(70 days)
Unimar Pipelle® Pipelle de Cornier™ Endometrial Suction Curette, Vabra Aspirator®
Not Found
No
The summary describes a mechanical suction curette and does not mention any AI or ML components or functionalities.
No.
The device is used for sampling and biopsy, which are diagnostic procedures, not therapeutic ones.
Yes
The device is used for endometrial sampling for histologic biopsy, which is a method of obtaining tissue for diagnostic examination.
No
The device description clearly states it is a physical curette that operates by negative pressure, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For endometrial sampling for histologic biopsy of the uterine mucosal lining." This describes a procedure to collect a tissue sample from the body.
- Device Description: The device is a "curette" that operates by "negative pressure" for "endometrial sampling." This is a tool used to physically obtain a sample.
- Lack of IVD Characteristics: IVD devices are used in vitro (outside the body) to examine specimens (like blood, urine, or tissue samples) to provide information about a patient's health. This device is used in vivo (inside the body) to collect the sample.
The collected tissue sample would then likely be sent to a laboratory for in vitro analysis (histology), which would involve IVD procedures and potentially IVD devices (like stains, reagents, microscopes, etc.). However, the curette itself is the tool for sample collection, not the diagnostic test performed on the sample.
N/A
Intended Use / Indications for Use
For endometrial sampling for histologic biopsy of the uterine mucosal lining.
Product codes
85 HHK
Device Description
The RI.MOS. s.r.l. curette operates by negative pressure and is a sterile, single-use, disposable device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
uterine mucosal lining
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
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.
Key Metrics
Not Found
Predicate Device(s)
Unimar Pipelle® Pipelle de Cornier™ Endometrial Suction Curette, Vabra Aspirator®
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
AUG 12 12
Section 8
510 (k) Summary
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.
-
- 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.
-
- The technological characteristics are the same or similar to those found with the marketed predicate device.
-
- 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
1
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
2
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)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
Noril G. Slegman
(Division Sign-Off)
(Division of Reproductive, Abdominal, ENT, and Radiological Devices 895 510(k) Number.