(169 days)
No
The description focuses on the electrosurgical modes and mechanical aspects of the device, with no mention of AI, ML, or related concepts.
Yes
The device delivers electrosurgical energy to cut and/or coagulate soft tissue, which are therapeutic actions in surgical procedures.
No
This device is designed to cut and/or coagulate soft tissue using electrosurgical energy during surgical procedures, not to diagnose medical conditions.
No
The device description clearly states it is a handheld, reusable hardware device (forceps and electrodes) designed to deliver electrosurgical energy.
No, 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. These tests are performed outside the body (in vitro).
- Device Function: The description clearly states that this device is used during surgical procedures to cut and/or coagulate soft tissue using electrosurgical energy. This is a direct intervention on the body, not a test performed on a sample.
The device's purpose is therapeutic and surgical, not diagnostic.
N/A
Intended Use / Indications for Use
The Black and Black monopolar forceps and electrodes are reusable devices intended for use in surgical procedures (such as general, urologic, thoracic, plastic and reconstructive, gynecologic, arthroscopic) where the surgeon desires monopolar radio-frequency electrosurgical energy to cut and/or coagulate tissue.
The Black and Black Surgical monopolar electrodes and forceps are reusable devices intended for use in surgical procedures (such as general, urologic, thoracic, plastic and reconstructive, gynecologic, arthroscopic) where the surgeon desires monopolar radio-frequency electrosurgical energy to cut and/or coagulate soft tissue.
Product codes
GEI
Device Description
The Black and Black monopolar forceps and electrodes are handheld, reusable devices designed to deliver monopolar RF electrosurgical energy to a surgical site to cut and/or coagulate tissue.
The surgeon activates the desired electrosurgical mode from the sterile field by using buttons on the device. Three electrosurgical modes are available:
- Cut: cuts tissue with minimal coagulation / hemostasis --
- Hemostasis with Division: divides tissue with controlled hemostasis
- Coag: coagulates bleeding vessels to promote hemostasis
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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)
K033232, Valleylab Bayonet Forceps, Conmed Bayonet Straight Tip with Cable, Snowden-Pencer Endo-Plastic Electrosurgical Dissector, Snowden-Pencer Monopolar Insulated Forceps, Olsen Hand Activated Monopolar Forceps
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
Norman M. Black III
2759 Hawthorne Drive
Atlanta, GA 30345
nblack3@mac.com
404-428-1813
K072/24
510(k) Summary of Safety and Effectiveness
1. Submitter Information
Norman M. Black III d/b/a Black and Black Surgical, Inc. 2759 Hawthorne Drive Atlanta, GA 30345 Contact: Norman Black Telephone: 404-428-1813 Fax Number: 770-491-3980 e-mail: nblack3@mac.com
Date summary prepared: August 1, 2007
2. Name of Device
Trade or Proprietary Name: Black and Black Electrosurgical Cutting and Coagulation Forceps and Electrodes
Common Name: Monopolar electrosurgical device
Classification Name: Class II, 21 CFR 878.4400, Electrosurgical Cutting and Coagulation Device and Accessories, Panel 79, GEI, General and Plastic Surgery
3. Predicate Devices
The Black and Black Surgical monopolar forceps and electrodes are substantially in function and intended use to the Colorado MicroDissection Needle (K033232), Valleylab Bayonet Forceps, Conmed Bayonet Straight Tip with Cable, Snowden-Pencer Endo-Plastic Electrosurgical Dissector. Snowden-Pencer Monopolar Insulated Forceps, and Olsen Hand Activated Monopolar Forceps. All devices are used for monopolar electrosurgery, allowing the surgeon to actuate the electrosurgical generator from the sterile field using either push button controls or a foot switch on the device.
4. Device Description
The Black and Black monopolar forceps and electrodes are handheld, reusable devices designed to deliver monopolar RF electrosurgical energy to a surgical site to cut and/or coagulate tissue.
JAN
18 2008
1
Norman M. Black III 2759 Hawthorne Drive Atlanta, GA 30345 nblack3@mac.com 404-428-1813
(Device Description continued)
The surgeon activates the desired electrosurgical mode from the sterile field by using buttons on the device. Three electrosurgical modes are available:
- Cut: cuts tissue with minimal coagulation / hemostasis --
- Hemostasis with Division: divides tissue with controlled hemostasis
- ﮯ Coag: coagulates bleeding vessels to promote hemostasis
5. Intended Use
The Black and Black monopolar forceps and electrodes are reusable devices intended for use in surgical procedures (such as general, urologic, thoracic, plastic and reconstructive, gynecologic, arthroscopic) where the surgeon desires monopolar radio-frequency electrosurgical energy to cut and/or coagulate tissue.
There are no specific contraindications associated with the Black and Black monopolar forceps and electrodes.
6. Summary of Technological Characteristics
The Black and Black monopolar forceps and electrodes have the same basic technological characteristics as the predicate devices noted above.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is facing to the right.
Public Health Service
JAN 1 8 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Black & Black Surgical, Inc. % Mr. Norman Black President 2759 Hawthorne Drive Atlanta, Georgia 30345
Re: K072124
Trade/Device Name: Black and Black Electrosurgical Cutting and Coagulation Forceps and Electrodes Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories. Regulatory Class: Class II Product Code: GEI Dated: December 05, 2007 Received: December 06, 2007
Dear Mr. Black.:
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 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.
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.
3
Page 2 - Mr. Norman Black
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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/cdrh/industry/support/index.html.
Sincerely yours,
Mark N Mulhearn
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Norman M. Black III 2759 Hawthorne Drive Atlanta, GA 30345 nblack3@mac.com 404-428-1813
Indications for Use
510(k) Number (K072124):
Device Name: Black and Black Electrosurgical Cutting and Coagulation Forceps and Electrodes
Indications For Use:
The Black and Black Surgical monopolar electrodes and forceps are reusable devices intended for use in surgical procedures (such as general, urologic, thoracic, plastic and reconstructive, gynecologic, arthroscopic) where the surgeon desires monopolar radio-frequency electrosurgical energy to cut and/or coagulate soft tissue.
AND/OR Prescription Use __ x __ (Part 21 CFR 801 Subpart D)
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R. Ogden
Sorminen
(Division Division of General, Restorative, and Neurological Devices
510(k) Number K072124
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