CrossBay Endometrial Tissue Sampler (ETS)

K192534 · Crossbay Medical · HHK · Mar 25, 2020 · Obstetrics/Gynecology

Device Facts

• Record ID: K192534
• Device Name: CrossBay Endometrial Tissue Sampler (ETS)
• Applicant: Crossbay Medical
• Product Code: HHK · Obstetrics/Gynecology
• Decision Date: Mar 25, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1175
• Device Class: Class 2

Intended 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.

Device Story

Sterile, single-use endometrial tissue sampler; consists of delivery catheter, everting membrane, inner aspiration catheter, and 3cc syringe. Operates by creating negative pressure via syringe; everting membrane facilitates placement of inner catheter into uterine cavity; device movement scrapes and aspirates mucosal tissue. Used in clinical settings by healthcare providers to obtain histological biopsy samples. Benefits patient by enabling minimally invasive tissue collection for diagnostic evaluation.

Clinical Evidence

Bench testing only. Includes biocompatibility (ISO 10993-5, -10), sterilization validation (ISO 11135, ISO 10993-7), packaging/shipping validation (ASTM F88, F2096, D4169), shelf-life (ASTM F1980), and mechanical/functional testing (tensile, flexural, leak, negative pressure, and uterine model comparison).

Technological Characteristics

Manual aspiration device; everting membrane (0.04mm wall thickness); inner aspiration catheter (1.3mm lumen); acorn tip (16mm length, 12.4mm OD). Materials validated per ISO 10993. Sterilization via Ethylene Oxide (ANSI/AAMI/ISO 11135).

Indications for Use

Indicated for patients requiring endometrial tissue biopsy; removes material from the uterus and mucosal lining via scraping and vacuum suction.

Regulatory Classification

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.

Predicate Devices

• Marina Ampler (MAS) (K021876)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

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.<br>13240 Evening Creek Drive, Suite 304<br>San Diego, CA 92128 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submission Correspondent: | Cindy Domecus, R.A.C. (US & EU)<br>Regulatory Consultant to CrossBay Medical Inc.<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| 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

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.

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