K Number

Device Name

CrossBay Endometrial Tissue Sampler (ETS)

Manufacturer

CrossBay Medical

Date Cleared

2020-03-25

(191 days)

Product Code

HHK

Regulation Number

884.1175

Intended Use

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K021876

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on mechanical and physical aspects of tissue sampling, with no mention of AI/ML terms or functionalities. The performance studies are related to biocompatibility, sterilization, packaging, and mechanical function, not algorithmic performance.

Therapeutic

No
The device is described as an Endometrial Tissue Sampler, indicated for obtaining tissue for histological biopsy by removing material from the uterus. This function is for diagnostic purposes, not for treating or alleviating a disease or condition.

Diagnostic

Yes

The device is used to obtain tissue for histological biopsy, which is a diagnostic procedure to identify diseases or abnormal conditions.

SaMD (Software as a Medical Device)

The device description clearly outlines a physical, sterile, disposable device with mechanical components (catheters, membrane, syringe) used for tissue sampling. The performance studies also focus on physical and functional characteristics of the hardware.

IVD (In Vitro Diagnostic)

Based on the provided information, the CrossGlideTM ETS, Endometrial Tissue Sampler, is not an IVD (In Vitro Diagnostic).

Here's why:

IVD devices are used to examine specimens derived from the human body in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This typically involves tests performed on blood, urine, tissue samples, etc., in a laboratory setting.
The CrossGlideTM ETS is a device used to obtain the tissue sample from the uterus. Its function is to collect the material for subsequent histological biopsy, which is the in vitro diagnostic process.
The description focuses on the mechanical process of tissue collection (scraping and vacuum suction) and the device's components for this purpose. It does not describe any analytical or testing function performed by the device itself on the collected sample.

In summary, the CrossGlideTM ETS is a specimen collection device, which is a crucial step in the diagnostic process, but it is not the diagnostic device itself. The histological biopsy performed on the collected tissue is the IVD part of the process.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

HHK

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

uterus, mucosal lining of the uterus

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

Biocompatibility testing: 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: Cytotoxicity, Vaginal Irritation, Sensitization.
Sterilization Validation: evaluated for adoption into the current ethylene oxide (EO) sterilization cycle of the contract sterilizer 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 assessed and shown to be in accordance with ISO 10993-7:2008.
Packaging, Shipping Validation, and Shelf-Life: conducted pursuant to ASTM guidelines (ASTM F88/F88M - 15, ASTM F 2096-11, ASTM D4169-16). Shelf-life supported by packaging and performance tests on samples exposed to accelerated aging conditions pursuant to ASTM F1980 – 16. Additional assessments included: 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 (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.

Key Metrics

Not Found

Predicate Device(s)

K021876

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services USA seal. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

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.

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

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 304
San Diego, CA 92128 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submission Correspondent: | Cindy Domecus, R.A.C. (US & EU)
Regulatory Consultant to CrossBay Medical Inc.
Phone: 650.343.4813
Fax: 650.343.7822
Email: 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.

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

THE PREDICATE DEVICE
Subject
Device &
Predicate
Device	K192534	K021876	Comparison
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.	The device 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
or for menstrual
extraction.	Different: The predicate
device can also be used for
menstrual extraction.
However, both devices have
the same intended use to
remove endometrial tissue for
biopsy samples
Device
Components	Inner catheter,
everting membrane,
aspiration with hole,
blue and white
stopcock compliant
tube, syringe	Catheter with
syringe
Catheter without
syringe	Different: The subject device
includes additional
components as compared to
the predicate device. These
differences do not raise
different questions of safety
and effectiveness (S&E).
Aspiration
Method	Manual	Manual	Same
Overall
Catheter
Length (cm)	43-48 cm	Unknown	Different: The length of the
predicate device is not known.
Differences in catheter length
do not raise different
questions of S&E.
Inner Catheter
Delivery
Catheter	Length: 315mm
(includes Stopcock)
Outer diameter: 2mm
Internal diameter:
1.3mm
Length: 156mm
(includes Acorn Tip)	Not Applicable
Length Unknown
3-3.5 mm (OD)	Different: The predicate
device does not include a
separate inner catheter.
Presence of an inner catheter
and its length do not raise
different questions of S&E.
Different: The length of the
predicate device is not known;
	Outer diameter:
4.1mm
Internal diameter
3.3.mm		however, its outer diameter is
smaller than the subject
device. The length and outer
diameter of the subject device
do not raise different
questions of S&E.
Everting
Membrane	Length: 65mm at full
deployment
Outer diameter:
3.5mm @ 3
atmospheres of
pressure
Wall thickness:
0.04mm	Not Applicable	Different: The predicate
device does not include an
everting membrane.
Presence of an everting
membrane in the subject
device does not raise different
questions of S&E.
Aspiration
Device Side
Hole &
Internal
Lumen	Side hole elliptical
opening
Internal lumen 1.3mm	Unknown	Different: The design of the
tip opening and inner lumen of
the predicate device is not
known. Differences in tip
design and internal lumen
diameter do not raise different
questions of S&E.
Acorn Tip	Length: 16mm
Outer diameter:
12.4mm	Not Applicable	Different: The predicate
device does not include an
acorn tip. The presence of an
acorn tip does not raise
different questions of S&E.
Sterilization
Method	Ethylene Oxide	Ethylene Oxide	Same

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.

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

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.