(366 days)
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No
The summary describes a purely mechanical device (cannulae and needles) for aspiration and infusion, with no mention of software, algorithms, or any terms related to AI/ML.
No
The device is indicated for aesthetic body contouring and general tissue aspiration, which are not typically considered therapeutic interventions for a disease or condition. It is used for procedures like removing fluid, soft tissue, and exudates, often in plastic and reconstructive surgery.
No
Explanation: The provided text describes the device's use for aspiration and infusion, specifically for removing fluid, soft tissue, and exudates, and for infusion in aesthetic body contouring and general tissue aspiration. These are therapeutic or procedural actions, not diagnostic ones. There is no mention of the device being used to identify or characterize a disease, condition, or health status.
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" and "remove fluid, soft tissue, and exudates and infusion". This describes a device used on the body for surgical or procedural purposes, not for testing samples outside the body to diagnose or monitor a condition.
- Device Description: The description details a "hollow stainless steel tube and multiple tips, handle and attachment connectors" used during "general, plastic, and reconstructive procedures". This aligns with surgical instruments, not diagnostic tests.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue samples) to provide diagnostic information. The device is used for physical manipulation of tissue and fluids.
- Predicate Device: The predicate device is "Suction Cannulae and Needles" (K113795), which are also surgical instruments, not IVDs.
In summary, the device's function and intended use clearly place it in the category of a surgical or procedural instrument, not an in vitro diagnostic device.
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
QPB, MUU, GEA
Device Description
INEX 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 disposable in configuration. They are used during general, plastic, and reconstructive procedures. INEX Cannulae and Needles are manufactured of stainless steel tubes, with Plastic Handles and Plastic Hubs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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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)
Biocompatibility testing per ISO-10993 demonstrated that the device is biocompatible.
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
§ 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 shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 9, 2021
Inex Raymond Patel Business Manager Za La Gobette 60540 Puiseux Le Hauberger Puiseux Le Hauberger, 60540 France
Re: K132353
Trade/Device Name: Suction Lipoplasty Accessories Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: QPB
Dear Raymond Patel:
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 July 30, 2014. 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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 30, 2014
INEX Mr. Raymond Patel Business Manager ZA LA GOBETTE 60540 Puiseux Le Hauberger France
Re: K132353
Trade/Device Name: Cannulae and Needles Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: MUU, GEA Dated: June 27, 2014 Received: June 30, 2014
Dear Mr. Patel:
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 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
2
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
for
Sincerely yours,
David Krause -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known)
Device Name Cannulae and Needles
Indications for Use (Describe)
The aspiration and infusion cannulae and needles are indicated for aesthetic body contouring and general tissue aspiration.
Type of Use (Select one or both, as applicable) [x] Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY ﺗﺮ : Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
04'00
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INEX
510(k) Summary in accordance with 21CFR 807.92.
Traditional 510(k) Submission by:
JUL 3 0 2014
INEX ZA LA GOBETTE 60540 Puiseux Le Hauberger France laboinex@wanadoo.fr Contact Person: Raymond Patel INEX 33(0)3.44.74.19.95
Date Prepared: July 29, 2014
Establishment Registration Number: 10042355
| 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: Black & Black Surgical, Inc. | |
| 510(k) Number: K113795 | |
| Substantially Equivalence Date: August 7, 2012 |
Device Description: INEX Cannulae and Needles are used to remove fluid, soft tissue, andCannulae and Needles are used to remove fluid, soft tissue, and exudates and infusion, INEX Device Description: utilizing a hollow stainless steel tube and multiple tips, handle and attachment connectors that are disposable in configuration. They are used during general, plastic, and reconstructive procedures.
Device Description Chart Length Features Packaging Description * Product Code 1 each, 10/box & Cannulae & A - Z letters and Various Straight and . curved 20/box 1 - 0 numbers. Needles
INEX Cannulae and Needles are manufactured of stainless steel tubes, with Plastic Handles and Plastic Hubs.
The aspiration and infusion cannulae and needles are indicated for aesthetic body contouring Indication for Use: and general tissue aspiration.
Shared Technical Characteristics with Predicate Device:
The INEX Cannulae and Needles are substantially equivalent in function and intended use to the Black Surgical Cannulae and Needles (K113795). Both devices are used for aesthetic body contouring and general tissue aspiration by means of aspiration and infiltration.
Biocompatibility testing per ISO-10993 demonstrated that the device is biocompatible.
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| Device | Design | Material | Function |
|---|---|---|---|
| INEX | Handle; Cannula | ||
| tube; Tip | Plastic Handle; | ||
| Stainless Steel | |||
| Cannula Tube; | |||
| Stainless Steel Tip | |||
| with eyelets(holes) | The Handle is used to grip (hold) and to | ||
| connect via tubing to the aspirator, wall | |||
| suction or pump; the Cannula tube is | |||
| used to provide length and strength; the | |||
| Tip is used to provide suction and | |||
| infiltration through eyelets (holes) in the | |||
| tip. | |||
| Black & Black | Handle; Cannula | ||
| tube; Tip | Aluminum Handle; | ||
| Stainless Steel | |||
| Cannula Tube; | |||
| Stainless Steel Tip | |||
| with eyelets(holes) | The Handle is used to grip (hold) and to | ||
| connect via tubing to the aspirator, wall | |||
| suction or pump; the Cannula tube is | |||
| used to provide length and strength; the | |||
| Tip is used to provide suction and | |||
| infiltration through eyelets (holes) in the | |||
| tip. | |||
| INEX | Luer Hub; Needle Tip | Polypropylene Luer hub; | |
| Stainless Steel Cannula | |||
| Tube; Stainless Steel Tip | |||
| with eyelets(holes) | The Luer hub is used to connect to an | ||
| aluminum handle via tubing to the | |||
| aspirator, wall suction, or pump; the | |||
| Cannula tube is used to provide length and | |||
| strength; the Tip is used to provide suction | |||
| and infiltration through eyelets (holes) in | |||
| the tip. |
Summary
The only difference between the Black Cannula and the INEX Cannula is the handle material. The Black and Black has an aluminum handle that can be autoclaved for multiple uses and the INEX Cannula has a plastic single use handle and is supplied sterile for single use. The two handles is the same which is to allow the surgeon to grip and maneuver the cannula and to connect the sterile tubing to an aspirator, wall suction, or pump.
The only difference between the Black needle and the INEX needle is the luer hub material. The Black and Black needle has a stainless steel luer hub that can be autoclaved for multiple uses and the INEX needle has a polypropylene single use luer hub and is supplied sterile for single use. The function of the same which is to allow the surgeon to join the needle to a handle and to connect the sterile tubing to an aspirator, wall suction, or pump.