(151 days)
EpiStat is intended for use by physicians and trained obstetrics/gynecology nurse practitioners during episiotomy repair procedures. EpiStat is intended to temporarily tamponade the post partum discharge of fluids from the vagina in order to assist with the episiotomy repair procedure.
V-Stat is intended for use by physicians for temporary haemostatic control following vaginal surgery procedures such as (a) post operative packing for posterior and anterior vaginal repairs (b) brisk introperative bleeding during urethral sling procedures and post operative packing to control sub-pubic haematoma following urethral sling procedures.
EpiStat is an inflatable balloon tamponade device designed to provide a safe and effective method of temporarily tamponading the vagina to assist with post partum episiotomy repair. EpiStat is provided sterile in peel-open packages and intended for onetime use.
V-Stat is an inflatable balloon tamponade device designed to provide a safe and effective method of achieving haemostatic control by direct or indirect compression of vaginal tissues as a result of the inflation of a balloon using air. V-Stat is provided sterile in peelopen packages and intended for one-time use.
The EpiStat & V-Stat Vaginal Tamponade Balloon is a Class I and Class II medical device, respectively, and its premarket notification 510(k) summary does not contain the level of detail typically found in studies for AI/ML-powered devices. The provided document concerns a traditional medical device (tamponade balloons) seeking substantial equivalence to existing predicate devices, rather than a novel AI/ML application. Therefore, many of the requested categories related to AI/ML device studies, such as ground truth, expert adjudication, MRMC studies, and training set details, are not applicable or cannot be extracted from this document.
However, based on the provided text, here's what can be gathered regarding acceptance criteria and performance for the EpiStat & V-Stat Vaginal Tamponade Balloon:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance | Comments |
|---|---|---|---|
| Mechanical Performance | Balloon burst strength | Successfully completed performance testing. | Demonstrated that the device "consistently performed within its design parameters." Specific quantitative thresholds for burst strength are not provided in this summary. |
| Tensile strength | Successfully completed performance testing. | Demonstrated that the device "consistently performed within its design parameters." Specific quantitative thresholds for tensile strength are not provided in this summary. | |
| Leak testing | Successfully completed performance testing. | Demonstrated that the device "consistently performed within its design parameters." Specific quantitative criteria for leak rate are not provided. | |
| Packaging & Sterilization | Packaging qualification | Successfully completed performance testing. | In compliance with internationally recognized standards. No specific metrics or thresholds are provided. |
| Sterilization | Successfully completed performance testing. | In compliance with internationally recognized standards. No specific metrics or thresholds are provided. | |
| Biocompatibility | Biocompatibility testing | Successfully completed performance testing in compliance with ISO 10993-1. | This indicates the device materials are safe for biological contact. Specific test results (e.g., cytotoxicity, sensitization) are not detailed. |
| Functional Equivalence | Indications for Use (EpiStat) | Intended for temporary tamponade of post partum discharge during episiotomy repair. | Stated to be "substantially equivalent to the National Hospital Packaging, Vag Packing" in terms of indications for use and functional effectiveness. |
| Indications for Use (V-Stat) | Intended for temporary haemostatic control following vaginal surgery (e.g., post-operative packing, brisk intraoperative bleeding control). | Stated to be "substantially equivalent to the National Hospital Packaging, Vag Packing" in terms of indications for use and functional effectiveness. | |
| Design & Operation | General design, materials, and principles of operation. | Incorporates the same general design, materials, and principles of operation used in other inflatable balloon tamponade devices. | Substantially equivalent to predicate devices. |
| Physical construction, principle of operation, deployment methodology. | Employs the same physical construction, principle of operation, and deployment methodology (inflated using air) as the Cook OB/GYN Tamponade Uterine Balloon Catheter Set and Boston Medical Products Epi-Stop Epistaxis Catheter. | Substantially equivalent to predicate devices. | |
| Manufacturing Quality | Manufacturing controls | Device will be manufactured according to specified process controls and in compliance with an ISO 9001/ISO 13485 Quality Assurance Program. | This is a commitment to quality manufacturing, not a direct performance test result. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not specify sample sizes for the performance tests (burst strength, tensile strength, leak testing, etc.).
- The data provenance is not specified. The tests are described as "Performance Testing" which implies an in-house or contracted laboratory setting, rather than clinical data from human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This information is not applicable and not provided in the document. The "ground truth" for a mechanical device is typically established by engineering specifications and objective physical measurements rather than expert human interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable and not provided in the document. Adjudication methods are relevant for subjective assessments, particularly in clinical studies or image interpretation, which are not described here.
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
- This information is not applicable and not provided. An MRMC study is relevant for AI/ML image interpretation or diagnostic tools, which this device is not.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not applicable and not provided. This device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the performance tests, the "ground truth" is based on objective engineering and manufacturing specifications and established industry standards (e.g., ISO 10993-1 for biocompatibility). There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for the device's physical and biological performance attributes.
8. The sample size for the training set
- This information is not applicable and not provided. The device is a physical tamponade balloon, not an AI/ML system requiring a training set.
9. How the ground truth for the training set was established
- This information is not applicable and not provided for the reasons stated above.
§ 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.