(228 days)
Not Found
No
The summary describes a mechanical device (cannulae and needles) for aspiration and infusion, with no mention of software, algorithms, or any terms related to AI/ML.
Yes
The device is indicated for "aesthetic body contouring and general tissue aspiration," which involves medical procedures for therapeutic and reconstructive purposes.
No
The device is described as cannulae and needles used for aspiration and infusion, specifically for removing fluid, soft tissue, and exudates, or for infusing substances for aesthetic body contouring. Its purpose is interventional (removal/infusion of material), not to diagnose a condition or disease.
No
The device description clearly states it is a hollow stainless steel tube with multiple tips, handle, and attachment connectors, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "aesthetic body contouring and general tissue aspiration." This describes a procedure performed directly on a patient's body, not a test performed on a sample taken from a patient outside the body.
- Device Description: The description details a device used to "remove fluid, soft tissue, and exudates and infusion" during surgical procedures. This is a surgical instrument, not a device used for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue samples) or providing diagnostic information based on such analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is purely procedural (aspiration and infusion).
N/A
Intended Use / Indications for Use
The aspiration and infusion cannulae and needles are indicated for aesthetic body contouring and general tissue aspiration.
Product codes (comma separated list FDA assigned to the subject device)
MUU, GEA (original letter), QPB (administrative change letter)
Device Description
Black and Black Surgical Cannulae and Needles are used to remove fluid, soft tissue, and exudates and infusion, utilizing a hollow stainless steel tube and multiple tips, handle and attachment connectors that are in reusable and disposable configuration. They are used during general, plastic, and reconstructive procedures.
Black and Black Surgical Cannulae and Needles are manufactured of stainless steel tubes, with Aluminum Handles.
The patient contacting material in Black and Black Surgical Cannulae and Needles is stainless steel.
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.
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
§ 878.5040 Suction lipoplasty system.
(a)
Identification. A suction lipoplasty system is a device intended for aesthetic body contouring. The device consists of a powered suction pump (containing a microbial filter on the exhaust and a microbial in-line filter in the connecting tubing between the collection bottle and the safety trap), collection bottle, cannula, and connecting tube. The microbial filters, tubing, collection bottle, and cannula must be capable of being changed between patients. The powered suction pump has a motor with a minimum of1/3 horsepower, a variable vacuum range from 0 to 29.9 inches of mercury, vacuum control valves to regulate the vacuum with accompanying vacuum gauges, a single or double rotary vane (with or without oil), a single or double diaphragm, a single or double piston, and a safety trap.(b)
Classification. Class II (special controls). Consensus standards and labeling restrictions.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Norman M. Black III Norman Black CEO 2759 Hawthorne Drive Ne Atlanta, Georgia 30345
June 9, 2021
Re: K113795
Trade/Device Name: Suction Lipolasty Accessories Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: QPB
Dear Norman Black:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated August 7, 2012. Specifically, FDA is updating this SE Letter because FDA has created a new product code to better categorize your device technology.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Cindy Chowdhury, OHT4: Office of Surgical and Infection Control Devices, 240-402-6647, Cindy.Chowdhury@fda.hhs.gov.
Sincerely,
Cindy Chowdhury -S
Cindy Chowdhury, Ph.D., M.B.A. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AUG 7 2012
Black and Black Surgical, Incorporated % Mr. Norman M. Black III Chief Executive Officer 2759 Hawthorne Drive, Northeast Atlanta, Georgia 30345
Re: K113795
Trade/Device Name: Liposuction Aspiration and Tumescent Infiltration Cannulae and Needles Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: MUU, GEA Dated: June 29, 2011 Received: July 05, 2011
Dear Mr. Black III:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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
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Page 2 - Mr. Norman M. Black III
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K113795
Device Name: Liposuction Aspiration and Tumescent Infiltration Cannulae and Needles
Indications for Use:
The aspiration and infusion cannulae and needles are indicated for aesthetic body contouring and general tissue aspiration.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The Counter Use (21 CFR 801 Subpart C)
ﺮ
(Please Do NoT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dai KMM
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K113795
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510(k) Summary in accordance with 21CFR 807.92. Assigned 510(k) number is K113795 Traditional 510(k) Submission by: Black & Black Surgical, Inc. 5238 Royal Woods Parkway Suite 170 Tucker, GA 30084 USA 770-414-4880 Contact Person: Norman M. Black III CEO, Black & Black Surgical Inc. 770-414-1813
C
A
AUG
7 2012
ACK & BLACK
Date Prepared: June 29, 2012
Establishment Registration Number: 3006142527
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| Suction Lipoplasty System | 21 CFR 878.5040 (05 Jan 1998)
Manual Surgical Instruments for General Use | | | |
|---------------------------------|------------------------------------------------------------------------------|--|--|--|
| | 21 CFR 878.4800 (1994) | | | |
| Common Usual Name: | Aspiration and infiltration Cannulae/Needles | | | |
| Proprietary Name: | - Lipoplasty/Liposuction Aspiration and | | | |
| | Tumescent Infiltration Cannulae/Needles | | | |
| | (Cannulae and Needles) | | | |
| Classification Name: | Class II, 21 CFR 878.5040, Suction Lipoplasty System, Panel | | | |
| | 79, MUU, General and Plastic Surgery | | | |
| Predicate Device: | Suction Cannulae and Needles | | | |
| Manufacturer: | Byron Medical, Inc. | | | |
| 510(k) Number: | K981172 | | | |
| Substantially Equivalence Date: | June 30, 1998 | | | |
| Device Description: | Black and Black Surgical Cannulae and Needles are used to remove fluid, | | | |
| | and exudates and infusion utilizing a hollow stainless steel tube and mul | | | |
soft tissue, and exudates and infusion, utilizing a hollow stainless steel tube and multiple tips, handle and attachment connectors that are in reusable and disposable configuration. They are used during general, plastic, and reconstructive procedures.
Device Description Chart
| Description* | Product Code | Length | Features | Packaging |
|---|---|---|---|---|
| Cannulae & | ||||
| Needles | B8- AAA- | |||
| B8-ZZZ | Various | Straight | 1 each |
Black and Black Surgical Cannulae and Needles are manufactured of stainless steel tubes, with Aluminum Handles.
The patient contacting material in Black and Black Surgical Cannulae and Needles is stainless steel.
The aspiration and infusion cannulae and needles indications are for aesthetic body Indication for Use: contouring and general tissue aspiration.
Shared Technical Characteristics with Predicate Device:
The Black and Black Surgical Cannulae and Needles are substantially equivalent in function and intended use to the Byron Suction Cannulae and Needles (K981172). Both devices are used for aesthetic body contouring and general tissue aspiration by means of aspiration and infiltration which the FDA has found to be substantially equivalent to these devices in accordance with Section 878.5040 Suction Lipoplasty System.
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