(194 days)
Not Found
Not Found
No
The summary describes surgical tools (diathermy loops and coagulation balls) and their intended uses, with no mention of AI, ML, image processing, or data analysis capabilities.
Yes
The device is used for the "diagnosis and treatment" of various conditions, indicating a therapeutic purpose in addition to diagnosis.
Yes
The "Intended Use / Indications for Use" section mentions "Diagnosis and treatment of some Cervical Intraepithelial Neoplasias (CIN I, III) and Cervical Dysplasia," indicating a diagnostic function.
No
The device description explicitly mentions "Diathermy loops and Coagulation Balls," which are physical hardware components used in surgical procedures, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended uses listed (Large Loop Excision, Extrenal Anogenital Lesions, Cervical Conizations, Large Vaginal Intraepithelial Neoplastic Lesions) describe procedures performed on the patient's body for diagnosis and treatment, not the analysis of samples taken from the body.
- The device description is for surgical tools. Diathermy loops and coagulation balls are instruments used in surgical procedures to cut and coagulate tissue. This is a therapeutic and diagnostic procedure performed directly on the patient.
- There is no mention of analyzing biological samples. The description focuses on the physical interaction with tissue.
Therefore, this device falls under the category of a surgical or therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
- Large Loop Excision of the Transformation zone in the Diagnosis and treatment of some ● Cervical Intraepithelial Neoplasias (CIN I, III) and Cervical Dysplasia
- Extrenal Anogenital Lesions. .
- Cervical Conizations. ●
- Large Vaginal Intraepithelial Neoplastic (VAIN) Lesions. ●
Product codes
85 KNF
Device Description
Ultra-Fine™ Diathermy Electrodes
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical, Anogenital, Vaginal
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.4160 Unipolar endoscopic coagulator-cutter and accessories.
(a)
Identification. A unipolar endoscopic coagulator-cutter is a device designed to destroy tissue with high temperatures by directing a high frequency electrical current through the tissue between an energized probe and a grounding plate. It is used in female sterilization and in other operative procedures under endoscopic observation. This generic type of device may include the following accessories: an electrical generator, probes and electrical cables, and a patient grounding plate. This generic type of device does not include devices used to perform female sterilization under hysteroscopic observation.(b)
Classification. Class II (performance standards).
0
Rocket Medical - New 510(k) Notification Ultra-Fine™ Diathermy loops and Coagulation Balls
$\frac{P}{K972856}$
Image /page/0/Picture/2 description: The image shows a black and white logo. The logo is a circle with a cross and a letter "R" inside. The cross is on the left side of the circle, and the letter "R" is on the right side. There are two diagonal lines under the letter "R".
Rocketmedical
FEB 11 1998
Summary of Safety and Effectiveness
Ultra-Fine™ Diathermy Electrodes
Rocket (Establishment number: devices. registered by These are class II 8010022/9610632). These devices are substantially equivalent to a great many medical devices which are currently in commerce and have been submitted to the FDA.
The devices we believe are safe and effective for the application for which they are intended, having been subjected to full design evaluation. They have been on sale and in commercial distribution within the UK and many other countries for more than 8 years and have during this period been found to be safe and effective.
Rocket Medical will, however, 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 and as such, applicable data will be recorded for this product.
CERTIFICATION
I hereby certify that this Summary of Safety and Effectiveness applies for the above indicated device.
21 July '97
Date
TZM
Signed by Leslie Todd Quality Assurance Manager Rocket Medical Wear Industrial Estate, Washington Tyne & Wear, England. NE37 1NE
1
Image /page/1/Picture/2 description: The image shows a logo for the Department of Health. The logo features a stylized depiction of a human head in profile, with three overlapping lines forming the face. The words "DEPARTMENT OF HE" are written vertically along the left side of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 11 100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
Rocket Medical PLC c/o Mr. Richard Keen Compliance Consultants 1151 Hope Street Stamford, CT 06907District 6 Re: K972856 Ultra-Fine™ Diathermy Loops and Coagulation Balls Dated: November 12, 1997 Received: December 4, 1997 Regulatory Class: II 21 CFR 884.4160/Procode: 85 KNF
Dear Mr. Keen:
We have reviewed your Section 510(k) notification of intent to market the device and we have determined the device is substantially equivalent for the indications for use stated in interstate in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 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 requirement, 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 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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" (2) 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/dsmamain.html".
Sincerely yours,
h.7. liau lfi
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal. Ear, Nose and Throat. and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page 1 of 1
Device Name: Ultra-Fine™ Diathermy loops and Coagulation Balls
Indications for Use:
್ಧ
- Large Loop Excision of the Transformation zone in the Diagnosis and treatment of some ● Cervical Intraepithelial Neoplasias (CIN I, III) and Cervical Dysplasia
- Extrenal Anogenital Lesions. .
- Cervical Conizations. ●
- Large Vaginal Intraepithelial Neoplastic (VAIN) Lesions. ●
signature
Signed L. Todd QA and Regulatory Affairs Manager Rocket Medical Plc
11th July 1997
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDHR, Office of Device Evaluation (ODE)
Robert D. Rätting
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K912856
Prescription use
OR
Over-The -Counter Use
(Optional Format 1-2-96)
Rocketmedical