The ELLAVI UBT is an 18 cm long intrauterine balloon tamponade device primarily comprised of thermoplastic elastomer. The balloon and internal tubing are made of thermoplastic elastomer, while the exterior tubing is made of polyvinyl chloride. A supply bag is the filled, connected, and hung at a pre-determined height based on the patient's systolic blood pressure. The device consists of a balloon that is inserted into the uterus transvaginally into the postpartum uterus after delivery and removal of the placenta. A valve is then opened, and this allows the fluid to inflate the balloon and apply pressure to achieve a hemostatic effect.

AI/ML Overview

The ELLAVI UBT device, intended for temporary control or reduction of postpartum uterine bleeding, underwent a series of non-clinical performance tests to demonstrate substantial equivalence to its predicate device, the Bakri Postpartum Balloon. The provided documentation primarily focuses on mechanical, biocompatibility, sterilization, and shelf-life testing. No clinical study data is provided in the document.

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Mechanical Testing
Visual Assessment	No visual defects	Verified no visual defects
Dimensional Verification	Verification of tube and balloon dimensions	Verified tube and balloon dimensions
Stretch Percentage	Verify the stretch percentage of the balloon when filled with 750 ml	Verified stretch percentage
Tube Kinking	Verify that the tube is unable to kink when handled as per normal use	Verified no kinking
External Wall Pressure	The external wall of the balloon must be able to exert 60 mm Hg to 120 mm Hg on the uterine wall	Verified pressure exertion within range
Pressure Maintenance (Balloon)	Maintain a pressure of 12 kPa for 20 seconds (p-test)	Verified pressure maintenance
Pressure Maintenance (Supply Bag)	Maintain a pressure of 12 kPa for 8 seconds (p-test)	Verified pressure maintenance
Balloon Burst Volume	Verify the burst volume of the balloon	Verified burst volume
Balloon Leak/Rupture	No leakage and/or rupture when subjected to 180 mm Hg for 24 hours	Verified no leakage/rupture
Balloon Drop Strength	Withstand a drop from 1 m when filled to maximum fill level	Verified drop strength
Balloon Fill Time	Verify the time it takes to fill the balloon to the normal fill level for different supply bag heights	Verified fill time
Balloon Fill with Partial Blockage	Able to fill to the normal fill level while inner tube is pressed against balloon wall	Verified fill with blockage
O-Ring Seal Force	Maintain a connection between the tube and the balloon	Verified connection maintenance
Force to Separate Balloon from Tubing	Verify the force required to break the O-ring seal in emergency while balloon is filled	Verified force required
Balloon Leak in Absence of O-Ring	No leaks when filled to maximum operating fill level with no O-ring	Verified no leaks
Tube/Tap Removal Force	Verify the force required to remove the tube from the tap	Verified force required
Supply Bag/Tap Removal Force	Verify the force required to pop the tube off the tap connection for a closed tap	Verified force required
Balloon Draining Time	Verify the time it takes the balloon to drain back to the supply bag for different supply bag heights and tube orientations	Verified draining time
Balloon Fill with a Kinked Tube	Can fill and/or drain with a kinked tube	Verified fill/drain with kinked tube
Biocompatibility Testing
Cytotoxicity (ISO 10993-5:2009)	Not cytotoxic	Not cytotoxic
Maximization Sensitization (ISO 10993-10:2010)	Not sensitizing	Non-sensitizing
Intracutaneous Irritation (ISO 10993-10:2010)	Not irritating	Non-irritating
Acute Systemic Toxicity (ISO 10993-11:2017)	Not acutely systemically toxic	Not acute systemically toxic
Material Mediated Pyrogenicity (ISO 10993-11:2017)	Does not elicit a material-mediated pyrogenic response	Does not elicit a material-mediated pyrogenic response
Sterilization & Shelf-Life
Sterilization	SAL of 10⁻⁶	Achieved SAL 10⁻⁶ (Ethylene Oxide)
Shelf-Life	3-year shelf-life	Established based on accelerated aging (ASTM F1980-21)
Simulated Shipping Distribution	In accordance with ASTM D4196-16	Conducted in accordance with ASTM D4196-16
Package Integrity	In accordance with ASTM F1980-16, F88/F88M-15, and ASTM F1929-15	Conducted in accordance with specified ASTM standards
Endotoxin Testing	Less than <20 EU/device	Demonstrated less than <20 EU/device (USP <85>)

2. Sample Size Used for the Test Set and Data Provenance

The provided document details non-clinical performance data (mechanical, biocompatibility, sterilization, and shelf-life testing). It does not describe a "test set" in the context of clinical or image-based studies with human subjects. Therefore, information about sample size, country of origin, or retrospective/prospective nature of such a test set is not applicable from this document. The tests performed are laboratory-based evaluations of the device's physical and material properties.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. The document describes non-clinical engineering and material science tests. "Ground truth" in the context of expert consensus for clinical diagnosis is not relevant to these types of tests.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" in the context of clinical or diagnostic performance that would require an adjudication method. The reported performance is based on direct measurements and observations from laboratory testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned or conducted, as this documentation pertains to non-clinical testing for substantial equivalence of a medical device.

