(86 days)
Not Found
No
The device description and intended use describe a simple mechanical needle for drug delivery, with no mention of AI or ML capabilities.
No
The device is a needle used for administering local anesthetics, which are therapeutic agents, but the device itself is a delivery tool, not a therapeutic device.
No
This device is designed for the injection of solutions into the cervix for local anesthesia and other procedures, not for the purpose of diagnosing a condition.
No
The device description clearly describes a physical needle, which is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the injection of solutions into the cervix for local anesthesia during various gynecological procedures. This is a direct intervention on the patient's body for therapeutic or procedural purposes.
- Device Description: The device is a needle designed for injection.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) for direct patient treatment/procedure preparation.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
85 HEE, 80 FMI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervix
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K910252, K000117, K012646, K013293
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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)
1
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 Road
Orange, 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, Single
Lumen |
| Classification: | Currently classified as a Class II, under Product
Code 85 HEE Regulation Number 884.5100 and Product
Code 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:
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.
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.
2
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.
3
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-Nit
Cervial Regional
Anesthesia Needle' | Terumo Medical Corp.
'Terumo 30 Ga.
Hypodermic Needle' | Nipro Medical Corp.
'Nipro Hypodermic
Needle' |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|--------------------------------------------------------------------------|--------------------------------------------------------------|---------------------------------------------------------|
| Feature: | K
(pending)
Class II, Product Code HEE
Regulation # 884.5100 and
Product Code FMI
Regulation # 880.5570 | K910252 | K000117 | K 012646 | K013293 |
| Intended Use: | For injection of solutions
(such 2% lidocaine with or
without 1:100,000
epinephine) into the cervix.
The application includes local
anesthetics such as eletro-
excision, elecro-fulguration,
CO2 laser excision and
vaporization, and when
required, endocervical
curettage and cervical
biopsies | Class II,
Product Code: HEE
Regulation # 884.5100 | Class II,
Product Code: HEE
Regulation # 884.5100 | Class II,
Product Code: FMI
Regulation # 880.5570 | Class II,
Product Code: FMI
Regulation # 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 uterine
anesthesia prior to Ob/Gyn
procedures. It consists of a
metal tube that is sharpened | Equivalent | Equivalent | Similar | Similar |
4
| 510(k) Premarket Notification Submittal
'Wallach Endocervical Block Needle'
By Wallach Surgical Devices, Inc.
SUMMARY CERTIFCIATION page of
SECTION 2
| April. 15, 2002 -Page 5 of 5 | |||
|---|---|---|---|
| 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 ¼" of its proximal end | |||
| a 21 gauge metal tube is | |||
| added to strengthen the shaft. | Equivalent | Equivalent | Equivalent |
| Material | |||
| Stainless Steel Tubing | |||
| Plastic Hub | Equivalent | Equivalent | Equivalent |
Conclusion:
Based on the indications for use, technological characteristics and companson to currently marketed devices, the Wallach
5
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.
6
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
7
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:
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.
(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 |
|---|---|
| --------------- | --------- |