(52 days)
No
The summary describes a manual, disposable speculum and does not mention any AI or ML capabilities.
No
The devices are described as aids for routine examination and procedures, without any mention of treating or alleviating a disease or condition. They are used to expose the interior of the vagina, which is a diagnostic or procedural function, not a therapeutic one.
No
Explanation: The device is described as an aid for routine examination and procedures, primarily for exposing the interior of the vagina. It does not perform any diagnostic function itself, such as detecting or identifying a disease.
No
The device description explicitly states that the devices are "sterile, single-use, disposable devices," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "expose the interior of the vagina" for routine examination and procedures. This is a physical manipulation and visualization of an anatomical site, not a test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The device is a speculum, a physical instrument used to open a body cavity. This is consistent with a medical device used for examination, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any diagnostic testing being performed by the device itself.
IVDs are typically used to analyze samples to provide information about a person's health status, such as diagnosing diseases, monitoring treatment, or screening for conditions. This device is a tool for physical examination.
N/A
Intended Use / Indications for Use
The RI MOS. s.r.l. Cuscovag, Specuvag and Specuvag AS devices are used to expose the interior of the vagina. The Cuscovag is indicated as an aid for routine examination in adolescent and geriatric women, the Specuvag as an aid for routine examination and the Specuvag AS as an aid for routine examination and procedures where smoke must be evacuated from the vaginal canal.
Product codes
85 HIB
Device Description
The RI. MOS. s.r.l. speculae line are sterile, single-use, disposable devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vagina
Indicated Patient Age Range
adolescent and geriatric women (for Cuscovag), Not specified for Specuvag and Specuvag AS.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Safety tests were conducted and passed in accordance with the relevant sections of ISO 10993.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.4530 Obstetric-gynecologic specialized manual instrument.
(a)
Identification. An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:(1) An amniotome is an instrument used to rupture the fetal membranes.
(2) A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant.
(3) An umbilical clamp is an instrument used to compress the umbilical cord.
(4) A uterine curette is an instrument used to scrape and remove material from the uterus.
(5) A fixed-size cervical dilator is any of a series of bougies of various sizes used to dilate the cervical os by stretching the cervix.
(6) A uterine elevator is an instrument inserted into the uterus used to lift and manipulate the uterus.
(7) A gynecological surgical forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynecological examination.
(8) A cervical cone knife is a cutting instrument used to excise and remove tissue from the cervix.
(9) A gynecological cerclage needle is a looplike instrument used to suture the cervix.
(10) A hook-type contraceptive intrauterine device (IUD) remover is an instrument used to remove an IUD from the uterus.
(11) A gynecological fibroid screw is an instrument used to hold onto a fibroid.
(12) A uterine sound is an instrument used to determine the depth of the uterus by inserting it into the uterine cavity.
(13) A cytological cervical spatula is a blunt instrument used to scrape and remove cytological material from the surface of the cervix or vagina.
(14) A gynecological biopsy forceps is an instrument with two blades and handles used for gynecological biopsy procedures.
(15) A uterine tenaculum is a hooklike instrument used to seize and hold the cervix or fundus.
(16) An internal pelvimeter is an instrument used within the vagina to measure the diameter and capacity of the pelvis.
(17) A nonmetal vaginal speculum is a nonmetal instrument used to expose the interior of the vagina.
(18) A fiberoptic nonmetal vaginal speculum is a nonmetal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.
(b)
Classification. (1) Class II (special controls). The device, when it is an umbilical clamp with or without a cutter, a uterine tenaculum which is sterile and does not use suction and is intended for single use, a nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.(2) Class I for the amniotome, uterine curette, cervical dilator (fixed-size bougies), cerclage needle, IUD remover, uterine sound, and gynecological biopsy forceps. 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.
0
JUL 19 1999
Section 7
510 (k) Summary
This summary of a 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. 8807.92.(c)
-
- The submitter of this premarket notification is:
Adena S. Riemer Affiliate EXPERTech Associates, Inc. 100 Main Street, Suite 120 Concord, MA 01742
- The submitter of this premarket notification is:
Tel: (978) 371-0066 Fax: (978) 371-1676
This summary was prepared on May 26, 1999.
-
- The name of the RI. MOS. s.r.l. devices known as the GINRAM® Cuscovag. Specuvag and Specuvag AS.
-
- The above device is substantially equivalent to KleenSpec® Specula marketed by Welch Allyn, K941272.
-
- The RI. MOS. s.r.l. speculae line are sterile, single-use, disposable devices.
-
- The device is intended as an aid in routine gynecological examinations, including a smoke evacuator model for procedures where such is required.
-
- The technological characteristics are the same or similar to those found with the marketed predicate devices.
-
- Safety tests were conducted and passed in accordance with the relevant sections of ISO 10993.
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 19 1999
RI, MOS, s.r.I. c/o Ms. Adena S. Riemer EXPERTech Associates, Inc. 100 Main Street, Suite 120 Concord. MA 01742
RE: K991827 GINRAM® speculae -- Cuscovag, Specuvag and Specuvaq AS Dated: Mav 26, 1999 Received: May 28, 1999 Requlatory Class: II 21 CFR §884.4530/Procode: 85 HIB
Dear Ms. Riemer:
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 (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 Requilations, 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 Requlation (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 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(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 Compiiance 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
510(k) Number (if known):
Device Name: RI MOS. s.r.l. GINRAM® speculae - Cuscovag, Specuvag and Specuvag AS"
Indications for Use:
The RI MOS. s.r.l. Cuscovag, Specuvag and Specuvag AS devices are used to expose the interior of the vagina. The Cuscovag is indicated as an aid for routine examination in adolescent and geriatric women, the Specuvag as an aid for routine examination and the Specuvag AS as an aid for routine examination and procedures where smoke must be evacuated from the vaginal canal.
(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
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K94182