CrossGlide ETS Plus

K201952 · Crossbay Medical · HHK · Aug 5, 2020 · Obstetrics/Gynecology

Device Facts

• Record ID: K201952
• Device Name: CrossGlide ETS Plus
• Applicant: Crossbay Medical
• Product Code: HHK · Obstetrics/Gynecology
• Decision Date: Aug 5, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.1175
• Device Class: Class 2

Intended Use

The CrossGlide™ ETS Plus is indicated for use for sonohysterography and 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 device for sonohysterography and endometrial biopsy. Comprises delivery catheter with everting membrane and inner aspiration catheter. Physician inserts device into uterine cavity; everting membrane facilitates cervical crossing. Saline infused via 10cc luer-lock syringe for sonohysterography. Same syringe used to aspirate saline and create negative pressure for tissue collection. Manual scraping and vacuum suction remove mucosal tissue. Used in clinical setting by physicians. Output is tissue sample for histological analysis. Benefits include combined diagnostic imaging and biopsy capability in one procedure.

Clinical Evidence

Bench testing only. Evaluated mechanical integrity (tensile, pressurization), functional performance of pinch clamps, and vacuum maintenance with 10cc syringe. Biocompatibility (cytotoxicity, irritation, sensitization) leveraged from predicate. Sterilization validated per ANSI/AAMI/ISO 11135:2014. Packaging/shelf-life validated per ASTM F88, F2096, D4169, and F1980.

Technological Characteristics

Sterile, single-use, manual suction curette. Materials identical to predicate. Everting membrane technology; hydraulic principle for cervical crossing. Components: delivery catheter, everting membrane, inner aspiration catheter, pinch clamps, 10cc syringe. Sterilization: Ethylene Oxide (ANSI/AAMI/ISO 11135:2014). No software or electronic components.

Indications for Use

Indicated for sonohysterography and endometrial tissue biopsy via scraping and vacuum suction in patients requiring uterine mucosal sampling.

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

• CrossBay™ Endometrial Tissue Sampler (K192534)

Reference Devices

• CrossBay SonoSure™ Sonohysterography and Endometrial Sampling Device (K133144)

Submission Summary (Full Text)

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August 5, 2020

CrossBay Medical % Cindy Domecus Principal Domecus Consulting Services LLC 1171 Barroilhet Drive Hillsborough, CA 94010

Re: K201952

> Trade/Device Name: CrossGlide™ ETS Plus Regulation Number: 21 CFR 884.1175 Regulation Name: Endometrial Suction Curette and Accessories Regulatory Class: II Product Code: HHK Dated: July 13, 2020 Received: July 14, 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

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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 (OS) 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 mediation-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,

Jason Roberts 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) K201952

Device Name CrossGlide™ ETS Plus

Indications for Use (Describe)

The CrossGlide™ ETS Plus is indicated for use for sonohysterography and 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 (21 CFR § 807.92(c))

#### 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>Principal, Domecus Consulting Services LLC<br>Regulatory Consultant to CrossBay Medical Inc.<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Summary Prepared: | August 3, 2020 |

## II. SUBJECT DEVICE INFORMATION

| Device Trade Name: | CrossGlide™ ETS Plus |
|--------------------|-------------------------------------------------|
| Common Name: | Curette, Suction, Endometrial (And Accessories) |
| Regulation Number: | 21 CFR §884.1175 |
| Regulation Name: | Endometrial suction curette and accessories |
| Regulatory Class: | II |
| Product Code: | HHK |

#### III. PREDICATE DEVICE INFORMATION

The predicate device is the CrossBay™ Endometrial Tissue Sampler, K192534. The reference device is the CrossBay SonoSure™ Sonohysterography and Endometrial Sampling Device, K133144.

The predicate device and the reference device have not been subject to a design-related recall.

#### IV. DEVICE DESCRIPTION

The CrossGlide™ ETS Plus is a sterile, disposable, single-use device which enables saline infusion sonohysteroraphy and the removal of mucosal tissue from the uterus for histological biopsy. The CrossGlide™ ETS Plus contains a Delivery Catheter with an everting Membrane, an Inner Aspiration Catheter that contains a lumen for saline infusion and aspiration. The everting Membrane places the Inner Aspiration Catheter into the uterine cavity. A proximal luer

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connector allows a 10cc luer lock syringe to infuse saline into the uterine cavity for sonohysterography. The 10cc syringe can be used to remove the saline from the uterine cavity and create negative pressure. Movement of the CrossGlide™ ETS Plus device, after creating negative pressure with the 10cc syringe, removes material and tissue from the uterine cavity.

