This needle is designed for injection of solutions (such as 2% lidocaine with or without 1:100,000 epinephrine) into the cervix Local anesthetics such as electroexcision, electrofulguration, CO2 laser excision and vaporization, and in some patients, endocervical curettage and cervical blopsies

Device Description

The needle is 27g, 3 ½ª long. It is used for uterine anesthesia prior to Ob/Gyn procedures. It consists of a metal lube that is sharpened at one end and at the other end joined to a female connector (Luer lock) designed to mate with a male connector (Nozzle) of a piston syringe or an intravascular administration set. Over 3 ¼" of its proximal end a 21 gauge metal tube is added to strengthen the shaft

AI/ML Overview

I am sorry, but I cannot provide a detailed description of acceptance criteria and a study proving device performance based on the provided text. The document is a 510(k) summary for a medical device (Endocervical Block Needle) and focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific performance metrics and acceptance criteria as you've requested.

Here's why I cannot fulfill your request based on the given information, and what I can extract:

What the document does provide:

Acceptance Criteria (Implicit via Equivalence): The implicit acceptance criterion for the Endocervical Block Needle is substantial equivalence to the Potocky Needle™ Disposable Injection Needle. The device is deemed acceptable if it can be shown to be as safe and effective as the predicate device.
Study That Proves the Device Meets Acceptance Criteria: The "study" is a comparison of technological characteristics between the Endocervical Block Needle and the Potocky Needle™. This comparison, presented as a table, claims equivalence across multiple attributes.

Why the specific details you requested are not present:

Table of Acceptance Criteria and Reported Device Performance: The document does not provide predefined numerical acceptance criteria (e.g., "device must achieve X accuracy" or "Y tensile strength") and then report specific performance results against those. Instead, it states "Equivalent" for various characteristics when compared to the predicate.
Sample Size for Test Set and Data Provenance: There is no mention of a test set, statistical sample sizes, or data provenance (e.g., country of origin, retrospective/prospective). The assessment is based on a comparative analysis of specifications, not a new clinical or performance study with a distinct test set.
Number of Experts and Qualifications for Ground Truth: Since no new performance study is described, there's no mention of experts establishing ground truth for a test set. The "ground truth" for equivalence is essentially derived from the established safety and efficacy of the predicate device.
Adjudication Method: Not applicable as no new performance data requiring adjudication is presented.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This type of study is for evaluating human performance, often with and without AI assistance, which is not relevant to a hypodermic needle's 510(k) submission.
Standalone Performance Study (Algorithm Only): Not applicable. This is a physical medical device, not an algorithm. Its performance is assessed through equivalence to a physically similar device, not a standalone algorithm.
Type of Ground Truth Used: The "ground truth" implicitly used is the established safety and efficacy profile of the predicate device (Potocky Needle™) as accepted by the FDA. There's no pathology, outcomes data, or expert consensus specifically generated for this new device's performance claims, beyond the general understanding that the predicate performs as intended.
Sample Size for Training Set: Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.
How Ground Truth for Training Set Was Established: Not applicable for the same reason as above.

In summary, the provided document demonstrates substantial equivalence through a comparative analysis of technological characteristics to a legally marketed predicate device, which is a common pathway for 510(k) clearance. It does not describe a performance study with specific acceptance criteria, test sets, or ground truth establishment in the way you've outlined for a new device's performance validation.

The table showing the comparison is:

Comparison of Technological Characteristics (Predicate vs. New Device)

Characteristic	Endocervical Block Needle (Reported Performance)
2-Target Population	Equivalent
3-Design	Equivalent
4-Materials	Equivalent
5-Performance	Equivalent
6-Sterility	Equivalent
7-Biocompatibility	Equivalent
8-Mechanical Safety	Equivalent
9-Chemical Safety	Not Applicable
10-Anatomical Sites	Equivalent
11-Human Factors	Equivalent
12-Energy used and/or delivered	Not Applicable
13-Compatibility with Environment & other devices	Equivalent
14-Where used	Equivalent
15-Standards met	Equivalent
16-Electrical Safety	Not Applicable
17-Thermal Safety	Not Applicable
18-Radiation Safety	Not Applicable

Acceptance Criteria: For each characteristic, the acceptance criterion is "Equivalent" to the predicate device (Potocky Needle™ Disposable Injection Needle). The reported performance across all relevant characteristics is that the Endocervical Block Needle is "Equivalent" to the predicate.

