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.

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).

AI/ML Overview

The provided document describes the Conceptus Stargate™ Falloposcopy Catheter and Trifurcated Irrigation Tubing Set, which is part of the STARRT™ Falloposcopy System. This system is intended as a secondary diagnostic tool for evaluating women with proximal tubal occlusion.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria with numerical targets. Instead, it focuses on demonstrating substantial equivalence to an existing cleared device (Conceptus VS™ Catheter) and qualitative improvements. The performance is largely framed around safety and effectiveness comparable to, or better than, the predicate device.

Acceptance Criterion (Inferred)	Reported Device Performance
Safety: Minimal force applied to wire tip	Laboratory testing demonstrated that small forces are applied to the wire tip during clinical use.
Safety: Force to advance catheter	Laboratory testing demonstrated that the force required to advance the Stargate Catheter is no greater than the force required to advance the VS Catheter (predicate).
Safety: Kinking likelihood	Laboratory testing confirmed that the Stargate Catheter is less likely to kink as compared to the VS Catheter (predicate).
Safety: Tubal damage (preclinical)	A fallopian tube catheterization histology study in rabbits demonstrated "no significant difference in fallopian tube damage between the catheterized and control tubes."
Effectiveness: Improved diagnostic capability	Clinical testing: 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 (predicate).

2. Sample Size Used for the Test Set and Data Provenance

Laboratory Testing: No specific sample size is provided for the laboratory tests on force and kinking.
Preclinical (Animal) Study: "A fallopian tube catheterization histology study in rabbits was conducted." The exact number of rabbits or fallopian tubes is not specified, but it compares "catheterized and control tubes."
Clinical Testing: The document states that "clinical testing was conducted." No specific sample size (number of patients or procedures) is provided for this clinical testing.
Data Provenance: The document does not explicitly state the country of origin for the data. Given Conceptus, Inc. is located in San Carlos, CA, USA, it is highly probable the studies were conducted in the USA. The studies appear to be prospective as they were conducted to validate the new device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Laboratory/Preclinical: Ground truth for these studies would be based on scientific measurements (forces, histological analysis). Experts in materials science or pathology would be involved, but specific numbers or qualifications are not stated.
Clinical Testing: "Participating clinicians reported that they were able to make a better diagnosis." The number of clinicians is not specified. Their qualifications are implied as "clinicians with experience in tubal evaluation" (from the Indications for Use), but specific details (e.g., "radiologist with 10 years of experience") are not provided. The ground truth for improved diagnosis is based on their expert clinical assessment.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for the clinical testing. The statement "Participating clinicians reported that they were able to make a better diagnosis" suggests a direct assessment by the clinicians during their use of the device, rather than a separate adjudication process of diagnostic outputs.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

The document does not describe a formal Multi Reader Multi Case (MRMC) comparative effectiveness study. While clinical testing compared the Stargate to the VS Catheter and clinicians reported an improvement, it's not presented as a structured MRMC study designed to quantify the effect size of human readers' improvement with AI vs. without AI assistance. This device is a catheter, not an AI diagnostic tool, so the concept of "human readers improve with AI" is not directly applicable here.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This device is a medical instrument (catheter), not a software algorithm. Therefore, the concept of "standalone (algorithm only)" performance is not applicable to this submission. Its performance is intrinsically tied to human operation.

7. The Type of Ground Truth Used

Laboratory Testing: Objective measurements (force, kink resistance).
Preclinical (Animal) Study: Histopathology (microscopic examination of tissue samples for damage).
Clinical Testing: Expert clinical assessment/diagnosis by participating clinicians. This falls under expert consensus/clinical judgment.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI. This device is a mechanical instrument, and its development and testing followed traditional medical device validation pathways, not AI model development.

9. How the Ground Truth for the Training Set Was Established

As there is no mention of a training set for an AI model, this question is not applicable to the provided document. The development of the Stargate Catheter relied on engineering design, laboratory testing, preclinical studies, and clinical observations rather than machine learning training.

Summary

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ATTACHMENT C

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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

Conceptus, Inc .. 1021 Howard Avenue, San Carlos, CA 94070 Phone:650/802-7240 · Fax:650/610-8363

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K974028

P292

Device Description, cont.

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.

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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

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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 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)

Over-The-Counter Use_

(Optional Format 1-2-96)

Regulation Number and Section

§ 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.