LEESPEC DISPOSABLE VAGINAL SPECULUM

K021017 · Itl Corporation Pty, Ltd. · HIB · Jun 19, 2002 · Obstetrics/Gynecology

Device Facts

• Record ID: K021017
• Device Name: LEESPEC DISPOSABLE VAGINAL SPECULUM
• Applicant: Itl Corporation Pty, Ltd.
• Product Code: HIB · Obstetrics/Gynecology
• Decision Date: Jun 19, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4530
• Device Class: Class 2

Intended Use

To be used by a medical professional to expose the interior of the vagina to facilitate visualization during gynecological or obstetrical procedures. For single use only.

Device Story

LeeSpec™ Disposable Vaginal Speculum is a non-metal, hand-held instrument constructed from high-impact polystyrene. Designed for single-use, it features dual biparting blades to expose the vaginal interior for visualization during gynecological or obstetrical procedures. The device is manually operated by a medical professional; it includes a locking and unlocking mechanism adjustable with one hand. By providing a clear view of the vaginal canal, the speculum assists clinicians in performing examinations and procedures. The device is intended for clinical settings.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

High-impact polystyrene construction; dual biparting blades; manual operation; one-handed locking/unlocking mechanism; single-use; non-sterile (implied by disposable nature).

Indications for Use

Indicated for use by medical professionals to expose the vaginal interior for visualization during gynecological or obstetrical procedures. No specific patient population or contraindications defined.

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.

Predicate Devices

• Medisul Disposable Vaginal Speculum (K000414)

Submission Summary (Full Text)

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KO21017

ITL Corporation 03/21/02

## JUN 1 9 2002

## 14 510k Summary

ITL Corporation Submitted by: P.O. Box 139 41-45 Tennant Street Fyshwick ACT 2609 Canberra, Australia

Contact Person: William L. Mobbs, BSc, MBA Director

Date Prepared: March 21, 2002

Proprietary Name: LeeSpec™ Disposable Vaginal Speculum

Common Name: Disposable Vaginal Speculum

Classification Name: Speculum, vaginal, disposable

Predicate Device: Medisul Disposable Vaginal Speculum (K000414)

Description of the Device: The LeeSpec™ Disposable Vaginal Speculum is a non-metal (polystyrene), hand held device used to expose the interior of the vagina.

Intended Use of the Device: To be used by a medical professional to expose the interior of the vagina to facilitate visualization during gynecological or obstetrical procedures. For single use only.

Technical Characteristics: The LeeSpec™ Disposable Vaginal Speculum is made of high impact polystyrene with dual biparting blades. It is manually operated and has a locking (open) and unlocking (release) features, which can be adjusted with one hand. The LeeSpec™ Disposable Vaginal Speculum has the same technological characteristics as and is substantially equivalent to the Medisul disposable Vaginal Speculum (K000414), as shown in the following table:

| Feature | ITL LeeSpec™ Disposable Vaginal Speculum | Medisul Disposable Vaginal Speculum (K000414) |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Instrument used by a medical professional to expose the interior of the vagina for gynecological or obstetrical procedures. | Instrument used by a medical professional to expose the interior of the vagina for gynecological or obstetrical procedures. |
| Materials of construction | Polystyrene | Polystyrene |
| Hand held and manually operated? | Yes | Yes |
| Design | Dual, biparting blades | Dual, biparting blades |
| Single use? | Yes | Yes |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

·

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 9 2002

Received: March 29, 2002

Mr. William L. Mobbs Director ITL Corporation 41-45 Tennant Street, Fyshwick Canberra, ACT 2609 AUSTRALIA

Re: K021017 Trade/Device Name: LeeSpec™ Disposable Vaginal Speculum Regulation Number: 21 CFR 884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: 85 HIB Dated: March 25, 2002

Dear Mr. Mobbs:

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 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/dsmaldsmamain.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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Premarket 510k Notification LeeSpecTM Disposable Vaginal Speculum

Exhibit L ITL Corporation

Page of

510k Number: _ Kのマノロ/ス

Device Name: LeeSpec™ Disposable Vaginal Speculum

Indications For Use:

The LeeSpec™ Disposable Vaginal Speculum is intended to be used by a medical professional to expose the interior of the vagina to facilitate visualization during gynecological or obstetrical procedures.

*Prescription Use*

David A. Syverson