The Fertiloscopy Kit is intended to be used for transvaginal hydro-laparoscopy, dye-test, salpingoscopy, and hysteroscopy during one procedure. The device is indicated for use in the diagnosis of tubo-peritoneal infertility.

Device Description

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Soprane S.A. Fertiloscopy Kit FH 1.29 / FTO 1.40:

The provided 510(k) summary is for a medical device (Fertiloscopy Kit), not an AI device. As such, many of the standard questions regarding AI device performance metrics (such as sensitivity, specificity, F1 score, effect size for human readers with AI assistance) and AI-specific ground truth details (like expert consensus, training set size) are not directly applicable or reported in this type of regulatory submission for a traditional medical device.

However, I can extract the information that is present and indicate where certain information is not provided.

Acceptance Criteria and Device Performance Study for Soprane S.A. Fertiloscopy Kit® FH 1.29 / FTO 1.40

This submission describes a traditional medical device, not an AI-powered device. Therefore, the acceptance criteria and performance study focus on safety, functionality, and clinical utility in comparison to existing predicate devices, rather than the statistical performance metrics typically associated with AI.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicitly based on Predicate Devices)	Reported Device Performance
Safety	No new safety concerns compared to predicate devices.	Leak testing of the balloon during inflation performed.
Sterility	Materials are sterile following sterilization procedures.	Sterility testing of the materials following sterilization performed.
Functionality/Effectiveness	Perform transvaginal hydrolaparoscopy, dye-test, salpingoscopy, and hysteroscopy.	"Fertiloscopy was shown to provide a 'diagnostic sequence giving, in a one time procedure, a complete and informative status of the uterus, tubes, ovary, and peritoneum.'"
Intended Use	Indicated for diagnosis of tuboperitoneal infertility.	The clinical study supports the device's utility in providing diagnostic information for tuboperitoneal infertility.
Biocompatibility	(Not explicitly stated, but assumed to be acceptable based on predicate devices)	(No specific data reported in this summary)

Notes on Acceptance Criteria:

For traditional medical devices seeking 510(k) clearance, the primary "acceptance criterion" is often substantial equivalence to legally marketed predicate devices. This means demonstrating that the new device has the same intended use, similar technological characteristics, and does not raise new questions of safety or effectiveness compared to the predicates.
The performance data provided supports this claim of substantial equivalence by showing the device performs its intended functions safely and effectively.

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

Sample Size (Test Set/Clinical Study): 160 patients.
Data Provenance: Not explicitly stated, but the company is based in France (Lyon, France). It is reasonable to infer the clinical study was likely conducted in Europe, possibly France, given the company's location, but this is not confirmed in the text. The study is prospective in nature, as it describes a clinical study where the Fertiloscopy device was used and evaluated.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified.
- Explanation: For a clinical study evaluating a diagnostic procedure like fertiloscopy, ground truth would typically be established by the clinicians (e.g., gynecologists, fertility specialists) performing and interpreting the procedure, potentially cross-referencing with other diagnostic methods or surgical findings. The summary does not detail the specific method of establishing "ground truth" or the number and qualifications of experts involved in the interpretation of the 160 patient cases.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified. Adjudication methods like 2+1 or 3+1 typically apply when assessing the agreement between multiple human readers and/or an AI system against a gold standard. This level of detail for interpreting the findings of a clinical procedure in a 510(k) summary is generally not included unless there's a specific, complex diagnostic endpoint being evaluated in a comparative manner.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: No, this type of study was not done.
Effect Size with/without AI: Not applicable, as this is not an AI device.

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

Standalone Performance: Not applicable, as this is not an AI device. The device itself is an instrument used by a clinician, so there is always a "human-in-the-loop."

7. The Type of Ground Truth Used

Type of Ground Truth: The study's conclusion, "Fertiloscopy was shown to provide a 'diagnostic sequence giving, in a one time procedure, a complete and informative status of the uterus, tubes, ovary, and peritoneum,'" suggests that the ground truth for the "diagnostic sequence" was likely based on clinical assessment/findings obtained directly from the procedure itself. This would be interpreted by the attending clinicians/surgeons. It's possible historical patient outcomes or subsequent diagnostic results were used for correlation, but it's not explicitly stated.

8. The Sample Size for the Training Set

Sample Size (Training Set): Not applicable. This is a traditional medical device, not an AI device that requires a training set. The "training" for such a device would involve technical design and engineering iterations, not machine learning.

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

Ground Truth Establishment (Training Set): Not applicable, as this is not an AI device.

