(222 days)
BT-Cath (BTC-100) is intended to provide temporary control or reduction of uterine bleeding during postpartum hemorrhage that is unresponsive to standard therapy including massage and oxytocin administration.
The BT-Cath consists of an extruded silicone dual lumen catheter with an inflatable molded silicone tamponade balloon attached on the distal end. One lumen of the catheter serves as the conduit through which saline is infused into the balloon after insertion into the bleeding uterus. When inflated properly to press against the uterine wall, the balloon provides compression against multiple sites of torn arteries, ruptured sinuses, lacerations and other tissue evoking hemorrhage. The second lumen, which is open at the distal end of the catheter, provides a drainage port for blood and other bodily fluids. At the proximal end of the catheter, a stopcock retains the saline in the balloon until a clinician gradually drains it allowing the uterus to contract. For ease of filling the balloon with multiple syringes, a check valve is also provided at the proximal end. The device is latex-free and provided sterile.
Here's an analysis of the provided text regarding the acceptance criteria and study for the BT-Cath device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Material/Design Equivalence | "insignificant differences in the physical dimensions and physical configuration of the balloon tamponade catheters. The technological characteristics, methods of use, materials, intended use, indications for use and contraindications are the same as the predicate devices." | The BT-Cath is described as an "extruded silicone dual lumen catheter with an inflatable molded silicone tamponade balloon attached on the distal end." This matches the general description of the predicate device (Bakri Uterine Balloon Tamponade) in terms of function and materials (silicone). The submission states "insignificant differences" between the BT-Cath and predicate. |
| Biocompatibility | Compatibility with biological systems. | "Biocompatibility...testing were also assessed to demonstrate substantial equivalence." (Implies satisfactory results to meet equivalence) |
| Shelf-Life | Ability to maintain functionality and sterility over an intended storage period. | "shelf-life testing were also assessed to demonstrate substantial equivalence." (Implies satisfactory results to meet equivalence) |
| Mechanical Integrity - Balloon | Structural integrity of the balloon, including: |
- Relationship of volume of saline infused into the balloon and resulting balloon diameter.
- Burst volume of the balloon.
- Ability of the balloon to hold its shape and not leak during repeated and prolonged inflations. | "Both the BT-Cath and the Bakri device were tested and found to achieve structural integrity with a reasonable safety factor." (This statement confirms that the BT-Cath met the mechanical integrity requirements for the balloon, matching the predicate.) |
| Mechanical Integrity - Catheter | Structural integrity of the catheter using leak tests. | "Both the BT-Cath and the Bakri device were tested and found to achieve structural integrity with a reasonable safety factor." (This statement confirms that the BT-Cath met the mechanical integrity requirements for the catheter, matching the predicate.) |
| Tensile Strength | Tensile strength in each joint in the devices. | "Both the BT-Cath and the Bakri device were tested and found to achieve structural integrity with a reasonable safety factor." (This statement confirms that the BT-Cath met the tensile strength requirements for joints, matching the predicate.) |
| Clinical Performance/Safety | Device consistently achieving its intended purpose without reported likelihood of patient injury. | "Clinical feedback was obtained after about 840 uses of BT-Cath by U.S. clinicians that indicates the device consistently achieved its intended purpose without any reported likelihood of patient injury." (This is presented as evidence of field performance meeting the safety and efficacy expectations.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "about 840 uses"
- Data Provenance: "U.S. clinicians" (prospective, real-world clinical feedback after deployment, rather than a controlled test set from a formal clinical trial for pre-market submission directly).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The document mentions "U.S. clinicians" providing feedback. It does not specify a number of experts or their qualifications for establishing a ground truth in the context of a controlled test set with expert consensus. The feedback provided is general clinical observation rather than a structured expert review of specific cases.
4. Adjudication Method for the Test Set
- No formal adjudication method is described. The "clinical feedback" appears to be an aggregation of observations from multiple clinicians.
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 MRMC comparative effectiveness study was done, nor is AI involved with this device. This is a medical device, specifically a balloon tamponade catheter, not an AI/software-as-a-medical-device (SaMD).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable as this is a physical medical device and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the clinical performance assessment seems to be real-world clinical outcomes and observations as reported by clinicians using the device. This is more akin to post-market surveillance data contributing to a pre-market submission, rather than a pre-defined ground truth for a structured clinical trial.
8. The Sample Size for the Training Set
- Not applicable. This is a physical medical device, not a machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not applicable as this is a physical medical 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.