CERVICAL ANESTHESIA NEEDLE, CONTRACERVICAL ANESTHESIA NEEDLE, MODEL #'S 720209 30GAU X 4 MM, 720210 30GAU X 6MM, 720208G

K983897 · Ri Mos. S.R.L. · HEE · Feb 1, 1999 · Obstetrics/Gynecology

Device Facts

• Record ID: K983897
• Device Name: CERVICAL ANESTHESIA NEEDLE, CONTRACERVICAL ANESTHESIA NEEDLE, MODEL #'S 720209 30GAU X 4 MM, 720210 30GAU X 6MM, 720208G
• Applicant: Ri Mos. S.R.L.
• Product Code: HEE · Obstetrics/Gynecology
• Decision Date: Feb 1, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The RI. MOS. Cervical and Intracervical Anaesthesia Needles are used to apply cervical and intracervical anesthesia block.

Device Story

The RI. MOS. cervical and intracervical anesthesia needles are sterile, single-use, disposable medical devices designed for use with standard medical syringes. They are utilized by clinicians to administer anesthesia blocks in the cervical or intracervical region. The device functions as a delivery mechanism for anesthetic agents, facilitating localized pain management during gynecological or obstetric procedures. By providing a dedicated needle for these specific anatomical sites, the device assists healthcare providers in performing anesthesia blocks, potentially improving patient comfort and procedural outcomes.

Clinical Evidence

Bench testing only.

Technological Characteristics

Sterile, single-use, disposable needles. Designed for use with standard medical syringes. No electronic components or software.

Indications for Use

Indicated for the application of cervical and intracervical anesthesia block in patients requiring such procedures.

Regulatory Classification

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.

Predicate Devices

• Potocky Needle (CooperSurgical)

Submission Summary (Full Text)

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1 1999 FEB

Section 7

## 510 (k) Summary

This summary of a 510 (k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. 8807.92.

- 1. The submitter of this premarket notification is:
Adena S. Riemer Affiliate EXPERTech Associates, Inc. 100 Main Street, Suite 120 Concord, MA 01742

Tel: [phone] Fax: [phone]

This summary was prepared on October 20, 1998.

- 2. The name of the RI. MOS. s.r.l. device is cervical anesthesia needle and intracervical anesthesia needle.
- 3. The above device is substantially equivalent to the Potocky Needle® marketed by CooperSurgical.
- 4. The RI. MOS. s.r.l. cervical and intracervical needles operate with standard medical syringes are are sterile, single-use, disposable devices.
- 5. The device is intended for applying cervical and intracervical anesthesia block.
- 6. The technological characteristics are the same or similar to those found with the marketed predicate device.

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Image /page/1/Picture/2 description: The image shows the address of the Food and Drug Administration. The address is 9200 Corporate Boulevard, Rockville MD 20850. The text is black and the background is white.

## FEB 1 1999

RI. MOS. s.r.l. c/o Adena S. Riemer Affiliate EXPERTech Associates, Inc. 100 Main Street, Suite 120 Concord, MA 01742

Re: K983897

Cervical and Intracervical Anaesthesia Needles Dated: October 30, 1998 Received: November 3, 1998 Regulatory Class: II 21 CFR 884.5100/Procode: 85 HEE

Dear Ms. Reimer:

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 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, 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 (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 (QS) 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 801 and additionally 800.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Sant. Daniel C. Schultz, M.D.

Capt. Daniel G. Schultz, M.D. Acting 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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510(k) Number (if known):___

Device Name: RI, MOS, Cervical and Intracervical Anaesthesia Needles

## Indications For Use:

The RI. MOS. Cervical and Intracervical Anaesthesia Needles are used to apply cervical and intracervical anesthesia block.

## (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, ENT, and Radiological Devices 1983897 510(k) Number.

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