TRANSVAGINAL ULTRASOUND PROBE HOLDER SYSTEM

K032585 · Ron-Tech Medical , Ltd. · HDC · Jan 9, 2004 · Obstetrics/Gynecology

Device Facts

• Record ID: K032585
• Device Name: TRANSVAGINAL ULTRASOUND PROBE HOLDER SYSTEM
• Applicant: Ron-Tech Medical , Ltd.
• Product Code: HDC · Obstetrics/Gynecology
• Decision Date: Jan 9, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.4530
• Device Class: Class 2

Intended Use

The SafeTChoice™ Transvaginal Ultrasound Probe Holder System is an accessory intended for use in conjunction with a transvaginal ultrasound transducer. The SafeTChoice™ Transvaginal Ultrasound Probe Holder System is intended to seize and hold the cervix and to hold and secure an ultrasound transducer in place, while performing sonographic procedures.

Device Story

System acts as mechanical accessory for transvaginal ultrasound transducers; consists of reusable uterine tenaculum with adaptor bar, sterile disposable adaptor, and disposable probe connector. Device secures transducer to tenaculum, allowing physician to manipulate ultrasound probe with one hand while performing procedure. Used in clinical settings by physicians during sonographic procedures. Benefits include improved procedural efficiency and ease of use by freeing one hand for clinical tasks.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical accessory system; includes reusable uterine tenaculum, disposable adaptor, and disposable probe connector. No electronic components, software, or energy sources.

Indications for Use

Indicated for use as an accessory to a transvaginal ultrasound transducer to seize and hold the cervix and secure the transducer in place during sonographic 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)

Submission Summary (Full Text)

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KD32585 p. 1 of 2

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9 2004 JAN

### 510(k) Summary:

SafeTChoice™ Transvaginal Ultrasound Probe Holder System

Date submitted: August 15, 2003

Company Name:

Ron-Tech Medical Ltd.

Contact Person: Doron Kilchevsky CEO

> Telephone: [phone] Fax: [phone]

Trade Name: SafeTChoice™ Transvaginal Ultrasound Probe Holder System

Classification name: Accessory to an ultrasound transducer

Classification: HDC/ITX

### Predicate Device:

Transvaginal Ultrasound Probe Holder device, Ron-Tech Medical Ltd. Israel, cleared under 510(k) no. K992071

### Description of the device:

The Safe TChoice™ Transvaginal Ultrasound Probe Holder System is an accessory used in conjunction with a transvaginal ultrasound transducer. The device is intended to hold and secure the ultrasound transducer in place on a uterine tenaculum, while performing the sonographic procedure. The configuration of the device allows the physician to manipulate the ultrasound transducer with one hand, thus freeing the other hand to perform the required procedure.

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K032585 p. 2 of 2

Image /page/1/Picture/1 description: The image shows the logo for Ron-Tech Medical LTD. The words "Ron-Tech" are in large, bold, black font, with a curved line above them. Below that, the word "Medical" is in a smaller font, and to the right of that, the letters "LTD" are stacked vertically in a very small font.

The SafeTChoice™ Transvaginal Ultrasound Probe Holder System consists of a reusable uterine tenaculum with an adaptor bar, a sterile, disposable adaptor and a disposable probe connector.

#### Indications for Use:

The Safe TChoice™ Transvaginal Ultrasound Probe Holder System is an accessory intended for use in conjunction with a transvaginal ultrasound transducer. The SafeTChoice™ Transvaginal Ultrasound Probe Holder System is intended to seize and hold the cervix and to hold and secure an ultrasound transducer in place, while performing sonographic procedures.

#### Substantial Equivalence:

The SafeTChoice™ Transvaginal Ultrasound Probe Holder System has the same intended use and the same principle of operation as the Transvaginal Ultrasound Probe Holder device, cleared under 510(k) no. K9992071.

#### Conclusion: **

The evaluation of the Safe TChoice™ Transvaginal Ultrasound Probe Holder System does not raise any additional concerns regarding safety and effectivity and may therefore be considered substantially equivalent to the predicate device.

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Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circle's perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

#### 9 2004 JAN

Ms. Doron Kilchevsky CEO Ron-Tech Medical, Ltd. 26 Hasivim St. Kiryat Matalon Petach-Tikva 49170 ISRAEL

K032585 Re:

Trade/Device Name: Transvaginal Ultrasound Probe Holder System Regulation Number: 21 CFR 884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Product Code: 85 HDC Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Product Code: 90 ITX Regulatory Class: II Dated: November 26, 2003 Received: December 12, 2003

Dear Ms. Kilchevsky:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have teviewed your becamed the device is substantially equivalent (for the indications felerenced above and navo uctemined ly marketed predicate devices marketed in interstate for use stated in the electore) to regard to tegars and the Medical Device Amendments, or to commerce prior to may 20, 1978, its ecordance with the provisions of the Federal Food, Ung, devices that nave occh reclassified in assess approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, dicierore, market are as act include requirements for annual registration, listing of general controls provisions 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), II your device is classified (500 acres) and secure) and or regulations affecting your device can be it may be subject to additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that I·DA'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 that I DA has made a determed by other Federal agencies. You must of any I cicrar studies and rogains.
comply with all the Act's requirements, including, but not limited to: registration and listing comply with an the recessfort (21 CFR Part 801); good manufacturing practice requirements as sct (21 CFR Part 807), labornig (21 OFF Part 820); and if applicable, the electronic forul in the quality 375tems (QD) res (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) I this letter will and in you ve organ finding of substantial equivalence of your device to a legally premairted predicated ... - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you dosite spoolite Dompliance 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 Additionally, 10 questions of [phone]. Also, please note the regulation entitled, "Misbranding Other or Complanes as ( . ) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . by recented to promative is not 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. 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

| 510(k) Number (if known): | K032585 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | SafeTChoice™ Transvaginal Ultrasound Probe Holder System |
| Indications for Use: | The SafeTChoice™ Transvaginal Ultrasound Probe Holder System is an accessory intended for use in conjunction with a transvaginal ultrasound transducer. The SafeTChoice™ Transvaginal Ultrasound Probe Holder System is intended to seize and hold the cervix and to hold and secure an ultrasound transducer in place, while performing sonographic procedures. |

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

Concurrence of CDRH, Office of Device Evaluation (ODE):

L Prescription Use (Per 21 CFR 801.109) Over the Counter Use_

Nancy C Snogdon
(Division Sign-Off)
11-2

Division of Reproductive, Abdominal, and Radiological Devices

OR

Radiological Devices
510(k) Number K032585