(206 days)
The DRG Disposable Vaginal Speculum is indicated for use to expose the interior of the vagina.
The DRG Disposable Vaginal Speculum is indicated for diagnostic procedures of the vagina and cervix.
The DRG Disposable Vaginal Speculum consists of a plastic inflatable bladder The DNO Disposable Vaginal of to uniformly press the vaginal walls open.
The provided text is a 510(k) premarket notification summary for the DRG Disposable Vaginal Speculum. This document describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain any information about acceptance criteria, performance studies, sample sizes, expert involvement, ground truth, or statistical analyses as would be required for a detailed description of device performance and its proof against acceptance criteria.
The 510(k) process primarily evaluates a new device for "substantial equivalence" to a legally marketed predicate device, rather than requiring extensive de novo clinical trials to prove performance against specific acceptance criteria in the manner an AI/ML medical device might. The core argument for substantial equivalence for this device would likely revolve around materials safety, design similarity, and functional equivalence to existing vaginal specula.
Therefore, I cannot fulfill your request for the specific details regarding acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment based on the provided document. This information is simply not present in this type of regulatory submission for this device.
{0}------------------------------------------------
K012535
Page 1 of 2
2002 mar 1
Premarket Notification 510(k) Summary of Safety and Effectiveness DRG Disposable Vaginal Speculum
Company Information
Doctors Research Group, Inc. 143 Wolcott Road Wolcott, CT 06716 (p) 203-879-9422 (f) 203-879-2835
Contact: Richard Deslauriers, MD
Registration Number: 1226001
Summary Preparation Date
August 3, 2001
Device Information
| Trade name: | DRG Disposable Vaginal Speculum |
|---|---|
| Common name: | Disposable Vaginal Speculum |
| Classification name: | Nonmetal Vaginal Speculum |
| Device Classification Panel: | Obstetrics/Gynecology |
| Regulation number: | 21CFR Part 884.4530 |
| Class: | II |
| Product Code: | HIB |
{1}------------------------------------------------
Page 2 of 2
Predicate Device
K000414 - Medisul Disposable Vaginal Speculum™ K984211 - Medscand Easy-Spec™ Disposable Vaginal Speculum Welch Allyn Disposable Vaginal Speculum
Device Description
The DRG Disposable Vaginal Speculum consists of a plastic inflatable bladder The DNO Disposable Vaginal of to uniformly press the vaginal walls open.
Indications For Use
The DRG Disposable Vaginal Speculum is indicated for use to expose the interior of the vagina. Merin Clink .
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling three overlapping, curved lines, possibly representing an abstract human figure or a flowing element.
Public Health Service
MAR 1 2002
Richard J. Deslauriers, M.D. President Doctors Research Group, Inc. 50 Altair Avenue PLYMOUTH CT 06782
Food and Drug Administration 00 Corporate Boulevard Rockville MD 20850
Re: K012535 Trade/Device Name: DRG Disposable Vaginal Speculum Regulation Number: 21CFR §884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: 85 HIB Dated: November 30, 2001 Received: December 3, 2001
Dear Dr. Deslauriers:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 3 re(s) pecies is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreative to togally to togally with Medical Device Amendments, or to conninered prior to rial) 2018-12-11 in accordance with the provisions of the Federal Food, Drug, de necs mat hat o oon recident a mavire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I va may, dicrosery mans 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act that I Dr. Has Intact and regulations administered by other Federal agencies. You must or uny with all the Act's requirements, including, but not limited to: registration and listing comply with an all the rece requirements as a 801); good manufacturing practice requirements as set (21 OFF Pat 601), accems (QS) regulation (21 CFR Part 820); and if applicable, the electronic rently and ation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
{3}------------------------------------------------
Page 2
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 needicate 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), please 11 your teen office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
Nancy C Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Vaginal Speculum 510(k) Additional Information
Doctors Research Group, Inc. 143 Wolcott Road Wolcott, CT 06716 (203) 879-9422
Statement of Indications For Use
510(k) Number (if Known): KG12535
Device Name: DRG Disposable Vaginal Speculum
Indications for use:
The DRG Disposable Vaginal Speculum is indicated for diagnostic procedures of the vagina and cervix.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C broaden
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K012535
Prescription Use
(Per 21 CFR 801.109)
§ 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.