(281 days)
Used for the treatment of abscesses and cysts of the Bartholin gland.
The Word Catheter-Silicone Bartholin Gland Balloon Set is used for treatment of abscesses and cysts of the Bartholin gland. The Word Catheter-Silicone Bartholin Gland Balloon Set is a 3 ml balloon catheter which is 5.5 cm in length and constructed of silicone. The catheter is sold with a 1" 21 gauge needle and a scalpel with a # 1 blade is used to lance the Bartholin gland cystlabscess, the syringe with needle is used to inflate the balloon catheter, and the catheter is placed in the cyst or abscess remaining for up to 28 days to allow the duct to re-epithelialize. The devices are provided sterile and are intended for one time use.
Here's an analysis of the provided information regarding the Word Catheter-Silicone Bartholin Gland Balloon Set, structured to address your specific requests:
The provided document describes a 510(k) premarket notification for a medical device seeking substantial equivalence to existing predicate devices. It does not contain information about a study proving the device meets specific acceptance criteria in terms of clinical outcomes or performance against a predefined threshold. Instead, it focuses on demonstrating equivalence through technical comparisons and standard engineering/biocompatibility testing.
Description of Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) submission focused on substantial equivalence rather than a clinical trial demonstrating performance against specific clinical acceptance criteria for a novel device, the "acceptance criteria" are predominantly related to manufacturing and material standards, as well as functional equivalence to predicate devices.
| Acceptance Criteria (Study Performed) | Standard/Method Referenced | Reported Device Performance | Comments |
|---|---|---|---|
| Balloon Integrity, Volume, Leak Testing | Modified recommendations from BS EN 1616:1997 (nearly identical to ASTM F623-99) | Assumed to meet the standard and be comparable to predicates. | Bench testing. Specific quantitative results (e.g., leak rate in ml/hr, volume retention percentage) are not provided in this summary. |
| Balloon Burst Testing | Modified recommendations from BS EN 1616:1997 (nearly identical to ASTM F623-99) | Assumed to meet the standard and be comparable to predicates. | Bench testing. Specific quantitative results (e.g., pressure at burst) are not provided. |
| Biocompatibility Testing | ISO 10993 series | Compliant with ISO 10993 series. | Conducted using Good Laboratory Practices (GLP). Demonstrates material safety for biological contact. |
| Sterility Testing | FDA guidances and recognized international standards | Assumed to meet established sterility standards. | Ensures the device is safe for patient use. |
| Performance Testing | FDA guidances and recognized international standards | Assumed to meet established performance standards and be safe and effective. | General statement indicating overall functionality. |
| Substantial Equivalence (Overall) | Comparison to predicate devices (K861385, K880497) | Found to be substantially equivalent in technology, materials, intended use, indications for use, patient population, performance, and size. | The FDA concurred with this assessment in their decision letter. |
Important Note: The document does not specify quantitative acceptance criteria (e.g., "burst pressure must be > X psi") or quantitative performance results for the device. Instead, it states that the device was tested according to recognized standards and demonstrated substantial equivalence to predicate devices. The "performance" is implicitly deemed acceptable if it meets these standards and is equivalent to a legally marketed device.
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify a "test set" of patient data or clinical samples. The testing described is primarily non-clinical (bench testing) and biocompatibility for the device itself.
- Data Provenance: Not applicable, as this is a non-clinical submission. The testing was conducted in a laboratory setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This submission focuses on the technical characteristics and safety of a medical device (catheter) through bench testing and material biocompatibility, not on a diagnostic algorithm or interpretation requiring expert review of data. There is no "ground truth" to be established by experts for a test set in the context of this 510(k) submission.
4. Adjudication method for the test set
- Not applicable. As there is no clinical test set or expert review process, no adjudication method was used.
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. This information is not present in the document. The device is a physical medical instrument (catheter), not an AI-assisted diagnostic or interpretive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical catheter, not an algorithm.
7. The type of ground truth used
- Not applicable. In the context of a medical device like a catheter, "ground truth" often refers to fundamental scientific principles, engineering standards (like those for materials strength or biocompatibility), and the established performance characteristics of the predicate devices. There is no patient-specific "ground truth" in this submission.
8. The sample size for the training set
- Not applicable. This submission is for a physical medical device and does not involve machine learning or a "training set."
9. How the ground truth for the training set was established
- Not applicable. This submission is for a physical medical device and does not involve machine learning or a "training set" with 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.