(29 days)
Not Found
Not Found
No
The device description and intended use clearly describe a simple, single-use mechanical device (a speculum) with no mention of any computational or data-driven features. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
No
The device is used to expose the interior of a vagina for gynecological procedures, which is a diagnostic or procedural aid, not a therapeutic intervention.
No
The device is described as a speculum intended to expose the interior of a vagina for gynecological procedures. Its function is to facilitate a procedure by providing access and visibility, not to diagnose a condition itself.
No
The device description clearly states it is a physical, single-use polystyrene speculum, which is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Medscand disposable speculum is a physical tool used to expose the interior of the vagina for visual examination or procedures. It does not analyze any biological samples or provide diagnostic information based on those samples.
The description clearly states its purpose is to "expose the interior of a vagina for gynecological procedures," which is a mechanical function, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Medscand disposable speculum is intended to expose the interior of a vagina for gynecological procedures.
Product codes
85 HIB
Device Description
The Medscand polystyrene speculum is a single-use device to be used by a medical professional to expose the interior of a vagina.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Vagina
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical professional
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Galenica disposable vaginal speculum
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
DEC 2 3 1998
K 984211
510 (k) Summary
SUBMITTER'S NAME, ADDRESS, TELEPHONE / FAX NUMBERS AND CONTACT PERSON.
Tennyson P. Tse, Ph.D. President and CEO Medscand (USA) Inc. 3930 N29th Avenue Hollywood, Florida 33020 (954) 922-2557 Tel: Fax: (954) 927-6890
DATE PREPARED
Date: November 20, 1998
NAME OF DEVICE, NAME AND ADDRESS OF SPONSOR
Name of device
Easy-Spec"; Medscand disposable plastic vaginal speculum
Sponsor
Medscand (USA) Inc. 3930 N29th Avenue Hollywood, Florida 33020
COMMON OR USUAL NAME
Vaginal speculum, disposable speculum, plastic speculum
1
K 984211
CLASSIFICATION NAME
Speculum, vaginal, disposable
PREDICATE DEVICE
Galenica disposable vaginal speculum
DEVICE DESCRIPTION AND INTENDED USE
The Medscand polystyrene speculum is a single-use device to be used by a medical professional to expose the interior of a vagina.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The Medscand disposable vaginal speculum is substantially equivalent to the Galenica disposable vaginal speculum in terms of intended use, design, materials, and principles of operation. The dimensions of the Medscand speculum are similar to those of Galenica speculum, which has been cleared by FDA. Galenica speculum has been in clinical use since 1984 and the Medscand speculum since 1993 ( in Europe ).
K:\docs\speculm.doc\summary.doc
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo is a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 3 1998
Tenny P. Tse, Ph.D. President and CEO Medscand (U.S.A.), Inc. P.O. Box 7733 Hollywood, FL 33081
Re: K984211
Disposable Vaginal Speculum Dated: November 20, 1998 Received: November 24, 2998 Regulatory Class: II 21 CFR 884.4530/Procode: 85 HIB
Dear Dr. Tse:
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 III (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 Requlations, 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 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 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 requlation 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,
J
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
3
INDICATIONS FOR USE
510 (k) Number ( new ): ✓ |
|-----------------------|---------------------------------------|
| ( Per 21 CFR 801.109) | |
or
| Over-The-Counter-Use | _________________ |
|---|---|
| ---------------------- | ------------------- |
K:\docs\speculm.doc\indicatn.doc
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, ENT, and Radiological Devices. | |
| 510(k) Number | K 984211 |