The CrossBay SonsoSure Sonohysterography and Endometrial Sampling Device is indicated for use to access the uterine cavity for saline infusion sonohysterography and to obtain endometrial biopsy, if indicated, utilizing the same device.

Device Description

The CrossBay Medical SonoSure Device is a catheter that enables saline infusion sonohysterography procedures and endometrial biopsy collection within a single device. The catheter is comprised of standard polymer materials and contains a silicone acorn tip to enable a cervical seal. The distal end of the device contains a retractable nylon brush for endometrial biopsy sampling. The distal end of the device contains an empty PVC bag that can be filled with saline. The device is provided sterile and is intended for single use only.

AI/ML Overview

Here's an analysis of the provided text regarding the CrossBay Medical SonoSure Sonohysterography and Endometrial Sampling Device:

Acceptance Criteria and Device Performance Study

Based on the provided 510(k) summary, the device's acceptance criteria and performance are primarily evaluated through non-clinical performance data (bench testing and biocompatibility). The document emphasizes substantial equivalence to predicate devices rather than establishing novel clinical performance metrics with specific acceptance criteria in a dedicated clinical study.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Inferred from testing)	Reported Device Performance
Physical/Mechanical	Adherence of endometrial biopsy brush bristles to catheter shaft when subjected to shear force	Performed according to product specifications; adherence confirmed through testing.
	Force at break assessments	Performed according to product specifications; results ensured mechanical safety.
Biocompatibility	Compliance with ISO 10993	Cytotoxicity: CompliantSensitization: CompliantIrritation: Compliant
Sterilization	Compliance with ISO 11135-1 and ISO 10993-7	Complies with requirements for ethylene oxide sterilization.
Packaging & Shelf Life	Seal strength (ASTM F88)	Packaging maintains sterility over duration of shelf life.
	Leak detection (ASTM F1929)	Packaging maintains sterility over duration of shelf life.
	Withstand transport without damage	Packaging can withstand transport without damage.
	Device mechanical safety and performance over shelf life	Device maintains mechanical safety and performance over shelf life.

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

Sample Size: The document does not specify a numerical sample size for the "test set" in terms of clinical subjects. The performance data discussed is non-clinical (bench testing, biocompatibility, sterilization, packaging). For these types of tests, samples would be units of the device itself (e.g., a certain number of devices for mechanical testing, material samples for biocompatibility). Specific numbers are not provided.
Data Provenance: The data is generated through "physical bench testing," "biocompatibility testing," and "sterilization" and "packaging and shipping validation studies." This indicates the data is from laboratory or controlled testing environments, not from clinical subjects or patient data. Therefore, "country of origin" or "retrospective/prospective" is not applicable in the typical sense for clinical studies. It's internal product development and testing data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This question is not applicable as the provided documentation describes non-clinical performance and does not involve establishing ground truth from experts on a test set (e.g., imaging diagnosis, pathology review). The "ground truth" for these tests are typically established by objective, measurable engineering and scientific standards (e.g., pass/fail criteria for mechanical strength, established limits for cytotoxicity).

4. Adjudication Method for the Test Set

This question is not applicable as the assessment is based on non-clinical performance data against established standards and specifications, not on subjective expert interpretation requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done.
The device is a physical medical instrument (catheter, brush), not an AI-powered diagnostic or assistive tool. Therefore, the concept of "human readers improving with AI assistance" is not relevant to this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance study was not done.
The device is a physical medical instrument, not an algorithm, and does not operate "standalone" without human interaction/use.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical tests described, the "ground truth" is derived from established scientific and engineering standards and specifications. For instance:
- Mechanical strength: Pass/fail criteria dictated by product specifications and engineering principles.
- Biocompatibility: Conformance to ISO 10993 standards and FDA guidance.
- Sterilization: Compliance with ISO 11135-1 and ISO 10993-7.
- Packaging: Adherence to ASTM guidelines.
There is no mention of expert consensus, pathology, or outcomes data being used to establish a "ground truth" for the performance evaluation presented.

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical medical instrument and does not involve machine learning or AI, thus there is no "training set."

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

This question is not applicable as there is no training set for this device.

