(191 days)
No
The device description and performance studies focus on the mechanical and material properties of a catheter for fluid and air delivery, with no mention of AI/ML or image processing.
No
The device is used for diagnostic purposes (sonohysterography and sonohysterosalpingography procedures to evaluate the uterus and fallopian tubes) by instilling saline and air, not for treating any condition.
Yes
Explanation: The device is indicated for use in sonohysterography and sonohysterosalpingography procedures for the evaluation of fallopian tubes and/or the uterus, specifically for generally recognized clinical indications such as suspected polyps, fibroids, adhesions, endometrial thickening, and/or the selective evaluation of fallopian tube patency. These are all diagnostic purposes.
No
The device description clearly states it is a catheter made of polymer materials with a silicone tip, handle, and PVC bag, indicating it is a physical medical device, not software only.
Based on the provided information, the CrossBay SonoFlow Sonohysterography and Sonohysterosalpingography Device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The SonoFlow device is used within the human body (uterine cavity, fallopian tubes, uterus) to facilitate imaging procedures.
- The device's function is to instill contrast media (saline and air) for imaging. It doesn't analyze biological samples or provide diagnostic information based on the analysis of those samples. The diagnosis is made by the physician interpreting the images obtained using the device.
- The description focuses on the device's mechanical function and biocompatibility. There is no mention of analyzing biological fluids or tissues.
Therefore, the SonoFlow device is a medical device used in conjunction with imaging equipment, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The CrossBay SonoFlow Sonohysterography and Sonohysterosalpingography Device is indicated for use to access the uterine cavity for sonohysterography and sonohysterosalpingography procedures. The SonoFlow Device can instill saline-only or a mixture of saline and air for performance of saline infusion sonohysterography and sono-hysterosalpingography (Sono-HSG), respectively, for the evaluation of the fallopian tubes and/or the uterus. The following are generally recognized clinical indications for saline infusion sonohysterography and sonohysterosalpingography procedures: suspected polyps, fibroids, adhesions, endometrial thickening, and/or the selective evaluation of fallopian tube patency.
Product codes
LKF
Device Description
The CrossBay Medical SonoFlow™ Device is a catheter that enables saline and air infusion of contrast media to perform sonohysterosalpingography and sonohysterography procedures. The catheter is comprised of standard polymer materials and contains a silicone acorn tip to enable a cervical seal. The distal end of the device contains an aeration component that provides an alternating pattern of saline and air as a stream of contrast media into the uterus and fallopian tubes. The proximal end of the device contains a handle with an air supply opening that allows the physician to reduce or eliminate the amount of air infusion selectively by occluding the opening of the air supply. The proximal end of the device contains an empty PVC bag that can be filled with saline. The device is provided sterile and is intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Uterus, fallopian tubes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician
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: Device evaluation consisted of functional testing performed pursuant to the device verification protocol. Bench testing included verification of device functionality, bond and joint tests of components, and an evaluation of the device's ability to deliver fluid and air. These tests were conducted on ethylene oxide sterilized units at baseline and on devices subjected to accelerated aging conditions equivalent to six (6) months and passing results were obtained.
Biocompatibility testing: The subject CrossBay SonoFlow device contains the same materials as the reference Cross Bay SonoSure device. The biocompatibility evaluation for the CrossBay SonoSure device was conducted in accordance with the requirements defined in ISO 10993 "Biological Evaluation of Medical Devices" and FDA's guidance ("Use of International Standard ISO 10993", draft document issued on 24 April 2013 and BlueBook Memorandum #G95-1 dated 01 May 1995). Testing included the following: 1) Cytotoxicity; 2) Vaginal Irritation; and, 3) Sensitization and demonstrated biocompatibility.
Sterilization Validation: The subject CrossBay SonoFlow device has equivalent components, materials, dimensions and weight as the reference Cross Bay SonoSure device. The sterilization validation for the CrossBay SonoSure device complies with the requirements prescribed in the applicable standards for ethylene oxide sterilization (ISO 11135-1:2007 "Sterilization of health care products -- Ethylene oxide -- Part 1: Requirement, validation and routine control of a sterilization process for medical devices" and ISO 10993-7:2008 "Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals").
Packaging and Shipping Validation: Packaging and shipping validation studies were successfully conducted on sterilized CrossBay Medical SonoFlow Devices pursuant to the applicable ASTM guidelines: ASTM F1929 "Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration"; D642 "Standard Test Method for Determining Compressive Resistance of Shipping Containers, Components and Unit Loads"; and, 5276 "Standard Test Method for Drop Test of Loaded Containers by Free Fall". Passing results were obtained.
Key Results: The CrossBay Medical SonoFlow Device is substantially equivalent to the proposed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.4530 Obstetric-gynecologic specialized manual instrument.
(a)
Identification. An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:(1) An amniotome is an instrument used to rupture the fetal membranes.
