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

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.

AI/ML Overview

The provided text is a 510(k) premarket notification for the GYNEX Extended Reach Needle. This document primarily focuses on establishing substantial equivalence to a predicate device and does not contain information on detailed acceptance criteria or a specific study proving the device meets them in the context of performance metrics like sensitivity, specificity, or reader improvement. This type of regulatory submission for a simple medical device like a needle typically demonstrates safety and effectiveness through comparison to existing devices and compliance with relevant standards, rather than complex performance studies.

Therefore, many of the requested sections about study details, sample sizes, expert qualifications, and ground truth cannot be answered from the provided text.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics like sensitivity, specificity, or accuracy. The "Comparison Table" in the document focuses on features for establishing substantial equivalence to the predicate device, not on quantitative performance against specific acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The document does not describe a clinical performance study with a test set. The validation is based on comparison to an existing predicate device and adherence to manufacturing and materials standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as no test set requiring expert ground truth is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no test set requiring adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a disposable needle, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a disposable needle, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable, as no ground truth is established for performance evaluation of this device type in this submission. The "ground truth" for regulatory approval here is primarily based on the predicate device's established safety and efficacy, and compliance with manufacturing and materials standards.

8. The sample size for the training set

Not applicable, as there is no training set for an AI algorithm described.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for an AI algorithm described.

Summary of available information:

The provided document describes the GYNEX Extended Reach Needle as a Class II medical device intended for administering regional anesthetic blocks. The regulatory submission (510(k)) aims to demonstrate substantial equivalence to legally marketed predicate devices, primarily the Potocky Needle (K910252) and preamendment devices.

Acceptance Criteria (Implicit via Substantial Equivalence and Standards):

While not explicitly presented as a "table of acceptance criteria" with numerical performance targets, the document establishes implicit acceptance criteria based on:

Indications for Use: The Gynex needle must be suitable for administering paracervical-pudendal anesthetic, matching the predicate.
Design: Leuer lock & threaded hub, comparable to predicate.
Sterilization Method: Supplied sterile and non-pyrogenic via radiation, with a Sterility Assurance Level (SAL) of at least 10⁻⁶. This is a critical safety criterion.
Dimensions/Sizes: 90mm with a 5mm 27 gauge tip, matching the Potocky predicate.
Material: 302 Stainless Steel, matching the predicate.
Manufacturing Standards: Compliance with voluntary standards such as ASTM, GYNEX Corporation Standard Operating Procedures (SOPs), vendor certification/qualification, Quality Systems Regulations (QSR), ISO materials standards, and ISO 9000 series quality regulations. This implies the device must meet specified mechanical properties, biocompatibility, and manufacturing quality.
Packaging: Individually packaged and labeled, with instructions for inspection and handling to maintain sterility.

Reported Device Performance (Implicit/Feature Comparison):

The "Comparison Table" provides the "reported device performance" in terms of features relative to the predicate:

FEATURE	Gynex Extended Reach Needle	Predicate Devices (Pudendal/Paracervical Needle & Potocky Needle)	Substantially Equivalent?
Indications for Use(s):	Administer Paracervical pudendal anesthetic	Administer Paracervical pudendal anesthetic	YES
Design:	Leuer lock & threaded hub	Leuer lock	YES
Sterilization Method:	Radiation - Supplied sterile - disposable	Steam Autoclave - reusable; Potocky - Supplied sterile - disposable	NO & YES
Sizes:	90mm w/ 5mm 27 gauge tip	6-8 inches - 20-25 gauge; Potocky - 90mm, 27 gauge	YES
Material:	302 Stainless steel	302 Stainless Steel	YES
Country of Origin:	Asia - Germany	Germany; Potocky - Asia - Germany	YES
Manufacturer:	Gynex Corporation	V. Mueller, Cooper Surgical	YES
Product Code:	84HEE (Note: Table lists 84HEE, text mentions 85HEE)	84HEE	YES
K - Number:	Pending	Preamendment & K910252 respectively	YES

Note on Sterilization: The "NO & YES" for sterilization indicates that Gynex's radiation sterilization method differs from "Steam Autoclave - reusable" but is equivalent to "Potocky - Supplied sterile - disposable." The FDA found this acceptable for substantial equivalence.

This document serves as a regulatory submission demonstrating substantial equivalence for a medical device, and as such, does not typically include detailed clinical performance studies often associated with diagnostic or AI-driven devices.

Summary

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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:

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 &Potocky Needle	SE?
Indications forUse(s):	Administer Paracervical pudendalanesthetic	Administer Paracervical pudendalanesthetic	YES
Design:	Leuer lock & threaded hub	Leuer lock	YES
SterilizationMethod:	Radiation - Supplied sterile -disposable	Steam Autoclave - reusablePotocky -Supplied sterile -disposable	NO&YES
Sizes:	90mm w/ 5mm 27 gauge tip	6-8 inches - 20-25 gaugePotocky - 90mm, 27 gauge	YES
Material:	302 Stainless steel	302 Stainless Steel	YES
Country ofOrigin ::	Asia - Germany	GermanyPotocky - Asia - Germany	YES
Manufacturer:	Gynex Corporation	V. Mueller, Cooper Surgical	YES
Product Code:	84HEE	84HEE	YES
K - Number:	Pending	Preamendment & K910252respectively	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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Image /page/3/Picture/2 description: The image shows a logo for the Department of Health & Human Services. The logo features a stylized symbol with three curved lines resembling a bird or abstract human figure. The text "DEPARTMENT OF HEALTH & HUM" is partially visible, arranged vertically along the left side of the symbol. The image is in black and white.

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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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.
1. 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

Prescription Use X

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional format 1-2-96)

GYNEX-EXTEND.doc

Regulation Number and Section

§ 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).