(127 days)
No
The device description and the absence of any mention of AI, ML, image processing, or performance studies related to algorithmic analysis strongly indicate that this is a purely mechanical device.
Yes
The device is used for "aesthetic body contouring," which involves physical alteration of the body for cosmetic purposes, often to improve appearance or reduce unwanted fat. This aligns with the definition of a therapeutic device as it directly modifies the body for a patient's benefit (in this case, aesthetic improvement).
No
The intended use explicitly states "aesthetic body contouring," which is a treatment or modification, not a diagnostic purpose.
No
The device description clearly states it is a hollow stainless steel tube with various tip shapes, lengths, and diameters, indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "aesthetic body contouring," which is a surgical procedure performed on the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a surgical instrument (cannulas) used for aspiration, not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (like reagents, analyzers, or diagnostic assays).
IVD devices are used to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical tool used directly on the body for a cosmetic procedure.
N/A
Intended Use / Indications for Use
The Richter Lipoplasty Cannulas and Accessories are intended for use in aesthetic body contouring.
Product codes
OPB, MUU
Device Description
The Richter Livoplasty Cannulas consist of a hollow stainless steel tube, with various tip shapes, lengths and diameters. The cannulas are provided with an attached aluminum handle for aspirator connection or with aluminum couplings for syringe connection. The cannulas are available with an optional PTFE coating. The Richter Lipoplasty cannulas are provided nonsterile
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
Not Found
Key Metrics
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Tecsa Technical Services Christine Emanuel Regulatory Affairs Consultant 1205 De La Vina Santa Barbara, California 93101
June 8, 2021
Re: K990602
Trade/Device Name: Richter Lipoplasty Cannulas And Accessories Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: OPB
Dear Christine Emanuel:
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 1, 1999. 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
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, represented by curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 1 1999
Ms. Christine Emanuel Regulatory Affairs Consultant TECSA Technical Services 1205 De La Vina Santa Barbara, California 93101
Re: K990602
Trade Name: Richter Lipoplasty Cannulas and Accessories Regulatory Class: II Product Code: MUU Dated: May 8, 1999 Received: May 13, 1999
Dear Ms. Emanuel:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Ouality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Christine Emanuel
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely vours,
fowell
Colie M. Witton, Ph.D., M.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Include the following "Indications For Use" page that contains the applicant's name, name of the device and the intended use of the device. The information, data and labeling claims in the entire the 510(k) submission must support and agree with the "indications for use" statement. *For a new submission, do NOT fill in the 510(k) number blank.
INDICATIONS FOR USE
Applicant: Richter Medical.
K990602 510(k) Number (if known): N/A*
Device Name: Richter Lipoplasty Cannulas and Accessories
Indications For Use:
The Richter Lipoplasty Cannulas and Accessories are intended for use in aesthetic body contouring.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Prescription Use Per 21 CFR 801.109
OR
Over-the-Counter
bäleda
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JUL - 1 1999
510(k) SUMMARY
This 510(k) summary is being submitted in accordance with the requirements of SMDA and 21CFR § 807.92
| Submitted by: | Richter LTDA
R. Coriolano 1643
Sao Paulo
SP-Brazil, CEP 05047-001
President: Sra. Maria da Graca Richter |
| --------------- | ---------------------------------------------------------------------------------------------------------------------- |
|---|
Fax Number: (011) 263-8636
Date Prepared: February 12, 1999
Device Name:
| Proprietary Name: | Richter Lipoplasty Cannulas and Accessories |
|---|---|
| Common Name: | Liposuction Cannulas |
| Classification: | Class II, 21 CFR 878.5040 |
Identification of Predicate Devices
- Byron Medical, Inc. Lipoplasty/Liposuction Aspiration and Tumescent . Infiltration Cannulae/Needles, 510(k) number K981172,
- .
LySonix Inc. Aspiration Cannulas, part of the Lysonix Suction Lipoplasty System, 510(k) number K980771
Device Description:
The Richter Livoplasty Cannulas consist of a hollow stainless steel tube, with various tip shapes, lengths and diameters. The cannulas are provided with an attached aluminum handle for aspirator connection or with aluminum couplings for syringe connection. The cannulas are available with an optional PTFE coating. The Richter Lipoplasty cannulas are provided nonsterile
Cannulas for Aesthetic Body Contouring Indication for Use:
Technological Characteristics
The design, use, and materials of the Richter Lipoplasty Cannulas and their predicate devices are equivalent, in that all these cannulas are designed to be used for aesthetic
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body contouring , are fabricated out of stainless steel with optional PTFE coating, with aluminum handles, and are provided nonsterile to the user. The technological characteristics of the Richter Lipoplasty Cannulas and their predicate devices are the same. The type of tip styles and shapes are the same standard designs as those provided by the predicate devices, as are the handle and coupling styles. In summary, no new technology, materials, or use is being introduced in the design of the Richter Lipoplasty Cannulas