This needle is designed for injection of solutions (such as 2% lidocaine with or without 1:100,000 epinephrine) into the cervix. The application includes local anesthetics such as electro-excision, electro-fulguration, CO2 laser excision, and vaporization, and when required, endocervical curettage and cervical biopsies.

Device Description

The Wallach Endocervical Block Needle is a Sterile, Disposable, Single Use device. The needle is 27ga., 3 1/2" long. It is used for uterine anesthesia prior to Ob/Gyn procedures. It consists of a metal tube 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 intra-vascular administration set. Over 3 1/4" of its proximal end a 21 gauge metal tube is added to strengthen the shaft.

AI/ML Overview

This document, a 510(k) Premarket Notification Submittal for the "Wallach Endocervical Block Needle," primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study that defines and meets specific acceptance criteria based on quantitative performance metrics.

However, based on the provided text, we can infer the implicit acceptance criteria are for the device to be functionally equivalent and safe as compared to existing, legally marketed predicate devices. The study conducted is a comparative analysis, rather than a performance study with defined numerical acceptance thresholds.

Here's an attempt to structure the information based on your request, highlighting what is provided and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance (as demonstrated by comparison)
Intended Use Equivalence: Designed for injection of solutions (e.g., 2% lidocaine +/- epinephrine) into the cervix for local anesthesia prior to Ob/Gyn procedures, including electro-excision, electro-fulguration, CO2 laser excision and vaporization, endocervical curettage, and cervical biopsies.	Equivalent. The Wallach Endocervical Block Needle's intended use is identical to or consistent with the intended uses of the predicate devices: Coopersurgical 'Potocky Needle', Avid Medical 'Avid-Nit Cervical Regional Anesthesia Needle', Terumo Medical 'Terumo 30 Gauge Hypodermic Needle', and Nipro Medical Crop 'Nipro Hypodermic Needle'. (Explicitly stated as "Equivalent" or consistent with predicate devices' intended use definitions for Class II, Product Code HEE & FMI).
Sterility & Disposable Use Equivalence: Sterile, Disposable, Single Use.	Equivalent. The Wallach Endocervical Block Needle is described as "Sterile, Disposable, Single Use," which is explicitly stated as "Yes" and compared as "Yes" to all four predicate devices.
Design Equivalence (Needle Dimensions & Components): 27 gauge, 3 ½" long metal tube, sharpened at one end, joined to a female Luer lock connector, with a 21 gauge metal tube over 3 ¼" of its proximal end for shaft strengthening.	Equivalent/Similar. - Coopersurgical 'Potocky Needle': Described as "Equivalent" in design. - Avid Medical 'Avid-Nit Cervical Regional Anesthesia Needle': Described as "Equivalent" in design. - Terumo Medical 'Terumo 30 Ga. Hypodermic Needle': Described as "Similar" in design. - Nipro Medical Corp 'Nipro Hypodermic Needle': Described as "Similar" in design. (The full description of the Wallach needle design is provided, and the predicates are compared against it).
Material Equivalence: Stainless Steel Tubing, Plastic Hub.	Equivalent. All predicate devices are noted as "Equivalent" in material.
Safety: No new hazards presented compared to predicate devices.	Met. "Hazard analysis evaluations performed on the Wallach Endocervical Block Needle indicated that there were no new hazards presented with the use of the Wallach Endocervical Block Needle as compared to the predicated devices."
Performance: Device performance is substantially equivalent to predicate devices.	Met. "Testing that was performed on the Wallach Endocervical Block Needle indicates that the devices are substantially equivalent in the performance and design of operation." (Specific performance metrics or test results are not detailed)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: This document does not describe a "test set" in the context of a clinical study or a statistically defined, independent dataset to evaluate a machine learning algorithm. The "testing" mentioned refers to hazard analysis and performance evaluations that deemed it substantially equivalent to existing devices, but no sample sizes for such tests are provided.
Data Provenance: Not applicable, as there's no defined "test set" of patient data or images. The evaluation is based on a comparison of design, materials, intended use, and a generic statement about performance testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This is not a study involving expert-established ground truth for a test set in the context of an AI/ML device. The "ground truth" for substantial equivalence is derived from regulatory classifications, established safety profiles, and intended uses of existing predicate devices.

