(116 days)
Not Found
No
The summary describes a mechanical device for controlling postpartum hemorrhage and does not mention any AI or ML components or capabilities.
Yes
The device is intended for the control and treatment of abnormal postpartum uterine bleeding or hemorrhage, indicating a therapeutic purpose.
No.
The Jada® System is intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage, indicating a therapeutic rather than diagnostic function.
No
The device description clearly details a physical, intrauterine device made of silicone and other materials, with a vacuum connector, seal valve, and cervical seal. This is a hardware device, not software only.
Based on the provided information, the Jada® System is not an In Vitro Diagnostic (IVD) 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 intervention performed directly on the patient's body.
- Device Description: The device is an intrauterine device designed to physically interact with the uterus and apply vacuum. It does not involve the examination of specimens derived from the human body (like blood, urine, tissue, etc.) outside of the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the body to provide information for diagnosis, monitoring, or screening. The Jada® System's function is to physically treat a condition within the body.
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 Jada® System is a 41 cm long intrauterine device primarily made of silicone. The vacuum connector and seal valve are made of polyvinylchloride and acrylonitrilebutadiene-styrene. 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 a vacuum tube. 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 syringe to the seal valve. The intrauterine loop has 20 vacuum pores oriented toward its inside diameter. The outer surface of the intrauterine loop is a silicone 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 lada® 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. Vacuum is then applied to a maximum value of 90 mmHg until bleeding is controlled. The device 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, vagina, external cervical os
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
Clinical Studies:
Clinical testing of the Jada® System included an initial pilot study of 10 women in Indonesia, an initial phase of the pivotal study of 13 women in Uganda, and an IDE pivotal study of 107 women in the U.S. Substantial equivalence was based in part on the pivotal study, as described below.
Pivotal Study:
- Study type: prospective, multicenter, single-arm, open label, literature-controlled study.
- Sample size: 107 subjects enrolled, 106 subjects evaluable (ITT Cohort).
- Data source: 12 sites in the U.S.
- Inclusion Criteria: Estimated blood loss (EBL) ranges:
- Vaginal delivery: 500 – 1500 mL EBL
- C-section delivery: 1000 – 1500 mL EBL
- Primary Effectiveness Endpoint: Control of postpartum hemorrhage, defined as the avoidance of non-surgical, second-line or surgical intervention to control uterine hemorrhage after the use of the Jada® System per the Instructions for Use.
- Non-surgical, second line procedures include uterine balloon therapy, uterine packing, or uterine artery embolization.
- Surgical intervention includes procedures such as uterine arterial ligation, uterine compression sutures or hysterectomy.
- Note: Continuation of the administration of uterotonics concomitant with and post Jada® System use is standard of care and does not constitute failure of the primary effectiveness endpoint.
- Primary Safety Endpoint: The incidence, severity and seriousness of device-related adverse events.
- Effectiveness Results:
- ITT Cohort: Treatment success rate was 94.3% (100/106, p
§ 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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and name on the right. The FDA part of the logo is in blue, with the acronym "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION" next to it.
August 28, 2020
Alydia Health % Cindy Domecus, R.A.C. Principal Domecus Consulting Services LLC 1171 Barroilhet Drive Hillsborough, CA 94010
Re: K201199
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: July 27, 2020 Received: July 29, 2020
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. Acting 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) K201199
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
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 - K201199
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@alvdiahealth.com
Submission Correspondent Cindy Domecus, R.A.C. (US & EU) Domecus Consulting Services LLC Phone: (650) 343-4813 Fax: (650) 343-7822 Email: DomecusConsulting@comcast.net
Date Prepared August 28, 2020
II. DEVICE
| Name of Device: | Jada® System |
|---|---|
| Common or Usual Name: | Vacuum-induced Hemorrhage Control |
| Regulation Name: | Obstetric-Gynecologic Specialized Manual Instrument |
| Regulation Number: | 21 CFR § 884.4530 |
| Regulatory Class: | II |
| Product Code: | OQY (Intrauterine Tamponade Balloon) |
III. PREDICATE DEVICE
The predicate device is the Bakri® Postpartum Balloon, Bakri® Postpartum Balloon with Rapid Instillation Components, K170622. The predicate device has not been subject to a design-related recall.
