DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGE

K052314 · Dynarex Corp. · HIB · Nov 9, 2005 · Obstetrics/Gynecology

Device Facts

• Record ID: K052314
• Device Name: DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGE
• Applicant: Dynarex Corp.
• Product Code: HIB · Obstetrics/Gynecology
• Decision Date: Nov 9, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4530
• Device Class: Class 2

Intended Use

The Dynarex Vaginal Specula is used to expose the interior of the vagina.

Device Story

Dynarex Vaginal Specula are hand-held, non-lubricated, injection-molded polystyrene devices; used to expose the interior of the vagina for visualization during gynecological and obstetrical procedures. Operated manually by clinicians via a thumb-adjustable lever mechanism to achieve multi-position opening. Device facilitates clinical examination and diagnostic/therapeutic procedures. Benefits include non-metal construction and simple mechanical adjustment for patient visualization.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Material: Polystyrene. Design: Injection-molded, clear plastic. Operation: Manual, thumb-adjustable lever action. Form factor: Multi-position, hand-held speculum. Sterility: Non-sterile.

Indications for Use

Indicated for use in patients requiring exposure of the vaginal interior to facilitate visualization during gynecological and obstetrical procedures.

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

• Dukal Vaginal Speculum (K020726)

Submission Summary (Full Text)

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NOV - 9 2005

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## 510(K) SUMMARY Dynarex Vaginal Speculum 510(k) #: K052314

| Submitter | Dynarex Corporation<br>10 Glenshaw Street<br>Orangeburg, NY 10962<br>USA |
|---------------------|-------------------------------------------------------------------------------------------------|
| | Phone: [phone]<br>Fax: [phone] |
| Contact Person | James Hurlman |
| Date of Summary | 08-04-2005 |
| Trade Name | Dynarex Vaginal Specula, 4900 Series<br>(Models 4911-Small, 4912 – Medium, and<br>4913 - Large) |
| Common Name | Speculum, Vaginal, Non-Metal |
| Classification Name | Obstetric-Gynecologic Specialized Manual<br>Instrument (21 CFR 884.4530) |
| Predicate Device | Dukal Vaginal Speculum<br>510(k) #: K020726 |

Intended Use

The Dynarex Vaginal Specula is used to expose the interior of the vagina.

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K052314
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### 510(K) SUMMARY Dynarex Vaginal Speculum 510(k) #: K052314

#### Description of Device:

The Dynarex vaginal speculum is a non-metal (polystyrene), non-lubricated, hand held device used to expose the interior of the vagina to facilitate visualization during gynecological and obstetrical procedures.

#### Technical Characteristics:

The Dynarex vaginal speculum has the same technological characteristics as, and is substantially equivalent to, the Dukal Vaginal Speculum, 510(k) #: K020726.

| Table of Comparisons | | |
|----------------------|-----------------------------------------------------------|-----------------------------------------------------------|
| Characteristic | Dynarex Vaginal Speculum | Dukal Vaginal Speculum |
| Indications for Use | This device is used to expose the interior of the vagina. | This device is used to expose the interior of the vagina. |
| Design | Injection Molded, clear plastic. | Injection Molded, clear plastic. |
| Materials | Polystyrene | Polystyrene |
| Performance | Hand operated, multi-position | Substantially Equivalent |
| Sterility | Non-Sterile | Non-Sterile |
| Mechanical Safety | Simple thumb adjustable lever action. | Substantially Equivalent |
| Lubrication | Non-Lubricated | Non-Lubricated |
| Packaging | Bulk Pack 10/Plastic Bag, and Individually wrapped. | Bulk Pack 10/Plastic Bag, and Individually wrapped. |

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Image /page/2/Picture/2 description: The image shows a circular logo with text around the perimeter and a stylized bird in the center. The text around the perimeter appears to be the name of a government department or agency. The bird in the center is depicted with three curved lines representing its wings and body, giving it a sense of motion or flight. The logo has a simple, clean design, using only black and white.

NOV - 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. James Hurlman Official Correspondent Dynarex Corporation 10 Glenshaw Street ORANGEBURG NY 10962

Re: K052314

Trade/Device Name: Dynarex Vaginal Specula, 4900 Series (Models 4911 - Small, 4912 - Medium and 4913 - Large Regulation Number: 21 CFR §884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: HIB Dated: October 10, 2005 Received: October 12, 2005

Dear Mr. Hurlman:

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 (Premarket Approval), it may be subject to such 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 this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.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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K052314

# Indications for Use

510(k) Number (if known): K052314

Dynarex Vaginal Specula, 4900 Series (Models 4911-Small, 4912 – Medium, Device Name: and 4913 - Large)

Indications For Use: This device is used to expose the interior of the vagina.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy Brogdon
(Division Sign-Off)

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K052314

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