(2) A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant.
(3) An umbilical clamp is an instrument used to compress the umbilical cord.
(4) A uterine curette is an instrument used to scrape and remove material from the uterus.
(5) A fixed-size cervical dilator is any of a series of bougies of various sizes used to dilate the cervical os by stretching the cervix.
(6) A uterine elevator is an instrument inserted into the uterus used to lift and manipulate the uterus.
(7) A gynecological surgical forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynecological examination.
(8) A cervical cone knife is a cutting instrument used to excise and remove tissue from the cervix.
(9) A gynecological cerclage needle is a looplike instrument used to suture the cervix.
(10) A hook-type contraceptive intrauterine device (IUD) remover is an instrument used to remove an IUD from the uterus.
(11) A gynecological fibroid screw is an instrument used to hold onto a fibroid.
(12) A uterine sound is an instrument used to determine the depth of the uterus by inserting it into the uterine cavity.
(13) A cytological cervical spatula is a blunt instrument used to scrape and remove cytological material from the surface of the cervix or vagina.
(14) A gynecological biopsy forceps is an instrument with two blades and handles used for gynecological biopsy procedures.
(15) A uterine tenaculum is a hooklike instrument used to seize and hold the cervix or fundus.
(16) An internal pelvimeter is an instrument used within the vagina to measure the diameter and capacity of the pelvis.
(17) A nonmetal vaginal speculum is a nonmetal instrument used to expose the interior of the vagina.
(18) A fiberoptic nonmetal vaginal speculum is a nonmetal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.
(b)
Classification. (1) Class II (special controls). The device, when it is an umbilical clamp with or without a cutter, a uterine tenaculum which is sterile and does not use suction and is intended for single use, a nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.(2) Class I for the amniotome, uterine curette, cervical dilator (fixed-size bougies), cerclage needle, IUD remover, uterine sound, and gynecological biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 20, 2015
CrossBay Medical, Inc. % Cindy Domecus Regulatory Consultant Domecus Consulting Services, LLC 1171 Barroilhet Avenue Hillsborough, CA 94010
Re: K142545
Trade/Device Name: CrossBay SonoFlow Sonohysterography and Sonohysterosalpingography Device Regulation Number: unclassified Regulation Name: unclassified Regulatory Class: unclassified Product Code: LKF Dated: February 14, 2015 Received: February 18, 2015
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. 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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Joyce M. Whang -S
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K142545
Device Name
CrossBay SonoFlow Sonohysterography and Sonohysterosalpingography Device
Indications for Use (Describe)
The CrossBay SonoFlow Sonohysterography and Sonohysterosalpingography Device is indicated for use to access the uterine cavity for sonohysterography and sonohysterosalpingography procedures. The SonoFlow Device can instill salineonly or a mixture of saline and air for performance of saline infusion sonohysterography and sono-hysterosalpingography (Sono-HSG), respectively, for the evaluation of the fallopian tubes and/or the uterus. The following are generally recognized clinical indications for saline infusion sonohysterosalpingography procedures: suspected polyps, fibroids, adhesions, endometrial thickening, and/or the selective evaluation of fallopian tube patency.
Type of Use (Select one or both, as applicable)
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)) K142545
I. SUBMITTER INFORMATION
| Submitter: | CrossBay Medical, Inc.
793 Sandoval Way
Hayward, CA 94544 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Cindy Domecus
Regulatory Consultant to CrossBay Medical
Phone: 650.343.4813
Fax: 650.343.7822
Email: domecusconsulting@comcast.net |
| Date Summary Prepared: | 14 February 2015 |
II. SUBJECT DEVICE INFORMATION
| Device Trade Name: | CrossBay Medical SonoFlow™ Sonohysterography and |
|---|---|
| SonoHysterosalpingography Device | |
| Common Name: | Hysterosonography and Hysterosalpingography Catheter |
| Regulatory Class: | Unclassified |
| Submission Type: | 510(k) |
| Product Code: | LKF (Cannula, Manipulator/Injector, Uterine) |
III. PREDICATE & REFERENCE DEVICE INFORMATION
- Primary Predicate Device - Femasys, Inc. - FemVue Saline-Air Device (K110288 - April 28, 2011)
- Predicate Device - Femasys Inc. - FemVue Catheter System (K083690 - June 23, 2009)
- . Reference Device - CrossBay Medical Inc. - SonoSure Sonohysterography and Endometrial Sampling Device (K133144 - March 19, 2014)
IV. DEVICE DESCRIPTION
The CrossBay Medical SonoFlow™ Device is a catheter that enables saline and air infusion of contrast media to perform sonohysterosalpingography and sonohysterography procedures. The catheter is comprised of standard polymer materials and contains a silicone acorn tip to enable a cervical seal. The distal end of the device contains an aeration component that provides an alternating pattern of saline and air as a stream of contrast media into the uterus and fallopian tubes. The proximal end of the device
4
contains a handle with an air supply opening that allows the physician to reduce or eliminate the amount of air infusion selectively by occluding the opening of the air supply. The proximal end of the device contains an empty PVC bag that can be filled with saline. The device is provided sterile and is intended for single use only.
