(153 days)
The CrossBay SonsoSure Sonohysterography and Endometrial Sampling Device is indicated for use to access the uterine cavity for saline infusion sonohysterography and to obtain endometrial biopsy, if indicated, utilizing the same device.
The CrossBay Medical SonoSure Device is a catheter that enables saline infusion sonohysterography procedures and endometrial biopsy collection within a single device. The catheter is comprised of standard polymer materials and contains a silicone acorn tip to enable a cervical seal. The distal end of the device contains a retractable nylon brush for endometrial biopsy sampling. The distal end of the device contains an empty PVC bag that can be filled with saline. The device is provided sterile and is intended for single use only.
Here's an analysis of the provided text regarding the CrossBay Medical SonoSure Sonohysterography and Endometrial Sampling Device:
Acceptance Criteria and Device Performance Study
Based on the provided 510(k) summary, the device's acceptance criteria and performance are primarily evaluated through non-clinical performance data (bench testing and biocompatibility). The document emphasizes substantial equivalence to predicate devices rather than establishing novel clinical performance metrics with specific acceptance criteria in a dedicated clinical study.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Inferred from testing) | Reported Device Performance |
|---|---|---|
| Physical/Mechanical | Adherence of endometrial biopsy brush bristles to catheter shaft when subjected to shear force | Performed according to product specifications; adherence confirmed through testing. |
| Force at break assessments | Performed according to product specifications; results ensured mechanical safety. | |
| Biocompatibility | Compliance with ISO 10993 | Cytotoxicity: Compliant |
| Sensitization: Compliant | ||
| Irritation: Compliant | ||
| Sterilization | Compliance with ISO 11135-1 and ISO 10993-7 | Complies with requirements for ethylene oxide sterilization. |
| Packaging & Shelf Life | Seal strength (ASTM F88) | Packaging maintains sterility over duration of shelf life. |
| Leak detection (ASTM F1929) | Packaging maintains sterility over duration of shelf life. | |
| Withstand transport without damage | Packaging can withstand transport without damage. | |
| Device mechanical safety and performance over shelf life | Device maintains mechanical safety and performance over shelf life. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a numerical sample size for the "test set" in terms of clinical subjects. The performance data discussed is non-clinical (bench testing, biocompatibility, sterilization, packaging). For these types of tests, samples would be units of the device itself (e.g., a certain number of devices for mechanical testing, material samples for biocompatibility). Specific numbers are not provided.
- Data Provenance: The data is generated through "physical bench testing," "biocompatibility testing," and "sterilization" and "packaging and shipping validation studies." This indicates the data is from laboratory or controlled testing environments, not from clinical subjects or patient data. Therefore, "country of origin" or "retrospective/prospective" is not applicable in the typical sense for clinical studies. It's internal product development and testing data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- This question is not applicable as the provided documentation describes non-clinical performance and does not involve establishing ground truth from experts on a test set (e.g., imaging diagnosis, pathology review). The "ground truth" for these tests are typically established by objective, measurable engineering and scientific standards (e.g., pass/fail criteria for mechanical strength, established limits for cytotoxicity).
4. Adjudication Method for the Test Set
- This question is not applicable as the assessment is based on non-clinical performance data against established standards and specifications, not on subjective expert interpretation requiring adjudication.
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
- No, an MRMC comparative effectiveness study was not done.
- The device is a physical medical instrument (catheter, brush), not an AI-powered diagnostic or assistive tool. Therefore, the concept of "human readers improving with AI assistance" is not relevant to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, a standalone performance study was not done.
- The device is a physical medical instrument, not an algorithm, and does not operate "standalone" without human interaction/use.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical tests described, the "ground truth" is derived from established scientific and engineering standards and specifications. For instance:
- Mechanical strength: Pass/fail criteria dictated by product specifications and engineering principles.
- Biocompatibility: Conformance to ISO 10993 standards and FDA guidance.
- Sterilization: Compliance with ISO 11135-1 and ISO 10993-7.
- Packaging: Adherence to ASTM guidelines.
- There is no mention of expert consensus, pathology, or outcomes data being used to establish a "ground truth" for the performance evaluation presented.
8. The Sample Size for the Training Set
- This question is not applicable. The device is a physical medical instrument and does not involve machine learning or AI, thus there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable as there is no training set for this 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.