HIERSPEC SPECULUM

K061339 · Medical Products Div. · HIB · Sep 19, 2006 · Obstetrics/Gynecology

Device Facts

• Record ID: K061339
• Device Name: HIERSPEC SPECULUM
• Applicant: Medical Products Div.
• Product Code: HIB · Obstetrics/Gynecology
• Decision Date: Sep 19, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4530
• Device Class: Class 2

Indications for Use

The Hier-Spec vaginal speculum is a non-metal (Acrylic and Polycarbonate), hand held device used to open the vagina and provide access to the cervix for gynecological or obstetrical examinations and procedures.

Device Story

HierSpec Speculum is a non-metal, hand-held, single-use disposable device; constructed from acrylic and polycarbonate. Used in professional medical facilities or clinical examination rooms by healthcare providers. Device inserted into vaginal canal in closed position; handles squeezed to rotate bow arms into horizontal position, opening vaginal canal for cervical access. Self-locks in open position. Compatible with standard gynecological instruments (spatulas, brushes, forceps, swabs). Provides mechanical access to cervix for examinations/procedures; benefits patient by facilitating clinical assessment.

Clinical Evidence

No clinical data. Substantial equivalence is based on design, material, and mechanical performance testing.

Technological Characteristics

Materials: Acrylic (PERSPEX CP-82-F) and Polycarbonate (Lexan 144R). Manual, hand-held, non-metal, disposable speculum. Mechanical operation: squeeze-handle mechanism with connecting rail to rotate bow arms. No energy source. Not sterile.

Indications for Use

Indicated for use in female patients requiring gynecological or obstetrical examinations and procedures to open the vaginal canal and provide access to the cervix.

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

• Kleenspec (K941272)

Submission Summary (Full Text)

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p.1012 K061339

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# 510(k) Summary of Safety and Effectiveness

Date Summary Prepared: 05/05/06

## SEP 1 9 2006

| Applicant: | Medical Products Division<br>A Division of Specialty Manufacturers, Inc.<br>2410 Executive Drive<br>Indianapolis, IN 46241 |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Phone: | [phone] |
| Fax: | [phone] |
| Establishment Registration Number: | Medical Products Division will submit FDA forms 2891 and 2892 following 510(k) clearance. |
| Contact: | Thomas W. Copeland |
| Phone: | [phone] |
| Fax: | [phone] |
| Prepared by: | Thomas Copeland, President<br>Medical Products Division<br>2410 Executive Drive<br>Indianapolis, IN 46241 |
| Phone: | [phone] |
| Fax: | [phone] |
| Device Information<br>Proprietary Name: | HierSpec Speculum |
| Common/Usual Name: | Disposable Vaginal Speculum |
| Classification Name: | Speculum, Vaginal, Nonmetal |
| Device Classification: | Class 2 |
| Regulation Number: | 21 CFR § 884.4530 |
| Product Code: | HIB |
| Predicate Device<br>Device Name: | Kleenspec |
| Manufacturer: | Welch Allyn |
| 510(k) Number | K941272 |
| Indications For Use | The Hier-Spec vaginal speculum is a non-metal (Acrylic and Polycarbonate), hand held device used to open the vagina and provide access to the cervix for gynecological or obstetrical examinations and procedures.<br>8-2 |

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K061339 p. 2 of 2

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### SUBSTANTIAL EQUIVALENCE COMPARISON

| CHARACTERISTIC | HierSpec Speculum | WelchAllyn Kleenspec®<br>Disposable Vaginal<br>Speculum |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Intended Use and<br>Indications for Use | The Hier-Spec vaginal speculum is a non-<br>metal (Acrylic and Polycarbonate), hand held<br>device used to open the vagina and provide<br>access to the cervix for gynecological or<br>obstetrical examinations and procedures. | Same |
| Design | When the device is in the closed position, for<br>insertion into the vagina, the bow arms are in<br>a horizontal position and the handles are open<br>to approximately 45 degrees. After the device<br>is inserted into the vagina, the handles are<br>squeezed together and the connecting rail<br>rotates the bow arms into a horizontal position<br>to open the vaginal canal. | Duck Bill Design |
| Materials of | Acrylic, Clear, PERSPEX CP- 82-F | Acrylic, Clear, PERSPEX |
| Construction | and GE Polycarbonate, Lexan 144R | CP- 82-F |
| Sterility | Not Sterile | Not Sterile |
| Biocompatibility | See Section 5, Page 5.1 and<br>Welch Allyn Technical Information Bulletin<br>580092A page 5.2 | Same |
| Mechanical Safety | Able to withstand the forces required for<br>proper insertion, (with or without lubrication)<br>and the compressive force exerted by normal<br>female vaginal contractions. | Same |
| Anatomical Sites | Vaginal canal. | Same |
| Human Factors | Single handed use. Self-locks in open<br>position. | Same |
| Compatibility with the<br>environment | Disposable | Same |
| Compatibility with other<br>devices | Compatible with various spatula, Cyto<br>brushes, packing forceps, sound and<br>tenaculum, Tischler Bioposy forceps,<br>scrapers, swabs, and probes. | Same |
| Where used | Professional medical facilities or office /<br>clinical examination rooms | Professional medical<br>facilities or office / clinical<br>examination rooms |
| Performance Standards | None | Same |
| Hand held and manually<br>operated | Yes | Yes |
| Single Use | Yes | Yes |

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

SEP 1 9 2006

Mr. Thomas W. Copeland Division President Specialty Manufacturers, Inc. 2410 Executive Drive INDIANAPOLIS IN 46241

Re: K061339

Trade/Device Name: HierSpec Vaginal Speculum Regulation Number: 21 CFR §884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: HIB Dated: August 28, 2006 Received: August 31, 2006

Dear Mr. Copeland:

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 cither 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.

Image /page/2/Picture/10 description: The image shows a logo for the FDA Centennial 1906-2006. The logo is circular and contains the letters FDA in the center. Below the logo, the word "Centennial" is written. Below that, there are three stars. Below the stars, the words "Protecting and Promoting Public Health" are written in a decorative font.

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Page 2 -

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.

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.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

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 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/cdrl/industry/support/index.html.

Sincerely yours,

Nancy Chogdon

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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#### Statement of Indications for Use 2.

510(k) Number: K061339

Device Name: HierSpec Speculum

#### INTENDED USE AND INDICATIONS FOR USE

The Hier-Spec vaginal speculum is a non-metal (Acrylic and Polycarbonate), hand held device The Her Upec raginal spand provide access to the cervix for gynecological or obstetrical examinations and procedures.

Carolyn P. Newland for N.C. Brogdon

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.