(49 days)
Not Found
No
The summary describes a disposable cartridge syringe for injecting solutions into the cervix and does not mention any AI or ML capabilities.
Yes
The device is used for injecting local anesthetics into the cervix for medical procedures, which aligns with the definition of a therapeutic device as it delivers a substance for treatment or pain relief.
No
The device is described as a "Disposable Cartridge Syringe" intended for the "injection of solutions (such as lidocaine)" into the cervix for local anesthesia during procedures like biopsies and excisions. It is used to deliver a substance, not to diagnose a condition.
No
The device description explicitly states "CerviNeedle™ Disposable Cartridge Syringe," indicating a physical, hardware-based medical device for injection. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the injection of solutions into the cervix for local anesthesia and related procedures. This is a therapeutic and procedural use, not a diagnostic one.
- Device Description: The device is described as a "Disposable Cartridge Syringe," which is a tool for delivering substances into the body.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the body (like blood, urine, tissue, etc.) or providing information for diagnosis. IVDs are designed to perform tests on such samples to provide diagnostic information.
Therefore, the CerviNeedle™ Disposable Cartridge Syringe is a medical device used for a therapeutic/procedural purpose, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
HEE
Device Description
Rocket Medical CerviNeedle™ Disposable Cartridge Syringe
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Rocket Medical plc - 510(k) Notification CerviNeedle™ Disposable Cartridge Syringe
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
1
Image /page/1/Picture/2 description: The image shows a logo with a stylized bird-like figure composed of three curved lines, resembling feathers or wings. The logo is encircled by text that reads vertically along the left side of the circle. The text appears to be in a sans-serif font and is oriented to be read from bottom to top.
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.
2
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 (800) 638-2041 or (301) 443-6597 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
3
Indications for Use
510(k) Number (if known):
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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