Instillation of a consistent alternating pattern of saline and air as a continuous stream of contrast media into the uterus and fallopian tubes to be used in conjunction with an intrauterine catheter for performance of sono-hysterosalpingogram (SonoHSG).
Instillation of saline as a continuous stream of contrast media into the used in conjunction with an intrauterine catheter for performance of saline infusion sonography (SIS).

Device Description

The Air Bubble-Based Infuser (ABBI™) is a dual-barrel syringe that can be connected to an intrauterine infusion catheter to instill a saline-air mixture as contrast media during sono-hysterosalpingogram (Sono HSG) procedures and saline only during hysterosonography (SIS) procedures. The device has a selector valve that allows the user to select infusion of a saline-air mixture for a Sono HSG procedure or saline alone for a SIS procedure. These procedures are used for the evaluation of the fallopian tube(s) selectively and/or the uterus.

The ABBI™ is labeled for use with the H/S Elliptosphere Catheter Set (K013972).

The device is a single use only and provided sterile using an ethylene oxide sterilization method. The device is intended to be used in a healthcare facility or hospital.

AI/ML Overview

The provided text describes the Air Bubble-Based Infuser (ABBI™) and its substantial equivalence to a predicate device, focusing on non-clinical performance data. It does not contain information about the use of AI, so I cannot provide details on AI-related aspects.

Here's a breakdown of the available information regarding acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance:

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. Instead, it lists the types of non-clinical tests performed to demonstrate substantial equivalence. The "performance" is implicitly stated as "demonstrates that the ABBI™ is substantially equivalent to the proposed predicate device."

Acceptance Criteria Category	Specific Test Performed	Reported Device Performance
Functional Performance	Filling and Infusion Test	Demonstrated substantial equivalence to predicate.
	Volume Capacity	Demonstrated substantial equivalence to predicate.
	Pressure and Vacuum	Demonstrated substantial equivalence to predicate.
	Torque Test	Demonstrated substantial equivalence to predicate.
	Multi-Fill Performance Test	Demonstrated substantial equivalence to predicate.
Material/Design Integrity	Steam Deformation Test	Demonstrated substantial equivalence to predicate.
	Feature Evaluation	Demonstrated substantial equivalence to predicate.
Biocompatibility	Cytotoxicity - MEM Elution (ISO 10993-5:2009)	Non-cytotoxic.
	Irritation Vaginal Irritation Study (ISO 10993-10:2010)	Non-irritating.
	Sensitization Guinea Pig Maximization (ISO 10993-10:2010)	Non-sensitizing.
Usability	Summative Usability Assessment	Demonstrated substantial equivalence to predicate.
Clinical Performance (Simulated)	Cadaver Device Evaluation Study	Demonstrated substantial equivalence to predicate.
Shelf Life	Accelerated Aging Study (functional characteristics & package integrity)	Supports a 1-year shelf life.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

The document does not specify the sample sizes used for any of the non-clinical tests or the cadaver study. It also does not provide information on the country of origin of the data or whether the studies were retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This information is not provided. The studies mentioned are primarily non-clinical device performance and biocompatibility tests, which typically do not involve establishing ground truth by human experts in the same way clinical diagnostic studies would. The "Summative Usability Assessment" might have involved human participants evaluating the device, but the number and qualifications of evaluators are not detailed.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not provided. Adjudication methods are typically associated with clinical studies involving interpretation of results, which is not described here.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is irrelevant as the provided text describes a medical device (an infuser) and its non-clinical performance and substantial equivalence to a predicate device, not an AI-powered diagnostic or assistive tool for human readers. There is no mention of AI in the document.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This is irrelevant as the provided text describes a medical device (an infuser) and its non-clinical performance, not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Given the nature of the tests (filling, volume, pressure, torque, deformation, biocompatibility), the "ground truth" would be established by physical measurements, chemical analyses, and biological responses according to established engineering and ISO standards, rather than expert consensus on diagnostic images or pathology. For the cadaver study, the ground truth would be the direct observation of the device's function within the cadaver.

