KENTEX DISPOSABLE VAGINAL SPECULUM

K030693 · Kentron Health Care, Inc. · HIB · Aug 27, 2003 · Obstetrics/Gynecology

Device Facts

• Record ID: K030693
• Device Name: KENTEX DISPOSABLE VAGINAL SPECULUM
• Applicant: Kentron Health Care, Inc.
• Product Code: HIB · Obstetrics/Gynecology
• Decision Date: Aug 27, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4530
• Device Class: Class 2

Intended Use

INTENDED TO BE USED FOR GENERAL THE UNGINA PROCEDURES. IT is INSERTED INTO THE VAGINA TRUCTOURES THE INTERioR OF THE VAGINA.

Device Story

Kentex Disposable Vaginal Speculum is a manual, non-metal instrument used for gynecological examinations. Device is inserted into the vagina to facilitate visualization of the vaginal interior. Intended for single-use to prevent cross-contamination. Operated by clinicians in clinical settings. Provides mechanical retraction of vaginal walls to allow physician inspection. Benefits include improved hygiene and reduced risk of patient-to-patient infection compared to reusable metal specula.

Clinical Evidence

Bench testing only.

Technological Characteristics

Non-metal, disposable vaginal speculum. Manual operation. Single-use design.

Indications for Use

Indicated for general vaginal procedures requiring visualization of the interior of the vagina.

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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K030693

## KENTRON HEALTH CARE, INC

3604 KELTON JACKSON ROAD P.O. BOX 120 SPRINGFIELD, TN 37172

Email: [e-mail] Phone: [phone] Fax: [phone]

> Premarket Notification 510K Summary of Safety and Effectiveness KENTEX Disposable Vaginal Speculum

Company Information: KENTRON HEALTH CARE, INC 3604 KELTON JACKSON ROAD SPRINGFIELD, TN 37172

CONTACT: NARI SADARANGANI, MD

SUMMARY PREPARATION DATE: MARCH 4, 2003

DEVICE INFORMATION:

| TRADE NAME: | KENTEX DISPOSABLE<br>VAGINAL SPECULUM |
|-------------|---------------------------------------|
|-------------|---------------------------------------|

DISPOSABLE VAGINAL COMMON NAME: SPECULUM

NON METAL VAGINAL CLASSIFICATION NAME: SPECULUM

CLASSIFICATION PANEL:

REGULATION NUMBER: 21CFR PART 884.4530

CLASS

OBSTRETICS AND GYNECOLOGY

11

PRODUCT CODE: HIB

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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains an abstract image of an eagle. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES" are written around the top half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 7 2003

Sadarangani, MD, FACC, FCCP President Kentron Health Care, Inc. 3604 Kelton Jackson Road P.O. Box 120 SPRINGFIELD TN 37172

Re: K030693 Trade/Device Name: Kentex Disposable Vaginal Speculum Regulation Number: 21 CFR 884.4530 Regulation Name: Obtsetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: 85 HIB Dated: June 23, 2003 Received: July 30, 2003

Dear Dr. Sadarangani:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA), 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 (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 or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (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 Section 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 the 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" (21CFR Part 807.97) you may obtain. 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 vours.

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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K030693/A'

Page

510(K) NUMBER (IF KNOWN) KO30693 DEVICE NAME: KENTEX VAGINAN SPECULUM DISPOSABLE KENTEX DiSPoSABLE VAGINA CARACTORA CONSULERAL GUARES INDICATIONS FOR USE: INTENDED TO BE USED FOR GENERAL THE UNGINA PROCEDURES. IT is INSERTED INTO THE VAGINA TRUCTOURES THE INTERioR OF THE VAGINA.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use OR Over-The-Counter-Use
(Per 21 CFR 801.109) (Optional Format 1-2-96)

(Division Sign-Off)

Division of Reproductive, Aucional,
and Radiological Devices
510(k) Number K030693

SK 5.4