JARIT HULKA UTERINE TENACULUM FORCEPS

K082349 · J. Jamner Surgical Instruments, Inc. · HDC · Nov 21, 2008 · Obstetrics/Gynecology

Device Facts

• Record ID: K082349
• Device Name: JARIT HULKA UTERINE TENACULUM FORCEPS
• Applicant: J. Jamner Surgical Instruments, Inc.
• Product Code: HDC · Obstetrics/Gynecology
• Decision Date: Nov 21, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4530
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

JARIT® Hulka Uterine Tenaculum Forceps are indicated to stabilize the cervix and manipulate the uterine fundus under direct pelviscopic visualization in women whose uteri are anteverted or retroverted.

Device Story

JARIT Hulka Uterine Tenaculum Forceps are 11-inch stainless steel, ring-handled manual surgical instruments featuring a ratchet closure. Distal end includes a single-tooth hook on one arm and a 3.6 mm diameter uterine sound probe on the other. Used by physicians in clinical or surgical settings to stabilize the cervix and manipulate the uterine fundus under direct pelviscopic visualization. Device is reusable and sterilizable.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Stainless steel construction; manual ring-handled instrument with ratchet closure; 11-inch length; 3.6 mm diameter uterine sound probe; reusable; sterilizable.

Indications for Use

Indicated for women with anteverted or retroverted uteri requiring cervical stabilization and uterine fundus manipulation during pelviscopic 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

• JARIT Braun Uterine Tenaculum Forceps (Preamendment)
• Hulka Tenaculum (Pilling Weck Surgical) (Preamendment)

Submission Summary (Full Text)

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KOr2345

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# NOV 21 2008

## 510(k) Summary

| Submitted by: | J. Jamner Surgical Instruments, Inc.<br>9 Skyline Drive<br>Hawthorne, NY 10532 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jennifer Bosley, Regulatory Affairs Manager<br>Integra Medical Instrument Group<br>C/o Miltex, Inc.<br>589 Davies Drive, York, PA 17402 USA<br>Phone: [phone]<br>Fax: [phone] |
| Date Prepared: | October 2, 2008 |
| 510(k) Number: | K082349 |
| Device Trade Name: | JARIT® Hulka Uterine Tenaculum Forceps |
| Common/Usual Name: | Uterine Tenaculum |
| Proposed Classification: | Obstetric-gynecologic specialized manual instrument<br>21CFR§884.4530(a)(15) Class II, 85HDC |

## Device Description:

JARIT Hulka Uterine Tenaculum Forceps are an 11-inch long stainless steel, ring-handled instrument with ratchet closure having a single-tooth hook at the distal end of one arm and a 3.6 mm diameter uterine sound probe at the distal end of the other arm. The device is reusable, sterilizable and packaged non-sterile.

## Indications for Use:

JARIT Huika Uterine Tenaculum Forceps are indicated to stabilize the cervix and manipulate the uterine fundus under direct pelviscopic visualization in women whose uteri are anteverted or retroverted.

## Predicate Devices:

| 510(k) # | Device | Manufacturer |
|--------------|---------------------------------------|--------------------------------|
| Preamendment | JARIT Braun Uterine Tenaculum Forceps | J. Jamner Surgical Instruments |
| Preamendment | Hulka Tenaculum | Pilling Weck Surgical |

## Substantial Equivalence:

The JARIT Hulka Uterine Tenaculum Forceps are substantially equivalent to the legally marketed predicate devices. The devices have the same intended use, design, materials and processing.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with three lines above them that may represent wings or feathers.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## NOV 2 1 2008

Ms. Jennifer Bosley Regulatory Affairs Manager Integra Medical Instrument Group - Miltex J. Jamner Surgical Instruments, Inc. 9 Skyline Drive HAWTHORNE NY 10532

K082349 Re:

> Trade/Device Name: JARIT® Hulka Uterine Tenaculum Forceps Regulation Number: 21 CFR §884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: HDC Dated: October 2, 2008 Received: October 3, 2008

Dear Ms. Boslev:

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, l'isting 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 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.

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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 agencics. 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 dcsire 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). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (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/odrh/industry/support/index.html.

Sincerely yours.

Jorgu M. Whang

Joyce M. Whang, Ph.D. Acting 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: K082349

Device Name: JARIT® Hulka Uterine Tenaculum Forceps

## Indications for Use:

JARIT® Hulka Uterine Tenaculum Forceps are indicated to stabilize the cervix and manipulate the uterine fundus under direct pelviscopic visualization in women whose uteri are anteverted or retroverted.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter-Use (Part 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)

Division Sign-Off)
Division of Reproductive, Abdominal,

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K082349

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