GYNEX IRIS HOOK, GYNEX ANGLE HOOK, GYNEX EMMETT TENACULUM

K980247 · Gynex Corp. · HDC · Mar 17, 1998 · Obstetrics/Gynecology

Device Facts

• Record ID: K980247
• Device Name: GYNEX IRIS HOOK, GYNEX ANGLE HOOK, GYNEX EMMETT TENACULUM
• Applicant: Gynex Corp.
• Product Code: HDC · Obstetrics/Gynecology
• Decision Date: Mar 17, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4530
• Device Class: Class 2

Intended Use

GYNEX Tenaculum Grasp/manipulate the cervix & soft tissue GYNEX Iris Hook Grasp/manipulate cervical tissue GYNEX Angle Hook Grasp/manipulate cervical tissue

Device Story

Manual surgical instruments; slender tapered 302 stainless steel rods with knurled proximal ends and distal hook/arc tips. Used by physicians in clinical or operating room settings to snare, grasp, hold, and manipulate cervical, fundus, and adjacent soft tissue. Devices are supplied non-sterile; require cleaning and steam autoclave sterilization before use. No electronic or automated components.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Material: 302 stainless steel. Form factor: Slender tapered rod, ~250mm length, 3mm-8mm tip diameter. Manual operation. Sterilization: Steam autoclave (270°F for 30 minutes). Complies with ISO materials standards and Quality Systems Regulations.

Indications for Use

Indicated for grasping and manipulating cervical and intravaginal soft tissue during gynecological 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

• UterineTenaculum (K890379)
• Champion Cervical Hook (K891349)
• Zinnanti Atraumatic Tenacula (K890133)

Reference Devices

• Emmett Tenaculum Hooks, V. Mueller, The Surgical Armamentarium, 1973

Submission Summary (Full Text)

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K980247
P193

| Summary of Safety and | |
|----------------------------------------|--|
| Effectiveness Information | |
| Premarket Notification, Section 510(k) | |
| Gynex Instruments | |
| GYNEX Corporation | |

Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92 MAR 17 1998Device Name: 1.

| Trade Name: | Gynex Iris Hook<br>Gynex Angle Hook<br>Gynex Emmett Tenaculum |
|-------------|---------------------------------------------------------------|
|-------------|---------------------------------------------------------------|

Common Name: Tissue hook, tenaculum

Classification Name: Tenaculum

- Establishment Name & Registration Number: 2.
GYNEX Corporation Name:

Number: 3032109

#### Classification: 3.

\$ 884.4530 Obstetric-gynecologic specialized manual instrument. (a) 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 (b) Classification. Class II (performance expose and illuminate the interior of the vagina. standards).

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Device Class: Class II

Classification Panel: Ob/Gyn Devices Panel

Product Code: 85HDC

## 4. Preamendments Device:

1. Emmett Tenaculum Hooks, V. Mueller, The Surgical Armamentarium, 1973.

## 5. Equivalent Legally Marketed Device(s):

- 1. UterineTenaculum, K890379 Mfg. by Kenetic Medical Products, Inc.
- 2. Champion Cervical Hook, K891349 Mfg. by Simpson/Basye, Inc.
- 3. Zinnanti Atraumatic Tenacula, K890133 Mfg. by Zinnanti Surgical, Inc.

### 6. Device Description:

The Gynex Iris and Angle Hooks & Emmett Tenaculums are made of 302 instrument grade stainless steel. All are used in similar way, each being a hook-like device used to snare, grasp, hold and manipulate the cervix, fundus and adjacent soft tissue. The important difference between the styles is that the radius of the hook tip is much smaller in the "Iris" and "angle" hook types. The devices are slender tapered metal rods, knurled on the proximal end and formed into a fine arc (hook) on the distal or working end. The devices are used to snare, hold and manipulate cervical and intravaginal tissue. Overall length of the hook/tenaculums is approximately 250mm for each type. The diameter of the hook tips is approximately 3mm for the Iris/angle styles and 8mm for the Emmett tenaculum style hook.

