(207 days)
The Diamics CerCol Cervical Sample Collector is indicated for the collection of cervical cytology material and its transfer for Pap analysis. The Diamics CerCol Cervical Sample Collector is not intended for use in pregnant women.
This device consists of a reusable handle and a multi-component assembly. The reusable handle provides a means of expanding and manipulating the CerCol™ Cervical Sample Collector so that the surface areas of the endo-cervix, ecto-cervix and transition zones of the cervix are completely contacted by the CerCol™ Cervical Sample Collector tip for the collection, transport, analysis and testing of exfoliated cervical epithelial cells. The CerCol™ Cervical Sample Collector will be available as a single use, non-sterile disposable device and the reusable handle will be available separately, but both components must be used together as part of the CerCol™ Cervical Sample Collector System.
The document K062433 describes the Diamics CerCol™ Cervical Sample Collection System, a device intended for the collection of cervical cytology material for Pap analysis. The submission focuses on demonstrating substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission primarily evaluates substantial equivalence based on the ability of the device to collect satisfactory cervical samples, indicated by the rate of satisfactory results and the presence of endocervical/transformation zone components, which are crucial for effective Pap testing.
| Acceptance Criterion | Target / Predicate Performance (based on MedScand Sample Collection Kit) | Reported Device Performance (Diamics CerCol™ Cervical Sample Collector) | Meets Criteria? |
|---|---|---|---|
| Satisfactory Sample Rate (Clinical Study 1) | 99.6% | 98.9% | Yes |
| Satisfactory Sample Rate (Clinical Study 2) | Not applicable (standalone CerCol study) | 99.0% | Yes |
| Endocervical/Transformation Zone Component | Not explicitly stated for predicate in this context | 98.0% (Clinical Study 2) | Yes |
| Biocompatibility | Deemed safe for intended use | Determined to be safe for intended use | Yes |
| Mechanical Performance (Expansion/Retraction) | Expected and adequate | Performs as expected and adequate | Yes |
| Conformance & Coverage | Expected | Performs as expected | Yes |
Note: The acceptance criteria are largely implied by demonstrating clinical performance comparable to the predicate device and by meeting pre-defined parameters in bench testing. Numerical targets are primarily derived from the predicate's performance or internal benchmarks for mechanical aspects.
2. Sample Size Used for the Test Set and Data Provenance
- Clinical Study 1:
- Test Set Size: 265 standard (predicate device) collections and 265 CerCol™ Cervical Sample Collections.
- Data Provenance: Pooled across two centers. No country of origin is explicitly mentioned, but typically for FDA submissions, studies are conducted in the US or in countries with comparable medical standards. The study appears to be prospective or concurrent as it compares two collection methods simultaneously.
- Clinical Study 2:
- Test Set Size: 102 CerCol™ Cervical Sample Collector collections.
- Data Provenance: Conducted at one center. No country of origin is explicitly mentioned. This study also appears to be prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not explicitly state the number or qualifications of experts used to establish the ground truth for interpreting the Pap analysis results. It refers to "satisfactory results" and "endocervical/transformation zone component," which would typically be determined by trained cytotechnologists and/or pathologists. However, the specific details about these experts are not provided in this summary.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method (e.g., 2+1, 3+1). It only mentions that the studies resulted in "satisfactory results," implying that the assessment of sample quality was done according to established laboratory protocols.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The studies described are clinical studies comparing the sample collection efficacy of the device to a predicate device, focusing on the quality of the collected sample rather than the diagnostic accuracy improvement of human readers with AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
This is a medical device for sample collection, not an AI or algorithm-based diagnostic tool. Therefore, a standalone algorithm-only performance study is not applicable to this device. The "Performance Data" section primarily addresses mechanical bench testing of the device components.
7. The Type of Ground Truth Used
The ground truth used in the clinical studies is based on the assessment of sample adequacy for Pap analysis. This includes:
- Satisfactory Result: Indicating that the collected sample is sufficient for cytological examination.
- Presence of Endocervical/Transformation Zone (EC/TZ) Component: Cytological evidence showing that cells from this critical area of the cervix (where most cervical cancers originate) have been collected. This assessment is typically made by trained laboratory personnel (cytotechnologists/pathologists) based on microscopic examination of the prepared slides.
8. The Sample Size for the Training Set
This document only describes performance and clinical studies for a medical device that collects samples. It does not describe an AI or machine learning model, so there is no "training set" in the context of AI. The "manufacturing process" section mentions Quality Control (QC) tests performed on 100% of manufactured devices, which could be considered an internal quality assurance process but not a "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
As there is no AI/ML model described, there is no "training set" and thus no ground truth established for it in this document.
§ 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.