Summary

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K133144 Page 1 of 3

510(k) Summary (21 CFR § 807.92(c))

Submitter:	CrossBay Medical, Inc.17141 Murphy Avenue, Suite 5CIrvine, CA 94901
Contact:	Cindy DomecusRegulatory Consultant to CrossBay MedicalPhone: 650.343.4813Fax: 650.343.7822Email: domecusconsulting@comcast.net
Date Summary Prepared:	18 March 14
Device Trade Name:	CrossBay Medical SonoSure Sonohysterography and EndometrialSampling Device
Common Name:	Saline Infusion Sonohysterography (SIS) Catheter, Endometrial Brush
Classification Name:	Obstetric-gynecologic specialized manual instrument(21 CFR §884.4530)
Product Code:	PGK (cannula, injector, uterine, enodometrial biopsy)HFE (endometrial brush)
Equivalent Devices:	Cook's Sonohysterography Biopsy Device (K060908 - 29 Jun 2006)Cook's Tao Endometrial Sampling Brush (K082066 - 07 Nov 2008)

Device Description:

Intended Use / Indications for Use:

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The Cook Sonohysterography Biopsy Technological Characteristics & Substantial Equivalence: Catheter served as the primary predicate device. The subject and predicate device have the same Indications for Use statement. The subject and predicate device have different technological characteristics as follows: mechanism of endometrial biopsy collection, dimensions, and design. The predicate device incorporates a curette to perform endometrial biopsy while the subject device utilizes a brush. However, the second predicate device, the Cook Tao Endometrial Sampling Brush, also utilizes a brush to collect endometrial biopsy samples.

The different technological characteristics of the subject device could affect safety and effectiveness. For example, regarding effectiveness, the different mechanism of endometrial biopsy collection may affect the adequacy of the sample. Regarding safety, the different mechanism of endometrial biopsy collect may affect the pain and/or discomfort associated with the procedure. The remaining different technological characteristics between the subject and predicate device are minor and should have minimal impact on safety and effectiveness.

The different technological characteristics of the subject device do not raise different types of safety and effectiveness questions as they are routinely encountered during premarket review of uterine catheters, endometrial aspirators, and endometrial brushes.

Accepted scientific methods exist to assess the effects of the different technological characteristics, including mechanical, animal, and/or clinical performance testing. The submission included sufficient performance data to assess the effects of the different technological characteristics, and the performance data demonstrate equivalence.

Non-Clinical Performance Data:Physical bench testing confirmed that the CrossBay Medical SonoSure Device performs according to the product specifications. Device evaluation consisted of physical, chemical and functional testing performed pursuant to the device verification protocol. Mechanical safety and performance testing was conducted to ensure adherence of the endometrial biopsy brush bristles to the catheter shaft when subjected to shear force. Additionally, this bench safety evaluation included force at break assessments. Biocompatibility testing was conducted according to ISO 10993 "Biological Evaluation of Medical Devices" and FDA's recent guidance ("Use of International Standard ISO 10993", draft document issued on 24 April 2013). The following biocompatibility tests were conducted: Cytotoxicity, Sensitization and Irritation. The sterilization complies with the requirements prescribed in the applicable standards for ethylene oxide sterilization (ISO 11135-1:2007 "Sterilization of health care products -- Ethylene oxide -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices" and ISO 10993-7:2008 "Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals"). Packaging and shipping validation studies were conducted pursuant to the applicable ASTM guidelines (ASTM F88 "Standard Test Method for Seal Strength of Flexible Barrier Materials"; and, ASTM F1929 "Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration"). The results of shelf life testing demonstrate that the packaging for the subject device maintains sterility over the duration of

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shelf life, the packaging can withstand transport without damage, and the subject device maintains its mechanical safety and performance over the duration of its shelf life

Summary:

Based on the product technical information, intended use / indications for use and bench performance data provided in this premarket notification, the CrossBay Medical SonoSure Device has been shown to be substantially equivalent to the currently marketed predicate devices.

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Image /page/3/Picture/1 description: The image shows the words "Public Health Service" in bold, black font. There is a period after the word "Service". The words are stacked on top of each other.

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

March 19, 2014

CrossBay Medical, Inc. % Cindy Domecus, R.A.C. Principal Domecus Consulting Services, LLC 17141 Murphy Avenue, Suite 5C Irvine, CA 94901

K133144 Re:

Trade/Device Name: SonoSure SonoHysterography and Endometrial Sampling Device Regulation Number: 21 CFR 884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: PGK, HFE Dated: February 18, 2014 Received: February 19, 2014

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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulterstion. 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 thany Federal statutes and regulations administered by other Federal agencies. You must

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Page 2 - Cindy Domecus

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 Small Manufacturers, International and Consumer Assistance 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" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

(2) Of NY art 000) produces/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Image /page/4/Picture/6 description: The image shows the text "Benjamin Fisher-S". The text is in a bold, sans-serif font. The letters "DA" are in a decorative, outlined font.

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 Statement

510(k) Number if Known: K133144

Device Name: CrossBay Medical SonoSure Sonohysterography and Endometrial Sampling Device

Indications for Use:

Prescription Use 図 (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrent of CDRH, Office of Device Evaluation (ODE)

Image /page/5/Picture/10 description: The image contains the text "Benjamin R. Fisher -S 2014.03.19 11:23:45 -04'00'". The text appears to be a name, date, and time stamp. The name is Benjamin R. Fisher, and the date is March 19, 2014. The time is 11:23:45, and the time zone is -04'00'.

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.