(30 days)
Not Found
No
The device description and performance studies focus on mechanical, packaging, biocompatibility, and sterilization testing of a physical device, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended to "provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage," which is a therapeutic purpose.
No
The Jada System is intended to control and treat abnormal postpartum uterine bleeding or hemorrhage, which is a therapeutic function, not a diagnostic one. It achieves this by applying vacuum to the uterus to control bleeding.
No
The device description clearly outlines a physical, intrauterine device made of silicone with various mechanical components and connections. The performance studies also focus on mechanical, packaging, biocompatibility, and sterilization testing of this physical device. There is no mention of software as a component or function of the device.
No, the Jada® System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage." This is a therapeutic and interventional use, not a diagnostic one.
- Device Description: The device is a physical intrauterine device designed to apply vacuum and pressure to control bleeding. It does not analyze biological samples (like blood, tissue, or other bodily fluids) to provide diagnostic information.
- Lack of Diagnostic Function: The description focuses on the mechanical action of the device (applying vacuum, inflating a seal) to treat a condition, not to diagnose it.
- Performance Studies: The performance studies described are mechanical testing, packaging testing, biocompatibility testing, sterilization, and shelf-life testing. These are typical for a medical device used for treatment, not for an IVD which would involve analytical and clinical performance studies related to diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Jada System does not perform this function.
N/A
Intended Use / Indications for Use
The Jada® System is intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted.
Product codes
OQY
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Uterus, genital tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical Testing:
Mechanical testing on the subject Jada System was identical to the testing performed on the predicate Jada System. Specifically, the following mechanical tests were performed at baseline (T=0) and on aged samples (T=1 year):
- Cervical Seal and Tube Dimensions: Verification of tube and seal dimensions
- Intrauterine Loop Portion Dimensional Test – Verification of intrauterine loop dimensions
- Vacuum Pore Diameter – Verification of vacuum pore size
- No Sharp Edges Verification of smooth edges and surfaces of device
- Attaining Pressure Drop Verification that cervical seal withstands pressure differential of 180 mmHg vacuum
- Static Load Test – Verification that the cervical seal withstands a static load of 1 lb applied axially along the tube without failure
- Overfill Capacity - Verification that cervical seal does not fail when filled with 180 mL water.
- 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
- Impact Load Test – Verification that the cervical seal withstands an impact test of dropping a 1 lb weight 2 ft axially along the tube without failure
- Connection Tube Junction Impact Load Test - Verification that the intrauterine loop withstands an impact test of dropping a 1 lb weight 2 ft axially along the Tube without failure
- Flow Rate Verification that the device with vacuum is able to evacuate 400 mL of simulated blood in 1 min or less
- Device Integrity Leak Test – Verification that the joints of the device do not leak when 180 mmHg of vacuum is applied
- Integration to Hospital Vacuum Line – Verification that the device connects to a vacuum tubing
- Inflation Tube Geometry – Verification that the cervical seal inflation lumen is functional
- Syringe Accommodation - Verification that a luer tapered syringe can be attached to the seal valve
- 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
- Cervical Seal Diameter and Bond Stability – Verification that the seal maintains a diameter of 70 mm and maintains integrity after 48 hours
- Clotted Blood Test – Verification that the device can evacuate simulated blood in the presence of clotted blood without occluding
- Vacuum Connector Bond Test – Vacuum connector bond remains intact after a proof load of 8.8 lbf is applied
- Seal Valve Bond Test - Seal valve bond remains intact after a proof load of 3.7 lbf is applied
Packaging Testing:
Testing of the kit packaging for the subject device consisted of transportation per ASTM-D4169-16 followed by gross leak detection per ASTM F2096-11 and for seal strength per ASTM F88/F88M-15. Furthermore, the Tyvek lidded tray of the subject Jada System was tested for aging (ASTM F1980-16) followed by packaging integrity testing for gross leak detection per ASTM F2096-11 and for seal strength per ASTM F88/F88M-15.
Biocompatibility Testing:
The biocompatibility evaluation for the subject Jada System was conducted in accordance with the FDA June 2016 guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process", Guidance for Industry and Food and Drug Administration Staff. The battery of testing included the following tests:
- Cytotoxicity
- Maximization Sensitization
- Vaginal Irritation
- Systemic toxicity
- Material Mediated Pyrogenicity
Sterilization and Shelf-Life Testing:
The subject and predicate Jada Systems are both sterilized using gamma radiation to a SAL of 10-6 according to ISO 11137-2: 2013. A shelf-life of 1 year has been established based on accelerated aging for the subject device.