## V. INDICATIONS FOR USE

The CrossGlide™ ETS Plus is indicated for use for sonohysterography and 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 INDICATIONS FOR USE WITH PREDICATE DEVICE

Table 1 below presents the Indications for Use for the subject and predicate devices, with the differences noted in bold font. The differences between the subject and predicate Indications for Use do not alter the intended use of the device. As a reference device is used in this submission, the Indications for Use for the reference device are also provided.

| Subject Device<br>CrossGlide™ ETS Plus | Predicate Device,<br>K192534<br>CrossGlide™ ETS | Reference Device<br>K133144<br>CrossBay SonoSure™<br>Sonohysterography and<br>Endometrial Sampling Device | | Subject Device<br>CrossGlide™<br>ETS Plus | Predicate<br>Device<br>K192534<br>CrossGlide™<br>ETS | Reference Device<br>K133144<br>CrossBay<br>SonoSure™<br>Sonohysterography<br>and Endometrial<br>Sampling Device | Comparison to<br>Predicate Device |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|--------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| The CrossGlide™ ETS Plus is<br>indicated for use for<br>sonohysterography and to<br>remove material from the<br>uterus and from the mucosal<br>lining of the uterus by scraping<br>and vacuum suction in order to<br>obtain tissue for histological<br>biopsy. | The CrossGlide™ ETS,<br>Endometrial Tissue<br>Sampler, is indicated for<br>use to remove material<br>from the uterus and from<br>the mucosal lining of the<br>uterus by scraping and<br>vacuum suction in order<br>to obtain tissue for<br>histological biopsy. | The CrossBay SonoSure™<br>Sonohysterography and<br>Endometrial Sampling Device is<br>indicated for use to access the<br>uterine cavity for saline infusion<br>sonohysterography and to<br>obtain endometrial biopsy, if<br>indicated, utilizing the same<br>device. | Device<br>Components | Inner catheter,<br>everting<br>membrane,<br>aspiration with<br>hole, blue and<br>white pinch<br>clamp,<br>compliant tube,<br>syringe | Inner catheter,<br>everting<br>membrane,<br>aspiration with<br>hole, blue and<br>white stopcock,<br>compliant tube,<br>syringe | Delivery catheter,<br>cytology brush, saline<br>infusion bag, handle,<br>acorn tip | Different: The<br>subject device has<br>the same components<br>as compared to the<br>predicate device<br>except the blue and<br>white stopcocks have<br>been substituted by<br>blue and white pinch<br>clamps, which<br>perform the same<br>function. This<br>difference does not<br>raise different<br>questions of safety<br>and effectiveness<br>(S&E). |
| Inflation<br>Method | Manual, with<br>3cc syringe | Manual, with<br>3cc syringe | N/A | Same | | | |
| Aspiration<br>Method | Manual, with<br>10cc syringe | Manual, with<br>3cc syringe | N/A | Same aspiration<br>method using<br>different size of<br>syringe | | | |
| Overall<br>Catheter<br>Length (cm) | 43-48 cm | 43-48 cm | 28 cm | Same | | | |
| Inner<br>Catheter | Length: 315mm<br>(includes<br>proximal<br>connector and<br>pinch clamp)<br>Outer diameter:<br>2mm<br>Internal | Length: 315mm<br>(includes<br>Stopcock)<br>Outer diameter:<br>2mm<br>Internal<br>diameter: 1.3mm | N/A | Same | | | |

### TABLE 1. COMPARISON OF INDICATIONS FOR USE

### VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The technological characteristics of the subject and predicate device are compared below in Table 2.

