(272 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties of cannulas and connectors, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The document states the device "is intended for use in aesthetic body contouring," which is not a therapeutic purpose.
No
The device is described as a "fat tissue harvest and injection cannula set" intended for "aesthetic body contouring," which is a therapeutic rather than a diagnostic purpose.
No
The device description explicitly lists physical components made of stainless steel (cannulas, needles, connector) and a plastic tray, indicating it is a hardware device, not software-only.
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 test performed on samples taken from the body.
- Device Description: The device consists of cannulas, needles, and connectors used for harvesting and injecting fat tissue directly into the body. This is consistent with a surgical or procedural device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting specific analytes, or providing diagnostic information.
IVDs are devices used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely procedural for aesthetic purposes.
N/A
Intended Use / Indications for Use
The st'rim™ fat tissue harvest and injection cannula set is intended for use in aesthetic body contouring.
Product codes (comma separated list FDA assigned to the subject device)
MUU
Device Description
The st'rim™ set consists of one tissue harvesting cannula, three injection (application) cannulas, two incision needles, all made of stainless steel, and a capped double-ended female Luer Lock connector for transfer of the fat tissue from the collection syringe to an injection syringe. The body contacting material is medical grade stainless steel and the contact duration is short-term. All components are provided in a preformed plastic tray. The set is a sterile, single-use device.
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
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)
Laboratory testing of the st'rimTM Luer Lock connectors was performed to evaluate gauging, liquid and air leaking, separation force, unscrewing torque, ease of assembly, resistance to overriding and stress cracking.
Packaging, sterilization and shelf life information and testing results were provided in the 510(k). The device set has been validated for a shelf life of 5 years.
Biocompatibility testing according to ISO 10993: Parts 5, 10 and 11 was performed, and reports were included in the 510(k).
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.
K060089, Tulip Disposable Cannulas, Cell Bio-Systems, Inc.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is an abstract symbol that resembles a stylized human figure in profile, with three overlapping faces.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 29, 2015
Thiebaud SAS % Ms. Patsy J. Trisler, JD, RAC Trisler Consulting 5600 Wisconsin Avenue, #509 Chevy Chase, Maryland 20815
Re: K142073
Trade/Device Name: st'rim™ Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: MUU Dated: March 16, 2015 Received: March 19, 2015
Dear Ms. Trisler:
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
1
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/Resourcesfor You/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.
Sincerely yours,
David Krause -S
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K142073
Device Name st'rim™M
Indications for Use (Describe) The st'rim™ fat tissue harvest and injection cannula set is intended for use in aesthetic body contouring.
| 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)
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510(k) SUMMARY— st'rim™ K142073
| Submitter Name: | Thiebaud SAS |
|---|---|
| Submitter Address: | 2 impasse des primbois |
| 74200 Margencel | |
| France | |
| Mailing address: | B.P. 160-F-74204 Thonon-les-Bains CEDEX |
| Contact Person: | Jean-Charles Persat, MD, Ph.D., President |
| Phone Number: | |
| Fax Number: | 33 (0)4 50 72 70 80 |
| 33 (0)4 50 72 54 44 | |
| Date Prepared: | March 16, 2015 |
| Device Trade Name: | st'rim™™ |
| Device Class: | II |
| Classification | |
| Number: | 21 CFR 878.5040 |
| Classification Name: | Suction Lipoplasty System |
| Product Code: | MUU |
| Predicate Device(s): | K060089, Tulip Disposable Cannulas, Cell Bio-Systems, Inc. |
| Statement of | |
| Intended Use: | The st'rim™™ fat tissue harvest and injection cannula set is |
| intended for use in aesthetic body contouring. | |
| Device Description: | The st'rim™™ set consists of one tissue harvesting cannula, three |
| injection (application) cannulas, two incision needles, all made | |
| of stainless steel, and a capped double-ended female Luer Lock | |
| connector for transfer of the fat tissue from the collection | |
| syringe to an injection syringe. | |
| The body contacting material is medical grade stainless steel | |
| and the contact duration is short-term. | |
| All components are provided in a preformed plastic tray. The | |
| set is a sterile, single-use device. | |
| Summary of Testing: | Laboratory testing of the st'rimTM Luer Lock connectors was |
| performed to evaluate gauging, liquid and air leaking, | |
| separation force, unscrewing torque, ease of assembly, | |
| resistance to overriding and stress cracking. | |
| Packaging, sterilization and shelf life information and testing | |
| results were provided in the 510(k). The device set has been | |
| validated for a shelf life of 5 years. | |
| Biocompatibility testing according to ISO 10993: Parts 5, 10 and | |
| 11 was performed, and reports were included in the 510(k). | |
| Comparison to the | |
| Predicate Devices: | The st'rimTM device set has the same intended use and the |
| same principles of operation as the Tulip Disposable Cannulas | |
| predicate. Both are intended for harvesting (aspiration) and re- | |
| injecting autologous fat tissue. Both devices are made of | |
| stainless steel. | |
| The technological differences include length and diameter of the | |
| cannulas and a coating on the Tulip predicate while the st'rimTM | |
| is uncoated. Sterilization methods also are different: st'rimTM is | |
| EtO sterilized, while the Tulip is E-beam sterilized. | |
| None of these differences raise new questions of safety or | |
| effectiveness. | |
| Conclusion regarding | |
| Substantial | |
| Equivalence: | The comparisons and data presented in the 510(k) lead to the |
| conclusion that the st'rimTM device set is substantially | |
| equivalent to the predicate device. |
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