Summary

{0}------------------------------------------------

MAR 1 3 2000

510(k) SUMMARY

Soprane S.A. Fertiloscopy Kit® FH 1.29 / FTO 1.40

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Thierry Loubens Président Directeur Général Soprane S.A. 102 Rue Duguesclin 69006 Lyon France Telephone: (011) (33) 4 72 74 40 75 Facsimile: (011) (33) 4 75 74 04 91

Howard M. Holstein, Esq. Hogan & Hartson L.L.P. 555 Thirteenth Street, N.W. Washington, D.C. 20004-1109 Telephone: (202) 637-5813 Facsimile: (202) 637-5910

Date Prepared:

August 6, 1999

Name of Device and Name/Address of Sponsor

Soprane S.A, Fertiloscopy Kit® FH 1.29 / FTO 1.40

Thierry Loubens Président Directeur Général Soprane S.A. 102 Rue Duguesclin 69006 Lyon France Telephone: (011) (33) 4 72 74 40 75 Facsimile: (011) (33) 4 75 74 04 91

Common or Usual Name

Intrauterine Balloon Catheter and Transvaginal Cannula

Classification Name

Rigid culdoscope and accessories (21 C.F.R. § 884.1640); semi-rigid hysteroscope and accessories (21 C.F.R. § 884.1690); cannula. manipulator/injector, uterine; and reposable surgical trocar (21 C.F.R. $ 884.1720)

Predicate Devices

Circon Corporation's ("Circon") Transvaginal Hydro® Laparoscopy . ("THLTM") System;

{1}------------------------------------------------

Cook OB/GYN's ("Cook") Intrauterine Balloon Access Catheter ("IBA . Catheter"):
Imagyn Medical, Inc.'s ("Imagyn") MicroSpan Hysteroscope Sheath . ("MicroSpan"); and
Origin Medsystems, Inc.'s ("Origin") Blunt Tip Trocar. .

Intended Use

The Fertiloscopy Kit is intended to be used for transvaginal hydrolaparoscopy, dye-test, salpingoscopy, and hysteroscopy during one procedure. The device is indicated for use in the diagnosis of tuboperitoneal infertility.

Technological Characteristics and Substantial Equivalence

The Fertiloscopy Kit has the same general intended use and similar principles of operation and technological characteristics as a combination of Circon's cleared THL, Cook's cleared IBA Catheter, Imagyn's cleared MicroSpan, and Origin's cleared Blunt Tip Trocar. The minor technological differences between the Fertiloscopy Kit and the Imagyn MicroSpan, Cook IBA Catheter, Circon THL, and Origin Blunt Tip Trocar do not raise any new questions of safety or effectiveness. Therefore, the Fertiloscopy Kit is substantially equivalent to its predicate devices.

Performance Data

Soprane has conducted leak testing of the balloon during inflation and sterility testing of the materials following sterilization. In a clinical study of 160 patients, Fertiloscopy was shown to provide a "diagnostic sequence giving, in a one time procedure, a complete and informative status of the uterus, tubes, ovary, and peritoneum."

Conclusion

The Fertiloscopy Kit's substantial equivalence is based on a narrative comparison of this device and its predicate devices' intended use, principles of operation and technological characteristics and bench testing and clinical testing.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized image of an eagle with its head turned to the left, overlaid with a human profile. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle and profile.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 3 2000

Soprane S.A. c/o Mr. Howard M. Holstein Hogan & Hartson, L.L.P. 555 Thirteenth Street, N.W. Washington, D.C. 20004

Re: K992655 Fertiloscopy Kit ® FH 1.29/FTO 1.40 Dated: January 18, 2000 Received: January 19, 2000 Requiatory Class: II 21 CFR §884.1640/Procode: 85 HEW 21 CFR §884.1690/Procode: 85 HIH 21 CFR §884.1720/Procode: 85 HET

Dear Mr. Holstein:

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 legally marketed predicate devices marketed in interstate commerce prior to May 26, 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 Cosmelic Ad (Act). 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 and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class III (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 equivalion assumes compliance with the Current Good Manufacturing Practice requirements, 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. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket 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) 594-4591. 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" (21CFR 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/dsmaldsmamain.html".

Sincerely yours,

Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

{3}------------------------------------------------

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Soprane S.A.'s Fertiloscopy Kit® FH 1.29 / FTO 1.40 Device Name:

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 C.F.R. 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Tamil U. Seymore

(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological D 510(k) Number

\\DC - 69874/1 - 0919534.01

Regulation Number and Section

§ 884.1640 Culdoscope and accessories.

(a)
Identification. A culdoscope is a device designed to permit direct viewing of the organs within the peritoneum by a telescopic system introduced into the pelvic cavity through the posterior vaginal fornix. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include trocar and cannula, instruments used through an operating channel, scope preheaters, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for culdoscope 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 culdoscope accessory instruments include: lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable) scissors, and suction/irrigation probe. 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.