RAMPIPELLA, SINGE PORT (720196) & WEDGE-SHAPED PORT (720217) by RI MOS. S.R.L.

The provided text describes a 510(k) submission for the RI.MOS. s.r.l. Rampipella, an endometrial suction curette. It's important to note that this is a traditional medical device, not an AI/ML powered device, so many of the requested fields (especially those related to AI/ML specific studies, ground truth, and expert involvement) are not applicable or not detailed in this type of submission.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Stated or Implied)	Reported Device Performance
Adequate histological grade tissue collection	Results showed sufficient amount and grade of tissue collection.
No adverse events	No adverse events were reported.
Substantial equivalence to predicate device	The device is substantially equivalent to the Unimar Pipelle® and Vabra Aspirator®.
Technological characteristics are same or similar to predicate	The technological characteristics are the same or similar to those found with the marketed predicate device.

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

Sample Size: Not specified. The document only states "Comparative clinical performance evaluations were conducted."
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). It is a clinical performance evaluation, implying prospective, but detailed information is not provided.

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

Not Applicable / Not Specified: The study focuses on the physical collection of tissue and safety, not on the interpretation of results by experts in a diagnostic context for an AI/ML device. The ground truth would inherently be the tissue itself, which would then be analyzed (presumably by pathologists, though not explicitly stated) to determine "histological grade tissue collection."

4. Adjudication Method for the Test Set:

Not Applicable / Not Specified: This concept typically applies to studies where human interpreters are making subjective assessments that need to be reconciled (e.g., in AI/ML validation). The reported study is a clinical performance evaluation of a physical device.

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:

No: This is not an AI/ML device. Therefore, no MRMC study or AI assistance evaluation would have been conducted or is applicable.

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

No: This is not an AI/ML device.

7. The Type of Ground Truth Used:

Histological Examination (Implied): The study evaluated "adequate histological grade tissue collection." This implies that the tissue samples collected by the device were subsequently examined histologically (likely by pathologists) to confirm their quality and suitability for diagnosis. The "ground truth" here is the actual quality and diagnostic utility of the collected tissue as determined by standard pathology practices.

8. The Sample Size for the Training Set:

Not Applicable: This is a physical medical device, not an AI/ML algorithm. There is no concept of a "training set" in this context.

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

Not Applicable: As above, there is no training set for a physical medical device.

Summary

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AUG 12 12

Section 8

510 (k) Summary

K941895

This summary of 510 (k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. §807.92.

The submitter of this premarket notification is: 1 .
James M. Delaney Associate EXPERTech Associates, Inc. 100 Main Street, Suite 120 Concord, MA 01742

Tel: (978) 371-0066 Fax: (978) 371-1676

This summary was prepared on June 1, 1999.

1. The name of the RI.MOS. s.r.l. device is Rampipella. The common name is curette, and the classification name is Endometrial suction curette.
The above device is substantially equivalent to the Unimar Pipelle® Pipelle de 3. Cornier™ Endometrial Suction Curette distributed by CooperSurgical and the Vabra Aspirator® distributed by Berkeley Medevices, Inc.
The RI.MOS. s.r.l. curette operates by negative pressure and is a sterile, single-use, 4. disposable device.
న. The device is intended for endometrial sampling for histologic biopsy of the uterine mucosal lining.
1. The technological characteristics are the same or similar to those found with the marketed predicate device.
1. Comparative clinical performance evaluations were conducted to establish adequate histological grade tissue collection. Results showed sufficient amount and grade of tissue collection, and no adverse events were reported.

ﺎ

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1:2 1999

RI. MOS. S.r.I. c/o Mr. James M. Delaney Associate EXPERTech Associates Inc. 100 Main Street. Suite 120 Concord, MA 01742

Dear Mr. Delaney:

Re: K991895 GINRAM® Rampipella Dated: June 1, 1999 Received: June 3, 1999 Requiatory Class: II 21 CFR §884.1175/Procode: 85 HHK

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 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). 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.

If your device is classified (see above) into either class II (Special Controls) or 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 equivalent determination 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 requlatory action. In addition. 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 the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(t) 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), piease 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/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting 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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Indications for Use Statement

510(k) Number K 991895 (if known)

Device Name RI. MOS. s.r.l. GINRAM® Rampipella

Indications for Use For endometrial sampling for histologic biopsy of the uterine mucosal lining.

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 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Noril G. Slegman
(Division Sign-Off)

(Division of Reproductive, Abdominal, ENT, and Radiological Devices 895 510(k) Number.

Regulation Number and Section

§ 884.1175 Endometrial suction curette and accessories.

(a)
Identification. An endometrial suction curette is a device used to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction. This device is used to obtain tissue for biopsy or for menstrual extraction. This generic type of device may include catheters, syringes, and tissue filters or traps.(b)
Classification. Class II (performance standards).