### 7. Applicant Name & Address:

GYNEX Corporation 16700 NE 79th St., Suite 204 Redmond, WA 98052

### Company Contact: 8.

Mr. Steve Angelo, President GYNEX Corporation 16700 NE 79th St., Suite 204 Redmond, WA 98052 425.882.1179 * 425.895.0115 - fax

# 9. Submission Correspondent:

Mr. David W. Schlerf Buckman Company, Inc. 1000 Burnett Av., Suite 450 Concord, CA 94520 510.356.2640 - 510.356.2654 - fax

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K980247
P3073

| Comparison Table:<br>10. | | | |
|--------------------------|---------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|-----|
| FEATURE | Gynex Iris/Angle Hook & Emmett<br>Tenaculum | Emmett Tenaculum<br>UterineTenaculum, Champion<br>Cervical Hook & Zinnanti<br>Atraumatic Tenacula | SE? |
| Indications for Use(s): | Snare, grasp, hold & manipulate cervical<br>and intravaginal tissue | Snare, grasp, hold & manipulate<br>cervical and intravaginal tissue | YES |
| Design: | Slender tapered metal rod | Slender tapered metal rod | YES |
| Sterilization Method: | Steam Autoclave | Steam Autoclave | YES |
| Sizes: | 3mm & 8mm tip diameter | 3mm & 4mm tip diameter | YES |
| Material: | 302 Stainless steel | 302 Stainless Steel | YES |
| Country of Orgin: | Germany | USA - Germany | YES |
| Manufacturer: | Gynex Corporation | Simpson/Basye, Kenetic Medical<br>Products, Zinnanti Surgical | YES |
| Product Code: | 84HDC | 84HDC | YES |
| K - Number: | Pending | Preamendment - K890379,<br>K891349, K891033 respectively | YES |

#### Voluntary Standards: 11.

United States Food and Drug Administration mandated performance standards for this device do not exist. Various voluntary performance standards are utilized. Voluntary standards utilized include ASTM, GYNEX Corporation. Standard Operating Procedures (SOP), vendor certification and qualification procedures, Quality Systems Regulations, ISO materials standards and ISO 9000 series quality requlations.

### Storage, Packaging & Sterilization Information: 12.

The Gynex Iris/Angle Hooks & Emmett Tenaculums are supplied in "clean only" condition and must be cleaned and sterilized prior to each use.

All packaging should be inspected on arrival for evidence of shipping damage. Damaged packaging may indicate the presence of unsafe product and it should not be used until carefully inspected. Any shipping damaged instruments should be returned promptly. Product for use in the operating room must be processed, opened, inspected, handled and placed into use following accepted operating room sterile technique.

Remove all labels and packaging materials before cleaning and sterilization. Wash the Gyzex Iris/Angle Hooks & Emmett Tenaculums thoroughly with hot water using a typical hospital grade surgical instrument detergent or soap. Ultrasonic cleaners may be employed. Cleaning, rinsing and sterilization must be performed in accordance with usual hospital practice before first or any subsequent use.

The recommended sterilization process for the instruments is steam autoclave sterilization. The recommended sterilization cycle is: saturated steam at 270° F for 30 minutes. This is the typical or usual steam sterilization cycle use for surgical instruments.

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Image /page/3/Picture/0 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three swooping lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle emblem.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 7 1998

Gynex Corporation c/o Mr. David W. Schlerf Buckman Company, Inc. 1000 Burnett Avenue, Suite 450 Concord, CA 94520

Re: K980247

Gynex Iris Hook, Gynex Angle Hook, and Gynex Emmett Tenaculum Dated: January 23, 1998 Received: January 23, 1998 Regulatory Class: II 21 CFR 884.4530/Procode: 85 HDC

Dear Mr. Schlerf:

We have reviewed your Section 510/k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions of 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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".

Sincerely yours

Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): _ K. 980247

Device Name(s):

- 1. GYNEX Tenaculum
- 2. GYNEX Iris Hook
- 3. GYNEX Angle Hook

Intended Use:

- 1. GYNEX Tenaculum Grasp/manipulate the cervix & soft tissue
- 2. GYNEX Iris Hook Grasp/manipulate cervical tissue
- 3. GYNEX Angle Hook Grasp/manipulate cervical tissue

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY

Concurrence of CDRH, Office of Device Evaluation (ODE)

Roler R Ratling

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

| 510(k) Number | K980247 |
|---------------|---------|
|---------------|---------|

| Prescription Use | OR | Over-The-Counter Use |
|----------------------|----|--------------------------|
| (Per 21 CFR 801.109) | | (Optional format 1-2-96) |

GYNEX-TENAC.doc