GYNEX EXTENDED REACH NEEDLE

K980238 · Gynex Corp. · HEE · Aug 21, 1998 · Obstetrics/Gynecology

Device Facts

• Record ID: K980238
• Device Name: GYNEX EXTENDED REACH NEEDLE
• Applicant: Gynex Corp.
• Product Code: HEE · Obstetrics/Gynecology
• Decision Date: Aug 21, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

1. Iniection and administration of anesthetic regional blocks (e.g., paracervical, uterosacral, and pudendal) that may be used during labor, delivery, or both. 2. Injection and administration of anesthetic regional blocks (e.q., paracervical, uterosacral, and pudendal) that may be used during minor surgical procedures.

Device Story

Gynex Extended Reach Needle is a disposable, 27-gauge, 90mm stainless steel needle used for administering regional anesthetic blocks (paracervical, uterosacral, pudendal) during labor, delivery, or minor surgical procedures. The device features a dual-diameter shaft; the section from the hub to 5mm from the tip has a larger diameter to assist in estimating insertion depth and preventing over-insertion into deep tissue. Available with standard or threaded hubs, the needle is supplied sterile and non-pyrogenic. It is intended for use by clinicians in clinical or operating room settings. The device facilitates precise anesthetic delivery, potentially improving patient comfort and safety during obstetric or surgical procedures.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing, material specifications, and design comparison to legally marketed predicate devices.

Technological Characteristics

302 instrument-grade stainless steel construction; 27-gauge, 90mm length; dual-diameter shaft for depth control; Luer lock or threaded hub options; radiation sterilization (SAL 10^-6); non-pyrogenic. Complies with ISO 9000 series and various ASTM standards.

Indications for Use

Indicated for patients requiring regional anesthetic blocks (paracervical, uterosacral, or pudendal) during labor, delivery, or minor surgical procedures.

Regulatory Classification

Identification

An obstetric anesthesia set is an assembly of antiseptic solution, needles, needle guides, syringes, and other accessories, intended for use with an anesthetic drug. This device is used to administer regional blocks (e.g., paracervical, uterosacral, and pudendal) that may be used during labor, delivery, or both.

Predicate Devices

• Potocky Needle Disposable Injection Needle (K910252)

Reference Devices

• Pudendal and paracervical block anesthesia instruments (V. Mueller, 1973)

Submission Summary (Full Text)

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K980238

1103

# ed Reach Needle arv of Safety and s Information Notification. Section 510(k)

Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92

## 1. Device Name:

Trade Name: Gynex Extended Reach Needle . Disposable Needle, disposable anesthetic needle Common Name: Classification Name: Obstetric anesthesia set & accessories

## 2. Establishment Name & Registration Number:

GYNEX Corporation Name: . Number: 3032109

## 3. Classification:

\$ 884.5100 Obstetric anesthesia set. (a) Identification. An obstetric anesthesia set is an assembly of antiseptic solution, needles, needle guides, syringes, and other accessories, intended for use with an anesthetic drug. This device is used to administer regional blocks (e.g., paracervical, uterosacral, and pudendal) that may be used during labor, delivery, or both. (b) Classification. Class II (performance standards).

## 4. Establishment Name & Registration Number:

Name: GYNEX Corporation Number: 3032109

## 5. Classification:

Device Class: Class II Classification Panel: Ob/Gyn Devices Panel Product Code: 85HEE

## 6. Preamendments Device:

- 1. Pudendal and paracervical block anesthesia instruments, Gynecology, Obstetrics, V. Mueller, The Surgical Armamentarium, 1973., pp. 219
## 7. Equivalent Legally Marketed Device(s):

- 1. Potocky Needle Disposable Injection Needle, K910252, Cooper Surgical.
..

- - - -

{1}------------------------------------------------

K980238

P293

## 8. Device Description:

The Gynex Extended Reach Needles are made of 302 instrument grade stainless steel. There are two styles each being 27 gauge and 90mm in length. One is equipped with a standard I hore are the other basing thas a threaded hub. Both are disposable. As is typical for this type of anesthetic needle, the shaft of the needle is dual diameter. That is, the shaft of the needle from the hub to within 5mm of the tip a is larger diameter. This allows for easy estimation of insertion depth during anesthetic administration and prevents over-insertion of needle into deeper tissue levels or spaces.

## Applicant Name & Address: 9.

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

## Company Contact: 10.

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

## 11. Submission Correspondent:

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

#### 12. Comparison Table:

| FEATURE | Gynex Extended Reach Needle | Pudendal/Paracervical Needle &<br>Potocky Needle | SE? |
|----------------------------|------------------------------------------------|-------------------------------------------------------------------------|------------|
| Indications for<br>Use(s): | Administer Paracervical pudendal<br>anesthetic | Administer Paracervical pudendal<br>anesthetic | YES |
| Design: | Leuer lock & threaded hub | Leuer lock | YES |
| Sterilization<br>Method: | Radiation - Supplied sterile -<br>disposable | Steam Autoclave - reusable<br>Potocky -Supplied sterile -<br>disposable | NO&<br>YES |
| Sizes: | 90mm w/ 5mm 27 gauge tip | 6-8 inches - 20-25 gauge<br>Potocky - 90mm, 27 gauge | YES |
| Material: | 302 Stainless steel | 302 Stainless Steel | YES |
| Country of<br>Origin :: | Asia - Germany | Germany<br>Potocky - Asia - Germany | YES |
| Manufacturer: | Gynex Corporation | V. Mueller, Cooper Surgical | YES |
| Product Code: | 84HEE | 84HEE | YES |
| K - Number: | Pending | Preamendment & K910252<br>respectively | YES |

{2}------------------------------------------------

K910238

P3093

## 13. Voluntary Standards:

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 regulations.

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

The Gynex Iris/Angle Extended Reach Needles are supplied sterile and non-pyrogenic.

All needles are individually packaged & labeled and supplied in multi-unit packages and boxes for ease in shipping and storage. 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 product may not be sterile and should be returned promotiv. Product for use in the operating room must be processed, opened, handled and placed into use following accepted operating room sterile technique.

Sterility Assurance Level (SAL) is at least 10°. A minimum of 2.5 Mrrad radiation exposure is The product is dosemetry released. The product is also non-pyrogenic. Vendor utilized. certification and secondary sampling is performed and documented.

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AUG 21 1998

Gynex Corporation c/o Mr. David Schlerf Buckman Company, Inc. 200 Gregorv Lane, Suite C-100 Pleasant Hill, CA 94523-3389

9200 Corporate Boulevard Rockville MD 20850

Food and Drug Administration

Re: K980238

GYNEX Extended Reach Needle Dated: June 20, 1998 Received: August 4, 1998 Regulatory Class: II 21 CFR 884.5100/Procode: 85 HEE

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 intersiate commerce pror 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 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 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 80 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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Page 1

510(k) Number (if known): __ K 980236

Device Name(s):

GYNEX Extended Reach Needles

Intended Use:

- 1. Iniection and administration of anesthetic regional blocks (e.g., paracervical, uterosacral, and pudendal) that may be used during labor, delivery, or both.
- 2. Injection and administration of anesthetic regional blocks (e.q., paracervical, uterosacral, and pudendal) that may be used during minor surgical procedures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert R. Sothin

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number K980238

OR

Prescription Use X

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional format 1-2-96)

GYNEX-EXTEND.doc