(153 days)
Not Found
No
The device description and performance studies focus on the physical and mechanical aspects of a catheter-based device for sonohysterography and endometrial sampling. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No
The device is used to access the uterine cavity for diagnostic procedures (saline infusion sonohysterography) and to obtain tissue samples (endometrial biopsy), not for treating a disease or condition.
Yes
The device is indicated for use to access the uterine cavity for saline infusion sonohysterography and to obtain an endometrial biopsy, which are procedures aimed at diagnosing conditions within the uterine cavity.
No
The device description clearly states it is a catheter comprised of standard polymer materials, a silicone acorn tip, a retractable nylon brush, and a PVC bag. It also details physical bench testing, biocompatibility testing, and sterilization validation, all indicative of a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is a catheter used to access the uterine cavity for saline infusion sonohysterography and to obtain an endometrial biopsy.
- Procedure: Saline infusion sonohysterography is an imaging procedure performed in vivo (within the body). Endometrial biopsy is the collection of tissue from the body.
- Lack of Analysis: The device itself is a tool for performing a procedure and collecting a sample. It does not perform any analysis or testing on a sample in vitro. The collected endometrial biopsy would likely be sent to a laboratory for in vitro analysis, but the device itself is not the IVD.
Therefore, the CrossBay SonsoSure Sonohysterography and Endometrial Sampling Device is a medical device used for a diagnostic procedure and sample collection, but it is not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CrossBay SonsoSure 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.
Product codes (comma separated list FDA assigned to the subject device)
PGK, HFE
Device Description
The CrossBay Medical SonoSure Device is a catheter that enables saline infusion sonohysterography procedures and endometrial biopsy collection within a single device. 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 a retractable nylon brush for endometrial biopsy sampling. The distal 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
Uterine cavity
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)
Non-Clinical Performance Data:Physical bench testing confirmed that the CrossBay Medical SonoSure Device performs according to the product specifications. Device evaluation consisted of physical, chemical and functional testing performed pursuant to the device verification protocol. Mechanical safety and performance testing was conducted to ensure adherence of the endometrial biopsy brush bristles to the catheter shaft when subjected to shear force. Additionally, this bench safety evaluation included force at break assessments. Biocompatibility testing was conducted according to ISO 10993 "Biological Evaluation of Medical Devices" and FDA's recent guidance ("Use of International Standard ISO 10993", draft document issued on 24 April 2013). The following biocompatibility tests were conducted: Cytotoxicity, Sensitization and Irritation. The sterilization 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: Requirements for development, 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 studies were conducted pursuant to the applicable ASTM guidelines (ASTM F88 "Standard Test Method for Seal Strength of Flexible Barrier Materials"; and, ASTM F1929 "Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration"). The results of shelf life testing demonstrate that the packaging for the subject device maintains sterility over the duration of shelf life, the packaging can withstand transport without damage, and the subject device maintains its mechanical safety and performance over the duration of its shelf life.
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.
Not Found
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
§ 884.4530 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
K133144 Page 1 of 3
510(k) Summary (21 CFR § 807.92(c))
| Submitter: | CrossBay Medical, Inc.
17141 Murphy Avenue, Suite 5C
Irvine, CA 94901 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Cindy Domecus
Regulatory Consultant to CrossBay Medical
Phone: 650.343.4813
Fax: 650.343.7822
Email: domecusconsulting@comcast.net |
| Date Summary Prepared: | 18 March 14 |
| Device Trade Name: | CrossBay Medical SonoSure Sonohysterography and Endometrial
Sampling Device |
| Common Name: | Saline Infusion Sonohysterography (SIS) Catheter, Endometrial Brush |
| Classification Name: | Obstetric-gynecologic specialized manual instrument
(21 CFR §884.4530) |
| Product Code: | PGK (cannula, injector, uterine, enodometrial biopsy)
HFE (endometrial brush) |
| Equivalent Devices: | Cook's Sonohysterography Biopsy Device (K060908 - 29 Jun 2006)
Cook's Tao Endometrial Sampling Brush (K082066 - 07 Nov 2008) |
Device Description:
The CrossBay Medical SonoSure Device is a catheter that enables saline infusion sonohysterography procedures and endometrial biopsy collection within a single device. 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 a retractable nylon brush for endometrial biopsy sampling. The distal 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.
