(421 days)
Not Found
Not Found
No
The device description focuses on electrosurgical electrodes and their physical configurations, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No
The device, Northgate's Cutting Loops and Knife Electrosurgical Electrodes, are adjuncts used during therapeutic procedures rather than being therapeutic devices themselves. They are tools used to cut and coagulate soft tissue for therapeutic ends like endometrial ablation or fibroid removal.
No
The device description states that the electrodes are used "to cut and coagulate soft tissue during electrosurgical procedures," which indicates a therapeutic rather than a diagnostic function. The "Intended Use / Indications for Use" also lists procedures that involve removal, transection, or ablation, all of which are treatments, not diagnoses.
No
The device description clearly states it is comprised of "Cutting Loops and Knife Electrosurgical Electrodes" and "Vapor-Tech Series Electrodes" with various tip configurations, which are physical hardware components used in electrosurgical procedures.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description clearly states that this device is used for electrosurgical procedures to cut and coagulate soft tissue within the uterus. This is a surgical intervention performed directly on the patient's body, not a test performed on a sample outside the body.
- Intended Use: The listed intended uses are all surgical procedures (biopsy, removal of fibroids/polyps, myomectomy, transection of adhesions/septa, endometrial ablation). None of these involve analyzing a sample for diagnostic purposes.
Therefore, this device falls under the category of a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
-
- Directed Biopsy
-
- Removal of submucous fibroids and large polyps
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- Submucous myomectomy
-
- Transection of intrauterine adhesions
-
- Transection of intrauterine septa
-
- Endometrial ablation
Product codes (comma separated list FDA assigned to the subject device)
85 HGI, 85 HIH
Device Description
Northgate's Cutting Loops and Knife Electrosurgical Electrodes are designed to be used with most major brands of Resectoscopes. The electrodes are used to cut and coagulate soft tissue during electrosurgical procedures.
The Vapor-Tech Series Electrodes are designed with several tip configurations: roller ball, roller barrel, cross grooved, grooved roller, ball, and Sled™
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 884.1690 Hysteroscope and accessories.
(a)
Identification. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
0
Image /page/0/Picture/0 description: The image shows a black background with many small white dots scattered across it. The dots are not uniformly distributed, but rather appear to be clustered in certain areas. The overall impression is that of a night sky filled with stars, or perhaps a grainy image of a textured surface.
SUMMARY OF SAFETY AND EFFECTIVENES
Common/Usual Name: Electrosurgical Electrodes
Proprietary Name: Vapor-Tech Roller Ball, Vapor-Tech Roller Barrel, Vapor-Tech Cross Grooved. Vapor-Tech Grooved Roller Vapor-Tech Ball, Vapor-Tech Sled™, Cutting Loop, and AUG - 8 1997 Knife Electrosurgical Electrodes
Classification: CLASS II
Materials:
All materials used to manufacture the Northgate Technologies Inc. Electrodes are non-toxic and have been previously used to manufacture other medical devices.
Description:
Northgate's Cutting Loops and Knife Electrosurgical Electrodes are designed to be used with most major brands of Resectoscopes. The electrodes are used to cut and coagulate soft tissue during electrosurgical procedures.
The Vapor-Tech Series Electrodes are designed with several tip configurations: roller ball, roller barrel, cross grooved, grooved roller, ball, and Sled™
Substantlal Equivalence:
Northgate's Electrosurqical Electrodes are substantially equivalent in design, materials, and intended use to numerous currently marketed devices. Other manufacturers of similar devices are Circon/ACMI, Olympus, Storz Products, Inc., and Richard Wolf.
Intended Use:
-
- Directed Biopsv
-
- Removal of submucous fibroids and large polyps
-
- Submucous myomectomy
-
- Transection of intrauterine adhesions
-
- Transection of intrauterine septa
-
- Endometrial ablation
600 Church Road, Elgin, II_60123 1-800-348-0424 IL: 847-608-8900 FAX: 847-608-9405 Northgate Technologies Incorporated
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Public Health Service
85 HIH
85 HGI
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 8 1997
Mr. Casey Kurek Re: K962271 Regulatory Manaqer Vapor-Tech™ Hysteroscopic Electrosurgical Electrodes Northgate Technoloqies, Inc. (Roller Ball, Roller Barrel, Cross Grooved, Grooved 600 Church Road Roller, Ball, Sled™, Cutting Loop and Knife) Elgin, Illinois 60123 Dated: May 13, 1997 Received: May 14, 1997 Regulatory Class: II
Dear Mr. Kurek:
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 devices marketed 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.
21 CFR §884.1690/Product Code:
21 CFR §884.4120/Product Code:
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 requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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" (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/dsmamain.html".
Sincerely yours,
W. Liao Yi-Ju
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
1 of Page
K962271 510(k) Number (if known):
Vapor-Tech™ Hysteroscopic Electrosurgical Electrodes Device Name: (Roller Ball, Roller Barrel, Cross Grooved, Grooved Roller, Ball, Sles™, Cutting Loop and Knife) --------------------------------------------------------------------------
Indications For Use:
-
- Directed Biopsy
-
- Removal of submucous fibroids and large polyps
-
- Submucous myomectomy
-
- Transection of intrauterine adhesions
-
- Transection of intrauterine septa
-
- Endometrial ablation
Cary Kurek 8.8.97
C. Kurek, Regulatory Manager
요소비율 C T T 박 번 T -
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
| Colin Ballard | |
|---|---|
| 510(k) Number | K962271 |
| Prescription Use | ✓ | OR | Over-the-Counter Use ______ |
|---|---|---|---|
| (Per 21 CFR 801.109) |
(Optional Format 1-2-96)