V. INDICATIONS FOR USE
The CrossBay SonoFlow Sonohysterography and Sonohysterosalpingography Device is indicated for use to access the uterine cavity for sonohysterography and sonohysterosalpingography procedures. The SonoFlow Device can instill saline-only or a mixture of saline and air for performance of saline infusion sonohysterography and sono-hysterosalpingography (Sono-HSG), respectively, for the evaluation of the fallopian tubes and/or the uterus. The following are generally recognized clinical indications for saline infusion sonohysterography and sonohysterosalpingography procedures: suspected polyps, fibroids, adhesions, endometrial thickening, and/or the selective evaluation of fallopian tube patency.
The Indications for Use Statement is not identical to each predicate device; however, the differences do not alter the intended use of the device nor do they affect the safety and effectiveness of the device relative to the predicates. Both the subject and predicate devices have the same intended use – for use during sonohysterography and sonohysterosalpingography procedures.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES
The subject and predicate devices are catheter based technologies that employ the use of similar materials of construction and share similar principles of operation. The devices are used during hysterosalpingography and hysterosonography procedures. At a high level, the subject and predicate devices share the following technological characteristics:
- Devices are all catheter based or require use of a catheter based device.
- Devices have similar dimensions and are comprised of standard medical grade materials.
The following technological differences exist between the subject and primary predicate device (FemVue Saline-Air):
- . The primary predicate device requires the use of a separate uterine catheter and saline / air infusion device; the subject device combines these functions.
- . The primary predicate device requires simultaneous air and saline infusion; the subject device contains a device feature that enables selective infusion of air within the saline media.
The different technological characteristics of the subject device do not raise different types of safety and effectiveness questions as they are routinely encountered during premarket review of saline infusion sonohysterography and Sono-HSG devices.
Accepted scientific methods exist to assess the effects of the different technological characteristics, including mechanical, animal, and/or clinical performance testing. The submission included sufficient
5
performance data to assess the effects of the different technological characteristics, and the performance data demonstrate equivalence.
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Bench Testing
Bench testing confirmed that the CrossBay Medical SonoFlow Device performs according to the product specifications. Device evaluation consisted of functional testing performed pursuant to the device verification protocol. Bench testing included verification of device functionality, bond and joint tests of components, and an evaluation of the device's ability to deliver fluid and air. These tests were conducted on ethylene oxide sterilized units at baseline and on devices subjected to accelerated aging conditions equivalent to six (6) months and passing results were obtained.
Biocompatibility testing
The subject CrossBay SonoFlow device contains the same materials as the reference Cross Bay SonoSure device. Additionally, the subject device is manufactured by the same contract manufacturer using similar processes to that employed for the predicate device. As such, the biocompatibility data previously provided in K133144 for the CrossBay SonoSure device is applicable to the subject device. The biocompatibility evaluation for the CrossBay SonoSure device was conducted in accordance with the requirements defined in ISO 10993 "Biological Evaluation of Medical Devices" and FDA's guidance ("Use of International Standard ISO 10993", draft document issued on 24 April 2013 and BlueBook Memorandum #G95-1 dated 01 May 1995). Testing included the following: 1) Cytotoxicity; 2) Vaginal Irritation; and, 3) Sensitization and demonstrated biocompatibility.
Sterilization Validation
The subject CrossBay SonoFlow device has equivalent components, materials, dimensions and weight as the reference Cross Bay SonoSure device. Additionally, the subject device is sterilized by the same contract sterilizer as the reference device using the same methodology. As such, the sterilization data previously provided in K133144 for the CrossBay SonoSure device is applicable to the subject device. The sterilization validation for the CrossBay SonoSure device complies with the requirements prescribed in the applicable standards for ethylene oxide sterilization (ISO 11135-1:2007 "Sterilization of health care products -- Ethylene oxide -- Part 1: Requirement, validation and routine control of a sterilization process for medical devices" and ISO 10993-7:2008 "Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals").
Packaging and Shipping Validation
Packaging and shipping validation studies were successfully conducted on sterilized CrossBay Medical SonoFlow Devices pursuant to the applicable ASTM guidelines: ASTM F1929 "Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration"; D642 "Standard Test Method for Determining Compressive Resistance of Shipping Containers, Components and Unit Loads"; and, 5276 "Standard Test Method for Drop Test of Loaded Containers by Free Fall". Passing results were obtained.
6
VIII: CONCLUSIONS
The CrossBay Medical SonoFlow Device is substantially equivalent to the proposed predicate devices.