Intended Use / Indications for Use:
The CrossBay SonsoSure 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.
1
The Cook Sonohysterography Biopsy Technological Characteristics & Substantial Equivalence: Catheter served as the primary predicate device. The subject and predicate device have the same Indications for Use statement. The subject and predicate device have different technological characteristics as follows: mechanism of endometrial biopsy collection, dimensions, and design. The predicate device incorporates a curette to perform endometrial biopsy while the subject device utilizes a brush. However, the second predicate device, the Cook Tao Endometrial Sampling Brush, also utilizes a brush to collect endometrial biopsy samples.
The different technological characteristics of the subject device could affect safety and effectiveness. For example, regarding effectiveness, the different mechanism of endometrial biopsy collection may affect the adequacy of the sample. Regarding safety, the different mechanism of endometrial biopsy collect may affect the pain and/or discomfort associated with the procedure. The remaining different technological characteristics between the subject and predicate device are minor and should have minimal impact on safety and effectiveness.
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 uterine catheters, endometrial aspirators, and endometrial brushes.
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 performance data to assess the effects of the different technological characteristics, and the performance data demonstrate equivalence.
Non-Clinical Performance Data:Physical bench testing confirmed that the CrossBay Medical SonoSure Device performs according to the product specifications. Device evaluation consisted of physical, chemical and functional testing performed pursuant to the device verification protocol. Mechanical safety and performance testing was conducted to ensure adherence of the endometrial biopsy brush bristles to the catheter shaft when subjected to shear force. Additionally, this bench safety evaluation included force at break assessments. Biocompatibility testing was conducted according to ISO 10993 "Biological Evaluation of Medical Devices" and FDA's recent guidance ("Use of International Standard ISO 10993", draft document issued on 24 April 2013). The following biocompatibility tests were conducted: Cytotoxicity, Sensitization and Irritation. The sterilization 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: Requirements for development, 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 studies were conducted pursuant to the applicable ASTM guidelines (ASTM F88 "Standard Test Method for Seal Strength of Flexible Barrier Materials"; and, ASTM F1929 "Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration"). The results of shelf life testing demonstrate that the packaging for the subject device maintains sterility over the duration of
2
shelf life, the packaging can withstand transport without damage, and the subject device maintains its mechanical safety and performance over the duration of its shelf life
Summary:
Based on the product technical information, intended use / indications for use and bench performance data provided in this premarket notification, the CrossBay Medical SonoSure Device has been shown to be substantially equivalent to the currently marketed predicate devices.
3
Image /page/3/Picture/1 description: The image shows the words "Public Health Service" in bold, black font. There is a period after the word "Service". The words are stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 19, 2014
CrossBay Medical, Inc. % Cindy Domecus, R.A.C. Principal Domecus Consulting Services, LLC 17141 Murphy Avenue, Suite 5C Irvine, CA 94901
K133144 Re:
Trade/Device Name: SonoSure SonoHysterography and Endometrial Sampling Device Regulation Number: 21 CFR 884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: PGK, HFE Dated: February 18, 2014 Received: February 19, 2014
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 adulterstion. 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 thany Federal statutes and regulations administered by other Federal agencies. You must
4
Page 2 - Cindy Domecus
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 (reporting of medical device-related 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 Small Manufacturers, International and Consumer Assistance 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" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
(2) Of NY art 000) produces/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Image /page/4/Picture/6 description: The image shows the text "Benjamin Fisher-S". The text is in a bold, sans-serif font. The letters "DA" are in a decorative, outlined font.
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
1
5
Indications for Use Statement
510(k) Number if Known: K133144
Device Name: CrossBay Medical SonoSure Sonohysterography and Endometrial Sampling Device
Indications for Use:
The CrossBay SonsoSure 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.
Prescription Use 図 (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrent of CDRH, Office of Device Evaluation (ODE)
Image /page/5/Picture/10 description: The image contains the text "Benjamin R. Fisher -S 2014.03.19 11:23:45 -04'00'". The text appears to be a name, date, and time stamp. The name is Benjamin R. Fisher, and the date is March 19, 2014. The time is 11:23:45, and the time zone is -04'00'.