The CrossGlideTM ETS, Endometrial Tissue Sampler, is indicated for use to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction in order to obtain tissue for histological biopsy.

Device Description

The CrossGlide™ ETS, Endometrial Tissue Sampler, is a sterile, disposable, single-use device which enables the removal of mucosal tissue from the uterus for histological biopsy. The CrossGlide™ ETS contains a Delivery Catheter with an everting Membrane and an Inner Aspiration Catheter. The everting Membrane places the Inner Aspiration Catheter into the uterine cavity. Movement of the ETS device, after creating negative pressure with the 3cc syringe, removes material and tissue from the uterine cavity.

AI/ML Overview

The provided text describes the CrossGlide™ ETS, an Endometrial Tissue Sampler, and its submission for FDA 510(k) clearance. The document focuses on establishing substantial equivalence to a predicate device rather than presenting a standalone study with detailed acceptance criteria and performance data for the device itself.

Based on the information provided, here's a breakdown of the requested elements:

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

The document does not explicitly state quantitative acceptance criteria or a specific study that proves the device meets these criteria in the context of clinical performance (e.g., diagnostic accuracy or tissue yield). Instead, it lists various tests conducted to demonstrate substantial equivalence to a predicate device and safety/functionality.

Acceptance Criteria Category	Reported Device Performance (Summary)
Biocompatibility	Met ISO 10993-1, 10993-5:2009, 10993-10:2010 standards for cytotoxicity, vaginal irritation, and sensitization.
Sterilization Validation	Validated according to ANSI/AAMI/ISO 11135:2014 for Ethylene Oxide (EO) sterilization. Residuals in accordance with ISO 10993-7:2008.
Packaging, Shipping, Shelf-Life	Met applicable ASTM guidelines (ASTM F88/F88M - 15, ASTM F 2096-11, ASTM D4169-16) and a shelf-life supported by accelerated aging (ASTM F1980 – 16).
Device Functionality over Shelf-Life	Passed dimensional assessments, compliant tube distension and pressure maintenance, assessment of device eversion feature, evaluation of deployment distance marking, negative pressure measurement for aspiration, mechanical testing (tensile joint strength, flexural, butt testing), leak testing.
Uterine Deployment & Specimen Collection	Functional testing compared subject and predicate device performance using a uterine model, demonstrating comparable function.
Safety (General)	Differences from predicate device not raising different questions of safety and effectiveness.
Effectiveness (General)	Differences from predicate device not raising different questions of safety and effectiveness.

2. Sample size used for the test set and the data provenance

The document does not mention a clinical test set in the traditional sense of patient data for evaluating diagnostic or clinical performance. The "test sets" mentioned relate to engineering and safety validation:

Biocompatibility tests: Sample sizes are typically small and determined by the specific ISO standard. Data provenance is implied to be from laboratory testing performed by the manufacturer or contracted labs.
Sterilization validation: Sample sizes are determined by AAMI/ISO standards. Data provenance is from laboratory testing.
Packaging, Shipping, Shelf-Life & Device Functionality: Sample sizes are determined by specific ASTM guidance. Data provenance is from laboratory testing.
Functional testing (uterine model): The specific number of devices tested on the uterine model is not provided. Data provenance is from laboratory testing using a physical model, not human data.

There is no mention of country of origin for any human data or whether studies were retrospective or prospective, as no human studies are described in detail.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. There is no described "test set" of patient cases requiring expert interpretation to establish ground truth for clinical performance. The ground truth for the engineering and safety tests would be defined by the specifications of the standards (e.g., whether a material is cytotoxic, whether a sterile barrier is maintained, whether a specific force is withstood).

4. Adjudication method for the test set

Not applicable. As no clinical test set requiring expert interpretation is described, no adjudication method is mentioned.

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.

Not applicable. This device is an endometrial tissue sampler, a physical medical device for tissue collection, not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI performance is irrelevant to this submission.

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

Not applicable. This is not an algorithm or AI device.

