(30 days)
The Jada® System is intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted.
The subject of this submission is the Jada System kit, which includes 1) the Jada System, 2) a commercially available pre-sterilized vacuum tubing, and 3) a commercially available pre-sterilized luer lock syringe.
The Jada System is a 41 cm long intrauterine device made of silicone. The device consists of an intrauterine loop on the distal end of a translucent tube. The proximal end of the tube has a vacuum connector for connection to the vacuum tubing. Proximal to the connection of the intrauterine loop is a donut-shaped cervical seal. The cervical seal is filled with and emptied of 60-120 mL of sterile fluid by attaching a luer lock syringe to the seal valve. The intrauterine loop consists of a loop tube with 21 vacuum pores oriented toward the inside diameter of the intrauterine loop. On the outer surface of the intrauterine loop is a shield which overhangs the vacuum pores to protect tissue from vacuum and to prevent the vacuum pores from plugging with tissue and blood clots.
Before placing the Jada System device inside the uterus, the intrauterine loop is compressed. The compressed loop is inserted into the uterus transvaginally. The cervical seal is placed within the vagina, at the external cervical os, and inflated and filled with 60-120 mL of sterile fluid. The vacuum tubing is attached to the vacuum connector on the Jada System and vacuum is then applied to a maximum value of 90 mmHg until bleeding is controlled. The Jada System should be fixed to the thigh along the tube.
The provided text describes a 510(k) submission for the Jada System, a device intended for the control and treatment of abnormal postpartum uterine bleeding or hemorrhage. The submission argues for substantial equivalence to a predicate device (also the Jada System) based on non-clinical performance data.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it describes various mechanical, packaging, biocompatibility, and sterilization tests performed, and states that these tests demonstrate "substantial equivalence" and that the device is "as safe and effective as the predicate device." The "performance" column below is derived from the descriptions of the tests and implies that the device met the implicit acceptance criteria for each test.
| Acceptance Criteria Category | Specific Test/Evaluation | Reported Device Performance/Conclusion |
|---|---|---|
| Mechanical Testing | Cervical Seal and Tube Dimensions | Verification of tube and seal dimensions (i.e., met specifications) |
| Intrauterine Loop Portion Dimensional Test | Verification of intrauterine loop dimensions (i.e., met specifications) | |
| Vacuum Pore Diameter | Verification of vacuum pore size (i.e., met specifications) | |
| No Sharp Edges | Verification of smooth edges and surfaces of device (i.e., passed) | |
| Attaining Pressure Drop | Verification that cervical seal withstands pressure differential of 180 mmHg vacuum (i.e., passed) | |
| Static Load Test | Verification that the cervical seal withstands a static load of 1 lb applied axially without failure (i.e., passed) | |
| Overfill Capacity | Verification that cervical seal does not fail when filled with 180 mL water (i.e., passed) | |
| Cervical Seal Inflation | Verification that cervical seal can be filled with 60 mL of water within 30 seconds with 10 lbs of force on syringe (i.e., passed) | |
| Impact Load Test (Cervical Seal) | Verification that the cervical seal withstands an impact test of dropping a 1 lb weight 2 ft axially without failure (i.e., passed) | |
| Connection Tube Junction Impact Load Test (Intrauterine Loop) | Verification that the intrauterine loop withstands an impact test of dropping a 1 lb weight 2 ft axially without failure (i.e., passed) | |
| Flow Rate | Verification that the device with vacuum is able to evacuate 400 mL of simulated blood in 1 min or less (i.e., passed) | |
| Device Integrity Leak Test | Verification that the joints of the device do not leak when 180 mmHg of vacuum is applied (i.e., passed) | |
| Integration to Hospital Vacuum Line | Verification that the device connects to a vacuum tubing (i.e., passed) | |
| Inflation Tube Geometry | Verification that the cervical seal inflation lumen is functional (i.e., passed) | |
| Syringe Accommodation | Verification that a luer tapered syringe can be attached to the seal valve (i.e., passed) | |
| Cervical Seal Deflation | Verification that cervical seal can be emptied of 60 mL of water within 30 seconds with 10 lbs of force on syringe (i.e., passed) | |
| Cervical Seal Diameter and Bond Stability | Verification that the seal maintains a diameter of 70 mm and maintains integrity after 48 hours (i.e., passed) | |
| Clotted Blood Test | Verification that the device can evacuate simulated blood in the presence of clotted blood without occluding (i.e., passed) | |
| Vacuum Connector Bond Test | Vacuum connector bond remains intact after a proof load of 8.8 lbf is applied (i.e., passed) | |
| Seal Valve Bond Test | Seal valve bond remains intact after a proof load of 3.7 lbf is applied (i.e., passed) | |
| Packaging Testing | Transportation (ASTM-D4169-16) | Followed standard; assumed passed (no damage reported) |
| Gross Leak Detection (ASTM F2096-11) (after transportation) | Passed (no leaks reported) | |
| Seal Strength (ASTM F88/F88M-15) (after transportation) | Passed (acceptable seal strength reported) | |
| Aging (ASTM F1980-16) (Tyvek lidded tray) | Performed for 1-year shelf-life; assumed passed (no degradation reported) | |
| Packaging Integrity (Gross Leak Detection & Seal Strength after aging) | Passed (no leaks, acceptable seal strength reported) | |
| Biocompatibility Testing | Cytotoxicity | Passed (no cytotoxicity reported) |
| Maximization Sensitization | Passed (no sensitization reported) | |
| Vaginal Irritation | Passed (no vaginal irritation reported) | |
| Systemic toxicity | Passed (no systemic toxicity reported) | |
| Material Mediated Pyrogenicity | Passed (no pyrogenicity reported) | |
| Sterilization | Gamma Radiation to SAL of 10^-6 | Achieved (device is sterilized to SAL 10^-6) |
| Shelf-Life Testing | Accelerated Aging | Shelf-life of 1 year established |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for the mechanical, packaging, biocompatibility, or sterilization tests. It only states that these tests were performed to support substantial equivalence.
The data provenance is from non-clinical testing (laboratory/bench testing) performed by Alydia Health. There is no mention of clinical data, human subjects, or any specific country of origin for test data, as it appears to be primarily laboratory-based engineering and material testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to the provided document. The studies described are non-clinical (bench testing) and do not involve human subject data requiring expert interpretation to establish a ground truth. The "ground truth" for these tests would be the specific pass/fail criteria defined by engineering and material standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable to the provided document, as it concerns non-clinical testing, not interpretation of clinical data where adjudication among experts would be necessary.
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. The device is an obstetric-gynecologic specialized manual instrument (Jada System) and not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study or AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The Jada System is a physical medical device, not an algorithm, and its performance relies on human-in-the-loop operation for placement and activation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests described:
- Mechanical Testing: The "ground truth" is defined by established engineering specifications, dimensional tolerances, force requirements, flow rates, and integrity standards (e.g., ability to withstand pressure, maintain dimensions, not leak, etc.).
- Packaging Testing: The "ground truth" is adherence to ASTM standards for transportation, leak detection, and seal strength.
- Biocompatibility Testing: The "ground truth" is the absence of adverse biological reactions as defined by ISO 10993-1 and specific test methodologies (e.g., no cytotoxicity, no sensitization, etc.).
- Sterilization and Shelf-Life Testing: The "ground truth" is achieving a Sterility Assurance Level (SAL) of 10^-6 and maintaining performance for the stated shelf-life as per ISO standards.
8. The sample size for the training set
This information is not applicable. The device is a physical medical instrument, not a machine learning or AI model, so there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
§ 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.