BURBANK TENACULUM, MODEL 09-0011-01

K030078 · Vascular Control Systems, Inc. · HDC · Jan 24, 2003 · Obstetrics/Gynecology

Device Facts

• Record ID: K030078
• Device Name: BURBANK TENACULUM, MODEL 09-0011-01
• Applicant: Vascular Control Systems, Inc.
• Product Code: HDC · Obstetrics/Gynecology
• Decision Date: Jan 24, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4530
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Burbank Tenaculum is an accessory used in conjunction with the Vascular Control Systems Transvaginal Doppler Probe. The device is intended to seize and hold the cervix and secure the Transvaginal Doppler Probe in place, while performing audible Doppler procedures.

Device Story

Stainless steel, ring-handled instrument; features distal hook for cervical grasping and guide rod for securing Vascular Control Systems Transvaginal Doppler Probe (TDP). Includes integrated uterine sound at distal end of guide rod for insertion through cervical opening into uterine cavity. Used by clinicians in clinical settings to stabilize ultrasound probe during Doppler procedures; facilitates probe positioning; improves procedural efficiency. Non-sterile, reusable device.

Clinical Evidence

Bench testing only. Device tested per design control procedures; met all product specifications.

Technological Characteristics

Stainless steel construction; ring-handled manual instrument with ratchet closure; includes hook and guide rod for probe stabilization; integrated uterine sound. Reusable, non-sterile. No energy source. Mechanical operation.

Indications for Use

Indicated for use by clinicians to seize and hold the cervix and secure a Transvaginal Doppler Probe during audible Doppler 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

• Transvaginal Ultrasound Probe Holder Device (K992071)
• Sims Uterine Sound (510(k) Exempt)

Submission Summary (Full Text)

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### SUMMARY OF SAFETY AND EFFECTIVENESS JAN 2 4 2003

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the SMDA and 21 CFR 807.92.

- 1. Submitter's name, address, telephone number, contact person, and date summary prepared:

| a. | Submitter: | Vascular Control Systems, Inc.<br>32236-E Paseo Adelanto<br>San Juan Capistrano, CA 92675<br>[phone] |
|----|------------------------|-------------------------------------------------------------------------------------------------------------|
| b. | Contact Person: | Al Memmolo<br>Vice President, Regulatory Affairs/Quality Assurance<br>[phone] ext. 108 |
| c. | Date Summary Prepared: | December 12, 2002 |

2. Name of device, including trade name and classification name:

| a. | Trade/Proprietary Name: | Burbank Tenaculum |
|----|-------------------------|--------------------------------------|
| b. | Classification name: | Uterine Tenaculum (21 CFR §884.4530) |

## 3. Identification of the predicate device or legally marketed device or devices to which substantial equivalence is being claimed:

| A. Company: | Ron-Tech Medical Ltd.. |
|---------------|---------------------------------------------|
| Device: | Transvaginal Ultrasound Probe Holder Device |
| 510(k): | K992071 |
| Date Cleared: | August 27, 1999 |
| B. Company: | Gilbert Surgical Instruments |

| Company: | Gilbert Surgical Instruments |
|----------|--------------------------------------------------------------------|
| Device: | Sims Uterine Sound |
| 510(k): | N/A (The Uterine Sound is a Class I device which is 510(k) Exempt) |

- A description of the device that is the subject of the 510(k), including explanation of 4. how the device functions, basic scientific concepts, significant physical and performance characteristics (design, material, physical properties):
The Burbank Tenaculum is a stainless steel, ring-handled instrument with a hook at the distal end of one arm and a guide rod attached to the distal end of the other arm. The proximal end of the guide rod is threaded to guide insertion of the Vascular Control Systems Transvaginal Doppler Probe (TDP) into the vagina and secure the TDP in place.

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A uterine sound is brazed at the distal end of the guide rod intended to be inserted through the cervical opening into the uterine cavity.

#### ડ. Statement of intended use:

The Burbank Tenaculum is an accessory used in conjunction with the Vascular Control Systems Transvaginal Doppler Probe. The device is intended to seize and hold the cervix and secure the Transvaginal Doppler Probe in place, while performing audible Doppler procedures.

### Statement of how the technological characteristics of the device compare to those of ર્. the predicate or legally marketed device.

Like the predicate Transvaginal Ultrasound Probe Holder Device, the Burbank Tenaculum is a ring-handled device with ratchet closure for seizing and holding the cervix. Also like the Transvaginal Ultrasound Probe Holder Device, the Burbank Tenaculum is designed with a hook for seizing and holding the cervix and is equipped with a mechanism to hold an ultrasound device. The Burbank Tenaculum also has a uterine sound which is substantially equivalent in design and materials as the Sims Uterine Sound. The materials used in the Burbank Tenaculum are similar to those of the predicate devices and are provided non-sterile, and reusable.

#### 7. Brief summary of nonclinical tests and results:

The Burbank Tenaculum has been designed and tested per design control procedures and was found to meet its product specifications. The Burbank Tenaculum does not raise new issues of safety, effectiveness, or performance of the product.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

JAN 2 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Vascular Control Systems, Inc. % Mr. Heinz Joerg Steneberg TÜV Rheinland of North America 12 Commerce Road NEWTON CT 06470

## Re: K030078

Trade/Device Name: Burbank Tenaculum and Transvaginal Ultrasound Probe Holder Regulation Number: 21 CFR 884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 85 HDC Product Code: 90 ITX Dated: January 6, 2003 Received: January 9, 2003

Dear Mr. Steneberg:

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 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 the 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" (21CFR Part 807.97) you may obtain. 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 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

Enclosure

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# Indications for Use Statement

510(k) Number (if known): K030078

Page 1 of 1

Device Name:

Burbank Tenaculum

Indications for Use:

The Burbank Tenaculum is an accessory used in conjunction with the Vascular Control Systems Transvaginal Doppler Probe. The device is intended to seize and hold the cervix and to hold and secure the Transvaginal Doppler Probe in place, while performing audible Doppler procedures.

(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)

Over-The-Counter-Use

David A. Symm

OR

020078 510(k) Nur