(88 days)
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Not Found
No
The provided 510(k) summary describes a device for soft tissue cutting and coagulation. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses on the intended use and anatomical site, which are consistent with a traditional surgical device.
Yes
The device is described as being used for "soft tissue cutting of the uterine cervix and coagulation, intraepithelial neoplasia, condylomata acuminata, and miscellaneous lesions," which are all therapeutic interventions.
No
The device is described for "soft tissue cutting" and "coagulation" of various lesions, which are therapeutic procedures, not diagnostic ones.
No
The provided 510(k) summary describes a device for soft tissue cutting and coagulation, which inherently requires hardware (e.g., an electrosurgical unit or laser) to perform these physical actions. The summary does not mention any software-only function like image analysis or data processing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used for soft tissue cutting and coagulation of the uterine cervix and various lesions. This is a surgical or therapeutic procedure performed directly on the patient's body.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body (such as blood, urine, or tissue) to detect diseases, conditions, or infections. They are used outside the body ("in vitro").
The description clearly indicates a device used on the patient for treatment, not a test performed on a sample from the patient.
N/A
Intended Use / Indications for Use
To be used for soft tissue cutting of the uterine cervix and coagulation, intraepithelial neoplasia, condylomata acuminata, and miscellaneous lesions; polyps, molluscum contagiosum, nevi, seborrheic keratosis, achricordon, etc.
Product codes
85 HGI
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
uterine 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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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
§ 884.4120 Gynecologic electrocautery and accessories.
(a)
Identification. A gynecologic electrocautery is a device designed to destroy tissue with high temperatures by tissue contact with an electrically heated probe. It is used to excise cervical lesions, perform biopsies, or treat chronic cervicitis under direct visual observation. This generic type of device may include the following accessories: an electrical generator, a probe, and electrical cables.(b)
Classification. Class II (performance standards).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is a common symbol associated with healthcare and medicine. The text "Department of Health" is arranged around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 2002
Re: K022593
Mr. Thomas J. Zinnanti President and CEO Thomas Medical, Inc. 4100-C Nine McFarland Drive ALPHARETTA GA 30004
Trade/Device Name: Thomas Medical Electrodes Regulation Number: 21 CFR 884.4120 Regulation Name: Gynecologic electrocautery and accessories
Regulatory Class: II Product Code: 85 HGI Dated: July 30, 2002 Received: August 5, 2002
Dear Mr. Zinnanti:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 (Act) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish 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 FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Par: 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Aet); 21 CFR 1000-1050,
1
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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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/dsmaldsmamain.html.
Sincerely yours.
Nancy C. Snogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Section #4
...
:
:
Indications for Use
| 510(k) Number: | K022593 (to be assigned) |
|---|---|
| Device Name: | Thomas Medical Electrodes |
| Intended Use: | To be used for soft tissue cutting of the uterine cervix and coagulation, intraepithelial neoplasia, condylomata acuminata, and miscellaneous lesions; polyps, molluscum contagiosum, nevi, seborrheic keratosis, achricordon, etc. |
:
:
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ |
|---|---|
| (Per CFR 801.109) |
OR
| Over-the-counter use | ____________________ |
|---|---|
| ---------------------- | ---------------------- |
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number |
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