6. Standalone Performance Study

The documented studies are standalone in the sense that they evaluate the device itself (its mechanical properties, biocompatibility, etc.) without human interaction as part of the performance evaluation. However, this is not a "standalone performance" in the context of algorithm-only performance for a diagnostic device, as the ELLAVI UBT is a physical medical instrument.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical tests described is based on engineering specifications, material science standards, and established laboratory testing protocols. For instance:

Mechanical Testing: Physical measurements against design specifications, established parameters (e.g., pressure ranges, fill volumes, time limits).
Biocompatibility Testing: Compliance with ISO 10993 series standards, where reactivity or toxicity is evaluated against established biological models.
Sterilization and Shelf-Life: Compliance with ISO 11135 and ASTM standards for sterility assurance levels, aging profiles, and package integrity.

8. Sample Size for the Training Set

Not applicable. The ELLAVI UBT is a physical medical device. It does not involve machine learning algorithms or a "training set" in the context of artificial intelligence.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

Summary

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November 13, 2023

SINAPI Biomedical (Pty) Ltd. % Yolanda Smith Regulatory Consultant Smith Associates 1468 Harwell Ave Crofton, Maryland 21114

Re: K230849

Trade/Device Name: ELLAVI UBT Regulation Number: 21 CFR 884.4530 Regulation Name: Obstetric-Gynecologic Specialized Manual Instrument Regulatory Class: II Product Code: OQY Dated: March 27, 2023 Received: March 28, 2023

Dear Yolanda Smith:

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 (the 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 available 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.

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K230849 - Yolanda Smith

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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. 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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

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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 -S

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

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Indications for Use

510(k) Number (if known) K230849

Device Name ELLAVI UBT

Indications for Use (Describe)

The ELLAVI UBT device is intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary - K230849

SUBMITTER I.

510(k) Owner Chris de Villiers SINAPI Biomedical (Pty) Ltd. 1 Lelie Street, ARC Infruitec, North Campus Idas Valley, Stellenbosch, South Africa 7600 Phone: (+27) 021 887 5260 Email: sales(@sinapibiomedical.com

Submission Correspondent Yolanda R Smith, Regulatory Consultant Smith Associates Phone: (888) 729-9674 Email: ysmith(@fdaconsultants.com

Date Prepared November 9, 2023

II. DEVICE

Name of Device:	ELLAVI UBT
Common or Usual Name:	Intrauterine Tamponade Balloon
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

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placenta. A valve is then opened, and this allows the fluid to inflate the balloon and apply pressure to achieve a hemostatic effect.

INDICATIONS FOR USE V.
The ELLAVI UBT device is intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted.

VI. COMPARISON OF INTENDED USE AND TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The table below compares the intended use and technological characteristics of the subject and predicate device.

Attribute	K230849Subject Device:ELLAVI UBT	K170622Predicate Device:Bakri PostpartumBalloonBakri PostpartumBalloon with RapidInstillationComponents	Comparison
Manufacturer	SINAPI Biomedical(Pty) Ltd.	Cook Incorporated	N/A
Product Code	OQY	OQY	Same
Indications forUse	The ELLAVI UBTdevice is intended toprovide temporarycontrol or reduction ofpostpartum uterinebleeding whenconservativemanagement iswarranted.	Bakri PostpartumBalloon is intended toprovide temporarycontrol or reduction ofpostpartumuterine bleeding whenconservativemanagement iswarranted.Bakri PostpartumBalloon with RapidInstillation Componentsis intended to providetemporarycontrol or reduction ofpostpartum uterinebleeding whenconservative	Same

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		management iswarranted.
Principle ofAction	Inserted into the uterusand is inflated to pressoutward on the uterinewalls, producingtamponade of thebleeding vessels	Inserted into the uterusand is inflated to pressoutward on the uterinewalls, producingtamponade of thebleeding vessels	Same
Design	Inflatable uterineballoon; no drainage sideport	Inflatable uterine balloonand a single drainageside port	Different
Rx/OTC	Rx	Rx	Same
Materials	Thermoplastic elastomer	Silicone	Different
Sterile	SAL 10-6	SAL 10-6	Same
Single-use	Yes	Yes	Same
Balloonvolume	400-750mL	500mL	Different
Balloon shape	Cylindrical	Round	Different
Catheter size	24F (8mm)	Not publicly available	Different
Number ofcatheterchannels	1	2	Different
Uterinedrainage	No	Yes	Different