8. The sample size for the training set:

This is irrelevant as the provided text describes a medical device (an infuser) and its non-clinical performance, not an AI model that requires a training set.

9. How the ground truth for the training set was established:

This is irrelevant as the provided text describes a medical device (an infuser) and its non-clinical performance, not an AI model that requires a training set.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized caduceus-like symbol with three human profiles facing right, stacked on top of each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 26, 2015

Cooper Surgical, Inc. James Keller VP Regulatory Affairs & Quality 95 Corporate Drive Trumbull, CT 06611

Re: K143415 Trade/Device Name: Air Bubble Based Infuser (ABBI™) Regulation Number: unclassified Regulation Name: unclassified Regulatory Class: unclassified Product Code: LKF Dated: November 19, 2014 Received: November 28, 2014

Dear James Keller,

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. 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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Herbert P. Lerner -S

for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K143415

Device Name Air Bubble-Based Infuser (ABBI^TM)

Indications for Use (Describe)

The ABBI (Air Bubble Based Infuser) is indicated for the following:

Instillation of a consistent alternating pattern of saline and air as a continuous stream of contrast media into the uterus and fallopian tubes to be used in conjunction with an intrauterine catheter for performance of sono-hysterosalpingogram (SonoHSG).
Instillation of saline as a continuous stream of contrast media into the used in conjunction with an intrauterine catheter for performance of saline infusion sonography (SIS).

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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K143415 – 510(k) Summary

Date Prepared:	February 24, 2015
510k submitter andPrimary Contact:	James KellerVP Regulatory Affairs & QualityCooperSurgical, Inc.95 Corporate Dr.Trumbull, CT 06611Phone: 203-895-1472Email: James.Keller@coopersurgical.com

Device Name:

ProprietaryName	Common Name	Classification Name	ProductCode
ABBITM	Cannula,Manipulator/Injector,Uterine	Unclassified	LKF

Predicate Information:

FemVue Saline-Air Device (Femasys, Inc.) - K110288

Device Description:

The ABBI™ is labeled for use with the H/S Elliptosphere Catheter Set (K013972).

The device is a single use only and provided sterile using an ethylene oxide sterilization method. The device is intended to be used in a healthcare facility or hospital.

Indications for Use:

The ABBI (Air Bubble Based Infuser) is indicated for the following:

-Instillation of a consistent alternating pattern of saline and air as a continuous stream of contrast media into the uterus and fallopian tubes to be used in

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conjunction with an intrauterine catheter for performance of sonohysterosalpingogram (SonoHSG).

Instillation of saline as a continuous stream of contrast media into the uterus to be used in conjunction with an intrauterine catheter for performance of saline infusion sonography (SIS).

Technological Characteristics:

The technological characteristics of the device are equivalent to the predicate, with the exception of (1) the added feature that allows the ABBT™ to infuse saline only in the performance of SIS (as opposed to only infusing saline-air) and (2) differences in materials between the predicate and the ABBI™

Performance Data:

The ABBI™ was tested by the following non-clinical methods to demonstrate substantial equivalence to the predicate device:

Filling and Infusion Test ●
Volume Capacity ●
Pressure and Vacuum
Torque Test ●
Steam Deformation Test
Feature Evaluation
Summative Usability Assessment ●
Multi-Fill Performance Test ●
Cadaver Device Evaluation Study .

The protocol and results of the following biocompatibility studies demonstrate that the ABBI™ is non-cytotoxic, non-irritating, and non-sensitizing, respectively.

Cytotoxicity - MEM Elution (ISO 10993-5:2009)
Irritation Vaginal Irritation Study (ISO 10993-10:2010) ●
Sensitization Guinea Pig Maximization (ISO 10993-10:2010) ●

The results of an accelerated aging study evaluating functional characteristics and package integrity support a 1-year shelf life for the ABBI™

Conclusion:

The performance testing demonstrates that the ABBI™ is substantially equivalent to the proposed predicate device.

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.