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

For the engineering and safety studies described:

Biocompatibility: Ground truth is against established limits and responses per ISO standards.
Sterilization: Ground truth is against sterility assurance levels (SALs) defined by AAMI/ISO standards, and residual limits.
Mechanical/Functional: Ground truth is against design specifications and functional requirements (e.g., maintaining negative pressure, correct deployment).
Uterine Model: Ground truth for comparison would be the ability to successfully deploy and collect "specimens" from the model as intended by the device design, presumably measured by quantitative factors or visual assessment of model interaction.

8. The sample size for the training set

Not applicable. This is not an AI/algorithm device that requires a training set.

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

Not applicable.

Summary Conclusion from the Document:

The provided document (a 510(k) summary) focuses on demonstrating substantial equivalence of the CrossGlide™ ETS to a legally marketed predicate device (Marina Ampler (MAS), K021876). The "study" described is a collection of engineering and validation tests (biocompatibility, sterilization, packaging, shelf-life, and functional testing using a uterine model) to ensure the new device is safe and performs as intended, and that its differences from the predicate device do not raise new questions of safety or effectiveness. It does not present a clinical study with detailed acceptance criteria for diagnostic performance or tissue yield, as would be common for diagnostic AI tools.

Summary

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CrossBay Medical Inc. % Cindy Domecus, RAC (US & EU) Principal, Domecus Consulting Services Domecus Consulting Services, LLC 1171 Barroihet Drive Hillsborough. CA 94010

Re: K192534

Trade/Device Name: CrossGlide™ ETS, Endometrial Tissue Sampler Regulation Number: 21 CFR 884.1175 Regulation Name: Endometrial Suction Curette and Accessories Regulatory Class: II Product Code: HHK Dated: February 20, 2020 Received: February 24, 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.

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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 803) for devices or postmarketing safety reporting (21 CFR 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 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 medical devices and radiation-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,

For

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) K192534

Device Name CrossGlideTM ETS, Endometrial Tissue Sampler

Indications for Use (Describe)

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- K192534

I. SUBMITTER INFORMATION

Submitter:	CrossBay Medical Inc.13240 Evening Creek Drive, Suite 304San Diego, CA 92128
Submission Correspondent:	Cindy Domecus, R.A.C. (US & EU)Regulatory Consultant to CrossBay Medical Inc.Phone: 650.343.4813Fax: 650.343.7822Email: domecusconsulting@comcast.net
Date Summary Prepared:	March 24, 2020

II. SUBJECT DEVICE INFORMATION

Device Trade Name:	CrossGlide™ ETS, Endometrial Tissue Sampler
Common Name:	Endometrial Sampling Device
Regulation Number:	21 CFR §884.1175
Regulation Name:	Endometrial Suction Curette and Accessories
Regulatory Class:	II
Product Code:	HHK (Curette, Suction, Endometrial [and accessories])

III. PREDICATE DEVICE INFORMATION

The predicate device is the Marina Ampler (MAS), K021876.

The predicate device has not been subject to a design-related recall.

IV. DEVICE DESCRIPTION

V. INDICATIONS FOR USE

The CrossGlide™ ETS, Endometrial Tissue Sampler, is indicated for use to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction in order to obtain tissue for histological biopsy.