IV. DEVICE DESCRIPTION
The Jada® System is a 41 cm long intrauterine device primarily made of silicone. The vacuum connector and seal valve are made of polyvinylchloride and acrylonitrilebutadiene-styrene. 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 a vacuum tube. Proximal to the connection of the Intrauterine Loop is
4
a donut-shaped cervical seal. The cervical seal is filled with and emptied of 60-120 mL of sterile fluid by attaching a syringe to the seal valve. The intrauterine loop has 20 vacuum pores oriented toward its inside diameter. The outer surface of the intrauterine loop is a silicone 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 lada® 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. Vacuum is then applied to a maximum value of 90 mmHg until bleeding is controlled. The device 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.
| Attribute | K201199
Subject Device:
Jada® System | K170622
Predicate Device:
Bakri® Postpartum
Balloon
Bakri® Postpartum
Balloon with Rapid
Instillation
Components | Comparison |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Manufacturer | Alydia Health | Cook Incorporated | 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. | Bakri® Postpartum Balloon is intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted.
Bakri® Postpartum Balloon with Rapid | Different |
- VI. COMPARISON OF INTENDED USE AND TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
5
| | | Instillation
Components is
intended to provide
temporary
control or reduction of
postpartum uterine
bleeding when
conservative
management is
warranted. | |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Principle 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 is inflated to press
outward on the uterine
walls, producing
tamponade of the
bleeding vessels | Different |
| Design | Inflatable cervical seal
and intrauterine loop
with vacuum pore | Inflatable uterine
balloon and a single
drainage side port | Different |
| Rx/OTC | Rx | Rx | Same |
| Materials | Silicone,
Polyvinylchloride
(PVC), Acrylonitrile-
Butadiene-Styrene
(ABS) | Silicone | Different |
| Sterile | SAL 10-6 | SAL 10-6 | Same |
| Single-use | Yes | Yes | Same |
The Indications for Use statement for the Jada® System is not identical to the predicate device; however, the differences do not alter the intended use of the device. Both the subject and predicate devices have the same intended use for the treatment of abnormal uterine bleeding when conservative management is warranted.
The following technological differences exist between the subject and predicate devices:
- . Principle of Operation: The subject device utilizes vacuum to affect tamponade on uterine walls, whereas the predicate device utilizes the fluidic pressure of an expanding balloon to affect tamponade
- . Design: The subject device's intrauterine loop has a looped (drain) tube with a series of Vacuum Pores on the inside surface. The intrauterine loop features an elliptical pattern that lays flat on the uterine tissue bed, whereas the
6
Alydia Health
predicate device has a single opening drain tube protruding out of the middle of the inflated balloon
- . Materials: The patient contacting portions of both devices are made of silicone. However, the subject device includes a seal valve and vacuum connector made of ABS and PVC, respectively. All patient contacting devices are made of silicone for the subject and predicate device.
These differences in technological characteristics do not raise different questions of safety and effectiveness. Non-clinical and clinical data provided by Alydia Health were used to address the differences related to design and principle of operation to demonstrate substantial equivalence to the predicate device.
PERFORMANCE DATA VII.
The following performance data were provided in support of the substantial equivalence determination.
Mechanical Testing
The following mechanical tests were performed:
- Cervical Seal and Tube Dimensions: Verification of tube and seal dimensions
- . Intrauterine Loop Portion Dimensional Test – Verification of intrauterine loop dimensions
- Removal of Intrauterine Portion Test Verification that intrauterine loop and ● shield remain intact during removal
- 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 minute or less
- Device Integrity Leak Test Verification that the joints of the device do not . leak when 180 mmHg of vacuum is applied
7
- . Integration to Hospital Vacuum Line – Verification that the device connects to a vacuum tube
- 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 – Verification that the vacuum connector withstands a tensile load of 8.8 lbf
- Seal Valve Bond Test – Verification that the seal valve withstands a tensile load of 3.7 lbf
Biocompatibility Testing
The Jada® System is a surface device in contact with a breached surface, with limited duration (