4. Adjudication Method for the Test Set

Not applicable, as there is no independent "test set" requiring adjudication by experts.

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 submission is for a physical medical device (needle), not an AI/ML diagnostic or assistive tool.

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

Not applicable. This is not an AI/ML algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission is the established regulatory status, safety, design characteristics, and intended uses of legally marketed predicate devices. The Wallach Endocervical Block Needle's characteristics are compared against these established predicates to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, and thus there is no "training set" in that context.

9. How the Ground Truth for the Training Set was Established

Not applicable. There is no training set mentioned or implied.

Summary of the "Study" that Proves the Device Meets Acceptance Criteria:

The "study" presented here is a substantive equivalence comparison to legally marketed predicate devices as per 510(k) requirements. The manufacturer, Wallach Surgical Devices, Inc., claims that the Endocervical Block Needle is "substantially equivalent" to the following predicates:

Coopersurgical 'Potocky Needle', K910252
Avid Medical 'Avid-Nit Cervical Regional Anesthesia Needle', K000117
Terumo Medical 'Terumo 30 Gauge Hypodermic Needle', K012646
Nipro Medical Corp 'Nipro Hypodermic Needle', K013293

The comparison is based on:

Intended Use: Identical.
Technological Characteristics (Design, Materials, Operation): Found to be equivalent or similar.
Performance: General statement that "Testing... indicates that the devices are substantially equivalent in the performance and design of operation." No specific test reports or data are included in this summary.
Safety: "Hazard analysis evaluations... indicated that there were no new hazards presented with the use of the Wallach Endocervical Block Needle as compared to the predicated devices."

The FDA's letter (K021224 dated July 12, 2002) confirms this and states that the device is "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed. This regulatory finding serves as the "proof" that the device meets the implied acceptance criteria for market entry under a 510(k) pathway.

Summary

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Image /page/0/Picture/0 description: The image shows the word "WALLACH" in a bold, sans-serif font. The letters are black and have a slightly distressed or textured appearance, giving them a vintage or worn look. The word is presented in all capital letters and is the central focus of the image.

JUL 1 2 2002

Surgical Devices, Inc.
235 Edison Road
Orange, CT 06477
(203) 799-2000
Fax: (203) 799-2002

510(k) Premarket Notification Submittal · Wallach Endocervical Block Needle' By Wallach Surgical Devices. Inc. SUMMARY CERTIFCIATION page of SECTION 2 April. 15, 2002 -Page 1 of 5

510(k) Summary/Statement Certification

Re: K 02 / 72 4 __

Device Name: "Wallach Endocervical Block Needle"

Check Only One:

1 510(k) Summary. Attached is a summary of safety and effectiveness 1. information upon which an equivalence determination could be based.

510(k) Statement, I Certify that, in my capacity as 2. GENERAL MANAGER, of WALLACH SURGICAL DEVICES,

INC.

I will make available all information included in this premarket notification of safety and effectiveness within 30 days of request by any person if the device described in the premarket notification submission is determined to be substantially equivalent. The information I agree to make available will be a duplicate of the premarket notification submission, including any adverse safety and effectiveness information, but excluding all patient identifiers, and trade secret and confidential commercial information, as defined in 21 CFR 20.61.

M. Mels

(Signature)

Michael Malis (Typed or Printed name)

2/15/02
(Dated)

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510(k) Premarket Notification Submittal 'Wallach Endocervical Block Needle' By Wallach Surgical Devices, Inc. SUMMARY CERTIFCIATION page of SECTION 2 April. 15, 2002 -Page 2 of 5

510(k) Safety and Effectiveness Summary

Applicant:	Wallach Surgical Devices, Inc,235 Edison RoadOrange, CT 06477
Registration:	1219739
Contact:	Michael Malis
Phone:	203-799-2000
Fax:	203-799-2002
Trade Name:	Wallach Endocervical Block Needle
Devices Generic Name:	Endocervical Block Needle
Classification Name:	Set, Anesthesia, Parcervical, and Needle, Hypodermic, SingleLumen
Classification:	Currently classified as a Class II, under ProductCode 85 HEE Regulation Number 884.5100 and ProductCode 80 FMI Regulation Number 880.5570 per 21 CFR.

