(90 days)
Conceptus VS™ Catheter, Clarus Medical, Model 5150 Tubing Set
Not Found
No
The summary describes a mechanical catheter and guidewire system for fallopian tube evaluation. There is no mention of software, image analysis, or any computational components that would suggest the use of AI or ML. The performance studies focus on mechanical properties and clinical usability compared to a predicate device.
No
The device is described as a "secondary diagnostic tool" for evaluating tubal occlusion and is designed for imaging and guiding other diagnostic tools. It does not provide any therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The STARRT System is indicated for use as a secondary diagnostic tool".
No
The device description clearly details physical components like a catheter, guidewire, and tubing set, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is described as a "secondary diagnostic tool for the further evaluation of women previously diagnosed with proximal tubal occlusion." This evaluation is performed in vivo (within the living body) using falloposcopy, not in vitro (outside the living body) on biological samples.
- Device Description: The device is a catheter and guidewire system designed for physical insertion into the fallopian tube for visualization (falloposcopy). This is an invasive procedure performed directly on the patient.
- Input Imaging Modality: The input is "Falloposcopy," which is a medical imaging technique performed in vivo.
- Anatomical Site: The device is used within the "Fallopian tube," which is an internal anatomical structure.
IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. This device directly interacts with and visualizes an internal organ within the patient.
N/A
Intended Use / Indications for Use
The STARRT System is indicated for use as a secondary diagnostic tool for the further evaluation of women previously diagnosed with proximal tubal occlusion by hysterosalpingography or selective salpingography.
Product codes (comma separated list FDA assigned to the subject device)
85 MKO
Device Description
The Conceptus Stargate Catheter is a single lumen device with a graded shaft flexibility. The distal end has a diamond shaped wire tip designed to guide the catheter and to keep fallopian tube epithelium away from the falloposcope lens during imaging. The hub located at the proximal end of the Conceptus Stargate Catheter has two ports. The sideport is used for the attachment of the Trifurcated Irrigation Tubing set. The endport serves as a conduit for the introduction of the Conceptus Falloposcopy Guidewire and Falloposcope.
The Conceptus Stargate Catheter and Falloposcopy Guidewire are transcervically delivered into the fallopian tube ostium through the lumen of the Coaxess™ Catheter which is delivered into the uterine cavity through the working channel of a rigid hysteroscope and positioned at the tubal ostium under hysteroscopic guidance. The Conceptus Stargate Catheter and Falloposcopy Guidewire are designed for use within the proximal portion of the fallopian tube (the first 2-3 cm of the tube).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fallopian tube
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinicians with experience in tubal evaluation
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)
Conceptus conducted laboratory, preclinical and clinical testing to confirm that the Stargate Catheter is safe and effective. The laboratory testing demonstrated that small forces are applied to the wire tip during clinical use. Laboratory testing further demonstrated that the force required to advance the Stargate Catheter is no greater than the force required to advance the VS Catheter. Lastly, laboratory testing confirmed that the Stargate Catheter is less likely to kink as compared to the VS Catheter.
A fallopian tube catheterization histology study in rabbits was conducted to demonstrate the safety of the Stargate Catheter. The objective of the study was to use the rabbit model to determine if fallopian tube catheterization as well as anticipated adverse events cause damage to the fallopian tube and if there is any resulting adverse impact on pregnancy rates. Study results demonstrate that their is no significant difference in fallopian tube damage between the catheterized and control tubes.
Lastly, clinical testing was conducted to validate the performance of the device. Participating clinicians reported that they were able to make a better diagnosis of tubal health with the Stargate Catheter as compared to the VS Catheter.
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.
Conceptus VS™ Catheter, Clarus Medical, Model 5150 Tubing Set
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
§ 884.1690 Hysteroscope and accessories.
(a)
Identification. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. 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.
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ATTACHMENT C
Image /page/0/Picture/1 description: The image shows the word "Conceptus" in a stylized, outlined font. Each letter is formed by a double line, creating a hollow effect. The letters are connected, forming a continuous word.
1974028
102
ام - ا
JAN 2 1 1998
510(K) SUMMARY As required by 21 CFR section 807.92(c)
Submitter's Name, Address, Phone and Fax Number Conceptus, Inc. 1021 Howard Ave. San Carlos, CA 94070 (650) 802-7240 Telephone: (650)508-7600 or (650)610-8363 Fax:
Contact Person Connie Acuff Manager Regulatory Affairs & Clinical Research
Date Summary Prepared October 21, 1997
Device Names
| Trade Name: | Stargate™ Falloposcopy Catheter and Trifurcated Irrigation Tubing Set (part of STARRT™ Falloposcopy System) |
|---|---|
| Common Name: | falloposcopy catheter and irrigation tubing |
| Classification Name: | Uterotubal carbon dioxide insufflator and accessories (per 21 CFR 884.1300) |
Device to Which Substantial Equivalence was Claimed
Substantial Equivalence for the Stargate Falloposcopy Catheter was claimed to the
Conceptus VS™ Catheter which, as part of the STARRT Falloposcopy System, was previously cleared for the diagnosis of Proximal Tubal Occlusion (PTO). Substantial Equivalence for the Trifurcated Irrigation Tubing was claimed to the Clarus Medical, Model 5150 Tubing Set which was previously cleared for fluid infusion for clearing the field of vision with endoscopes.