The Indications for Use statement for the ELLAVI UBT is identical to the predicate device, except for the additional component included in the predicate 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:

. Design: The subject device expands to fill the entire uterine cavity and does not have a drain tube, whereas the predicate device has a single opening drain tube protruding out of the middle of the inflated balloon. The shape and size of the balloon are different.
Materials: The patient contacting portions of the subject device is made of ● thermoplastic elastomer (balloon and internal tubing), while the predicate device is made of silicone.

These differences in technological characteristics do not raise different questions of safety and effectiveness. Non-clinical performance testing provided by SINAPI Biomedical (Pty) Ltd. was used to address the differences related to design and principle of operation to demonstrate substantial equivalence to the predicate device.

VII. PERFORMANCE DATA

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

Mechanical Testing

The following mechanical tests were performed at baseline and at the end of the threeyear shelf-life:

Visual Assessment verification of no visual defects ●
Dimensional Verification verification of tube and balloon dimensions ●
Stretch Percentage Verify the stretch percentage of the balloon when filled with . 750 ml
Tube Kinking Verify that the tube is unable to kink when handled as per normal ● use
External Wall Pressure The external wall of the balloon must be able to exert 60 ● mm Hg to 120 mm Hg on the uterine wall
Pressure Maintenance - Verify that the balloon can maintain a pressure of 12 kPa for 20 seconds by p-test; Verify that the supply bag can maintain a pressure of 12 kPa for 8 seconds by p-test
. Balloon Burst Volume - Verify the burst volume of the balloon
Balloon Leak/Rupture Verify that the balloon and components show no sign of ● leakage and/or rupture when subjected to a hydrostatic pressure equal to 180 mm Hg for 24 hours
Balloon Drop Strength - Verify that the balloon is able to withstand a drop from 1 m when filled to the maximum fill level
Balloon Fill Verify the time it takes to fill the balloon to the normal fill level for . different supply bag heights
Balloon Fill with Partial Blockage – Verify that the balloon is able to fill to the normal fill level while the inner tube is pressed against the balloon wall
O-Ring Seal Force Verify that the O-ring maintains a connection between the ● tube and the balloon
Force to Separate the Balloon from the Tubing Verify the force required to ● break the O-ring seal in case of emergency while the balloon is filled
Balloon Leak in the Absence of an O-Ring – Verify if any leaks are present when the balloon is filled to its maximum operating fill level with no O-ring in place
Tube/Tap Removal Force Verify the force required to remove the tube from the ● tap
Supply Bag/Tap Removal Force Verify the force required as applied to the ● supply bag to pop the tube off the tap connection for a closed tap
. Balloon Draining Time – Verify the time it takes the balloon to drain back to the supply bag for different supply bag heights and tube orientations
Balloon Fill with a Kinked Tube Verify that the balloon can fill and/or drain ● with a kinked tube

Biocompatibility Testing

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The ELLAVI UBT is a surface device in contact with a breached surface, with a limited contact duration (< 24 hours).

The biocompatibility evaluation for the ELLAVI UBT was conducted in accordance with the FDA September 2020 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 biocompatibility evaluation included the following tests:

Cytotoxicity (ISO 10993-5:2009) ●
Maximization Sensitization (ISO 10993-10:2010) ●
Intracutaneous Irritation (ISO 10993-10:2010) ●
. Acute Systemic Toxicity (ISO 10993-11:2017)
Material Mediated Pyrogenicity (ISO 10993-11:2017) ●

The results demonstrate that the ELLAVI UBT is not cytotoxic, non-sensitizing, nonirritating, not acute systemically toxic, and does not elicit a material-mediated pyrogenic response.

Sterilization and Shelf-Life Testing

The ELLAVI UBT is sterilized using ethylene oxide to a SAL of 10th, according to ISO 11135:2014. A shelf-life of 3-years has been established based on accelerated aging in accordance with ASTM F1980-21. Simulated shipping distribution was conducted in accordance with ASTM D4196-16. Package integrity testing was conducted in accordance with ASTM F1980-16, F88/F88M-15, and ASTM F1929-15. Endotoxin testing was conducted in accordance with USP <85> to demonstrate less than <20 EU/device.

VIII. CONCLUSIONS

The non-clinical performance data described above demonstrate that the ELLAVI UBT is as safe and effective as the predicate device and supports a determination of substantial equivalence.

Regulation Number and Section

§ 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.