(61 days)
Not Found
Not Found
No
The device description is for a simple mechanical needle and there are no mentions of AI, ML, image processing, or data sets typically associated with AI/ML devices.
No.
The device is a needle for injecting solutions, not a device that itself provides a therapeutic effect. It is used as a tool to administer medication (local anesthetics) that provides the therapeutic effect.
No
The device is described as a needle for injecting solutions for anesthesia, which is a therapeutic rather than a diagnostic function.
No
The device description clearly describes a physical needle made of metal, which is a hardware component.
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 anesthesia during Ob/Gyn procedures. This is a therapeutic/procedural use, not a diagnostic one.
- Device Description: The description details a needle for delivering substances into the body, which is consistent with a medical device used for treatment or procedures, not for testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) in vitro (outside the body) to provide diagnostic information.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This needle does not fit that description.
N/A
Intended Use / 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 Local anesthetics such as electroexcision, electrofulguration, CO2 laser excision and vaporization, and in some patients, endocervical curettage and cervical blopsies
Product codes
85 HEE, 80 FMI
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
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Potocky needle™ Disposable Injection Needle from Coopersurgical
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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:
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
12-Intended use of the device: (Indicalions for use typed on a separate FDA form)
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
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)
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ਂ ਰ ---
586888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888 .ON XA F MA EE: DI NOM 76-12-VON
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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 |
2
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.
3
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
4
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)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
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