Study Status: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or documented in this summary.
- Effect Size: Not applicable, as no MRMC study was conducted.
Explanation: MRMC studies are typical for evaluating the impact of AI algorithms on human reader performance, especially in diagnostic imaging. This device is a manual surgical instrument, not an AI/ML diagnostic tool, so such a study would not be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
- Standalone Study Status: No, a standalone performance study (algorithm only) was not done.
- Explanation: This device is a manual medical instrument that requires human operation. It is not an algorithm, so the concept of "standalone performance" for an algorithm does not apply.
7. The Type of Ground Truth Used:
- Type of Ground Truth: Not applicable. No "ground truth" in terms of clinical outcomes, pathology, or expert consensus on a dataset was used for this submission. The "ground truth" for a 510(k) of this type is essentially the known safe and effective performance of the predicate devices.
8. The Sample Size for the Training Set:
- Sample Size: Not applicable. There is no AI/ML algorithm involved, so no training set was used.
9. How the Ground Truth for the Training Set was Established:
- Ground Truth for Training Set: Not applicable. No AI/ML algorithm or training set.
Summary of the 510(k) Approach for this Device:
This 510(k) submission relies entirely on substantial equivalence. The manufacturer argues that:
- The OAC curette component is similar to the Milex and Pipelle curettes.
- The OAC hysteroscope component is similar to Imagyn's MicroSpan Hysteroscope.
- Because the components are similar to already-cleared predicate devices, and the intended use is consistent with those predicates ("visualizing the interior of the uterus and obtaining an endometrial tissue sample adequate for histological evaluation"), the OAC should also be considered safe and effective.
The FDA's clearance letter confirms their determination of "substantial equivalence" based on this argument, meaning the device can proceed to market without new clinical performance studies demonstrating novel safety or effectiveness.
§ 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.