(94 days)
The Modified Hysterosalpingography Set is to be used for the injection of contrast material in the examination of the uterus and fallopian tubes.
The Modified Hysterosalpingography Set consists of three parts: a double-lumen, balloon bearing catheter; a semirigid placement sheath, and a syringe to inflate the balloon.
The double-lumen catheter will be available in two diameters, 5F and 7F, and is composed of a radiopaque flexible plastic tube 30cm. long. The distal end will have either a side port or end port. The balloon which is composed of a synthetic elastomer of a natural, clear polyurethane material is mounted 5 to 8 mm proximal to the The proximal end of the catheter is composed distal end. of a fitting leading to a bifurcation; one extension is for balloon inflation, the other for contrast injection.
The semi-rigid sheath has an internal diameter to allow easy movement over the catheter and an outside diameter The length sufficient to provide semi-rigid flexibility. The distal end is flanged to provide a smooth is 20cm. non-traumatic surface to the tissues.
The syringe is either a 3cc or 6cc size for the 5F or 7F catheter, respectively. The 3cc syringe has a vent at the 1.5cc graduation providing that volume for inflation of The recommended volume for the 7F balloon the 5F balloon. is 4.0cc.
This 510(k) summary describes a medical device, the Modified Hysterosalpingography Set, and asserts its substantial equivalence to a predicate device. The performance data provided focuses on non-clinical tests to support this claim, rather than a study with acceptance criteria related to a specific clinical diagnostic accuracy or efficacy target typically seen with AI/ML or imaging devices.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the device (a hysterography set) and the 510(k) summary (focused on substantial equivalence, not clinical diagnostic performance), the acceptance criteria are not for diagnostic accuracy but rather for functional and material equivalence.
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Inflation Characteristics | Inflated diameter of polyurethane balloon is not significantly different from predicate device balloons. | "Inflation comparisons showed that the inflated diameter of the polyurethane balloon is not significantly different from the balloons of the predicate device." |
| Over-inflation Resistance | Balloons withstand a volume of three times the prescribed label volume without ill effects. | "Over-inflation of the polyurethane balloons showed that the balloons will withstand a volume of three times the prescribed volume on the label with no ill effects." |
| Fatigue Life | Withstand 50 inflation-deflation cycles. | "The proposed balloon passed a fatigue test of 50 inflation-deflation cycles, representing a five-fold margin of safety over the expected practice in actual use." |
| Biocompatibility | Balloon material is identical to catheter material (except radiopaque component/pigment); catheter material has a history of safe use (no adverse effects in 500,000+ procedures since 1984). | "The balloon material is the same as that of the catheter except that the balloon material contains no radiopaque component or pigment, and is completely transparent. The polyurethane material used for the catheter tubing has been in use since 1984 in more than 500,000 procedures with no report of any adverse effect on body tissues." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a numerical "sample size" in the context of typical clinical studies for diagnostic devices. The tests described are component-level functional and material tests. For "Inflation comparisons," "Over-inflation," and "Fatigue test," the sample size would typically refer to the number of balloons/devices tested. This number is not explicitly stated in the provided text.
- Data Provenance: The tests are non-clinical (laboratory/benchtop) tests. There is no mention of country of origin, nor is it a retrospective or prospective clinical study. The biocompatibility claim refers to a historical record of safe use of the catheter tubing material, implying retrospective data of clinical use from an unspecified geographical location.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts & Qualifications: Not applicable for the described non-clinical tests. These tests are objective measurements (e.g., diameter, volume, cycle count) and material property evaluations, not subject to expert interpretation for ground truth.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The tests are objective measurements, not involving subjective interpretation or adjudication by multiple readers/experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a medical instrument (catheter set) used for diagnosis (injection of contrast material), not a diagnostic algorithm or imaging interpretation system that would typically undergo such a study.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. This device is a physical medical instrument, not an algorithm, and therefore doesn't have "standalone algorithm performance."
7. The Type of Ground Truth Used
The "ground truth" for the performance claims is based on:
- Objective Measurements: For inflation characteristics and over-inflation resistance.
- Mechanical Testing Results: For fatigue life.
- Material Equivalence and Historical Device Safety Data: For biocompatibility, referencing the predicate device's material and its long history of clinical use.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Training Set Ground Truth Establishment: Not applicable. As this is not an AI/ML device, there is no training set or associated ground truth.
§ 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.