(22 days)
No
The device description and performance studies focus on mechanical and material properties, not computational analysis or pattern recognition. There is no mention of AI or ML in the document.
No
The device is used for sonohysterography and to obtain tissue for histological biopsy, which are diagnostic procedures, not therapeutic.
Yes
The device is indicated for "sonohysterography," which is a diagnostic imaging procedure, and to "obtain tissue for histological biopsy," which is a diagnostic procedure.
No
The device description clearly outlines a physical, sterile, disposable, single-use device with catheters, membranes, lumens, and luer connectors for performing sonohysterography and tissue removal. The performance studies also focus on physical and functional bench testing, biocompatibility, sterilization, packaging, and shelf-life, all related to a physical device. There is no mention of software as a component or the primary function of the device.
Based on the provided information, the CrossGlide™ ETS Plus is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The primary intended use is for sonohysterography (an imaging procedure) and to obtain tissue for histological biopsy. While the tissue will be used for an in vitro diagnostic test (histology), the device itself is used for the collection of the sample, not for performing the diagnostic test on the sample.
- Device Description: The description focuses on the mechanical aspects of the device for saline infusion, aspiration, and tissue removal. It does not describe any components or functions related to analyzing biological samples or providing diagnostic information directly.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body in vitro to provide information for diagnostic purposes. The device's role is to facilitate the collection of the specimen.
In summary, the CrossGlide™ ETS Plus is a medical device used for a procedure (sonohysterography) and for collecting a sample for a subsequent IVD test (histology). It is not an IVD device itself.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
HHK
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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: 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, 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".
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary (21 CFR § 807.92(c))
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)
Principal, Domecus Consulting Services LLC
Regulatory Consultant to CrossBay Medical Inc.
Phone: 650.343.4813
Fax: 650.343.7822
Email: domecusconsulting@comcast.net |
| 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
4
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
CrossGlide™ ETS Plus | Predicate Device,
K192534
CrossGlide™ ETS | Reference Device
K133144
CrossBay SonoSure™
Sonohysterography and
Endometrial Sampling Device | | Subject Device
CrossGlide™
ETS Plus | Predicate
Device
K192534
CrossGlide™
ETS | Reference Device
K133144
CrossBay
SonoSure™
Sonohysterography
and Endometrial
Sampling Device | Comparison to
Predicate Device |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|--------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | 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 CrossBay SonoSure™
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
Components | Inner catheter,
everting
membrane,
aspiration with
hole, blue and
white pinch
clamp,
compliant tube,
syringe | Inner catheter,
everting
membrane,
aspiration with
hole, blue and
white stopcock,
compliant tube,
syringe | Delivery catheter,
cytology brush, saline
infusion bag, handle,
acorn tip | Different: The
subject device has
the same components
as compared to the
predicate device
except the blue and
white stopcocks have
been substituted by
blue and white pinch
clamps, which
perform the same
function. This
difference does not
raise different
questions of safety
and effectiveness
(S&E). |
| Inflation
Method | Manual, with
3cc syringe | Manual, with
3cc syringe | N/A | Same | | | |
| Aspiration
Method | Manual, with
10cc syringe | Manual, with
3cc syringe | N/A | Same aspiration
method using
different size of
syringe | | | |
| Overall
Catheter
Length (cm) | 43-48 cm | 43-48 cm | 28 cm | Same | | | |
| Inner
Catheter | Length: 315mm
(includes
proximal
connector and
pinch clamp)
Outer diameter:
2mm
Internal | Length: 315mm
(includes
Stopcock)
Outer diameter:
2mm
Internal
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.
5
6
| | Subject Device
CrossGlide™
ETS Plus | Predicate
Device
K192534
CrossGlide™
ETS | Reference Device
K133144
CrossBay
SonoSure™
Sonohysterography
and Endometrial
Sampling Device | Comparison to
Predicate Device |
|----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| | diameter: 1.3mm | | | |
| Delivery
Catheter | Length: 156mm
(includes Acorn
Tip)
Outer diameter:
4.1mm
Internal diameter
3.3.mm | Length: 156mm
(includes Acorn
Tip)
Outer diameter:
4.1mm
Internal diameter
3.3.mm | Length: 100mm
(includes Acorn Tip) | Same |
| Everting
Membrane | Length: 65mm at
full deployment
Outer diameter:
3.5mm @ 3
atmospheres of
pressure
Wall thickness:
0.04mm | Length: 65mm
at full
deployment
Outer diameter:
3.5mm @ 3
atmospheres of
pressure
Wall thickness:
0.04mm | N/A | Same |
| Aspiration
Device Side
Hole &
Internal
Lumen | Side hole
elliptical
opening
Internal lumen
1.3mm | Side hole
elliptical
opening
Internal lumen
1.3mm | N/A | Same |
| Acorn Tip | Length: 16mm
Outer diameter:
12.4mm | Length: 16mm
Outer diameter:
12.4mm | Length: 22.5mm
Outside diameter:
20.5mm | Same |
| Sterilization
Method | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | Same |
| Saline
Infusion
Method | Manual
(syringe) | NA | Same | Different: The
predicate device is
not indicated for
saline infusion. As
such the reference |
| Subject Device
CrossGlideTM
ETS Plus | Predicate
Device
K192534
CrossGlideTM
ETS | Reference Device
K133144
CrossBay
SonoSureTM
Sonohysterography
and Endometrial
Sampling Device | Comparison to
Predicate Device | |
| | | | device is included to
provide scientific and
technical information
to address the safety
and effectiveness of
the saline infusion
capability of the
subject device. | |
7
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.
8
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
9
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.