VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555L

K022948 · Medical Action Industries, Inc. · HIB · Nov 4, 2002 · Obstetrics/Gynecology

Device Facts

• Record ID: K022948
• Device Name: VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555L
• Applicant: Medical Action Industries, Inc.
• Product Code: HIB · Obstetrics/Gynecology
• Decision Date: Nov 4, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4530
• Device Class: Class 2

Intended Use

To be used by medical professionals to expose the interior of the vagina to facilitate visualization during gynecological and obstetrical procedures.

Device Story

The MAI vaginal speculum is a non-metal, hand-held device constructed from polystyrene. It is designed for single-use by medical professionals in clinical settings to expose the interior of the vagina, facilitating visualization during gynecological and obstetrical procedures. The device functions as a manual instrument to maintain vaginal opening, allowing the clinician to perform examinations or procedures. It provides a disposable alternative to reusable metal speculums, reducing the risk of cross-contamination.

Clinical Evidence

Bench testing only.

Technological Characteristics

Non-metal, polystyrene construction. Manual, hand-held form factor. Single-use. No energy source or software components.

Indications for Use

Indicated for use by medical professionals to expose the interior of the vagina for visualization during gynecological and obstetrical procedures. Single-use device.

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

• Leespec Disposable Vaginal Speculum (K021017)

Submission Summary (Full Text)

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| Section Seven: 510(k) Summary for Vaginal Speculums | | | | | |
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| Submitted by: | Medical Action Industries, Inc. (MAI)<br>25 Heywood Road<br>Arden, North Carolina 28704<br>Telephone: [phone] |
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| Contact Person: | Mr. Dennis Kanupp |
| Date Prepared: | September 4, 2002 |
| Proprietary Name: | Not Applicable |
| Common Name: | Disposable vaginal speculum |
| Classification Name: | Speculum, Vaginal, Non-metal |
| Predicate Device: | Leespec Disposable Vaginal Speculum |

Description of Device: The MAI 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 medical professionals to expose the interior of the vagina to facilitate visualization during gynecological and obstetrical procedures.

Technical Characteristics: The MAI vaqinal speculum has the same technological characteristics as and is substantially equivalent to the Leespec Disposable Vaginal Speculum (K021017), manufactured by ITL Corporation.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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## Public Health Service

NOV 4 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medical Action Industries, Inc. % Ms. Sharon Suess Graham Consultant Ryan Dietrich Engineering 2 Summit Drive ARDEN NC 28704

Re: K022948

Trade/Device Name: Vaginal Speculum Regulation Number: 21 CFR 884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: 85 HIB Dated: September 4, 2002

Received: September 5, 2002

Dear Ms. Graham:

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, Drue, 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/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Snigdon

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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Medical Action Industries, Inc · Vaginal Speculum 510(k) submission

vaginal speculum 510(k) submission

# Section Six: Indications for Use Statement

510(k) Number: K 022948

Device Name: Vaginal Speculum

Indications for Use: Vaginal Speculums are single use and shall be used to expose 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 _ V (Per 21 CFR 801.109)

OR

Over-The Counter Use _

David A. Wagner
(Division Sign-Off)

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