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

THE PREDICATE DEVICE
SubjectDevice &PredicateDevice	K192534	K021876	Comparison
Indications forUse	The CrossGlide™ ETS,Endometrial TissueSampler, is indicatedfor use to removematerial from theuterus and from themucosal lining of theuterus by scraping andvacuum suction inorder to obtain tissuefor histological biopsy.	The device isindicated for use toremove materialfrom the uterus andfrom the mucosallining of the uterusby scraping andvacuum suction inorder to obtaintissue forhistological biopsyor for menstrualextraction.	Different: The predicatedevice can also be used formenstrual extraction.However, both devices havethe same intended use toremove endometrial tissue forbiopsy samples
DeviceComponents	Inner catheter,everting membrane,aspiration with hole,blue and whitestopcock complianttube, syringe	Catheter withsyringeCatheter withoutsyringe	Different: The subject deviceincludes additionalcomponents as compared tothe predicate device. Thesedifferences do not raisedifferent questions of safetyand effectiveness (S&E).
AspirationMethod	Manual	Manual	Same
OverallCatheterLength (cm)	43-48 cm	Unknown	Different: The length of thepredicate device is not known.Differences in catheter lengthdo not raise differentquestions of S&E.
Inner CatheterDeliveryCatheter	Length: 315mm(includes Stopcock)Outer diameter: 2mmInternal diameter:1.3mmLength: 156mm(includes Acorn Tip)	Not ApplicableLength Unknown3-3.5 mm (OD)	Different: The predicatedevice does not include aseparate inner catheter.Presence of an inner catheterand its length do not raisedifferent questions of S&E.Different: The length of thepredicate device is not known;
	Outer diameter:4.1mmInternal diameter3.3.mm		however, its outer diameter issmaller than the subjectdevice. The length and outerdiameter of the subject devicedo not raise differentquestions of S&E.
EvertingMembrane	Length: 65mm at fulldeploymentOuter diameter:3.5mm @ 3atmospheres ofpressureWall thickness:0.04mm	Not Applicable	Different: The predicatedevice does not include aneverting membrane.Presence of an evertingmembrane in the subjectdevice does not raise differentquestions of S&E.
AspirationDevice SideHole &InternalLumen	Side hole ellipticalopeningInternal lumen 1.3mm	Unknown	Different: The design of thetip opening and inner lumen ofthe predicate device is notknown. Differences in tipdesign and internal lumendiameter do not raise differentquestions of S&E.
Acorn Tip	Length: 16mmOuter diameter:12.4mm	Not Applicable	Different: The predicatedevice does not include anacorn tip. The presence of anacorn tip does not raisedifferent questions of S&E.
SterilizationMethod	Ethylene Oxide	Ethylene Oxide	Same

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As noted in the table above, there are differences in the indications for use statements and technological features of the subject and predicate devices. However, as stated in the table, the differences in indications for use do not represent a new intended use, and the differences in technological features do not raise different questions of safety and effectiveness.

VII. PERFORMANCE DATA

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

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Biocompatibility testing

Biocompatibility testing was conducted according to ISO 10993-1 "Biological Evaluation of Medical Devices" and FDA's guidance "Use of International Standard ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process." Testing included the following:

Cytotoxicity (ISO 10993-5:2009) .
. Vaginal Irritation (ISO 10993-10:2010)
. Sensitization (ISO 10993-10:2010)

Sterilization Validation

The CrossGlide™ ETS was evaluated for adoption into the current ethylene oxide (EO) sterilization cycle of the contract sterilizer. The evaluation process was performed utilizing the AAMI Guidance contained in TIR28:2016 Product adoption and process equivalence for ethylene oxide sterilization. The EO Sterilization Cycle was validated in accordance with ANSI/AAMI/ISO 11135:2014. Residuals from the sterilization process were assessed and shown to be in accordance with ISO 10993-7:2008.

Packaging, Shipping Validation, and Shelf-Life

Packaging and shipping validation studies were conducted pursuant to the applicable ASTM guidelines (ASTM F88/F88M - 15 "Standard Test Method for Seal Strength of Flexible Barrier Materials"; and, ASTM F 2096-11 "Standard Test Methods for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble leaks)"; ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems). The shelf-life is supported by packaging and performance tests conducted on samples exposed to accelerated aging conditions pursuant to ASTM F1980 – 16 "Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices". Additional assessments to support device function over its shelf-life included the following:

. Dimensional assessments
Compliant tube ability to be distended and maintain targeted pressure ●
Assessment of device eversion feature ●
Evaluation of device marking to confirm correct deployment distance of the inner ● catheter beyond the everting membrane
. Negative pressure measurement to confirm ability to aspirate tissue samples
Mechanical testing, including tensile joint strength, flexural testing and butt testing
Leak testing
. Functional testing of the subject and predicate device to compare uterine deployment and specimen collection using a uterine model

VIII: CONCLUSIONS

The subject and predicate devices have the same intended use and comparable technological characteristics. The differences in technological characteristics between the

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subject and predicate devices do not raise different questions of safety and effectiveness. The performance data demonstrate that the subject device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 884.1175 Endometrial suction curette and accessories.

(a)
Identification. An endometrial suction curette is a device used to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction. This device is used to obtain tissue for biopsy or for menstrual extraction. This generic type of device may include catheters, syringes, and tissue filters or traps.(b)
Classification. Class II (performance standards).