Key results: The nonclinical performance data described above demonstrate that the Jada System is as safe and effective as the predicate device and supports a determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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September 30, 2021
Alydia Health % Cindy Domecus, R.A.C. Principal Domecus Consulting Services LLC 1171 Barroilhet Drive Hillsborough, CA 94010
Re: K212757
Trade/Device Name: Jada System Regulation Number: 21 CFR§ 884.4530 Regulation Name: Obstetric-Gynecologic Specialized Manual Instrument Regulatory Class: II Product Code: OQY Dated: August 30, 2021 Received: August 31, 2021
Dear Cindy Domecus:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
1
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Monica D. Garcia, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212757
Device Name Jada System
Indications for Use (Describe)
The Jada® System is intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary - K212757
I. SUBMITTER
510(k) Owner
Colby Holtshouse Alydia Health 3495 Edison Way Menlo Park, CA 94025 Phone: 650-275-3772 Fax: 415-354-3473 Email: colby(@alydiahealth.com
Submission Correspondent Cindy Domecus, R.A.C. (US & EU) Domecus Consulting Services LLC Phone: (650) 343-4813 Fax: (650) 343-7822 Email: Cindy(@)DomecusConsulting.com
Date Prepared September 29, 2021
| II. DEVICE | |
|---|---|
| Name of Device: | Jada System |
| Common or Usual Name: | Vacuum-induced Hemorrhage Control System |
| Regulation Name: | Obstetric-Gynecologic Specialized Manual Instrument |
| Regulation Number: | 21 CFR § 884.4530 |
| Regulatory Class: | II |
| Product Code: | OQY |
III. PREDICATE DEVICE
The predicate device is the Jada System, K201199. This predicate has not been subject to a design-related recall.
IV. DEVICE DESCRIPTION
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
4
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.
V. INDICATIONS FOR USE
The Jada® System is intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted.
VI. COMPARISON OF INTENDED USE AND TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| Attribute | K212757
Subject Device:
Jada System | K201199
Predicate Device:
Jada System | Comparison |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Manufacturer | Alydia Health | Alydia Health | N/A |
| Product Code | OQY | OQY | Same |
| Indications for
Use | The Jada System is intended
to provide control and
treatment of abnormal
postpartum uterine bleeding
or hemorrhage when
conservative management is
warranted. | The Jada System is intended
to provide control and
treatment of abnormal
postpartum uterine bleeding
or hemorrhage when
conservative management is
warranted. | Same |
| Mechanism of
Action | Inserted into the uterus and
establishes a vacuum to
cause the uterine walls to
press against one another,
producing a tamponade
of the bleeding vessels. | Inserted into the uterus and
establishes a vacuum to
cause the uterine walls to
press against one another,
producing a tamponade
of the bleeding vessels. | Same |
| Design | Inflatable cervical seal and
intrauterine loop with
vacuum pores. The
intrauterine loop tube
vacuum pore count is
increased from 20 to 21 and
the seal valve features luer
syringe attachment. | Inflatable cervical seal and
intrauterine loop with
vacuum pores. Seal Valve
features the friction syringe
attachment. | Different |
| Rx/OTC | Rx | Rx | Same |
| Materials | Silicone, polycarbonate,
Acrylonitrile- Butadiene-
Styrene (ABS) | Silicone, Polyvinylchloride
(PVC), Acrylonitrile-
Butadiene-Styrene (ABS) | Different |
| Sterile | SAL 10-6 | SAL 10-6 | Same |
| Single Use | Yes | Yes | Same |
The subject and predicate device have identical indications for use statements and have the same intended use - the treatment of abnormal uterine bleeding when conservative management is warranted.
The subject Jada System is an updated version of the predicate Jada System with modifications to 1) improve manufacturability, 2) streamline packaging, and 3) improve user experience and aesthetics of the device. Following is a list of technological characteristics that remain the same between the subject and predicate devices:
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- Vacuum induced collapse of the uterus causing the uterine walls to press against one another, producing tamponade of the bleeding vessels.
- Intrauterine loop to transmit vacuum to the uterine space.
- Drain pores within the intrauterine loop to evacuate blood, body fluids, and residual clots from the ● uterine space.
- Filled and expanded cervical seal to enable the maintenance of vacuum within the uterine space.
- Vacuum connector for attachment of vacuum tubing.
- Seal valve with automatic shut-off for filling the cervical seal.
- In-dwelling treatment within the uterus and genital tract