(49 days)
For injection of solutions (such as lidocaine with or without 1:100,000 eninephine) into the cervix. This application includes outlines that require local anaesthetics such as loop excision (LEEP), 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.
CerviNeedle™ Disposable Cartridge Syringe
The provided text is a 510(k) summary for the Rocket Medical plc CerviNeedle™ Disposable Cartridge Syringe. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study data against specific acceptance criteria.
Therefore, many of the requested details about acceptance criteria, performance studies, sample sizes, and expert qualifications are not present in this document.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria or detailed performance data against them are provided in the 510(k) summary. The summary states:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in terms of quantitative metrics. | The device is "safe and effective for its intended use" based on "indications for use, technical characteristics and comparison to currently commercial marketed devices." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not provided. The 510(k) summary does not describe a performance study with a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not provided. The 510(k) summary does not describe a performance study that involved experts establishing ground truth for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No performance study requiring adjudication is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a manual cartridge syringe, not an AI-powered diagnostic device. Therefore, an MRMC study related to AI assistance for human readers is irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a manual medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the context of a performance study for this device. The "ground truth" for the 510(k) submission is the demonstration of substantial equivalence to existing, legally marketed predicate devices.
8. The sample size for the training set
Not applicable. This device does not use machine learning or require a training set.
9. How the ground truth for the training set was established
Not applicable. This device does not use machine learning or require a training set.
Summary of Safety and Effectiveness Information Presented (from the document):
The 510(k) submission for the CerviNeedle™ Disposable Cartridge Syringe relies on demonstrating substantial equivalence to existing predicate devices. The key elements are:
- Substantial Equivalence: The device is deemed substantially equivalent to the CooperSurgical Inc Potocky Needle™ Disposable Injection Needle (#K910252), Wallach Surgical Devices Inc, Endocervical Block Needle (#K021224), and A & A Medical Inc, Endocervical Block Needle (#K973671).
- Basis for Safety and Effectiveness: The conclusion of safety and effectiveness is drawn from "indications for use, technical characteristics and comparison to currently commercial marketed devices." This implies that because the device is technically similar and intended for the same uses as already approved devices, it is considered safe and effective.
- Ongoing Monitoring: Rocket Medical plc states they "continue 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." This indicates a post-market surveillance commitment rather than detailed pre-market study data in the 510(k).
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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
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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.
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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 (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
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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
Page 1 of 1
§ 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).