Predicate Devices to which we are claiming substantial equivalence:

Coopersurgical 'Potocky Needle', K910252 1
Avid Medical 'Avid-Nit Cervical Regional Anesthesia Needle', K000117 2.
Terumo Medical 'Terumo 30 Gauge Hypodermic Needle', K012646 3.
Nipro Medical Crop 'Nipro Hypodermic Needel', K013293 4.

Product Description:

Indications for Use:

It is designed for injection of solutions (such as 2% lidocaine with or without 1:100,000 epinephrine) into the cervix. The application includes local anesthetics such as electro-excision, electro-fulguration, CO2 laser excision and vaporization, and when required, endocervical curettage and cervical biopsies.

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Safety and Performance:

Substantial equivalence for this device is based on design, operation, intended use, materials, and performance claims. Testing that was performed on the Wallach Endocervical Block Needle indicates that the devices are substantially equivalent in the performance and design of operation.

Hazard analysis evaluations performed on the Wallach Endocervical Block Needle indicated that there were no new hazards presented with the use of the Wallach Endocervical Block Needle as compared to the predicated devices.

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510(k) Premarket Notification Submitted
Sy Wallach Endocervical Findocervical Blook News Coming Comments
SUMARY Currently Burgical Processor Comments of Caracter of
April. 15

Comparison Chart

	Wallach Surgical Devices, Inc.'Wallach Endocervical Block Needle'	Coopersurgical'Potocky Needle'	Avid Medical Inc.'Avid-NitCervial RegionalAnesthesia Needle'	Terumo Medical Corp.'Terumo 30 Ga.Hypodermic Needle'	Nipro Medical Corp.'Nipro HypodermicNeedle'
Feature:	K(pending)Class II, Product Code HEERegulation # 884.5100 andProduct Code FMIRegulation # 880.5570	K910252	K000117	K 012646	K013293
Intended Use:	For injection of solutions(such 2% lidocaine with orwithout 1:100,000epinephine) into the cervix.The application includes localanesthetics such as eletro-excision, elecro-fulguration,CO2 laser excision andvaporization, and whenrequired, endocervicalcurettage and cervicalbiopsies	Class II,Product Code: HEERegulation # 884.5100	Class II,Product Code: HEERegulation # 884.5100	Class II,Product Code: FMIRegulation # 880.5570	Class II,Product Code: FMIRegulation # 800.5570
		Equivalent	Equivalent	Equivalent	Equivalent
Sterile, Disposable Single Use	Yes	Yes	Yes	Yes	Yes
Design:	The needle is 27ga., 3 ½"long. It is used for uterineanesthesia prior to Ob/Gynprocedures. It consists of ametal tube that is sharpened	Equivalent	Equivalent	Similar	Similar

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510(k) Premarket Notification Submittal'Wallach Endocervical Block Needle'By Wallach Surgical Devices, Inc.SUMMARY CERTIFCIATION page ofSECTION 2April. 15, 2002 -Page 5 of 5
end joined to a femaleconnector (Luer lock)designed to mate with a maleconnector (Nozzle) of apiston syringe or an intra-vascular administration set.Over 3 ¼" of its proximal enda 21 gauge metal tube isadded to strengthen the shaft.	Equivalent	Equivalent	Equivalent
MaterialStainless Steel TubingPlastic Hub	Equivalent	Equivalent	Equivalent

Conclusion:

Based on the indications for use, technological characteristics and companson to currently marketed devices, the Wallach

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Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, resembling a bird-like shape.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Michael Malis General Manager of Operations WALLACH Surgical Devices, Inc. 235 Edison Road ORANGE CT 06477

Re: K021224

JUL 12 2002

Trade/Device Name: Endocervical Block Needle Regulation Number: 21 CFR 884.5100 Regulation Name: Obstetric anesthesia set Regulatory Class: II Product Code: 85 HEE Dated: April 15, 2002 Received: April 17, 2002

Dear Mr. Malis:

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, listing 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 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.

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 agencies. 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Wallach Surgical Devices, Inc. Section 7

Page 1 of 1

510(k) Number (if known): _ Koz1224

Device Name: _ _ Wallach Endocervical Block Needle

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

(Division Sign-Off)

Division of Reproductive, Abdominal,

and Radiological Devices

510(k) Number	K021224
---------------	---------

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).