(233 days)
The KTA Adipose Treatment Kit is intended for medical and surgical procedures involving autologous fat grafting that consists in: -harvesting, -centrifuging, and -reinjecting autologous adipose tissue, Within the same procedure.
The KTA Adipose Treatment Kit range consists in a family of products which are designed to harvest, process with minimal manipulation and reinject small - KTAMICRO, KTAEASY, KTAMY - to large -KTAMACRO, KTAMACROMED, KTASPIN - volumes of autologous fat in the following specialties: Neurosurgery, Gastrointestinal Surgery, Urological Surgery, Plastic and Reconstructive Surgery, General Surgery, Orthopedic Surgery, Gynecological Surgery, Thoracic Surgery, Laparoscopic Surgery, Arthroscopic Surgery,
The KTA Adipose Treatment Kit consists of a sterile (EtO) single use disposable pack used for the aspiration, harvesting, centrifuging and reinjection of autologous adipose tissue during the same procedure. Each kit contains the necessary equipment such as syringes, cannulas, needles, containers, Luer Lock caps / connectors and a standard M8 single use nut for the centrifuge
The KTA Adipose Treatment Kit is a medical device intended for autologous fat grafting procedures. The provided text describes the device's acceptance criteria and the studies conducted to demonstrate its performance and substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a table of "acceptance criteria" alongside specific performance metrics in a pass/fail format for each criterion. Instead, it lists the types of performance tests conducted and generally states that "All testing met their predetermined acceptance criteria."
However, based on the "Performance Data" and "Performance Testing" sections, we can infer the categories of acceptance criteria and the generalized reported performance:
| Category of Performance Testing | Implied Acceptance Criteria (General) | Reported Device Performance (General) |
|---|---|---|
| Shipping Validation | Device integrity maintained after shipping simulations. | Met predetermined acceptance criteria. |
| Real Time and Accelerated Aging (Shelf-life) | Device components remain functional and sterile over stated shelf-life. | Met predetermined acceptance criteria. |
| Usability Testing | Device is easy and intuitive to use for its intended purpose. | Met predetermined acceptance criteria. |
| Connections Compatibility (connective forces and connection seal strength) | Connections are secure and maintain integrity under use (e.g., pressure). | Met predetermined acceptance criteria. |
| Maximum Pressure and Vacuum | Device components withstand specified pressure and vacuum without failure. | Met predetermined acceptance criteria. |
| Dimensional Analysis | Device components meet specified dimensions and tolerances. | Met predetermined acceptance criteria. |
| Resistance to Corrosion | Metallic components show no significant corrosion. | Met predetermined acceptance criteria. |
| Assembly Testing | Device components assemble correctly and function as intended. | Met predetermined acceptance criteria. |
| Biocompatibility Testing | Materials are non-cytotoxic, non-sensitizing, and non-irritating. | No cytotoxic potential, no delayed sensitization, irritation response met requirements (non-irritant). |
| Cell Viability Testing | The fat processing method maintains acceptable cell viability. | Met predetermined acceptance criteria. |
| Side Testing (Catheters/Introducers - Cannulas) | Cannulas withstand specified air pressure (3.2 bars). | Met predetermined acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: The document does not specify the sample sizes used for each individual performance test (e.g., how many cannulas were tested for pressure resistance, how many kits for usability). It refers generally to "bench testing."
- Data Provenance: The studies were non-clinical bench tests performed in vitro "in accordance with ISO/IEC standards and/or internal procedures / European standards." There is no mention of country of origin for the data other than the manufacturer being Stemcis S.A.S. based in France. These tests are inherently prospective in nature, as they involve testing the manufactured device against pre-defined criteria.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This question is not applicable to the provided information. The studies described are non-clinical bench tests (e.g., material testing, mechanical testing) and not human reader studies or studies requiring expert clinical judgment to establish "ground truth." The "ground truth" for these tests is based on objective measurements against engineering and biological standards (e.g., ISO 10993 for biocompatibility, specified pressure limits for cannulas).
4. Adjudication Method for the Test Set:
- This question is not applicable as the studies are non-clinical bench tests and do not involve human adjudication of results in the traditional sense of clinical studies. Performance is measured against objective, predetermined technical specifications and standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:
- This question is not applicable. The KTA Adipose Treatment Kit is a physical medical device (kit for fat grafting), not an AI algorithm or an imaging device requiring interpretation by human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:
- This question is not applicable. As stated above, the KTA Adipose Treatment Kit is a physical medical device, not an algorithm. Its performance is evaluated through bench testing of its components and overall function, not through standalone algorithm performance.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):
- For the non-clinical performance tests, the "ground truth" is based on:
- International Standards: e.g., ISO 10993-1 for biocompatibility.