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| | Subject Device<br>CrossGlide™<br>ETS Plus | Predicate<br>Device<br>K192534<br>CrossGlide™<br>ETS | Reference Device<br>K133144<br>CrossBay<br>SonoSure™<br>Sonohysterography<br>and Endometrial<br>Sampling Device | Comparison to<br>Predicate Device |
|----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| | diameter: 1.3mm | | | |
| Delivery<br>Catheter | Length: 156mm<br>(includes Acorn<br>Tip)<br>Outer diameter:<br>4.1mm<br>Internal diameter<br>3.3.mm | Length: 156mm<br>(includes Acorn<br>Tip)<br>Outer diameter:<br>4.1mm<br>Internal diameter<br>3.3.mm | Length: 100mm<br>(includes Acorn Tip) | Same |
| Everting<br>Membrane | Length: 65mm at<br>full deployment<br>Outer diameter:<br>3.5mm @ 3<br>atmospheres of<br>pressure<br>Wall thickness:<br>0.04mm | Length: 65mm<br>at full<br>deployment<br>Outer diameter:<br>3.5mm @ 3<br>atmospheres of<br>pressure<br>Wall thickness:<br>0.04mm | N/A | Same |
| Aspiration<br>Device Side<br>Hole &<br>Internal<br>Lumen | Side hole<br>elliptical<br>opening<br>Internal lumen<br>1.3mm | Side hole<br>elliptical<br>opening<br>Internal lumen<br>1.3mm | N/A | Same |
| Acorn Tip | Length: 16mm<br>Outer diameter:<br>12.4mm | Length: 16mm<br>Outer diameter:<br>12.4mm | Length: 22.5mm<br>Outside diameter:<br>20.5mm | Same |
| Sterilization<br>Method | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | Same |
| Saline<br>Infusion<br>Method | Manual<br>(syringe) | NA | Same | Different: The<br>predicate device is<br>not indicated for<br>saline infusion. As<br>such the reference |
| Subject Device<br>CrossGlideTM<br>ETS Plus | Predicate<br>Device<br>K192534<br>CrossGlideTM<br>ETS | Reference Device<br>K133144<br>CrossBay<br>SonoSureTM<br>Sonohysterography<br>and Endometrial<br>Sampling Device | Comparison to<br>Predicate Device | |
| | | | device is included to<br>provide scientific and<br>technical information<br>to address the safety<br>and effectiveness of<br>the saline infusion<br>capability of the<br>subject device. | |

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At a high level, the subject and predicate devices comprise the following same technological elements:

- . Both the subject and predicate device use a delivery catheter to place the aspiration device into the uterine cavity to remove material.
- Both the subject and predicate device employ a syringe to apply vacuum on the aspiration . device.
- . Both the subject and predicate device use similar materials in the construction of the catheter.
- . Both the subject device and predicate device utilize everting Membrane technology using the same materials, configuration, dimensions, and hydraulic principle for crossing the cervical canal.
- . Both the subject device and the predicate device have the same sterilization method, packaging construction and materials.

The following technological differences exist between the subject and predicate device:

- The subject device uses a 10cc syringe to apply vacuum suction to the Aspiration Device. The predicate device uses a 3cc syringe to apply vacuum suction.
- . The subject device utilizes a Blue Pinch Clamp and a White Pinch Clamp as one-way valves (on/off). The predicate device utilizes a Blue Stopcock and White Stopcock as one-way valves in the same locations on the catheter. The stopcock and pinch clamp share the same function and performance characteristics.
- . The subject device utilizes a 10cc syringe to infuse saline trough the catheter and into the uterine cavity.

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The differences in technology do not raise different questions of safety and effectiveness, as both the subject and predicate device operate to transfer fluid/tissue through the catheter via manual pressure.

# VIII. PERFORMANCE DATA

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

## Bench Testing

Physical bench testing confirmed that the CrossGlide™ ETS Plus performs according to the product specifications. Device evaluation consisted of physical and functional testing performed pursuant to test protocols that were used to support clearance of the predicate or reference device. Mechanical testing, including tensile and pressurization testing, was conducted to determine if the pinch clamps could operate during expected functional conditions. Additional pressurization testing was conducted to determine if the use of a 10cc syringe can maintain adequate negative pressure required for sample collection. The subject device successfully passed all functional bench testing (i.e., met predefined acceptance criteria).

### Biocompatibility testing

The subject device utilizes identical materials and manufacturing as the predicate device. Therefore, biocompatibility testing on the predicate device, which was conducted according to ISO 10993-1 "Biological Evaluation of Medical Devices" and FDA's guidance "Use of International Standard ISO 10993-1", final document issued on June 16, 2016 can be leveraged to support the biocompatibility of the subject device. Testing included the following with passing results: 1) Cytotoxicity, 2) Vaginal Irritation, and 3) Sensitization.

## Sterilization Validation

The subject device utilizes the same product design and packaging as the predicate device. The predicate device 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 originally validated in 2016, using the overkill method, in accordance with ANSI/AAMI/ISO 11135:2014. The results and conclusion of this evaluation confirmed that the subject device could be adopted into the previously validated cycle.

#### Packaging, Shipping Validation, and Shelf-Life

The subject device utilizes the same product design and packaging as the predicate device. 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

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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, using Distribution Cycle 13. 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".

## IX: CONCLUSIONS

The CrossGlide™ ETS Plus Sonohysterography and Endometrial Tissue Sampler has the same intended use as the predicate device. There are differences in the indications for use statements for the subject and predicate devices. The differences between the subject and predicate Indications for Use do not alter the intended use of the device. In addition, the subject device has the similar technological characteristics as the predicate device and the differences do not raise different questions of safety and effectiveness. Finally, the submitted testing demonstrates that the subject device is as safe, as effective, and performs as well as the predicate device. Therefore, the CrossGlide™ ETS Plus is substantially equivalent to the cleared predicate device.