DEPALT VAGINAL SPECUIM AND DEPALT LIGHTING SYSTEM

K072762 · Depalt, Inc. · HIB · Jan 22, 2008 · Obstetrics/Gynecology

Device Facts

• Record ID: K072762
• Device Name: DEPALT VAGINAL SPECUIM AND DEPALT LIGHTING SYSTEM
• Applicant: Depalt, Inc.
• Product Code: HIB · Obstetrics/Gynecology
• Decision Date: Jan 22, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4530
• Device Class: Class 2

Intended Use

Depalt Vaginal Speculum is used for the purposes of visualization and exposure of the interior of the vagina by a medical professional during gynecological and obstetrical procedures/examinations. Depalt Lighting System provides the light necessary to illuminate the field during procedures/examinations.

Device Story

Depalt Vaginal Speculum is a nonmetal, single-use disposable device designed to expose the interior of the vagina. It is used in conjunction with the Depalt Lighting System, which provides illumination for the examination field. The device is intended for use by medical professionals in clinical settings during gynecological and obstetrical procedures. By providing physical exposure and illumination, the device assists the clinician in visualizing the vaginal anatomy, thereby facilitating diagnostic or therapeutic procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Constructed of Polystyrene. Nonmetal, single-use, disposable design. Manual operation. Lighting system provides illumination for the examination field.

Indications for Use

Indicated for use by medical professionals for visualization and exposure of the vaginal interior during gynecological and obstetrical procedures and examinations.

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 Single Use Vaginal Speculum and 790 series Cordless Illumination System (K070964)
• Dynarex Vaginal Speculum (K052314)

Reference Devices

• Bionix Reddy Lite

Submission Summary (Full Text)

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K072762

Depalt Inc.

01/15/2008

Premarket 510 (k) Notification------------------------------------------------------------------------------------------------------------------------------------------------Depalt Vaginal Speculum and Depalt Lighting System

## 510(k) Summary

| Submitted by: | Depalt Inc.<br>5013 Stonewick Court<br>Plano, Tx 75093 | JAN 22 2008 |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | Rajeev Patel MD FACEP<br>Chairman/CEO | |
| Date Prepared: | September 20, 2007 | |
| Proprietary Name: | Depalt Vaginal Speculum 2000. Series and Depalt Lighting System | |
| Common Name: | Speculum, Vaginal, Nonmetal | |
| Predicate Device: | Kleenspec Single Use Vaginal Speculum and 790 series Cordless<br>Illumination System by Welch Allyn, Inc. K070964 (510k number) | |
| | Dynarex Vaginal Speculum by Dynarex Corporation<br>K052314 (510k number) | |
| | Bionix Reddy Lite listed with FDA on 12/30/1996.<br>Device Class 1. Product Code: KYT | |
| Description: | Depalt Vaginal Speculum is a nonmetal, single use (disposable)<br>medical device used to expose the interior of the vagina. The<br>vaginal speculum may be used with or without the Depalt Lighting<br>System. <p>Depalt Lighting System provides the light necessary to illuminate during procedures and examinations.</p> | |
| Intended Use: | Depalt Vaginal Speculum is used for the purposes of visualization and exposure of the interior of the vagina by a medical professional during gynecological and obstetrical procedures/examinations. <p>Depalt Lighting System provides the light necessary to illuminate the field during procedures/examinations.</p> | |
| Material Used: | The Depalt Vaginal Speculum is constructed of Polystyrene. | |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular fashion around the symbol. The caduceus is composed of three curved lines that resemble a stylized representation of the snakes and staff. The text is in all caps and is evenly spaced around the circle.

JAN 22 2008

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Mr. Rajeev J. Patel Chairman/CEO Depalt, Inc. 5013 Stonewick Court PLANO TX 75093

Re: K072762

Trade/Device Name: Depalt Vaginal Speculum and Depalt Lighting System Regulation Number: 21 CFR 884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: HIB Dated: December 10, 2007 Received: December 14, 2007

## Dear Mr. Patel:

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.

Image /page/1/Picture/10 description: The image is a circular logo commemorating the centennial of the FDA from 1906-2006. The letters FDA are in the center of the logo in a stylized font. The word "Centennial" is written in cursive below the letters FDA.

Protecting and Promoting Public Health.

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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 Center for Devices and Radiological Health's (CDRH's) 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrb/industry/support/index.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

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Premarket 510 (k) Notification—Revised Version Depalt Vaginal Speculum and Depalt Lighting System 510(k) # K072762 Depalt Inc. 01/15/2008

## Indication for Use

| 510(k) Number (if known): | K072762 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Depalt Vaginal Speculum and Depalt Lighting System |
| Indication For Use: | Depalt Vaginal Speculum is used for the purposes of<br>visualization and exposure of the interior of the vagina by a<br>medical professional during gynecological and obstetrical<br>procedures/examinations.<br><br>Depalt Lighting System provides the light necessary to<br>illuminate the field during procedures/examinations. |

Prescription Use _ X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use _ (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Helmut

(Division Sign-Off)

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number
6132163