- Internal Procedures/European Standards: for various mechanical and functional tests.
- Predetermined Acceptance Criteria: specific numerical or qualitative targets defined for each test (e.g., 3.2 bars air pressure resistance for cannulas, specific cell viability percentages).
- Objective Measurements: Results are compared against these established standards and criteria.
8. The Sample Size for the Training Set:
- This question is not applicable. The device is not an AI model or algorithm that requires a "training set." The tests performed are to validate the physical device's performance against established safety and efficacy standards.
9. How the Ground Truth for the Training Set Was Established:
- This question is not applicable for the same reason as point 8.
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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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 10, 2019
Stemics S.A.S % Catherine Gloster President Gloster Biomedical International, LLC 577 North Hope Avenue Santa Barbara, California 93110
Re: K190386
Trade/Device Name: KTA Adipose Treatment Kit Regulation Number: 21 CFR 878.5040 Regulation Name: Suction Lipoplasty System Regulatory Class: Class II Product Code: MUU Dated: February 15, 2019 Received: February 19, 2019
Dear Ms. Gloster:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For Cindy Chowdhury, Ph.D., M.B.A. Acting 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
Enclosure
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Indications for Use
510(k) Number (if known) K190386
Device Name KTA Adipose Treatment Kit
Indications for Use (Describe) The KTA Adipose Treatment Kit is intended for medical and surgical procedures involving autologous fat grafting that consists in: -harvesting, -centrifuging, and -reinjecting autologous adipose tissue, Within the same procedure.
The KTA Adipose Treatment Kit range consists in a family of products which are designed to harvest, process with minimal manipulation and reinject small - KTAMICRO, KTAEASY, KTAMY - to large -KTAMACRO, KTAMACROMED, KTASPIN - volumes of autologous fat in the following specialties:
Neurosurgery, Gastrointestinal Surgery, Urological Surgery, Plastic and Reconstructive Surgery, General Surgery, Orthopedic Surgery, Gynecological Surgery, Thoracic Surgery, Laparoscopic Surgery, Arthroscopic Surgery,
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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(7 STEMCIS
510(k) Summary
| Submission Date: | 10/6/2019 |
|---|---|
| K190386 | |
| SUBMITTER INFORMATION | |
| Company Name: | STEMCIS SAS |
| Company Address: | 2 rue du Professeur Paul Milleret25000 BesançonFRANCE |
| Contact Person: | Stéphane Giraud+33 967 501 298Email: stephane.giraud@stemcis.com |
DEVICE INFORMATION
| Trade Name: | KTA Adipose Treatment Kit |
|---|---|
| Common Name: | Adipose Treatment Kit |
| Classification Name: | 21CFR 878.5040 |
| Device Class: | Class II |
| Product code: | MUU |
| Predicate Devices: | K081848 Lipose Fat Transfer SystemK121005 Harvest AdiPrep™ Adipose Transfer System |
| Device Description: | The KTA Adipose Treatment Kit consists of a sterile (EtO) single usedisposable pack used for the aspiration, harvesting, centrifuging andreinjection of autologous adipose tissue during the same procedure.Each kit contains the necessary equipment such as syringes,cannulas, needles, containers, Luer Lock caps / connectors and astandard M8 single use nut for the centrifuge |
| Indications for Use: | The KTA Adipose Treatment Kit is intended for medical and surgicalprocedures involving autologous fat grafting that consists in:• Harvesting,• Centrifuging, and• Reinjecting autologous adipose tissue,Within the same procedure.The KTA Adipose Treatment Kit range consists in a family of productswhich are designed to harvest, process with minimal manipulationand reinject small – KTAMICRO. KTAEASY, KTAMY – to large – |
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(ĮSTEMCIS
| KTAMACRO, KTAMACROMED, KTASPIN – volumes of autologous fatin the following specialties:Neurosurgery, Gastrointestinal Surgery, Urological Surgery, Plasticand Reconstructive Surgery, General Surgery, Orthopedic Surgery,Gynecological Surgery, Thoracic Surgery, Laparoscopic Surgery,Arthroscopic Surgery. | ||
|---|---|---|
| Performance Data: | Bench testing has been performed to demonstrate the substantialequivalence of the devices to the predicates. Bench testing included:shipping validation, real time and accelerated aging, usability testing,connections compatibility (connective forces and connection sealstrength), maximum pressure and vacuum, dimensional analysis,resistance to corrosion, assembly testing, biocompatibility testing,and cell viability testing. | |
