Jada System

K212757 · Alydia Health · OQY · Sep 30, 2021 · Obstetrics/Gynecology

Device Facts

• Record ID: K212757
• Device Name: Jada System
• Applicant: Alydia Health
• Product Code: OQY · Obstetrics/Gynecology
• Decision Date: Sep 30, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.4530
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Jada System is a sterile, single-use, silicone intrauterine device designed for postpartum hemorrhage control. Device consists of an intrauterine loop with 21 vacuum pores and an inflatable cervical seal. Operated by clinicians in clinical settings; device is inserted transvaginally into the uterus. Cervical seal is inflated with 60-120 mL of sterile fluid to secure the device at the external cervical os. Vacuum is applied (max 90 mmHg) via external vacuum source to induce uterine collapse, creating a tamponade effect on bleeding vessels. Device includes a drain tube to evacuate blood and fluids. Output is the mechanical tamponade of the uterus; healthcare providers monitor bleeding control and fluid evacuation. Benefits include non-invasive hemorrhage management compared to more aggressive surgical interventions.

Clinical Evidence

Bench testing only. No clinical data presented. Performance testing included mechanical verification (vacuum flow rates, seal integrity, bond strength, clotted blood evacuation), biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity), and packaging/sterilization validation (ASTM D4169-16, F2096-11, F88/F88M-15, F1980-16).

Technological Characteristics

Materials: Silicone, polycarbonate, ABS. Principle: Vacuum-induced uterine tamponade. Form factor: 41 cm intrauterine loop with inflatable cervical seal. Connectivity: Connects to external hospital vacuum line. Sterilization: Gamma radiation (SAL 10^-6). Standards: ISO 10993-1 (biocompatibility), ISO 11137-2:2013 (sterilization), ASTM D4169-16 (transportation), ASTM F2096-11/F88/F88M-15 (packaging).

Indications for Use

Indicated for control and treatment of abnormal postpartum uterine bleeding or hemorrhage in patients where conservative management is warranted.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Jada System (K201199)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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: [phone] Fax: [phone] Email: colby(@alydiahealth.com

Submission Correspondent Cindy Domecus, R.A.C. (US & EU) Domecus Consulting Services LLC Phone: [phone] Fax: [phone] 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

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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<br>Subject Device:<br>Jada System | K201199<br>Predicate Device:<br>Jada System | Comparison |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Manufacturer | Alydia Health | Alydia Health | N/A |
| Product Code | OQY | OQY | Same |
| Indications for<br>Use | The Jada System is intended<br>to provide control and<br>treatment of abnormal<br>postpartum uterine bleeding<br>or hemorrhage when<br>conservative management is<br>warranted. | The Jada System is intended<br>to provide control and<br>treatment of abnormal<br>postpartum uterine bleeding<br>or hemorrhage when<br>conservative management is<br>warranted. | Same |
| Mechanism of<br>Action | Inserted into the uterus and<br>establishes a vacuum to<br>cause the uterine walls to<br>press against one another,<br>producing a tamponade<br>of the bleeding vessels. | Inserted into the uterus and<br>establishes a vacuum to<br>cause the uterine walls to<br>press against one another,<br>producing a tamponade<br>of the bleeding vessels. | Same |
| Design | Inflatable cervical seal and<br>intrauterine loop with<br>vacuum pores. The<br>intrauterine loop tube<br>vacuum pore count is<br>increased from 20 to 21 and<br>the seal valve features luer<br>syringe attachment. | Inflatable cervical seal and<br>intrauterine loop with<br>vacuum pores. Seal Valve<br>features the friction syringe<br>attachment. | Different |
| Rx/OTC | Rx | Rx | Same |
| Materials | Silicone, polycarbonate,<br>Acrylonitrile- Butadiene-<br>Styrene (ABS) | Silicone, Polyvinylchloride<br>(PVC), Acrylonitrile-<br>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 <24 hours
- Drain tube to remove blood and fluid from postpartum uterus
- All patient contacting materials are silicone

The following technological differences exist between the subject and predicate devices:

- . The seal valve on the subject device features a luer syringe attachment instead of the friction syringe attachment of the predicate device, to provide a more secure attachment of the syringe.
- The inflation lumen that is used to fill the cervical seal on the subject device has a larger crosssectional area, to allow easier filling and removal of fluid from the Cervical Seal during use.
- The seal valve orientation of the subject device was changed from 12 o'clock to 9 o'clock/3 o'clock, to achieve a lower profile of the device in the device packaging.
- The seal valve body on the subject device was changed to clear polycarbonate from the white ABS (acrylonitrile butadiene styrene) of the predicate device. The polycarbonate valve enables a luerlock syringe fitting with higher flow.
- The vacuum connector on the subject device was changed to white ABS from the clear PVC (polyvinyl chloride) of the predicate device, to improve the aesthetics of the device.
- The intrauterine loop tube vacuum pore count was increased from 20 to 21 on the subject device, to improve manufacturability.
- The sterile packaging of the subject device was changed to a Tyvek lidded tray from a pouch with a ● device backing card of the predicate device, to improve the appearance of the packaging, remove the complexity of the backing card and to achieve a smaller form factor for the sterilized unit.
- . The subject device will be provided for the user in a kit carton that contains the Jada System, a commercially available pre-sterilized 60 mL syringe and a commercially available pre-sterilized 12' vacuum tubing for customer convenience.

These differences in technological characteristics do not raise different questions of safety and effectiveness and can be addressed through performance testing. Non-clinical data provided by Alydia Health were used to address the differences related to design and packaging to demonstrate substantial equivalence to the predicate device, as discussed in Section VII.

#### VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

### 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):

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- . 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 1b 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 1b 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 Jada System is a surface device in contact with a breached surface, with limited duration (< 24 hours).

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

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- 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° according to ISO 11137-2: 2013. A shelf-life of 1 year has been established based on accelerated aging for the subject device.

#### VIII. CONCLUSIONS

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.