(120 days)
Not Found
No
The 510(k) summary describes a surgical electrode for excision and does not mention any software, image processing, or AI/ML terms.
Yes
The device is used for the "excision of inner cervix during supracervical hysterectomy," which is a treatment for a medical condition, making it a therapeutic device.
No
The device is described as an "Endocervical Hysterectomy Electrode" indicated for "treatment" (excision) during surgery, not for diagnosis.
No
The device is described as an "Endocervical Hysterectomy Electrode," which is a physical surgical instrument, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Excision of inner cervix during supracervical hysterectomy." This describes a surgical procedure performed directly on the patient's body, not a test performed on a sample taken from the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information based on the analysis of samples
- Using reagents or assays
The device is an electrode used for a surgical procedure, which falls under the category of a surgical instrument or device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
Endocervical Hysterectomy Electrode is indicated for treatment of following Condition
- Excision of inner cervix during supracervical hysterectomy.
Product codes
HGI
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
inner cervix
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
MODERN MEDICAL EQUIPMENT MFG. LTD.
5F Gold King Ind. Bldg., - Tai Lin Pai Rd., - KwaiChung, Hong Kong
Modern Medical Equipment
C/O E & M Engineering 1705 Dabney Road, Richmond, Va. 23230
Tel : (804) 353 7160 Fax : 804 - 353 7161 21 June 2007
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401)
Rockville, Maryland 20850 Re: 510(k) Premarket Notification, 510 K # 070877
Gyn LLETZ Electrode
Dear Sir or Madam, RE: 510(k) Notification
9200 Corporation Blvd.
This is to notify you that Modern Medical intends to manufacture the following device and market it in the United States.
The following information and the attached technical information are provided in accordance with 21CFR 807.87
a. Device Name
| Classification Name: | Gyn LLETZ Electrode |
|---|---|
| Common/ Usual name: | LOOP Electrode |
| Proprietary Name: | Endocervical Electrode / EZ hysterectomy Electrode |
b. Establishment Registration
| Owner Operator number | 9005334 |
|---|---|
| Registration number: | 9680721 |
| Establishment Name, | Modern Medical Equipment |
| C/O E & M Engineering | |
| 1705 Dabney Road, | |
| Richmond, Va. 23230 |
JUL 2 7 2007
1
K070877 page 2 of 2
Telephone: Fax: Email address: (804) 353 7160 (804)353 7161 bstillman@enmengineering.com
c. Classification Information Classification and Review Panel: Obstetrics/Gynecology
Class:
Product Code HGI
- d. Performance Standards or Special Controls
Meet the electrical and mechanical requirements of ANSI/AAMI HF-18 Standard for Electrosurgical Devices.
II
-
e. Labeling
Copies of draft labeling for this device is attached -
f. Rationale for Substantial Equivalence
The subject device is substantially equivalent to the predicate device.
| Company | Jevice | K number |
|---|---|---|
| Apple Medical | Fisher Cone Biopsy Electrode | |
| and the comments of the comments of the comments of the comments of the comments of the comments of the comments of the contribution of the contribution of the contribution o | K061651 |
A discussion regarding the reason and basis for substantial equivalence of the device to the legally marketed predicate device is attached, "Substantial Equivalence to Predicate Devices".
In accordance with the Safe Medical Devices Act of 1990 (SMDA), the safety and effectiveness information upon which this substantial equivalence determination is based will be made available by Modern Medical to interested persons upon request.
To the best of my knowledge, the information and date submitted herein is truthful and accurate. If you require any additional information or clarification, please contact me.
Sincerely,
Bob Stitt
Bob Stillman Modern Medical Equipment
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
JUL 27 2007
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Modern Medical Equipment % Mr. Bob Stillman Official Correspond E & M Engineering, Inc. 1705 Dabney Road RICHMOND VA 23230
Re: K070877
Trade/Device Name: Endocervical Hysterectomy Electrode Regulation Number: 21 CFR 884.4120 Regulation Name: Gynecologic electrocautery and accessories Regulatory Class: II Product Code: HGI Dated: July 13, 2007 Received: July 16, 2007
Dear Mr. Stillman:
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 (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 898. In addition FDA may publish further announcements concerning your device in the Federal Register.
Image /page/2/Picture/10 description: The image is a black and white circular logo. The logo has the letters "FDA" in the center. Above the letters, the numbers "1906-1906" are written. Below the letters, the word "Centennial" is written. There are three stars below the word "Centennial".
omoting Publio Hoalth
3
Page 2 -
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 Part 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 Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology). | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours.
Nancy Chogdon
Nancy C. Brogdon Director. Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
U.S. Food and Drug Administration
Center for Devices and Radiologic Health
Indications for Use
510K number (if known) : K070877 Device Name : Endocervical Hysterectomy Electrode
Indications for Use A. Endocervical Hysterectomy Electrode is indicated for treatment of following Condition
- Excision of inner cervix during supracervical hysterectomy.
| Prescription Use | |
|---|---|
| Use | |
| (Part 21 CFR 801 Subpart D) |
AND/OR
Over-The counter
CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office device evaluation (ODE)
Helene Renner
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number