(90 days)
The RI. MOS. Cervical and Intracervical Anaesthesia Needles are used to apply cervical and intracervical anesthesia block.
The RI. MOS. s.r.l. cervical and intracervical needles operate with standard medical syringes are are sterile, single-use, disposable devices.
The provided text is a 510(k) summary for a medical device: "RI. MOS. s.r.l. cervical anesthesia needle and intracervical anesthesia needle." This document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study that establishes performance against specific acceptance criteria.
Therefore, most of the requested information regarding acceptance criteria and performance studies is not available in the provided text. The 510(k) process for devices like needles primarily relies on showing that the new device has the same intended use, technological characteristics, and performance as an existing, legally marketed device.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Not Available. The document does not define specific acceptance criteria (e.g., in terms of mechanical strength, sterility, or anesthesia efficacy) nor does it report the device's performance against such criteria. The submission is a claim of substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Available. No test study or data provenance is mentioned.
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 Available. There is no mention of a test set, experts, or ground truth establishment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Available. No adjudication method is mentioned as there is no test set or study.
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 is a medical needle, not an AI-assisted diagnostic device. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a medical needle, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Available. No ground truth is established or mentioned in the context of a performance study. For a 510(k) submission of this type, the "ground truth" for regulatory review is the substantial equivalence to a predicate device based on its intended use and technological characteristics.
8. The sample size for the training set
- Not Applicable. This is not a machine learning or AI device that would require a training set.
9. How the ground truth for the training set was established
- Not Applicable. As above, no training set or associated ground truth establishment.
Summary of available information from the document:
- Device Name: RI. MOS. s.r.l. cervical anesthesia needle and intracervical anesthesia needle.
- Intended Use: Applying cervical and intracervical anesthesia block.
- Predicate Device: Potocky Needle® marketed by CooperSurgical.
- Basis for Acceptance: Substantial equivalence to the predicate device, meaning the new device has "the same or similar technological characteristics" and intended use as the predicate. The FDA's letter (FEB 1 1999) explicitly states that the device is "substantially equivalent" for the stated indications for use.
- Device Characteristics: Sterile, single-use, disposable devices that operate with standard medical syringes.
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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.
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- The submitter of this premarket notification is:
Adena S. Riemer Affiliate EXPERTech Associates, Inc. 100 Main Street, Suite 120 Concord, MA 01742
- The submitter of this premarket notification is:
Tel: (978) 371-0066 Fax: (978) 371-1676
This summary was prepared on October 20, 1998.
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- The name of the RI. MOS. s.r.l. device is cervical anesthesia needle and intracervical anesthesia needle.
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- The above device is substantially equivalent to the Potocky Needle® marketed by CooperSurgical.
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- The RI. MOS. s.r.l. cervical and intracervical needles operate with standard medical syringes are are sterile, single-use, disposable devices.
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- The device is intended for applying cervical and intracervical anesthesia block.
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- 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 (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/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.
009
§ 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).