GLOBAL HEALTHCARE VAGINAL SPECULUM

K013835 · Dynascend Consulting Int'L, LLC · HIB · Jan 17, 2002 · Obstetrics/Gynecology

Device Facts

• Record ID: K013835
• Device Name: GLOBAL HEALTHCARE VAGINAL SPECULUM
• Applicant: Dynascend Consulting Int'L, LLC
• Product Code: HIB · Obstetrics/Gynecology
• Decision Date: Jan 17, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4530
• Device Class: Class 2

Intended Use

The Global Healthcare's Vaginal Speculum is intended to be used for general vaginal examination. It is inserted into the vagina to expose the cervix.

Device Story

The Global Healthcare Vaginal Speculum is a manual instrument used for gynecological examinations. It is inserted into the vaginal canal to dilate and expose the cervix for visual inspection by a clinician. The device is a specialized manual instrument intended for use in a clinical setting.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual vaginal speculum; specialized manual instrument; Class II; 21 CFR 884.4530.

Indications for Use

Indicated for general vaginal examination to expose the cervix in patients requiring such procedures by a clinician.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 7 2002

Mr. Alam Ahmed President Global Healthcare 1144 Canton Street STE. 103 ROSWELL GA 30075

Re: K013835

Trade/Device Name: Global Healthcare Vaginal Speculum Regulation Number: 21 CFR 884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II

Product Code: 85 HIB Dated: November 15, 2001 Received: November 19, 2001

Dear Mr. Ahmed:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your booking 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 cholosare) to regally comment date of the Medical Device American by D comments with to May 20, 1970, are enames with the provisions of the Federal Food, Drug, devices mark form room roomstiled in assessment of a premarket approval application (PMA). and Costient Act (Act) that do not required to the general controls provisions of the Act. The I ou may, incretore, market the act include requirements for annual registration, listing of general controls provisions of wactice, 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 your device is classified (600 a00 regulations affecting your device can be It may of Subjoor to additional constions, 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 I rease of advised that I DT 3 issualite of our device complies with other requirements of the Act that I Dr has made a dolorimiations administered by other Federal agencies. You must of any I oderal statutes and roginements, including, but not limited to: registration and listing Compry with and Hec Frequirements, as 801); good manufacturing practice requirements as set (21 CFR Part 007), laooming (21 CFR Part 820); and if applicable, the electronic forth in the quality bybelins (sections 531-542 of the Act); 21 CFR 1000-1050.

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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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510(k) Number (if known):__K013835

Device Name:_Global Healthcare Vaginal Speculum

Indications For Use:

The Global Healthcare's Vaginal Speculum is intended to be used for general The Global Healthouro of vaginal operation in is inserted into the vagina to expose the cervix.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 3-10-98)

Narayc bawshn

Division of Reproductive, Abdominat,
and Radiological Devices
510(k) Number K013835