Device Description
The Conceptus Stargate Catheter is a single lumen device with a graded shaft flexibility. The distal end has a diamond shaped wire tip designed to guide the catheter and to keep fallopian tube epithelium away from the falloposcope lens during imaging. The hub located at the proximal end of the Conceptus Stargate Catheter has two ports. The sideport is used for the attachment of the Trifurcated Irrigation Tubing set. The endport serves as a conduit for the introduction of the Conceptus Falloposcopy Guidewire and Falloposcope.
Conceptus, Inc .. 1021 Howard Avenue, San Carlos, CA 94070 Phone:650/802-7240 · Fax:650/610-8363
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P292
Device Description, cont.
The Conceptus Stargate Catheter and Falloposcopy Guidewire are transcervically delivered into the fallopian tube ostium through the lumen of the Coaxess™ Catheter which is delivered into the uterine cavity through the working channel of a rigid hysteroscope and positioned at the tubal ostium under hysteroscopic guidance. The Conceptus Stargate Catheter and Falloposcopy Guidewire are designed for use within the proximal portion of the fallopian tube (the first 2-3 cm of the tube).
Intended Use
The Stargate Catheter as part of the STARRT Falloposcopy System is intended for use as a secondary diagnostic tool for further evaluation of women previously diagnosed with proximal tubal occlusion by hysterosalpingography or selective salpingography.
Technological Characteristics
The Conceptus Stargate Catheter is substantially equivalent to the Conceptus VS Catheter and will replace that device in the Conceptus STARRT Falloposcopy System. The primary difference between the Stargate Catheter and VS Catheter is a diamond shaped wire which has been added to the distal tip of the Stargate Catheter. The primary purpose of the wire tip is to keep tubal epithelium away from the falloposcope lens to optimize imaging of the fallopian tube lumen.
Data Supporting Substantial Equivalence
Conceptus conducted laboratory, preclinical and clinical testing to confirm that the Stargate Catheter is safe and effective. The laboratory testing demonstrated that small forces are applied to the wire tip during clinical use. Laboratory testing further demonstrated that the force required to advance the Stargate Catheter is no greater than the force required to advance the VS Catheter. Lastly, laboratory testing confirmed that the Stargate Catheter is less likely to kink as compared to the VS Catheter.
A fallopian tube catheterization histology study in rabbits was conducted to demonstrate the safety of the Stargate Catheter. The objective of the study was to use the rabbit model to determine if fallopian tube catheterization as well as anticipated adverse events cause damage to the fallopian tube and if there is any resulting adverse impact on pregnancy rates. Study results demonstrate that their is no significant difference in fallopian tube damage between the catheterized and control tubes.
Lastly, clinical testing was conducted to validate the performance of the device. Participating clinicians reported that they were able to make a better diagnosis of tubal health with the Stargate Catheter as compared to the VS Catheter.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake entwined around it, overlaid on three horizontal bars. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Connie Acuff Manager, Clinical Research & Regulatory Affairs Conceptus. Inc. 1021 Howard Avenue San Carlos, CA 94070
JAN 2 1 1998 Re: K974028 Stargate™ Falloposcopy Catheter and Trifurcated Irrigation Tubing Dated: October 21, 1997 Received: October 23, 1997 Regulatory Class: II 21 CFR 884.1690/Procode: 85 MKO
Dear Ms. Acuff:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Drog, and Cosmetic Act (Act). You may, therefore, 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.
If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours
h.Liau Yin
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
STATEMENT OF INDICATIONS FOR USE
K974028 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Stargate™ Falloposcopy Catheter and Trifurcated Irrigation Tubing Set (part of STARRT™ Falloposcopy System)
Indications for Use:
The STARRT System is indicated for use as a secondary diagnostic tool for the further evaluation of women previously diagnosed with proximal tubal occlusion by hysterosalpingography or selective salpingography.
| • | The STARRT System is only designed to access the proximal portion of the fallopian tube, i.e. the first 2-3 cm. It should only be advanced as far as necessary to achieve a meaningful study, recognizing that possible adverse effects of more distal advancement, particularly upon normal tubes, have not yet been determined. |
|---|---|
| • | The STARRT System is not intended for tubal recanalization, and there is no data available, in particular, pregnancy data, showing clinical benefit for this use. Studies are underway. |
| • | The STARRT System is not to be used for gamete or embryo transfer, or other assisted reproduction techniques. |
| • | The STARRT System should only be used by clinicians with experience in tubal evaluation. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert R Ratliff
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K974028
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)