Summary

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8173

K93671

510(k) Summary As Required by 21 section 807.92 ( c )

NOV 26 1997

A & A Medical, Inc. 1-Submitter Name: 4100 Nine McFarland Drive, suite B 2-Address: Alpharetta, GA 30004 (770) 343- 8400 3-Phone: (770) 343- 8985 4-Fax: 6-Contact Person: Jihad Mansour 6-Date summary prepared: September 24th , 1997 7-Device Trade or Proprietary Name: Endocervical Block Needle 8-Device Common or usual name:Hypodernic Needle 9-Device Classification Name: Hypodernic Single Lumen Needle 10-Substantial Equivalency is claimed against the following device:

Potocky needle™ Disposable Injection Needle from Coopersurgical

11-Description of the Device:

12-Intended use of the device: (Indicalions for use typed on a separate FDA form)

13-Safety and effectiveness of the device:

The Endocervical Block Needle is safe and effective as the Potocky Needle TM . Indeed, it is equivalent This is better expressed in the tabulated companson (Paragraph 14 below)

PTO->>

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14-Summary comparing technological characteristics with other 1203 predicate device:

P.S. GENERAL COMPARISON RESULT BETWEEN Botocky Needle TM and Endocervical Block Needle is found tabulated below. Comparison of specific elements will be attached in the main submission as per FDA guidance for 510(k) Notifications for Hypodermic Single Lumen Needles

2-Target Population	Equivalent
3-Design	Equivalent
4-Materials	Equivalent
5-Performance	Equivalent
6-Sterility	Equivalent
7-Biocompatibility	Equivalent
8-Mechanical Safety	Equivalent
9-Chemical Safety	Not Applicable
10-Anatomical Sites	Equivalent
11-Human Factors	Equivalent
12-Energy used and/or delivered	Not Applicable
13-Compatibility with Environment & other devices	Equivalent
14-Where used	Equivalent
15-Standards met	Equivalent
16-Electrical Safety	Not Applicable
17-Thermal Safety	Not Applicable
18-Radiation Safety	Not Applicable

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Image /page/2/Figure/2 description: This image is a flowchart titled "510(k) Substantial Equivalence Decision-Making Process (Overview)." The flowchart begins with the question "New Device is Compared to Marketed Device?" and proceeds through a series of questions to determine if the new device is substantially equivalent. The flowchart includes decision points, such as "Does New Device Have Same Intended Use?" and "Does Descriptive or Performance Information Demonstrate Equivalence?" The flowchart concludes with a determination of "Substantially Equivalent" or a need for more information.

A more Detailed version is also available in pdf version or found directly below.

Image /page/2/Figure/4 description: The image shows the text "Page 3 of 3". This indicates that it is the last page of a document. The text is written in a clear, legible font. The page number is explicitly stated, providing a clear reference point within the document.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract image of an eagle with three heads.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jihad Mansour QA/RA Manager A & A Medical, Inc. 4100 Nine McFarland Drive, Suite B Alpharetta, Georgia 30004

Re: K973671

Endocervical Block Needle Dated: September 24, 1997 Received: September 26, 1997 Regulatory Class: II 21 CFR §884.5100/Product Code: 85 HEE 21 CFR §880.5570/Product Code: 80 FMI

NOV 26 1997

Dear Mr. Mansour:

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 Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 requirement, 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 does not affect any obligation you might have under sections 531 through 542 of the Act for devices under 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 (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/dsmamain.html".

Sincerely yours,

William Yu

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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November 24, 1997 of____________________________________________________________________________________________________________________________________________________________________________ Page_

510(k) Number (if known): K973671

1 1

Device Name:_ Endocervical Block Needle

Indications For Use:

This needle is designed for injection of solutions (such as 2% lidocaine with or without 1:100,000 epinephine) into the cervic Local anesthetics such as electroexcision, electrofulguration, 1. 100,000 spinopinino, into the some patients, endocervical curettage and cervical biopsies

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ruther R. Ratting/

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K973671

Prescription Use_Y (Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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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).