CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE

K052365 · Rocket Medical Plc · HEE · Oct 17, 2005 · Obstetrics/Gynecology

Device Facts

• Record ID: K052365
• Device Name: CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE
• Applicant: Rocket Medical Plc
• Product Code: HEE · Obstetrics/Gynecology
• Decision Date: Oct 17, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For injection of solutions (such as lidocaine with or without 1:100,000 eninephine) into the cervix. For use in procedures that require local anaesthetics such as loop excision (LEEP), electro-fulguration, CO2 laser excision and vaporization, and when required, endocervical curettage and cervical biopsies. For use with 2.2ml glass vials, such as those containing local anaesthetic agents.

Device Story

CerviNeedle™ is a disposable cartridge syringe designed for the administration of local anesthetic solutions into the cervix. The device accepts 2.2ml glass vials containing anesthetic agents (e.g., lidocaine with/without epinephrine). It is intended for use by clinicians during gynecological procedures such as LEEP, electro-fulguration, laser excision, and biopsies. The device functions as a manual delivery system, allowing the physician to inject anesthetic directly into the cervical tissue to manage pain during these procedures. By providing a sterile, disposable delivery mechanism, it facilitates local anesthesia, thereby improving patient comfort and enabling the performance of minor surgical interventions in a clinical setting.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual cartridge syringe for 2.2ml glass vials. Disposable, single-use design. Mechanical actuation for fluid delivery. No electronic components, software, or energy sources.

Indications for Use

Indicated for patients undergoing cervical procedures requiring local anesthesia, including loop excision (LEEP), electro-fulguration, CO2 laser excision/vaporization, endocervical curettage, and cervical biopsies.

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™ Disposable Injection Needle (K910252)
• Endocervical Block Needle (K021224)
• Endocervical Block Needle (K973671)

Submission Summary (Full Text)

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## Rocket Medical plc - 510(k) Notification CerviNeedle™ Disposable Cartridge Syringe

K052365

OCT 17 2005

## Summary of Safety and Effectiveness

CerviNeedle™ Disposable Cartridge Syringe Common or usual name:

Cartridge Syringes Classification name:

This is a class II device, registered by Rocket Medical plc (Establishment number: 8010022/9610632). This device is substantially equivalent to medical devices which are currently in commerce and have been submitted to the FDA.

CooperSurgical Inc Potocky Needle™ Disposable Injection Needle #K910252 Wallach Surgical Devices Inc, Endocervical Block Needle, #K021224 A & A Medical Inc, Endocervical Block Needle, #K973671

Based on the indications for use, technical characteristics and comparison to currently commercial marketed devices, the Rocket Medical CerviNeedle™ Disposable Cartridge Syringe has been shown to be safe and effective for it's intended use.

Rocket Medical plc continues to search all appropriate sources for information relating to safety and effectiveness and maintains an in-house reporting system to identify adverse safety and effectiveness information and as such, applicable data is recorded for this product.

## CERTIFICATION

I hereby certify that this Summary of Safety and Effectiveness applies for the above indicated device.

25/8/2005
Date

Tiany Cimar

Signed by Tracy Charlton Regulatory Affairs Manager Rocket Medical plc Wear Industrial Estate, Washington Tyne & Wear, England. NE38 9BZ

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OCT 17 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Tracy Charlton Regulatory Affairs Manager Rocket Medical, PLC Wear Industrial Estate Washington Tyne and Wear UNITED KINGDOM NE38 9BZ

Re: K052365

Koszoos
Trade/Device Name: CerviNeedle™ Disposable Cartridge Syringe Models R57870-00-PK and R57870 Regulation Number: 21 CFR §884.5100 Regulation Name: Obstetric anesthesia set Regulatory Class: II Product Code: HEE Dated: August 25, 2005 Received: August 31, 2005

Dear Ms. Charlton:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have and have determined the device is substantially equivalent (for the indications for use stated in above and her to legally marketed predicate devices marketed in interstate commerce prior to the cholosate) to tegans man date of the Medical Device Amendments, or to devices that have been May 20, 1976, and sharmer with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that recrassitive in accordatios inproval application (PMA). You may, therefore, market the do not require approval or a provisions of the Act. The general controls provisions of the Act ac reo, subject to the good and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket If you devise is classisting to such additional controls. Existing major regulations affecting your Alphovar, It the you soft to anti-ederal Regulations, Title 21, Parts 800 to 898. In addition, FDA are ros blish 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 I rease oc actives that is in that your device complies with other requirements of the Act or any I DA nas made a acternitions administered by other Federal agencies. You must comply with all the r cacal states and regulaing, 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 (QS) (21 CFR Part 801); and if applicable, the clectronic 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 Section 510(k) I his letter with and w yours of substantial equivalence of your device to a legally promatics notification: "The Plassification 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 If you desire specific act 100 for your as a collowing numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation on your responsibilities under the Act from the 807.77). Tou may onain other gational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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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## Indications for Use

510(k) Number (if known):

K052365

Device Name: CerviNeedle™ Disposable Cartridge Syringe

Indications For Use:

For injection of solutions (such as lidocaine with or without 1:100,000 eninephine) into the r or injection of Solutions (outlines that require local anaesthetics such as loop cervix. Tric upplication india CCP), elecro-fulguration, CO2 laser excision and vaporization, and when required, endocervical curettage and cervical biopsies.

For use with 2.2ml glass vials, such as those containing local anaesthetic agents.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Nancy C. Higdon

Division of Reproductive, and Radiological De 510(k) Number

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