| Technological Characteristicsand Comparison to PredicateDevice(s): | This submission describes the KTA Adipose Treatment Kit ascompared to the predicate devices. Based on the intended use,design, materials, and technological characteristics presented in thispremarket notification as summarized in the Table below, theSTEMCIS KTA Adipose Treatment Kit has been shown to besubstantially equivalent to the currently marketed predicate devices. |
SUBSTANTIAL EQUIVALENCE COMPARISON CHART
| Features | Subject deviceKTA range | K081848 Predicate | K121005 Predicate |
|---|---|---|---|
| Classification andregulation number | System, Suction, Lipoplasty21CFR 878.5040 | System, Suction, Lipoplasty21CFR 878.5040 | System, Suction, Lipoplasty21CFR 878.5040 |
| Product code | MUU | MUU | MUU |
| Features | Subject deviceKTA range | K081848 Predicate | K121005 Predicate |
| Indications for use& intended use | The KTA Adipose TreatmentKit is intended for medical andsurgical procedures involvingautologous fat grafting thatconsists in:• Harvesting,• Centrifuging, and• Reinjectingautologous adiposetissue, | The Lipose Fat TransferSystem is intended to beused in the aspiration,harvesting, and reinjecting ofautologous fat | The AdiPrep™ AdiposeTransfer System is used inmedical procedures involvingthe harvesting andtransferring of autologousadipose tissue. The AdiPrep™system is used forconcentrating adipose tissueharvested with a legallymarketed system.The AdiPrep™ adiposetransfer system is intendedfor use in the followingsurgical specialties when theconcentration of harvestedadipose tissue is desired.Neurosurgery,Gastrointestinal Surgery,Urological Surgery, Plasticand reconstructive Surgery,General Surgery, OrthopedicSurgery, GynecologicalSurgery, Thoracic Surgery,Laparoscopic Surgery,Arthroscopic Surgery |
| TechnologicalcharacteristicsProcessing packcomponents | Components-syringes withremovable plunger, centrifugetubes with filter, aspiration &fat injection cannula, fatinjection syringes, skinpuncture needles, and oilextraction syringe & needle.Cannula & syringes composedof medical grade plastics | Components-syringes withremovable plunger,centrifuge tubes with filter,aspiration & fat injectioncannula, fat injectionsyringes, skin punctureneedles, and oil extractionsyringe & needle | Components-syringes withremovable plunger,centrifuge tubes with filter,aspiration & fat injectioncannula, fat injectionsyringes, skin punctureneedles, and oil extractionsyringe & needle. Cannula &syringes composed ofmedical grade plastics |
| Sterilizationmethod | Ethylene-Oxide Gas (EtO) | Gamma radiation | Ethylene-Oxide Gas (EtO) |
| Sterility AssuranceLevel | SAL 10-6Shelf life: 3 years | SAL 10-6 | SAL 10-6 |
| Features | Subject deviceKTA range | K081848 Predicate | K121005 Predicate |
| Packaging | Tyvek® sealing | Tyvek® sealing | Tyvek® sealing |
| Disposable orreusable | Single use, disposable | Single use, disposable | Single use, disposable |
| Biocompatibility | Biocompatible | Biocompatible | Biocompatible |
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(7 STEMCIS
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OSTEN
NON-CLINICAL PERFORMANCE DATA
SAFETY BENCH TESTING
In accordance with ISO 10993-1, KTA Adipose Treatment Kit is categorized as an external communicating device with limited contact duration (<24 hours) with tissues. The biocompatibility tests recommended by ISO 10993-1 were performed. Results showed that the KTA Adipose Treatment Kit showed no cytotoxic potential, no delayed sensitization was observed and irritation response met the requirements and is considered non-irritant.
PERFORMANCE TESTING
In vitro testing was performed on the KTA Adipose Treatment Kit in accordance with ISO/IEC standards and/or internal procedures / European standards to assure reliable design and performance. In vitro testing included:
- . Side testing applying to catheters / introducers (Cannulas 3.2 bars air pressure resistance),
- Connective forces,
- . Connection seal strength,
- . Maximum pressure and vacuum,
- . Resistance to corrosion,
- . Biocompatibility,
- . Cell viability,
- Usability testing,
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(ĮSTEMCIS
- Assembly testing,
- . Shipping test,
- Shelf-life (accelerated aging and real time).
All testing met their predetermined acceptance criteria.
CONCLUSION
KTA Adipose Treatment Kit is substantially equivalent to the predicate devices in Indications for Use, composition and design. It is as safe and as effective as the predicate. STEMCIS considers KTA Adipose Treatment Kit to be substantially equivalent to the predicate devices.
§ 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.